ML20236W433
| ML20236W433 | |
| Person / Time | |
|---|---|
| Site: | 07100192 |
| Issue date: | 07/31/1998 |
| From: | Ayres R VECTRA TECHNOLOGIES, INC. |
| To: | NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM) |
| References | |
| RAA-98-041, RAA-98-41, NUDOCS 9808050273 | |
| Download: ML20236W433 (4) | |
Text
_ _ _ _ _ _ _ - _ _ _ _ _ _ _ _ _ _ _. _
e 7/'6 b TRANSNUCLEAR WEST July 31,1998 j
RAA-98-041 United States Nuclear Regulatory Commission Document Control Desk 11555 Rockville Pike Washington, DC 20555-001
Subject:
Transnuclear West, Inc. Quality Assurance Program Enclosed is controlled copy No. 002 of the Transnuclear West, Inc. Quality Assurance Manual, Revision 0 which describes the company's quality assurance program. Please sign the white I
copy of the receipt acknowledgement and retum it in the self-addressed, stamped envelope.
The yellow copy is for your records.
Transnuclear West, Inc. requests an amendment to Quality Assurance Program Approval No.
0192 to change the company name from VECTRA Technologies, Inc. to Transnuclear West, Inc. (TN West). Additionally, the Quality Assurance Manual is now referenced throughout the l
current program description and TN West wishes to obtain direct approval of the TN West manual as the quality assurance program description document. TN West requests your i
approval of this manual for compliance to 10CFR71, Subpart H. After we receive your formal approval of the manual, it will replace the VECTRA Quality Assurance Program description and Quality Assurance Manual for TN West activities governed by 10CFR71. The required $640.00 amendment fee is enclosed.
The VECTRA manual was converted to the TN West manual with several changes. On a global basis, the company name was changed to TN West and the responsibilities were revised to be consistent with the company organizational structure shown in Figure 1-1 of the manual.
Section 1.0 was changed extensively to reflect this company organization. A description of any j
other substantive changes is attached to this letter. With these exceptions, the enclosed manual remains essentially the same as the VECTRA manual currently in use.
khb Please call me at 510-744-6034 or Walter Bak at 510-744-6018 with any questions.
Sincerely, 1
h h' OI ichard. Ayres pd
&p Quality Assurance Manager cc: Ms. P. L. Eng with uncontrolled copy of TN West Quar.ty Assurance Manual Transnuclear West Inc.
39300 Civic Center Drive, Suite 280, Fremont, CA 94538 g,'
Phone: 510-795-9800 + Fax: 510-744-6002 l
t 9808050273 980731 l
C PDR l
J
I Attachment RAA-98-041 Page 1 of 2 SUBSTANTIVE CHANGES VECTRA QA MANUAL CONVERSION TO TN WEST QA MANUAL l
Glossary:
l Deleted definitions for the terms consulting, managed task, service organization, small project, and staff augmentation because they are not directly applicable to TN West operations.
Section 1.0:
Defined the TN West organization as a single business ut.., having multiple locations and a single quality assurance organization with the Quality Assurance Manager reporting to the President.
Clarified that Quality Assurance Manager functions may be performed by other quality assurance personnel when so defined in the TN West Quality Procedures.
Section 2.0:
Updated scope to be consistent with TN West business operations.
Revised references to quality assurance criteria documents to 10CFR50, Appendix B; 10CFR71, Subpart H; 10CFR72, Subpart G; and ANSl/ASME NQA-1,1994.
Retired the Review Board function because the disposition of discrepancies is adequately handled by the engineering, project, licensing, and quality assurance functions of TN West.
Required management audits be conducted by an organization independent of the TN West organization being audited.
Required an annual summary report of the quality assurance program because the TN West Quality Procedures now require more frequent trending and common cause analyses and reports.
Deleted Non-conformance Reports, Audit Finding Reports and Quality Discrepancy Reports from the annual summary report because they are covered by the review of Corrective Action Reports.
l Section 3.0:
I f
Transferred responsibility for design verification to Engineering Manager.
s
_-a----____
i l
I Attachment
.RAA-98-041 Page 2 of 2 Section 6.0:
Provided for use of a centralized document control function.
Section 10.0:
I Provided for other quality assurance personnel to evaluate inspection results when e
permitted in the quality procedures.
Section 15.0:
Eliminated Review Board function. Refer to Section 2.0 changes above for further explanation.
Added "or other referenced documents" for Licensing Manager review of non-conformances.
Section 16.0:
Removed reference to 10CFR50.55e.
Required annual summary report of the status of Corrective Action Reports. Refer to Section 2.0 changes above for further explanation.
I Section 17.0:
Consolidated " product nonpermanent" and " programmatic nonpermanent" record classifications into a single " nonpermanent" classification.
Section 18.0:
1 Required Quality Assurance Manager to make arrangement for conducting the e
management audits rather than performing same.
!E____________
TRANSNUCLEAR WEST ACKNOWLEDGMENT TRANSMITTAL l
I Date: Julv 31.1998 Control No.: QQ2 To: Document Control Desk U.S. Nuclear Regulatory Commission 11555 Rockville Pike l
Rockville, MD 20852 l
The following document is enclosed:
TRANSNUCLEAR WEST QUALITY ASSURANCE MANUAL REVISION 0 1
Please complete the following:
1.
Sign and date below and return original to:
j Transnuclear West Inc.
I 39300 Civic Center Drive, Suite 280 Fremont,CA 94538.
Attention: Richard A. Ayres
. Phone: (510) 744-6034 FAX: (510)744-6002 Received:
Date:
White:
Original Yellow:
Recipient File Copy
TRANSNUCLEAR WEST 1
l QUALITY ASSURANCE MANUAL l
Transnuclear West, Inc.
l l
Controlled Copy Number: 002 l
Issued To:
Document Control Desk U.S. Nuclear Regulatory Commission 11555 Rockville Pike Rockville, MD 20852 Transnuclear West Inc.
39300 Civic Center Drive, Suite 280, Fremont, CA 94538 Phone: 510-795-9800 + Fax: 510-744-6002 q
Qndhm A7 UU LV LDd i
i oO TRANSNUCLEAR WEST
)
i STATEMENTOF POLICY AND AUTHORITY The Transnuclear West, Inc (TN West) Quality Assurance Manual states the policies, assigns the responsibilities,and describes and summarizes the procedures governing the design, procurement, fabrication, construction, testing and operation of quality-related components, systems and structures for nuclear applications as defined by contract or licensing / certification regulations. This TN West Quality Assurance Program is also applicable to non-nuclear projects when specified by contract.
Compliance with the TN West Quality Assurance Program as described in this Quality Assurance Manual is mandatory for all TN West organizations and personnel whose activities affect quality.
O The President of TN West retains the overall responsibility for implementation of all V
activities performed in accordance with this Manual. The Quality Assurance Manager is responsible for assuring implementation of the policies and procedures described by this manual.
The Quality Assurance Manager, reporting to the President, is given full responsibility for maintaining this Manual and for assuring implementation of the quality assurance program throughout TN West. He has the authority to initiate management action to limit further processing on items of indeterminate quality, to resolve any def;ciencies, and to assure that satisfactory resolution has been achieved prior to authorizing further processing.
I i
1 By:
Robert M. Grenie'r President i
Date: 7/28/98 (v\\
o9 7.
.v l V y v v t
w ___-___-______________ __ __._
SECTION i QUALITY ASSURANCE
,,y,3,c, g O
1 4~.~ucu m.'
MANUAL PAGE 1 OF 2 1
TABLE OF CONTENTS SECTION DATE REVISION STATEMENT OF POLICY AND AUTHORITY 7/28/98 N/A I
i TABLE OF CONTEN TS 7/28/98 0
ii GLOSSARY 7/28/98 0
1.0 ORGANIZATION 7/28/98 0
2.0 QUALITY ASSURANCE PROGRAM 7/28/98 0
3.0 DESIGN CONTROL 7/28/98 0
pO 4.0 PROCUREMENT DOCUMENT CONTROL 7/28/98 0
5.0 PROCEDURES, INSTRUCTIONS, AND DRAWINGS 7/28/98 0
6.0 DOCUMENT CONTROL 7/28/98 0
7.0 CONTROL OF PURCHASED ITEMS AND SERVICES 7/28/98 0
8.0 IDENTIFICATION AND CONTROL OF MATERIALS, 7/28/98 0
PARTS, AND COMPONENTS 1
9.0 CONTROL OF SPECIAL PROCESSES 7/28/98 0
I 10.0 INSPECTION 7/28/98 0
l l
l 11.0 TEST CONTROL 7/28/98 0
12.0 CONTROL OF MEASURING AND TEST EQUIPMENT 7/28/98 0
13.0 HANDLING, STORAGE, AND SHIPPING 7/28/98 0
SECTION i QUALITY ASSURANCE va
,,y,,,,, o O
... ucu.
MANUAL PAGE 2 oF 2 14.0 INSPECTION AND TEST STATUS 7/28/98 0
15.0 CONTROL OF NON-CONFORMING ITEMS 7/28/98 0
16.0 CORRECTIVE ACTION 7/28/98 0
17.0 RECORDS 7/28/98 0
18.0 AUDITS 7/28/98 0
1 l
l 0
1 SECTioN: li QUALITY ASSURANCE REVISION 0 1-..oc-m.'
MANUAL PAGE 1 oF 3 i
oUALITY ASSURANCC EIANAGER PRESIDENT DATE
'D 7/28/98 GLOSSARY APPROVAL - The act of endorsing or authorizing an action, document or related activity. As used in this manual approval requires a signature and date.
AS-BUILT DATA - Data recorded into documents that describe the conditions actually achieved in a completed product.
AUDIT - A planned and documented activity performed to determine by investigation, examination, or evaluation of objective evidence the adequacy of and compliance with established procedures, instructions, drawings, and other applicable documents, and the effectiveness of implementation.
CERTIFICATION - The act of determining, verifying, and attesting in writing to the qualifications of personnel, processes, procedures, or items in accordance with specified requirements.
CONTROLLED DOCUMENT - A document that has been reviewed for adequacy, approved for release by authorized personnel, and distributed to, and used at, the location where the prescribed activity is performed. Controlled documents are typically finalized technical documents, procedures or instructions.
CRITERIA - Technical requirements describing performance objectives, operating conditions and requirements, limitations regarding materials, compliance with codes or standards and any technical requirements for design, fabrication, installation, testing, operation, maintenance or quality i
assurance.
EXAMINATION - An element of inspection consisting of investigation of materials, components, supplies or services to determine conformance to specified requirements that can be determined by such investigation. Examination is usually nondestructive and includes physical manipulation, gauging and I
measuring.
l INSPECTION - Examination or measurement to verify whether an item or activity conforms to specified requirements.
LTEM - A broadly used term describing an appurtenance, assembly, component, equipment, material, module, part, structure, subassembly, subsystem, system or unit.
NON-CONFORMANCE - A deficiency in the characteristics, documentation or procedure which renders the quality of an item or activity unacceptable or indeterminate.
SECTION ii QUALITY ASSURANCE 1..... m..... 1 REVISION O MANUAL PAGE 2 oF 3 PROCUREMENT DOCUMENTS - Purchase requisitions, purchase orders, drawings, contracts, g
specifications, or instructions used to define requirements for purchase.
QUALITY ADMINISTRATION - Coordination of the quality-related activities of personnel and determination that such activities are performed in the prescribed manner.
QUALITY ASSURANCE - The planned and systematic actions necessary to provide adequate l
confidence that a material, component, system or service meets the established requirements. Quality
. assurance includes quality administration and quality control.
QUALITY CONTROL - Those quality assurance actions performed to measure and control the characteristicsof an item or process to established requirements.
RECEIVING - Taking delivery of an item at a designatedlocation.
RECORDS - Documentary evidence of the quality of items and activities affecting cNality. For purposes of this manual, a documentis considered to be a record only after the documentis final.
REPAIR - The process of restoring a non-conforming characteristic to a condition such that the capability of an item to function reliably and safely is unimpaired, even though that item still does not conform to the original requirement.
REVIEW - A technical assessment that a document or activity complies with the appropriate requirements. As used in this manual, review requires a signature and date.
REWORK - The process by which an item is made to conform to original requirements by completion or correction.
SPECIAL PROCESS - A process in which verifying the results are highly dependent on the control of the process or the skill of the operators, or both, and in which the specified quality cannot be readily determined by inspection or test of the product.
SURVEILI.ANCE - The act of monitoring or observing to verify whether an item or activity conforms to specified requirements.
SPECIFICATION - A concise statement of the requirements a product, material or process must satisfy in order to be acceptable.
TECHNICAL DOCUMENTS - Documents that translate technical requirements into reports, calculations, drawings, specifications, instructions and procedures necessary for procurement, fabrication, installation, testing, operation and maintenance.
l
secron -"
QUALITY ASSURANCE vaa~.auu.*a...r
"'"'S'"
MANUAL PAGE 3 oF 3 USE-AS-IS or ACCEPT-AS-IS - A disposition which may be imposed upon a non conforming item, when it is established that the discrepancy will not adversely affect the item's performance or interfaces to it. A use as-is or accept-as-is disposition raust provide justification that indicates the item under consideration will continue to meet all engineering and functional requirements, including performance, maintainability, fit and safety.
O I
l
)
i
\\
l t
SECTloN 1.0 m @u."" * " " *'QUALITY ASSURANCE gQ
,,y,3,,, g MANUAL PAGE 1 OF 9 QUALITY ASSURANCE MANAGER PRESIDE T c
DATE r-C
'l*"
7/28/98 ij 1.0 ORGANIZATION 1.0 SCOPE This section identifies the functional organization and assigns the responsibilities to assure effective execution of the TN West Quality Assurance Program.
1.1 General TN West is organized to effectively manage multiple products and services in various offices. TN West maintains a common business and quality assurance policy for all productions, sentices and offices.
D (N
The Company functional reporting relationships are shown on Figure 1-1 and are further explained in subsequent sections of this manual as they relate to activities controlled by this quality assurance program. A single, common Quality Assurance organization is maintained _by the Company for all products, sentices and offices. The various functional managers are responsible for proper implementation of the TN West Quality Assurance Program for their respective function.
The Quality Assurance organizational structure is shown in Figure 1-2.
Individual Quality Assurance personnel may reside in various office and field locations but are part of the Company-wide Quality Assurance organization reporting to the Quality Assurance Manager, it is recognized that changes in the organizational structure, or newly created positions with varying responsibilities, may occur within TN West. Prescribed duties defined in this Manual and related implementing procedures are specifically assigned to certain l
individuals and it is incumbent upon each manager to assign (in writing) the appropriate responsibilities to those individuals assuming newly created or revised positions. The project planning document (see Quality Assurance Manual Section 2.0) assigns these responsibilities on a project specific basis.
l l
Situations may arise, particularly with small projects, that require one individual to assume more than one role. For example, Project and Engineering Management may m
be the same individual. This is permitted by this quality assurance program, provided
[d
\\
that an equally qualified individual, other than the originator, performs the reviewing, checking and/or design verifying functions.
SEcTION: 1.0 (7}
m @u.~u u m m.'
QUALITY ASSURANCE
,,y,3,,, o MANUAL V
PAGE 2 oF g l
The levels of management required to manage a project are dependent upon the scope and complexity of the work. For example, on large multi-disciplined projects, a spec fic Project Manager may be assigned. Smaller projects, however, do not warrant this level of management and several small projects may be efficiently managed by a single individual.
t The extent of quality assurance related activities performed at the job site is dependent upon the nature, scope and complexity of the contracted scope of work and is defined in the project planning document.
l 1.2 TN West Organization 1.2.1 President The President of TN West is responsible for the following activities with regard to the TN West Quality Assurance Program:
a.
Issuing the Statement of Policy and Authority which requires the use of this Quality Assurance Manual by TN West.
b.
Maintaining final authority for the implementation of the requirements of
.he quality assurance program as defined in this Quality Assurance Manual.
Approving this TN West Quality Assurance Manual and quality c.
procedures.
I i
1.2.2 Quality Assurance Manager l
The Quality Assurance Manager shall have demonstrated management capabilities and shall possess either:
a.
A Bachelor's Degree in a specialty whict, is applicable to the l
performance of quality assurance activities and three (3) years of direct quality assurance experience, or b.
Ten (10) years of experience in progressively responsible quality af,surance positions.
The Quality Assurance Manager shall also meet the qualification requirements
(,/
of NOA-1, Supplement 2S-3 for Lead Auditor within ninety (90) days of assuming the position.
?
sECTION: 1.0 p
QUALITY ASSURANCE
,,y,,,,, g 3
m u.~ucu o w..'
MANUAL PAGE 3 OF 9 The Quality Assurance Manager is responsible to the President, for defining quality assurance policy in the TN West Quality Assurance Manual consistent with applicable codes, standards, and regulatory criteria.
This reporting relationship provides the Quality Assurance Manager sufficient authority and organizational freedom to identify quality problems; initiate, recommend, or provide solutions; and verify implementation of solutions.
The Quality Assurance Manager is assigned quality assurance responsibilities for all products and services in all TN West offices and is responsible for monitoring the TN West Quality Assurance Program for those activities and offices. " Monitoring" includes performing audits, surveillance, identifying and reporting noncompliance, and verifying implementation of corrective actions.
As an additional aspect of the monitoring process, the Quality Assurance Manager is responsible for Quality Assurance Engineering overviews to assure p
adequate controls are specified within TN West control documents to facilitate t
effective monitoring activities.
The Quality Assurance Manager, or others in the Quality Assurance organization as defined in the Quality Procedures, have the authority and organizational freadom to conduct the following activities:
1 a.
Identify quality problems.
I b.
Initiate, recommend or provide solutions, and verify implementation of solutions.
c.
Review implementing Quality Procedures to assure correct i
interpretation of the requirements set forth in this manual.
d.
Maintain and control the TN West Quality Assurance Manual and Quality Procedures.
e.
Establish Corporate Policy for development of qualification and certification programs for personnel required to be certified.
f.
Reviev CorreAive Action Reports to determine deportability under the provbions c! ?OCFR21.
g.
Control or stop further processing, delivery, or installation of a non-V conforming item, deficiency, or unsatisfactory condition until proper disposition has occurred. The stop work process shall be implemented I
i SECTION. 1.0 QUALITY ASSURANCE
,,,cy o i
v.... ucu
=.r MANUAL l
PAGE 4 oF 9 l
l when the Quality Assurance Manager determines that a significant condition adverse to quality (reference Section 16.0 of the QA Manual) warrants work stoppage. The responsible manager is notified to stop work by receipt of a "Stop Work Order" and is responsible for assuring that the specified work has been stopped. The Quality Assurance Manager is responsible for verifying that work has been stopped by performing surveillance.
h.
Arrange for annual Quality Assurance Management Audits of the various TN West organizations, inclucing the Quality Assurance organization, to verify implementation of quality assurance responsibilities and to determine the status and effectiveness of the TN West Quality Assurance Program.
i.
Maintain liaison with regulatory agencies and clients to obtain acceptance of the quality assurance program.
g J.
Review contract-related documents to approve applicable quakty assurance requirements.
k.
Conduct training and indoctrination in quality assurance program requirements.
l.
Interface with clients and regulators during audits.
m.
Conduct audits of quality-related activities to verify proper implementation of the quality assurance program.
n.
Review and approve project planning documentation.
o.
Review and approve project instructions.
p.
Analyze non-conformance reports to identify adverse quality tiends for management review, assessment and root cause determination.
q.
Sign Certificates of Conformance and/or Compliance when those documents are contractually required.
l The Quality Assurance Manager may delegate specific actions, writing to l
other quality assurance personnel who are qualified for these responsibilities g\\
based on their education, training, and experience.
SECTIOR 1.0 g
QUALITY ASSURANCE
,,y,3,c y a g
MANUAL mo. umo -.'
PAGE 5 oF 9 l
l The Quality Assurance Manager is also responsible for the development, compilation and maintenance of adequate records for activities assigned to the QA organization and for auditing TN West project records to substantiate implementation of this Quality Assurance program. Section 17.0 of this manual provides guidance for the development, classification, storage and turnover of QA records.
The Quality Assurance Manager shall be assigned no duties which will interfere with or compromise the function's independence from cost and schedule when opposed to quality considerations.
The Quality Assurance Manager reports on the status and adequacy of the quality assurance program to the President through distribution of audit reports, Corrective Action Reports, status reports, meetings, and telephone contact.
1.2.3 Engineering Manager The engineering department provides technical services and qualified personnel to support the various projects in accomplishing the required scope of work. The Engineering Manager is responsible for the technical quality of the engineering work and for compliance with the appropriate requirements as defined in this Quality Assurance Manual. The Engineering Manager may delegate specific actions in writing to other engineers who are qualified for these responsibilities based on their education, training, and experience.
The Engineering Manager is responsible for stopping work on appropriate technical work when so directed by the Qua!ity Assurance Manager.
I 1.2.4 Project Manager The Project Manager is the primary contact with clients on matters including progress, budgets, schedules, changes and procedures. The Project Manager has overall responsibility and authority for the proper definition and execution of work required for completion of the project in accordance with contractual l
requirements. The Project Manager is responsible for compliance with the appropriate requirements as defined in this Quality Assurance Manual. The Project Manager is responsible for developing a project planning document for projects within the scope of this Quality Assurance Manual. When required by contract, the Project Manager has the authority to issue a Certificate of p
Conformance and/or Compliance in conjunction with the Quality Assurance Manager attesting that the items or services provided comply with contractual requirements.
The Project Manager may delegate specific project management actions in writing to a Project Engineer, or others, who are N______________-_-_
1 l
sEcTION. 1.0 QUALITY ASSURANCE m
TMANENUCLEAR WEST MANUAL l
PAGE 6 oF 9 qualified for these responsibilities based on their education, training, and experience.
l The Project Manager is responsible for stopping work on the project when so directed by the Quality Assurance Manager.
1.2.5 Licensing Manager When TN West has responsibility for licensed products, a Licensing Manager shall exist to manage the licensing related activities. The Licensing Manager is also responsible for reviewing non-conformance reports to assess the non-conformance impact on the licensed product requirements. The '_ censing Manager initiates required actions to reconcile those issues deemed to be significant for licensing considerations. The Licensing Manager shall indicate by signature on the non-conformance report, or other document referenced thereon, that all licensing considerations (including Safety Analysis and Safety Evaluation Reports) have been reviewed and no deviation with license requirements exists, or if resolution is required, a plan has been established to reconcile the deviations.
The Licensing Manager may delegate specific licensing actions in writing to others who are qualified for these responsibilities based on their education, training, and experience.
1.2.6 Project Engineer As defined in the project planning document, each project may be assigned a Project Engineer who reports to the Project Manager. The Project Engineer is responsible for ensuring that assigned project related activities are carried out in accordance with the project criteria received from the Project Manager and the applicable quality procedures.
The Project Manager, or others, may perform these activities when so defined in the project planning document.
]
l 1.3 Branch Offices When TN West establishes branch offices (including field sites), these offices shall comply with the qually assurance program for the activities within the scope of this i
quality assurance manual. The Quality Assurance Manager is assigned responsibility for quality assurance activities at any such branch offices and has a direct line of communication and responsibility to the President for these activities. The Quality Assurance Manager is responsible for ensuring implementation of the TN West Quality m
Assurance Program at any branch offices.
SECTION: 1.0 3
%.aucu w..'
QUALITY ASSURANCE
,,y,,,,, g rou MANUAL PAGE 7 OF 9 1.4 Discutes involvina Quality Disagreements involving quality requirements or activities between quality assurance personnel and other TN West department personnel are resolved by referring the matter upwards through the chain of responsility of both the quality assurance department and the department involved until the concem has been properly resolved.
(
i l
L_______.____._________-._....--
~
O I
~
NO TA R
TS I
9 N
I M
F D
0 O
A 1
N 8
O I
E T
C G
E A
~
S P
~
T N
E M
E G
LAU N
C A
N T I
M
,R TA R
E S H
~
E
~
C E C G
1W A
N N
N T
1 N
GR A
A E RO E
NE M
l R
R AI I
g I
M E
I D
SG G
T E
S NA N
U U
A E
EN I
L CA R
S G CI P
L E
Z R
S FUN I
N A
NA G
I Y
SG N
E T
NR E
AO H
I L
R T
A T
O
~
T U
TR Q
R O
'E P
G ER YA M
R E
GANA T
%T S
M E
W GN
~
I R
S A
N EL E
C E
C U
I N
Y C L
s T
I 1
N L
A A
E R
U T
nO Q
O N
A
=
l!
9 E
r 0
o IV 1
o T
C N
9 E'
R O
T 3,
E I
O^
R C
y G
E A
EV C
S P
T D
A N
A U
E M
N C T T
A N R D
I I
M U
A gT A
,T P E
S E PR C
E D 2 W N
E E
YCR 1
A RC TNE
~
_ O R
E LAG I
?
R AN ARA U
EA UUN -
U S
S I
A FUS G
NS N
Y SA l
YI TR T
N IL E Y
A E I
L A T UIN A
RI U
T L QGN A
E Q
U Q
1 S
E D T
' RO
^ ON
" C E E E RS T
RH T
EG
@T I
S LI E
S P
W P R E
R U V A
S O E
L C
U MS N
A O
R
SECTioN 2.0 g
QUAlfTY ASSURANCE ngy,,,,, g j
m
..m.o -.'
MANUAL PAGE 1 OF 5 OuAUTY ASSURANCE MANAGER PRESIDENT DATE N/
M*
7'28/98 y
/
I(
2.0 QUALITY ASSURANCE PROGRAM 2.0 SCOPE The TN West Quality Assurance Program complies with NRC Regulatk's, Regulatory Guides, ANSI /A' 'iE Standards, and TN West quality assurance policies as spa,ifically defined herein.
The TN West Quality Assurance Program defines the policias, assigns the responsibilities, and summarizes the procedures goveming the design, procurement, fabricat:on, construction, handling, shipping, storing, cleaning, assembly, inspection, testing, operation, maintenance, repair and modification activities of quality-related (safety) components, systems, and structures for nuclear applications. The TN West Quality Assurance Program is also applicable to non-nuclear drojects to the extent specified by contract.
2.1 General (p
V) 2.1.1 The TN West Quality Assurance Program described herein addresses the requirements of the quality assurance enteria documents identified in this section and applies to the activities identified above (at TN West, its branch offices and in field locations) affecting the quality of radioactive material transport / storage packages and nuclear power plant structures, systems, and components that prevent or mitigate the consequences of postulated accidents that could cause undue risk ta the health and safety of the public. The project team, including personnel of supporting departments whose activities affect quality, shall comply with the provisions of this quality assurance program.
j 2.1.2 The TN West Quality Assurance Program conforms to quality assurance criteria contained in ANSI /ASME NQA 1994; 10CFR21; 10CFR50, Appendix B; 10CFR71, Subpart H; 10CFR72, Subpart G; and other quality assurance program criteria not specifically identified. Applicable quality requirements are specified by the client contract or appropriate regulatory criteria for licensing projects.
2.1.3 The TN West Quality Assurance Program provides a basis of commitment and placement of responsibility for the duration of the contract or licenaing effort. The procedural methods for implementing the requirements of the TN West Quality Assurance Mancal are contained in the quality procedures. Applicability of other quality standards, unique client requirements, or other considerations may dictate i
(
the need for an organization or branch office to utilize quality procedures specific to that organization or location. Therefore, each TN West organization, or branch s
office has the authority to develop, in accordance with Gection 5.0 of this Quality i
SECTioN-2.0 QUALITY ASSURANCE
,,y,3,0, o g-MANUAL 1..
. ucu = -.'
PAGE 2 oF 5 Assurance Manual, quality procedures unique to that location.
Proje.
instructions are utilized to address unique project requirements which are not specifically covered by the quality procedures. A further description for the review, approval, and control oi quality procedures and project instructions is contained in Section 5.0 of this manual.
2.1.4 The project planning document is the key controlling feature util;ted by TN West to specify the appropriate regulatory, licent.ing or contractual gaality assurance program requirements. The applicable quality assurance program criteria, 3r parts thereof, are identified in the project planning document to assure adequate quality assurance coverage. Project planning shall be performed in accordance with applicable quality procedures and shall provide, as a minimum, for the following activities:
a.
Establishing project team responsibilities.
b.
Determining quality assurance program applicability, c.
Defining project scope and special technical and quality requirements for the project.
Preparation and approval of project planning for quality related projects involves both project and quality assurance personnel. All project planning documents for quality related projects are reviewed by the Quality Assurance Manager to assure j
that quality assurance controls are commensurate with the specific activity, item j
complexity, importance to safety, and client-imposed contractual or appropriate regulatory Mansing requirements.
2.1.5 The TN West Quality Assurance Program provides for accomplishing activities affecting quality under suitably controlled conditions with consideration given to the following:
a.
Use of appropriate equipment.
l b.
Suitable environmental conditions for accomplishing the activity.
c.
Assurance that prerequisites for the given activity have been satisfied.
l 2.1.6 The TN West Quality Assurance Program takes into account the need for special controls, processes, test equipment, tools, and skills to attain the required quality.
(V
(
t
SECTION: 2.0 QUALITY ASSURANCE yy,,,, o v..... m......'
MANUAL PAGE 3 oF 5 I
2.1.7 The TN West Quality Assurance Program recognizes the need for verification of quality by inspection, monitoring and test.
4 2.1.8 When permitted by the yplicable Federal Regulations, quality controls may be applied using graded criteria, based on an item's safety significance. When used, the graded approach will be discussed in the applicable project planning documentation and applied using approved quality procedures.
2.2 Quality Assurance Manual Review. Acoroval and Control 2.2.1 The TN West Quality Assurance Manual sections shall be reviewed and approved by the Quality Assurance Manager and approved by the President.
2.2.2 The Quality Assurance Manager is responsible for the maintenance and distribution of the Quality Assurance Manual.
2.2.3 Revisions to the TN West Quality Assurance Ma1ual shall be indicated by a vertical line in the right hand margin unless a complete new edition of the manual is issued. In the case of a new edition, the manual shall be clearly identified as a new edition and each section shall be issued as revision zero.
2.2.4 The Quality Assurance Manager is responsible for the issuance of controlled copies of the TN West Quality Assurance Manual when requested.
Only controlled copies of the TN West Quality Assurance Manual shall be issued intemal to the corporation. All controlled copies of the manual will be assigned a l
sequential number which shall appear on the title page of each controlM copy.
'ihe Quality Assurance Manager is responsible for ensuring that currat revisions are sent to all controlled manual holders. It is, however, the responsibility of the manual holders to keep the manuals up-to-date.
Quality Assurance Manual holders, and others within the Company that implement quality assurance program requirements, shall be placed on controlled distribution for a complete set of quality procedures by the Quality Assurance Manager. A single manual may be assigned to one individual at a remote location, to be shared with others at that location. Controlled distribution of quality procedures to extemal recipients (other than TN West employees) is on an as requested basis.
Controlled distribution shall include a transmittal acknowledgement which is to be signed by the document recipient and retumed to the document distributor. If the document recipient fails to retum the transmittal acknowledgement to the document distnbutor within the time frame designated on the transmittal, verbal j
adncddgernent may be obtained and documented to verify that the document i
i l
l l
I
n SECTioN: 2.0 QUALITY ASSURANCE
,,y,3,,,; o t
1.....oc o. a -.'
MANUAL
\\
i PAGE 4 oF 5 j
I l
Was received. The document distributor will maintain a file of acknowledgements for each Quality Assurance Manual / Quality Procedure set and has the option of removing an extemally distributed document from the controlled distribution list at any time if receipt acknowledgement is not obtained. Receipt acknowledgement for overdue intemally distributed documents shall be obtained by contacting the individual or their supervisor, if necessary.
2.2.5 The Quality Assurance Manager may authorize issuance of uncontrolled copies of the TN West Quality Assurance Manual and quality procedures for information only extemal to the corporation. Uncontrolled copies of the Quality Assurance Manual and quality procedures will be up-to-date at the time of issuance and will be stamped " UNCONTROLLED" indicating that no future revisions will be issued to the document holder.
2.3 Manaaement Review of Quality Assurance Proaram 2.3.1 The Quaiity Assurance Manager shall inform the TN West President of the status and adequacy of the TN West Quality Assurance Program. Quality Assurance Management Audits of the vanous TN West organizations shall be conducted annually by an organization independent of the TN West organization being audited. These audit reports shall ha transmitted to the responsible manager of the affected organization for action as required and distributed to the Quality Assurance Manager and the President.
2.3.2 The Quality Assurance Manager shall prepare an annual summary report of the quality assurance program which shall be distributed to the President for review.
This report shall include the status of Corrective Action Reports and Nonconformance Reports and shall identify any trends adverse to quality. The i
report shall also include a review of the Quality Assurance Manual to ensure its consistency with the quality assurance criteria documents identified in this Section.
2.4 Indoctrination and Trainina 2.4 1 The Quality Assurance Manager will provide quality assurance program
! indoctrination training for new employees.
2.4.2 Periodic update training for personnel who participate in the quality assurance program will be conducted by the Quality Assurance Manager.
2.4.3 When necsssary, training in projed unique quality requirements will be provided by the appropriate Project Manage.
SECTION: 2.0 QUALITY ASSURANCE
,,y,3,os. o 1.....ucu m.'
MANUAL PAGE 5 OF 5 2.4.4 When required by applicable codes and standards, qualified personnel shall be appropriately certified in accordance with approved quality procedures.
2.4.5 Proficiency of personnel who participate in the quality assurance program is maintained by continuing execution of their assigned responsibilities, retraining, reexamining, and/cr decertifying as appropriate.
2.4.6 Records of quality assurance training and retraining shall be maintained by the Quality Assurance Manager to demonstrate implementation of the training program. Project unique training records shall be maintained by the Project Manager.
t f
I
1 SEcTION: 3.0
== s/ h QUALITY ASSURANCE y,y,s,cy o r
rom. mm. m.'
k MANUAL PAGE 1 OF 3 n
QUALITY ASSURANCE MAN GER PRESID T DATE o
7/28/98
/
\\[
3.0 DESIGN CONTROL 3.0 SCOPE This section defines the requirements and assigns the responsibilities to assure that design and engineering activities are properly planned, documented and controlled.
3.1 General 3.1.1 Quality procedures shall be established and implemented to assure applicable
(
technical requirements such as design bases, regulatory requirements, codes, I
standards and client-specified requirements are correctly translate f into calculations, specifications, design drawings, procedures, instructions, and design, topical and safety analysis reports. The quality procedures shall also O
ensure that appropriate quality standards are specified and included in technical documents.
3.1.2 Changes or deviations from specified technical requirements or quality standards shall be identifie'i documented and controlled.
3.1.3 Records of design control measures shall be identified, documented and controlled in accordance with applicable quality procedures and shall be available for review.
3.1.4 As appropriate for the type of project and the contracted scope of work, quality procedures shall provide measures for the following activities:
I a.
Controlling items suw as physics, stress, thermal, nydraulic and accident analyses.
I b.
Compatibility of materials.
I
{
c.
Accessibility for in-service inspection, maintenance and repair.
d.
Delineation of acceptance criteria for inspections and tests.
l e.
Selection and review for suitability of application of materials, carts,
)
A equipment and processes that are essentia! to the function of the j
structure, system or component.
1 i
1 sECfloN: 3.0 QUALITY ASSURANCE h
i REVIStoN: O l
g 1..
. o m. m.'
MANUAL PAGE 2 oF 3 The identification of items and characteristics designated as important to safety are included in the details of " Topical" and " Safety Analysis Reports" when these documents are required.
When required, these reoorts are produced in accordance with regulatory requirements.
3.1.5 Design documents shall be checked for both computational accuracy and appropriate design criteria by competent design personnel other than those who performed the original design.
3.1.6 Quality procedures shall be established and implemented to identify and control design interfaces and for coordination among participating organizations. Such procedures shall describe the review, approval, release, distribution and revision of documents involving interfaces.
3.1.7 Verification of design adequacy, such as performance of design reviews, attemate calculations or qualification testing shall be in accordance with
(
applicable quality procedures.
The particular design verification method (s)
(
utilized shall be identified and shall be based on regulatory and contractual
\\
requirements, the design complexity, the degree of standardization and tne state of the art considerations applicable to material, fabrication processes, and operating conditions.
Where testing is used to verify the accuracy of the design in lieu of design review or attemate calculations, it shall include qualification tes. ting under the most adverse design conditions.
3.1.8 Design verification shall be performed by competent individuals or groups other j
than those who performed the original design but who may be from the same i
organization or the same project team. Regardless of their title, individuals performing design verification shall not have immediate supervisory responsibility (except as allowed by Paragraph 3.1.9) and shall not have specified a singular design approach or ruled out certain design considerations or established the design inputs used in the design. The design verification shall include a review to ensure that design characteristics can be controlled, inspected, tested, and that inspection and test criteria are identified.
3.1.9 Design verification may be performed by the design originators supervisor provided the supervisor !s the only individual in the organization competent to perform the verification. In this case the following provisions apply:
)
O l
a.
The necessity for the supervisor to perform the verification shall be documented and apprc/ed in advance by the supervisors management, l
and e
sECTION 3.0 QUALITY ASSURANCE
,,y,,,,, g Os m~.~ umo -.'
MANUAL PAGE 3 oF 3 b.
Effectiveness of the supervisor's design verification and the frequency of use of this verification method sha!! be periodically assessed by performance of comprehensiveinternal audits.
3.1.10 Changes to approved design documents, including field changes, are subject to design control measures commensurate with those applied to the original design, based on the importance to safety of the change under consideration. Design changes are reviewed and approved by the person or organization that performed the review and approval of the initialissue of the design document or by other equally qualified perunnel or organizations as determined by the Project Manager. The personnel or organization (s) designated t.' perform the review and appr0valof changes shall be competent in the specific area of interest and have access 10 the background information and data related to the document being changed. Changes to approved design documents, including field changes and defective or non mnforming items that are repaired or accepted-as-is, are subject to the desi n et.ntrol requirements described above. Design changes are 0
reflected by applicable ahanges to drawings, reports and specifications when required to provide accurate as-built information. The venfication records for specific items provide the basic as-built data and information.
3.1.11 Computer programs used for design analysis or verification shall be controlled in accordance with approved quality procedures. These quality procedures shall provide for verification of the accuracy of computer results and for the assessment and resolution of reported computer program errors.
3.2 Responsibilities 3.2.1 The Project Engineer is responsible for assuring that technical documents such as drawings, specifications, reports and calculations have been properly prepared and checked.
3.2.2 The Engineering Manager is responsible for verifying design adequacy through independent design verification and for the computational accuracy and appropriateuse of analyticalcomputerprograms.
3.2.3 The Project Manager is responsible for coordinadun of design interfaces among participating organizations and for maintaining records of activities related to design.
O
SECTioN. 4.0 QUALITY ASSURANCE MANUAL l
TRANSNUCLEAR WEST PAGE 1 OF 2 QUALITY AsSU CE MAN GER PRESIDENT DATE
/
[l/
w 7/28/98 o
1 4.0 PROCUREMENT DOCUMENT CONTROL 4.0 SCOPE This section defines the requirements and assigns the responsibilities for the preparation, review, approval and control of procurement documents for items and services.
4.1 General 4.1.1 Procurement activities are performed in accordance with approved quality procedures to implement the policies defined in this Quality Assurance Manual section.
Procurement documents shall identify the scope of work, technical requirements, I
m I
T quality assurance program requirements, rights of access, inspection and test O
requirements, special process requirements, documentation requirements and requirements for reporting and dispositioning of non-conformances, as applicable, to the item or service being procured.
4.1.2 Procurement documents shall be reviewed prior to release by qualified quality assurance personnel to assure that quality requirements are correctly stated, inspectable, and controllable; there are adequate acceptance and rejection criteria; and the procurement document has been prepared, reviewed ard approved in accordance with applicable quality procedures.
I 4.1.3 Procurement documents shall also require documentation that identifies arn procurement requirements which have not been met, together with a description or listing of those non-conformances dispositioned "use as is" or " repair."
4.1.4 Changes to procurement documents shall be subject to the s9me review and approval as the original procurement document.
4.1.5 Selection of procurement sources shall be in accordance with Section 7.0 of this Quality Assurance Manual.
4.2 Responsibilities O
4.2.1 The Project Engineer is responsible for establishing the technical requirements of the procurement.
l l
l
SECTioN 4.0 QUALITY ASSURANCE v.4~.~uca.....'
,,y,s,0, o j
MANUAL
(
PAGE 2 oF 2 4.2.2 The Project Manager is responsible for documenting the technical and other requirementsof the procurementin the procurementdocuments.
4.2.3 The Project Manager is responsible for assuring that all applicable client and quality assurance requirements have been adequately included in procurement documents and for assuring that procurement documents have been properiy controlled.
4.2.4 The Quality Assurance Manager is responsible for reviewing procurement documents including cubsequent changes, to verify that they include or reference the requirementsof this section.
l F
s i
l E__----_-----
sECTION-5.0 QUALITY ASSURANCE
[
Revision 0 mu.~ucuo -.'
MANUAL PAGE 1 OF 2
~
QuAUTY ASSU MANAGER PRESIDENT DATE
/[A/
twl-7/28/98 i(
5.0 PROCEDURES, INSTRUCTIONS, AND DRAWINGS 5.0 SCOPE This section defines the requirements and assigns the responsibilities for the preparation, revision, review and approval of procedures, instructions and drawings which prescribe activities affecting quality.
5.1 General 5.1.1 Activities that affect quality shall be acr,omplished in accordance with written procedures, instructions and/or drawings as appropriate to the activity being performed.
(p]
5.1.2 Procedures, instructions and drawings shall include the appropriate quantitative or qualitative acceptance criteria for determining that important activities have been satisfactorily accomplished.
5.1.3 Quality procedures define the methods for implementation of the Tf1 West Quality Assurance Manual requirements for both office and field activities.
5.1.4 Quality procedures, signed by the President and Quality Assurance Manager, are generic to all TN West organizations and branch offices, unless otherwise identified.
j i
5.1.5 Each TN West organization and branch office is authorized to develop quality procedures that are suitable to their method of operation. In no case shall a quality procedure deviate from th? quality criteria specified by the TN West Quality Assurance Manual.
5.1.6 Project instructions will be wr;tten, as necessary, to implement special requirements determined by cliont contracts or project needs, and will be applicable only to that project or client for both office and field activities or as defined in the project instruction.
5.1.7 All revisions to procedures, inMructions and drawings shall be prepared, reviewed
{
and approved in the same manner as the original document.
O m
SECTloN. 5.0 QUALITY ASSURANCE
[s Revision: 0 1....uc u.. m.'
MANUAL PAGE 2 oF 2 1
5.2 Responsibilities 5.2.1 The Quality Assurance Manager is responsible for the preparation, approval, maintenance, control and distribution of quality procedures to implement the requirements of the TN West Quality Assurance Manual.
5.2.2 The Quality Assurance Manager is responsible for review of all quality procedures.
5.2.3 The TN West President is responsible for the approval of the quality procedures.
5.2.4 When an organization or branch office develops separate quality procedures specific to their organization or location, the authority for review, approval, maintenance, distribution and control is the same as that indicated above in Sections 5.2.1 through 5.2.3.
m 5.2.5 Tne individuals responsible for preparation, review and approval of procedures, instructions and drawings that prescribe activities affecting quality are identified by the quality procedure that genersbo > e document.
O v
i
SECT,0N 6.0 n
QUALITY ASSURANCE
,,y,s,,, o g
- v. u.~ u cu. w..'
MANUAL PAGE 1 oF 2 QUALITY ASSURA MANAGER PRESIDENT DATE
//[ k s 7/28/98 6.0 DOCUMENT CONTROL 6.0 SCOPE i
I This section defines the requirements and assigns the responsibilities to control the review, I
issuance and distribution of documents which prescribe activities affecting quality. These requirements pertain to all organizations and branch offices as well as activities performed by TN West at the field sites.
6.1 General 6.1.1 Documents which requi7 control in accordance with this section are finalized technical documents, procedures and instructions.
p 6.1.2 Documents that prescribe activities affecting quality shall be reviewed and approved for technical adequacy and inclusion of appropriate quality requirements prior to approval and issuance.
The quality procedure that generates the document describes the requirements for the review and approval functions.
6.1.3 Changes to documents which prescribe activities affecting quality shall be reviewed and approved by the same organization that performed the initial review and approval, or by equally qualified responsible uganizations as determined by the Project Manager. However, such review and approval is not required when the changes are inconsequential, such as the correction of minor typographical errors. Such changes shall be made by the appropriate organization or branch office personnel by lining out the ir, correct data, adding the new information, initiating and dating the correction.
6.1.4 Documents which prescribe activities affecting ouality shall be distributed to, and used at, the location where the activity will bc gdormed prior to implementation of work.
The intemal and extemal distrib' tion of technical documents to u
responsible personnel are predetermined and established for each project.
Distribution to individuals at the client's facility is as specified by the client.
6.1.5 Obsolete or superseded documents shall be either removed from the work area and destroyed or appropriately marked to identify that they have been replaced by a later revision.
V l
l
SECTioN: 6.0 QUALITY ASSURANCE REVISloN: 0 u....ocu MANUAL PAGE 2 oF 2 6.1.6 A master list may be used to identify the latest revision of each document. When used, the master list shall be distributed to predetermined, responsible personnel.
The master list shall be updated as required to remain accurate.
6.1.7 Controlled distribution of documents which prescribe activities affecting quality shall be accomplished by the use of distribution logs and transmittal forms or other means of positive receipt acknowledgement.
6.2 Responsibilities 6.2.1 The Project Manager is responsible for the receipt, issuance and distribution of controlled documents within the scope of the project. The Project Manager is also responsible, through chent direction, for identifying responsible personnel at the client's facility who are to receive and use quality-related documents generated by TN West.
6.2.2 The Quality Assurance Manager is responsible for the issuance and distribution
(
of controlled documents within the scope of quality assurance activities.
6.2.3 The applicable department manager, generating quality-related procedures or instructions, is responsible for the issuance and distribution of those documents.
6.2.4 Individuals who utilize documents which prescribe activities affecting quality are responsible for using the latest revision, as identified in the appropriate distribution records, or obtaining controlled distribution for those documents.
6.2.5 A centralized document control organization may issue and distribute controlled i
documents where so specified in the quality procedures.
l I
1 l
SECTION 7.0 l
QUALITY ASSURANCE v...~ ucu. m.'
MANUAL PAGE 1 oF 3 QUAUTY ASSuRANC '
NAGER PRESIDENT DATE
~
7/28/98 I(
7.0 CONTROL OF PURCHASED ITEMS AND SERVICES I
7.0 SCOPE I
This section defines the requirements and assigns the responsibilities to assure that purchased items and services, including special processes, whether purchased directly or through i
subcontractors, conform to specified procurement document requirements. Such measures include, as appropriate, provisions to properly plan, document, monitor and control the quality of j
purchawd items and services.
l 7.1 General 7.1.1 Control of purchased items and services shall be performed in accordance with approved quality procedures.
t\\
7.1.2 Prier to award of contract, suppliers shall be subjected to a documented technical and quality assurance evaluation for their capabity to provide items or services and related records in accordance with tr.e requirements of approved procurement documents.
7.1.3 The technical and quality assurance evalue.nons are not required for any one of the following conditions:
The supplier is currently on TN West Approved Suppliers List (ASL) for a.
similaritems or services.
b.
The supplier is currently on the client's ASL or has t een spec!*ically l
selected by the client and documentation attesting to this approval has been supplied from the client to TN West.
c.
The supplier holds a valid Certificate of Authorization or Quality System Certificate from the American Society of Mechanical Engineers (ASME) for the activities described in the procurement documents.
Implementation audits are required for supp!iers whose initial listing on the l
ASL is based on their ASME Certification.
l
- qV t
I
SECTION 7.0 QUALITY ASSURANCE
,,y,3,0s o v..... m... -. '
MANUAL PAGE 2 OF 3 7.1.4 Items and services shall be controlled, monitored (surveillance)and verified upon receipt by qualified personnel to assure conformance with procurement docurnents. Surveillance of the suppliers activities shall be performed when determined necessary by the Quality Assurance Manager. When conducted, surveillance shall be documented on a surveillance report. The extent or need of surveillance activities by TN West, at the supplier's location, is dependent on the folicwing conditions:
s The complexity or uniqueness of the item and its importance to safety.
a.
b.
The need for special controls and surveillance over procerses and equipment. Surveillanceis performed on those items where verification of procurement requirements cannot be determined upon receipt.
The degree to which functionai compliance can be demonstrated by c.
receiptinspection and test.
f d.
The availability of quality history or the degree of standardization of
\\
identicalitems.
7.1.5 When purchased items are received, a receiving inspection shall be performed in sccordance with the requirements specified by Section 10.0 of this Quality Assurance Manual.
7.1.6 For commercial"off-the-shelf" items, where specific quality assurance contreb appropriate for nuclear applications cannot be imposed in a practicable manner, additional quality verification requirements shall be performed to the extent necessary to verify the acceptability and conformance of an item to procurement document requirements. When dedication of commercialgrade items for use in a quality related application is required, such dedication shall be performed in accordance with an approved procedure.
7.1.7 Quality assurance audits shall be con 6ucted to verify compliance with applicable quality requirements at intervals consistent with the importance, complexity and quantity of items or services provided. However, quaW/ assurance audits of suppliers are not required when any one of the following conditions exist:
a.
The supplier has been apsved by the client for the specific procurement ard documentation so gating has been provided to TN West.
b.
The supplier is a regulatory agency or a nationally recognized standards laboratory, such as the U.S. National Institute of Standards and Technology.
l SECTloN: 7.0
?L QUALITY ASSURANCE t
p m.. Q
=-.'
REVIStoN: O ucu MANUAL d
PAGE 3 oF 3 7.2 Responsibilities 7.2.1 The Project Manager is responsible for the following activities in relation to procurement:
a.
Planning and executing the procurement process.
b.
Evaluating the suppliefs technical capability to perform the scope of work specified by the procurement documents.
Notifying the Quality Assurance Manager for the performance of c.
scheduled source surveillance.
7.2.2 The Quality Assurance Manager is responsible for performing the following activities in relation to procurement:
p a.
Evaluating the suppliefs quality at2urance program to the requirements of the specified procurement documents.
b.
Performing supplier surveillance activities.
t Conducting supplier quality assurance audits to the requirements c.
I specified herein.
I 7.2.3 The Quality Assurance Manager is responsible for maintenance and distribution of the ASL.,
7.2.4 The supplier is responsible for first-line inspection and verification of items and services, including special processes, within their contractual scope of work.
I pd
(
i t
SECTioN. 8.0 QUALITY ASSURANCE
/]
1.
N.NUCHAR WEST MANUAL PAGE 1 oF 1 QUAUTY ASSURAN MANA R PRESIDENT DATE A[b
/
4 m
7/28/98 i t 8.0 IDENTIFICATION AND CONTROL OF MATERIALS, PARTS, AND COMPONENTS 8.0 SCOPE This section defines the requirements and assigns the responsibilities for the identification and control of materials, parts and components, including partially fabricated subassemblies received or constructed by TN West.
8.1 General 8.1.1 Quality procedures shall identify the appropriate criteria and responsibilities to assure that identification is maintained, either on the item or on records traceable D
to the item, to preclude use of incorrect or defective items.
8.1.2 When required by the applicable specification (procurement, fabricaticts, construction, erection), the identification of materials and parts shall be traceable to the appropriate documentation such as drawings, specifications, purchase orders, manufacturing and (nspection documents, deviation report.s and physical and chemical material test reports.
8.1.3 Quality procedures shall identify the appropriate critetia and retpAsibilities to assure that the correct identification of material, parts and components is verified and documented as described in Section 10.0 of Wis Quality Assurance Manual throughout fabrication, operation, assembling, shipping and inspection.
8.1.4 Hardware identification requirements shall be determined during the generation of orawings (design and manufacturing) and specifications such that the location and method of identification does not affect the fofm, Ot, function, or quality of the item being identified.
8.2 Responsipj@ies 2.2.1 The Quality. Assurance Manager shall be respohsibie for assuring that items are adeqyately identified and traceable to the appropriate reference documentation.
e 8.2.2 The Project Manager shall be responsible for assuring that all documentation f
identified as a deliverable by the purchase document is receNed and is V
acceptable.
I sECTION: 9.0 j
QUALITY ASSURANCE d
REVISloN. 0 1....~ um. m.'
MANUAL PAGE 1 oF 2 QUALITY ASSURANC NAGER PRESIDENT 1
DATE N/s M"
7/28/98
- i l
I 9.0 CONTROL OF SPECIAL PROCESSES 9.0 SCOPE This section defines the requirements and assigns the responsibilities to assure that special processes such as nondestructive examination, chemical cleaning, lead pouring, welding, fabrication, weld overlay, heat treating, waste processing and induction heating stress i
improvement are acceptably performed and to assure that special processes are performed by qualified personnel using qualified procedures and equipment.
9.1 General 9.1.1 Special processes shall be controlled using special purpose fctms such as travelers to define the sequential operations which must occur. These forry j
include provision to record the procedures, personnel and material identities l
related to each sequence. They will also provide a vehicle for the establishment of quality assurance hold / witness points.
l 9.1.2 Special process procedures, equipment and personnel shall be qualified for f
conforman'.;e to applicable codes, standards and specifications.
9.1.3 Quality procedures shall be developed to require that special processes be performed using qualified procedures, equipment and personnel.
i l
9.1.4 Qualification records of special process procedures, equipment and personnel shall be established and maintained.
9.1.5 When special processes are subcontracted, TN Wcat procurement documents shall require the supplier to submit or make available for TN West review, special process procedure qualif, cation data. Selection and control of special process subcontractors shall be in accordance with Section 7.0 of this Quality Assurance Manual.
9.2 Responsibilities 9.2.1 The Project Manager is responsible for the following activities in relation to special processes:
1 V
a.
Review and approval of TN West procedures which describe and control special processes for his/her project.
SECTION 9.0 QUALITY ASSURANCE
,3,3,,,
o
.... uct......'
MANUAL PAGE 2 OF 2 b.
Review of subcontractorspecial process procedures when applicable.
9.2.2 The Project Manager is responsible for maintenance and turnover of records associated with the execution and acceptability of special processes except for nondestructive examination personnel qualification a J certification records for which the Quality Assurance Manager is responsible.
9.2.3 The Quality Assurance Manager is responsible for final approval of special process procedures as well as inspection procedures or data sheets that pr /ide for recording evidence of acceptable use of special process procedures, equipment and personnel.
9.2.4 The Quality Assurance Manager is responsible for maintaining a qualification program and certification records for personnel involved with special proqess inspection and nondestructive examination.
O 0
t
c SECTloN: 10.0 QUALITY ASSURANCE O
y,y,,,c, o
)
1.....
MANUAL PAGE 1 oF 3 OUALITY ASSURANC NAGER PRESIDEN DATE
/[ b d0 7/28/98 v (
l l
10.0 INSPECTION I
10.0 SCOPE l
i I
This section defines the requirements and assigns the responsibilities to assure that inspectior, and surveillance activities are performed by appropriately trained and qualified personnel using written, approved procedures.
This section includes inspection of items, upon receipt by TN West at the designated location, and also includes surveillance and in-process and final inspections of TN West or TN West subcontractor fabricated, constructed, operated or erected items, systems, components or structures.
I i
10.1 General l'(
10.1.1 Inspection and surveillance personnel shall have been appropriately trained
)
l and shall be qualified to the requirements of ANSI /ASME NQA-1 for the level j
of inspection / surveillance which they are performing.
)
10.1.2 inspection and surveillance personnel shall be individuals other than those who performed or directly supervised the activity being inspected and they shall not report directly to the immediate supervisors who are responsible for the activity being inspected.
i 10.1.3 Inspection and surveillance personnel shall utilize written, approved procedures, checklists or instructions which delineate the acceptance criteria j
for the items under inspection.
j i
The approved, written procedures, checklists or instructions shall provide for l
the following, as required for the inspection or surveillance:
a.
Identification of characteristics or activities to be inspected, witnessed or verified, including criteria for acceptance, b.
A description of the method of inspection or surveillance.
c.
Identification of required procedures, drawings, specifications or other documentation and revisions necessary to facilitate the inspection.
d.
Identification of the inspector or data recorder and recording the results of the inspection or surveillance operation.
l
SECTION: 10.0 QUALITY ASSURANCE n
,,y,,,,, g g
MANUAL 1....uc m.
PAGE 2 OF 3 l
e.
Specifying necessary measuring and test equipment, referencing accuracy requirements.
10.1.4 Inspection shall be performed to verify the following characteristics, as a minimum:
l a.
The material, component or equipment is properly identified and corresponds to the requirements of the purchase or fabrication control documents.
I b.
Material, components, equipment and acceptance records satisfy the inspection instructions prior to acceptance, installation or use.
c.
Specified inspection, test and other records (such as certificates of conformance attesting that the material, components and equipm'ent conform to specified requirements) are available and acceptable prior to installation or use. These records are periodically evaluated by audit, p
surveillance, independent inspection or test to assure validity.
l
\\'
10.1.5 Procedures shall be established to assure that TN West hold points, including client hold points, are identified and work will not proceed until acceptance by authorized personnel.
j 10.1.6 Inspection and surveillance results shall be documented and evaluated, and a l
determination of their acceptability shall be made.
10.1.7 Results of surveillance and inspections (receiving, in-process, assembly, final packaging and shipping) shall be documented on an inspection checklist or other process control document and shall be maintained as quality records.
l 10.2 Responsibilities 10.2.1 The Quality Assurance Manager is responsible for maintaining a qualification program for inspection and non-destructive examination personnel and for approving procedures, planning, travelers or other documents which establish inspection hold points.
10.2.2 The Quality Assurance Manager is responsible for approving inspection procedures, checklists or instructions or other documents to identify inspection hold points where work is stopped.
Oi V
i
l l
SECTION. 10.0 l
QUALITY ASSURANCE REVIStoN: 0 v.....ocui m.'
MANUAL l
PAGE 3 oF 3 i
(
l 10.2.3 Inspection personnel are responsible for performing the inspection using calibrated inspection, measuring and test equipment as defined in Section 12.0 of this Quality Assurance Manual and for compiling records to document the inspections.
10.2.4 Level ll or 111 Certified Inspectors (ANS!/ASME NQA-1), or other quality assurance personnel identified in quality procedures are responsible for evaluating inspection results to determine their acceptability.
10.2.5 The Project Manager is responsible for developing procedures, planning, travelers or other documents to control the fabrication or operations activities, and for assuring that work will not proceed until acceptance by the inspector.
l 10.2.6 The Project Manager is responsible for maintaining inspection records in
\\
1 accordance with this Quality Assurance Manual.
l l'
l l
l l
1 O
l SECTioN: 11.0 l
QUALITY ASSURANCE O
/
s REVISION: 0 TRANSNUCLEAR WEST PAGE 1 OF 2 QUAUTY ASSU MANA'ER PRESIDENT DATE
(
//d7u 7/28/98 I
11.0 TEST CONTROL 11.0 SCOPE This section defines the requirements and assigns the responsibilitico for the control of testing activities performed by TN West.
11.1 General 11.1.1 Test requirements and acceptance criteria shall be provided by the organization requesting the test unless otherwise designated by contract.
11.1.2 Approved, written test procedures or instructions shall be develcped that i
provide the following, as required:
(%
a.
The requirements and acceptance limits contained in applicable test specifications or design and procurement documents.
b.
Instructions for performing the test.
c.
Test prerequisites such as calibrated instrumentation, adeouate test equipment and instrumentation (including their accuracy requirements),
completeness of item to be tested, suitable and controlled environmental conditions, and provisions for data collection and storage.
d.
Mandatory inspection hold points for witness by the client or the TN West inspector (as equired).
l e.
Acceptance and rejection criteria.
f.
Methods of documenting or recording test data and results.
g.
Provisions for assuring test prerequisites have been met.
11.1.3 The test results shall be documented and evaluatea io ?ssure the test requirements and acceptance criteria have been satisfied.
p 11.1.4 Test personnel shall have appropriate training and shall be qualifed to the requirements of ANSI /ASME NQA-1 for the level of testing which they are performing.
t L
SECTioN 11.0 QUALITY ASSURANCE
,,, g (g
m ~.~ucu o w..'
MANUAL l
PAGE 2 oF 2 11.1.5 Testing records and records of training shall be maintained as quality records.
11.2 Responsibilities f
l 11.2.1 The organization requesting the test is responsible for issuing documentation that delineates the criteria and requirements of the test unless otherwise
{
specified by contract.
11.2.2 The Project Engineer is responsible fe,r preparing test procedures that are responsive to the test requirements and acceptance enteria.
11.2.3 The Engineering Manager end, whe's appli;able, the organization requesting the test are re:;ponsible fur reviewing ard approving the test procedures.
11.2.4 The Engineering Manager is responsible for properly training test personnel (or assuring that previous training has been accomplished) for the level at which the test personnel are performing.
The Engineering Manager is also responsible for evaluating and approving the test results to assure that the test y/
requirements have been satisfied.
11.2.5 The Quality Assurance Manager is responsible for establishing and maintaining a program for the qualification of test personnel to the requi.ements specified herein. The Quality Assurance Manager is alsn responsible for performing audits and/or surveillance of testing activities.
l 11.2.6 Test personnel are responsible for using calibrcted inspection, measuring and test equipment as defined in Section 12.0 of this Quality Assurance Manual.
i i
r~N
(
)
v w______________
SECTION. 12.0 QUALITY ASSURANCE g
,,y,,,,, g rou.uocuo -.'
MANUAL PAGE 1 OF 2 I
QUALITY ASSURA cE MAN /GER PRESIDENT DATE
/fN t
7 7/28/98 I
12.0 CONTROL OF MEASURING AND TEST EQUIPMENT 12.0 SCOPE This section defines the requirements and assigns the responsibilities for the control of measuring and test equipment used for acceptance of inspections or tests perfomled by TN West.
12.1 General 12.1.1 Measures shall be established and documented to assure that tools, gages, l
instruments and other inspection, measuring and test equipment used in l
activities affecting quality are of proper range, type and accuracy to venfy conformance to established requirements.
12.1.2 To assure accuracy, inspection, measuring and test equipment shall be controlled, calibrated, adjusted and maintained at prescribed intervals, or prior to use, against certified equipment having known valid relationships to nationally recognized standards. If no national standards exist, the basis for calibration shall be documented.
12.1.3 Special calibration and control measures on rules, tape measures, levels and other sucn de sices are not required where normal commercial practices provide adequate accuracy.
12.1.4 The method and interval of calibration for each item shall be defined and shall be based on the type of equipment, stability characteristics, required accuracy and other conditions affecting measurement control.
Special l
calibration shall be performed when accuracy of the equipment is suspect.
l 12.1.5 Unless limited by state-of-the-art, calibrating standards shall have an error requirement of no more than one-quarter (1/4) of the tolerance of the equipment being calibrated.
12.1.6 When inspection, measuring and test equipment are found to be out of calibration, an evaluation shall be made and documented of the validity of inspection or test results performed and of the acceptability of items inspected or tested since tiie previous calibration.
SECTION: 12.0 QUALITY ASSURANCE
,,y,,,,, g MANUAL v....oct......'
PAGE 2 oF 2 12.1.7 If any inspection, measuring or test equipment is consistently found to be out of calibration, it shall be repaired or replaced.
12.1.8 Inspection, measuring and test equipment shall be marked to indicate calibration status.
12.1.9 Quality procedures describe the proced ral details for the proper execution and documentation for the control of inspection, measuring and test equipment.
12.1.10 Written, approved procedures shall be developed to control the issuance of measuring and test equipment such as instruments, tools, gages, fixtures, reference and transfer standards, and nondestructive test equipment that is used in the acceptance of inspection and test operations.
4 12.1.11 Records of calibration of measuring and test equipment shall be maintained as quality records.
12.2 Responsibilities 12.2.1 The Quality Assurance Manager is responsible for the implernentation of the calibration program gincluding the responsibility for maintaining calibration records of measuring and test equipment).
12.2.2 The Quality Assurance Manager is responsible for implementing procedures to control the issuance and use of measuring and test equipment.
12.2.3 Personnel performing inspections and tests are responsible for using calibrated inspection, measunng and test equipment.
3 i
V
SEcTioN: 13.0 QUALITY ASSURANCE
,,, g MANUAL PAGE l' OF 1 QUALITY ASSU E P.^%^/ 'ER PRESIDENT oATE N/, s 7/28/98 i t l
13.0 HANDLING, STORAGE, AND SHIPPING 13.0 SCOPE This section defines the requirements and assigns the responsibilities for special handling, preservation, storage, cleaning, packaging and shipping of materials, components'and systems purchased, fabricated, constructed, operated or erected by TN West.
13.1 General i
13.1.1 Procedures shall be established to describe the control of cleaning, handling, preservation, storage, packaging and shipping of materials, components and systems, when specified by design and. procurement specification requirements, to preclude damage, loss or deterioration by environmental conditions such as temperature or humidity.
l 13.1.2 Special handling, preservation, storage, cleaning, packaging and shipping requirements shall be established by qualified individuals in accordance with predetermined work and inspection instructions.
13.1.3 Special handling tools and equipment shall be inspected and tested in accordance with written, approved procedures, and at specified time intervals, to verify that the tools and equipment are adequately maintained.
13.2 Responsibilities 13.2.1 The Project Engineer is responsible for reviewing and approving procedures and instructions which describe the control of cleaning, handling, shipping and storage of materials, components and systems.
t 13.2.2 The Quality Assurance Manager is responsible for reviewing and approving procedures, instructions and checklists which provide for the inspection of special handling, preservation, storage, cleaning, packaging and shipping requirements ofitems by TN West.
13.2.3 The Project Manager is responsible for implementation of receipt, storage, handling and shipping instructions of purchased items and materials. This includes the responsibility for providing special handling, special coverings, special equipment, special environments and adequate storage areas as
~
applicable.
j iL____________
l l
SECTION: 14.0 m @u.~ocu o -.'
QUALITY ASSURANCE pQ
,,y,,,,, g MANUAL PAGE 1 OF 1 QUALITY ASSuRpCE MANA ER l PRESIDENT DATE 7/28/98
/
I(
14.0 INSPECTION AND TEST STATUS 14.0 SCOPE This section defines the requirements and assigns the responsibilities for the control of inspection and test status indicators, including the authority for application and removal of I
inspection and test status indicators.
14.1 General l
14.1.1 Procedures shall be established to indicate the inspection and test status of materials, items, structures, systems and components throughout fabrication, l
installation, operation and test.
l l
/
14.1.2 Procedures shall be established to control the application and removal of
(
inspection and welding stamps (when used) and status indicators such as tags markings, labels and stamps.
14.1.3 The status of non-conforming, inoperative or malfunctioning structures, systems and components shall be documented and identified to prevent inadvertent use, in accordance with Section 15.0 of this Quality Assurance Manual. However, prescribed duties, as defined in this Manual and related implementing procedures, are specifically designated to certain individuals.
14.1.4 Procedures shall be established to assure that items accepted and released are identified as to their inspection status prior to forwarding them to a controlled storage area or releasing them for installation, operation or further work.
l 14.2 Responsibilities 14.2.1 The Quality Assurance Manager is responsible for approving procedures that provide for the identification of inspectinn and test status indicators, including the application and removal of status indicators such as tags and labels.
14.2.2 The Quality Assurance Manager is responsible for assuring that the status of non-conforming, inoperative or malfunctioning structures, systems or p
components is indicated.
14.2.3 Production, test and operations personnel are responsible for compliance with indicated inspection and test status indicators.
SECTION. 15.0 QUALITY ASSURANCE
,,y,,,,, g
(
1..
. u c a. m.'
MANUAL PAGE 1 OF 2 QUAUTY ASSURA MANAGER PRESIDENT DATE
.MN//.
7/28/98
/
\\{
15.0 CONTROL OF NON-CONFORMING ITEMS 15.0 SCOPE This section defines the requirements and assigns the responsibilities for the control, identification segregation, documentation and close-out of non-conforming items to prevent their inadvertent installation or use in fabrication, construction, operations or erection.
15.1 General 15.1.1 Procedures shall be established to describe the identification, documentation, segregation, review, disposition, and notification to affected organizations of non-conforming items, materials, systems, parts and components
}
i5.1.2 Non-conforming items shall be dispositioned as "use-as-is", " reject", " repair" or
" rework".
15.1.3 Non-conforming items dispositioned "use-as-is" or " repair" shall include technicaljustification to indicate and assure continued compliance with design, regulatory and contractual requirements.
15.1.4 Items dispositioned as " rework", " repair", or replacement items shall be inspected and tested in accordance with the original inspectior. and test requirements or acceptable attematives which are in compliance with the specified acceptance criteria.
15.1.5 Non-conforming items dispositioned "use-as-is" or " repair" shall be reported to the client unless such reporting is formally waived by the client.
15.2 Responsibilities 15.2.1 The Project Engineer is responsible for determining and approving the disposition of non-conforming items.
i 15.2.2 The Quality Assurance Manager is responsible for reviewing and approving the I
disposition of non-conforming items.
/
SECTION 15.0 QUALITY ASSURANCE 1.....uca.....'
MANUAL tO PAGE 2 OF 2 15.2.3 The Project Manager is responsible for approving the disposition of Non-conformance Reports. The Project Manageris also responsible for segregating non-conforming items when practical, reportic' non-conforming items to the client, and in conjunction with production, operations, test and QA personnel, implementing the approved disposition.
15.2.4 For licensed products, the Licensing Manager is responsible for reviewing reports of non-conformances, or other referenced documents to assess the impact of the discrepancy on the licensing commitments.
I 15.2.5 All employees are responsible for notifying their supervisor of any potential non-(
conforming condition affecting hardware, documentation or services.
I l
l l
I l
o
r r
SECTION: 16.0 n
QUALITY ASSURANCE
()
1 4. ucu MANUAL PAGE I oF 2 QUALITY ASSURA MANA ER I PRESIDENT e
DATE
@/,
'tL-h 7/28/98
/
( (
16.0 CORRECTIVE ACTION I
16.0 SCOPE This section defines the requirements and assigns the responsibilities for identifying and correcting significant conditions adverse to quality, including provisions to pmvent securrence.
16.1 General 16.1.1 A condition adverse to quality such as a non-conformance, failure, malfunction, deficiency, deviation, and defective material or equipment shall be documented and corrected as soon as practical after the condition has been determined.
Sections 15.0 and 18.0 describe the requirements for documenting and correcting these conditions.
\\
16.1.2 Significant conditions adverse to quality including the cause of the condition and the corrective action to preclude repetition shall be documented and reported to organization management and the Quality Assurance Manager.
For the purpose of this section, a significant condition adverse to quality is defined as, but not limited to, an unsatisfactory quality trend, bypassing of required inspection.s, tests, or other critical operations, or a defect or failure as defined by 10 CFR 21, 16.1.3 Timely follow-up action shall be taken to verify proper implementation and close-out of the required corrective action.
16.1.4 A summary report of the status of Corrective Action Reports shall be prepared on an annual basis by Quality Assurance Manager for distribution to the l
President for review.
16.2 Responsibilities 16.2.1 All TN West personnel are responsible for reporting potentially significant conditions adverse to quality to the Quality Assurance Manager.
16.2.2 The Quality Assurance Manager is responsible for assuring implementation of the corrective action program, including follow-up and close-out actions.
1 L_._________...____.______..
SECTION 16.0 QUALITY ASSURANCE vnausmucosan w
MANUAL PAGE 2 oF 2 l
16.2.3 The Quality Assurance Manager is responsible for reviewing all Corrective Action Reports (where required by quality procedures) to determine if the deviation or deficiency documented en the Corrective Action Report is potentially reportable to the Nuclear Regulatory Commission in accordance with 10 CFR 21, 16.2.4 For licensed products, the Licensing Manager is responsible for reviewing I
Corrective Action Reports to assess the impact of the discrepancy on the licensing commitments.
16.2.5 Production, operations, test and quality assurance personnel, as identified, are responsible for correcting significant conditions adverse to quality.
O
e SECTioN 17.0 QUALITY ASSURANCE ramusuuctuan was' MANUE PAGE 1 oF 3 ouAUTY ASSURAN,cfr NAGE PRESIDENT DATE
[k 7/28/98
/
1 17.0 RECORDS 17.0 SCOPE This section defines the requirements and assigns the responsibilities for establishing the control and disposition of quality records generated by TN West.
17.1 General 17.1.1 Records shall be maintained to furnish evidence of activities affecting the quality of structures, systems and components that are safety-related or important to safety according to applicable regulations.
These reco~rds include records of design, procurement, fabrication, assembW, erection, and use; operating logs and the results of reviews, inspections, tests, and audits; l
p results from monitoring of work performance and material analyses; results of maintenance, modification, and repair activities; qualification of personnel, procedures and equipment; and related instructions, procedures, and drawings.
Inspection and est records shall include the following when applicable:
a.
A description of the type of observation.
b.
The date and results of the inspection or test.
c.
Information related to conditions adverse to quality, d.
Inspector or data recorder information, e.
Evidence as to the acceptability of the results.
f.
Action taken to resolve any discrepancy noted.
17.1.2 Quality procedures shall be developed identifying specific documents generated by TN West which are considered quality records consistent with 17.1.1.
These quality procedures shall also identify requirements for indexing, record retention period, storage method (s) and location (s),
classification, and responsibility.
I
SECTioN 17.0 QUALITY ASSURANCE
,,y,syy o 1 4~.~ucu a w.='
MANUAL U)
PAGE 2 oF 3 1
17.1.3 Unless otherwise specified by applicable regulations, codes, standards, or contracts, identified quality records shall be classified for processing and retention purposes. Identified quality records shall be classified as lifetime or non-permanent as described by Regulatory Guide 1.28 using an approved quality procedure.
17.1,4 Where TN West is the licensee for licensed equipment or shipping / storage containers, identified quality records shall be maintained for the period specified in applicable regulations.
For activities governed by 10CFR71, these records shall include records of design, fabrication, assembly, and use; results of reviews, inspections, tests, and audits; results monitoring of vmrk performance and materials analyses; results of maintenance, modification, and repair activities; qualification of personnel, procedures, and equipment; and related instructions, procedures, and drawings. These records are lifetime records. Product specific records shall be maintained for the life of the specific packaging plus three (3) years.
Program recorde shall be maintained for three (3) years beyond the cate a
when TN West last engages in activities for which the Quality Assurance Program was developed.
For activities governed by 10CFR72, these records shall be the same as for 10CFR71 activities above. These records are lifetime records and shall be maintained for the life of the license.
Nonpermanent records generated by TN West are those supporting reccrds required to demonstrate implementation of the TN West QA Program, but are not specifically required by 10CFR71 or 10CFR72 (e.g., a QA audit of a project which is not a 10CFR71 or 10CFR72 project). These records shall be maintained for a period of ten (10) years from the date of generation.
17.1.5 For nonlicensed products and where TN West is not the licensee, lifetime and non-permanent records applicable to a specific scope of work or contract may be transmitted to the client during execution of the work Upon completion of the scope of work or contract, all records which have not been previously transferred will be offered to the client for disposition. TN West does not permanently store quality records for such projects unless specifically requested to do so by the client.
17.1.6 Records shall be indexed to provide for identification, records retention period, and storage location.
Records shall be filed and maintained in facilities that provide a suitable environment to minimize deterioration or I
(
damage and to prevent loss subsequent to completion of work during the L______________
sECTION. 17.0 QUALITY ASSURANCE Q'-
REVISION. 0 r.... oc a*. m.'
MANUAL PAGE 3 OF 3 specified retention time or until transferred to the client, as required by applicable codes, standards, and contracts.
17.1.7 Protection for records is provided by using one of the following storage methods:
Two sets of identical records are maintained at separate starage a.
locations, or b.
The official copy of all records is maintained in approved fire-proof files or vault (s), at a single location.
When agreed by contract, one of the two (2) sets of records required in "a" above may be those submitted by TN West to the client.
17.2 Responsibilities 17.2.1 The Project Manager is responsible for identifying, indexing, and storing product related records under his jurisdiction.
17.2.2 The Quality Assurance Manager is responsible for identifying, indexing, and storing programmatic records under his jurisdiction for the specified retention period. Inis includes responsibility for maintenance of training records for testers, inspectors, and auditors.
17.2.3 The Quality Assurance Manager is responsible for scheduling periodic audits of TN West quality assurance records.
17.2.4 The Quality Assurance Manager is responsible for performing periodic audits of TN West project quality records.
I i
1 l
1 I
s
____..__.___o
SEcTioN. 18.0 QUALITY ASSURANCE TRANSNUCI. EAR W887 MANUAL PAGE 1 OF 2 I
QUALITY ASSU E MA GER PRESIDENT DATE NI l
~
I(
dA as 7/28/98
/
i 18.0 AUDITS 18.0 SCOPE This section defines the requirements and assigns the responsibilities for a comprehensive system of planned and documented audits including audits of supp'iers and site activities to verify compliance with all aspects of TN West Quality Assurance Program and to determine the effectiveness of the program.
18.1 General 18.1.1 Audits shall be scheduled in a manner to provide coverage and coordination with ongoing quality assurance program activities commensurate with the o
status and importance of the activity. All elements of TN West Quality i
- f. J Assurance Program shall be audited at least once each year.
l The need for re-audit of deficient areas shall also be considered. Audits shall be planned to assure effective implementation of quality assurance activities during design, procurement, fabrication, construction, operations, erection, inspection and testing.
1 18.1.2 Audits shall be performed in accordance with pre-established written procedures using checklists and conducted by trained and certified personnel having no direct responsibilities in the areas being audited. Objective evidence I
shall be examined for compliance with quality assurance program requirements.
18.1.3 Audit results shall be documented by auditing personnel and shall be distributed to.and reviewed by management having responsibility in the area being audited.
l 18.1.4 Quality Assurance Management Audits shall be performed to determine the effectiveness of functions for which the various TN West organizations are responsible.
18.1.5 Audit follow-up shall be conducted to assure that appropriate corrective action has been specified and implemented for deficient areas.
i v
i SECTioN 18.0 QUALITY ASSURANCE
,,y,,,,, g 1.....ocu.....'
MANUAL PAGE 2 OF 2 18.2 Responsibilities 18.2.1 The Quality Assurance Manager is responsible for implementing a quality assurance audit program suitable to the type, scope and complexity of the work for that location. This activity also includes supplier audits and audits of quality assurance related activities at field sites.
18.2.2 The Quality Assurance Manager is responsible for planning, scheduling and making arrangements for annual Quality Assurance Management Audits.
18.2.3 Management of the audited organization is responsible for correcting the deficiencies identified by the audit,
' O l
I l
i 1
I 1
4
-