ML20129K172
| ML20129K172 | |
| Person / Time | |
|---|---|
| Issue date: | 10/28/1996 |
| From: | Bangart R NRC OFFICE OF STATE PROGRAMS (OSP) |
| To: | Federline M NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| References | |
| NUDOCS 9611080203 | |
| Download: ML20129K172 (3) | |
Text
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1 OCT 2 8 9B)
MEMORANDUM TO:
Margaret V. Federline, Acting Director Division of Waste Management Office of Nuclear Material Safety and Safeguards FROM:
Richard L. Bangart, Director Office of State Programs
SUBJECT:
REVIEW OF DRAFT STANDARDS FOR THE NATIONAL ENVIRONMENTAL LABORATORY ACCREDITATION CONFERENCE l
The Office of State Programs (OSP) is responding primarily to the questions posed in your October 5,1996 memorandum transmitting the National Environmental Laboratory 1
Accreditation Conference (NELAC) draft standards.
Under the Integrated Materials Performance Evaluation Program (IMPEP) indicator
" Technical Quality of Inspections," NRC generally evaluates the capability of an Agreement State to analyze samples. If concems related to sample analysis are identified, NRC could review the quality assurance / control program for a laboratory used by an Agreement State.
In that evaluation process, however, NRC would not specifically require accreditation of the laboratory used by the Agreement State. Proper accreditation, however, would be evidence of laboratory proficiency. NRC endorsement of the NELAC standards could result i
in a need to re-evaluate the extent to which Agreement State laboratory capabilities are assessed during an IMPEP review. Similarly, endorsement of NELAC standards either by rule or through regulatory guidance applicable to NRC licensees, may surface questions as to whether Agreement States should adopt similar requirements or guidance that would be applicable to Agreement State licensees. For these reasons, OSP requests that the NELAC endorsement matter be coordinated with this office as future decisions are made. At some point, it may also be appropriate to request comments from Agreement States.
The OSP contact for this memorandum is Kathleen Schneider, 415-2320 or e-mail address KXS.
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October 28, 1996 MEMORANDUM TO:
Margaret V. Federline, Acting Director Division of Waste Management Office of Nuclear Material Safety and Safeguards FROM:
Richard L. Bangart, Director / [( @t (
6 Office of State Programs
SUBJECT:
REVIEW OF DRAFT STANDARDS FOR THE NATIONAL ENVIRONMENTAL LABORATORY ACCREDITATION CONFERENCE The Office of State Programs (OSP) is responding primarily to the questions posed in your October 5,1996 memorandum transmitting the National Environmental Laboratory Accreditation Conference (NELAC) draft standards.
Under the Integrated Materials Performance Evaluation Program (IMPEP) indicator
" Technical Quality of Inspections," NRC generally evaluates the capability of an Agreernent State to analyze samples. If concerns related to sample analysis are identified, NRC could review the quality assurance / control program for a laboratory used by an Agreement State.
In that evaluation process, however, NRC would not specifically require accreditation of the laboratory used by the Agreement State. Proper accreditation, however, would be evidence of laboratory proficiency. NRC endorsement of the NELAC standards could result in a need to re-evaluate the extent to which Agreement State laboratory capabilities are assessed during an IMPEP review. Similarly, endorsement of NELAC standards either by rule or through regulatory guidance applicable to NRC licensees, may surface questions as to whether Agreement States should adopt similar requirements or guidance that would be applicable to Agreement State licensees. For these reasons, OSP requests that the NELAC endorsement matter be coordinated with this office as future decisions are made. At some point, it may also be appropriate to request comments from Agreement States.
- The OSP contact for this memorandum is Kathleen Schneider,415-2320 or e-mail address KXS.
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TASK # - 6S251 DATE-10/10/96 MAIL CTRL. - 1996 TASK STARTED - 10/10/96 TASK DUE - 10/24/96 TASK COMPLETED -
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TASK DESCRIPTION - REVIEW OF DRAFT STANDARDS FOR THE NATIONAL ENVIRON-MENTAL LABORATORY ACCREDIATION CONFERENCE REQUESTING OFF. - NMSS REQUESTER - M. FEDERLINE WITS -
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Addressees - Memorandum dated 10/5/96
SUBJECT:
REVIEW OF DRAFT STANDARDS FOR THE NATIONAL ENVIRONMENTAL LABORATORY ACCREDITATION CONFERENCE Donald A. Cool. Director Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards Eliz6beth 0. Ten Eyck. Director Division of Fuel Cycle Safety
.and Safeguards Office of Nuclear Material Safety and Safeguards Tim Martin. Acting Director Divition of Reactor Program Management Offi;e' of Nuclear Reactor Regulation Frank J. Congel. Director Incident Response Division Office for Analysis and Evaluation of Operation Data Charles W. Hehl. Director Division of Nuclear Materials Safety Region I Bruce Mallet. Director Division of Nuclear Materials Safety Region II Cynthia Pederson. Director Division of Nuclear Materials Safety Region III Ross A. Scarano. Director Division of Nuclear Materials Safety Region IV Richard Bangart. Director
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October 5, 1996 MEMORANDUM TO:
Those on Attached List FROM:
Margaret V. Federline. Acting Director ' ' A Division of Waste Management Office of Nuclear Material Safety and Safeguards
SUBJECT:
REVIEW OF DRAFT STANDARDS FOR THE NATIONAL ENVIRONMENTAL LABORATORY ACCREDITATION CONFERENCE The National Environmental laboratory Accreditation Conference (NELAC) is a voluntary association of State and Federal Officials whose mission is to foster the generation of laboratory data of known and documented quality through the development of national performance standards for environmental laboratories to be implemented by State and Federal accrediting authorities in a consistent fashion.
The purpose of this memorandum is to request your assistance in reviewina the attached standards that were developed by NELAC.
The NELAC standards are currently organized into six sections: Constitution and Bylaws. Proficiency Testing. On-site Assessment. Accreditation Process.
Quality Systems, and Accrediting Authority.
The annual meeting of NELAC was held on July 22-24. ]996.
During this meeting. a majority of the standards were accepted by the conference during the voting session.
The conference decided to delay voting on the radicanalysis sub-section of the Quality Systems section pending further review and revision.
Although comments are being requested in regards to the entire NELAC standards document, particular focus is requested in reviewing the radioanalysis sub-section of the Quality Systems section (pages D-15 through D-18 of the Quality Systems section.
Appendix D).
The radioanalysis sub-section should be reviewed within the context of the Quality Systems section.
In addition to technical comments regarding the radioanalysis sub-section.
please provide input that will serve to answer the following questions:
1)
How would NELAC standards potentially affect the NRC?
i 2)
Do the NELAC standards contradict current or planned NRC regulations.
guidance, or generally accepted practices?
CONTACT:
Donna Moser. NMSS/DWM (301) 415-6753 AirWaHOf% 5pf.
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l 2
Multiple Addressees 3)
Should the NRC endorse NELAC?
If so should NELAC be endorsed through regulatory guidance (i.e.. revise Regulatory Guide 4.15 to include NELAC accreditation)?
All comments regarding this document are appreciated and are requested by October 25. 1996.
Attachments:
As stated 1
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NATIONAL ENVIRONMENTAL LABORATORY ACCREDITATION CONFERENCE DRAFT i
CONSTITUTION AND BYLAWS l
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June 1, 1996 1
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6 NBAC Constitution and Bytews Revision 3 June 1,1996 Page i of is TABLE OF CONTENTS a
CONSTITUTION and BYLAWS CONSTITUTION 1
ARTICLE I - GENERAL.
1 ARTICLE II - OBJECTIVES 1
A.
Forum 1
B.
Mechanism 1
C.
Consensus 1
D.
Uniformity 1
E.
Cooperation.
2 ARTICLE III - MEMBERSHIP 2
ARTICLE IV - OFFICERS....................
2 SECTION 1 - EX OFTICIO OFFICERS 2
A.
Director 2
B.
Executive Secretary 2
SECTION 2 - ELECTIVE OFFICERS 2
A.
Eligibility 3
B.
Nominations and Elections 3
I ARTICLE V - APPOINTIVE OFFICIALS 4
SECTION 1 - OFFICIALS, SPECIFIC 4
A.
Appointment.
4 B.
Assumption of Office 4
i ARTICLE VI - MEETINGS OF THE CONFERENCE.
)
4 A.
Annual Meeting 4
B.
Interim Meeting.
4 C.
Special Meetings 5
D.
Rules of Order 5
ARTICLE VII - FEES AND DUES 5
ARTICLE VIII - AMENDMENTS TO THE CONSTITUTION.
5 ARTICLE IX - BYLAWS 5
SECTION 1 - SUPPLEMENTATION OF CONSTITUTION 5
SECTION 2 - AMENDMENTS AND REPEALS OF THE BYLAWS 5
SECTION 3 - RENUMBERING 6
BYLAWS 7
ARTICLE I - APPLICATION FOR MEMBERSHIP 7
^
SECTION 1 - FORM OF APPLICATION 7
ARTICLE II - FEES, MEMBERSHIP RECORDS i
7 i
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I NELAC Constitution and Bytows newsien a June 1,1996 Pgp E of E SECTION 1 - FEES.
7 SECTION MEMBERSHIP YEAR 7
SECTION 3 - BILLING 7
SECTION 4 - EVIDENCE OF MEMBERSHIP.
7 ARTICLE III - USE OF THE INSIGNIA.
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7 ARTICLE IV - BOARD OF DIRECTORS.
7
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SECTION 1 - MEMBERSHIP.
7
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SECTION 2 - DUTIES 8
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ARTICLE V - DUTIES OF THE OFFICERS 8
SECTION 1 - CHAIR 8
SECTION 2 - CHAIR-ELECT O
SECTION 3 - PAST CHAIR.
9 SECTION 4 - DIRECTOR.
9 SECTION 5 - EXECUTIVE SECRETARY 9
SECTION 6 - TREASURER 9
SECTION 7 - ASSISTANT TREASURER 9
SECTION 8 - PARLIAMENTARIAN 10 ARTICLE VI - COMMITTEES...................
10 SECTION 1 - GENERAL i
10 SECTION 2 - ADMINISTRATIVE COMMITTEES 10 A.-
Terms 10 B.
Duties.
11 SECTION 3 - STANDING COMMITTEES 11 A.
Terms 11 B.
Duties.
11 SECTION 4 - SPECIAL COMMITTEES, TASK FORCES AND STUDY GROUPS 12 SECTION 5 - SUBCOMMITTEES 13 i
ARTICLE VII - VOTING SYSTEM.
13 SECTION 1 - HOUSE OF REPRESENTATIVES.
13 A.
Official Designation.
13 B.
Composition 13 C.
Method of Designation 14 SECTION 2 - HOUSE OF DELEGATES.
14 A.
Designation 14 B.
Requirements.
14 SECTION 3 - VOTING RULES................
14 A.
Applicability 14 B.
Quorum.
14 C.
Voting.
15 D.
Committee Report Voting 16 SECTION 4 - FLOOR AMENDMENTS 16 A.
Procedure 16 B.
Editorial Changes 16 SECTION 5 - SEATING 17 A.
Arrangement 17
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NELAC 4
Constitution and Bytows Rodnon 3 June 1,1996 Page lii of iii B.
Supervision 17 SECTION 6 - PROCEDURES.
17 SECTION 7 - CHANGES IN ORGANIZATION AND PROCEDURE 17 Figure 1.
Seating Arrangement 18 l
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Nf. LAC 1
Consutution and Sylews 1
Revision 3 l
June 1,1996 1
Page 1 of 18
- i CONSTITUTION ARTICLE I - GENERAL This organization shall be known as "The National Environmental
)
1 I
Laboratory Accreditation Conference" (NEIAC or the Conference) and is sponsored by the United States Environmental Protection Agency (US EPA) as a voluntary association of State and Federal Officials.
The purpose of the organization is to foster the generation of i
environmental laboratory data of known and documented quality i
through the development of national performance standards for i
environmental laboratories, to be implemented by state and federal accrediting authorities in a consistent fashion.'
I ARTICLE II - OBJECTIVE 8 The objectives of the National Environmental Laboratory Accreditation Conference are:
A.
Forum J,
n To provide a national forum for the discussion of all questions i
related to standards for environmental laboratory accreditation by l
officials of the Federal Government and regulatory officials of the l
States, Territories and Possessions of the United States, and their i
political subdivisions, and the District of Columbia, members and
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representatives of the regulated community, the public, and other interested parties.
l B.
Mechanism i
To provide a
mechanism to establish policy and coordinate activities within the Conference on matters of national and international significance pertaining to environmental laboratory j
accreditation standards.
j c.
Consensus To develop a
consensus on uniform standards for laboratory accreditation and implementhtion of those standards by the j
accrediting authorities.
i D.
Uniformity i
To encourage and promote uniform standards of quality for assessment and accreditation requirements among the various accrediting authorities.
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I*The Constitution end tyiews wm be reviewed et a toter date to accommodate the unHaue c GLP program, taking into consideration the recommendations of the Environmental Laborotory Advisory Board
- e of the
NELAC Constitution and Sylaws Revision 3 June 1,1996 Page 2 of 18 E.
Cooperation To foster cooperation among environmental laboratory accrediting authorities and regulatory officials, and between them and ' the manufacturing, industrial, business, academic, consumer, and other interests affected by their official activities.
i ARTICLE III - MEMBERSHIP i
Membership consists of two categories:
i Voting Membership is limited to officials who are in the employ of the Government of the United
- States, and the
- States, the Territories, the Possessions of the United States, or the District of Columbia and who are actively engaged in environmental regulatory programs or accreditation of environmental laboratories.
Ceneral Membership includes representatives of laboratories, l
nanufacturers, industry, business, consumers, academia, laboratory I
associations, industrial associations, laboratory accreditation casociations, political subdivisions of States, Territories and Possessions of the United States, other federal officials not engaged in environmental activities, and other persons who are interested in the objectives and activities of the Conference.
ARTICLE IV - OFFICERS DECTION 1 - Er OFFICIO OFFICER 5 A.
Director The Director of the US EPA National Environmental Laboratory l
Accreditation Program is the er officio Director of the Conference.
l
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D.
Executive secretary The Executive Secretary is an employee of the US EPA who is c nversr.nt with laboratory accreditation.
She/he serves the i
Ccnference and its Board of Directors.
i i
l CECTION 2 - ELECTIVE OFFICERS The Elective officers of the Conference shall be:
- Chair,
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Chair - Elect, Immediate Past-Chair, and 6 members-at-large to serve on the NELAC Board of Directors.
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t The consecutive reelection of a chair-Elect is prohibited; the Chair-Elect shall not serve on any committee other th e une Board
... - - - - - _. _. _ ~ -. _ _. _ _ _ _
NELAC Constitution and Bytowe Revision 3 June 1,1996 Page 3 of 18 of Directors.
Should the Chair-Elect for any reason be unable or unwilling to be installed as Chair, his/her successor shall be elected in the manner prescribed below.
In this event, the newly elected Chair-Elect shall be installed as Chair.
t A.
Eligibility i
1.
Any Voting Member in good standing shall be eligible to hold any office provided that the individual meets the other requirements set forth in the Constitution and Bylaws.
2.
Only a state official is eligible for election to Chair-Elect.
B.
Nominations and Elections 1.
Nominating Committee The Chair shall appoint a Nominating Committee consisting of the most recent active Past Chair as Committee Chair, four (4) voting members, to be geographically representative insofar as possible, and five (5) general members.
2.
Nominations The Nominating Committee shall submit one name for each a.
elective office and present.its recommendation to the Conference.
\\
b.
Additional nominations for officers may be made from the floor by any voting member at the Ann'ual Meeting provided that prior consent of the nominee has been obtained in l
writing and f
presented to the presiding officer at the time of the nomination.
4 j
3.
Elections i
officers shall be elected during a designated session of the i
l Annual Meeting by a formal recorded vote of the members in attendance and eligible to vote on Conference motions.
l 4.
Terms of Office The Chair, Chair-Elect, and Past Chair, shall serve for a.
a term of one year or until their successors are respectively qualified and elected or appointed. After serving one year as Chair-Elect, the incumbent will succeed to the office'of Conference Chair.
I
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The six Board of Directors members-at-large shall serve for 3-year terms; two elected each year.
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NELAC Constitution and Bytows
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S*IYs"se Ju pas. 4.t is All officers shall take office immediately following the c.
close of the Annual Meeting at which they were elected.
i 5.
Filling Vacancies In case of a vacancy in any of the elective offices, the Board of Directors shall fill the office by appointment.
i The term of this appointment shall be until the date of:the next Annual Meeting, at which time the voting members vote to confirm the appointment or elect a candidate to fill the remaining time in the initial term that was vacated.
ARTICLE V - APPOINTIVE OFFICIALS CECTION 1 - OFFICIALS, SPECIFIC A.
Appointment i
officials to conduct Conference activities.The Conference Chair shall a i
i S.
Assumption of Office oppointment and will serve through the subsequent Annu the conference unless otherwise requested b
{
or specified in the Constitution or Bylaws.y the Conference Chair, ARTICLE VI - MEETINGS OF THE CONFERENCE A.
Annual Neeting i
An Annual Meeting of members shall be held.
nosting shall include the election of officers,The agenda for this various committees, task forces, and study groups, other items reports from the pending issues requiring action by vote. pertinent to the conference, an Tha Annual Meeting may include the presentation of technical papers, discussions, displays, or other events at the discretion of the Board of Directors.
D.
Interim Meeting Tha Interim Meeting of the Board of Directors and those Standing Ccamittees designated by the Chair shall be held
- annually, cpproximately six months prior to the Annual Meeting to develop the cgsnda and committee recommendations for presentation to and action by the membership at the Annual Meeting.
Draft resolutions and
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i NELAC Constitution and Sylews Revision 3 June 1,1996 Page 5 of 18 i
standards regarding environmental laboratory accreditation shall be discussed and modified as appropriate in the Interin Meeting.
l C.
Special Meetings I
j 1.
The Conference Chair is authorized to call a meeting of the Board of Directors at any time deemed necessary by the Chair to be in the best interest of the conference.
1 l
2.
Committees of the Conference are authorized to hold meetings at times other than the Annual Meeting or Interim Meeting.
D.
Rules of Order The rules contained'in the latest version of Robert's Rules of Order shall govern the Conference in all cases to which they are applicable, and in which they are not inconsistent with the Constitution or Bylaws or special rules of the Conference.
ARTICLE VII - FEE 8 AND DUES Reserved ARTICLE VIII - AMENDMENTS TO THE CONSTITUTION This constitution may be amended, added to, or repealed at any Annual Meeting of the Membership under normal conference procedures. However, proposed changes must be included in the agenda of the Board of Directors for the preceding Interim Meeting, published in the Recommendations of the Board of Directors in its report, and discussed at the general session of the Board of Directors at the Annual Meeting at which said changes will be voted upon.
~
Amendments to the Constitution must be approved by a minimum of a two-thirds vote of the voting Members in attendance at the Annual Meeting in both the House of Representatives and the House of Delegates.
ARTICLE II - BYLAWS SECTION 1 - SUPPLEMENTATION OF CONSTITUTION This Constitution shall be supplemented by Bylaws which shall detail the methods of operation of the Conference.
Such Bylaws shall not be inconsistent with the provisions of the Constitution.
SECTION 2 - AMENDMENTS AND REPEALS OP THE BYLAW 8 The Bylaws may be amended, added to, or repealed at any Annual
['
Meeting of the Membership under normal conference procedures.
l NELAC Constitution and Sylews i
4 Revision 3 June 1,1996 Peps 6 of 18 However, proposed changes must be included in the agenda of the i
Board of Directors for the Interim Meeting, published in the t
Recommendations of the Bm rd of Directors in its Tentative Report, i
cnd discussed at the general session of the Board of Directors at the Annual Meeting at which said changes will be voted upon.
Amendments to the Bylaws must be approved by a majority vote of the Voting Members in attendance at the Annual Meeting in both the House of Representatives and the House of Delegates.
CECTION 3 - RENUMBERING The Executive Secretary is authorized to renumber the Articles and Sections of the Constitution or Bylaws to accommodate any changes made.
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t NELAC Constitution and Sylews l
Revision 3 June 1,1996 Page 7 of 18 BYLAW 8 i
ARTICLE I - APPLICATION FOR MEMBERSHIP 8ECTION 1 - FORM OF APPLICATION A completed registration' form for the Annual Meeting of the National Environmental Laboratory Accreditation Conference (NEIAC) shall serve as the application for membership.
The registration form must be completed by all potential members, whether or not attending the Annual Meeting.
ARTICLE II - FEE 8, MEMBERSEIP RECORDS SECTION 1 - FEES Reserved SECTION 2 - MEMBERSHIP YEAR Registration for membership shall be prior to the Annual Meeting each year and will cover the period from the beginning of one Annual Meeting to the beginning of the next Annual Meeting.
SECTION 3 - BILLING Reserved.
SECTION 4 - EVIDENCE OF MEMBERSHIP Reserved.
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ARTICLE III - USE OF THE INSIGNIA The insignia of,the Conference may be used or displayed only for official publications, announcements, and documents of the
{
conference unless expressly authorized in writing by the Board of i
Directors of the Conference.
ARTICLE IV - BOARD OF DIRECTOR 8 l
SECTION 1 - MEMBERBEIP A.
The Board of Directors consists of the Director, Executive j
Secretary, Chair of the Conference, Chair-Elect, the most recent still active Past Chair of the Conference, and the six at-large voting members.
B.
The Nominating Committee in recommending candidates for the Board of Directors shall consider geographic representation.
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NELAC Constitution end Sylews Revision 3 June 1,1996 Page 8 of 18 C.
The term of the Board of Directors begins with the adjournment of the Annual Meeting at which its members are elected or appointed.
Six of the Board of Directors are members-at-large with three-year terms.
SECTION 2 - DUTIES A.
The Board of Directors has leadership responsibility for the Conference and is charged with guiding tP Conference in its i
primary mission of establishing stssdards for the accreditation of environmental laboratories.
B.
It establishes administrative procedures and policy on internal matters and serves as the policy and coordinatin body in matters of national and international significance.g C.
It holds accountable, reviews, and approves actions of all committees.
D.
It utilizes the Standing Committees to resolve technical criteria issues regarding laboratory accreditation.
E.
It acts for the Conference in all routine or emergency situations.
F.
It authorizes interim meetings of Conference Committees as necessary.
G.
It fills any vacancy in any elective office of the Conference occurring.during the term of office.
r I
H.
It approves appointments to all committees and appointed
. Conference officials.
I.
It brings recommendations to the Conference for consideration and action as appropriate.
4 ARTICLE V - DUTIES OF TEE OFFICERS j
CECTION 1 - CHAIR The Conference Chair is the presiding officer at the meetings of the conference and of the Board of Directors, makes appointments to the several Standing and Administrative Committees, and appoints other conference officials to serve during his or her term of t
office.
All appointments will be made with the consent of the i
Deard of Directors.
l CECTION 2 - CHAIR-ELECT l
The Chair-Elect will:
f.
l NELAC Constitution and Bytows Revision 3 June 1,1996 l
Page 9 of 18 A.
serve as acting Chair of the Conference and the Board of i
Directors in the event that the Chair is unable to carry out j
the duties of that office, i
B.
perform other duties assigned by the Conference Chair, including presiding over sessions of the meetings of the Conference as assigned by the Conference chair and assisting the chair in the discharge of his or her duties; and C.
serve on the Board of Directors.
SECTION 3 - PAST CHAIR l
i The most recent still-active Past Chair will serve on the Board of Dir'ectors, serve as Chair of the Nominating Committee, and perform such duties as may be assigned by the Conference Chair.
The conference Past Chair may preside over sessions of the meetings of the conference as assigned by the conference Chair and assist the Chair in the discharge of his or her duties.
SECTION 4 - DIRECTOR The Director coordinates all laboratory accreditation activities i
within US EPA for purposes of establishing a single uniform environmental laboratory accreditation system. The Director serves as the link with US EPA and other federal agency policy makers, l
those responsible for implementation of the National Environmental j
Laboratory Accreditation Program, the NELAC Board of Directors, the i
Environmental Laboratory Advisory Board, and the Accreditation Authority Review Board.
The Director serves on the Board of i
Directors as an ex officio member and is responsible for the appointment and support of an Executive Secretary to the Board of l
Directors.
SECTION 5 - EXECUTIVE SECRETARY i
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The Executive Secretary acts as the executive officer of the Conference, as an ex officio member, secretary and executive i
officer of the Board of Directors, and the non-voting secretary to each standing committee; certifies eligible voters and records the vote of the Conference; keeps the records of the proceedings of the i
- meetings, in its administrative procedures.and manages the conference administration as p j
SECTION 6 - TREASURER i
j Reserved SECTION 7 - ASSISTAP TREASURER Reserved I
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Constitution and Sylews I
Revision 3 i
June 1,1996 Page 10 of 18 l
SECTION 8 - PARLIAKENTARIAN The Parliamentarian shall, when requested by the Chair, help in resolving procedural matters at meetings of the NELAC.
The parliamentarian shall use the lateist edition of Robert's Rules of Order and any special rules adopted by NELAC.
ARTICLE VI - COMMITTEES CECTION 1 - GENERAL Except as otherwise provided, each Administrative and Standing i
committee will consist of ten Members, five Voting Members and five General Members who may not vote.
All members are appointed by the Chair of the Conference, with the concurrence of the Board of Directors, to serve staggered terms'on a rotating basis or until a cuccessor is appointed.
Except for the Nominating Committee, each committee annually celects one of its voting Members to serve as its chair, who may cucceed himself or herself.
When necessary, an appointment will be made to any of the standing or administrative committees to fill any vacancy for the unexpired portion of the member's term.
OECTION 2 - ADMINISTRATIVE COMMITTEES A.
Terms 1.
Conference Management committee. The term of service shall be three years; two Voting Members and two General Members will be appointed each of two years and one Voting Member and one
)
General Member the third year.
2.
Nominating Committee. The, chair is the Conference Past Chair.
Four Voting members and five General members shall be appointed annually to serve one year.
3.
Membership Committee.
The term of service will be two years.
Two Voting and two General members will be appointed one year and three Voting and three General Members the alternate year.
4.
Education and outreach Committee.
The term of service will be
{
three years.
Two voting and two General members will be appointed in each of two years and one Voting and one General member will be appointed in the third year.
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e NELAC Constitution and Bylews Resson 3 June 1,1996 Feee 11 of 18 B.
Duties 1.
Conference Management Committee. This committee recommends to i
the Board of Directors the places and dates of each Annual and Interim Meeting of the Conference; and advises and assists the Executive Secretary with the logistic details of the Interim and Annual meetings and with preparing publications for the Annual and Interim Meetings.
2.
Nominating Committee.
This committee presents a slate of nor.innes for all elective offices ct the Annual Meeting.
The nar.as and qualifications of these nominees shall appear in the report of the Nominating Committee and be published in the Conference Announcement.
3 3.
Membership Committee.
This committee initiates membership invitations and publicizes the Conference to prospective members.
This committee coordinates membership concerns in all affairs of the Conference, recommends procedures regarding conflicts and challenges related to membership matters and establishes criteria for verifying the credentials of persons seeking to participate in the House of Delegates.
4.
Education and outreach Committee.
This committee develops informational materials to promote understanding of the importance of consistent standards for environmental sampling and analysis in order to foster data of the appropriate quality on which to base environmental decisions.
This committee also provides and solicits information and develops a spirit of cooperation between NEIJLC and other organizations and federal agencies.
i SECTION 3 - STANDING COMMITTEES 4
l A.
Terms t
1 j
Standing Committee members serve staggered five year terms, one Voting Member and one General Member being appointed annually.
I 1
B.
Duties 4
1.
Program Policy and Structure Committee.
This committee generates the Constitution and Bylaws of the Conference, and j
interprets the intent and meaning of the Constitution and j
- Bylaws, presents.
amendments, proposes changes in organizational structure, and defines roles and responsibilities as appropriate, for approval of the i
membership.
This committee develops modifications to the scope, structure, and requirements to the tiers and fields of j
testing.
1
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NELAC Constituin and Sylews Revision 3 June 1,1996 Pese 12 of 18 l
2.
The Accrediting Authority committee. Tn1s committee develops the standards for use by the US EPA to ov.ersee compliance by State and Federal accrediting authoritius with NELAC standards.
This committee considers. matters concerning reciprocity of accreditation.
3.
Quality Systems Committee.
This committee develops and keeps current uniform standards for quality systems in testing operations.
The elements of the quality system include organizational structure, responsibilities, procedures, processes and resources (e.g., facilities, staff, equipment) for implementing quality management in testing operations.
l 4.
Proficiency Testing Committee.
This committee develops 1
j standards for the proficiency testing
- samples, develops I
j criteria for selection of the providers of the samples, and develops and updates protocols for the use of proficiency test samples and data in the accreditation of laboratories.
)
5.
On-Site Assessment Committee.
This committee generates procedures for the on-site assessments, and publishes standard j
check lists based on these procedures.
This committee also establishes the frequency of inspection, and the minimum education, experience, and training requirements of the assessors.
l l
6.
Accreditation Process Committee. This committee generates and i
develops procedures for the administrative aspects of the
)
accreditation process of environmental laboratories, for use by the accrediting authorities, including the requirements for accreditation, procedures for changes in accreditation status, roles and responsibilities of laboratories, and appeal processes.
7.
Implementation Committee. This committee provides the Standing
{
Committees with current information on regulations and laws i
that impact laboratory testing and accreditation.
The Implementation Committee is also responsible for the i
development of model State legislation and regulations that i
reflect the findings and actions of NELAC.
OECTION 4 - SPECIAL COMMITTEES, TASK FORCES AND STUDY GROUPS Special committees, task
- forces, and study groups may be 4
catablished by the Conference Chair as the need arises or as requested by the conference. Members will be appointed for as long as deemed appropriate.
Upon completion of their assigned tasks, g
such bodies shall be dissolved by the Chair of the conference.
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NELAC Constitution and Spews Revision 3 June 1.1996 Page 13 of 18 SECTION 5 - SUBCOMMITTEE 8 Upon request of any committee, the conference Chair may appoint a subcommittee (s) to assist that committee in fulfilling its responsibilities.
The conference Chair may appoint Voting or General members in any combination, as the need arises or the Conference requests. The Chair and members of the subcommittees are required to operate under the same rules and procedures as the parent committee.
l 1
ARTICLE VII - VOTING SYSTEN
)
t All questions before a meeting of the Conference that are to be decided by a formal recorded vote of the Voting Members are voted upon in accordance with the followiner voting structures and procedures.
SECTION 1 - HOUSE OF REPRESENTATIVE 8 A.
Official Designation This body of officials shall be known as the
" House of Representatives".
B.
Composition 1.
Each State, Territory, Possession of the United States, and the District of Columbia, is authorized one official to serve as its representative in the House of Representatives at the NELAC Annual Meeting. The representative shall be named by the
{
respective Governor or the Mayor for the District of Columbia, and shall remain as the named representative of that State, t
Territory, Pcssession of the United States, or the District of i
Columbia, until such time as the Governor or Mayor appoints j
someone else, or the individual is no longer an employee of the State. At the discretion of the Governor or Mayor, alternate to the House of Representatives may be named to an serve when the principal is unable to attend a national 1
meeting of the conference.
In the absence of the principal, the alternate will be provided all of the rights and privileges of the principal in the House of Representatives, j
provided that he or she has met all other requirements for j
Voting membership.
If the Governor or Mayor has not appointed a representative to the House of Representatives then the j
members of that State in the House of Delegates shall elect one of its members to vote for that State in the House of
{
Representatives.
2.
Each of seven US EPA Assistant / Associate Administrators l
(Office of Solid Waste and Emergency Response; Office of Air
{
and Radiation; Office of Research and Development; Office of i
___-.-m I
NELAC Constitution and Sylews i
Revision 3 June 1,1996 Page 14 of 18 l
4 Water; Office of Prevention, Pesticides, and Toxic Substances;
}
Office of Enforcement and Compliance Assurance; and Office of j
Regional Operations and State / Local Relations)and each of the ten Regional Administrators, or his j
appoint one member.
or her designee, may 4
f 3.
Each cabinet level federal department (Department of I
i Agriculture, Department of Commerce, Department of Defense, Department of Energy, Department of Interior, and Health and Human Services) with environmental laboratory accreditation, certification or evaluation activities may appoint one
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official to the House of Representatives as determined by the Department Secretary.
t 1
4.
The Nuclear Regulatory Commission may appoint one representative to the House of Representatives.
I j
C.
Method of Designation Prior to the NELAC Annual Meeting, the Executive Secretary shall certify to the Board of Directors the names of the Voting members cnd their alternates in the House of Representatives.
4
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CECTION 2 - BOUSE OF DELEGATES 1
j A.
Designation 3
All other environmental officials of the States, Territories, Pcssessions of the United States, the District of Columbia and the Fcderal Government (those not sitting in the House of i
Representatives) are grouped as a body known as the " House of D31egates".
j D.
Requirements No other special ' requirements apply.
The number of potential tambers is not limited.
4 CCCTION 3 - YOTING RULES A.
Applicability _-
These procedures (rules) apply only to the Annual Meetings of NELAC.
However, only votin are permitted to vote in j
committee or other meetings. g members 3.
guorum l
A quorum of the House of Representatives is required for official voting. This quorum consists of representatives from fifty percent of the States, Territories and Possessions of the United States,and i
f
.. n..
e NELAC Constitution and Bytewe Revision 3 June 1.1996 Page 15 of 18 the District of
- Columbia, and fifty percent of Federal j
representatives.
No quorum is required for a vote in the House of Delegates.
C.
Voting At the conclusion of debate on a notion, there shall be a call for the vote, and the vote on the motion will be taken in accordance with the following method.
1.
Minimum Votes t
a.
House of Representatives. A majority of the eligible and present participating representatives must cast their votes in favor of an issue for the motion to be passed.
b.
House of Delegates.
A majority of those eligible and i
present delegates must cast their votes in favor of an issue for the motion to be passed.
l 2.
Motion Accepted The motion is accepted if it passes in both Houses.
)
3.
Disposition of Failed Motions If the original motion fails, or if an amended motion a.
fails, the original or amended motion is returned to the proposing committee for further consideration.
b.
The Chair may consider a new motion on the same subject prior to returning the issue to committee, if the conditions regarding floor amendments (Article VII, Section 4 of the Bylaws)have been met.
The proposing committee may drop the motion or reconsider c.
it for submission the following year.
4.
Proxy Votes Proxy votes are not permitted.
Since issues and recommendations in the committees' interim reports are often modified and amended at the Annual Meeting, the attendance of officials at the NELAC Annual Meeting and voting sessions is vital.
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NELAC i
Constitution and Bytows Revision 3 June 1,1996 P es 1e of is i
5.
Method of Indicating vote i
a.
Voting is by show of hands, standing vote or machine (electronic).
There shall be no voice voting.
No abstentions are recorded.
b.
Voting by both Houses is simultaneous, i
i j
6.
Recording a.
The Executive Secretary is responsible' for the establishment of a means for recording the vote of the conference on any matter, as well as providing a means for the certification of eligible voters at any time a
{
vcte is called.
b.
Hottse of Representatives.
The votes of the Representatives are recorded and published on a state-by-j state or agency-by-agency basis.
c.
House of Delegates.
The vote of the Delegates are I
recorded as number of yeas or nays, and are not recorded
{
on a state-by-state or agency-by-agency basis, i
l D.
Committee Report Voting i
i Tha specific recommendations from each committee report shall be eubject to the approval of the membership at the Annual Meeting as i
sxpressed by a vote on each individual recommendation.
Alternatives that may be used in voting on the reports are to vote i
i en the entire report, vote on individual items.to vote on grouped items or sections or to A voting member with the support of 10 other voting members may request that the vote be on individual i
j itcas.
j GECTION 4 - FLOOR AMENDMENTS A.
Procedure J
i 1.
A Voting member can offer an amendment from the floor to the
}
notion under consideration.
2.
A two-thirds majority favorable vote of each House on the amendment is required for passage.
1 D.
Editorial Changes Following completion of voting on a Committee's report, the j
C:mmittee Chair may make a motion to extend editorial privileges to
e e
NELAC ews n June 1,1996 Pope 17 of 18 the Executive Secretary to make editorial changes in the final report.
SECTION 5 - SEATING
]
A.
Arrangement The seating arrangement for voting sessions is shown in Figure 1.
B.
Supervision The members of the Board of Directors will control placement and movement of delegates.
The Executive Secretary will count votes.
SECTION 6 - PROCEDURES The Conference officers and committees are to observe the principles of due process; specifically, to give reasonable advance notice of contemplated committee studies, items to be considered for committee action, and tentative or definite recommendations for i
conference action, and to provide that all interested parties have an opportunity to be heard by committees and by the Conference.
4 l
SECTION 7 - CHANGES IN ORGANISATION AND PROCEDURE Proposals for changes in organization or procedure of the conference are not acted upon until the Annual Meeting of the Conference following the Annual Meeting at which such proposals are j
made.
l l
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l 1
NELAC ConstituG.i and Petwo Redsion 3 i
June 1,1996 Page 18 of 18 j
FRONT OF ROOM
.i 1
1 4
1 BOARD-OF
{
DIRECTORS
.i 4
1 I
i i
d j
HOUSE.0F HOUSE OF GENERAL i
-REPRESENTATIVES DELEGATES ~
MEMBERS-l
. State and State and
- Federal Federal 1Non-Voting.,
Designated Officials j
Representatives t
i l
l 4
i i
i 1
i i
Figure 1.
Seating Arrangement i
i i
i i
?
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d f
I 4
3 4
i 4
5 d
NATIONAL ENVIRONMENTAL LABORATORY ACCREDITATION i
CONFERENCE l
i DRAFT 1
PROFICIENCY TESTING h
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a.
. 3: ?:' -
l June" 1; 1996-g
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S&}nvotno,g-
o NATIONAL ENVIRONMENTAL LABORATORY ACCREDITATION CONFERENCE f
DRAFT ON-SITE ASSESSMENT i
June 1,'1996 9GluWD n4-p,p,
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NELAC Proficiency Testing Revision 3 June 1,1996 Page i of i TABLE OF CONTENTS PROFICIENCY TESTING 2.0 PROFICIENCY TESTING PROGRAM 1
2.1 ACCREDITATION AND APPROVAL OF PROFICIENCY TESTING (PT) i PROGRAMS 1
{
2.1.1 SPECIFIC PROCEDURES FOR ACCREDITATION AND NELAC APPROVAL OF PT PROGRAM PROVIDERS.
3 l
2.2 ENROLLMENT IN PROFICIENCY TESTING PROGRAM (S) 3 2.3 REQUIREMENTS FOR TESTING PT SAMPLES 4
2.4 EVALUATION OF PROFICIENCY TESTING RESULTS 5
2.4.1 SCORING OF PROFICIENCY TESTING STUDY RESULTS 5
2.4.2 ACCREDITATION CRITERIA AND STATUS 5
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1
h;e Nm.AC Prefielency Testing new6eien 3 June 1,1996 j
Page 1 of G i
2.0 PROFICIENCY TESTING PROGRAM
]
Proficiency testing (PT) is an independent means of evaluating a
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1aboratory's performance in comparison to a group of laboratories testing identical unknown samples at the same time under controlled j
conditions. The required PT programs in which a laboratory must
]
participate in order to 'become accredited are defined in this j
section.
3 1
Laboratory participation in PT programs fulfills only one part of j
the quality assessment requirements of NELAC.
Therefore, an j
effective on-site audit of all laboratory operations at appropriate j
intervals is an essential complement to regular proficiency testing.
4 4
2.1 ACCREDITATION AND APPROVAL OF PROFICIENCY TESTING (PT)
PROGRAMS 4
This section provides the criteria which all PT program providers shall meet in order to be approved by NELAC or its designee.
While j
rigorous and demanding, it is anticipated that several governmental and private sector organizations will meet NELAC acceptance criteria and become approved.
NELAC program criteria and on-going oversight by the PT Provider oversight body will assure that the l
performance of all laboratories will be evaluated in an effective, i
i fair and consistent manner.
NELAC or its designee will approve PT program providers on an 1
analyte / method suite basis for each type of sample matrix in each regulatory program.
Each applicant offering PT programs must provide written documentation of the study samples it seeks approval for.
The following sample descriptors are referred to i
collectively as field of testing:
i a)
Regulatory or environmental program (e.g., Safe Drinking Water Act);
3' b)
Analyte / method suites (e.g., regulated volatiles) ; and c) samples matrix types (e.g., soil, vaste oil, water).
In order for a provider to have a PT program approved by NELAC for 4
i field of testing, it must annually offer a minimum of four i
a studies with a maximum of 90 days between PT studies.
This j
schedule will allow a laboratory with a failed result to quickly re-establish its acceptable performance.
i 3
The matrix of all PT samples must reasonably resemble the matrix for which the laboratory seeks accreditation.
The target concentration of each analyte in each lot of PT samples must be j
unique and each lot of samples may be used only once for J
l J
NELAC Profielency Testing ne*6en a June 1,1996 Pope 2 of S l
l proficiency testing purposes. The target value for each analyte in
)
each sample lot must be randomly varied throughout the year over a j
concentration range to cover the analytical range of the i
appropriate promulgated method (s).
The required analytes in each j
sample covering each field of testing is determined by NEMC or its i
designee and is updated annually as required.
i l
The samples must be designed, manufactured and tested by.the PT program provider for homogeneity, stability and verification of target values.
This testing must verify that ths quality of all l
samples is appropriate for use in each field of testing PT study.
j Each PT program provider must demonstrate that it has the
{
procedures and resources to notify participants of the start date of each study and to distribute the PT samples and quickly resolve j
any. problems resulting from the shipping process.
{
The PT program provider must have enough participants to result in
+
20 valid data points for each analyte in each study.
- However, NEMC or its designee may wave this requirement for analytes which j
are analyzed infrequently by the laboratory community. This number of data points will allow valid statistics to be applied to each l
ctudy's data set.
NEMC or its designee shall provide (and update on an annual basis) the data acceptance criteria which all PT
)
program providers shall use for all PT studies data.
In this way,
{
all laboratories' performance will be judged fairly and consistently. Each FT program provider must demonstrate that it can receive and evaluate the data and issue a report within 21 calendar days of the close of each study.
Each PT program provider must certify that it is free of any organizational conflict-of-interest.
A PT sample producer shall never split a sample lot and offer these same samples for sale as unknowns before the unknown samples are used in a PT study.
In
- addition, each provider must demonstrate that its security procedures are adequate to maintain confidentiality of all target
{
values through the closing date of each study.
All records must be retained for a period of five years.
i Final NELAC approval is contingent on the PT program provider demonstrating that it has adequate policies and procedures to: 1) assure freedom from organizational conflict-of-interest; and 2) maintain absolute confidentiality and security of all target values
~
i through the close of each study.
In addition, the PT program provider must demonstrate that the design and operation of each PT j
program for which it seeks approval meets NEMC requirements.
1 A list of all NELAC approved PT providers will be maintained by NELAC or its designee.
This list shall be continually updated and published on intervals not to exceed six months.
On this same interval, NEMC or its designee shall also publish the list of i
e Mm.AC I
n 2._ i Testing Routeien 3 t
June 1,1996 Page 3 of S analyte / method suites necessary to satisfy the PT requirements in a given field of testing for each regulatory program.
l l
While accreditation and NELAC approval are granted on an annual i
basis, a PT program provider shall be de-accredited or de-approved i
if
- serious, documented deficiencias identified by primary accrediting agencies, NELAC or PT study participants are not l
resolved within 30 calendar days of being notified in writing of
}
the problem.
]
j 2.1.1 SPECIFIC PROCEDURES FOR ACCREDITATION AND NELAC APPROYAL j
OF PT PROGRAM PROVIDERS i
Providers must meet NELAC specified standards for an internal quality management program. The provider's overall program must be accredited by NELAC or its designee.
NELAC or its designee will conduct periodic reviews of providers.
These reviews will include the
- program, operations, QA/QC processes, systems, records, data management, security and all other applicable operations.
The specific procedures for approval by NELAC or its designee of a PT program provider are detailed in the attached Appendix 1, (to be added later).
2.2 ENROLLMENT IN PROFICIENCY TESTING PROGRAM (8)
In order to be accredited initially, and to maintain accred. cation, each laboratory must enroll in a NELAC-approved PT program (s) for all fields of testing for which the laboratory desires accreditation.
Each laboratory shall participata in four PT studies per year.
Each study shall require the analysis of one test sample for each field of testing.
This section provides the i
time that a laboratory has to analyze the PT samples and report the results. In addition, this section provides the NELAC-required data evaluation and acceptance criteria to be used in PT studies.
At the time it applies for accreditation, as well as prior to changing or adding PT suppliers at any time, each laboratory shall notify its primary accrediting authority or designee which program (s) it chooses to participate in to meet PT requirements.
For those tests for which PT samples are not available, the laboratory must assure the reliability of its testing procedures by maintaining a total quality management system that meets the applicable NELAC requirements.
Laboratories seeking accreditation may select any provider from the list of NELAC-approved PT program providers and shall bear the cost of any PT program subscription.
Each laboratory must authorize the PT program provider to report its results and acceptance status
NEAC pressioney Testins i
Aewision 3 June 1,190s p
4 4e j
.directly to the appropriate primary accrediting authority or i
designee and NEMC or its designee, as well as to the lab itself.
All participants' results shall be evaluated according to accepted protocols using the acceptance criteria established and required by NEMC.
These acceptance criteria may be revised annually.
PT program providers must report an evaluation of test results within j
21 calendar days of the close of each study.
The laboratory's i
j individual results and their acceptance shall be provided to the laboratory, its primary accrediting authority or designee and NEMC 4
i er its designee.
i j
2.3 REQUIREMENTS FOR TESTING PT SAMPLES l
A laboratoiy must participate in four NEMC-approved single-sample 1
PT programs per year for each field of testing for which it seeks 3
or wants to maintain accreditation.
The samples must be analyzed cnd the results returned to the PT program provider no later than 30 calendar days from the date of sample receipt. The laboratory's 1
canagement and all analysts must attest to the fact that all PT i
camples were tented using the same staff, procedures, equipment, i
facilities and frequency used ~ to analyte routine environmental i
j camples.
i l
Laboratories must comply with the following restrictions on the transfer of PT samples and communication of PT sample results:
a)
A laboratory may not send any PT sample or a portion of a PT sample to another laboratory for any analysis for which it seeks accreditation-b)
A laboratory may not knowingly receive any PT sample or i
portion of a PT sample from another laboratory for any l
analysis which the sending laboratory seeks accreditation; i
c)
Laboratory management and staff may not communicate with any I
individual at another laboratory (even intra-company) i concerning the PT sample results until after the closing date i
j of the relevant study; and l
d)
Laboratory management and staff may not attempt to obtain the
[
target value of any PT sample from the program provider until after the closing date of the relevant study.
r Any laboratory that the primary accrediting authority or NEMC datermines intentionally referred any PT sample to another Icboratory for analysis before the closing date of the study and l
cubmits the other laboratory's results as its own will have its cccreditation revoked for a minimum period of one year.
Any icboratory that knowingly receives any PT sample from another l
l leboratory for testing before the closing date of the study must i
I
ie DELAC l
i Testing Novielen 3 i
June 1,1996 P.psws i
immediately notify its primary accrediting agency of the receipt of l
those samples.
Laboratories not doing so may also have their accreditation revoked for a minimum period of one year.
This policy is not intended to prevent interlaboratory testing designed as part of a methods development or evaluation study, and only l
j applies to PT samples used for NELAC accreditation purposes.
I j
The laboratory shall receive and handle all PT samples under the
{
chain-of-custody initiated by the PT provider.
The laboratory jl shall maintain for five years a copy of all written or printed records (including but not limited to bench sheets, instrument i
strip charts or print-outs, data calculation and report forms) j resulting from the analysis of any PT sample.
These records shall include a copy of the PT program report forms used by the laboratory to record PT results, and an attestation statement i
i signed by the laboratory management and analysts stating that the PT samples were tested in the same manner as routine samples.
All j
of these laboratory records shall be made available to the primary accrediting staff during on-site audits of the laboratory.
3 1
2.4 EVALUATION OF PROFICIENCY TESTING RESULTS For the first calendar year after the NELAC program becomes j
established, the data acceptance criteria used historically by EPA j
for the WS, WP and DMRQA studies will be used to assess all PT i
study results.
This approach will assure continuity and consistency in the evaluation of PT results by all program providers.
Subsequently, the data acceptance criteria will be j
reviewed annually at the NELAC Annual Conference by the Performance j
Testing Committee or its designee. The committee or its designee i
will alsio consider alternative data acceptance criteria at the l
Conference.
These new criteria would be test-run using the PT j
results in the NELAC data-base and appropriate adjustments made before the new criteria are brought on-line.
i 2.4.1 SCORING OF PROFICIENCY TESTING STUDY RESULTS PT program providers shall evaluate results from all PT studies j
using accepted statistical protocols and NELAC-mandated acceptance
{
criteria as described in Appendix 2 (to follow at a later date).
1 Each result shall be scored on a pass-fail basis.
The PT program
{
provider shall provide the participant laboratories, the primary j
accrediting authority and NELAC or its designee a report showing 4
the target value, study mean, acceptance range and the pass-fail status for each analyte for each laboratory participant.
Each participant laboratory shall only receive an evaluation of its own results.
2.4.2 ACCREDITATION CRITERIA AND STATUS i
l There shall be two accreditation categories: 1) accredited; and 2) t l
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. ~ -
e NELAC Prenaiency Testing Revielen 3 June 1,1998 Page S of S not accredited.
The primary accrediting authority shall use the results of the NELAC-required PT samples in conjunction with the results of the on-site audit and any other published criteria in determining a laboratory's accreditation status.
A laboratory can be accredited for a specific field of testing upon passing any two out of three consecutive PT samples, provided that all other accreditation criteria are met.
If an NELAC accredited laboratory submits failing results on two out of three consecutive PT samples for a specific field of testing, the laboratory's cccreditation status for that field of testing is changed to "not j
cccredited".
The laboratory shall immediately submit a written carrective action plan to its primary accrediting authority or dnsignee and analyze another PT sample within 30 calendar days.
i
{
Upon meeting the criteria described above for accreditation, i.e.,
i passing two out of three consecutive PT samples, the laboratory i
regains its " accredited
- status for that field of testing.
Note i
that this procedure allows the laboratory to request and analyze rcnedial (make-up) samples.
the "two-out-of-three" These remedial samples count within them successfully.
criteria even if the lab fails to analyze 4
Laboratories shall agree to test additional PT samples at the option of the primary accrediting agency for the following cituations:
1)
A major change in the ownership, management or supervision of the laboratory;
}
2)
Significant substantiated complaints by the laboratory's clients, past or present employees; 3) seriously unsatisfactory results on any PT sample; and 4)
A request by the laboratory to be reinstated in a field of 1
testing.
4 I
f a
1
NELAC On-site Assosoment Revision 3 June 1,1996 Pgm i of i TABLE OF CONTENTS ON-SITE ASSESSMENT 3.1 Introduction 1
3.2 On-Site Assessment Personnel 1
3.2.1 Training.
1 3.2.2 Basic qualifications.
2 3.2.3 Additional qualifications 2
3.2.4 Assessor qualification.
2 3.3 Frequency of On-Site Assessments 3
3.3.1 Frequency 3
3.3.2 Follow-up assessments 3
3.3.3 Changes in laboratory capabilities.
3 3.3.4 Announced and unannounced visits.
3 3.4 Pre-Assessment Procedures.
4 3.4.2 Scope of the assessment 4
3.4.2.1 Laboratory assessments 4
3.4.2.2 Records review 4
3.4.3 Information collection and review 5
3.4.4 Assessment documents 5
3.4.5 Confidential Business Information (CBI) considerations.
6 3.5 Assessment Schedule / Format 7
3.5.1 Length of assessment.
7 3.5.2 Opening conference.
7 3.5.3 Records review.
8 3.5.4 Staff interviews.
10 3.5.5 Closing conference.
10 3.5.6 Follow-up procedures.
10 3.6 Standards For Assessment 11 3.6.1 Assessor's manual 11 3.6.2 Assessor's role 12 3.6.3 Checklists 13 3.6.4 Assessment standards.
13 3.7.1 Checklists.
14 3.7.2 Report format 14 3.7.3 Distribution.
15 3.7.4 Report deadline 15 3.7.5 Release of report 15 3.7.6 Report storage time 15
i NELAC On-site Aseeeoment 3
neweien a i
June 1,1996 i
Page 1 of 15 3.0 On-site Assessment 3.1 Introduction The on-site assessment is an integral and requisite part of a laboratory accreditation program and will be one of the primary means of determining - a laboratory's capabilities and qualifications. During the on-site assessment, the assessment team will collect and evaluate information and make observations which will be used to judga the laboratory's confer =ance : ith established i
accreditation standards.
l It is essential that the on-site assessment conducted by any accrediting authority in the United States wishing to be recognized l
by'the National Environmental Laboratory Accreditation Program be t
conducted in a uniform, consistent manner.
Reasons for fostering i
3 this consistency include a need to assure the base quality of data coming from the laboratories; to allow more confident comparision
{
of results generated by different laboratories; to facilitate
)
l reciprocity; and for the laboratory community to accept the accreditation standards.
l This section describes the essential elements that are to be included in any acceptable on-site assessment and the j
qualifications and requirements for assessors.
3 i
The responsibility for promulgating and enforcing occupational i
safety and health standards rests with the U.S.
Department of f
Labor.
While it is not within the scope of the assessment team to evaluate all health and safety regulations, any obviously. unsafe l
condition (s) observed should be described to the appropriate laboratory official and reported to the accrediting authority. The j
accreditation on-site assessment is not intended to certify that j
the laboratory is in compliance with any applicable health and l
safety regulations.
j 3.2 on-site Assessment Personnel 3.2.1 Training i
The National Environmental Laboratory Accreditation Conference (NELAC) specifies the minimum level of education and training for j
assessors, including refresher / update training.
The NELAC also develops standards for training requirements.
The assessor j
training program will be developed and implemented by either l
accrediting authorities, accrediting bodies, or other entities.
All assessor training programs, must meet the NELAC standards.
Until such time as the NELAC has developed and published training i
requirements for laboratory assessors, each accrediting authority i
I L
NELAC i
One Assosoment
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Roweson 3 June 1,1996 Page 2 of 15 s
4
)
shall approve the training and experience requirements for each of l
its-assessors (federal, state and/or third party).
t When the NEMC has completed the development and promulgation of j
assessor training program standards, accrediting authorities, j
accrediting bodies, or other entities may petition the NEIAP for i
approval of various formal training programs which meet the NEIAC j
stan.dards.
i j
3.2.2 Basic qualifications f
q j
A laboratory assessor may work for a Federal, State, or a third l
party accrediting body.
An assessor must be an experienced j
professional and hold at least a B.S. degree in a basic science, or have equivalent education and experience in laboratory assessment or related fields.
t j
Each assessor must also have satisfactorily completed an approved j
assessor training program and take periodic update / refresher j
training, as specified by NEIAC.. Each new candidate assessor must undergo training with a qualified assessor during four or more l
actual assessments until judged proficient by the accrediting outhority.
4 3.2.3 Additional qualifications
}
In addition, the assessors must:
a)
Be familiar with the relevant legal regulations, i
accreditation procedures, an'd accreditation requirements; j
b)
Have a thorough knowledge of the relevant assessment i
methods and assessment documents; l
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c)
Be thoroughly familiar with the various forms of records described in Section 3.5.3 - Records Review; i
j d)
Be thoroughly cognizant of data reporting, analysis, and q
reduction techniques and procedures; 4
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e)
Be technically conversant with the specific tests or types of tests for which the accreditation is sought and, j
where
- relevant, with the associated sampling and preservation procedures; and i
f)
Be able to communicate effectively, both orally and in writing.
j 3.2.4 Assessor qualification Esfore an assessor can conduct on-site assessments, the individual a
j
e NELAC Omeste Aeoessment Revision 3 June 1,1996 Page 3 of 15 must be qualified by an accrediting authority.
Each assessor must e
sign a statement before conducting an assessment certifying that no conflict of interest exists and any supporting information as required by the accrediting authority.
Failure to provide this information will make the proposed assessor ineligible to participate in the assessment program.
)
3.3 Frequency of On-Site Assessments 3.3.1 Frequency Accrediting authorities must require an on-site assessment of each facility that is accredited at least every two years.
Assessments may be conducted more frequently for cause, at the option of the accrediting authority.
3.3.2 Follow-up assessments l
In addition to routine assessments, assessors may need to conduct i
follow-up assessments at laboratories where a deficiency was i
identified by the previous assessment.
These assessments may be, but are not necessarily limited to, determining whether a
1 laboratory has corrected its deficiency (ies), or determining the merit of a formal appeal from the laboratory.
When deficiencies are of such severity as to possibly warrant the downgrading of a laboratory's accreditation status, any follow-up assessment that is planned or conducted should be completed and reported within forty-
)
j five days after the original assessment.
Nothing in this section L <uld be construed as requiring an
}
accrediting authority to reassess a f acility prior to taking a j
regulatory or administrative action affecting the status of the i
facility's accreditation.
Nothing in this section should be i
construed as limiting in any way the accrediting authorities 1
j ability to revoke or otherwise limit a laboratory's accreditation l
upon the identification of such deficiencies as to warrant such action.
3 3.3.3 Changes in laboratory capabilities j
l The accrediting authority may also deem necessary an assessment when a major change occurs at a laboratory in personnel, equipment, or in a laboratory's location that might alter or impair analytical i
capability and quality.
3.3.4 Announced and unannounced visits r
The accrediting authority, at its discretion, may conduct either l
unannounced or announced on-site assessments.
The accrediting
. authority is not required to provide advance notice of an i
j assessment.
a i
4 NELAC on-este Aeoessment Aewision 3 June 1,1996 Page 4 of 15 3.4 Pre-Assessment Procedures f
3.4.1 Assessment planning A good assessment begins with planning, which should commence well before the assessment team visits the laboratory.
Planning is the means by which the lead assessor identifies all the required cetivities to be completed during the assessment process.
Planning includes conducting a thorough review of NELAP and/or State records pertaining to the laboratory to be inspected.
This may save time because familiarity with the operation, history, and compliance ctatus of the laboratory increases the efficiency and focus of an en-site visit.
l Pre-assessment activities include:
deciding the scope of the i
casessment; reviewing NELAP/ State information; providing advance i
notification of the assessment to the laboratory, when appropriate; obtaining any security clearances which may be necessary; 4
I coordinating the assessment team; and gathering assessment j
documents.
Section 3.4.5 discusses Confidential Business j
Information (CBI) issues.
j 3.4.2 scope of the assessment The first step in the assessment planning process is deciding what j
type of assessment will be conducted.
The assessment may be a i
ganeral one to determine the capability of the laboratory to j
parform environmental testing or a specific examination of a cortain area of testing.
The assessment must include both an oppraisal of the laboratory's operations and a review of the' cppropriate records.
The assessment for a field of testing must cover all of the tests for which the laboratory seeks cccreditation.
i 3.4.2.1 Laboratory assessments A laboratory assessment should review the ability of the lab to l
conduct environmental testing.
The examination of the systems, processes and procedures of the laboratory should give a general conse of its past and present capabilities to perform work of known j
and documented quality.
During a laboratory assessment, the ocsessment team may identify a number of samples or a recently l
ccupleted or on-going project and evaluate to what extent the tests l
cre being conducted according to NELAC standards.
't' i
3.4.2.2 Records review l
The purpose of a records review is to determine whether the testing Icboratory has maintained necessary documentation of data and other information to technically substantiate reports previously issued.
t During a records review, the assessment team will conduct an i
1
e NELAC Ort site Asseeement Reenon 3 June 1,1996 Page 5 of 15 4
overall audit of data and will compare data with submitted reports 3
to determine whether the data were collected, generated, and reported following the NELAC standards.
4 3.4.3 Information collection and review 4
Prior to initiating an on-site assessment, the assessment team shall make determinations as to which laboratory records they wish to review prior to the actual site visit.
These records, from the files of the accrediting authority, the national laboratory accreditation database, or the laboratory itself may include, but are not limited to:
a)
Copies of previous assessment reports and proficiency testing sample results; b)
General laboratory information such as laboratory submitted self-assessment
- forms, SOPS and Quality Assurance Plan (s);
c)
Official laboratory communications and associated records with appropriate accrediting authority staff.
d)
Available documents from recipients of reports from the laboratory; e)
The laboratory's application for accreditation; f)
The existing program regulations and special requirements that apply to the areas for which accreditation is sought (i.e.
security clearances, radioactive exposure protocols, etc.); and g)
The most recently approved analytical methods for the tests for which the laboratory has requested accreditation.
3.4.4 Assessment documents Documents necessary for the assessment and which may need to be provided to the laboratory management or staff should be assembled before the assessment, whenever possible.
The lead assessor should obtain copies of the required assessment forms, including the NELAC-approved checklist (s).
Other types of documents that may be required include:
Assessment Confidentiality Notice; Conflict of Interest Form; Assessor Credentials;
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NELAC On-site Assosoment i
Revision 3 June 1,1996 Pope 6 of 15 i
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Assessment Assignment (s);
l Assessment Notification Letter; Attendance Sheet (s)
(opening and closing conference);
{
- and, Assessment Appraisal Form.
l In
- addition, the lead assessor should be able to provide information about how to obtain copies of documents and materials associated with an assessment from the accrediting authority.
3.4.5 Confidential Business Information (CBI) considerations During on-site assessments, it is likely that the accrediting agency staff will come into possession of some confidential business information, such as names and addresses of clients, rates charged different
- clients, trade
- secrets, including some formulations of reagents etc. that may be part of the assessment information but which must be protected from unauthorized release.
The type of information that may be considered confidential business information is defined in Title 40.
Code of Federal Reaulations, Part 2.
For this data to be adequately protected, certain actions are required immediately prior to or at the onset of the on-site assessment.
NEMC standards protect Confidential Business Information (CBI) from disclosure.
CBI includes trade secrets (including process, formulation, or production data) and certain financial information, the uncontrolled disclosure of which could cause damage to a laboratory's competitive position.
In general, disclosure of CBI is prohibited, except in certain limited situations.
A lead assessor must present notice to laboratory representatives of their right to claim data at the laboratory as CBI and such claims are frequently made.
Because the assessment team is very likely to require access to CBI before (i.e., while preparing for an assessment), during, and after an assessment, the lead assessor nust be knowledgeable of NEMP/ State procedures governing access to, handling of, and disclosure of CBI.
The lead assessor and others who may use the information must have CBI access authorization, since only authorized individuals may have access to CBI.
A CBI-cleared lead assessor may obtain access to CBI documents from the accrediting authority by requesting access to the information from the appropriate official.
Whether or not it is anticipated that CBI documents will be collected during an assessment, the lead assessor must provide a NEIAP/ State assessment confidentiality notice to the responsible
e l-l NELAC On site Assessment Revision 3 June 1,1996 Page 7 of 15 laboratory official at the beginning of the assessment.
This i
notice informs laboratory officials of their right to potentially i
claim part of the assessment data as CBI.
The lead assessor should i
be familiar with the procedures for asserting a CBI claim and the j
standards that the claimed information must meet.
l The lead assessor must take custody of all CBI documents before leaving the laboratory, and must maintain them in custody, using i
all proper procedures and safeguards, until they can be received by the accrediting authority.
i j
3.5 Assessment schedule / Format 3.5.1 Length of assessment l
The length of an on-site assessment will depend upon a number of i
factors such as the number of tests for which a lacoratory desires i
accreditation, the number of assessors available, the size of the laboratory, the number of problems encountered during the
.l i
assessment, and the cooperativeness of the. laboratory staff.
The i
accrediting body should assign an adequate number of assessors to complete the assessment within a reasonable period of time.
Assessors must strike a balance between thoroughness and practicality, but in all cases must determine to what effect the laboratories' operations meet NELAC standards.
3.5.2 Opening conference Arrival at the facility should normally occur during established working hours. The responsible laboratory official (s) should be located as soon as the assessment team arrives on the premises.
A laboratory's refusal to admit the assessment team for an assessment can result in an automatic failure of the laboratory to receive accreditation or loss of an existing accreditation by the laboratory, unless there are extenuating circumstances that are accepted and documented by the accreditation authority.
The team leader must notify the accrediting authority as soon as possible after refusal of entry.
An opening conference must be conducted and shall address the following topics:
a) the purpose of the assessment; b) the identification of the assessment team; c) the tests that will be examined; 4
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NELAC on a. Assessment Revision 3 June 1,1996 Pege 8 of 15 1
- d) any pertinent records and operating procedures to be examined during the assessment and the names of the individuals in the laboratory responsible for providing the assessment team with the necessary documentation; e) the roles and responsibilities of key ma.1 agers and staff in the laboratory; f) the procedures related to Confidential Business Information; g) any special safety procedures that the laboratory may think necessary for the protection of the assessment team while in certain parts of the facility (under no circumstance is an assessment team required or even allowed to sign any waiver of responsibility on the part of the laboratory for injuries incurred by a team member during an inspection to gain access to the facility);
4 h) the standards that will be used by the assessors in i
judging the adequacy of the laboratory operation; i) confirmation of the tentative time for the exit conference; 4
j) provision of the assessment appraisal form to the responsible laboratory official (to be submitted to NEIAP and the accrediting authority); and t
k) discussion of any questions the laboratory may have about the assessment process.
3.5.3 Records review Records will be reviewed by assessment team members for accuracy, completeness and the use of proper methodology for each test and analyte to be evaluated.
A minimum record set that must be examined as part of a
accreditation assessment includes; a) application for accreditation from the laboratory; b) previous assessment results and reports including proficiency testing results; c) laboratory management structure and chains of responsibility (e.g. organizational charts);
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e NELAC On site Aeoesoment Revision 3 June 1,1996 l
Pope 9 of 15 j
d) qualifications statements of all key staff involved in the analysis or reporting of results for which i
accreditation has been requested.and a a:atching of the staff qualifications with the statements submitted with the applications; e) quality assurance plan (s) for the laboratorf; f) standard operating procedures and metho(iclogies for each
)
parameter for which accreditation is sought; i
g) maintenance and calibration records of specific pieces of laboratory equipment separate and apart from that j
encompassed in analyte specific records;
)
h) procedures for the make-up and calibration of stock j
solutions and standard reagents; a
i) origins, purities, assays and expiration dates of primary standards, analytical reagents and standard reference materials; i
i j
j) records associated with method-specific QA\\QC j
requirements; i
j k) the specific records associated with the initial method f
validation study in the laboratory which must be examined in detail with the historical calibration data; 1) records associated with the methods used to estimate precision and accuracy in general for specific analyses; i
m) sample receipt and handling documentation; n) proficiency testing sample receipt and handling procedures; o) information about the proficiency testing providers; p) records of any internal audits conducted or corrective actions taken by the laboratory itself; and i
q) the report of the laboratory's annual management review.
The laboratory must mark all confidential information.
The lead assessor must handle it as required by appropriate laws and regulations. All other information for all aspects' of application, 3
assessment and accreditation of laboratories is considered public information.
If the laboratory requests that information other i
i i
- -.. ~ -. -... -
e NELAC OeMe Asseeement Revision 3 June 1,1996 Pope 10 of 15 than noted above is confidential, the information should be treated as confidential until a ruling can be made by the accreditation authority.
3.5.4 Staff interviews As an element of the assessment process, the assessment team may cvaluate an' analysis regimen by requesting that the analyst normally conducting the procedure give a step-by-step description of exactly what is done and what equipment and supplies are needed to complete the regimen.
Any deficiencias shall be noted and discussed with the analyst.
The deficiencies will also be discussed in the closing conference.
The assessment team members shall have the authority to conduct interviews with any/all staff.
Calculations, data transfers, calibration procedures, quality control / assurance practices, Edherence to SOPS and report preparation shall be assessed for each test with the appropriate analysts (s).
3.5.5 closing conference The assessment team should meet with representative (s) of the j,
laboratory following the assessment for an informal debriefing and discussion of findings with the possible exception of any issues of 1
improper and/or potentially illegal activity which may be the cubject of further action.
It should be noted that the assessment j
team in no way limits its ability to identify additional problem j
creas in the final report should it become necessary.
i i
In the event the laboratory disagrees with the findings of the cssessor(s), and the team-leader adheres to the original findings, j
the deficiencies with which the. laboratory takes exception shall be documented by the team leader and included in the report to the l
cccreditation authority for consideration.
The accrediting j
suthority will make the final determination as to the validity of the contested elements.
i The assessment team should inform the laboratory representative (s) 1 that an assessment report encompassing all relevant infermation concerning the ability of the applicant laboratory to comply with i
the accreditation requirements is forthcoming.
3.5.6 Follow-up procedures j-The accrediting authority will issue the assessment report to the cpplicant laboratory outlining any area of deficiency.
The j
~cpplicant laboratory must then submit a plan of corrective action cnd supporting documentation that addresses all deficiencies noted i
.~
s a
e NELAC on-site Assosoment Revision 3 June 1,1996 Pge 11 of 15 i
in the report not later than thirty days from when the report is received.
After reviewing the assessor's report (s) and any completed corrective action (s) reported by the laboratory, the accrediting authority will make the determi~ nation of the accreditation status for a laboratory.
If the deficiencies listed are substantial or
- numerous, an additional on-site assessment may be conducted before a final decision for accreditation can be made.
3.6 Standards For Assessment 3.5.1 Assessor's manual The NELAC will develop a manual (s) for on-site assessors to help ensure that on-site assessments are performed in a uniform, consistent manner.
The manual (s) will be provided when assessors take the NELAC required training (Section 3.2.1) and will serve as guidance for on-site assessment personnel.
The manual (s) provided to on-site assessors should include instructions for evaluating the following items:
a)
- Size, appearance, and adequacy of the laboratory facility; b)
Organization and management of the laboratory; i
c)
Qualifications and experience of laboratory personnel; d)
Receipt, tracking and handling of samples; e)
Listing / inventory, condition, and performance of laboratory instrumentation and equipment; i
f)
Source, traceability and preparation of calibration / verification standards; g)
Test methods (Including the adequacy of the laboratory's standard operating procedures as well as confirmation of i
the analyst's adherence to SOPS, and the analyst's proficiency with the described task);
h)
Data reduction procedures, including an examination of I
raw data and confirmation that final reported results are derived from raw data and original observations;
_ _ _ _ ~.
a 1
i NELAC
- l on-site Assessment novision a j
June 1,1996 q
Page 12 of 15 4
l 1)
Quality assurance / quality control procedures, including adherence to the laboratory's quality assuranca plan and adequacy of the plan; I
j j)
General health and safety procedures as they relate to good laboratory practices; and 1
]
k)
Laboratory waste disposal procedures.
3.d.2 Assessor's role l
When performing an on-site laboratory assessment, the assessor must i
i cppraise each of the areas listed in Section 3.6.1 and perform a thorough assessment of the records for each of the tests for which
{
occreditation has been requested.
l The on-site assessor should use a variety of tools in the l
cssessment process.
The experience of the assessor, his/her observations, interviews with laboratory staff, and examination of
- SOPS, raw data, and the laboratory's documentation all play important roles in the assessment.
The accreditation of a particular laboratory will depend to a large extent on the cssessment team's findings and recommendations.
Much of the on-Dite assessment will depend upon the assessor's observations of i
existing conditions.
The recommendation not to accredit a
i laboratory, or to change a laboratory's accreditation status, must be based on factual information and not upon subjective ovaluations.
Therefore, it is crucial that the on-site assessor l
have a clear understanding of the laboratory's procedures and l
policies and that the assessor document any deficiencies in the j
report of the on-site assessment.
The assessment team must use specific documentation in its reporting of deficiencies.
The assessor should discuss any i
deficiencias with the laboratory's management at the exit f
conference.
i During the assessment, sufficient information may become available 1
to suspect that a particular person has violated an environmental j
law or regulation, such as knowingly making a false statement on a j
report.
This information should be carefully documented since further action may be necessary.
In the event that evidence of
. improper and/or potentially illegal activities have or may have occurred, the assessment team should present such information to l
the accrediting authority for appropriate action (s). These issues, Ot the discretion of the accrediting authority, may or may not be cubjects or issues of the closing conference.
- However, the cssessor should continue to gather the information necessary to j-complete the accreditation assessment.
i
e s
a NELAC Orweite Assosoment Roseion 3 June 1,1996 Pese 13 of 15 3.6.3 Checklists Standardized checklists must be used for the on-site assessment.
The use of checklists does not replace the need for assessor observations and staff interviews, but is another tool which assists in conducting a ' thorough and efficient assessment.
A checklist is not a substitute for assessor training and experience.
Note: It is anticipated that standardized checklists will be developed or adopted by NELAC's On-Site Assessment Committee for the assessor's review of test methods.
I 3.5.4 Assessment standards I
J The areas to be evaluated in an on-site assessment shall include:
a)
- Size, appearance, and adequacy of the laboratory facility; b) organization and management of the laboratory; c)
Qualifications and experience of laboratory personnel; i.
d)
Receipt, tracking and handling of samples; e)
- Quantity, condition, and performance of laboratory 1
instrumentation and equipment; f)
Preparation and traceability of calibration standards; e
g)
Test methods (Including the adequacy of the laboratory's standard operating procedures as well as confirmation of the analyst (s) adherence to SOPS, and the analyst (s)
{
proficiency with the described task);
h)
Data reduction procedures, including an examination of raw data and confirmation that final reported results can i
be traced to the raw data / original observations; i)
Quality assurance / quality control procedures, including adherence to the laboratory's quality assurance plan (s) and adequacy of the plan (s);
j)
General health and safety procedures as they relate to good laboratory practices; and k)
Laboratory waste disposal procedures.
~ - ~. -
e NELAC t
OWte Assosoment Revision 3 June 1,1996 Page 14 of 15 These areas should be evaluated against the standards detailed in Section 5, Quality Systems, of the NEIAC Standards.
Additional information on the process for evaluating these areas can be found in the Assessors Manual (section 3.6.1).
3.7 Documentation of on-site Assessment 3.7.1 Checklists The checklists used by the assessors during the assessment shall become a part of the permanent file kept by the accrediting authority for each laboratory.
3.7.2 Report format The final site visit report shall be written to contain a description of the adequacy of the laboratory as it relates to the assessment standards in Section 3.6.4.
Assessment reports should be generated in a narrative format.
Deficiencies must be addressed at a minimum.
Documentation of existing conditions at the laboratory should be included in each report to serve as a baseline for future contacts with the facility.
1 Assessment reports will contain:
a)
Identification of the organization assessed (name and address),
b)
Date of the assessment, c)
Identification and affiliation of each assessment team
- member, d)
Identification of participants in the assessment process, e)
Statement of the objective of the assessment, l
f)
- Summary, g)
Assessment findings (deficiencies) and requirements, and h)
Comments and recommendations.
The Findings and Requirements Section must be referenced to a NEIAC Otandard so that both the finding (deficiency) is understood and the specific requirement is outlined. The team leader shall assure that the results within the final report conform to established standards for the evaluated parameters.
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j.
e 4
NELAC On-site Assosoment 4
Revision 3 June 1,1996 Page 15 of 15
{
The Comments and Recommendations Section can be used to convey recommendations aimed at helping the laboratory improve.
3.7.3 Distribution i
]
The accrediting authority shall be recognized as having the responsibility for the distribution of the assessment reports. The i
]
assessment team leader shall compile, edit and submit the final j
report to the accrediting authority.
3.7.4 Report deadline
);
No, more than thirty (30) days shall elapse from the completion of
)
the assessment until the report is completed by the accrediting 1
authority and copies are transmitted to the laboratory and the i
National Accreditation Database. An exception to this deadline may be necessary in those circumstances where an investigation or other action has been initiated by the accrediting authority, in which j
case the laboratory must be notified.
f.
3.7.5 Release of report h
on-site assessment reports should be released initially by the accrediting authority only.
The reports will be released to the responsible laboratory official (s).
The assessment report shall not be released until findings of the assessment have been finalized, all Confidential Business Information has been stricken from the report in accordance with prescribed procedures, and the report has been provided to the laboratory.
1 l
In accordance with the Freedom of Information requirements, any documentation adjudged to be proprietary, financial and/or trade j
information, or relevant to an ongoing enforcement investigation, will be considered exempt from release to the public.
I 3.7.6 Report storage time t
l Copies of all assessment reports and laboratory responses must be j
retained by the assessors and the accrediting authority for a j
period of at least five years, or longer if required by specific l
State or Federal regulations, i
1, l
i t
l J
i i
i i
i NATIONAL ENVIRONMENTAL LABORATORY ACCREDITATION l
CONFERENCE 4
a 4
DRAFT ACCREDITATION PROCESS
.4 e
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, ;3 Jtme' ;1', J 199'6 v
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- ALID)40t-7V 21f/.
NuAc Accreditation Process Revision 3 June 1,1996
}
Page i of i TABLE OF CONTENTS i
1.
ACCREDITATION PROCESS 4
4.0 ACCREDITATION PROCESS.
1 1
i 4.1 COMPONENTS OF ACCREDITATION.
1 1
4.1.1 Personnel Qualifications.
1 4.1.2 On-site Assessments 2
4.1.3 Performance Evaluation Samples.
5 I
4.1.4 Corrective Action Reports 5
i 4.1.5 Accountability for Analytical Standards 7
4.1.6 Fee Process for National Accreditation.
7 4.1.7 Application 7
4.1.8 Transfer of Ownership / Change of Ownership, Change of Analytical Personnel, and/or Location of Laboratory.
9 4.1.9
" Certification of Compliance" Statement 10 4.2 PERIOD OF ACCREDITATION.
11 4.3 MAINTAINING ACCREDITATION.
12 j}
4.3.1 Performance Evaluation Samples.
12 4.3.2 On-Site Assessments 12 4.3.3 Other Accreditation Elements.
13 4.3.4 Notification and Reporting Requirements 13 4.3.5 Record Keeping and Retention.
13 4.3.6 Payment of Fees 13 l
4.4 DENIAL, SUSPENSION, AND REVOCATION OF ACCREDITATION.
14.
4.4.1 Denial.
'14 1
4.4.2 Revocation.
15 4.4.3 Suspension.
15 4.4.4 Voluntary Withdrawal.
16 4.5 INTERIM ACCREDITATION 16 4.5.1 Interim Accreditation 16 4.5.2 Revocation of Interim Accreditation 17 4.5.3 Exception Process 17 4.6 AWARDING OF ACCREDITATION.
17 4.6.1 The Certificate of Accreditation.
18 4.6.2 Changes in Areas of Accreditation 18
-. -. ~ _
o NELAC Accreditation Process Revision 3 June 1,1996 Paes 1 of 19 4.0 ACCREDITATION PROCESS (NB. MMY OF THE STANDARDS AND ELEMENTS LISTED IN THIS CHAPTER ARE REFLECTIVE OF STANDARDS WORKED OUT AND SET FORTH IN OTHER CHAPTERS DEALING WITH DETAILED EXPLANATIONS OF THESE ELEMENTS.
THEREFORE, IT IS ANTICIPATED THAT MANY OF THE DETAILS (EG. THE NUMBER OF PERFORMANCE EVALUATION SAMPLES TO BE DONE) WILL CHANGE AS THE DISCUSSIONS AND CONCLUSIONS IN THESE OTHER CHAPTERS CHANGE.)
4.1 COMPONENTS OF ACCREDITATION These criteria must be fulfilled for accreditation. The components and criteria are herein described.
Details of some of the requirements described below will be found in other sections of these Standards. For the following discussion of standards, in general (laboratories involved in environmental testing or measurement, analysis, monitoring or compliance), governmental, federal, state, municipal, county, local, commercial and private j
laboratories should all be accredited in a State with which they do j
business.
l 4 1.1 Personnel Qualifications 1
This component ensures that the elements of education, training and experience are addressed.
It should be recognized that some of
}
these elements are interconnectable, i.e. a greater magnitude of i
training and/or experience may substitute for lesser degrees of j
formal education.
l The laboratory shall have sufficient personnel, having the necessary education, training, technical knowledge and experience for their assigned functions, i
The laboratory shall ensure that the training of its personnel is j
j kept up-to-date.
4~
l Training is considered up to date when documentation in the. files I
indicate acceptable performance of a blind sample at least once per i
year and a signature that technical personnel have read, understood and agreed to perform the most recent version of the method or operating procedures.
Evidence must be on file that demonstrates j
all employees are aware and using the latest edition of the laboratories in house quality documentation.
All personnel shall be responsible for complying with all QA requirements.
Each laboratory position must have a combination of experience and education to adequately demonstrate a specific knowledge of their particular function and a general knowledge of laboratory operations, analytical
- methods, quality l
~
assurance / quality control procedures, and records management.
l.
e e
NELAC f.
Accreditation Process Revision 3 i
i June 1.1996 Pete 2 of 19 4.1.2 on-site Assessments l
l
. On-site assessments and evaluations may be of two types: announced l
E.nd unannounced.
The assessment ensures that the environmental l
laboratory is capable of performing analyses to the
- level, j
precision and accuracy required by the specified method (or performance based method). Announced assessments test these methods j
ond evaluate the results against the criteria under the best circumstances in a
controlled environment.
The unannounced 4
l nssessment measures the abilities of the laboratory to meet these l
otandards for methods on an average day under normal working conditions and in a normal working environment.
Each type of assessment has limitations and advantages, but the information cbtained from both will provide a higher degree of confidence in the ability of the laboratory to attain a required level of competence in the quality of data produced. A state regulatory
~
-suthority may delegate the responsibility of both Announced and Unannounced Assessments to a
third party.
- However, the responsibility and accountability for meeting the standards of the NELAC are the responsibility of the State regulatory authority.
2 The accrediting authority is the primary state in which the l
laboratory conducts business; however the ultimate decision as to j
the proper accrediting authority is determined by the individual j
state in which the laboratory headquarters management is located.
i Refer to On-site Assessment Section for additional information j
regarding frequency, procedures,
- criteria, scheduling and j
documentation of on-site Assessments.
Individual sites are generally subject to the same application
~
process, fees, inspections and other requirements as environmental laboratories (NB. A site that 2nly does sample collections is not considered an environmental laboratory and will not be subject to these requirements).
In addition to laboratories, any site that reports environmental data to clients and/or regulatory authorities will be subject to some or all of these requirements.
l Announced Assessments - A State regulatory authority may delegate the responsibility for Announced Assessments to a third party.
However, the responsibility and accountability for meeting the standards of the NELAC are the responsibility of the State j
regulatory authority. The elements present in and criteria for
(
announced assessments for national accreditation are:
I a)
The assessment must be performed a minimum of one time per two years and must be conducted on-site; i.e.,
the site at which the actual analyses take place.
A site is defined as a j.
structure or group of structures at the same geographical location.
In the case of mobile laboratories (i.e. On the i
. back of trucks, in vans on boats or ships etc.), gitt is i
defined as the mobile unit itself as long as the actual analysis or any portion of that analysis takes place on this j
unit.-
Any remote laboratory sites are considered separate j
4 r
e a
i NELAC Accreese Process r
i Revision 3 June 1,1996 Page 3 of 19 L
sites and subject to separate Announced and Unannounced i
Assessments, again provided that the analysis or any portion j
of the analysis take place at that site; i
1 b)
The assessment may consist of any or all of the categories 2
and/or methods for which the laboratory wants to obtain accreditation; l
j c)
The inspector must have access to sl1 information and data in I
the areas the lab has or is raquesting accreditation both for
{
analyses completed and labor atory pe rsonnel.
This includes information designated as Confidential Business Information l
(CBI).
The inspector must be c1rared to have access to and j
view such CBI.
The inspector (whether from the accrediting i
authority or a third party) cannot remove, copy and remove i
copies or otherwise communicate CBI (40 CFR Part 2). Under no l
circumstances are auditors to reveal CBI, for profit or not.
Violation will result in the loss of the ability to audit and j
is libel for criminal prosecution; i
j d)
The results of the assessment and performance will be sent to j
the National Database on Environmental Laboratories.
All i
information contained in the National Database will be considered to be public information and accessible to any i
individual;
}
a)
At least two Performance Evaluation (PE) samples of different l
l concentrations, once per quarter in.each category for which j
they have applied for accreditation, for each method or field of testing, must be successfully analyzed according'to the l
standards established for quality assurance / quality control, precision and accuracy.
It may be required to analyze PE l
samples during the on-site assessment.
Marginal performance on any previous PE samples can be grounds for requiring that 1
j a subsequent PE ' sample analysis be performed under the observation of an inspector; and f)
The number of individuals conducting the on-site assessments should not be excessive, and the accreditation authority should be sensitive to fee structure, cost, and the number of 1
inspectors.
l Unannounced Assessments - A State regulatory authority may delegate the responsibility for Unannounced Assessments to a third party.
,l However, the responsibility and accountability for meeting the i
standards of the NELAC are the responsibility of the State j
regulatory authority. The elements and criteria for the unannounced assessments for the purpose of the national accreditation program are:
i E
4 9
I:
e e
NELAC Accreditetson coes June 1,1996 PeGe 4 of 19 a)
Upon presentation of appropriate credentials, the assessor must be provided access to the laboratory facility or site at reasonable times; b)
Elements a) through d) under announced assessments are also applicable to unannounced assessments; c)
Performance Evaluation samples may be distributed and analyses run in the categories and for the methods that are determined by and prescribed by the assessor. The Performance Evaluation samples and requested analyses must be performed by methods approved by NELAC or the appropriate regulatory authority under which the analyses are being conducted.
At the discretion of the inspector, he(she) may leave the PE samples for analysis and not be required to be on-site when the actual analysis (analyses) is (are) performed; d)
All Performance Evaluation samples and other analyses required by the inspector are to be done as directed by the inspector.
These include parameters such as:
specified equipment, analysts and times, but are not limited to these factors; c)
The unannounced assessment should not unduly disturb the normal operating routine of the laboratory or site, and should be conducted during normal working hours; f)
The inspector for an unannounced audit should make every effort to ascertain that the laboratory or site is i.
operational and 11.
currently performing the appropriate type of i
analysis before initiating such an inspection.
j j
g)
The number of individuals conducting the on-site assessments should not be excessive, and the accreditation authority
]
should be sensitive to fee structure, cost, and the number of inspectors.
i Factors Examined in Announced and Unannounced Laboratory I
Assessments i
Refer to On-site Assessments for assessment criteria required to be satisfied for accreditation. It should be noted, the inspector is j
not limited to these factors in reaching an evaluation and 1
conclusion.
Other factors may be considered and must be documented as appropriate.
Laboratories will be furnished with an Deficiency Report documenting any deficiencies found in the factors listed above or ony others considered by the inspector.
It shall also include whether a specific method passed or failed based on the Performance Evaluation sample.
All such reports are public record and any or i
j -.
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s l
1 I
NELAC Accreditation Procese
)
Revision 3 l
June 1,1996 j
Page 5 of 19 all of the information contained therein may be put into the i
National Database.
Proprietary data and Confidential Business l
i l
Information will be excepted from all public records as provided by j
the procedures described in Section 3.4.6.
4.1.3 Performance Evaluation Samples i
When appropriate for the evaluation and available, a critical l
l component of laboratory assessments is the analysis of the 1
Performance Evaluation Samples.
Refer to Performance Evaluation
- Testing, specifically Testing of
- samples, for additional i
information regarding separate treatment of Performance Evaluation samples, discussion of issues of availability, and purity and distribution.
Performance Evaluation samples would be used and j
evaluated in the accreditation process in the following manner:
4 I
a)
Each laboratory or site seeking accreditation must receive,
{
examine, and analyze initial Performance Evaluation sample (s) for each category (e.g.,
drinking water, hazardous waste, l
etc.) in which they.are requesting accreditation.
i b)
Each laboratory seeking accreditation shall also be required 5
to perform analyses on at least two Performance Evaluation j
samples of different concentrations, once per quarter in each category'for which they have applied for accreditation or for j
which the laboratory is currently accredited.
c)
The laboratory will be informed of their score on the Performance Evaluation samples by the state agency or j
authorized third party contractor within 60 days from the cliasing date of submission.
The results of all of the Performance Evaluation sample tests indicating satisfactory or unsatisfactory compliance will also be public record.
j d)
The results of the Performance Evaluation sample analysis will be considered by the State or authorized third party j
accreditor to the State, along with other information obtained from announced and/or unannounced assessments in determining j
whether accreditation should be granted, denied or modified i
for a category or method within a category, or whether the i
laboratory should lose accreditation for a category or method j
within a category.
i 4.1.4 corrective Action Reports i
For purposes of this document, Deficiency Report refers to the i
report of items to be corrected / addressed and is issued by the j
accrediting authority or authorized third party. Corrective Action i
Report refers to the report issued by the laboratory in response to i
deficiencies.
1 i
s NELAC Accreditation Process Revision 3 l
June 1,1996 I
Paps 6 of 19 r
I a)
The accrediting authority or authorized third party must present a Deficiency Report to the laboratory within 60 working days of the inspection.
b)
After being notified of deficiencies, the laboratory will have no more than 20 working days from the date of receipt of the report to provide a corrective Action Report to correct deficiencies noted in the Deficiency Report.
c)
The state authority or authorized third party contractor will respond to the action noted in the Corrective Action Report within 30 working days of receiving it.
d)
A laboratory can lose accreditation or have accreditation suspended in a category or a method within a category by any i
or all of the following items:
1.
Failing to submit / respond with a Corrective Action Report that addresses all deficiencies that are noted in a Deficiency Report; 11.
Failing to implement Corrective Actions in Corrective Action Reports two times within the time limits specified by the accrediting authority; iii. Providing an unacceptable response in a Corrective Action Report; e)
All information included and documented in a Deficiency Report and the Corrective Action Report are considered to be public information.
Other states participating in the National i
Environmental Laboratory Accreditation Program would have access to this information through a national database.
At a minimum, the database would include the following information:
1.
Name and location of laboratory; 11.
Categories and/or methods for which the laboratory is currently accredited and date of accreditation; and/or lii. Categories and/or methods for which the laboratory has lost accreditation during the current accreditation period and the date of loss of accreditation.
iv.
State contact (s).
f)
If the laboratory fails to implement corrective actions to remedy deficiencies noted within the required time period, accreditation for categories or specific methods within those categories will be immediately revoked or suspended.. All such reports are public record and any or all of the information contained therein may be put into the National Database.
Proprietary data and Confidential Business Information will be excepted from all public recccds.
o
(
NELAC Accreditation Process i
Revision 3 l
June 1,1996 Page 7 of 19 4.1.5 Accountability for Analytical standards Elements in a national program that ensure consistency and promote the use of quality assurance / quality control procedures to generate quality data for regulatory purposes are a)
NELAC requires that each laboratory seeking national accreditation have a named Quality Assurance Officer or a person designated as accountable for data quality.
NELAC 1
strongly recommends that the Quality Assurance Officer be a person other than any supervisor of laboratory analysts, who reports directly to the laboratory management and not to the laboratory supervisor in matters related to quality assurance and quality control of analyses, methods relating to these analyses, and instrumentation.
b)
NELAC requires that each laboratory seeking national accreditation have a Quality Assurance Manual on-site that may be reviewed as part of the inspection process.
c)
NELAC will consider that the accountability for negligence, the falsification of data, records or instrument parameters will rest upon the analyst, the laboratory management and the company.
4.1.6 Fee Process for National Accreditation Refer to Policy and Structure, specifically funding of the program (Section 1.10),
regarding the funding of state accreditation i
programs, including a fee structure covering the actual cost of an I
accreditation, a)
The cost incurred in the application process for national environmental laboratory accreditation will be called an accreditation fee.
b)
Where required and if applicable, accreditation fees will be paid in accordance with existing state regulations, levels and j
practices to the state granting the accreditation or i
designated authorized third party accreditor.
I c)
Where required and if applicable, the level and timing of fee payments will be established by the individual State to which the laboratory is applying for accreditation. Additional fees on the laboratory may be levied by other individual States with which the laboratory chooses to do business.
4.1.7 Application l
The National Environmental Laboratory Accreditation Program i
encompasses a standardized set of elements in each application for accreditation that will be reported to and recorded in the national
NELAC Accreditation Process Revision 3 June 1,1996 Pop S of l9 database.
The application package includes any specific state regulatory requirements that are essential for accreditation within an individual state.
A state participating in NELAC will include in its application form the following:
c)
Legal name of laboratory b)
Laboratory mailing address c)
Billing address (if different from b))and contact person d)
Name of owner 0)
Address of owner f)
Location (full address) of laboratory g)
Name.and phone number of laboratory contact person h)
Name and phone number of Quality Assurance Officer 1)
Name and. phone number of laboratory management representative j)
Laboratory hours of operation k)
Primary State of Accreditation (if requesting Mutual 1
Recognition)
{
1)
Accrediting State Agency (also list third party accreditor if applicable)
D)
Categories for which the laboratory is requesting accreditation n)
Methods employed o)
Equipment in the laboratory specific to environmental methods p)
Description of laboratory type (for example)
Commercial Federal Hospital or health care State Academic Institutes Public water system Public wastewater system Industrial (an industry with discharge permits)
Mobile other (Describe) q)
Certification of compliance by laboratory management (vide infra:
4.1.9) r)
Laboratory facilities c)
Fees paid to:
t)
Description of geographical location u)
FAX number v)
Lab identification number (for renewal) v)
Key Personnel (include
- duties, educational background, experience)
A laboratory seeking renewal of accreditation will f ol '.ow the process outlined by the state in which they are currently cccredited.
.. _.. _. _ ~
I s
l l
NELAC l
Accre&tetion Process I*
Rowlsion 3 June 1,1996 Pge 9 W 19 l
4.1.s Transfer of ownership / change of ownership, Change of 1
Analytical Personnel, and/or Location of Laboratory Accreditation may be transferred when the legal status or ownership of an accredited laboratory changes without affecting its staff, l
equipment, and organization.
The accrediting agency may charge a l
transfer fee and may conduct an on-site assessment to verify affects of such changes on laboratory performance.
The following conditions apply to the change in ownership and/or i
the change in location of a
laboratory that has national accreditation.
i j
a)
Any change in ownership and/or location of an accredited laboratory must be reported in writing to the primary state (s) i and the National Environmental Laboratory Accreditation Program within 30 calendar days of such a change taking
]
effect.
b)
Such a
change in ownership and/or location will not necessarily require reaccreditation or reapplication'in any or all of the categories in which the laboratory is currently j
accredited.
i i
c)
Change in ownership and/or location may require an on-site i
assessment with the elements of the assessment being l
determined by the inspector.
i l
d)
Any change in ownership must assure historical traceability of 1
the laboratory accreditation number (s).
e)
For a change in ownership, one of the following conditions 1
must be in effect:
i 1.
The previous-(transferring) owner must agree in writing, 1
before the transfer of ownership takes place, to be i
accountable and liable for any analyses, data and reports j
generated up to the time of legal transfer of ownership; I
i j
ii.
The buyer (transferee) must agree in writing to be accountable and liable for any analyses, data and reports i
l generated after the legal transfer of ownership occurs.
iii. All records and analyses performed pertaining to 1
accreditation must be kept for a minimum of 10 years and are subject to inspection by accrediting State authorities (or their third party designee) during this period without prior notification to the laboratory.
This stipulation is applicable regardless of change in ownership, accountability or liability.
t NELAC Accreditation Process
~
neweien a June 1,1996 Page 10 of 19 iv.
If ownership is transferred, the transferee will not be responsible for payment of fees to States during the remainder of the yearly period, provided that the i
previous owner has fully paid the required fees to the j
said States (or their third party designees).
There may i
be, however, financial liability incurred in terms of 4
Transfer Fees (vide supra).
j f)
For a change in key analytical laboratory personnel for which educational, training or experience requirements exist, the State or accrediting authorities must be notified within 30 4
j calendar days of when such a change occurs.
4.1.9
" Certification of compliance" statement The following
" Certification of compliance" statement must accompany the application for laboratory accreditation.
It must be j
nigned and dated by both the laboratory management and the quality j
cssurance officer, or other designated person, for that laboratory.
o j
CERTIFICATION BY APPLICANT The applicant understands and acknowledges that the laboratory is rcquired to be continually in compliance with the National
}
Environmental Laboratory Accreditation Program's standards and requirements concerning laboratory accreditation and standards and j
will be subject to the penalty provisions provided therein.
The applicant understands and acknowledges that accreditation is cpecifically subject to unannounced assessments.
Authorized representatives of any state in which the laboratory is occredited may make an announced or unannounced inspection, search, I
cr examination of an accredited or interim approved laboratory
{
whenever the
- state, at its discretion considers such an i
inspection, search or examination necessary, o determine the extent t
i of the laboratory's compliance with the conditions of its cccreditation and NELAC standards.
Additionally, ths applicant cuthorizes the officially designated State inspector to; 1) make copies of alsy analyses or records relevant to the accreditation process, and 2) remove any or all such copies from the facility for j
purposes of evaluation or regulatory enforcement.
Any refusal to ollow entry to the state's representatives at reasonable times or during normal business hours or to allow copies of records relevant to laboratory accreditation to be made shall constitute a violation of a
condition of accreditation and grounds for refusal of j
occreditation, revocation of' accreditation, or loss of i
occreditation.
The applicant hereby certifies that all certified environmental analyses performed are done in accordance with applicable guidelines.
i
e NELAC Accre6tetion Process Revision 3 June 1,1996 Page 11 of 19 I hereby certify that I am authorized to sign this application on behalf of the applicant / owner and that there are no misrepresentations in my answer to the questions on this application.
Signature Quality Assurance officer or Name of Quality Assurance officer other designated responsible individual Print Name of Applicant Laboratory Date (Legal Name)
Signature Name Laboratory Management Representative Laboratory Management Representative 4.2 PERIOD OF ACCREDITATION For a laboratory in good standing, the period for accreditation within categories for methods or analytes will be 12 months and will be considered to be ongoing once a laboratory has been accredited for that category or method within a category.
To maintain accreditation the laboratory shall meet the requirements of Section 4.3, Maintaining Accreditation.
Failure to meet the requirements delineated in Section 4.3 shall constitute grounds for revocation or suspension.of accreditation as specified in Section 4.4.
Additionally, failure to pay the required fees as determined by the participating states within the stipulated deadlines or by I
the stipulated dates may result in loss of accreditation.
This information may be entered into the National Database in a timely and effective manner. The NEIAC recognizes that different states operate the yearly period with different start times.
The individual laboratory being accredited is responsible for tracking the individual State's periods of accreditation and is responsible for paying the necessary fees (if applicable) to those states to maintain accreditation.
Individual States may elect to extend the 4
j period of accreditation to lessen the impacts on individual laboratories with respect to Announced and Unannounced inspections, however in no case should this extension period of time exceed six months.
The extension must specifically state what date the extension period expires.
This information should be entered in the National Database.
i l
There is a separate process for accreditation for new categories, i
methods and analytes (vide supra: Application Process, 4.1.7).
Each ' year the National Environmental Laboratory Accreditation Program will provide each laboratory with a current directory with information on what categories, methods, and analytes for which they are accredited.
Additionally, new categories, methods, and analytes will appear on the actual certificate that is reissued as
1 e
e l
^
NELAC Accreditation Process Revision 3 1
June 1,1996 Page 12 ef 19 I
these items are added and/or deleted during the year. All new j
categories will be included in updates to the database in a timely j
cnd effective manner.
All such updates are public record and any j
er all of the information contained therein shall be put into the
)
National Dctabase.
Proprietary data and Confidential Business j
Information will be excepted from all public records.
1 j
4.3 NAINTAINING ACCREDITATION l
Accreditation remains in effect until revoked by the accrediting l
cuthority, until discontinued by the accredited laboratory, or until expiration of accreditation date. To maintain accreditation, j
the accredited laboratory shall complete or comply with elements l
4.3.1 TO 4.3.6.
Failure to complete or comply with these elements i
nay.be cause for downgrading or revoking accreditation. In this
)
olement, downgrading refers to the removal and elimination of a portion of methods or categories for which the laboratory was j
previously certified.
4.3.1 Performance Evaluation samples c
l Performance Evaluation samples appropriate for the accredited nGthodology shall be required to be performed on at least two
}
Parformance Evaluation samples of different concentrations, enoe l
par quarter in each category for which they have applied for i
j accreditation. These samples must be procured from an acceptable l
l ccurce.
It must be successfully analyzed and reported to the accrediting body within required deadlines.
In the event of unsatisfactory performance and required reanalysis, repeat analysis i
chall also be completed and reported within established deadlines.
Peor performance on a Performance Evaluation sample or failure to j.
cubmit results within required deadlines may be cause for dcwngrading accreditation.
In this element, downgrading refers to i
l the removal and elimination of a portion of methods or categories l
l for which the laboratory was previously certified.
2 i
4e3.2 on-site Assessments on-site assessments shall be performed by the accrediting agency at 7
i o minimum frequency of once every two years.
Unannounced on-site casessments or follow-up on-site assessments may be conducted more j
. frequently, for cause, at the option of the accrediting authority.
t Situations which might trigger an unannounced on-site assessment or I
follow-up on-site assessment include, review of a previously daficient on-site assessment, poor performance on a Performance Evaluation sample, change in other accreditation elements, or other information concerning the capabilities or practices of the j
cccredited laboratory.
On-site assessments, regardless of frcquency, shall be successfully completed to maintain
^
cccreditation.
Deficiencies identified during the on-site cocessment shall be corrected within deadlines established in these j
guidelines or according to deadlines in an acceptable corrective i
4 i
... _ _ _ _ _ ~ _. _.
j.
l-NELAC 1
Accre&tstion Process i
Revision 3 l
June 1,1996 j
Page 13 of 19 j
i l
l Action Report.
Failure to pass an on-site assessment or to correct deficiencies according to the provisions of an acceptable j
corrective action plan may be cause for downgrading accreditation.
4.3.3 other Accreditation Elements
)
The accredited laboratory shall maintain other key accreditation I
elements which served as the basis for initial accreditation i
including the facility, organization and management, qualifications of key personnel, sample handling procedures, calibration standards, analytical methods, data reduction procedures, Standard Operating Procedures (SOP's) and laboratory quality assurance plan.
4 Failure to maintain, revise, or replace any of these key components may be cause for downgrading accreditation status.
In this element, downgrading refers to the removal and elimination of a portion of methods or categories for which the laboratory was previously certified.
1 j
4.3.4 Notification and Reporting Requirements The accredited laboratory shall notify the accrediting body of any changes in key accreditation criteria within 30 calendar days including but not necessarily limited to the laboratory ownership, l
location, key personnel, and major instrumentation. The accredited j
lab shall also comply with any other reporting requirements j
identified in these guidelines. All such updates are public record and any or all of the information contained therein may be put into the National Database.
4.3.5 Record Keeping and Retention All lab records associated with accreditation' parameters must be easily accessible, including raw and processed data associated with each analysis, changes in method standard operating procedures, or the laboratory quality assurance plan, shall be maintained for a minimum of ten years unless otherwise designated for a longer period in another regulation or authority. (NB. This is the floor requirement for records retention.
It is the responsibility of the laboratory and/or client to determine and comply with the specific record retention times in order to comply with a particular statute or regulation.)
In the case of data used in litigation, the laboratory is required to store such records for a longer period upon written notification from the accrediting agency / authority or other regulatory agency.
4.3.6 Payment of Fees The accredited lab shall pay all fees associated with maintaining accreditation to the accrediting body within established deadlines.
The individual laboratory being accredited is responsible for tracking the individual State's periods of accreditation and is
.l NELAC Accredetetion Procoes Revision 3 l
June 1,1996 Page 14 of 19 responsible for paying the necessary fees (if applicable) to those states to maintain accreditation.
4.4 DENIAL, SUSPENSION, AND REVOCATION OF ACCREDITATION Denial, Suspension or Revocation of accreditation in the primary f
state will automatically cause the same action within all other states in which the laboratory is accredited.
This information, as well as voluntary withdrawals, appeal processes and procedures will be entered into the National Database.
4.4.1 Denial
. Denial - shall mean to refuse to accredit a laboratory applying for initial accreditation or renewal of accreditation.
j Reasons to deny an initial application or reapplication may include.
]
a)
Failure of laboratory staff to meet the personnel qualifications as required by the accrediting authority.
These qualifications may include education, training and experience requirements.
b)
Failure to successfully perform Performance Evaluation tests as required by the accrediting authority.
c)
Failure to attest that analysis are performed by approved or
. documented methodologies and/or in accordance with the requirements of the accrediting authority.
l d)
Failure to respond to a Deficiency Report from the On-Site i
Inspection with a
Corrective Action Report within the specified amount of time.
1 c)
Failure to implement the Corrective Actions detailed in the Corrective Action Report within the specified time frame.
t j
f)
Failure to pay required fees.
1 g)
Failure to pass required On-site Inspection (s)
A laboratory shall have two opportunities to correct the areas of deficiencies which results in a denial of accreditation.
If the laboratory is not successful in remedying said deficiencies, it cust wait six months before again applying for accreditation.
Upon reapplication, the laboratory may again be responsible for all or part-of the fees incurred as part of the initial application for cccreditation.
+
e NELAC Accredatation Process Revision 3 June 1,1996 Page 15 of 19 4.4.2 Revocation Revocation - shall mean the total withdrawal of a laboratory's accreditation by the accrediting authority.
The laboratory cannot reapply for accreditation for 6
- months, by which time the reason /cause of the revocation must be corrected.
Reasons for revocation may include:
a)
Failure to participate or unsatisfactory performance in the Performance Evaluation testing program as required by the program.
b)
Submitting Performance Evaluation sample results generated by another laboratory as your own.
c)
Misrepresentation of any material fact pertinent to receiving initial approval.
d)
Denial of entry at reasonable times or during normal business hours for laboratory inspection.
e)
Conviction of charges of the falsification of any report of or relating to a laboratory analysis.
f)
Failure to remit the accreditation fee or fees within the time limit as established by the individual state authority may be grounds for immediate loss of accreditation in that state.
The loss of accreditation will immediately be entered in the national database.
i No laboratory's accreditation will be revoked or denied without the l
right to due process.
4.4.3 Buspension l
suspension - shall mean the temporary removal of a laboratory's i
accreditation for a defined period of time.
The purpose of 1
suspension is to allow a laboratory time to correct deficiencies or area of non-compliance with program requirements as defined by regulation.
A suspended laboratory would not have to reapply for accreditation if the cause/causes for suspension are corrected within six months.
A laboratory's accreditation may be suspended in total or in part.
It may retain those areas of accreditation where it continues to. meet the standards and requirements of the program.
Reasons for suspension may include:
a)
Failure to successfully perform Performance Evaluation tests t
pursuant to the requirements of the program;
i NELAC
(
Accre&tetion Procese s
Revision 3 June 1,1996 i
Paes 16 of 19
}
b)
Failure to submit and implement corrective action related to i
deficiencies found during laboratory inspections within the required time period; 4
c) 1,oss of personnel with the required educational, training and j
experience qualifications; or i
d)
Failure to pay accreditation application fees.
o)
A laboratory can lose accreditation or have accreditation suspended in a category or a method within a category by any or all of the following items:
1.
Falling to submit / respond with a Corrective Action Report; 11.
Failing to implement corrective actions in Corrective Action Reports two times; iii. Providing an unacceptable response in a Corrective Action Report; iv.
Failing to address each item noted as a deficiency in the Deficiency Report; Failing the same Performance Evaluation sample analysis v.
two consecutive times for the same analyte; or vi.
Failing to achieve an overall testirg event (PE Sample) passing score for two consecutive testing events or two out of three consecutive testing events.
4.4.4 voluntary Withdrawal If an environmental laboratory wishes to withdrawal from NEIAC, it nust notify the accrediting authority no later than 30 days before the end of the orcreditation year.
Danial, revocation, and suspension in one state will be applicable for. all states participating in NEIAC.
The status of each laboratory's accreditation (active, denied, revoked, or suspended) will be entered in the National Database.
4.5 INTERIM ACCREDITATION 4.5.1 Interia' Accreditation
's If a laboratory completes all of the requirements for accreditation oxcept that of an on-site assessment because the accrediting cuthority is unable to schedule the assessment in a timely manner, an interim accreditation may be issued and will be in effect until tho assessment requirements have been completed.
A state may provide for the use of an authorized third party to accredit icboratories when the state will be unable to perform an on-site Accessment in a timely manner. Interim accreditation will allow a Inboratory to perform analyses and report results of samples with tho same status as a fully weredited laboratory until an on-site
NELAC Accredetetion Process Revision 3 June 1,1996 Page 17 of 19 assessment has been completed only in the state where the interim accreditation was granted.
Interim accreditation may still be granted when Performance Evaluation samples are not available from a source acceptable to the National Environmental Laboratory Accreditation Program.
The period for granting Interim Accreditation may not exceed one year.
This period may be extended for an additional period of one year or until NELAC is fully operational.
The Interim Accreditation status is considered to be a matter of public record and will be entered into the National Database in a timely manner, along with the reasons for granting an Interim Accreditation.
If a laboratory or site has a valid accreditation based on current i
standards in a state or by an accrediting authority that do not me'et minimum NELAC standards outlined in section 4.1.1 and 4.1.7, 1
the laboratory or site may be granted an Interim Accreditation.
This Interim Accreditation will be reviewed on a yearly basis by the state or accrediting authority and either granted or revoked at that time.
If the primary state of accreditation is unable to process the Interim Accreditation, another State participating in NELAC may grant an Interim Accreditation on a year-by-year basis.
This must be noted in the National Database.
4.5.2 Revocation of Interim Accreditation Revocation of interim accreditation may be initiated for due cause as described in 4.4.0 by order of the accrediting authority.
4.5.3 Exception Process NELAC will develop an Exception Process to allow states to submit detailed plans for step-by-ste coming into NELAC compliance. p implementation for two years while The NELAC board may then assist the i
i state in formulating an exception process if that state is having difficulties implementing NELAC.
Interin Accreditation may be l
extended an additional year in states while in the process of l
coming into compliance with NELAC.
l 4.6 AWARDING OF ACCREDITATION When a participating laboratory has met the requirements specified for receiving accreditation, the laboratory will receive a single certificate awarded on behalf of the state accrediting authority.
The certificate will provide the following information:
the name of the laboratory, address of the laboratory, the specifications of the accreditation action (for example, the laboratory may be i
accredited for analysis of water or for use of a
specific analytical methodology, etc.).
Addenda or attachments to the certificate are allowed and will be considered to be official i
documents.
Information on the addenda or attachments may include
- scope, methods, analytes...etc.
The laboratory must have a certificate for each state in which it is accredited.
Even though i
NELAC Accreditation Process Revision 3
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June 1,1996 Page 18 of 19 a parent laboratory is accredited, the subf acilities (laboratories operating under the same parent organization, analytical procedures, and quality assurance system) are also required to become accredited. The subfacilities accredited will be listed on the certificate of the parent laboratory, but each site must be accredited separately and will be issued their own certificate of Accreditation.
A site or subfacility is defined as a structure or group of structures at the same geographical location.
In the case of mobile laboratories (i.e. on the back of trucks, in vans, on boats or ships etc.), site is defined as the mobile unit itself as long as the actual analysis or any portion of that analysis takes place on this unit.
Also, any sub-facilities or remote laboratory sites are considered separate sites and subject to caparate Announced and Unannounced Assessments, again provided that the analys'is or any portion of the analysis take place at that cite.
For awarding of accreditation, NELAC quality of standards will apply to individuals who apply test substances, collect samples, prepare samples, and analyze samples.
4.6.1 The certificate of Accreditation The certificate will be signed by a member of the accrediting authority and will be considered an official document.
It will be transmitted as a sealed and dated (effective date and expiration date) document containing the NELAC Insignia from the accrediting authority.
The certificate will include specific categories, parameters, and methods for which the laboratory or site is accredited.
i To address the concern that an individual state may revoke a j
laboratory's accreditation for work in that state, the certificate will explain that continued accredited status depends on successful cngoing participation in the program.
The certificate will urge a i
customer to verify the laboratory's current accreditation standing within a particular state. The certificate sust be returned to the cccrediting authority upon loss of accreditation. However, this does not require the return of a certificate which has simply j
expired (reached the expiration date).
4.6.2 Changes in Areas of Accreditation j
If an accredited laboratory increases its areas of accreditation, 1
e new certificate will be awarded which details the spectrum of j
cccreditations the laboratory has achieved.
4.7 Enforcement l
The development of an enforcement component of the National l
Environmental Laboratory Accreditation Program (NELAC) should be l
e NELAC Accreditation Process Revision 3 June 1,1996 Page 19 of 19 based on explicit
- values, or principles, with which all participants concur The proposed basic principles are:
a)
The program should be fair to all participants; b)
The rules should be well publicized; c)
The program needs of the participating agencies must be upheld; and d)
The due process rights of participating laboratories must be protected.
The major components of the program shall include:
a)
Since NELAC is a voluntary program, it can not enforce civil or criminal penalties but rather all enforcement actions are taken independently by EPA or state agencies and communicated to all other NELAC participating agencies. Any civil / criminal actions are taken by participating agencies and/or accrediting authorities.
b)
NELAC enforcement is limited to suspension (short-to-long-term) of individual accrediting authorities from NELAC only.
c)
An effective information-sharing database used by all participating agencies is essential to ensure informed decision-making based on lab performance.
d)
If states have too many enforcement actions against them, a
meeting of the executive board will be convened to discuss corrective actions with that state.
4 a
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l NATIONAL ENVIRONMENTAL LABORATORY ACCREDITATION i
CONFERENCE 4
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DRAFT QUALITY SYSTEMS:
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Page i of lii ii QUALITY SYSTEMS l
1 TABLE OF CONTENTS l
5.0 QUALITY SYSTEMS 1
4 5.1 SCOPE.
1 j
5.2 REFERENCES
2 1
1 1
5.3 DEFINITIONS 2
j 5.4 ORGANIEATION AND MANAGEMENT.
2 5.4.1 Legal Definition of Laboratory.
2 j
5.4.2 Organisation.
2 i
j 5.5 QUALITY SYSTEM - ESTABLISEMENT, AUDITS, ESSENTIAL j
QUALITY CONTROLS AND DATA VERIFICATION 5
i 5.5.1 Establishment 5
l 5.5.2 Quality Manual.
5
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5.5.3 Audits.
7 5.5.3.1 Internal Audits.
7 5.5.3.2 Managerial Review.
7 j
5.5.3.3 Audit Review 8
5.5.3.4 Performance Audits 8
5.5.3.5 Corrective Actions 8
j 5.5.4 Essential Quality Control Procedures.
9 l
i 5.6 PERSONNEL 10 5.6.1 General requirements for laboratory staff 10 5.6.2 Laboratory Management Responsibilities.
11 l
E.6.3 Records 12 I
l 5.7 PHYSICAL FACILITIES - ACCOMMODATION AND ENVIRONMENT 12 I
5.7.1 Environment 12 5.7.2 Work Areas.
12 l
5.8 EQUIPMENT AND REFERENCE MATERIALS 13 5.9 MEASUREMENT TRACEABILITY AND CALIBRATION 14 5.9.1 General Requirements.
14 5.9.2 Traceability of Calibration 14 5.9.3 Reference Standards 15 j
5.9.4 Documentation and Labeling of Standards and i
Reagents 15 l
5.9.5 Calibration 16 5.9.5.1 General Requirements 16 5.9.5.2-Acceptance criteria for Support Equipment 16 5.9.5.2.1 Analytical Support Equipment.
16 5.9.5.2.2 Autoclaves.
17 i
5.9.5.3 Initial Calibrations 17 1
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Quahty Systems Draft 1
June 1,1996 ReMnon 3 Pgm W of ui 4
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5.9.5.4 Calibration Verification 19 5.9.5.4.1 Initial Calibration Verification.
19 4
i 5.9.5.4.2 Continuing Calibration Verification 19 i
l 5.10 TEST METHODS AND STANDARD OPERATING PROCEDURES 20 4
5.10.1 Methods Documentation.
20
)
5.10.1.1 Standard Operating Procedures (SOPS) 20 l
5.10.2 Test Methods.
22
]
5.10.2.1 Method Validation / Initial Demonstration of l
Method Performance 23 5.10.3 Sample Aliquots 23 j
5.10.4 Data Verification 23 j
5.10.5 Documentation and Labeling of Standards and Reagents.
23 j
5.10.6 Computers and Electronic Data Related Requirements i
24 4
1 5.11 SAMPLE MANDLING, SAMPLE ACCEPTANCE POLICY AND SAMPLE i
RECEIPT.
25 5.11.1 Sample Tracking 25 j
5.11.2 Sample Acceptance Policy.
26 1
5.11.3 Sample Receipt Protocols 26 t
5.11.4 Storage Conditions 28 5.11.5 Sample Disposal 29 5.12 RECORDS 29 l
5.12.1 Record Keeping System and Design.
29 l
5.12.2 Records Management and Storage.
30 5.12.3 Laboratory Sample Tracking.
31 5.12.3.1 Sample Randling.
31 5.12.3.2 Laboratory Support Activities.
32 5.12.3.3 Analytical Records 32 5.12.3.4 Administrative Records 32 5.12.4 Legal or Evidentiary Custody Procedures 33 j
5.12.4.1 Basic Requirements 33
{
i 5.12.4.2 Required Information in Custody Records.
34 l
5.12.4.3 Controlled Access to Samples 35 i
5.12.4.4 Transfer of Samples to Another Party 35 1
5.12.4.5 Sample Disposal.
35 5.13 LABORATORY REPORT FORMAT AND CONTENTS 36 4
5.14 SUBCONTRACTING ANALYTICAL SAMPLE 8 39
)
5.15 OUTSIDE SUPPORT SERVICES AND SUPPLIES 39 i
5.16 COMPLAINTS 40 APPENDIX A TECHNICAL REFERENCE 8 1
i APPENDIX B DEFINITIONS FOR QUALITY SYSTEMS 1
L
i 4
i NELAC l.
OudW Sptoms Draft June 1,1996 Revision 3 Page iii of iii APPENDIX C CHECKLIST FOR DEMONSTRATION OF METHOD PERFORMANCE 1
)
Prodecure for Initial Demonstration of Capability 1
i j
Method Performance System certification Statement 3
i Checklist for Initial Demonstration of Method Performance 5
l Checklist for continuing Damonstration of Method Performance 9
APPENDIX D ESSENTIAL QUALITY CONTROL REQUIREMENTS 1
D.1 Chemical 1
l D.1.1 Positive and Negative Controls 1
D.1.2 Analytical variability / Reproducibility 2
1 D.1.3 Method Evaluation.
2 D.1.4 Sensitivity.
3 D.1.5 Data Reduction 3
l D.1.6 Quality of Standards and Reagents.
3 l
D.1.7 Selectivity.
3 D.1.8 Constant and Consistent Test Conditions.
4 D.2 Whole Effluent Toxicity.
4 i
D.2.1 Positive and Negative Controls 4
i D.2.2 variability and/or Reproducibility 6
j D.2.3 Accuracy 6
D.2.4 Test Sensitivity 6
D.2.5 Selection of Appropriate statistical Analysis Methods 6
l D.2.6 Selection and Use of Reagents and standards 7 i
D.2.7 Selectivity.
7 i
D.2.8 Constant and Consistent Test Conditions.
7 l
D.3 Microbiology.
9 D.3.1 Positive and Negative Controls 9
D.3.2 Test variability / Reproducibility 10 j
D.3.3 Method Evaluation.
10 D.3.4 Test Performance 11
{
D.3.5 Data Reduction 11 D.3.6 Quality of Standards, Reagents and Media 12 D.3.7 Selectivity.
13 l
D.3.8 Constant and Consistent Test Conditions.
13 D.4 Radionnalysis 16 D.4.1 Positive and Negative Controls 16 i
D.4.2 Laboratory variability / Reproducibility 16 D.4.3 Method Evaluation.
17 D.4.4 Sensitivity.
18 D.4.5 Data Reduction 18 D.4.6 Quality of Standards and Reagents 19 i
D.4.7 Selectivity.
19 D.4.8 Constant and Consistent Test Conditions.
19
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D.5 Air Testing.
20 i
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NELAC Quehty Systems Draft June 1,1996 Revision 3 Page 5-1 of 36
't 5.0 QUALITY SYSTEMS INTRODUCTION i
Quality Systems include all quality assurance (QA) policies and quality control (QC) procedures, which shall be delineated in a QA Plan to help ensure and document the quality of the analytical data.
Laboratories seeking accreditation under NEIAP aust assure 2
implementation of all QA policies and the essential applicable QC procedures specified in this chapter.
The QA policies, which establish essential QC procedures, are applicable to environmental laboratories regardless of size and complexity.
It is the intent of this section to provide sufficient detail concerning QA and QC requirements so that all accrediting authorities evaluate laboratories consistently and uniformly.
Section 5 is organized according to the structure of ISO /IEC Guide 25, 1990.
The text from ISO /IEC Guide 25 is in bold and a different font.
Modifications to this text have been made to i
eliminate confusion as to the intent or use of ISO /IEC Guide 25 language in the NELAP standards.
In these cases, the changes are noted as underlined and in a different font for proposed text and struck through for deleted text.
Where deemed necessary, specific areas within this section may contain more information than specified by ISO /IEC Guide 25.
All items identified in this chapter shall be available for on-site inspection or data audit.
i 5.1 SCOPE a)
This Standard Guide sets out the general requirements in accordance with which a laboratory has to demonstrate that it operates, if it is to be recognized as competent to carry out specific environmental eelibrationein tests, b)
Additional requirements and information which have to be disclosed for assessing competence or for determining compliance with other criteria may be specified by the organization or authority granting the recognition (or approval),
depending upon the specific character of the task of the laboratory.
In addition to the ISO /IEC Guide 25 standard, the supplemental language in this chapter, specifies the essential activities, records and procedures that a laboratory must implement to be considered for accreditation under NELAP.
If more stringent standards or requirements are specified by the test method or by regulation, the laboratory shall demonstrate that such requirements are met.
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NELAC I
Quakty Systems Ocft June 1,1996 Revision 3 i
4 Page 5-2 of 36 c)
This standard Guide is for use by environmental c:S= der. r.d testing laboratories in the development and implementation of their quality systems.
j lt may also be used by accreditation bodies, certifiestion bodies and others j
concerned with the competence of environmentallaboratories.
5.2 RzFzRzMcas See Appendix A l
5.3 DEFINITIONS i
j The relevant definitions from ISO /IEC Guide 2, ISO 8402 ANSI /ASOC E-4,1994,
.the IEA " Glossary 21 Ouality Assurance Terns.and Acronyms", and the i
international vocabulary ofbasic andgeneral terms in metrology (VIM) are opplicable, the most relevant being quoted in Anoendix 3 below together with further j
definitions applicable for the purposes of this standard Guide.
3 See Appendix B l
5.4 ORGANIZATION AND MANAGzMENT l
1 f
5.4.1 Legal Definition of Laboratory j
The laboratory shall be legally identifiable. It shall be organized and shall operate in j
cuch a way that its permanent, temporary and mobile facilities meet the requirements j
of this Standard Guide.
5.4.2 Organization 1
4 i
The laboratory shall:
a) have managerial staff with the authority and resources needed to discharge their duties; a
j b) have arrangements to ensure that its personnel are free from arey commercial,-
financial and other pressures which might adversely affect the quality of their work; J
c) be organized in such a way that confidence in its independence of Judgment 1
and integrity is maintained at all times:
d) specify and document the responsibility, authority, and interrelation of all personnel who manage, perform or verify work affecting the quality of j
calibrations and tests;
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June 1,1996 Revision 3 Page 5-3 of 36 E
Such documentation shall include:
1) a clear description of the lines of responsibility in the 4
j laboratory and shall be proportioned such that adequate j
supervision is ensured.
An organizational chart is recommended and 2) job descriptions for all positions.
l j
e) provide supervision by persons familiar with the calibration or test methods and i
procedures, the objective of the calibration or test and the assessment of the results. The ratio of supervisory to non-supervisory personnel shall be such as to ensure adequate supervision; f) have a technical director (s) enenegee (however named) who has overall i
responsibility for the technical operatione sf. the environmental testina
]
laboratory; The technical director shall certify that personnel with i
appropriate educational and/or technical background perform j
all tests for which the laboratory is certified.
Such certification shall be documented.
The technical director shall meet the requirements specified j
.1 in The Accreditation Process.
)
i g) have a quality assurance of ficer maneger (however named) who has responsibility for the quality system and its implementation. The quality l
assurance of ficer menegee shall have direct access to the highest level of
}
management at which decisions are taken on laboratory policy or resources, l
and to the technical managere in some laboratories, the quality assurance
)
offic_tr-moneger may also be the technical director menegee or deputy l
technical director manager; i
The quality assurance officer (and/or his/her designee) shall:
i 1) serve as the focal point for QA/QC and be responsible for
{
the oversight and/or review of quality control data; i
2) where applicable, have functions independent from 1
laboratory operations for which they have quality assurance oversight; i
3) be able to evaluate data objectively and perform l
assessments without outside (e.g., managerial) influence; I
l 4) have documented training and/or experience in QA/QC
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NELAC
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Pete 5-4 of 38 i
j procedures and be knowledgeable in the quality system as i
defined under NELAP; i
j 5) have a general knowledge of the analytical methods for j
which data review is performed; and-1' 6) where applicable, conduct internal audits on the entire i
technical operation annually.
1 j
h) nominate deputies in case of absence of the technical director or quality
)
assurance officer manager; j
The laboratory shall accomplish this by having contingency j
plans in the event that either the technical director or quality assurance officer is absent.
}
i) where relevant, have documented policy and procedures to ensure the j
protection of clients' confidentialinformation and proprietary rights;
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j) where appropriate, participate in inter-laboratory comparisons and proficiency i
testing programs.
l For purposes of qualifying for and maintaining accreditation, j
j aach laboratory shall participate in a proficiency test i
i program.as outlined in Chapter 2.0.
5.5 l
QUALITY SYSTEM - ESTABLISHMENT, AUDITS, ESSENTIAL QUALITY CONTROLS AND DATA VERIFICATION j
5.5.1 Establishment!
The laboratory shall establish and maintain a quality system appropriate to the type, rcnge and volume of environmental eelibeetion end testing activities it undertakes.
a.
The elements of this system shall be documented.
b.
The quality documentation shall be available for use by the laboratory
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personnel.
The laboratory shall define and document its policies and objectives for, and its c.
commitment to good laboratory practice and quality of ;;1ibratis..
testing services.
4 d.
The laboratory management shall ensure that these policies and objectives are documented in a quality manual and communicated to, understood, and Implemented by all laboratory personnel concerned.
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NELAC j
Quahty Systems Draft June 1,1996 i
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The quality manual shall be maintained current under the responsibility of the e.
quality assurance officer manager.
)
5.5.2 Quality Manual I
i' The quality manual, and related quality documentation, shall state the laboratory's policies and operational procedur'es established in order to meet the requirements of i
this Standard Guide.
The Quality Manual shall list on the title page: a document title;
]
the laboratory's full name and address; the name, address (if i
different frcem above),
and telephone number of individual (s) j responsible for the laboratory; the name of the quality assurance i
officer (however named);
the identification of all major
}
organizational units which are to be covered by this quality manual
}
and the effective date of the version; 4
The quality manual and related quality documentation shall also contain:
a) a quality policy statement, including objectives and commitments, by top 3
management; i
j b) the organization and management structure of the laboratory, its place in any parent organization and relevant organizational charts; I
c) the relations between management, technical operations, support services and l
the quality system;
}
i d) procedures for control and maintenance of documentation; including
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document control of laboratory notebooks; instrument logbooks; j
standards logbooks; and records for data reduction, validation storage and reporting; e) job descriptions of key staff and reference to the job descriptions of other staff; f) identification of the laboratory's approved signatorie; ';;h;;; :hl; ;;;;;;; 5; l
eppeepeiete); at a minimum, the title page must have the signed i
concurrence, (with appropriate titles) of all responsible j
parties including the QA officer, technical director, and i
laboratory owner (if applicable);
j g) the laboratory's procedures for achieving traceability of measurements; t
j h) the laboratory's scope of ::S:::!;n; :ndl;; tests; i
j
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e NELAC Quakty Systems Draft 4
June 1.1996 Revision 3 Pege 5 6 of 36 i
)
i) ensuring that the laboratory reviews all new work to ensure that it has the appropriate facilities and resources before commencing such work; i
j) reference to the calibration, verification and/or test procedures used; 4
k) procedures for handling submitted samples :S:::!:n: : d :::: ::.-.:;
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1) reference to the major equipment and reference measurement standards used i
An Enll Aa the facilities And services used by tha laboratorv; i
I m) reference to procedures for calibration, verification and maintenance of equipment; 1
j n) reference to verification practices including interlaboratory comparisons, proficiency testing programs, use of reference materials and internal quality control schemes; i
j t
i o) procedures to be followed for feedback and corrective action whenever testing j
discrepancies are detected, or departures from documented policies and l
procedures occur; 4
4 p) the laboratory management arrangements for exceptionally permitting i
departures from documented policies and procedures or from standard specifications; i
q) procedures for dealing with complaints; i
r) procedures for protecting confidentiality and proprietary rights; j
a) procedures for audit and review; 1
t) processes / procedures for establishing that personnel are i
adequately experienced in the duties they are expected to j
carry out and/or receive any needed training.
5.5.3 Audits 5.5.3.1 Internal Audits The laboratory shall arrange for annual technical systems audits of its activities i
ct appropriate intervals to verify that its operations continue to comply with the r2quirements of the quality system. Such audits shall be carried out by thA ouality
)
assurance officer.gr desionee(s) Ehe arg trained ADA aualified AE j
auditors And :::!n:d :nd :;u:::!;;d :::ff who are, wherever possible, independent i
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- e NELAC Quakty Systems Draft June 1,1996 Revision 3 i
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of the activity to be audited. Where the audit findings cast doubt on the correctness
{
.or validity of the laboratory's calibrations or test results, the laboratory shall take immediate corrective action and shall immediately notify, in writing, any client whose j
work may have been affected.
5.5.3.2 Managerial Review 1
i j
The quality system adopted to satisfy the requirements of this standard Guide shall be reviewed at least once a year by the management to ensure its continuing q
suitability and effectiveness and to introduce any necessary changes orimprovements.
5.5.3.3 Audit Review 1
i All' audit and review findings and any corrective actions that arise from them shall be i
documented. The cuality assurance officer ;;;;;. ::p;rf!: f;; r:!?/ shall ensure that these actions are discharged within the agreed timescale.
I t
5.5.3.4 Performance Audits i
in addition to periodic audits the laboratory shall ensure the quality of results provided to clients by implementing checks. These checks shall be reviewed and shallinclude, as appropriate, but not be limited to:
l a) internal quality control schemes using whenever possible statistical techniques; (see 5.5.4 below) j b) participation in proficiency testing or other interlaboratory comparisons; l
c) eegulee use of certified reference materials and/or in-house quality control using l
secondary reference materials as specified in section 5.5.4; i
j d) replicate testings using the same or different methods; a
l e) re-testing of retained samples items; 1
f) correlation of results for different characteristics of an sample 4 tem.
j 5.5.3.5 Corrective Actions i
d a)
In addition to providing acceptance criteria and specific protocols for corrective actions in the Method Standard operating Procedures (see 5.10.1.1),
the laboratory shall implement general procedures to be followed to determine when j
quality control data are out of control.
These procedures shall include but are not limited to the following:
4 i
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1) identify the individual (s) responsible for assessing each QC data type; 2) identify the individual (s) responsible for initiating and/or recommending corrective actions; 3) define how the analyst.should treat a data set if the associated QC measurements are unacceptable; 4) specify how out-of-control situations and subsequent i
i corrective actions are to be documented;-and 5) specify procedures for management (including the QA officer) to review corrective action reports.
b)
To the extent possible, samples shall be reported only if all i
quality control measures are acceptable.
If a quality control-i measure is found to be out of control, and the data is to be
- reported, all samples associated with the failed quality j
control measure shall be reported with the appropriate data qualifying code (s).
5.5.4 Essential Quality control Procedures The following general quality control principles shall apply, where applicable, to all testing laboratories.
The manner in which they are implemented is dependent on the types of tests performed by the laboratory (i.e.,
chemical, microbiological, radiological).
The otandards for any given test type shall assure that the applicable principles are addressed:
c)
All laboratories shall have protocols (as required in Section 5.10.1.1) in place to monitor the following quality controls:
1)
Adequate positive and negative controls to monitor tests such as blanks, spikes, reference toxicants, zero blanks;.
2)
Adaquate tests to define the variability and/or reproducibility of the laboratory results such as duplicates; 3)
Measures to ensure the accuracy of the test data including sufficient calibration and/or continuing calibrations, use of certified reference materials, proficiency test samples, or other measures; 4)
Measures to evaluate test performance, such as method detaction limits or range of applicability such as linearity; l
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NELAC i
Quakty Systems Draft June 1,1996 Revision 3 Page 5 9 of 36 i
i 5)
. Selection of appropriate formulae to reduce raw data to 1
final results such as linear regression, internal i
standards, or statistical packages; i
6)
Selection and use of reagents and standards of j
appropriate quality; 7)
Measures to assure the selectivity of the test for its j
intended purpose; and l
8)
Measures to assure constant and consistent test 4
}
conditions (both instrumental and environmental) where required by the method such as temperature, humidity, light, or specific instrument conditions.
4 b)
All quality control measures shall be assessed and evaluated on an on-going basis, and quality control acceptance limits shall be used to determine the validity of the data.
The acceptance / rejection criteria shall be updated at a frequency i
established by the method or by the NEIAP standards.
/
c)
The laboratory shall have procedures for the development of acceptance / rejection criteria where no method or regulatory criteria exists.
d)
The method specified and/or method-recommended <!uality control j
protocols shall be followed. The essential standards outlined in Appendix D shall be used if no protocols are written into j
the method or if the method protocols are less stringent.
The essential quality control' measures for testing categories are 1
{
found in Appendix D of this chapter.
1
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5.6 PERSONNEL 5.6.1 General requirements for laboratory staff i
The laboratory shall have sufficient personnel, having the necessary education, training, technical knowledge and experience for their assigned functions.
All personnel shall be resp)nsible for complying with all quality assurance / quality control requirements that pertain to their organizational / technical function.
Each laboratory staff member must have a combination of experience and education to demonstrate 4
adequately a specific knowledge of their particular function and a general knowledge of laboratory operations, analytical methods, i
quality assurance / quality control procedures and records
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management.
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NELAC Quality Systems Draft June 1,1996 Revision 3 i
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5.6.2 Laboratory Management Responsibilities 1
j Laboratory management shall be responsible for:
(
j a) defining the minimal level of qualification, experience and skills necessary for all positions in the laboratory.
In j
addition.to education a n d / o'r' e x p e r i e n c e,
basic laboratory skills such as using a balance, colony counting, aseptic 4
j techniques or chemically transferring reagents shall be considered; j
b)
Assuring that all technical laboratory staff have demonstrated 3
initial and ongoing proficiency in the activities for which they are responsible. such demonstration shall be documented; j
c)
Th: ':t;;;;;ry ch:" Ensurina enetwo that the training of its personnelis kept
]
up-to-date; i
Training shall be considered up-to-date when documentation in j
the files indicate acceptable performance of a blind sample at least once per year and a signature certifying that technical personnel have read, understood and agreed to perform the most recent version of the method, the approved method (if 4
applicable) or standard operating procedure. Evidence must be on file that demonstrates all employees are aware and using l
the latest edition of the laboratories' in house quality i
documentation.
Training courses or workshops on specific l
equipment, analytical techniques or laboratory procedures j
shall all be documented; 1
i d)
Documenting all analytical and operational activities of the i
laboratory; 4
i e)
Supervision of all personnel employed' by the laboratory, j
including those persons designated as principle analysts; i
j f)
Assuring that all sample acceptance criteria (Section 5.9) are net and that samples are logged into the sample tracking system and properly labeled and stored; and 4
i g)
The production and quality of all data reported by the l
laboratory.
5.6.3 Records Records on the relevant qualifications, training, skills and experience of the technical personnel shall be maintained by the laboratory, includina records on demonstrated proficiency for each laboratory method, such as the criteria outlined in 5.10.2.1 for chemical testing.
J' i
e NELAC Quahty Systems Draft June 1,1996 Reesion 3 Page 5-11 of 36 5.7 PHYSICAL FACILITIES - ACCOMMODATION AND ENVIRONMENT 5.7.1 Environment a)
Laboratory accommodation, eelibretienend test areas, energy sources, lighting, heating and ventilation shall be such as to facilitate proper performance of esiibretiene+e tests.
b)
The environment in which these activities are undertaken shall not invalidate the results or adversely affect the required accuracy of measurement. Particular care shall be taken when such activities are undertaken at sites other than the permanent laboratory premises.
c)
The laboratory shall provide facilities for the effective monitoring, control and recording of environmental conditions as appropriate. Due Attention shall be paid, for example, to biological sterility, dust, electromagnetic interference, humidity, mains voltage, temperature, and sound and vibration levels, as appropriate to the calibrations or tests concerned.
d)
In instances where monitoring or control of any of the above mentioned items are specified in a
test method or by i
regulation, the laboratory shall meet and document adherence to the laboratory facility requirements.
NOTE - It is the laboratory's responsibility to comply with the relevant health and safety requirements. This aspect, however, is outside the scope of this Guide.
5.7.2 Work Areas i
a)
There shall be effective separation between neighboring areas when the activities therein are incompatible including culture handling or incubation areas and volatile organic chemicals handling areas.
i b)
Access to and use of all areas affecting the quality of these activities shall be i
defined and controlled.
1 c)
Adequate measures shall be taken to ensure good housekeeping in the laboratory and to assure that contamination is unlikely.
j d)
Work spaces must be available to ensure an unencumbered work j
area. Work areas include:
}
1) access and entryways to the laboratory; j
2) sample receipt area (s);
3) sample storage area (s);
e l
NELAC Quahty Systeme Dr:ft June 1.1996 Revision 3 Pepe 512 of 36 4) chemical.and waste storage area (s); and 5) data handling and storage area (s).
5.s EQtTIPMENT AND REFERENCE MATERIAL 8 c)
The laboratory shall be furnished with all items of equipment (including reference materials) required for the' correct performance of enlibratiew tests igt which accreditation in souaht. In those cases where the laboratory needs to use equipment outside its permanent controllt shall ensure that the relevant requirements of this EtandArd Guide are met.
l b)
All equipment shall be properly maintained, insoected And cleaned.
Maintenance procedures -hall be documented.
I c)
Any item of the equipment which has been subjected to overloading or mishandling, or which gives suspect results, or has been shown by verification or otherwise to be defective, shall be taken out of service, clearly identified and wherever possible stored at a specified place until it has been repaired and shown by calibration, verification or test to perform satisfac'.orily.
The laboratory shall examine the effect of this defect on previous callhrations
.QI tests.
j d)
Each item of equipment including reference materials shall, when appropriate, j
be labeled, marked or otherwise identified to indit ate its calibration status.
i e)
Records shall be maintained of each major ite'n ol equipment and all reference materials significant to the ::S::de..; :: analvtical tests performed.
I These records shall include documentation on all routine and nonroutine maintenance activities and reference material
{
verifications.
I j
The records shall include:
i 1) the name of the item of equipment; 2) the manufacturer's name, type identification, and serial number or other unique identification; 3) date received and date placed in service; 4) current location, where appropriate; 5) condition when received (e.g. new, used, reconditioned);
6) copy of the manufacturer's instructions, where available; 7) dates and results of calibrations and/or verifications and date of the next calibration and/or verification; l
8) details of maintenance carried out to date and planned for the future; i
i i
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c l
l f
NELAC Quakty Systems Draft j
June 1,1996 l
j Revision 3 l
Page 5-13 of 36 l
)
j and 9) history of any damage, malfunction, modification or repair.
i 5.9 MEASUREMENT TRACEABILITY AND CALIBRATION j
5.9.1 General Requirements i
All measuring and testing equipment having an effect on the accuracy or validity of eelibretiene-ee tests shall be calibrated and/or verified before being put into service.
The laboratory shall have an established program for the calibration and verification j
of its measuring and test equipment. This includes balances, thermometers and control standards.
Test equipment and measuring operations j
shall be standardized and verified before use and on a continuing basis.
5.9.2 Traceability of calibration l
1 l
l a)
The overall program of calibration and/or verification and validation of equipment shall be designed and operated so as to ensure that, wherever l
applicable, measurements made by the laboratory are traceable to national j
standards of measurement where available.
l b)
Calibration certificates shall wherever applicable indicate the traceability to j
national standards of measurement and shall provide the measurement results i
and associated uncertainty of measurement and/or a statement of compliance
}
with an identified metrological specification.
The laboratory shall j
maintain records of all such certifications.
l I
c)
Where traceability to national standards of measurement is not applicable, the j
laboratory shall provide satisfactory evidence of correlation of results, for example by participation in a suitable program of interlaboratory comparisons
{
j or proficiency testingt 5.9.3 Reference Standards a
l a)
Reference standards of measurement held by the laboratory shall be used for calibration only and for no other purpose, unless it can be demonstrated that j
their performance as reference standards has not been invalidated. Reference l
standards of measurement shall be calibrated by a body that can provide traceability to a national standard of measurement.
b)
There shall be a program of calibration and ver' fication for reference standards.
I t
c)
Where relevant, reference standards and measuring and testing equipment shall t
i
NELAC Quakty Systems Dr:ft June 1.1996 Revision 3 Page 514 of 36 be subjected to in-service checks between calibrations and verifications.
Reference materials shall, where possible, be traceable to national or international standards of measurement, or to national or international standard reference materials.
5.9.4 Documentation and Labeling of Standards and Reagents 0)
The laboratory shall retain records, such as manufacturer's statement of purity, of the origin, purity and traceability of all standards and reagents (including balance weights and thermometers).
These records shall include the date of receipt, storage conditions, and, if applicable, the date of opening and an expiration date.
b)
Detailed records shall be maintained on reagent and standard preparation.
These records shall indicate traceability to purchase stocks or neat compounds, and must include the date of preparation and preparer's initials.
c)
Where calibrations do not include the generation of a
calibration
- curve, such as thermometers,
- balances, or titrations, records shall indicate the calibration date and type (balance weight, thermometer serial number, primary standard concentration) of calibration standard that was used.
d)
All prepared reagents and standards must be uniquely identified and the contents shall be clearly identified with preparation date, concentration (s) and preparer's initials.
5.9.5 calibration 5.9.5.1 General Requirements j
c)
All calibration curves shall be dated and labeled with method, instrument, analysis date, analyte concentrations and analyte i
response (or response factor).
1 i
b)
When used, the axes of the calibration curve shall be labeled.
{
For electronic data processin systems that automatically compute the calibration curve, g the equation for the curve and i
the correlation coefficient must be recorded.
The equation for the line and the correlation coefficient shall also be recorded when the calibration curve is prepared manually.
i c)
A criteria for the acceptance of a calibration curve, for j
- example, an acceptable correlation coefficient, shall be established and documented.
If applicable, the method specified criteria shall be met.
l
. -. -. - - - - - ~. ~. - -.. -
e r
NELAC l
Quehty Systems Draft i
June 1,1996 l
Revision 3 Paes 5-15 of 36 5.9.5.2 Acceptance criteria for support Equipment 5.9.5.2.1 Analytical support Equipment These standards apply to all devices that may not be the actual test instrument, but are necessary to support laboratory operations. These include' but are not limited to: balances, ovens, refrigerators,
- freezers, incubators, water baths, temperature measuring devices (including thermometers and thermistors) and volumetric dispensing devices (such as Rapipete, Eppendorfe, or automatic dilutor / dispensing devices). All support equipment shall be:
a),
maintained in proper working order following the maintenance schedule recommended by the manufacturer.
The records of all activities including service calls shall be kept.
b) calibrated annually, using NIST traceable references, over the entire range in which the equipment is used.
The results of such calibration shall be within i the manufacturer's stated sensitivity or:
1)
The equipment shall be removed.from service until repaired; or 2)
The laboratory shall prepare a deviation curve and correct all measurements for the deviation.
All measurements shall be recorded and maintained.
c)
Prior to each day's use, balances, ovens, refrigerators, freezers, incubators and water baths shall be checked with NIST traceable references in the expected use range.
Additional monitoring as prescribed by the method shall be performed for any device that is used in a critical test (such as incubators or water baths).
The acceptability of use or continued use shall be per method specified requirements or i the manufacturer's stated sensitivity.
5.9.5.2.2 Autoclaves The sterilization temperature and pressure of each run must be documented by the use of appropriate chemical or biological sterilization indicators.
Autoclave tape may be used to indicate that a load has been processed, but not to demonstrate completion of an acceptable sterilization cycle.
e NELAC ouehty Systems Draft June 1,1996 r
Revision 3 Page 5-16 of 36 5.9.5.3 Initial calibrations a)
When available, all initial calibrations shall be verified with standards obtained from a second or different source.
These verification standards shall be analyzed with each initial calibration, b) calibration curves shall be prepared as specified in the method.
If a method does not provide guidance in the preparation of a calibration curve, the laboratory shall establish the appropriate number of standards for use in the initial calibration using the following:
1)
Determine the percent relative standard deviation (%RSD) by a.
Taking at least seven replicate measurements of a standard with a
concentration approaching the lowest quantitation level or; b.
Performing a calibration linearity test (such as response factor or calibration factor) on at least 3 standards having concentrations that cover over the expected calibration range.
2)
The minimum number of standards to be used in the initial calibration is dependent on the resulting %RSD:
%RSD Number 91 Calibration Points 0 - <2 1**
i 2 - <10 3
10 - <25 5
>25 7
- Assumes linearity through the origin (0.0).
For analytes for which there is no origin (such as pH), a two point calibration curve shall be used.
4)
If the resulting curve is non-linear, additional standards shall be used.
3)
The number of standards as determined from the above table and a
blank shall be used for the initial calibration of the method.
c)
The sample results must be bracketed by calibration standards under all circumstances.
In those situations where the result will be used in a decision related to the determination of a non-occurrence or "non-detect" of a contaminant, the standard shall approach the lowest quantitative level for the method.
o NELAC Quakty Systems Draft June 1,1996 Revision 3 Page 5-17 of 36 d)
In addition to the verification by second-source standards (see a) above), the calibration curve shall be subjected to a calibration linearity test, such as a linear regression or percent RSD.
5.9.5.4 calibration verification When not specified by the analytical method, the value of the analyte (s) in the following calibration verification standards shall be within 15% of the true value unless the laboratory can demonstrate that wider limits are applicable.
5.9.5.4.1 Initial Calibration Verification a)
When an initial calibration curve is not run on the day of analysis, the integrity of the initial calibration curve shall be verified on each day of use (or 24 hour2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> period) by initially analyzing a blank and a standard at the method specified concentration or a mid-level concentration if not specified by method.
b)
If the initial calibration verification fails, the standard shall be immediately analyzed and evaluated a second time.
If the results are still unacceptable, a new initial calibration curve shall be established and verified.
5.9.5.4.2 continuing calibration verification Additional standards shall be analyzed after the initial calibration curve or the integrity of the initial calibration curve (see 5.9.5.3.a or 5.9.5.4.1 above) has been accepted.
a)
These standards shall be analyzed at a frequency of 5% or every 12 hours1.388889e-4 days <br />0.00333 hours <br />1.984127e-5 weeks <br />4.566e-6 months <br /> whichever is more frequent and may be the standards used in the original calibration curve or standards from another source.
The frequency shall be increased if the instrument consistently drifts outside acceptable limits before the next calibration.
b)
The concentration of these standards shall bee determined by j
the anticipated or known concentration of the samples and/or method specified levels.
At least one standard shall be at a low level concentration.
To the extent possible, the samples in each interval (i.e. every 20 samples or every 12 hours1.388889e-4 days <br />0.00333 hours <br />1.984127e-5 weeks <br />4.566e-6 months <br />) should be bracketed with standard concentrations closely representing the lower and upper range of reported sample concentrations.
If this is not possible, the standard calibration checks should vary in concentration throughout the
~
range of the data being acquired.
o e
i NELAC Ouehty Systems Draft June 1,1996 Rev6sion 3 Pr9e 5-12, of 36 c)
A new curve shall be run if two back-to-back runs of one continuing calibration ' check is outside acceptable limits.
]
When the continuing calibration check limit is exceeded high' (i.e.,
high bias),
and there are non-detects for the
_ corresponding analyte in all environmental samples associated with the continuing calibration check, then those non-detects may be reported otherwise,' the samples affected by the l
unacceptable check shall be reanalyzed after a new calibration d
curve has been established, evaluated and accepted.
Additional sample analysis cannot occur until a
new calibration curve is established and verified.
J 5.10 TEST METHODS AND STANDARD OPERATING PROCEDURES l
5.10.1 Methods Documentation a)
The laboratory shall have documented instructions on the use and operation of j
all relevant equipment, on the handling and preparation of samples leems and i
j for calibration and/or testing, where the absence of such instructions could J
jeopardize the calibrations or tests.
3 j
b)
Allinstructions, standards, manuals and reference data relevant to the work of l
the laboratory shall be maintained up-to-date and be readily available to the j
staff.
{
5.10.1.1 Standard operating Procedures (SOPS) i Laboratories shall maintain standard operating procedures that l
accurately reflect all phases of current laboratory activities such as assessing data integrity, corrective actions, handling customer l
complaints, and all test methods.
l a)
These documents may be agaipment manuals provided by the j
manufacturer, or internally written documents.
t j
b)
The test methods may be copies of published methods as long as any changes in the methods are documented and included in the i
methods manual (see 5.10.1.2).
c)
Copies of all SOPS shall be accessible to all personnel.
I j
d)
The SOPS shall be logically organized and shall have the i
signature (s) of the approving authority.
l a)
Each SOP shall clearly indicate the effective date of the l
document, and the revision number.
l 5.10.1.2 Laboratory Method Manual (s) i i
e NELAC Quahty Systems Draft June 1,1996 Rmesn 3 Page 5-19 of as a)
The laboratory shall have and maintain an in-house methods manual (s) for each analyte or test to be certified.
b)
This manual may consists of copies of published or referenced methods or standard operating procedures that have been written by the laboratory.
Each method shall include where applicable:
1) identification of the test method and where applicable, the' analyte name with qualifier (the qualifier is a word, phrase or number that better identifies the method; e.g.,
" Iron, Total", or " Chloride, Automated Ferricyanide", or "Our Lab. Method SOP No. 101");
2) applicable matrix or matrices; 3) method detection limit; 4) scope and application; 5) summary of the method; 6) definitions; 7) interferences; 8) safety; i
9) equipment and supplies; 10) reagents and standards; 11) sample collection, preservation, shipment and storage; 12) quality control; 13) calibration and standardization; 14) procedure; 15) calculations; 16) method performance; 17) pollution prevention; 18) data assessment and acceptance criteria for quality l
control measures; 19) corrective actions for out-of-control data; l
20) contingencies for handling out-of-control or l
unacceptable data; t
21) waste management; 22) references; and 23) any tables, diagrams, flowcharts and validation data c)
In cases where minor modifications to the published. method have been made by the laboratory such as change in type of column or change in operating conditions, or where the referenced method is ambiguous or provides insufficient detail such as reagent purity or reagent concentration, these changes or clarifications shall be documented as an appendix to the referenced method.
l
q NELAC l
Quahty Systems Draft June 1,1996 f
I Revision 3
{
Page 5-20 of 36 h
5.10.2 Test Methods I
I a)
The laboratory shall use appropriate methods and procedures for all eelibretiene j
ond tests and related activities within its responsibility (including sampling, j
handling, transport and storage, preparation of items, estimation of uncertainty l
1 of measurement and analysis of eelibretiemend/or test data). They shall be consistent with the accuracy required, and with any standard specifications relevant to the calibrations or tests concerned.
8 1
b)
When the use of mandated methods for a sample matrix is 1
}
required, only those methods shall be used unless an EPA program office allows for the use of performance-based methods or non-legally mandated methods.
In these
- cases, the laboratory shall meet the relevant start-up and ongoing 1
validation procedures and calibrations as specified in j
5.10.2.1 including a method detection limit study (D.1.4.a. ).
1 j
c)
Where methods are not specified, the laboratory shall, wherever possible, select i
methods that have been published in international or national standards, those i
published by reputable technical organizations or in relevant scientific texts or l
journals.
)
d)
Where it is necessary to employ methods that have not been established as i
standard, these shall be subject to agreement with the accrediting authority and client, be fully documented and validated, and be available to j
the client and other recipients of the relevant reports.
e)
The criteria listed in 5.10.2 b must be met for all methods.
5.10.2.1 Method Validation / Initial Demonstration of Method l
Performance j
Prior to acceptance and institution of any method, satisfactory initial demonstration of method performance, in conformance with i
the relevant EPA guidelines, is required.
In the absence of j
nGthod-specified requirements, this demonstration shall follow the cutlined protocols in Appendix C of this document.
Thereafter, continuing demonstration of method performance, in conformance with the relevant EPA guidelines, is required.
In both cases, the cppropriate standard performance checklist (see Appendix C) must be completed and retained by the laboratory to be made available upon rcquest.
All associated supporting data necessary to reproduce the cnalytical results summarized in the checklists must be retained by i
the laboratory.
Initial demonstration of method performance must l
be completed each time-there is a change in equipment, personnel or j
procedure.
a 6
l i
NELAC Quanty Systems Draft June 1,1998 Revision 3 Page 5-21 of SS 5.10.3 sample Aliquots Where sampling las in obtainina sample aliqruots irgin a submitted sample) is carried out as part of the test method, the laboratory shalf use documented procedures and appropriate statistical techniques to obtain reeresentative subsamples.
- '::: C z j ::.
5.10.4 Data verification Calculations and data transfers shall be subject to appropriate checks.
a)
The laboratory shall establish Standard Operating Procedures to ensure that the reported data is free from transcription and calculation errors, b)
The laboratory shall establish a Standard Operating Procedures to ensure that all quality control measures are reviewed, and evaluated before data is reported.
5.10.5 Documentation and Labeling of Standards and Reagents Documented procedures shall exist for the purchase, reception and storage of j
consumable materials used for the technical operations of the laboratory.
a)
The laboratory shall retain records, such as manufacturer's statement of purity, of the origin, purity and traceability of all standards and reagents (including balance weights and thermometers).
These records shall include the date of
{
receipt, storage conditions, and, if applicable, the date of l
opening and an expiration date.
b)
Detailed records shall be maintained on reagent and standard preparation.
These records shall indicate traceability to purchase stocks or neat compounds, and must include the date i
i of preparation and preparer's initials.
i l
c)
Where calibrations do not include the generation of a
calibration
- curve, such as thermometers,
- balances, or j
titrations, records shall indicate the calibration date and l
type (balance weight, thermometer serial number, primary standard concentration) of calibration standard that was used.
d)
All prepared reagents and standards must be uniquely o
identified and the contents shall be clearly identified with j
preparation date, concentration (s) and preparer's initials.
i s,.
-,,-.-.c
.. ~ - - - - -... ~
e a I l
NELAC Quakty Systems Draft June 1,1996 Revision 3 i
Page 5-22 of 36 l
l j
5.10.6 Computers and Electronic Data Related Requirements j
j Where computers or automated equipment are used for the capture, processing,
{
manipulation, recording, reporting, storage or retrieval of esilbretion.or test data, the j
laboratory shall ensure that:
o) v.W requirements of this Standard Guide are compNed with.
section 8.1 through 8.11 of t,he EPA Document "2185 Good Automated Laboratory Practicas" (1995), shall be adopted as the standard for all laboratories employing microprocessors and computers.
b) computer software is documented and adequate for use; I
c) procedures are established and implemented for protecting the integrity of data; such procedures shallinclude, but not be limited to, integrity of data entry or capture, data storage, data transmission and data processing; d) computer and automated equipment is maintained to ensure proper functioning and provided with the environmental and operating conditions necessary to maintain the integrity of calibration and test data; e) it establishes and implements appropriate procedures for the malt tenance of security of data including the preventior, of unauthorized access to, and the unauthorized amendment of, computer records.
5.11 SAMPLE BANDLING, SAMPLE ACCEPTANCE POLICY AND SAMPLE RECEIPT
]
Regardless of the laboratory's level of control over sampling 1
cctivities, the following are essential to ensure sample integrity i
and valid data.
5.11.1 sample Tracking a)
The laboratory shall have a documented system for uniquely identifying the items to be eelibreted-ee tested, to ensure that there can be no confusion regarding the identity of such items at any time.
This system shall include identification for all
- samples, subsamples and subsequent extracts and/or digestates.
The laboratory shall assign a unique identification (ID) code to each sample container received in the laboratory.
Multiple aliquots of a sample that have been received for different analytical tests, such as nutrients,
- metals, or VOCs, must be assigned a different ID code, such as a prefix or suffix.
The use of container shape, size or other physical characteristic, such as amber glass, or purple top, is not an acceptable means of
~.. - - _. -
a 4
I NELAC l
Quakty Systems Drott June 1,1996 4
)
Revision 3 Page 5 23 of 36 i
identifying the sample.
b)
This-laboratory code shall maintain an unequivocal link with the unique field ID code assigned each container.
c)
The laboratory ID code shall be placed on the sample container as a durable label.
d)
The laboratory ID code shall be entered into the. laboratory records (see 5.11.3.d) and shall be the link that associates the sample with related laboratory activities such as sample preparation or calibration.
e).
In cases where the sample collector and analyst are the same individual or the laboratory preassigns numbers to sample containers, the laboratory ID code may be the same as the field ID code.
5.11.2 sample Acceptance Policy The laboratory shall have a written sample acceptance policy that clearly outlines the circumstances under which samples will be accepted.
Data from any samples which do not meet the following criteria must be flagged in an unambiguous manner clearly defining the nature and substance of the variation.
This sample acceptance policy shall be made available to sample collecting personnel and shall include, but is not limited to, the following areas of concern:
a)
Proper, full, and complete documentation, which shall include sample identification, the
- location, date and time
'of collection, collector's name, preservation type, sample type and any special remarks concerning the sample; b)
Proper sample labeling to include unique identification and a labeling system for the samples with requirements concerning the durability of the labels (water resistant) and the use of indelible ink; c)
Use of appropriate sample containers.
d)
Adherence to specified holding times; and i
e)
Adequate sample volume.
Sufficient sample volume must be available to perform the necessary tests.
5.11.3 sample Receipt Protocols a)
Upon receipt, the condition of the samole'eelitwetiener4eet4 tem, including any 4
g
NELAC Queirty Systems Draft June 1,1996 Rev6eion 3 Page 5 24 of 36 I
abnormalities or departures from standard condition as prescribed in the-i relevant enlibretion-or test method, shall be recorded. All items specified l
j in 5.11.2 above shall be checked.
j 1)
All samples which require thermal preservation shall be
)
considered acceptable if the arrival temperature is j
within +/-2*C of the requ' ired temperature or the method j
specified range.
For samples with a
specified temperature of 4*C, samples with a temperature of 0.1 to j
6*C shall be acceptable.
Samples that are hand delivered to the laboratory immediately after collection may not
]
meet this criteria.
In these cases, the samples shall i
be considered ac.ceptable if there is evidence that the j
chilling process has begun such as arrival on ice.
I 2)
The laboratory SOP shall define the procedures for
{
checking chamical preservation using readily available j
i techniques, suct: es pH, free chlorine or temperature, j
prior to sample preparation or analysis.
j b)
The results of all checks shall be recorded.
I j
c)
Where there is any doub! as to the item's suitability for testina, eelibretion l
er-teet, where the sample hem does not conform to the description provided, j
or where the ::S :d;.. 0;' test required is not fully specified, the laboratory i
shall consult the client for further instruction before proceeding. The laboratory i
shall establish whether the samols item has received all necessary preparation, i
or whether the client requires preparation to be undertaken or arranged by the laboratory.
If the sample does not meet the sample receipt acceptance criteria listed in 5.11.3.a. 5.11.3.b or 5.11.3.c, l
the laboratory shall either:
i 1)
Retain e-R correspondence and/or records of conversations concerning the final disposition of j
rejected samples; or t
i 2)
Fully document any decision to proceed with the analysis l
of compromised samples:
4 i
1.
The condition of these samples shall, at a minimum, be noted on the chain of custody or transmittal form and laboratory receipt documents.
i
)
}
ii.
The analysis data shall be appropriately
" qualified" on the final report.
d)
The laboratory shall utilize a permanent, sequential log, such 3
as a log book or electronic record, to document receipt of all 1
l-NELAC 4
Quality Systems Dreft June 1,1996 Revision 3 Page 5 25 of 38 i.
sample containers. The following information must be recorded j
in the laboratory chronological log:
Y l
1)
Date and time of laboratory receipt of sample; 2)
Sample collection date; 3)
Unique laboratory ID code (see 5.11.1);
j 4)
Field ID code supplied by sample submitter;
)
5)
Requested analyses, including approved method number, if j
applicable; I
6)
Signature or initials of data logger; i
7)
Comments resulting from inspection for sample acceptance i
rejection; and j
8)
Sampling kit code (if applicable).
e)
All documentation, such as memos or transmittal forms, that is i
transmitted to the laboratory by the sample transmitter shall i
be retained.
l 1
f)
A complete chain of custody record (Section 5.12.4),
if
}
utilized, shall be maintained.
5.11.4 storage conditions l
The laboratory shall have documented procedures and appropriate facilities to avoid i
deterioration or damage to the sample ::S:;;::
- 50
- m, during storage, j
handling, preparation, and eelibeetion er test; any relevant instructions provided with j
the item shall be followed. Where items have to be stored or conditioned under specific environmental conditions, these conditions shall be maintained, monitored and recorded where necessary.
/
l a)
Samples shall be stored according to the conditions specified by preservation protocols:
i i
1)
Samples which require thermal preservation shall be i
l stored under refrigeration which is +/-
2' of the specified preservation temperature unless method specific i
criteria exist. For samples with a specified temperature of 4*C, samples with a temperature of 0.1 to 6*C shall be i
acceptable.
3 2)
Samples shall be stored away from all standards, I
- reagents, food and other potentially contaminating sources.
i b)
Sample fractions,
- extracts, leachates and other sample preparation products shall be stored according to 5.11.4.a above or according to specifications in the method.
i
l
~
NELAC ouskty Systems Droft j
June 1,1996 Page 36 c.
Where a sample ;;!!b:::!;.;:: :::: h:. or portion of tha sample-en4 tem is i
to be held secure (for example, for reasons of record, safety or value, or to l
enable check calibrations or tests to be performed later), the laboratory shall l
i have storage and security arrangements that protect the condition and integrity l
of the secured items or portions concerned.
)
5.11.5 sample Disposal The laboratory shall have documented procedures for the receipt, retention or safe j
disposal of calibration or test items, including all provisions necessary to protect the integrity of the laboratory, i
j 5.12 RECORDS i
The laboratory shall maintain a record system to suit its particular circumstances and I
comply with any applicable regulations.
Tha system shall produce uneauivocal, accurate records which document all laboratorv activities. Ihg laboratorv -4t shall retain on record all original observations, calculations and derived data, calibration records and a copy of the eelibretion
- f
- :, :::: :::: f!::::, ;; test report for an appropriate period.
There are two levels of record keeping:
- 1) sample custody or tracking and 2) legal or evidentiary chain of custody.
All ossential requirements for sample custody are outlined in Sections 5.12.1, 5.12.2 and 5.12.3.
The basic requirements for legal chain of custody (if required or implemented) are specified in Section 5.12.4.
5.12.1 Record Keeping system and Design The records for each eelibration-end test shall contain sufficient information to permit th::: repetition.
The record keeping system must allow historical reconstruction of, all laboratiory activities that produced the resultant sample analytical data.
The history of the sample must be readily understood through the documentation.
This shall i
include interlaboratory transfers of samples and/or extracts.
a)
The records shall include the identity of personnel involved in sampling, i
preparation, calibration or testing.
b)
All information relating to the laboratory. facilities equipment, analytical
- methods, and related laboratory activities, such as sample receipt, sample preparation, or data verification shall be documented.
c)
The record keeping system shall facilitate the retrieval of
s NELAC Quality Systems Draft June 1.1996 Revision 3 Page 5-27 of 36 all working files and archived records for inspection and verification purposes.
d)
All documentation entries shall be signed or initialed by l
responsible staff. The reason for the signature or initials shall be clearly indicated in the records such as " sampled j
by",
" prepared by", or " reviewed by").
e)
All generated data except those that are generated by automated data collection systems, shall be recorded directly, promptly and legibly in permanent ink.
f)
Entries in records shall not be obliterated by methods such as erasures, overwritten files or markings.
All corrections to j
record-keeping errors shall be made by one line marked through the error.
The individual making the correction shall sign 4
l (or initial) and date the correction.
These criteria also l
shall apply to electronically maintained records.
g)
Refer to 5.10.6 for Computer and Electronic Data.
5.12.2 Records Management and Storage a)
All records (including those pertaining to calibration and test equipment),
certificates and reports shall be safely stored, held secure and in confidsnce to the client. NELAC-related records shall be available to the accrediting authority.
i b)
All records of an organization that are pertinent to a specified project shall be retained for a minimum of five years unless otherwise designated for a longer period of time i
in another regulation.
The records specified in 5.12.3 and 5.12.4 above shall be retained.
All hardware and software necessary for the historical reconstruction of data must be 4
maintained by the laboratory.
c)
Records that are stored or generated by computers or personal computers (PCS) shall have hard copy or write-protected backup copies.
d)
The laboratory shall establish a document control system which ensures that all standard operating procedures, manuals, or documents clearly indicate the time period during which the procedure or document was in force.
f)
Access to archived information shall be documented with an access log.
These records shall be protected against fire, theft, loss, environmental deterioration, vermin and, in the case of' electronic records, electronic or magnetic sources.
f 1
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e NELAC 1
Quahty Systems Draft i
June 1,1996 ReWeion 3 Page 5 28 of 36 j
h)
In the event that a laboratory transfers or goes out of business, the laboratory shall have a plan to ensure that the 2
records are maintained or transferred according to the j
clients' instructions.
1 5.12.3 Laboratory Sample Tracking 5.12.3.1 Sample Bandling A record of all procedures to which a sample is subjected while in the possession of the laboratory shall be maintained.
These shall include but are not limited to all records pertaining to.
a)
Sample preservation including appropriate sample container and compliance with holding time; j
b)
Sample identification, receipt, acceptance or rejection and log-in; c)
Sample storage and tracking including shipping receipts, j
transmittal
- forms, and internal routing and assignment l
records; d)
Sample preparation including cleanup and separation protocols, ID codes,
- volumes, weights, instrument printouts, meter l
readings, calculations, reagents; i
e)
Sample analysis; f)
Standard and reagent origin, receipt, preparation, and use; g)
Equipment receipt, use, specification, operating conditions I
.and preventative maintenance; j
h) calibration criteria, frequency and acceptance criteria; i
i)
Data and statistical calculations,
- review, confirmation, interpretation, assessment and reporting conventions; j)
Method performance criteria including expected quality control requirements; k)
Quality control protocols and assessment; 1)
Electronic data
- security, software documentation and verification, software and hardware audits,
- backups, and records of any changes to automated data entries; l
n)
All automated sample handling systems; n)
Records storage and retention; and o)
Sample disposal including the date of sample or subsample i
disposal and name of the responsible person.
5.12.3.2 Laboratory Support Activities i
In addition to documenting all the above-mentioned activities, the l
following shall be retained:
a)
All original raw data, whether hard copy or electronic, for l
calibrations, samples and quality control measures, including analysts work sheets and data output records (chromatograms,
}
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i NE1AC Quality Systems Draft June 1,1996 Reenm 3 Page 5 29 of 36 strip charts, and other instrument response readout records);
b)
A written description or reference to the specific method used
{
which includes a description of the specific computational steps used to translate parametric observations into a reportable analytical value; c)
Copies of. final reports; d)
Archived standard operating procedures; e)
Correspondence relating to laboratory activities for a
specific project; f)
All corrective action reports, audits and audit responses; g)
Proficiency test results and raw data; and h)
Data review and cross checking.
5.12.3.3 Analytical Records The essential information to be associated with analysis, such as strip charts, tabular printouts, computer data files, analytical notebooks, and run logs, shall include:
a)
Laboratory sample ID code; b)
Date of analysis; c)
Instrumentation identification and instrument operating conditions / parameters (or reference to such data);
d)
Analysis type; e)
All calculations (automated and manual); and f)
Analyst's or operator's initials / signature.
5.12.3.4 Administrative Records The following shall be maintained:
a)
Personnel qualifications, experience and training records; j
b)
Initial and continuing demonstration of proficiency for each analyst; and i
c)
A log of names, initials and signatures for all individuals who are responsible for signing or initialing any laboratory 4
record.
5.12.4 Legal or Rvidentiary custody Procedures The use of legal chain of custody (COC) protocols is strongly recommended and may be required by some state or federal programs.
j In addition to the records listed in 5.12.3 and the performance standards outlined in 5.12.1 and 5.12.2, the following protocols shall be incorporated if legal COC is implemented by the organization.
i l
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NELAC ouelity Systems Draft June 1,1996 Revision 3 Page 5-30 of 36 5.12.4.1 Basic Requirements The chain of custody records shall establish an intact, contiguous record of the p'tysical possession, storage and disposal of sample i
containers, collected samples, sample aliquots, and sample extracts or digestates.
For ease of discussion, the above-mentioned items shall be referred to as samples:
a)
A sample is in someone's custody if:
3 1)
It is in one's actual physical possession; 2)
It is in one's view, after being in one's physical possession; 3)
It is in one's physical possession and then locked up so that no one can tamper with it; 4)
It is kept in a secured area, restricted to authorized i
personnel only.
b)
The COC records shall account for all time periods associated with the samples.
c)
The COC records shall include signatures of all individuals who had access to individual samples.
d)
In order to simplify record-keeping, the number of people who physically handle the sample should be minimized.
A 4
designated sample custodian, who is responsible for receiving, storing and distributing samples is recommended.
o)
The COC records are not limited to a single form or document.
However, organizations should attempt to limit the number of documents that would be required to establish Coc.
f)
I,egal chain of custody shall begin at the point established by the federal or state oversight program.
This may begin at the point that cleaned sample containers are provided by the laboratory or the time sample collection occurs.
g)
The COC forms shall remain with the samples during transport or shipment.
h)
If samples are shipped, the shipping container shall be sealed in such a manner so that tampering by unauthorized personnel is immediately evident.
1)
Mailed packages should be registered with return receipt
e a
NELAC Quahty Systems Draft June 1,1996 ReWeion 3 Page 5 31 of 36 requested.
If packages are sent by common carrier, receipts should be retained as part of the permanent chain-of-custody documentation, j)
If required, individual sample containers shall be sealed in such a way to prevent tampering.
k) once received by the laboratory, laboratory personnel are responsible for the care and custody of the sample and must be prepared to testify that the sample was in their possession and view or secured in the laboratory at all times from the moment it was received from the custodian until the time that the analyses are completed or the sample is disposed.
5.12.4.2 Required Information in Custody Records In addition to the information specified in 5.11.1.a and 5.11.1.b, tracking records shall include, by direct entry or linkage to other records:
a)
Time of day and calendar date of each transfer or handling procedure; b)
Signatures of all personnel who physically handle the sample (s);
c)
All information necessary to produce unequivocal, accurate records that document the laboratory activities associated with sample receipt, preparation, analysis and reporting; and d)
Common carrier documents.
5.12.4.3 controlled Access to samples Access to all legal samples and subsamples shall be controlled and documented.
a)
A clean, dry, isolated room, building, and/or refrigerated space that can be securely locked from the outside must be designated as a custody room.
b)
Where
- possible, distribution of samples to the analyst performing the analysis must be made by the custodian (s).
}
c)
The laboratory area must be maintained as a secured area, restricted to authorized personnel only.
d)
Once the sample analyses are completed, the unused portion of the sample, together with all identifying labels, must be
a e
l NELAC Ouelety Systems Dren 4
June 1,1996 Revision 3 Page 5 32 of 36 i
returned to the custodian. The returned tagged sample must be i
retained in the custody room until permission to destroy the sample is received by the custodian or other authority.
I j
5.12.4.4 Transfer of Samples to Another Party i
Transfer of samples, subsamples, digestates or extracts to another j
party are subject to all of the requirements for legal chain of
- custody, 1
i 5.12.4.5 sample Disposal j
0)
If the sample is part of litigation, disposal of the physical sample shall occur only with the concurrence of the affected legal authority, sample data user and/or submitter of the l
sample.
l b)
All conditions of disposal and all correspondence between all parties concerning the final disposition of the physical j
sample shall be recorded and retained.
i c)
Records shall indicate the date of disposal, the nature of j
disposal (such as sample
- depleted, sample disposed in i
hazardous waste facility, or sample returned to client), and the name of the individual who performed the task.
5.13 LABORATORY REPORT FORMAT AND CONTENTS The results of each ::::i::tha, test, or series of eelibretieneer tests carried out by the l
laboratory shall be reported accurately, clearly, unambiguously and objectively, in l
cccordance with any instructions in the esiibeetion-ee test methods. The results shall eheuid normally be reported in a eelibed:n ::n!:::::, test report or teet l
eartifieete and shall showid include all the information necessary for the interpretation of the ::!!i :i er test results and all information required by the method used.
n)
Each ::::::::;;; ;; report shall include at least the following information (those l
prefaced with "where relevant" are not aandatory):
1, j
1) a title, e.g. "C:::t ::::n C;;;;;:::::", " Test Report", or " Test Certificate",
" Certificate of Results" or " Laboratory Results";
2) name and address of laboratory, and location where the ::::i:::!:n ::
l test was carried out if different from the address of the laboratory and phone number with name of contact person for questions;
}
3) unique identification of the certificate or report (such as serial number) 1
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NELAC 4'
Quahty Systems Desft j
June 1,1996 Revision 3 i
Paes 5-33 of 36 j
and of each page, and the total number of pages; j
This requirement may be presented in several ways:
{
i.
The total number of pages may be listed on the 4
first page of the report as long as the subsequent j
pages are identified by the unique-report i
identification and consecutive numbers, or 11.
Each page is identified with the unique report j
identification, the pages are identified as a number of the total report pages (example: 3 of 10, j
or 1 of 20).
j other methods of identifying the pages in the report may i
be acceptable as long as it is clear to the reader that I
discrete pages are associated with a specific report, and that the report contains a specified number of pages.
l 1
4) name and address of client, where appropriate and project name if
}
applicable; 5) description and unambiguous identification of the 5;:= ::::i ::: :
tested sample including the client identification code; j
6) characterization and condition of the samole ::!!br:::::::::::!::=;
7) date of receipt of sample ::!i ::;n :: ::::!::=, date and time of sample collection, and date(s) of performance efeelibretio#Hw test, wh;;; ;;::;:::::, and time of sample preparation and/or analysis if the required holding time for either activity l
is less than or equal to 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br />; 8) identification of the ::::t:::!;; :: test method used, or unambiguous
{
description.of any non-standard method used; i
i
{
9) where relevant, reference to sampling procedur, t::: ::'.:V:G;;
i 10) any deviations frn n, additions to or exclusions from the-eelibration-ee test method, and a1y other information relevant to a specific eelibretion er test, such as environmental conditions including the use of j
relevant data qualifiers; 1
11) measurements, examinations and derived results, supported by tables, graphs, sketches and photographs as appropriate, and any failures j
identified; A
description of the transformations, 1
i i
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-m
~.----,n n
NELAC Quahty Systems Draft June 1,1996 Rev6eion 3 Pese 5-34 of 36 calculations, or operanons performed on the data, a summary and analysis of the data.
Where applicable, identification of whether data is calculated on a dry weight or wet weight basis; identification of the reporting units such as ug/l or ag/kg and for Whole Effluent Toxicity, identification of the statistical package used to provide data.
12) where relevant, a statement of the estimated uncertainty of the l
eelibration-ee test result 'wh;;; ;;5: ;O; I
In situations where required by the client or regulatory agency, this information shall be provided.
It may be required of laboratories involved in trace analyses, where there is an uncertainty associated with detection limits.
l 13) a signature and title, or an equivalent identification of the person (s) l accepting responsibility for the content of the certificate or report
{
(however produced), and date of issue; l
14) where relevant, a statement to the effect that the results relate only to the items eelibreted-er tested nr in.t.hg sanple am received h the laboratory:
15) a statement that the certificate or report shall not be reproduced except in full, without the written approval of the laboratory; j
16)
Clear identification of all data provided by outside
- sources, such as air temperature or ambient water l
l temperature; 1
]
b)
Laboratories who are operated by a facility and whose sole j
function is to provide data to the facility management for compliance purposes must provide items 1,3,4,5,7,8,10, and 11
-l from the above list to management.
The facility management I
must assure that the remaining items are added in the report to the regulatory authority.
q l
c)
Where the certificate or report contains results of enlibratieno-oe tests performed by sub-contractors, these results shall be clearly identified.
4 q
j d)
Particular care and attention shall be paid to the arrangement of the certificate
}
or report, especially with regard to presentation of the eelibrationaw test data i
and ease of assimilation by the reader. The format shall be carefully and 4
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NELAC Quahty Systems Draft June 1,1996 Revision 3 Page 5-35 of 36 i
specifically designed for each type of eeldwetion or test carried out, but the headings shall be standardized as far as possible.
e)
After issuance of the report, the laboratory report shall l
remain unchanged.
Material amendments to a calibration certificate, test report or test certificate after issue shall be made only in the form of a further document, or data transfer' including the statement " Supplement to Gelibration C;r :'! ::: ';; Test Report or Test Certificate), serial number... [or as j
otherwise identified]", or equivalent form of wording. Such amendments shall j
meet all the relevant requirements of this Standard Guide.
f)
The laboratory shall notify clients promptly, in writing, of any event such as the j
identification of defective measuring or test equipment that casts doubt on the validity of results given in any calibration certificate, test report or test certificate or amendment to a report or certificate.
i g)
The laboratory shall ensure that, where clients require transmission of j
- br:::; ; : test results by telephone, telex, facsimile or other electronic or electromagnetic means, staff will follow documented procedures that ensure i
that the requirements of this Efandard Guide are met and that confidentiality is
{
preserved.
j h)
The laboratory shall certify that the test results meet all i
requirements of NELAP or provide reasons and/or justification if they do not.
4 4
5.14 SUBCONTRACTING ANALYTICAL 8 AMPLE 8 a)
Where a laboratory sub-contracts any part of the enlibratierHw testing, this work shall be placed with a laboratory complying with these requirements (that in the laboratory shall ha accredited under NELhC). The laboratory shall ensure and be able to demonstrate that its sub-contractor is competent to perform the activities in question and complies with the same criteria of competence as the laboratory in respect to th's work being sub-contracted. The laboratory shall advise the client in writing of its intention to sub-contract any portion of the testing to another party.
b)
The laboratory shall record and retain details of its investigation of the competence and compliance of its sub-contractors and maintain a register of all sub-contracting.
This register shall include all records i
pertaining to the qualifications of subcontracted laboratories including records of any applicable certifications.
m m
j 1
NELAC Quakty Systems Draft j
June 1,1996 j
Revision 3 Page 5 36 of 36 l
5.1s oUTSIDE StTPPORT SERVICES AND StTPPLIES 1
]
a)
Where the laboratory procures outside services and supplies, other than those referred to in this Standard Guide, in support of eelibretienewpr tests, the laboratory shall use only those outside support services and supplies that are j
of adequate quality to sustain confidence in the laboratory's eelibretienewpr tests.
I i
b)
Where no independent assurance of the quality of outside support services or i
supplies is available, the laboratory shall have procedures to ensure that purchased equipment, materials and services comply with specified i
requirements. The laboratory should, wherever possible, ensure that purchased equipment and consumable materials are not used until they have been l
inspected, calibrated or otherwise verified as complying with any standard j
specifications relevant to the calibrations or tests concerned.
i
{
c)
The laboratory shall maintain records of all suppliers from whom it obtains
]
support services or supplies required for calibrations DI tests.
0 5.16 COMPLAINTS 4
l The laboratory shall have documented policy and procedures for the resolution of cnmplaints received from clients or other parties about the laboratory's activities. A record shall be maintained of all complaints and of the actions taken by the laboratory.
Where a complaint, or any other circumstance, raises doubt concerning the.
laboratory's complisnce with the laboratory's policies or procedures, or with the l
rcquirements of this standard Guide or otherwise concerning the quality of the.
laboratory's calibrations or tests, the laboratory shall ensure that those areas of Cctivity and responsibility involved are promptly audited in accordance with the I
S3ction 5.5.3.1.
4 i
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-~.
NELAC 1
Quakty Systems Draft i
June 1,1996 Revision 3 l
Pope A 1 of 2 4
4 APPENDIX A TECHNICAL REFERENCE 8 i
j 40 CFR Part 136, Appendix A, paragraphs 8.1.1 and 8.2
]
American Association for Laboratory Accreditation 1996.
j General Requirements for Accreditdtion "American National Standards Specification and Guidelines for 4
Quality Systems for Environmental Data Collection and Environmental Technology Programs (ANSI /ASQC E-4)", 1994 4
Catalog of Bacteria, American Type Culture Collection, Rockville, MD j
i EPA 2185 - Good Automated Laboratory Practices, 1995 a
" Glossary of Quality Assurance Terms and Acronyms",
Quality j
Assurance Division, Office of Research and Development, USEPA
" Guidance on the Evaluation of Safe Drinking Water Act Compliance l
Monitoring Results from Performance Based Methods", September 30, 1994, Second draft.
1 International vocabulary of basic and general terms in metrology (VIM):
1984. Issued by BIPM. IEC. ISO. and OIML 4
ISO 3534-1:
" Statistics, vocabulary and symbols Part 1:
j Probability and general statistical terms" i
ISO 7218: Microbiology General Guidance for Microbiological l
Examinations i
ISO 8402:
1986.
Quality - Vocabulary 4
i ISO 9000:
1987.
Quality management and quality assurance standards - Guidelines for selection and use i
ISO 9001:
1987.
Quality Systems - Model for quality assurance in l
design / development, production, installation and servicing i
ISO 9002:
1987.
Quality systems - Model for quality assurance in i
production and installation ISO /IEC Guide 2:
1986.
General terms and their definitions concerning standardization and related activities ISO /IEC25:
1990.
General requirements for the competence of calibration and testing laboratories
NELAC Quakty Systems Draft June 1,1996 Revision 3 Page A 2 of 2
" Laboratory Biosafety Manual *, World Health Organization, Geneva, 1983 Manual for 12e Certification of Laboratories Analyzing Drinking Water EPA.f/0/9-90/008
/
Manual of Method for General Bacteriology, Philipp Gerhard at al.,
American Society for Microbiology, Washington, 1981 Performance Based Measurement System, EPA D9fC Method Panel, PBM workgroup, 1996 I
l l
4 l
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l l
.. - - - - - ~ ~
.~_
.-= ---
is NE.AC '
i Quality Systeme Draft June 1,1996 Revision 3 i
Page S 1 of 11 APPENDIZ B DEFINITIONS FOR QUALITY SYSTEMS The following definitions are used in the text of Quality Systems.
In writing this document, the following hierarchy of definition references were used:
ISO 8402, ANSI /ASQC E-4, EPA's Quality i
Assurance Division Glossitry of Terms, and finally definitions developed by NELAC and/or the Quality Assurance Standing Committee.
The source of each definition is noted.
)
Acceptable Criteria:
Specified limits placed on characteristics l
of an item, process, or service defined in requirement documents.
j (ASQC) 1 Accreditation: the process by which an agency or organization evaluates and recognizes a program of study or an institution as meeting certain predetermined qualifications or standards, thereby i
accrediting the laboratory.
In the context of the National j
Environmental Laboratory Accreditation Program (NELAP),
this j
process is a voluntary one.
(NELAP) l Accrediting Authority:
the agency having responsibility and
}
accountability for environmental laboratory accreditation and who j
grants accreditation.
For the purposes of NELAC, this is EPA,
{
other federal agencies, or the state.
(NELAP)
Accrediting Body:
the organization that actually executes the j
accreditation process, i.e.,
receives and reviews accreditation i
applications, reviews QA documents, reviews proficiency testing i
- results, surveys the site,
'etc.,
whether EPA, the state, or contracted private party.
(NELAP)
?
j Accuracy:
the degree of agreement between an observed value and an i
accepted reference value.
Accuracy includes a combination of random error (precision) and systematic error (bias) components j
which are due to sampling and analytical operations; a data quality indicator. (Glossary of Quality Assurance Terms, QAMS, 8/31/92).
j!
Analytical Reagent (AR) Grades designation for the high purity of certain chemical reagents and solvents given the American 4
Chemical Society.
(Quality Systems)
Batch:
environmental samples which are prepared and/or analyzed j
together with the same process and personnel, using the same lot (s) j of reagents, with a maximum time between the start of processing of i
the first and last sample in the batch to be 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />.
The size of i
a batch can range from one environmental sample to 20 environmental i
samples.
All environmental samples in the batch must be of the t
i i
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i i
NELAC Quakty Systems D,ett June 1,1996 Rev6sion 3 Fece 9 2 of 11 1
came matrix as defined by NEIAC.
The resulting
- extracts, digestates or concentrates may be combined to into any analytical batch.
An analytical batch can include prepared samples criginating from various environmental matrices and can exceed 20 j
camples. (Quality systems)
Olanks A sample that has not been exposed to the analyzed sample Otream in order to monitor contamination during
- sampling, transport,~ storage or analysis.
The blank is subjected to the l
usually analytical and measurement process to establish a zero baseline or background value and is sometimes used to adjust or carrect routine analytical results.
(ASQC, Definitions of Environmental Quality Assurance Terms,1996)
Blind samples a subsample for analysis with a composition known to the submitter.
The analyst / laboratory may know the identity of the
{
cCaple but not its composition.
It is used to test the analyst's cr laboratory's proficiency in the execution of the measurement
-process, t
C211brations the set of operations which establish, under cpecified conditions, the relationship between values indicated by 1
a measuring instrument or measuring system, or values represented l
by a material measure, and the corresponding known values of a Esasurand.
(VIM - 6.13) l
}
Calibrate to determine, by measurement or comparison with a standard, the correct value of each scale reading on a meter or i
other devise, or the correct value for each setting of a control knob.
The levels of the applied calibration standard should j
bracket the range of planned or expected sample measurements.
4 Calibration curve:
the graphical relationship between the known i
- values, such as concentratior s, of a
series of calibration j
standards and their instrument response, i
j Calibration Method: Defined technical procedure for performing a i
calibration.
1 Calibration standard:
a solution prepared from the primary 4
dilution standard solution or stock standard solutions and the j
internal standards and surrogate analytes.
The Calibration colutions are used to calibrate the instrument response with respect to analyte concentration.
(Glossary of Quality Assurance
{
Torms, QAMS, 8/31/92).
C0rtified Reference Material (CRM):
A reference material one or j
nore_of whose property values are certified by a technically valid procedure, accompanied by or traceable to a certificate or other i
4 a
j
1 4
g NELAC Quahty Systems Draft June 1,1996 Revision 3 Pope B-3 of 11 i
documentation which is issued by a certifying body.
(ISO Guide 30 l
- 2.2)
Chain of custody an unbroken trail of accountability that insures the physical security of samples, data and records.
I compromised samples:
thos'e samples which were improperly sampled, or with insufficient documentation (chain of custody and other sample records and/or labels),
improper preservation and/or containers were used, or the holding time has been exceeded. Under normal conditions compromised samples are not analyzed.
If emergency situations require
- analysis, the results must be appropriately qualified.
Confirmation:
verification of the presence of a component through the use of an analytical technique based on a different scientific principle from the original method.
These may include:
Second column confirmation Alternate wavelength Derivatization Mass spectral interpretation i
Alternative detectors or Additional cleanup procedures.
Corrective Action:
action taken to eliminate the causes of an existing nonconformity, defect or other undesirable situation in order to prevent recurrence.
(ISO 8402)
Data Audit:
a qualitative and quantitative evaluation of the documentation and procedures associated with environmental measurements to verify that the resulting data are of acceptable j
quality (i.e., that they meet specified acceptance criteria.
Data Reductions the process of transforming raw data by arithmetic or statistical calculations, standard
- curves, concentration factors, etc., and collation into a more useful form.
Document controls the act of ensuring that documents (and revisions thereto) are proposed, reviewed for accurecy, approved s
for release by authorized personnel, distributed properly and controlled to ensure use of the correct version at the location where the prescribed activity is performed.
(ASQC, Definitions of Environmental Quality Assurance Terms, 1996)
Double Blind samples a sample submitted to evaluate performance with concentration and identity unknown to the analyst.
Duplicate Analysost the analyses or measurements of the variable of interest performed identically ?n two subsamples of the
--w
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NELAC Quakty Systems Draft June 1,1996 Revisiert 3 q
Page B 4 of 11 i
came sample.
The results from duplicate analyses are used to cvaluate analytical or measurement precision but not the precision j
cf sampling, preservation or storage internal to the laboratory.
J Bolding Times (Maximum Allowable Bolding Times): the maxih times j
that samples may be held prior to analysis and still be con.Adered l
valid. (40 CFR Part 136).
)
Initial Demonstration of Analytical capability:
procedure to cstablish the ability to generate acceptable accuracy and precision which is included in many of the EPA's analytical methods.
In i
i general the procedure includes the addition of a
specified j
concentration of each analyte (using a QC check sample) in each of j
four separate aliquots of laboratory pure water.
These are carried through the entire analytical procedure and the percentage recovery cnd the standard deviation are determined and compared to specified j
limits. (40 CFR Part 136).
4 Instrument Blank: a clean sample (e.g., distilled water) processed
[
j through the instrumental steps of the measurement process; used to l
determine instrument contamination.
(Glossary of Quality Assurance 1
Torms, QAMS, 8/31/92).
t j
Internal standard:
a known amount of standard added to a test portion of a sample and carried through the entire measurement l
process as a reference for evaluating and controlling the precision j
and bias of the applied analytical method.
Laboratory:
Body that calibrates and/or tests.
?
i I
NOTES:
i j
1.
In cases where a laboratory forms part of an organization that carries out other activities besides calibration and testing, j
j the term
" laboratory" refers only to those parts of that l
crganization that are involved in the calibration and testing i
process.
2.
As used herein, the term " laboratory" refers to a body
~
j that carries out calibration or testing
- at or from a permanent location,
- at or from a temporary facility, or l
j
- in or from a mobile facility.
(ISO ???)
Laboratory control sample (quality control sample):
an uncontaminated sample matrix spiked with known amounts of analytes i
from a source independent of the calibration standards.
It is g:nerally used to establish intra-laboratory or analyst specific j
precision and bias or to assess the performance of all or a portion i
of the measurement system.
(Glossary of Quality Assurance Terms, j
i i
l I
NELAC i
Quahty Systems Draft June 1,1996 Row 6eion 3 i
Page B-5 of 11
(
QAMS, 8/31/92).
Laboratory Duplicate:
Aliquots-of a sample taken from the same cot.tainer under laboratory conditions and processed and analyzed independently.
Legal ca.ain of custody (coc): an unbroken trail of accountability I
that ensures the physical security of samples, data and records.
(Glossary of Quality Assurance Terms, QAMS, 8/31/92).
Manager (however named):
the individual designated as being responsible for the overall operation, all personnel, and the physical plant of the environmental laboratory.
A supervisor may report to the manager.
In some cases, the supervisor and the manager may be the same individual.
Matrix:
The component or substrate which contains the analyte of interest.
For purposes of batch determination, the following j
matrix types shall be used:
1 Drinking water:
Any aqueous sample that has been designated a potable or potential potable water source.
i Aqueous:
Any aqueous sample excluded from the definition of a water matrix or Saline / Estuarine source.
Includes surface water, groundwater and effluents.
Saline / Estuarine:
Any aqueous sample from an ocean or estuary, or other salt water source such as the Great Salt Lake.
j Non-aqueous liquid: Any organic liquid with <15% settleable t
solids.
Biological Tissue:
Any sample of a biological origin such as fish tissue, shellfish, or plant material.
Such samples shall be grouped'according to origin.
j Solids:
Includes
- soils, sediments, sludges and other matrices with >15t settleable solids.
i chemical Wr.ste:
A product or by-product of a industrial i
process that results in a matrix not previously defined.
Air Samples:
Media used to retain the analyte of interest 1
from an air sample such as sorbant tubes or summa canisters.
Each medium shall be considered as a distinct matrix.
(Quality Systems) 4 l
Matrix spike (spiked sample, fortified sample): prepared by adding a known mass of target analyte to a specified amount of matrix sample for which an independent estimate of target analyte i
concentration is available.
Matrix spikes are used, for example, to determine the effect of the matrix on a method's recovery efficiency.
(Glossary of Quality Assurance Terms, QAMS, 8/31/92).
Matrix spike Duplicate (spiked sample / fortified sample duplicate):
1 a second replicate matrix spike is prepared in the laboratory and I
analyzed to obtain a measure of the precision of the recovery for 4
f f
.._____._m
[
4 NELAC Quality Systems D,ett i
June 1,1996 I
j Revisson 3 4
y Pge be o 11 l
1 each analyte.
(Glossary of Quality Assurance Terms,
- QAMS,
]
8/31/92).
i Mays permitted, but not required (TRADE) l I
Method Blank:
a clean sample processed simultaneously with and j
under the same conditions as sadples containing an analyte of j
j interest through all steps of the analytical procedures.
(Glossary of Quality Assurance Terms, QAMS, 8/31/92).
7 Method Detection Limit (Analytical Detection Limit):
the minimum
{
concentration of a substance (an analyte) that can be measured and reported with 99% confidence that the analyte concentration is greater than zero and is determined from analysis of a sample in a
~
given matrix contairing the analyte. (4 0 CFR Part 136 Appendix B).
Must denotes a requirement that must be met. (Random House College Dictionary)
Cogative Controls measures taken to ensure that a test, its components, or the environment do not cause undesired effects, or produce incorrect test results.
NELAC: National Environmental Laboratory Accreditation Conference.
A voluntary organization of state and federal environmental officials and interest groups purposed primarily to establish nutually acceptable standards for accrediting environmental laboratories.
A subset of NELAP. (NELAC)
NELAP: the overall National Environmental Laboratory Accreditation Program of which NELAC is a part.
(NELAC)
Performance Audits the routine comparison of independently cbtained quantitative measurement system data with routinely cbtained data in order to evaluate the proficiency of an analyst or laboratory.
Performance Based Measurement System (PBMS): a set of processes wherein the data quality needs, mandates or limitations of a program or project are specified and serve as criteria for colecting appropriate methods to meet those needs in a cost-offective manner.
Proficiency Testing Program: the aggregate of providing rigorously controlled and standardized environmental samples to a laboratory for analysis, reporting of results, statistical evaluation of the results in comparison to peer laboratories and the collective demographics and results summary of all participating laboratories.
A
1 NELAC Quahty Systems Draft June 1,1996 Revision 3 Page &7 of 11 i
Proficiency Test sample (PE):
a sample, the composition of which is unknown to the analyst and is provided to test whether the analyst / laboratory can produce analytical results within specified performance limits.
(Glossary of Quality Assurance Terms, QAMS, 8/31/92).
Positive Controls measufes taken to ensure that a test and/or its components are working properly and producing correct or expected results from positive test subjects.
Precision:
the delgree to which a
set of observations or measurements of the same property, usually obtained under similar conditions, conform to themselves; a data quality indicator.
precision is usually expressed as standard deviation, variance or i
range, in either absolute or relative terms.
(Glossary of Quality Assurance Terms, QAMS, 8/31/92).
Preservation:
refrigeration and or reagents added at the time of j
sample collection to maintain the chemical and or biological j
integrity of the sample.
Preficiency Testing:
Determination of the laboratory calibration or testing performance by means of interlaboratory 4
j comparisons. (ISO /IEC Guide 2 - 12.6, amended)
Protocol: a detailed written procedure for field and/or laboratory operation (e.g.,
- sampling, analysis) which must be strictly j
followed.
Pure Reagent Water:
shall be ASTM Type I or Type II water in which i
no target analytes or interferences are detected as required by the analytical method.
4 Quality Assurance:
an integrated system of activities involving j
- planning, quality
- control, quality assessment, reporting and
~
quality improvement to ensure that a product or service meets defined standards of quality with a stated level of confidence.
(Glossary of Quality Assurance Terms, QAMS, 8/31/92).
Quality control:
the overall system of technical activities whose 4
purpose is to measure and control the quality of a product or service so that it meets the needs of users.
(Glossary of Quality Assurance Terms, QAMS, 8/31/92).
3 Quality control sample:
an uncontaminated sample matrix spiked with known amounts of analytes from a source independent from the calibration standards.
It is generally used to establish intra-laboratory or analyst specific precision and bias or to assess the 3
performance of all or a portion of the measurement system.
1
~. ~ _. _
e NELAC Quality Systeme Draft I
June 1,1996 Revision 3 l
Pete B-S of 11 f
(Glossary of Quality Assurance Terms, QAMS, S/31/92).
1 I
Quality Manual:
A document stating the quality policy, quality cystem and quality practices of an organization.
This may be also
]
called a Quality Assurance Plan or a Quality Plan.
HQIE - The quality manual may call up other documentation relating to the laboratory's quality arrangements.
Quality systems a structured and documented management system l
describing the policies, objectives, principles, organizational cuthority, responsibilities, accountability, and implementation plan of an organization for ensuring quality in its work processes, products (items), and services.
The quality system provides the framework for planning, implementing, and assessing work performed 3
1 l
by the organization and for carrying out required QA and Qc.
(ANSI /ASQC E-41994) i Range:
the difference between the minimum and the maximum of a j
cct of values.
Raw Data any original factual information from a measurement cctivity or study recorded in a laboratory notebook, worksheets, 3
rccords, memoranda, notes,or exact copies thereof and that are
{
nacessary for the reconstruction and evaluation of the report of j
j the activity or study. Raw data may include photography, microfilm cr microfiche copies, computer printouts, magnetic media,' including 4
dictated observations, and recorded data Trom automated i
instruments.
If exact copies of raw data have been prepared (e.g.,
tapes which have been transcribed verbatim, data and verified cccurate by signature), the exact copy or exact transcript may be i
cubmitted.
Reagent Blank (method reagent blank):
a sample consisting of i
reagent (s), without the target analyte or sample matrix, introduced into the analytical procedure at the appropriate point and carried through all subsequent steps to determine the contribution of the reagents and of the involved analytical steps.
(Glossary of Quality Assurance Terms, QAMS, 8/31/92).
i ROference Material A material or substance one or more properties i
of which are sufficiently well established to be used for the calibration of an apparatus, the assessment of a measurement acthod, or for assigning values to materials. (ISO Guide 30 - 2.1)
R0ference standard: A
- standard, generally of the highest j
cGtrological quality available at a given location, from which 4
Coasurements made at that location are derived. (VIM - 6.08) d 4
4 6
~
v
o NELAC Oue ity Systems Dreft June 1.1996 Revision 3 PeGe 9 9 of 11 Requirement:
A translation of the needs into a set of individual quantified or descriptive specifications for the characteristics of an entity in order to enable its realization and examination.
Reference Toxicants see D.2.1.a Replicate Analyses:
the measurements of the variable of-interest performed identically on two or more subsamples of the same sample within a short time interval.
Sample Duplicate: two samples taken from and representative of the same population and carried through all steps of the sampling and analytical procedures in an identical manner.
Duplicate samples are used to assess variance of the total method including sampling and analysis.
(Glossary of Quality Assurance
- Terms, QAMS, 8/31/92).
selectivity:
(Analytical chemistry) the capability of a method or instrument to respond to a target substance or constituent in the presence of nontarget, substances, sensitivity:
the capability of a
method or instrument to discriminate between measurement responses representing different levels (e.g., concentrations) of a variable of interest.
Shalls denotes a requirement that is mandatory whenever the criterion for conformance with the specification requires that there be no deviation.
This does not prohibit the use of alternative approaches or methods for implementing the specification so long as the requirement is fulfilled.
(Style Manual for Preparation of Proposed American National Standards, American National Standards Institute, eighth edition, March 1991).
i i
should denotes a
guideline or recommendation whenever noncompliance with the specification is permissible.
(style Manual i
for Preparation of Proposed American National standards, American National Standards Institute, eighth edition, March 1991).
standard Operating Procedures (sops):
a written document which i
details the method of an operation, analysis or action whose j
techniques and procedures are thoroughly prescribed and which is accepted as the method for performing certain routine or repetitive l
tasks.
(Glossary of Quality Assurance Terms, QAMS, 8/31/92).
4 spikes a known mass of target analyte added to a blank sample or subsample; used to determine recovery efficiency or for other j
quality control purposes.
standard Reference Material (SRM):
a certified reference 1
g 1
l I
i
l 1
NELAC 3
Quality Systems Draft June 1,1996 Revision 3 Pese 510 of 11
)j material produced by the U.S. National Institute of Standards and Technology and characterized for absolute content, independent of i
cnalytical method.
1 j
Cupervisor (however named):
the individual (s) designated as being responsible for a particular area or category of scientific j
cnalysis.
This responsibility includes direct day-to-day l
cupervision of technical employees, supply and instrument adequacy 1
cnd upkeep,.
quality assurance / quality control duties and i
accertaining that technical employees have the required balance of i
cducation, training and experience to perform the required j
cnalyses.
Currogate:
a substance with properties that mimic the analyte of interest.
It is unlikely to be found in environment samples and is cdded to them for quality control purposes.
(Glossary of Quality Assurance Terms, QAMS, 8/31/92).
4 Gystems Audit (also Technical systems Audit):
a
- thorough, oystematic on-site, qualitative review of the facilities, l
cquipment, personnel, training, procedures, record keeping, data
{
validation, data management, and reporting aspects of a total Ecasurement system.
I tonknical Director:
Definition needs to be developed
}
TOchnical Employee:
the designated individual who performs the i
" hands-on" analytical methods and associated techniques and who is tho one responsible for applying required laboratory practices and i
j cther pertinent Quality controls to meet the required level of l
quality.
t Toots A technical operation that consists of the determination
}
of one or more characteristics or performance of a given product,
- noterial, equipment, organism, physical phenomenon, process or cOrvice according to a specified procedure.
1 NOTE - The result of a test is normally recorded in a document cometimes called a test report or a test certificate.
(ISO /IEC i
Guide 2 - 12.1, amended) i Toct Method:
Defined technical procedure for performing a test.
r i
Tooting Laboratory: Laboratory that performs tests. (ISO /IEC Cuide 4
2 - 12.4) 4
]
Traceability:
The property of a result of a measurement whereby it con be related to appropriate standards, generally international or
(
I 1
o-.-
e o
l i
4 NELAC Quality Systems Draft s
June 1,1996 Revision 3 Page 5-11 of 11 4
national standards, through an unbroken chain of comparisons.
(VIM j
- 6.12) l 4
Test sensivity/ Power:
D.2.4.a verification:
confirmation by examination and provision of i
evidence that specified requirements have been met.
NOTE In connection with the management of measuring j
equipment, verification provides a means for checking that the deviations between values indicated by a measuring instrument and corrtemponding known values of a measured quantity are consistently 3
smaller than the maximum allowable error defined in a standard, 1
regulation or specification peculiar to the management of the measuring equipment.
1 The result of verification leads to a decision either to
}
restore in service, to perform adjustments, or to repair, or to j
downgrade, or to declare obsolete.
In all cases it is required that a written trace of the verification performed shall be kept on the measuring instrument's individual record.
validation:
the process of substantiating specified performance i
j criteria.
Verification:
the process of establishing or confirming the truth or factualness of data.
l l
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i s
1 1
.m g.
NELAC Quehty Systems Desft June 1,1996 i
Revision 3 Pope C 1 of 10 i
APPENDIX C j
CHECKLIST FOR DEMONSTRATION OF METROD PERFORMANCE
)
PROCEDURE FOR INITIAL DEMONSTRATION OF CAPABILITY An initial demonstration of method performance must be made prior to using any method, and at any time there is a change of equipment l
personnel or procedure (see 5.10.2.1).
All initial demonstrations, continuing demonstrations and method certification shall be documented through the use of the forms in j
this appendix.
i l
The following steps, which are adapted from the EPA methods published in 40 CFR Part 136, Appendix A, shall be performed:
4 j
a)
A quality control check sample concentrate shall be obtained from EPA or a certified source.
If not available, the QC check sample may be prepared by the laboratory using stock standards that are prepared independently from those used in j
instrument calibration.
b)
The concentrate shall be diluted in a volume of laboratory i
pure water sufficient to prepare four aliquots at the required j
method volume to a concentration approximately 10 times the I
method-stated or laboratory-calculated method detection limit.
4 c)
The four aliquots shall be prepared and analyzed according to the method.
d)
Using the four results, calculate the average recovery ( ) in l
the appropriate reporting units (such as pg/L) and the j
standard deviation (s) (in the same units) for each parameter of interest.
i a)
For each parameter, compare s and to the corresponding I
acceptance criteria for precision and accuracy in the method
{
(if applicable) or laboratory-generated acceptance criteria (if a non-standard method).
If s and for all parameters j
meet the acceptance criteria, the analysis of actual samples j
may begin.
If any one of the parameters exceed the acceptance range, the performance is unacceptable for that parameter.
f)
When one ore more of the tested parameters fail at least one of the acceptance criteria, the analyst must proceed according to 1) or 2) below.
i j
1)
Locate and correct the source of the problem and repeat the test for all parameters of interest beginning with c) i C
a NELAC Quakty Systems Draft June 1,1996 Revision 3 Page C-2 of to above.
2)
Beginning with c)
- above, repeat the test for all parameters that failed to meet criteria.
Repeated failure, however, will confirm a general problem with the measurement system.
If this occurs, locate and correct the source of the problem and repeat the test for all compounds of interest beginning with c).
I l
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- - - _ - - ~ _ -
8 I
NELAC Quahty Systems Draft June 1,1996 Revision 3 Paes C-3 of 10 Nethod Performance System Certification Statement Date:
Page _of _
Facility Name:
Discharge Point ID (where applicable):
EPA Program and Applicable Regulation:
Medium:
(i.e., wastewater, drinking water, soil, sir, waste solid, leachate, sludge, other)
Analyte, Class of Analytes or Measureand (CAS # where available)
(i.e, barium, trace metals, benzene, volatile organics, etc.)
We, the undersigned, CERTIFY that:
- 1. the methods in use at this facility for the analyses of samples for the Programs of the U.S.
Environmental Protection
- Agency, have met the Initial and any required Continuing Demonstration of Method Performance Criteria specified under the Performance-Based System.
2.
A copy of the Performance-Based Method, written in EMMC format, and copies of the reference method and laboratory-specific SOPS are available for'all personnel on-site.
- 3. The data and checklists associated with the initial and continuing demonstration of method performance are true, accurate, complete and self-explanatory.
5
- 4. All raw data (including a copy of this certification form) necessary to reconstruct and validate these performance related i
j analyses have been retained at the
- facility, and that the i
.i
}
True Consistent with supporting data.
1 Accurate: Based on good laboratory practices consistent with sound l
scientific principles / practices.
complete: Includes the results of all supporting performance testing.
self-Explanatory: Data properly labeled and stored so that the resulta j
are clear and require no additional explanation.
l
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w.
y
O NELAC Quehty Systems Draft June 1,1996 Revision 3 Pe9e C-4 of 10 t
associated information is well organized and available for review by authorized inspectors.
Laboratory Manager's Name and Title Signature Date Quality Assurance Officer's Name Signature Date This certification form must be completed when the performance-based method is originally certified, each time the continuing demonstration of method performance is documented and whenever a change of personnel involves the Laboratory Manger or the Quality Assurance Officer.
i i
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Eo s
4 NEU.C Quahty systems Draft i,
June 1,1996 Revision 3 3
Pese c 5 of 10 i
i Checklist for initial Demonstration of Method Performance i
l Provide a checklist (Qt REGb matrix included in the demonstration.
Date:
Page of l
j h F:;;:;i Name:
{
Discharge Point ID (where applicable):
j EPA Program and Applicable Regulation:
i Medium:
j (i.e., wastewater, drinking water, soil, sir, waste solid, leachete, sludge, other) l Analyte, Class of Analytes of Other Measureand:
(i.e., barium, trace metals, benzene, volatile organics, etc.)
i i
1 initial Demonstration of Method Performance (f/ ~^'.
l Category
- .J Performance -
Results Perf.
obtained Spec.
- Criteria t2/
i Based onJ:
Achieved
' V)
^
i Measurement : Reference
. J Quality:
.. f
^
Method,,
- Objective A
4 l
- 1. Written method laddressing all' elements in the j
EMMC format) attached j
- 2. Title, number and date/rev, of " reference method", if applicable (3) i
- 3. Copy of the reference method, if applicable,
{
maintained at facility I
- 4. Differences between PBM and reference method
)
(if applicable) attached
- 5. Concentrations of calibration standards 1
4 d
a NELAC Quality systems Draft June 1,1996 Revision 3 Pese C.e of to initial Demonstration of Method Performance /1)
Category Perfarmance.
. Results
? Perf.
Criteria (2/
Obtained
- Spec. -
Besed on -
Achieved M-Measurement Reference Quality Method Objective
- 6. %RSD or slope / correlation coefficient of calibration regression
- 7. Performance range tested (with units)
- 8. Sample (s) used in initial demonstration have recommended preservative, where applicable.
- 9. Samples (s) used in initial demonstration met recommended holding times, where applicable
- 10. Interferences
- 11. Qualitative identification criteria used
- 12. Performance Evaluation studies performed for i
- nalytes of interest, where available:
j Last study sponsor and title:
l Last study number:
1
- 13. Analysis of extemal reference material j
Last study sponsor and title:
j Last study number:
i
- 14. Authenticity of reference material
- 15. Surrogates used, if applicable 4
j
- 16. Concentrations of surrogates, if applicable I
i a
l 1
j.
i NELAC Quahty Systems Draft i
June 1, te96 Revision 3 i
i Pese C 7 of 1o i
- Initial Demonstraten of Method Performance (11 s
+
4 4
I.
Category.
. Performance
. Results
' :. Perf.
]
Criteria (2):
Obtained
- Spec.'
Based on; Achieved M) i c.
l Measurement' Reference
'I-
. Ouality.
u.
~
Method -
?. Objective' s
)
- 17. Recoveries of Surrogates appropriate to the j
proposed use, i
if applicable l
- 18. Sample preparation i
i
- 19. Clean up procedures 1
1 4
- 20. Method Blank
}
- 21. Matrix (reagent water, drinking water, soil,
{
waste solid, sir, etc.)
- 22. Spiking system, appropriate to method and j
application 1
- 23. Spike levels (w/ units corresponding to final sample concentration)
- 24. Source of spiking material
- 25. Number of spikes t
- 26. Precision (analyte by analyte)
I
- 27. Bias (analyte by analyte) l
- 28. Detection Limit tw/ units; analyte by analyte)
- 29. Confirmation of Detection Limit 1
- 30. Quantiation Limit (w/ units: analyte by analyte)
- 31. Frequency (Initial Demonstration to be performed) 1
- 32. Other criterion (specify) j
- 33. Other criterion (specify) 4,
- 34. Other criterion (specify) i
,i
,.3-.
._-s-..
.m
NELAC Quality Systems Dreft June 1,1996
-~,
Reesion 3 Page C-8 of 10 i.
' Provido a detailed narrative description of the initial demonstration.
- For multi-analyte methods, enter the range of performance critaria and attach an analyte-specific list.
8 If a reference method is the source of the performance criteria, the reference method should be appropriate to the required application, and the listed criteria should be fully consistent with that reference method.
1
]
Name and signature of c:ch analyst involved in the initial demonstration of method j
p rformance-(includes "ll steps in the proposed method / modification):
i N:me Signature Date i
l Nrme Signature Date i
i N me Signature Date
}
The certifiention above must accompany this form each time it is submitted.
^
I
^
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L l
1 e
4
\\
e a
)
)
i NELAC j
Quahty Systems Draft
)
June 1,1996 i
Revision 3 J
Page C-9 of 10 Checklist for Continuing Demonstration of Method Performance
)
i i
Date:
Page _of _
]
Facility Name:
i
.I Discharge Point ID, where applicable:
EPA Program and Applicable Regulation:
Medium:
j (i.e., wastewater, drinking water, soil, sir, waste solid, leachate, sludge, other) 1 Analyte, Class of Analytes or Measureand (CAS # where available)
(i.e., barium, trace metals, benzene, volatile organics, etc.)
i 1
Continuing Demonstration of Method Performance.
4 Caiesory -
Required l spesino noeune Perf. spec.
Perfonnance Obtemed Achieved
}
Cntene
- V1
- 1. Method blank (taken throueh eN etops in the procedure) l
- 2. Conoontre6one of eehbreton etenderde used to worify j
working rense (with unite), where opphoeble 1
- 3. Cahbration verification
- 4. Cahbration eheck etendeed a
i S. Externel QC semple (where evadable) i i
- e. Performence evolustion (PEl studies, if M*-
Last study sponsor and title:
Last study number:
- 7. Det onelytes for which results were "not acceptable"in PE i
j etudy f
- e. Surrogotes used, if applic ble a
- e. Concentration /o of Surro'ptes,if applicable i
i te. Recovery of Surrogates 8 acceptance range for multionelyte methode),if appbcable 1
1 T. Metrix
~
11 Metria spike compounde e
4 A
.m.
__... _. _ _. _ _ _ _ _ _ _ ~ _..
s j
NELAC Quahty Systems Draft June 1,1996 Revision 3 Paes C-10 of 10 i
l
- 13. Ceneontremon of Metris spike sempounde
- 14. Reeevee6es of Metvis spike compounde
- 15. Quebtstive identifiestion evitene used
[
]
is. sempie,repare n 1,. Ca e u.es f
- 18. Connemenon l
1s. other esioee,y is ify>
a i
l ao. oin., o
,y se,.eify>
i i
i i
Name and signature of each analyst involved in continuing demonstration of method performance (includes all steps in the proposed method / modification):
j Name Signature Date I
s Name Signature Date i
4 Name Signature Date The certification above must accompany this form each time it is submitted.
1
+
e e
NELAC Quakty Systems Drott June 1,1996 Revision 3 PeGe D-1 of 19 APPENDII D ESSENTIAL QUALITY CONTROL REQUIREMENTS The method specified and/or method-recommended quality control I protocols shall be followed.
The essential standards outlined'in this appendix shall be used if no protocols are written into the method or if the method protocols are less stringent.
{
D.1 Chemical Testing D.1.1 Positive and Negative Controls a)-
Negative Controls 1)
Method Blanks - Shall be performed at a frequency of one per batch of samples per matrix type per sample extraction or preparation method.
The results of this analysis shall be one of the QC measures to be used to assess batch acceptance.
If blank contamination is found, the analysis of all samples associated with the blank must be stopped until the source of the contamination is identified and measures are taken to correct, minimize or eliminate the problem.
The results of samples affected by the contaminated blank shall either be
{
4 reprocessed for analysis or reported with appropriate data i
j qualifying codes.
i b)
Positive Controls j
1.
Matrix Spikes DL10. - Shall be performed at a frequency of l
one g.20 samples per matrix type per sample extraction or preparation method except for analytes for which spiking solutions are not available such as, total suspended solids, l
total dissolved solids, total volatile solids, total solids, pH, Eelor, odor, temperature, dissolved oxygen or turbidity.
The i
helected sample (s) shall be rotated among client samples so that various matrix problems may be noted and/or addressed.
Poor performance in a matrix spike may indicate a problem with the sample composition and shall be reported to the client whose sample was used for the spike.
i 2)
Laboratory Control Sample - (QC Check Samples) shall be i
l analyzed at a minimum of 1 per batch of 20 or less samples per 4
matrix type per sample extraction or preparation method except for analytes for which spiking solutions are not available such as total suspended
- solids, total dissolved
- solids, total volatile solids, total solids, pH, color, odor, temperature, i
dissolved oxygen or turbidity.
The results of these samples i
shall be used to determine batch acceptance.
NOTE: the Matrix i
l I
NELAC l
Quelity Svetems Dreft June 1,1996 Revision 3 Page D-2 of 19 i
spike (see 1 above) may be used as a control as long as the acceptance criteria are as stringent at the LCs.
Surrogate compounds must be added to all 3)
Surrogates
- samples, standards, and blanks, whenever possible, for all organic chromatography methods.
The acceptance criteria specified by the method sh'all be used to evaluate sample acceptance.
4)
The laboratory is expected to spike all method-listed constituents.
- However, in cases where the constituents interfere with accurate assessment (such as simultaneously spiking chlordane, toxaphene and PCBs in Method 608), the method has an extremely long list of constituents (such as Method 8270 or.6010) or constituents are incompatible, a representative number (10%) of the listed components may be used to control the method.
The selected components shall represent all chemistries, elution patterns and masses and shall include permit specified analytes and other client requested components.
The laboratory shall ensure, however, that all method listed components are used in the spiP.e mixtures within a two-year time period, and that no one component or components dominate the 1
spike mixture.
D.1.2 Analytical variability /Reproducibilit7 Matrix Soike Duolicates (MSDS) Sr Laboratgy,y Duplicates -Shall be analyzed at a minimum of 1 in 20 samples per matrix type per sample cxtraction or preparation method.
The laboratory shall document their procedure to select the use of appropriate type of duplicate.
The selected sample (s) shall be rotated among client samples so that 4'
various matrix problems may be noted and/or addressed.
Poor performance in the duplicates may indicate a problem with the sample composition and shall be reported to the client whose sample was used for the duplicate.
t D.1.3 Method Evaluation i
j In order to ensure the accuracy of the reported result, the following procedures shall be in place:
a)
Initial Demonstration gi Analvtical Canability (Section i
5.10.2.1) shall be performed initially and with a significant change, such as a new analyst, instrument or technique.
b) calibration - Calibration protocols specified in Section 5.10.1 shall be followed.
I
a 4
NELAC 3
Quahty Systems Drof
{
June 1,199E a
Revision 2 Pa08 D-3 of 15 c)
Proficiency Test Sanoles - The results of such analyses (5.4.2.j,
or 5.5.3.4) shall be used by the laboratory to evaluate the ability.
of the laboratory to produce accurate data.
1 D.1.4 Bensitivity 4
a)
Hethod detection Linits - Method detection limits shall be determined by 40 CFR Part 136, Appendix B unless specified by a i
method or program.
The detection limit shall be initially determined for the compounds of interest in each method in i
laboratory pure water or the matrix of interest and shall be verified annually.
All procedures used must be documented j
including the matrix type.
4 D.1.5 Data Reduction The procedures for data reduction, such as use of linear regression, i
shall be documented.
D.1.6 Quality of Standards and Reagents i
a)
The source of standards shall comply with 5.9.2.
b)
Reacent Ouality. Water Ouality add Checks:
i 1)
Reagents - In methods where the purity of reagents is not specified, analytical reagent grade shall be used.
i Reagents of lesser purity than those specified by the method shall not be used.
The labels on the container should be checked to verify j
that the purity of the reagents meets the requirements of the
{
particular method.
Such information shall be documented.
j 2)
Water - The quality of water sources shall be monitored and i
documented and shall meet method specified requirements.
f D.1.7 Belectivity 1
a)
Absolute retention time and relative retention time aid in the !
i I
identification of components in chromatographic analyses and to l
l evaluate the effectiveness of a column to separate constituents.
The laboratory shall develop and document acceptance criteria j
for retention time windows.
b)
A confirmation shall be performed to verify the compound identification when positive results are detected on an 1 1
uncharacterized samples.
Such confirmations shall be performed
{
on organic tests such as pesticides, herbicides, or acid extractable or when recommended by the analytical method except when the analysis involves the use of a mass spectrometer.
i i
4
..e
NELAC Ouekty Systems Droft June 1,1996 Revision 3 Page D-4 of 19 Confirmation is required unless stipulated in writing by the client.
All confirmation shall be documented.
D.1.8 Constant and Consistent Test Conditions a)
The laboratory shall assure that the test instruments consistently operate within the ' specifications of the test methods and equipment manufacturer.
b)
Glassware Cleanina - Glassware shall be cleaned to meet' the sensitivity of method.
Any cleaning and storage procedures that are not specified by the method shall be documented in laboratory records and SOPS.
D.2 Whole Effluent Toxicity D.2.1 Positive and Negative Controls a)
Positive Control Reference toxicant Reference Toxicants tests indicate the sensitivity of the test organisms being used and demonstrate a laboratory's ability to obtain consistent results with the method.
1)
The laboratory must demonstrate its ability to obtain consistent, results with reference toxicants before it performs toxicity tests with effluents for permit compliance purposes.
i An intralaboratory coefficient of variation (%CV) is not established for each test method.
- However, a testing laboratory shall maintain control charts for the control performance and reference toxicant statistical endpoint (such as NOEC or ECp) and shall evaluate the intralaboratory i
variability with a specific reference toxicant for each method.
In addition, a laboratory must produce test results j
that meets test acceptability criteria (such as such as l
greater than 80% survival in the control) as specified in l
the specific test method.
l 11 Intra-laboratory precision on an ongoing basis must be determined through the use of reference toxicant tests and plotted in quality control charts. As specified in the test
- methods, the control charts shall be plotted as point i
estimate values, such as EC25 for chronic tests and LC 50 for acute tests, over time within a laboratory.
2)
Frequency:
i The frequency of reference toxicant testing shall comply i
t
i i
y NELAC Quehty Systems Draft June 1,1996 y
Revision 3 Page D-5 of 19 with the EPA or state permitting authority requirements.
]
1 11 Reference toxicant tests shall be performed at least once a i
month if using test organisms cultured within the testing
]
laboratory during that month.
]
3)
The USEPA test methods for EPA /600/4-91-002, EPA /600/4 l 003 and EPA /600/4-90-027F do not currently speciff a particular i
reference toxicant and dilution series, however, if the state or i
permitting authority identifies a reference toxicant or dilution I
series for a particular test, the laboratory shall follow the specified requirements.
1 i
4)
Test Acceptability Criteria (TAC) - The test acceptability 4
criteria (for example, the chronic Carlodaphnia test, requires 80% or greater survival and an average 15 young per female in the controls) as specified in the test method must be achieved for both the reference toxicant and affluent test. The criteria shall be calculated and shall meet the method specified requirements for performing toxicity:
i j
i The control population of Carlodaphnia shall contain no more than 20% males.
l 11 An individual test may be conditionally acceptable if temperature, dissolved
- oxygen, pH and other specified j
conditions fall outside specifications, depending on the degree of the departure and the objectives of the tests (see test conditions and test acceptability criteria specified i
for each test method).
The acceptability of the test shall depend on the experience and professional judgment cif'the technical employee and the permitting authority.
j b)
Neoative control - Control, Brine Control or. Dilution Water -
The standards for the use, type and frequency of testing are specified by the methods and by permit and shall be followed.
l D.2.2 variability and/or Reproducibility Intra-laboratory precision shall be determined on'an ongoing basis through the use of further reference toxicant tests and related control charts as described in item 5.5.4.2.1 a) above.
4 f
j D.2.3 Accuracy l
This principle is not applicable to Wh' ole Effluent Toxicity.
one%
s.
4 d
---..m 4-,
,--,--e-w
i NELAC l
Quahty Systems Draft j
June 1,1996 i
Revision 3 Page D-S of 19 D.2.4 Test sensitivity i
a)
Test sensitivity (or test power) of the tests will depend in
{
part on the number of replicates per concentration, the significance level selected (0.05), and the type of statistical analysis.
If the variability remains constant, the sensitivity of l
the test will increase as the riumber of replicates is increased.
4 Test sensitivity is the minimum significant difference (MSD)
{
between the control and test concentration that is statistically j
significant.
If the Dunnett's procedure is used, the MSD shall be j
calculated according to the formula specified by the EPA method and j
reported with the test results.
b)
For non-normal distribution and or heterogenous variances the l
MSD can be estimated, but is not required.
c)
Point estimates: (LCp, ICp, or Ecp) - Confidence intervals shall 3
be reported as a measure of the precision around the point j
estimate value.
i d)
The MSD shall be calculated and reported for only chronic j
endpoints.
In addition, the calculated endpoint is typically a lethal concentration of 50%
(LC 50), thereforte, confidence intervals shall be reported as a measure of the precision around the point estimate value.
In order to have sufficient replicates to perform a reliable MSD, such tests shall have a i
minimum of four replicates per treatment so that either
}
parametric or non parametric tests can be conducted.
D.2.5 selection of Appropriate statistical Analysis Methods
?
a)-
The methods of data analysis and endpoints will be specified by j
language in the permit or, if not present in the permit, by the EPA j
methods manuals for Whole Effluent Toxicity.
[
\\
b)
. Dose Response Curves - When required, the data shall be plotted l
in the form of a curve relating the dose of the chemical to I
}
cumulative percentage of test organisms demonstrating a response 9
such as death.
I D.2.5 selection and Use of Reagents and standards l
i a)
The grade of all reagents used in Whole Effluent Toxicity tests is specified in the method except the reference standard.
All reference standards shall be prepared from chemicals which are i
analytical reagent grade or better.
The preparation of all standards and reference toxicants shall be documented.
1 i
I
. _. ~,
i e
NELM Quality Systems Dref June 1,199-Revision :
Page D-7 of It b)
All standards and reagents associated with chemica]
measurements, such as dissolved oxygen, pH or specific conductance, shall comply with the standards outlined in 5.5.4.1 above.
D.2.7 selectivity l
This principle is not applicable.
The selectivity of the test is j
specified by permit.
i D.2.s constant and consistent Test conditions a)
If closed refrigerator-sized incubators are used, culturing and testing of organisms shall be separated to avoid loss of cultures due to cross-contamination.
b)
The laboratory or a contracted outside expert shall positively identify test organisms to species on an annual basis.
The taxonomic reference (citation and page(s))and the names (s) of the taxonomic expert (s) must be kept on file at the laboratory.
c)
Instruments used for routine measurements of chemical and physical parameters such as pH, DO, conductivity,
- salinity, alkalinity, hardness, chlorine, and weight shall be calibrated, and/or standardized per manufacturer's instructions and Section 5.5.4.1.
Temperature shall be calibrated per section 5.9.5.2.3.
All measurements and calibrations shall be documented.
d)
Test temperature shall be maintained as specified in the methods manuals.
The average daily temperature of the test solutions must be maintained within 1*C of the selected test temperature, for the duration of the test.
The minimum frequency of measurement shall be once per 24 hour2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> period.
The test temperature for continuous flow toxicity tests shall be recorded and monitored continuously. i e)
Water used for culturing and testing shall be analyzed for toxic metals and organics annually or whenever the minimum acceptability criteria for control survival, growth or reproduction are not met and no other cause, such as contaminated glassware or poor stock, can be identified.
The method specified analytes and concentration levels shall be followed.
f)
New batches of food used for culturing and testing shall be analyzed for toxic organics and metals.
If food combinations or:
recipes are used, analyses shall be performed on the final product upon the use of new lot of any ingredient.
If the concentration of total organic chlorine exceeds 0.15 ug/g wet weight, or the total concentration of organochlorine pesticides plus PCBs exceeds 0.30 ug/g wet weight, or toxic metals exceeds 20 ug/g wet weight, the food must not be used.
1 8
NELAC Quality Systems Drott June 1,1996 Revision 3 Page D-8 of 19 g)
Test chamber size and test solution volume shall be as specified in the methods manuals.
h)
Test organisms shall be fed the quantity and type food specified in the methods manuals.
They shall also be fed at the intervals J
specified in the methods.
i i)
Light intensity shall be maintained as specified in the methods manuals.
Measurements shall be made and recorded on a yearly basis. Photoperiod shall be maintained as specified in the methods and shall be documented at least quarterly.
For algal tests, the light intensity shall be measured and recorded at the start of each test.
j)
At a minimum, during chronic testing DO and pH shall be measured daily in at least one replicate of each concentration.
DO may be measured in new solutions prior to organism transfer, in old solutions after organisms transfer, or both.
t k)
All cultures used for testing shall be maintained as specified in the methods manuals.
1)
Age and the age range of the test organisms must be as specified in the manuals.
a)
The maximum holding time (lapsed time from sample collection to first use in a test) shall not exceed 35 hours4.050926e-4 days <br />0.00972 hours <br />5.787037e-5 weeks <br />1.33175e-5 months <br /> without the permission of the permitting authority.
n)
All samples shall be chilled to 4 *C during or immediately after collection. They shall be maintained at 0.1 to 6*c and the arrival temperature shall be no greater than 6*C.
Samples that are hand delivered to the laboratory immediately after collection (i.e.,
within 1 hour1.157407e-5 days <br />2.777778e-4 hours <br />1.653439e-6 weeks <br />3.805e-7 months <br />) may not meet the laboratory temperature acceptance criteria.
In these cases, the laboratory may accept the samples if there is evidence (such as arrival on ice) that the chilling process has begun.
o) organisms obtained from an outside source must be from the same batch.
D.3 Microbiology These standards apply to laboratories undertaking the examination of raterials,.
products and substances involving microbiological analysis, recovery or testing.
The procedures involve the culture Eedia, the test sample and the microbial species being isolated, tested or enumerated.
I O
NELAC Quahty Systems Draft June 1,1996 Revision 3
(
l Page D-9 of 19 a)
Microbiological testing refers to and includes the detection, r
l isolation, enumeration and identification of microorganisms and their metabolites, as well as sterility testing.
It includes assays using microorganisms as part of a detection system and j
their use for ecological testing.
i i
b)
These standards are doncerned with the quality of test results I
and not specifically with health and safety measures.
In the performance of microbiological
- testing, safety and health matters must always be considered and conform with regulatory and national policies in this area.
l c)
Clothing appropriate to the type of testing being performed should be worn, and often includes protection for hair, beard, i
hands and shoes.
Clothing worn in the microbiological laboratory should be removed before leaving the area.
D.3.1 Positive and Negative Controls 5
a)
Negative Controls The laboratory shall demonstrate that the cultured samples have not been contaminated through sampling handling / preparation or environmental exposure.
These controls shall include sterility checks of media arid blanks such as filtration blanks.
1)
All blanks and uninoculated controls specified by the method shall be prepared and analyzed at the frequency stated in the method.
2)
A pinimum of one uninoculated control shall be prepared and analyzed unless the same equipment is used to prepare :
samples for incubation (such as a filtration unit).
In such cases, the la,boratory shall prepared a series of blanks using the equipment.
At least one beginning and ending control shall be prepared, with additional controls inserted after every 10 samples.
b)
Positive Controls Positive controls demonstrate that the medium can support the growth of the test organism, and that the medium produces the specified or expected reaction to the test organism,.
On a monthly basis, at least one pure culture of a known positive reaction shall be included with the sample test batch.
- w I
l NEAC l
j oushey sveiene prett June 1, itse j
Revision 3 I
Pete D 10 of 19 f
i j
D.3.2 Test variability / Reproducibility l
i i
a), Duplicates At least 5% of the positive samples shall be duplicated.
In laboratories with more than one analyst, each shall make parallel analyses on at least one positive sample per l
1 month.
l b)
Where
- possible, participation in, or organization of I
- collaborative trails, proficiency testing, or interlaboratory l
j comparisons, either formal or informal, must be done.
D.3.3 Method Evaluation i
i 0)
In order to demonstrate the suitability of a method for
[
]
specified purpose, an intended purpose, the laboratory shall j
establish, through method validation, a set of acceptance criteria for the performance characteristics of the method unless such criteria are specified by the method.
These j
criteria must demonstrate that the method provides a
{
correct / expected result with respect to specified limits of detection, selectivity, repeatability, sensitivity and i
i reproductivity.
)
t i
1)
Accepted (official) methods or commercialized test kits For official methods, or methods from recognized national or international standard organizations, may not require a full validation.
Laboratories are
- required, however, to j
demonstrate proficiency with the method prior to first use.
I 2)
Qualitative microbiological test methods in which the i
response is expressed in terms of presence / absence, shall be j
validated by estimating, if possible, the specificity, 1
relative trueness, positive deviation, negative deviation, i
repeatability, reproducibility and the limit of l
determination within a defined variability. The differences due to the matrices must be taken into account when testing
{
different sample types.
3)
The validation of ~ microbiological test methods shall be i
performed under the same conditions as those of a real..
i assay.
This can be achieved by using a combination of j
naturally contaminated products and spiked products.
I 4)
All validation data shall be recorded and stored at least as long as the method is in force, or if withdrawn from active l
use, for at'least 5 years past the date of last use.
i s
i b)
Laboratories shall participate in the proficiency test program j
specified by NEIAC (5.4.2.j or 5.5.3.4).
Further, laboratories i
1 i
l l
NELA Quahty Systems Dre
~
. on Pee. o 11 of 1 j should regularly participate in schemes which are relevant t their scope of accreditation.
Such program provide ar ;
independent means by which a laboratory may objectively assest and demonstrate the reliability and trueness of results producec :
l by its analytical methods.
{
D.3.4 Test Performance
- All growth and recovery media must be checked to assure that the,
target organisms respond in an acceptable and predictable manner (see D.3.b).
D.3.5 Data Reduction f
I a )'
f The calculations, data reduction and statistical interpretations specified by each method shall be followed.
i i
l b)
If the method specifies colony counts, such as membrane filter i
or colony counting, then the ability of individual analysts to ;
j count colonies shall be verified at least once per month, by i having two or more analysts count colenies from the same plate.
i D.3.6 Quality of standards, Reagents and Media 1
The laboratory shall ensure that the quality of the reagents and j
media used is appropriate for the tee.t concerned.
i a)
Culture media may be prepared in the laboratory from the j
different chemical ingredients, from commercial dehydrated ;
l powders or may be purchased ready to use.
l b)
Reagents and commercial dehydrated powders shall be consumed j
within the shelf-life of the product and shall be documented ;
according to 5.9.4.
The laboratory shall retain all j j
manufacturer supplied " quality specification statements" which i
may contain such information as shelf life of the product, i
{
storage conditions, sampling regimen / rate, sterility check ;
{
including acceptability criteria, efficacy checks including the,
organism i
- used, their culture collection reference and i i
acceptability criteria, date of issue of specification, or !
i-statements assuring that the relevant product batch meets the ;
j product specifications.
i 1
c)
Distilled water, deionized water or reverse osmosis produced,
l water free from bactericidal and inhibitory substances shall be t i
used in the preparation of media solutions and buffers.
Where required by the method, the quality of the water (such as pH, j
chlorine residual, specific conductance or metals) shall be '
^
monitorce at the specified frequency and evaluated according to t
I j
i i
i t
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v
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v-r
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4 Tv' 7
I
e NELAC Quality Systeme Oteft June 1,1996 Rowision 3 Page D 12 of 19 the stated standards.
Records shall be maintained on all activities.
d)
Media, solutions and reagents shall be prepared, used and stored according to a
documented procedure following the manufacturer's/ author's instructions.
e)
All laboratory media shall be checked to ensure they support the growth of specific microbial cultures.
In addition, selective media should be checked to ensure they suppress the growth of non-target organisms.
In preference to using the commonly used streak method, it is better to use a quantitative procedure, I
where a know (often low) number of relevant crganisms are inoculated into the medium under test and the recovery evaluated.
f)
Each lot of laboratory detergent shall be checked to ensure that residues from the detergent do not inhibit or promote growth of microorganisms.
D.3.7 selectivity a)
All confirmation / verification tests specified by the method shall be performed according to method protocols.
b)
In order to demonstrate traceability and selectivity, laboratories shall use reference cultures (See Figure D-1) of microorganisms obtained from a recognized national collection or an organization recognized by the accreditation body.
I 1)
Reference cultures may be subcultured once to provide reference stocks. Appropriate purity and biochemical checks shall be made and documented.
The reference stocks shall be preserved by a
technique which maintains the desired characteristics of the strains.
Examples of such methods are freeze-drying, liquid nitrogen storage and deep-freezing methods.
Reference stocks shall be used to prepare working stocks for routine work.
If reference stocks have been thawed, they must not be re-frozen and re-used.
2)
Bacterial working stocks shall not be sub-cultured under normal conditions.
However working stocks may be subcultured up to a defined number of subcultures when:
i it is required by standard methods or 11 laboratories can provide documentary evidence demonstrating that there has been no loss of viability, no changes in biochemical activity and/or no change in morphology.
i I
i
e i
NELAC j
Quakty Systems Draft j
June 1,1996 j
Revision 3 Pope D-13 of 19 j
}
3)
Working stocks shall not be subcultured to replace reference l l
stocks.
f i
4)
A scheme for handling reference cultures is included in l figure D.1.
j D.3.8 constant and consistent Test conditions a)
The laboratory shall devise an appropriate environmental !
l monitoring program to indicate trends in levels of contamination l 3
appropriate to the type of testing being carried out.
l Acceptable background counts shall be determined and there shall i
l be a documented procedures to deal with situations in which I
j these limits are exceeded.
l i
i j
b)
- Walls, floors, ceilings and work surfaces should be non-
]
absorbent and easy to clean and disinfect.
Wooden surfaces of j
fixtures and fitting shall be adeweately sealed.
Measures i
should be taken to avoid accumulation of dust by the provision i
j of sufficient storage space by har ag minimal paperwork in the t
laboratory and by prohibiting plah.:s and personal possessions l
from the laboratory work area.
{
c)
Temperature measurement devices j
1)
Where the accuracy of temperature measurement has a dir'act t
effect on the result of the analysis, temperature mer.suring j
devices such as liquid-in-glass thermometers, thermocouple, j
platinum resistance thermometers used in incubators, l
l autoclaves and other equipment shall be the appropriate quality to achieve the specification in the test method.
The graduation of the temperature measuring devices must be i
appropriate for the required accuracy of measurement and they shall be calibrated to national or international j
standards for temperature (see 5.9.5.2.3).
l 2)
The stability of temperature, uniformity of temperatura l
distribution and time required to achieve equilibrium j
conditions in incubators, waterbaths, ovens and temperature controlled rooms shall be established, for
- example, i
- position, space between and height of stacks of Patri i
dishes.
i f.
d)
Autoclaves 1)
The performance of each autoclave shall be initially evaluated by establishing its functional properties, for example heat distribution characteristics with respect to
.I typical uses.
Autoclaves shall be capable of meeting l
4 5
j NELAC i
Qualiw Svetems Drott i
i June 1,1996
{
Revision 3 i
1 Pete D-14 of 19 l
specified temperature tolerances.
Pressure cookers fitted only with a
pressure gauge are not recommended for sterilization of media or decontamination of wastes.
2)
Records of autoclave operations including temperature and time shall be maintained.
This shall be done for every cycle.
Acceptance / reject! ion criteria shall be established and used to evaluate the autoclave efficiency and effectiveness.
l 3
j 0)
Volumetric equipment such as automatic dispensers, dispenser / diluters, mechanical hand pipettes and disposal pipettes may all be used in the microbiology laboratory.
Regular checks as outlined in Section 5.9.5.2.4 shall be performed and documented.
4 i
j f)
Conductivity meters, oxygen meters, pH meters, hygrometers, and other similar measurement instruments shall be calibrated according to the method specified requirements (see 5.9.5).
j Timers shall be checked regularly to ensure accurate timing.
D.4 Radionnalysis l
l A radioanalytical laboratory shall analyze both intralaboratory and
{
interlaboratory quality control samples on a routine basis as d scribed in the laboratory's Quality Assurance Plan.
These quality centrol samples shall account for at least 10 percent of the total j
cnalytical load and shall not be limited to one type or category.
Where possible, the laboratory shall employ the use of blind and dauble-blind quality control samples.
i D.4.1 Positive and Negative controls I
c)
Neantive Control - Reagent Blank - The laboratory shall analyze
)
reagent blanks so as to provide a means of evaluating and quantifying potential contamination resulting from the samples' 4
i passage through the analytical process.
The volume or weight of i
the blank shall be approximately equal to the volume or weight of samples routinely analyzed, and the blanks shall be carried through the entire analytical process. These blanks shall be included with each batch of samples that must be prepared (that is, chemically separated) prior to analysis.
i b)
Positive Control - Matrix Spike - The laboratory shall analyze matrix spike samples to evaluate the effect of the sample matrix j
upon the analytical methodology.
The activity level of the matrix spike sample shall be comparable to the activity levels of samples i
routinely analyzed.
The laboratory shall prepare and analyze matrix spike samples for each type of matrix and method.
Matrix s
le j e l
NEL Quahty Systems C
],
June 1,1?
4 Rowan Pope D 15 of l l
spike samples shall be performed initially for each matrix typ i
and verified annually.
If a sample matrix is determined to.!
substantially different from the original matrix (for example, t1 J original was pristine ground water, and the submitted samples a2' j
effluent from a wastewater treatment facility) the laboratory sha:
establish and characterize the "new matrix" with spike samples !
i l
]
D.4.2 Laboratory variability / Reproducibility i
The laboratory shall perform replicate analyses to ' evaluate th precision of an analysis.
The size of replicate samples shall b j
approximately equal to the size of samples routinely analyzed.
g a).
Replicates of actual samples shall be analyzed at least once pe quarter.
i b)
Replicates of matrix spikes samples shall be analyzed at thi same frequency as matrix spikes (D.4.1.b).
i j
c)
Replicates of traceable reference material (D.4.3.a) shall be j
analyzed at least annually.
j D.4.3 Method Evaluation 1
l a)
Traceable Reference Material The laboratory shall analyzt, traceable reference materials to evaluate the accuracy anc j precision of an analytical methodology or an analyst. Traceable l Reference Material, as defined by ANSI N42.2 Neasurement Qualit} l l
Assurance For Radioassay Laboratories is a NIST preparec'
]
standard reference material (SRM) or a
sample of
- knowl, i
concentration prepared from a NIST traceable reference materia'.3 1
(derived standard material).
The material shall be analyze initially, and on a continuing annual frequency.
b)
Calibration of Radiation Measurement Systems All measure i
shall be performed on an annual basis, and at any time there is ai j
equipment change or whenever significant changes in the analytica instrumentation is detected.
1)
Performance assessments shall, at a minimum, utilize tt l j
following practices:
(1) baselining each measuremer j
system's response characteristics, (2) stability check wit, j
control chart plot, and (3) background check with. contre chart plot.
The frequency of the performance assessment l
aust be sufficient to promptly identify and correct invald j
results and must also consider radiation measurement syste i
(RMS).
For a RMS which is used to identify radionuclides the stability check shall also include geometry-specif3 energy-calibration sources.
1 i
i I
NELAC e
Quakty Systems Draft June 1,1996 Revision 3 Pege D 16 of 19
)
2)
Radiation instrumer,tet.lon energy calltrr etion (channel number of the multichannel ana'Jyzer versas the radiation energy),
i l
full-energy peak efficiency, radiont.clide activity l
i (concentration) precision and test method precision and bias 2
should be checked with appropriate standard sources.
1 c)
Quality control Assessment
- All measures shall be trended by i
j statistical techniques to establish acceptance criteria.
The i
j laboratory shall establish and follow a written standard operating procedure that outlines the protocols to be followed i
should any quality control measure exceed the established acceptance criteria.
D.4.4 sensitivity 0)
Counter
Background
A major factor in determining the i
l sensitivity of measurement procedures is the background of the i
counter.
Therefore, the counter background must be reduced as much as practicable.
l 1)
Where applicable, anticoincidence counting methods shall be i
used to reduca the influence of cosmic ray cascade radiation j
interferences.
2)
The background of the counter must be minimized by j
preventing counter contamination with radioactive materials.
1 3)
Backgrounds shall be recorded on each day's use.
These records shall be statietically analyzed to determine correction factors and acceptance ranges.
j b)
The Environmental Detection Limit (EDL) (that is, the smallest i
level at which a radionuclide in an environmental medium can be unambiguously distinguish.ed for a given confidence interval j
using a particular combination of sampling and measurement procedures, sample
- size, analytical detection
- limit, and i
processing procedure) shall be specified for the 0.95 or greater confidence interval. The EDL shall be established initially and i
verified annually for each method and sample matrix.
I
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The analytical detection limit (Ig) is the smallest amount of an i
j analyte that can be distinguished in a sample by a given measurement procedure throughout a given (e.g., 0.95) confidence q
interval.
The analytical detection limit shall be established initially and verified annually for each method and sample j
natrix.
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NELA Quehty Systems Dre i
June 1,199 a
Revision Page D 17 of 1:
c)
Method Uncertainties - The laboratory shall have the ability tc trace all sources of method uncertainties and their propagatior to reported results.
i D.4.5 Data Reduction Procedures utilized in th'e computation of final concentrations of radioactive materials shall include an independently derived verification of results.
D.4.s Quality of standards and Reagents A radioanalysis laboratory must have an operational internal quality control program that ensures that all radiation detection instruments are calibrated and functioning.
a)
The quality control program shall establish and maintain provisions for radionuclide standards traceability.
1.
Reference standards that are used in a radioanalytical laboratory must be obtained from either the National Institute of Standards and Technology (NIST) or suppliers who participate in supplying NIST standards or NIST traceable radionuclides.
2.
NIST standards must be accompanied with a certificate of calibration which describes the standard's (1) principle radionuclide, mass or volume, and chemical composition; (2) reference time and date; (3) measurement result (activity of principal and possible daughter radionuclides per gram of solution; (4) measurement method; (5) a statement of purity (list of known or suspected radionuclide impurities, their activities, and how they were measured);
(6) decay information (statement of the assumed half-life and other decay information); and (7) and estimate of errors (includes errors from the measurements themselves and those created by the decay assumptions).
3.
In all radionuclide measurements, the volumes, shapes, and physical and chemical characteristics of the standards and their containers must be as identical as practicable for the most accurate results.
D.4.7 selectivity Gross measurements such as Gross alpha, beta, or gamma measurements may be used in screening general activity levels, however they must not be used to characterize a sample.
NELAC Quakty Systems Draft June 1,1996 Resnon 3 i
Page D 18 of 19 D.4.8 Constant and Consistent Test conditions To prevent incorrect analysis results caused by the spread of contamination among samples, the laboratory shall establish and cdhere to written procedures to minimize the possibility of cross-contamination between samples.
High-and low-activity samples shall be either processed in different Ihboratories, or separate, distinct locations of the laboratory. Weekly surveys of gross activity levels in the laboratory shall be conducted and any detectable contamination chall be removed.
D.5 Air Testing Analyses for Air Toxics shall follow the essential quality controls for chemistry outlined in Section 5. 5.4.1.
For air testing, the i
blank, laboratory control sample and a desorption effic:lency (auch as charcoal tubes) shall be used.
Matrix spikes and dupitcatra samples chall be used when feasible.
l 9
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NELA(
Quakty Systems Draf June 1,1991 Rowsion :
Page D-19 of 11 Figure D-1 USE OF REFERENCE CULTURES (BACTERIA)
' Flow Chart Reference culture from source recognized by NELAC culture once Purity Checks and Biochemical Tests as Appropriate Reference Stocks Retained under specific Conditions:
Freeze dried, liquid nitrogen storage, deep frozen or other storage means under specified conditions and storage times /
Purity Checks and Biochemical Tests as Appropriate Thaw / Reconstitute Purity Checks and Biochemical Tests as Appropriate Working Stocks Maintained under specific conditions and storage times Regular / Daily Quality Controls 8
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NATIONAL ENVIRONMENTAL 3
LABORATORY ACCREDITATION l
CONFERENCE E
DRAFT ACCREDITING. AUTHORITY.
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June 1,1996 Pege i of i TABLE OF CONTENTS ACCREDITING AUTHORITY 6.0 Accrediting Authority 1
6.1 Foreword.
1 6.2 PROCESS FOR AN ACCREDITING AUTHCRITY TO BE NELAC/NELAP RECOGNIZED / APPROVED 1
6.3 ORGANIZATIONAL RESPONSIBILITIES FOR ACCREDITING AUTHORITIES 4
6.4 RECOGNITION / APPROVAL CRITERIA BY NELAC/NELAP TO BECOME.
6 6.5 RESPONSIBILITIES, ROLES AND QUALIFICATIONS OF THE NELAC/NELAP RECOGNITION / APPROVAL ASSESSMENT TEAM.
8 6.6 ACCREDITING BODIES 22 6.7.
COMPLETING A NELAC/NELAP APPROVAL / RECOGNITION AGREEMENT 22 APPENDIX A
......................... A-1 APPENDIX B
......................... B-1 APPENDIX C C-1
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NELAC j
Accrediting Authority Reesion 2 j
June 1,1996 Page 1 of 23
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6.0 Accrediting Authority i
6.1 Poreword J
This section defines the process and operating requirements established by the National Environmental Laboratory Accreditation Conference (NELAC) for an Accrediting Authority to become nationally recognized. It provides the policies and criteria that i
an Accrediting Authority must meet to apply for and maintain recognition.
l The section is organized based upon ISO /IEC Guide 25:1990, ISO /IEC Guide 58:1993 and ILAC Fourth Draft:1994.
Where necessary to l
clearly define requireme:nts, the standards given contain more information and are more clearly stated than the text found in the ISO /IEC Guides and ILAC Fourth Draft.
Portions of this chapter j
were also taken from the National Assessment Training of Australia
~
(NATA) and the Assessment of Laboratories Quality Systems--Course
- Notes, 4th Edition, 1995 (American Association For Laboratory Accreditation).
i l
In all cases the Accrediting Authority is a government organization 1
at the state or federal level.
The Accrediting Authority may elect i
to employee another public or non-public organization to perform some of its activities.
These are known a Accrediting Bodies.
Accrediting Bodies report to the Accrediting Authority and are the
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responsibility of the Accrediting Authority.
NELAC/NELAP Recognition / Approval cannot be delegated or transferred to an i
i Accrediting Body. This section defines those functions that can be delegated to an Accrediting Body and those functions that must be the responsibility of the Accrediting Authority.
It should be noted that as a precondition for an Accrediting l
Authority to gain NELAC/NELAP Recognition / Approval it must grant j
reciprocity to all other Accrediting Authorities with other NELAC/NELAP Recognition / Approval. 'It is recognized that agreements on mutual recognition of Accrediting Authorities aimed at the j
removal of barriers to across-border trade may have to cover other J
aspects not explicitly specified in these general requirements. To create confidence and harmonize the interpretation and implementation of standards, each Accrediting Authority should encourage technical cooperation and exchange experience among laboratories accredited by it, and it should be prepared to exchange information on accrediting procedures and practices with j.
other Accrediting Authorities.
4 6.2 PROCESS FOR AN ACCREDITING AUTHORITY TO BE NELAC/NELAP i
RECOGNISED/ APPROVED l
6.2.1 An Accrediting Authority applying for NELAC/NELAP Recognition / Approval shall submit an application to NELAC/NELAP at
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L NELAC 4
Accrediting Authority Revision 2 4
June 1,1996 l
Pope 2 of 23 the following address:
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The Accrediting Authority shall submit an application to i.
NEMP/NEMC at the time it wishes to become j
recognized / approved.
i n
i.
The Accrediting Authority will also submit a renewal application at least every two years in order for it to maintain recognition / approval status.
b)
The Accrediting Authority shall complete the application supplied by NEMC/NEMP, and the application will include, but not be limited to, the following:
1.
The name of the Accrediting Authority; t
I 11.
The analytical areas in which the Accrediting Authority I
i seeks Recognition / Approval; i.
iii. The primary responsible person for administering the Accrediting Authority Program; i
k iv.
The names and responsibilities of Accrediting Bodies used by the Accrediting Authority; 4
v.
The names and education / experience of Accrediting j
I l
Authority staff responsible for performing on-site 1
l audits;
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vi.
The source of performance evaluation samples used by'the Accrediting Authority for proficiency testing, l
vii. The funding structure used to support Accrediting Authority functions; j
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viii The program details (Standard Operating Procedures) used by the Accrediting Authority to enforce its program; ix.
The program details (Standard operating Procedures) used j
by the Accrediting Authority to evaluate laboratories; All information outlined in section 6.4.2; X.
xi.
Any other information which is reasonably necessary to 1
enable the NEMC/NELAP to determine whether the applicant i
i should be accreditad.
i 4
'e NELAC i
Accrediting Authonty Roweson 2 June 1,1996 Page 3 of 23 6.2.2.
The Accrediting Authority will be required to have an on-site audit of its program by NELAC/NELAP Program staff in order j
to be granted NELAC/NELAP Recognition / Approval. A repeat audit will i
be conducted every 4 years.
}
a)
At the on-site audit the Accrediting Authority will provide i
all necessary records and staff in order for the evaluation team to make an accurate recommendation to NELAC/NELAP for its-i Recognition / Approval.
6.2.3.
Granting and suspension of NELAC/NELAP Approval / Recognition I
a)
After completion of a successful assessment by the NELAC/NELAP Approval / Recognition Assessment Team the Accrediting Authority will be granted approval based on the review and procedures of j
NELAC/NELAP.
j b)
NELAC/NELAP Approval / Recognition shall be granted for two year periods.
i I
c)
NELAC/NELAP Approval / Recognition can be suspended within the l
two year period if the Accrediting Authority is found to be j
deficient in following NELAC standards.
l' 1.
{
When NELAC/NELAP Approval / Recognition is suspended the Accrediting Authority shall within thirty days notify all l
the laboratories participating in its program.
6.2.4.
Provisional NELAC/NELAP Approval / Recognition status.
I a)
If an l
Accrediting Authority with NELAC/NELAP Approval / Recognition is found to be deficient in following i
NELAC standards it will be given thirty days to submit a i
corrective plan of action to the NELAC/NELAP j
Approval / Recognition Assessment Team Leader.
I b)
During the time period between the notification of the i
Accrediting Authority's deficiencies and the correction of these deficiencies the Accrediting Authority will have Provisional Status.
a f
1.
I When an Accrediting Authority receives notice from NELAP or the NELAC/NELAP Approval / Recognition Assessment Team
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Leader that it has been found not be following NELAC standards and that it has been given Provisional Status
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it has fourteen days to notify the laboratories in its
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program.
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ii.
Provisional Status will be rescinded and full status granted if and when the Accrediting Authority corrects all deficiencies as given in its corrective action plan.
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NELAC j
Accrediting Authonty Revision 2 l
June 1,1996 f
Pope 4 of 23 l
6.3 ORGANI5ATIONAL RESPONSIBILITIES FOR ACCREDITING AUTHORITIES l
6.3.1.
The Accrediting Authority will have an organization with
^
the necessary authority and resources to carry out its program responsibilities, which shall include the following:
i c)
A document granting the Accrediting Authority the authority to j
administer an accreditation program; i
b)
The ability to demonstrate that it is a legally identifiable public entity; c)
The ability to cover liabilities arising from its operations l
and/or activities; I
3 d)
.The financial stability and resources needed to support all the activities necessary to be an Accreditation Authority; i.
The Accrediting Authority shall have and make available on request a description of the means by which it receives its financial support.
o)
A document detailing its quality system that includes an organizational structure that enables it to give confidence in its ability to perform the necessary activities to a
Recognized / Approved Accrediting Authority; f)
The documents detailing its policies and procedures for operating an Accrediting Authority, that will include the following; i.
Policies and decision-making procedures that distinguish between activities surrounding the activities for evaluating laboratories and any other activities in which the Accrediting Authority and the agency it is part of is engaged; 11.
Policies and Procedures for the resolution of complaints and appeals received from laboratories about the handling of laboratory accreditation matters, or from the users of the users of the services provided by an accredited laboratory.
g)
Policies and Procedures that demonstrate that the Accrediting Authority program manager and staff to be free from any commercial, financial and any other pressures which might influence the results of the accrediting process; h)
Rules and structures for the appointment and operation of committees involved in the assessment and future activities of the Accrediting Authority;
. ~ _ -
e NELAC Accrediting Authority Revision 2 June 1,1996 Page 5 of 23 i.
Committees shall be free from any commercial,' financial or other pressures that might influence decisions, or; ii.
Shall have a structure where members are chosen to provide impartiality through a balance of interests where no single interest predominates.
i i)
The Accrediting Authority shall not offer consultancies or other services that may compromise the objectivity of its accrediting process and decisions; I
i j)
The Accrediting Authority will operate consistent with applicable laws to safeguard, at all levels of the organization, confidentiality of the information obtained 1
relating to applications, assessments and accrediting of l
laboratories; I
k)
The Accrediting
$uthority will have the rights and responsibilities r.eeded to administer its accrediting l
activities; 1)
The Accrediting Authority will employ a sufficient number of personnel with the necessary education, training, technical knowledge and experience needed to handle the type, range and 4
volume of the accrediting activities it administers; 1.
These personnel will be assigned to the Accrediting 1
Authority program manager (or senior executive) that is responsible to organization or agency to which the Accrediting Authority Program reports.
m)
The Accrediting Authority shall have policies for either controlling the ownership, use and display of accrediting document; or for controlling the manner in which an accredited laboratory my refer to its accredited status; or both.
6.3.2.
The procedures under which an Accrediting Authority operates shall be administered in a non-discriminatory manner.
a)
Ability of a laboratory to have access to, and be able to participate in, a program operated by an Accredited Authority shall not be conditional upon the size of the laboratory or membership in any association or group; b)
There shall be no undue financial conditions to restrict the participation of laboratories in an Accrediting Authority Program.
i
~
6.3.3 The competence of laboratories applying for accreditation or for laboratories wishing to maintain accreditation shall be assessed on at least a minimum of those established by NELAC.
~
NELAC Accrediting Authority Revision 2 June 1,1996 Page 8 of 23 a)
The Accrediting Authority may need to interpret NELAC standards for a specific calibration or test. When this is necessary the interpretations shall be made by relevant and impartial committees or persons possessing the appropriate technical competence.
1.
The Accrediting Authority shall publish information for which interpretations are made.
l b)
The Accrediting Authority shall require accredited laboratories to maintain impartiality and integrity.
j c)
The Accrediting Authority shall confine its requirements, assessments and decisions on accreditation to those matters I
specifically related to the scope of the accreditation being considered.
l l
6.3.4 The Accreditation Authority shall not delegate its i
responsibility for granting, maintaining, extending, suspending or j
withdrawing the accreditation of laboratories.
i 5.4 RECOGNITION / APPROVAL CRITERIA BY NELAC/NELAP TO BBCOME AN l
ACCREDITING AUTHORITY 1
(
6.4.1 The Accrediting Authority must be successfully audited by a NELAC/NELAP team of auditors at least once every two years.
J' a)
If NELAC/NELAP suspects that the Accrediting Authority is
. experiencing problems-or that it is not following the
)
standards as established by NELAC, the Accrediting Authority i
may be audited more frequently.
b)
NELAC/NELAP Recognition / Approval Agreements will normally be j
comprehensive in nature.
i i.
When the Accredited Authority is applying for j
recognition / approval in limited analytical areas, the l
recognition / approval agreements may only cover portions j
of the full scope of NELAC standards.
6.4.2.
The Accrediting Authority will be expected to prepare for the process for receiving NELAC/NELAP Recognition / Approval.
Following are some requirements that Accrediting Authorities shall j
follow when preparing for the recognition / approval process; c)
The Accrediting Authority shall be an operational / active program and not a proposed program; b)
The Accrediting Authority shall have at least ??? months / years of operational experience; w
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J NELAC Accrediting Authority s
Revision 2 June 1,1996 Page 7 of 23 1
'i.
Includes completing the initial stage of all activities necessary to accredit laboratories in its program;
)
ii.
A reasonable number of laboratory accreditations shall have been granted, and these shall have - based on the requirements and guidelines established by NELAC.
j c)
The Accrediting Authority shall have a full-time program manager; i
1.
The program manager shall have sufficient experience in i
the development and/or operation of a
laboratory i
accrediting authority, d)'
The Accrediting Authority shall have access to an appropriate 4
measurement system that allows accredited laboratories to make measurements that are traceable to national or international standards of measurement; i
I e)
The Accrediting Authority shall have a quality manual or other i
document (s) that contains its policies and procedures and the j
responsibilities for implementation; 3
f)
The Accrediting Authority shall have available all current technical and non-technical criteria it has published.
To include; i.
Formal rules and regulations affecting the Accrediting i
Authority's operations and the obligations of the
^
laboratories it accredits; 11.
Explanatory material describing the mechanics of l
operation of the laboratory accreditation system; such as annual reports, questionnaires, newsletters, guidance documents, reports of proficiency test programs, etc.
g)
The Accrediting Authority shall have available the full details and backgrounds of it staff.
To include; i.
Educational backgrounds; J
ii.
Work experience prior to employment with the Accrediting Authority; iii. Work experience in laboratory accrediting activities.
h)
The Accrediting Authority shall have available a directory (or i
other listing) of the laboratories it accredits and the
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accreditation status of each laboratory.
i l
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I NELAC j
Awreddng Authonty Revision 2 June 1,1996 Page 8 of 23 i)
The Accrediting Authority shall have available all formal
))
recognitions and reciprocal agreements it holds either nationally or internationally.
}
i.
To include recognitions / agreements with government authorities, private sector organizations, other laboratory accreditation systems, etc.
j)
The Accrediting Authority shall have compared its activities with those established by NELAC, and have a document available
{
defining its findings.
l 5.5 RESPONSIBILITIES, ROLES AND QUALIFICATIONS OF THE NELAC/NELAP j
RECOGNITION / APPROVAL ASSESSMENT TEAM 6.5.1 The NELAC/NELAP Recognition / Approval Assessment Team will review the application and the information given in 6.2 prior to
{
the on-site audit.
c)
As part of the review process the NELAC/NELAP Recognition / Approval Assessment Team will appoint a team leader.
G.5.2 The NELAC/NELAP Recognition / Approval Assessment Team leader will prepare an agenda detailing the schedule of activities to be performed during the on-site audit of the Accrediting Authority.
The agenda will be given to the Accrediting Authority as soon as available, and in most cases at least one month prior to the cn-site audit, a)
The agenda will include the following; i.
All activities with time schedules to be evaluated during the on-site audit; ii.
The
- names, titles, affiliations, and on-site audit responsibilities of the members of the NELAC/NELAP Assessment Team; iii. The names and titles of all Accrediting Authority staff that need to be available during the on-site audit; iv.
The dates and times of scheduled audits of the Accrediting Authority's laboratory assessors, to include attending the actual on-site laboratory audit of selected assessors.
6.5.3 The Accreditation Authority shall respond to the NELAC/NELAP Approval / Recognition Team with comments concerning the audit at least two weeks prior to the scheduled audit.
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NELAC Accrediting Authority Revision 2 June 1,1996 Page 9 of 23 6.5.4.
The NELAC/NELAP Approval / Recognition Assessment Team will perform pre on-site
- audit, on-site audit (opening
- meeting, assessment of Accreditation Authority policy and procedures, assessment of the activities of laboratory assessors) and exit interview activities relating to the evaluation of an Accreditation Authority.
a)
The pre on-site audit will include the following activities.
1.
Initial appraisal of all documents submitted by the Accreditation Authority either at the request of the NELAC/NELAP Approval / Recognition Assessment Team or submitted with the application; 11.
Preparation of a detailed agenda for the evaluation of the Accreditation Authority; iii. Assembling of all necessary checklists, hastionnaires, and information needed to audit the Accreditation Authority; iv.
Documenting the responsibilities of all NELAC/NELAP Approval / Recognition team members; 1.
The team leader should give to all team members the overall division of work responsibilities, to include estimates of time needed to complete assigned tasks and the schedule for completing the audit of the Accrediting Authority.
b)
The components and responsibilities of the on-site audit of an Accreditation Authority are as follows.
i.
The NELAC/NELAP Approval / Recognition Assessment Team will begin the on-site activities associated with the evaluation of an Accrediting Authority with an Opening Meeting.
The purpose of the opening Meeting is as follows:
1.
To confirm the objectives of the audit; 2.
To present the scope of the activities to be covered during the audit; 3.
To confirm the activities associated with the on-site auditing of laboratory assessments; 4.
To make arrangements for reporting the outcomes of the audit.
I
j NELAC l
Accrediting Authority l
Revision 2 i
June 1,1996 i
Page 10 of 23 11.
After the Opening Meeting the NELAC/NELAP l
Approval / Recognition Assessment Team will conduct a detailed evaluation of the activities of the Accrediting i
Authority.
This involves a process of discussions with the full-time manager and staff, and the examination of the Accrediting Authority's implementation of it policies i
and procedures to determine compliance.with NELAC standards. The accreditation criteria of the Accrediting Authority and the operations of the laboratories it accredits will be compared to NELAC standards. This will l
include, but not be limited to, the following elements.
- 1.,
The scope of the systen; 2.
Assurance that thers are no restrictions to access to the system; 3.
The legal status of the Accrediting Authority; i
4.
The financial stability, sources of funds and resources of the Accrediting Authority; 5.
The availability and backgrounds of technical staff; 6.
The organization structure of the Accrediting i
Authority and the responsibilities of individual staff assigned to the structure; i
7.
The effectiveness of the Accrediting Authority's quality system as compared to the criteria given NELAC Section 5.0.
i 8.
The roles of the governing body and any external j
l committees, and their relationships to the I
Accrediting Authority and it full-time manager (or j
of ficer) ;
9.
The procedures for the selection,
- training, contracting and appointment of laboratory assessors-i 10.
The procedures for maintaining records of laboratory assessors and the usage of these records; 11.
The procedures for submitting and processing i
applications to the Accrediting Authority to become j
an accredited laboratory; i
t i
e e
NELAC Acc, editing Authority Revision 2 June 1.1996 Pge 11 of 23 12.
The procedures for preparing and issuing laboratory assessment reports; 13.
The procedures for
- granting, maintaining, suspending, withdrawing and reinstating laboratory accreditation; 14.
The policies for preparing laboratory accreditation schedules; 15.
The procedure for maintaining the records of each applicant and accredited laboratory; 16.
The procedures for ensuring confidentiality by staff, laboratory assessors and external committees where applicable; 17.
The procedures for dealing with complaints and disputes; 18.
The availability of a.ccreditation criteria documentation and assessment procedural documentation to Accrediting Authority technical staff, Accrediting Bodies and external committees; 19.
The procedures by which laboratories may appeal the decisions of the Accrediting Authority; 20.
The Accrediting Authority's relationships with technical and other organizations both nationally and internationally; 1
21.
The existence and extent of Accrediting Authority 1
activities conducted by Accrediting Bodies; 22.
The existence and content of recognition agreements with other Accrediting Authorities; 23.
The conditions for use of the Accrediting j
Authority's logo or reference to accreditation by a laboratory; I
1 24.
The policies and procedures for use of proficiency testing data by the Accrediting Authority, for both j
tests conducted by the Accreditin tests conducted by other programs; g Authority and 25.
The policies for involvement of accredited laboratories in proficiency testing programs;
l t
NELAC Accrediting Authority Revision 2 Jurw 1,1996 Page 12 of 23 26.
The policies for use of proficiency testing data for granting and maintenance of accreditation.
iii. As part of the on-site audit the NELAC/NELAP Approval / Recognition Assessment Team will audit the assessments of laboratories by the Accrediting Authority staff.
This will involve, wherever practicable, both attendance at initial assessments of laboratories seeking accreditation and attendance at reassessment and/or surveillance assessments of laboratories already holding accreditation.
The purpose of attending and witnessing assessments include the following.
1.
To confirm that laboratory assessors are properly briefed and trained to conduct assessments; 2.
To confirm that assessment teams / individuals are using the criteria and procedures established by NELAC and adopted by the Accrediting Authority; 3.
To confirm that the assessment teams / individuals are effective in determining and recording / reporting the technical competence of laboratories for the tests for which accreditation is sought or held, and that they are effective in identifying any noncompliance with NELAC and Accrediting Authority requirements for accreditation.
4.
To review the quality of guidance documents available for laboratory assessors, together with any supplementary criteria or rules used to evaluate laboratories accredited by the Accrediting Authority.
iv.
The NELAC/NELAP Approval / Recognition Assessment Team will conduct an exit interview with the Accrediting Authority at the end of the on-site audit.
At the exit interview the Team will present and discuss a draft report of its findings.
The Accrediting Authority will be given the opportunity v.
to review the NELAC/NELAP Approval / Recognition Assessment Team draft report before the final report and recommendation is given.
6.5.5.
The activities of the NELAC/NELAP Approval / Assessment Team will also include, but not be limited to, the following items.
a)
The Team will evaluate the published accreditation criteria of the Accrediting Authority to determine whether there is
je l
j NELAC Accrediting Authority Revision 2 1
June 1.1996 Pope 13 of 23 sufficient documentation to evaluate the technical competence j
of the laboratories in the fields in which it grants accreditation.
i.
The evaluation will be conducted either as part of the j
pre on-site audit or during the course of the on-site audit.
i 11.
The evaluation will be based both on the criteria l
established by NELAC and interpretations of the supplementary criteria for specific fields of testing in 4
which the Accrediting Authority operates.
l b)
The pre on-site audit and on-site audit will include an initial appraisal of the documented policies and procedures used by the Accrediting Authority when compared to NELAC standards.
This will be followed by an evaluation of the l
implementation by the Accrediting Authority of those policies i
and procedures, and appraisal of the effectiveness of the i
systems accreditation process to accredit technically j
competent laboratories that comply with NELAC standards and j
any other specified technical criteria.
1.
Evaluation with NELAC standards will require the j
exercising of some judgment and perhaps interpretation by the NELAC/6 FLAP Approval / Recognition Assessment Team. It is unlikely that each topic will be addressed in exactly j
the same manner by different Accrediting Authorities.
i
{
1.
The collection of sufficient detailed information on each topic to allow appraisal of the suitability j
of the practices used by the Accrediting Authority is required.
4
}
2.
Significant differences in approach by different j
Accrediting Authorities should not effect j
NELAC/NELAP Recognition / Approval.
But,these should be highlighted as they could effect the establishing of future Accrediting Authority j
recognition agreements.
c)
The NELAC/NELAP Approval / Recognition Assessment Team should prepare a set of briefing notes, checklists or questionnaires to detail their understanding of the operations of the various y
i facets of the NELAC standards.
These will be based on 1
i guidance established by NELAP.
a i
d)
The witnessing of on-site laboratory assessments conducted by l
the Accrediting Authority will be to determine whether applicant and/or accredited laboratories are technically 4
i
I
=
NELAC Accredting Authority Revision 2 June 1,1996 Pope 14 of 23
+
i competent to perform the tests or calibrations for which they j
seek or hold accreditation, j
i.
For a comprehensive system it will normally be necessary to witness at least three and preferably four on-site laboratory m:dit per assessment of an Accrediting Authority.
This will require that NEMC/NEMP l
Approval / Recognition Assessment Teams will need to split up to visit separate laboratory assessments.
11.
During the course of the assessment of an on-site laboratory audit it is essential that NEMC/NELAP Approval / Recognition Assessment Team members act only as observers.
Team members must avoid influencing the I
performance and activities of the laboratory assessors and the responses of laboratory staff.
Any of the Teams observations of the laboratories, laboratory assessors or to the practices of the Accrediting Authority should only be provided to the Accrediting Authority's representatives at the exit interview or in the draft and i
final reports.
iii. Part of the assessment of an on-site laboratory audit should include consideration of any guidance documents provided to laboratory assessors, and any supplementary criteria or rules needed to evaluate laboratories covered by the Accrediting Authority.
iv.
The assessment team should examine the procedures used to report the finding of on-site laboratory assessors and to ensure that corrective actions are carried out by laboratories within required time periods.
The roles and interactions of any Accrediting Bodies used v.
by the Accrediting Authority to conduct laboratory on-site assessments, with the laboratory assessors employed full time and directly with the Accrediting Authority should be evaluated.
e)
The NELAC/NELAP Approval / Recognition Assessment Team should schedule its activities to include the preparation of a draft recommendation report.
The report should be presented to the Accrediting Authority as part of the exit interview.
i.
The draft report should include at least an overview of the observations made by the Assessment Team during the full course of the on-site assessment.
1.
The overview should summarize the main findings of the NELAC/NELAP Approval / Recognition Assessment
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NELAC Accrediting Authority Revision 2 June 1,1996 Page 15 of 23 Team and it should be signed by all the Teams members.
f)
The NELAC/NELAP Approval / Recognition Assessment Team leader shall present at least a detailed verbal summary of the content of the draft final report to the Accrediting Authority as part of the exit interview.
I 1.
The Accrediting Authority will have the opportunity to comment on and discuss the draft findings of the NELAC/NELAP Approval / Recognition Assessment Team for the purpose of correcting any misunderstandings that may have arisen.
g)~
The NELAC/NELAP Approval / Recognition Assessment Team leader shall complete a final report.
i.
The final report will be given to all team members for their approval and signature.
11.
After approval by all team members the final report will be given to the Accrediting Authority.
iii. The fully signed final report will be given to the NELAC Accrediting Authority Standing Committee and to NELAP.
l iv.
The NELAC Accrediting Authority Standing Committee will review the report,' make recommendations and present it to l
the Chair, NELAC.
6.5.6. The NELAC/NELAP Approval / Recognition Assessment Team will be composed of persons that have the necessary expertise, experience an competency to evaluate and environmental laboratory Accrediting Program.
The composition of the team will vary depending on the scope of the Accrediting Program.
The Team will be composed of persons with the necessary education, training, technical knowledge and experience for evaluating the type and scope of accreditations offered.
a)
The number of persons on the Assessment Team will. vary depending on the scope of the laboratory Accreditation Program.
i.
The Assessment Team will be composed of at least three members.
l b)
The Assessment Team members need to be will qualified to assure that only high quality accreditation programs are granted NELAC/NELAP Approval / Recognition.
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NELAC Accredting Autho,ity Revision 2 i
June 1,1996 Page 16 of 23 1.
For inst'ance, an Accrediting Authority that offers 4
accreditation for the analysis of air, drinking water, l
solid and hazardous wastes, water quality or other i
program would need to be evaluated by a team that has expertise in each of the represented areas.
11.
The Assessment Team members must be familiar with accreditation processes, NELAC standards, and be knowledgeable of laboratory practices, procedures and regulations.
iii. The Assessment Team members must be familiar with applicable laboratory standards for which the Accrediting Authority serves.
iv.
The Assessment Team members must have a
thorough knowledge of relevant assessment methods and assessment documents.
v.
The Assessment Team members must be able to communicate effectively, both in writing and orally.
vi.
The Assessment Team members must be free of any i
commercial, financial or other pressures or conflicts of interest that might cause them to act in other than an impartial or nondiscriminatory manner.
c)
Requirements for Assessors 1.
Professional Requirements A university degree (or I
equivalent) is a
pre-requisite for an Assessor.
Although, it must be recognized that people occasionally change their career path and sometimes achieve professional standards in areas of science and technology unrelated to their first degree.
1.
Assessor candidates shall have competed at least secondary education.
That is, that part of national education system that comes after the primary or elementary stage, but prior to that which qualifies for a degree.
2.
Assessor candidates shall have demonstrated competence in clearly and fluently expressing concepts and ideas orally and in writing in their national language.
ii.
Auditing competence Assessors shall have a sound understanding of the philosophy of accreditation systems.
L
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NELAC Accredieng Authority Revision 2 June 1,1996 Page 17 of 23 1.
Assessors shall have a thorough knowledge of the content of accreditation system standards 2.
Assessors shall be able to apply the requirements of accreditation systems to different organizations.
3.
Assessors shall be able to conduct an assessment effectively.
4.
Assessors shall be trained in the skills and techniques of auditing and shall be able to demonstrate their skills and proficiency in assessing.
iii. Inter personal and Administrative skills Assessors shall have effective adminietrative and leadership skills.
To include, but not be limited to the following.
1.
Administrative skills; 2.
Planning and organizing ability; 3.
Flexibility and ability to adapt to changing circumstances; 4.
Capacity to work independently and systematically;-
5.
Leadership (especially for team leader);
6.
Communication skills (all forms);
7.
Ability to secure cooperation from others; 8.
Conflict resolution skills; 9.
Decision making skills.
iv.
Personal attributes The following will have an influential role in generating confidence in and respect for an assessment team and assessment team members.
1.
Objective and unbiased approach; 1
2.
Sensible and practical outlook; 3.
Commitment to the assessment activities; 4.-
Good outward impression.
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NELAC Accrediting Authonty Revision 2 June 1,1996 Page 18 of 23 v.
Training Assessor candidates shall have undergone training to the extent necessary to ensure their competence in the skills required for conducting on-site assessments and for managing on-site assessments.
Training in the following areas shall be regarded as particularly relevant.
l 1.
Standards against which on-site assessments (quality system audits) are performed;.
2.
Assessment techniques for examining, questioning, evaluating and reporting 3.
Skills required for managing an on-site assessment (audit),
such as
- planning, organizing, communicating and directing-4.
Competence shall be demonstrated through written or cral examination, or other acceptable means.
vi.
Experience - Assessor candidates shall have minimum of four years full-time appropriate practical workplace experience (not including training).
1.
At least two years of the four years experience shall have been in a laboratory.
2.
Assessor candidates shall have experience in auditing prior to leading an Assessment Team or participating as an Assessment Team member.
Experience shall include participating in a minimum of four on-site assessments that include documentation, review, actual laboratory auditing
{
and audit reporting.
i 3.
All necessary experience shall be reasonably j
current.
viii Language - Assessors shall be fluent in the agreed upon language of the audit or have language support staff as i
part of the Assessment Team.
i i
1.
No assessor shall participate in an audit without i
language support staff where he/she is not fluent in the agreed upon language of the audit.
2.
Where language support staff is necessary the person shall be fluent in the agreed upon language i
of the audit, have the necessary technical language i
skills, and shall not be subject to any pressures that would effect the performance of the audit.
. - - = -
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NELAC Accre& ting Authority Revision 2 June 1,1996 Page 19 of 23 d)
Duties of the NELAC/NELAP Approval / Recognition Assessment Team members.
1.
Duties and Responsibilities of the Assessment Team leader.
1.
The Assessment Team leader is ultimately responsible for the proper implementation of all phases of the assessment process as given in 6.5.
2.
The Assessment Team leader is specifically i
responsible for the leadership of the Assessment Team during planning and preparation, the on-site assessments, and completion of the final report / recommendation.
3.
The Assessment Team leader is responsible for tracking any corrective actions or follow-up activities required of the Accredited Authority.
~
During the planning and preparation pha~se of the 4.
on-site assessment, the principal tasks of the Team Leader will include, but are not limited to, the following.
Reviewing the Accrediting Authority's documentation to determine compliance with NELAC standards.
Preparing the assessment checklists to be used during the on-site assessment.
Selecting and briefing the Assessment Team.
Developing the assessment plan.
Making all the arrangements associated with the assessment.
)
Acting as the primary contact with the Accrediting Authority.
5.
During the on-site assessment, the principal tasks of the Team Leader will include, but not be limited to, the following:
Managing the assessment to ensure that it is conducted properly and that its objectives are achieved.
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NELAC
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Accrediting Authority Revieson 2 June 1,1996 i
PeGe 20 of 23 d
i j
Monitoring the activities of the Assessment Team i
members, and providing them with necessary support.
i l
Playing a central role in assessment of the i
important accreditation elements.
t-Assembling the findings of the assessment, and i
confirming the nature of any nonconformities.
1 Acting as the spokesperson for the Assessment j
l Team, especially in the presentation of the results of the assessment to the Accreditation Authority and NELAC/NELAP.
i i
l 6.
On completion of the on-site assessment, the
]
principal tasks of the Team Leader will include, but not be limited to, the following.
Completing the draft and final assessment team j
(
reports.
~
f Following up on nonconformities raised during i
the assessment to ensure that effective corrective j
action is taken.
I i
Completing the administrative tasks associated with the completion of the assessment in accordance l
j with NEIAC/NELAP procedures.
(
t f
11.
Duties and responsibilities of Assessment Team Members.
I 4
j 1.
The role of Assessment Team Members will be to i
j assist the Team Leader and perform the functions l
{
necessary to conduct an effect on-site assessment of an Accrediting Authority.
2.
Team Members shall fulfill the roles and tasks that have been assigned to them by the Team Leader.
3.
Team Members shall conduct and complete their
{
j assigned roles and tasks within the constraints of l
the assessment plan.
t i
4.
Team Members shall keep the Team Leader informed of i
their
- findings, especially any major j
nonconformities they discover.
j j
5.
Team Members shall accumulate and record the j
objective evidence needed to support their findings.
i i
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t NELAC l
Accro6 ting Authority Revision 2 i
June 1,1996
+
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Peoe 21 of 23 i
6.-
Team Members shall assist the Team Leader in the i
preparation of the draft and final written reports i
on the on-site assessment.
4
)
e)
Roles of the Assessment Team Members l
j 1.
Team Leader - The Team Leader shall be a professionally i
qualified member appointed by NELAC/NELAP.
He/she shall
(
be thoroughly familiar with the policies, rules and J
procedures of NELAC/NELAP, and shall be able to draw upon all the resources of NELAP in arranging the assessment i
j and preparing the briefing documents.
1.
The Team Leader shall manage the assessment to
}
ensure that its objectives are maintained.
l 2.
The Team Leader shall coordinate and monitor the activities of the assessment team and ensure that they receive all the cooperation necessary from the Accrediting Authority.
l 3.
The Team Leader shall have a primary role in the auditing of the accrediting program.
f l
4.
The Team Leader shall be the spokesperson for a
NELAC/NELAP and the assessment team throughout the audit.
5.
The Team Leader at the ~end of the audit shall i
implement NELAC/NELAP's procedures for reporting the results of the audit and for initiating any follow up action that is needed.
i 11.
Team Members - Team Members will help to ensure that j
every assessment team acts on behalf of NELAC/NELAP and 1
that the team contains experts who have a
sound understanding of NELAC standards and auditing processes.
j 1.
Team Members shall assess the technical integrity of the Accrediting Program.
i 2.
Team Members shall assist the Team Leader in 2
assessing the Accrediting Authority, especially at the interfaces between the program and the laboratories included in its program.
i 3.
Team Members shall identify for the Team Leader the technical deficiencies disclosed by the assessment so that these can be summarized in the exit interview.
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e NELAC Accrediting Authority Revision 2 l
June 1,1996
)
Pese 22 of 23
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4.
Team Members will help to prepare the draft and final written reports in accordance with j
NELAC/NELAP procedures.
l 4
f)
Assessment Team Members will be required to have training relating to the evaluation of Accrediting Authorities.
1 f
1.
Training should either be conducted by NELAP or be approved for use by NELAC/NELAP.
1 I
11.
Training in the following areas is appropriate.
j 1.
Knowledge and understanding of the standards against which assessments may be conducted.
1 2.
Assessment techniques for examining, questioning, evaluating and reporting.
l 3.
Skills for managing an assessment, such as planning, organizing, communicating and directing.
i 6.6 ACCREDITING BODIES i
6.6.1.
The Accrediting Authority may use Accrediting Bodies to i
perform some of the functions in the accreditation preenss.
Accrediting Bodies are non-government agencies.
i i
a)
Accrediting Bodies cannot be used to grant, suspend, revoke or assess penalties on accredited laboratories.
4 l
6.6.2.
Accrediting Bodies shall provide descriptions to the NELAC/NELAP Approval / Recognition Assessment Team of any separate j
functions or affiliations it has to activities other than
}
laboratory accreditation.
i 6.6.3.
The Accrediting Authority will need to clearly define the roles of the Accrediting Bodies for each Accrediting Body it has i
subcontracted part of the laboratory assessment process.
6.7.
COMPLETING A NELAC/NELAP APPROYAL/ RECOGNITION AGREEMENT 6.7.1.
Af ter completion of the on-site assessment and final report it is necessary for the Accrediting Authority and NELAP to have documented all actions taken as a result of the Assessment teams activities.
j l
6.7.2.
The final text of the agreement needs to be approved by the Accrediting Authority and NELAP.
i a)
For some agreements the text is standardized.
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NELAC Accrediting Authority j e Revision 2 June 1,1996
]
Page 23 of 23 b)
Agreements shall reflect any special circumstances.
i c)
NELAP/NELAC Recognition Agreements shall in most cases follow a standardized format (see Appendix C).
l 6.7.3.
Recognition Agreements shall have at least the following information.
j a)
Purpose - Explaining the aim of the agreement.
b)
Backgroun'd - A brief description of the key feature of the Accrediting Authority covered by the agreement.
l c)
Understanding - A list of the obligations of the Accrediting Authority and of NELAC/NELAP.
- Normally, this includes declaring equivalence of confidence in the Accrediting Authority's ability to administer its program; the willingness 1
for the Accrediting Authority to accept NELAC standards and to promote the use of NELAC standards; the capability of the Accrediting Authority to resolve differences between j
laboratories; and the willingness of the Accrediting Authority j
to exchange information and literature.
d)
Name and address of parties to the agreement.
1 e)
Liaison Officers The identification of staff in the Accrediting Authority and NELAC/NELAP who will be the primary contact points for matter included in the agreement.
l f)
Period of Agreement - Two years is typical for an agreement i
unless a shorter time period is necessary.
i g)
Appendix - Comparison of Practices and Criteria - A summary of the analyses of the similarities and differences of the Accrediting Authority to the NELAC standard. This could be an 4
important component of some agreements as it is a recognition that although different techniques may be used for certain aspects of the program, all parties accept that the and result j
is a comparable level of confidence in each systems operation.
i j
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l NELAC Accrediting Authority
)
Revision 2 June 1.1996 i
Page A.1 of 1 APPENDII A Example of a timetable for a NELAC/NELAP Approval / Recognition
{
Assessment Team to evaluate an Accreditation Authority (by a Team i
of at least two (2)).
i Before Visit A NELAC/NELAP Approval / Recognition Assessment Team leader is appointed.
Authority's documentation is examined by team members i
and questions prepared.
Allocation is made of specific evaluation tasks to individual team members.
A team meeting is conducted before-site assessment.
Day 1 - At offices of Accrediting Authority presentations by team i
leader outlining aims, objectives and procedure to be adopted by l
audit team; background presentation on authority's operation by senior staff of Accrediting Authority, discussions with staff of
{
Accrediting Authority on its administration and its quality system and its implementation.
Day 2 - Attendance as observers at laboratory assessment visit (s):
typically one or two members of team at one laboratory with 4
Accrediting Authority's assessors and two at another; or one team i
member at each of two assessments.
Day 3-Attendance as observers at laboratory reassessment or surveillance visit (s): typically one or two members of team at one laboratory with Accrediting Authority's assessors and one or two at
- another, or one team member at each of two reassessment or l
surveillance visits.
t Day 4 - Audit of authority's assessor training, and proficiency i
testing activities plus any administrative aspects not covered on Day I.
Day 5 - completion of summary of report completion of draft final report presentation and discussion of findings to accreditation authority at offices of Accrediting Authority *.
Each evening the team should assemble at their hotel and discuss the day's findings as recorded on checklists and questionnaires and then prepare a draft report.
Post-evaluation Team leader should complete a draft report, checking its accuracy with team members and submit it to the authority that has been i
evaluated for comment.
i After receiving comments the Team Leader is responsible for preparing the final report.
i
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NELAC Accredeting Autlwrity Revision 2 June 1.1996 Page B-1 of 2 APPENDIX B-Contents of Audit Reports It is recommended that audit reports follow a format similar to the following:
j
- 1. A cover page - identifying team leader, team members, dates of audit and organizations involved.
- 2. A summary page prepared and signed by team members and handed over to the Accrediting Authority at the exit interview.
This should contain the main conclusions and recommended actions needed to conclude an agreement.
- 3. An introduction reason for audit, participants, criteria against which audit is performed, activities undertaken during audit, provision of documentation and translations, planning of laboratory visits and object of report.
- 4. A history of the Accreditation Authority under assessment including:
Relationship to government, responsibilities, management, numbers of accreditation, staffing levels and agreements with other authorities.
- 5. Observations on administration of system:
i Covering complianca with the NEMC Standard.
Comments should follow headings of NEMC Sections 6.1 - 6 7.
- 6. Observations on the assessment of the authority's technical criteria (against the NELAC Standard and supplementary criteria) providing details of examination of the Accrediting Authority's
~
technical criteria and guidance documents.
- 7. Observations on evaluation of the performance of laboratory assessors used by the system, including observations made at visits 4
as compared with the NEMC Standard and on organization of visits, compliance by laboratories traceability in laboratories, non-compliance reporting and assessment reports.
l 4
- 8. observations on use of proficiency testing by the Accrediting Authority.
9.
Where appropriate, compliance with any other standards in addition to the NEMC Standard.
- 10. Summary
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NELAC Accre/. ting Authority Revision 2 a
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- 11. Appendices List of documents supplied before evaluation Details of visit program Miscellaneous material 6
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9 l
NELAC Accrediting Authonty Revision 2 June 1,1996 Page C-1 of 4 APPENDIX C Typical Content of a NELAC Recognition Agreement betwaan an Accrediting Authority and NELAC
- 1. Agreement Accrediting Authority Recognition Agreement i
The Accrediting Authority denotes the {to be defined} who are responsible for operating accreditation systems for testing in {to be defined).
The criteria for the operation of accrdited testing laboratories and for the operation of the recognized Accrediting Authority are specified in the {to be defined).
The cooperation of the NELAP for testing started formally In {to be defined} and is based on the NELAC Standards. An ongoing program of cooperation has been set up which is aimed at establishing confidence between authority's, so that agreements can be entered into that recognize the technical equivalence of the operation of their accreditation systems for testing laboratories.
e a
l NELAC
[e
~
Accrediting Authority d
Revision 2 j
June 1,1996 i
j P80s C-2 of 4 i
RECOGNITION AGREEMENT l
i 1.
This Agreement is based on the results of the evaluations I
carried out in accordance with the NELAC Standard Section 6 l
Accrediting Authority.
l 2.
-The parties entering this Agreement are the Accrediting i
Authority in the {to be defined) and NELAC that have signed the 7
l Agreement on behalf of the accrediting systems for testing for which they are responsible.
i i
3.
On the basis of the equivalence of the operation of the j
Accrediting Authority, hereinafter also referred to as l
- Systems (s) ",
hereby
- declared, each signatory to this NELAP l
Agreement ~ states that his/her agency will:
I recognize the operation of the other systems by the Accrediting Authorities that are Signatories of this NELAP j
Agreement as equivalent to its own; I
j II recommend acceptance on an equal basis with those of its own accredited testing laboratories of the Test Report: and Test i
l Certificates from the testing laboratories that are accredited
{.
by the other Accrediting Authorities that are Signatories to j
this NELAP Agreement; i
III promote the acceptance of Test Reports and Test Certificates of accredited laboratories of Systems that are operated by the Accreditation Authorities that are Signatories to this NELAP j
agreement by all users in its own state; IV investigate all complaints by a Signatory to this NELAP i
Agreement resulting from Test reports and Test Certificates i
issued by the accredited laboratories of its own System; V
notify all other Signatories as soon as possible of any significant changes that have or will occur in the status and j
or operational practices of its own Accrediting Authority and j
system.
- 4. If a Signatory wishes to withdraw from this Agreement for any reason whatsoever, NELAP shall be notified in writing not later than six months in advance of withdrawing.
Upon withdrawing of the 4
]
Accrediting Authority, this Agreement shall be null and void.
5.~Any amendment of the text of the Agreement shall be made in cccordance with the rules of procedure of NELAC.
- 6. This Agreement consists of three pages and is signed on behalf j
of each participating recognized accreditation agency that operates o recognized accreditation system for testing laboratories.
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'h NELAC Accrediting Authority Roweson 2 June 1,1996 Page C-3 of 4
- 7. This Agreement has come into force on (to be defined}.
- 8. Signatories Authorized Representatives of Nationally Recognized Accreditation body responsible far operating NEIAC and of the Accredited Authority which ara party'to the Agreement.
{to be defined}
{to be defined}
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NELAC i
Acc, editing Autho,ity I
Rowsion 2 June 1,1996 l
Page C-4 of 4
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l CODE OF CONDUCT FOR ASSESSORS The NELAC/NELAP requires each of its assessors to adhere to code of conduct. The following code covers the essential ethical behavior of assessors.
CODE OF CONDUCT l
All assessors are required to confirm formally their willingness to observe and be bound by the following code.
(a) To act in a strictly trustworthy and unbiased manner in relation to NELAC/NELAP and any organizations involved in an essessment by them or personnel for whom they are responsible; (b) To disclose to NELAC/NELAP any relationships they may have with k
the organization to be assessed before undertaking any assessment function of that organization; (c) To not accept sny inducement, gift, commission, discount or any l
cther profit from the organizations
- assessed, from their rspresentatives, or from any other interested person nor knowingly allow personnel for whom they are responsible to do so (d) Tc not disclose the findings, or any part of them, of the nesessment team or which they are responsible, or any other information gained in the course of the assessments to any third
- party, unless auchorized in writing by both the assessee and NELAC/NELAP to do so; (e) To not act in any way prejudicial to the reputation or interest i
of the NELAC/NELAP or to the Accrediting Organization; j
(f) To in the event of any alleged breach of this code, cooperate fully in any formal enquiry proceedings.