ML20050A856
| ML20050A856 | |
| Person / Time | |
|---|---|
| Site: | 07100231 |
| Issue date: | 03/05/1982 |
| From: | Johnson B, Reynolds L CHEM-NUCLEAR SYSTEMS, INC. |
| To: | |
| Shared Package | |
| ML20050A844 | List: |
| References | |
| 20400, QA-AD-001, QA-AD-1, NUDOCS 8204020333 | |
| Download: ML20050A856 (46) | |
Text
.
')/- oD3/
CHEM-NUCLEAR SYSTEMS INC.
1
(]
- (*
P.O. Box 1866 e Bellevue, Washington 98009 e (206) 827-0711 O
w e
o>
/
RECENED b
IAAR 171982
- If
\\4
,,....s--e-sen cj s-q q
wf as s
.Aqs QUALITY ASSURANCE PROGRAM 5?
6' '
/Q O
DOCKETED Q
USNRC Ab
'I
'MR 191982 > - 1 I
m' s s
73 t'4It SEcppy s
CCan ctgg f/
s
\\ '/
'k v
't Prepared by:
Manas >r, Quality Assurance Approved by:
Dir. tor of Regulator Apa ' r Approved by:
%/jpq PresD eni, CNSI ums:a cm
(]
Assigned to:
\\' J
- yzc3 l
8204020333 820305 PDR ADOCK 07100231 C
?
F 3
l PAGE REVISION STATUS j
Page Rev.
I B
II B
III B
IV B
V B
VI A
VII B
1 -1 B
1-2 8
1-3 8
1-4 8
2-1 B
2-2 B
2-3 8
3-1 B
3-2 B
4 -1 B
4-2 8
5-1 8
5-2 B
6-1 B
O e-2 8
6-3 8
6-4 B
7-1 B
7-2 B
7-3 8
8-1 B
8-2 8
9-1 B
10-1 B
10-2 B
11-1 8
11-2 8
12-1 B
12-2 B
13-1 B
14-1 B
14-2 B
15-1 B
15-2 B
16-1 B
17-1 B
17-2 B
18-1 B
18-2 B
O DOCUME N T REV.
SHEET QA-AD-001 B
I L
CNSO 1002/8-78
3 r
REVISIONS Rev.
Description Revised Approved A
Revised per Change Request QA-AD-001-01
- d. b ' d L.E.Reynolds Change Request approved by SRB 8/30/79 f/ //77 9/5/79 B
Revised per Change Request QA-AD-001-02
[{
Change Request approved by SRB 2/18/82 2//</[82,
!O O
REV.
SHEET QA-AD-001 8
II e
J CNSO 1002/8 78
r 3
[
TABLE OF CONTENTS Page TITLE PAGE PAGE REVISION STATUS I
REVISIONS II TABLE OF CONTENTS III FOREWARD VII 1.0 ORGANIZATION 1 -1 2.0 QUALITY ASSURANCE PROGRAM 2-1 2.1 Management 2-1 2.2 Personnel Qualifications 2-1 2.3 Quality Assurance Policies, Goals and Cbjectives 2-2
( ])
2.4 Quality assurance Manual Distribution 2-2 2.5 Implementing Procedures 2-3 3.0 DESIGN CONTROL 3-1 4.0 PROCUREMENT DOCUMENT CONTROL 4-1 5.0 INSTRUCTIONS, PROCEDURES AND DRAWINGS 5-1 6.0 DOCUMENT CONTROL 6-1 6.1 Document Types Controlled 6-1 6.2 Document Review 6-1 6.3 Document Control 6-1 6.4 Document Change Control (Excluding Drawings) 6-2 6.5 Drawing Control 6-3 6.6 Document Control for Suppliers 6-3 6.7 Document Availability 6-4 Od DOCUME NT REV.
SHEET t
QA-AD-001 B
III CNSO 'D02/8-78
r 3
TABLE OF CONTENTS (cont'd)
Page 7.0 CONTROL OF PURCHASED MATERIAL, EQUIPMENT AND SERVICES 7-1 7.1 Supplier Evaluation 7-1 7.2 Procurement Requirements 7-1 7.3 Supplier Surveillance 7-2 7.4 Receiving Inspection 7-3 7.5 Supplier Audit 7-3 8.0 IDENTIFICATION AND CONTROL OF COMPONENTS AND MATERIALS 8-1 8.1 Components and Materials 8-1 8.2 Bulk Raw Material 8-2 9.0 CONTROL OF SPECIAL PROCESSES 9-1 9.1 Personnel Certification 9-1 9.2 Subcontractor Control 9-1 9.3 Procedures 9-1 10.0 INSPECTION 10-1 10.1 Inspection Procedures 10-1 10.2 Supplier Inspection 10-2 10.3 Indirect Control 10-2 11.0 TEST CONTROL 11-1 11.1 Test Procedures 11-1 11.2 Test Records 11-2 11.3 Test Control for Procured Items 11-2 11.4 Modifications, Repairs and Replacements 11-2 12.0 CONTROL OF MEASURING AND TEST EQUIPMENT 12-1 12.1 CNSI's Equipment Calibration and Control 12-1 O
'22 "ees r'#9 #8 test ta#4 e=t t s#8ce#tr cters i z-'
P 12.3 Inspection Validity 12-2 DOCUMENT REV.
SHEET QA-AD-001 B
IV CNSO 1002/8 78
r 3
TABLE OF CONTENTS (cont'd)
Page 13.0 HANDLING, STORAGE AND SHIPPING 13-1 13.1 Procured Items 13-1 13.2 Transport Casks 13-1 14.0 INSPECTION, TEST AND GPERATING STATUS 14-1 14.1 Equipment Status 14-1 14.2 Establishment of Examinations and Tests 14-1 14.3 Hold Points 14-1 14.4 Check Lists of Examinations, Tests and Inspections 14-2 14.5 Examination og Process Status 14-2 14.6 Inspection Status 14-2 14.7 Control of Inspection Stamps 14-2 0
15.0 NONCONFORMING MATERIALS, PARTS OR COMPONENTS 15-1 15.1 Internal Nonconformances 15-1 15.2 Subcontractor Control 15-1 15.3 Verification of Rework or Repair Acceptability 15-1 15.4 Nonconfonnance Disposition 15-2 15.5 Assessment of Nonconformances 15-2 16.0 CORRECTIVE ACTION 16-1 17.0 QUALITY ASSURANCE RECORDS 17-1 17.1 Maintenance and Access to Records 17-1 17.2 Contents of Record Files 17-1 17.3 Permanent Records 17-2 17.4 Non-Permanent Records 17-2 17.5 Record Storage Facilities 17-2 O
v DOCUME N T REV.
SHEET QA-AD-001 B
Y j
CNSO 1002iB 78
r 3
1 TABLE OF CONTENTS (cont'd) l Page l
18.0 AUDITS 18-1 I
i 18.1 Audit Schedule 18-1 l
l 18.2 Audit Personnel 18-1 I
18.3 Audit Reports 18-1 18.4 Audit Follow-Up 18-2 i
4 4
i
' O l
O DOCUMENT REV.
SHEET QA-AD-001 A
VI
)
4 CNSO 1002/8 78
r 3
FOREWORD s
This program defines and describes the basic policies and procedures used by Chem-Nuclear Systems, Inc. (CNSI) to establish quality assurance requirements for all activities affecting safety related functions of CNSI systems and com-ponents, including transport casks.
The activities include designing, pur-chasing, fabricating, handling, shipping, storing, inspecting, testing, oper-ating and using, maintaining, repairing arid modifying.
Chem-Nuclear Systems, Inc. top management has approved and fully supports adherence to the policies contained in this program.
It is intended that policies described in this program meet or exceed the ap-propriate requirements of ASME Boiler and Pressure Yessel Code Section VIII, ANSI N45.2-1977,10CFR50 Appendix B,10CFR71 Appendix E and MIL-Q-9858A.
This program, in full or in part, is subject to review and comment by customer representa ti ve s.
Revisions or additions to the program will be made as necessary to confona to the current needs of the company.
All revisions will be dated and referenced on the revision page in f ront of the program.
Copies of the Quality Assurance Program will be issued to the customer and government representatives, as required.
Assigned copies of this program will be serialized and a record maintained showing the transmittal of each re-vision.
Information copies of the program may be distributed without seriali-zation and they will not be updated with revisions.
This program is reviewed in total by CNSI's mar,a]ement at least once a year to assure conformance to current practices and requirements.
The Quality Assurance (QA) Program for ChSI was established and implemented by the President of CNSI.
The Q. A. Program has the full support of CNSI's man-agement and all CNSI's employees shall adhere to its provisions.
(O V
DOCUMENT REV.
SHEET QA-AD-001 B
VII CNSQ 1002,8 78
r 3
c 1.0 ORGANIZATION The Quality Assurtace organization within Chem-Nuclear Systems, Inc.,
consists of a Quality Assurance Manager with the overall responsibility for providing quality assurance of design, fabrication and operation.
He has a staff of quality assurance personnel reporting to him, who are as-signed to the following areas:
A.
Vendor inspection B.
Engineering / Fabrication C.
Field operations D.
Barnwell operations Personnel assigned to vendor inspection are responsible for quality as-surance activities to assure CNSI that all vendor and/or subcontractor activities are conducted in accordance with a written program that ad-dresses the applicable criteria of CNSI's Quality Assurance Program.
(]
Quality assurance for engineering / fabrication is responsible for verify-U ing that all equipment has been designed, fabricated and tested in ac-cordance with established CNSI procedures and design documents.
Quality assurance for field operations has the responsibility for audit perfonnance of all CNSI field operations.
Audits include verification of field unit operation in accordance with prescribed procedures and in-structions.
Personnel assigned to the Barnwell site are responsible for monitoring all quality-related activities.
Special emphasis is placed on assuring that the operation (use) and maintenance of casks licensed per 100FR71 are conducted in accordance with written procedures.
They also have the responsibility for monitoring the rolling stock maintenance and health physics activities performed at Barnwell.
All quality assurance personnel report to the Quality Assurance Manager.
p The Quality Assurance Manager reports to the Director of Regulatory Af-f airs of Chem-Nuclear Systems, Inc., (see Figure 1-1).
DOCUMENI REV.
SHEET QA-AD-001 B
l -1 j
CNSO 1002,8 78
l 3
k 4)
DIR. REGULATORY ATFAIRS Q.A. MANAGER / CORPORATE O
- 54. Q. A. ENGl? LEER Q.A. MANAGER /BARNWEEL SECRETARY Q A. ENGINEER Q.A. INSP/ AUDITOR SR. QA INSP.
Q.A, INSP.
Q.A. INSP.
Q.A. INSP, Q.A. INSP.
Q.A. INSP.
Q.A. INSP.
Figure 1-1 W.WmT REV.
SHEET QA-AD-001 B
1-2
)
CNSO 1002,8 78
r 3
p This reporting route has been selected specifically to allow the Quality V
Assurance Manager sufficient authority and autonomy to implement and direct CNSI's Quality Assurance program, to assure confonnance to quality requirements, and to function independent of undue influences and re-sponsibilities for schedules and costs (see Figure 1-2).
Quality Assurance personnel shall have the responsibility and authority, specified in written procedures, to perfonn the following functions ef-fectively and without hindrance or reservation:
a.
Identify quality p roblems, stop unsati sfactory work, and control further proce ssing, delivery or installation on nonconfoming material; b.
Recommend and/or approve solutions through proper channels; c.
Verify implementation of solutions.
Position descriptions of the Quality Assurance Manager and all Quality Assurance personnel shall include prerequisite experience and/or required O
training, which assures that they are competent to perfom the assigned G
duties.
Qualifications for the position of Quality Assurance Manager are as follows:
a.
A bachelor's degree in a technical field; or equivalent experience; b.
At least ten years of experience in engineering or manufacturing; c.
A working knowledge of applicable quality-related codes, standards, and regulatory requirements; d.
The ability to prescribe, apply and assess compliance with the ap-plicable requirements.
While other organizations may be delegated the tasks of establishment and execution of a quality assurance program, it must be recognized that the responsibility for equipment owned and operated by CNSI is retained by CNSI.
The Quality Assurance Manager, upon notification of need for further direction or resolution of Q. A.
problems, has the authority to communicate or direct comunications with any contractor doing business with CNSI.
Ordinarily, such communications will be through the branch of O
CNSI having responsibility for the function provided by the contractor.
O DOCUMENT REV.
SHEET QA-AD-001 B
l-3 CNSO 1002. 8 78
3 r-G
,:e.
.l.f-
- s. t..:.
- r-
. t r..
-g
- s a,:
re EEE.
I((
i e.
is e,
i._,
.a ss.
z.
e e.
,ca,
==.
.e 1
.r..
C 2
es a.
o.
- u. -
-~
u lii:
O
- aa.
- =.
s 2: -
!. 31..'
.= 5 t. -.
s z
E.
e
.n.
u
- =--
S. e' t.
E.
~..
.:e,
- 3.
a.
- v.
E5:
E r.i -
- d-O io-
=_.
22.
e_.
. _e..
.=-
H:
i 14:
c ol e t..
t i
i:
5
- r-3--
Sk
- t*-
I
\\
l 1
l
)
v eigure 1-2 DOCUMENT R E V-SHEET QA-AD-001 B
14 t
CNSO 1002<8 78
r 3
e 2.0 QUALITY ASSURANCE PROGRAM The Quality Assurance Program is comprised of those planned and system-atic actions necessary to assure adequate confidence that CNSI activities i,
will be conducted in a sati sf actory manner and that equipment and material will perfom satisfactorily in service.
It is the intent of this program to insure that activities are conducted in a manner that has the degree of reliability on which safety and performance of these activities were evaluated.
The CNSI Quality Assurance Program applies to the design, manufacture and operation of casks, liners, mobile solidiff-cation units, demineralization units, decontamination units and the operation of transportation trailers.
2.1 Management In order to assure effective implementation, assess the scope and status, and detemine the effectiveness of the Q. A.
Program, the President of CNSI has appointed a member of Senior Management, with (m
broad authority, to execute these function.
Programmatically, these b
functions are executed through the use of internal audits, field investigations, customer / user service reports and internal reporting p rocedures.
2.2 Fersonnel Qualifications The personnel assigned to perfom quality functions are indoctri-nated in accordance with ANSI N45.2.6, NRC Regulatory Guide 1.58, ANSI N45.2.12 and other applicable documents.
Indoctrination and training is established such that:
a.
Personnel responsible for perfoming quality-related activi-ties are instructed as to the purpose, scope and implement-ation of quality-related manuals, instructions and procedures; b.
Personnel perfoming quality-affecting activities are trained in the principles and techniques of the activity being per~
f omed; c.
The scope, objective and the method of implementing the in-O doctrination and training are documented; G
DOCUMENT REV.
SHEET QA-AD-001 8
2-1
(
j CNSQ 1002,8 78
r 3
O d.
Proficiency of personnel perfoming quali ty-af fecting O
activities shall be monitored and documented on a periodic ba si s.
2.3 Quality Assurance Policies, Goals and Objectives It is the policy of CNSI that all activities which are governed by the Code of Federal Regulations, licenses, Certificates of Compli-ance, Letters of Approval or other regulatory requirements, be con-ducted in accordance with written, approved procedures which in-corporate the regulatory requirements in c.nanner which is easily understood by the user / operator.
Quality-related activities shall be perfomed with specified equipment and under suitable environ-mental conditions, and prerequi sites shall be satisfied prior to inspection, operation or test.
Adherence to the procedure require-ments is mandatory for all CNSI employees.
Procedures affecting health and safety are required to be submitted to the Safety Review Board for approval prior to implementation.
It is the stated goal and objective of the CNSI Quality Assurance Program to provide those mechanisms and environments necessary to achieve a reliable Quality Assurance Program for all activities which affect health and safety or are specified by a regulatory re-qui rement.
This goal and objective is achieved through the use of written procedures, management memoranda and management / staff meet-ings which are designed to evaluate the effectiveness of this pro-gram as applicable to each CNSI activity.
Differences of opinion between QA personnel and other CNSI depart-ments shall be resolved in a meeting of the Safety Review Board.
2.4 Quality Assurance Manual Distribution, Measures to control the distribution of the Quality Assurance Nanual and revisions thereto are described in Section 6 of this document.
2.5 CNSI Implementing Procedures This program incorporates the 16 criteria addressed in 10CFR71, Ap-pendix E and 10CFR50, Appendix B.
Implementation of this program is accomplished through written approved procedures.
DOCUMENT REV.
8 SHEET 2-2 QA-AD-001 L
J CNSO 1002,8 78
r 3
Q 3.0 D_ESIGN CONTROL V
The Design Control Program at CNSI ensures that design characteristics, especially those related to safety, are contrelled, inspected, and test-ed; that designs developed by the CNSI Engineering Department meet all applicable regulatory requirements; and that design activities are car-ried out in a planned, controlled, and orderly manner.
A comprehensive system of established procedures and policies is used for developing and implementing design projects, as well as controlling de-sign documents (drawings) and design document distribution.
Various individuals in the CNSI Engineering Department bear responsibil-ity for the selection and control of design parameters and for the de-velopment of design documents.
Their responsibilities are summarized below:
a.
The Project Engineer is responsible for the initial interpretation of design requirements and for confirming that applicable regulatory requirements are correctly translated into specifications, drawings, procedures, and instructions.
Design requirements are also reviewed by Cuality Assurance to ensure that suitable design controls are applied in accordance with applicable codes, standards and CNSI policies.
b.
The Design Lead coordinates with the Project Engineer and serves as a liaison between drafting, the Project Engineer, and Quality Assurance.
The Design Lead also supervises drafting and confirms that design specifications are preperly referenced on drawings and other design documents.
c.
The Design Draftsman produces accurate and precise drawings that confonn to the design specifications and that properly list or ref-erence those specifications.
d.
The Design Checker reviews the drawings for technical accuracy and checks the design to ensure that the equipment can and will perform the functions for which it was designed.
n
, b DOCUME N T REV.
SHEET QA-AD-001 B
3-1 j
CNSO 1002s 8 78
r 3
e.
CNSI Quality Assurance Department reviews the design to confim that OV all quality assurance requirements'. have been identified and'.in-
~
corporated in the finished design.
f.
The Engineering Manager reviews the cesign and - confims that the total design package meets all regulatory requirements and is ready for release and fabrication.
The Design Control Program provide s for design reviews at regul&r intervals to assure that design characteristics can be controlled, in-spected, and tested, and that inspection and test criteria are iaenti-fied.
Fomal design reviews include the Project Engineer, the Design Lead, and any other individuals or groups involve'd in the development of.
the design.
Design reviews may be called at any time a problem is identified.
Records are kept of these design reviews, and measures are, taken to ensure that design errors are' corrected and not repeated.
Design controls also extend to other individuals or groups in-interfacing ~
design organizations.
b<m Materials, parts, equipment, and processes are controlled as outlined in Section 7.0 of this document.
The procurensnt documents specify all'de-sign base requirements including the applicable' regulatory requirements, material and component requirements, dr'awings, ' specifications, codes 'and.
~
industry standards, test and inspection criteria,' and special process instructions.
No equipment is released to the requisitioning party until it meets the requirements specified in the purthase order.
All materi-als, parts, and equipment are reviewed for suitability-prior to selection.
Drawing changes are accomplished as outlined in Section 6.5 of this docu-ment.
Engineering Change Orders (ECO's), Advenced. Drawing Change No-
~
tices (ADCN's) and/or design documents (drawings) must be approved by the Project Engineer, Quality Assurance, and the Engineering Manager before a revi sed drawing can be releared. ' Drawing revisions are subject to the same reviews and approvals as the original drawing.
CNSI drawing control procedures ensure that obsolete drawing copies are destroyed at the time g
a revised drawing is released.
U DOCUMENT REV.
SHEET QA-AD-001 B
3-2 j
CNSO 1002/8 78
r 3
4.0 PROCUREMENT 00'CUMENT CONTROL
,/ ~ '
The procuremer.t of materials, components, or services affecting assem-blies for use at customer sites or other licensed activities is accomp-lished with a written Purchase Order.
Purchase Order foms are controll-ed by the Purthasing Department.
Only Purthasing is authorized to re-lease Purchase ~ Orders, and is responsible for confoming with established procurement and record keeping procedures.
The sequence of events lead-ing to Purchase Order issuance, and the associated record keeping activi-ties comply with CNSI written procedures.
It f$ the CNSI policy that procurement documents, except for administrat-i'le supplies, are reviewed by the cognizant department / site manager.
the depa'lment/ site manager or his designee detemines that the Wiiere r
~
prosurement scti$n is
' governed by regulatory requi rements, the procurement document is submitted to Quality Assurance for review and comment.
'O.
The C6ality Assurance reviewer examines the procurement document to as-
/
sure' that complete in,fomation is provided to identify:
'a.
The applicable 10CFR. Part 50, Appendix B and 10CFR71, Appendix E
,f-requirements which must be addressed; b.
The design, basis technical requi rements including the applicable
' regulatory ~requirem' nts, material and component identification re-e
/
qui rements, drawing s, specifications, codes and industrial stand-ards, tests ai.d inspection requi rements, and special process in-structions;.-
c.
The documentation to be prepared, maintained, and submitted to the r
pisthaser for review and approval; d.'
The records t,o be / retained, controlled, and maintained by the sup-
. < plier, and'those delivered to the purthaser prior to use or install-
~
ation of the materials or components; e.
The procuring age'ncy's right of access to supplier's facilities and records for source inspection and audit; f.
Inspection, witness and hold points as applicable.
DOCUMENT REV.
SHEET t
4-1 CNSO 1002,8 78
s r
3 s
n The individual authorized to control and release Purchase Orders prepares the Purchase Order, incorporating all applicable infonnation referenced in the preceding paragraph.
One copy of all Purchase Orders is maintain-ed in a control file.
I Procurement documents for spare or replacement parts shall be subject to the same controls that are applied to the original equipment.
Changes and revisions to procurement documents are subject to the same review process as original documents.
Original and revised procurement documents shall be clearly annotated to indicate the completion of the aforementioned review and approval se-4 quence.
1 O
O DOCUMEN T REV.
SHEET QA-AD-001 0
4-2 e
CNSO 1002.8 78
r 3
r' m 5.0 INSTRUCTIONS, PROCEDURES AND DRAWINGS U
Activities af fecting quality in design, manufacturing, operation, and maintenance are prescribed by documented instructions, procedures or drawings of a type appropriate to the circumstances.
They include quant-itative and/or qualitative acceptance criteria for determination that the prescribed activities have been satisfactorily perfonned.
The activities are accomplished in accordance with the instructions, procedures or draw-ings.
The purpose of the instructions, procedures and drawings as described herein is to provide and communicate standards for the quality determi-nation within the company, to the vendors and to the customers and are directed at maintenance of an overall quality program.
These written instructions are available for review by customer representatives.
Procedures and instructions are prepared by the cognizant department.
All instructions and procedures are maintained current with a documented method of revision.
Instructions, procedures and drawings are readily available to personnel at locations requiring their use.
The drawings, instructions and procedures detail, where applicable, any equipment, environmental conditions and the method te Le used to determ-ine the condition of the item under examination.
Prerequi site cali-l bration of all special test equipment it clearly stated in detail.
All acceptance criteria are clearly defined, i
l The CNSI Quality Assurance organization reviews and concurs with inspect-ion plans; test, calibration and special process procedures; drawings, specifications and their changes; and verifies that methods for complying l
with applicable standards are specified in instructions, procedures and i
drawings requiring such verification.
O DOCUMENT REV.
SHEET l
QA-AD-001 8
5-1 e
CNSO 1002.8 78
r 3
The CNSI's Q. A.
organization shall review instructions, procedures and O
drawings to ensure that adequate quantitative and qualitative criteria v
are present.
The CNSI's procedure for document preparation shall be followed in the course of preparation, review, approval and control of instructions and procedures.
Drawings shall be prepared, reviewed, approved and controll-ed in accordance with written procedures.
(~3 J
DOCUME N T REV.
SHEET QA-AD-001 B
5-2 CNSO 1002,8-78
r 3
6.0 DOCtJMENT CONTROL p%.)
CNSI procedures control drawings, specifications, procedures, instruct-fons and their respective changes.
6.1 Document Types Controlled The control includes all documents and their changes affecting the quality program.
These documents include, but are not limited to, design drawings and specifications, manufacturing drawings, procure-ment documents, quality assurance manuals, manufacturing, inspect-ion, operating and testing instructions, test procedures and design change requests.
The control system provides adequate and timely distribution of all documents to recipients listed on a document distribution list and prompt removal of all obsolete documentation.
6.2 Document Review All design drawings, design procedures and specifications are issued O
by Engineering.
They are reviewed and approved by Quality Assurance for adequacy and compliance with applicable quality standards and/or contractual requi rements.
The review assures the availability of all information required to conform with design requirements.
The review process is the same for document changes.
Procedures and instructions are reviewed by CNSI's Quality Assur-ance.
Procedures which are not safety-related are approved by the cognizant department or site manager.
All safety-related procedures are reviewed and approved by CNSI's Safety Review Board.
6.3 Document Control Execution of an effective document control system requires the fol-lowing:
a.
Each document shall have an identifying number and a complete descriptive title.
b.
Each document shall have means for identifying the revi sion status and the effective date of each revision.
DOCUME N T REV.
SHEET QA-AD-001 B
6-1 j
CNSO 1002.8 78
r 3
n The number of copies made and issued of a document is cnntrolled by U
a document distribution list maintained in the document file.
The removal of obsolete documents and procedures, is accomplished im-mediately when such material is made obsolete by a new or revised document.
Obsolete document copies are destroyed except for a history copy maintained in the document file.
Procedures and their changes are distributed on a fomal basis and are of standard format.
In cases of emergency, however, approved handwritten procedures or marked-up changes can be considered satis-factory as long as they are converted to the standard fom and be-come of ficial within 30 days.
Drawings and/or documents sent to a customer or subcontractor are accompanied by a document transmittal letter showing the drawing and/or document number, revision and date of transmittal.
A copy of the transmittal letter is kept on file.
A Purchase orders for manufacturing type projects are amended to indi-cate the effect of engineering changes.
On completed projects, as-built drawings and documents are maintained in the project file.
6.4 Document Change Control (Excluding Drawings)
Proposed changes to existing documents shall be recorded on CNSI change request forms.
These forms may also be used to submit pro-posed changes to CNSI customers when their approval is required prior to change incorporation.
All proposed changes are reviewed by Quality Assurance prior to their approval to determine the effect of the change on the quality of the article and the resultant changes in inspection procedures or operations.
Quality Assurance shall approve changes only after re-ceipt of a completed Change Request with authorized approval sig-natures.
Departments approving the change (s) shall be the same as indicated on the approval page of the document to be changed.
p) t DOCUMENT lREV.
SHEET B
6-2 QA-AD-001 l
CNSO 1002,8 78
r 3
Approved change requests are ir.corporated in the document.
The changed document is distributed to the individuals indicated in the v
document distribution log.
6.5 Drawing Control Drawing changes are made using the Engineering Change Order (ECO) fom.
The fom is a one-part reproducible form used to specifically delir,eate a proposed change.
The fom is also used to submit pro-posed changes to customers when their approval is required prior to change incorporation.
All proposed changes are reviewed by Engineering and Quality Assur-ance prior to their approval to detemine the effect of the change on the quality of the article and the resultant changes in inspect-ion procedures or operations.
Revisions, changes and modifications of affected systems are made only after approval of the ECO.
Ap-proved changes are maintained in an EC0 file by Engineering.
O 6.6 Document Control for Suppliers 1
Subcontractors and vendors are required to maintain an effective drawing control system when drawings are provided to CNSI as part of the contractual requirements.
Procurement of articles to CNSI's design requires a document control sy stem that includes assurance of notification of changes to the subcontractor or vendor, verification of change incorporation and appropriate identification of those items on which the change is incorporated.
Procurement of articles of subcontractor's design requires a docu-ment control system that assures notification of CNSI by the sub-contractor of the proposed change, approval of the change by CNSI and appropriate identification of the items on which the change is incorporated.
O DOCUMENT REV.
SHEET QA-AD-001 B
6-3 CNSQ 1002,8 78
r 3
6.7 Document Availability Documents shall be available prior to comencement of work at the locations where activities involving them are to be performed.
O O
DOCUMENT REV.
SHEET QA-AD-001 B
6-4 CNSO 1002<8 78
r 3
f 7.0 CONTROL OF PURCHASED MATERIAL, EQUIPMENT AND SERVICES The procurement control methods CNSI uses establish measures to assure that procured items and/or services are clearly and adequately specified in procurement documents and are supplied by vendors and subcontractors who are capable of producing items and furnishing services which confonn to procurement document requirements.
These procurement methods, are controlled by procedures and/or instructions for vendor evaluation, re-view of procurement requirements and surveillance of vendor's facility.
7.1 Supplier Evaluation CNSI Engineering, Procurement, and Quality Assurance personnel participate in evaluation of procurement sources.
Recommendations of procurement sources are based on these evaluations.
Results of supplier evaluations performed prior to contract award are docu-mented and filed.
The evaluations cover review of capabilities and facilities for technical, manufacturing and quality perform-p ance, and include any or all of the following as appropriate:
V a.
Historical performance data, particularly in product quality and delivery; b.
Review and comment on supplier's quality assurance program; c.
Source audits to verify supplier's implementation of his quality assurance program, as required; d.
Source qualification programs.
The evaluation considerations include the elements of the NRC's Quality Assurance Criteria to the extent these criteria are ap-plicable to the equipment being procured.
Actions to correct de-ficiencies in the supplier's organizstion or quality program are resolved with the supplier's management prior to fabrication of ordered items.
7.2 Procurement Requirements Requirements to be met by the supplier are detailed in the pro-curement documents which may include procurement specification.
Procurement specifications detail the aspects of supplier quality assurance, for example, inspection reports, provisions for in-DOCUMENT REV.
SHEET QA-AD-001 B
7-1 j
CNSO 1002,8 78
r 3
n spection, equipment calibration prior to use, and provisions for U
inspection af ter component repair.
The procurement specification may also require the successful bidder to submit the following for CNSI's review:
a.
Special process procedures for perfonning welding, heat treatment, nondestructive examination; b.
Recomended inspection point program; c.
Appropriate documentation as required by applicable codes, standards and procurcment documents; d.
Notices of nonconformances and deviations; e.
Test procedures in accordance with applicable codes and standards.
7.3 Supplier Surveillance CNSI's Quality Assurance is responsible for conducting and docu-menting supplier surveillance.
Surveillance activities typically include:
a.
Witnessing test inspections, nondestructive examinations and various special process operations; b.
Monitoring heat treatment, welding, cleaning, preserving, and packaging activities; c.
Verifying supplier confonnance with establided procedures, such as:
1.
use of CNSI accepted drawings and procedures 2.
use of accepted product and process quality planning 3.
document change control 4.
material identification and traceability control 5.
control and calibt, tion of measuring equipment 6.
control of major repair welding d.
Reviewing completed product gaality documentation and/or checklists prior to release of equipment for shipment.
Documentation of nonconformances shall be provided by suppliers as prescribed by this program.
CNSI's quality assurance personnel perfonn a review to assure the validity of supplier documentation during in-process, testing and DOCUMENT REV.
SHEET QA-AD-001 B
7-2 j
CNSO 1007e8 78
r 3
p final inspection stages.
The entire documentation package is re-U viewed prior to shipment of manufactured items.
This document-ation includes material test reports, inspection and test reports, NDE reports and applicable code data reports.
The frequency and extent of the surveillance are consistent with the complexity and quantity of the item or service being furn-ished.
7.4 Receiving Inspection Receipt inspections shall be perfonned on purchased items (includ-ing spare or replacement parts) to assure that:
a.
Material, components or equipment are properly identified and correspond to the receiving documentstion; b.
Inspection records ur certificates of conformance attesting to the acceptance of material, components and equipment are available and are filed in the project file prior to use; c.
Items accepted and released are identified as to their in-spection status prior to forwarding them to a controlled storage area or releasing them for installation or further work.
7.5 Supplier Audit Measures for evaluation of suppliers are described in the audit section of this document.
i O
V DOCUME N T REV.
SHEET QA-AD-001 B
7-3 j
CNSO 1002,8 78
r 3
8.0 IDENTIFICATION AN9 CONTROL OF COMPONENTS AND MATERIALS The identification and control as described herein shall apply to com-ponents, production materials, bulk raw materials, parts and assemblies at all stages of fabrication and installation from receipt of components and material to completion of the system or component.
These require-ments shall be imposed on CNSI's subcontractors and suppliers.
8.1 Components and Materials The inspection status of components and materials shall be ac-complished by marking, tagging or stamping components or materials at the appropriate stages of fabrication or installation.
Identification of components and materials shall be accomplished with a method that will provide legible identification without adverse effect on its life and utility.
Components or materials not suitable for individual marking, shall O
be individually tagged or shall be placed in an identified con-O tainer.
The storage area shall contain only components or materials which have been inspected and accepted.
Surveillance shall be maintain-ed over the storage areas to assure that material s subject to certification control or age limit requirements are properly seg-regated, dated and controlled.
This surveillance shall also in-clude checking for conformance to proper standards of packaging and storage of all components, materials, parts and assemblies.
8.2 Bulk Raw Material Following the acceptance of bulk raw materials, a tag showing the purchase order, the material identification, mill heat number or heat code and the date of receipt shall accompany the material.
If during fabrication all identification has been removed from the part of the material being used, the remnant shall be marked be-fore being returned to stock.
DOCUMENT REV.
SHEET QA-AD-001 8
8-1 cNso1002/s38
r 3
Material marking shall not be affected by contact incident to normal handling, exposure to the elements, shipment or storage.
All markings shall offer ready readability and prompt identiff-cation of the material.
Physical marking of material shall be accomplished in a manner which will not adversely affect the machining, forming or fabrication of the material.
Identification requirements shall be determined during generation of specifications and design drawings.
Identification of materials and parts for safety-related systems or components shall be traceable to the appropriate documentation, such as drawings, specifications, purchase orders, manufacturir.g and inspection doc-uments, deviation reports and physical and chemical mill test re-ports.
O DOCUMENT REV.
SHEE1 QA-AD-001 is 82 CNSO 1002 8 78
r 3
9.0 CONTROL OF SPECIAL PROCESSES O
All special f abrication, installation and inspection processes which have an effect upon the quality of the component, system or fabrication operation shall be controlled by process procedures.
9.1 Personnel Certificatig Personnel responsible for perfonnance, inspection and control of special processes and operations which require special skills and have an effect upon quality shall be certified.
Personnel for these processes or operations shall be trained and qualified in accordance with the codes and/or standards applicable to the process.
The period of effectivity for all certifications shall be specified and each individual shall be re-certified at the end of such period as required by applicable standards.
Inspection results and quality audits shall be used as indicators of the need for additional training and recertification of f abrication, in-stallation and inspection personnel without regard for established re-certification periods.
A record of the names of certified personnel, their skills and certification periods shall be main-tained on file for review at the facility performing special p roce sse s.
9.2 Subcontractor Control Special processes perfonned by CNSI's subcontractors and suppliers shall be specified in procurement documents and shall be monitored by Quality Assurance for confonnance to CNSI requirements.
9.3 Procedures Special process procedures shall be reviewed and app roved by Quality Assurance which conducts a surveillance to assure that the approved procedures are adequately followed.
Process procedures shall include the method, qualification requi rements, equipment and associated control parameters, bd DOCUMENT REV.
SHEET QA-AD-001 B
9-1 CNSQ 1002/8 78
F 3
10.0 INSPECTION The established inspection program at CNSI verifies the confomance of quality related activities with the applicable requirements.
The veri-fication is performed in accordance with written inspection procedures, instructions or drawings.
Personnel performing the inspection are inde-pendent from the individuals perfoming the activity being inspected.
Equipment modifications, repairs and replacement are inspected in ac-cordance with the original design and inspection requirements unless an
. approved alternative exists.
Provisions for mandatory inspection hold point identification requiring witnessing by an inspector are incorpor-ated in the appropriate documents, such as procurement specifications, test procedures, etc.
The inspection program also provides for identification and document-ation of deficiencies discovered during inspection.
10.1 Inspection Procedures Inspection procedures and instructions are written documents which provide the following information:
A.
Identification of characteristic s and/or activities to be inspected; B.
Identification of the individual or group responsible for perfoming the inspection; C.
Acceptance and rejection criteria; D.
A description of the inspection method; E.
Recorded evidence of completing and verifying a manufactur-ing, inspection, or test operation; F.
Recording inspector or data recorder and the results of the inspection operation.
DOCUMENT REV-SHEET QA-AD-001 B
10-1 j
CNSO 1002 8 78
F 3
Inspection procedures and/or instructions are used in conjunction with the applicable specifications or drawings when inspection operations are perfonned.
Inspection procedures are maintained current by established document control measures.
10.2 Supplier Inspection CNSI identifies inspection requirements in procurement documents issued to subcontractors and suppliers.
The subcontractors and suppliers are responsible for inspection of their p','oducts, and CNSI Quality Assurance verifies their controls to assure adequacy of inspection.
Supplier's inspection plans are required to recognize those CNSI notification or hold points specified by pro-curement documents.
10.3 Indirect Control In the event that direct inspection is not possible, indirect control of the inspection process shall be provided by monitoring
()
processing methods, equipment and personnel where applicable, oU DOCUMENT REV.
SHEET QA-AD-001 B
10-2 cme tem n
r 3
11.0 TEST CONTROL A test control program established at CNSI assures that all required testing is identified and perfonned in accordance with written test pro-
- cedures, which incorporate the requirements and acceptance limits i
specified by the applicable design documents.
11.1 Test Procedures Test procedures prepared by the responsible CNSI department are reviewed by Quality Assurance in accordance with standards, pro-cedures or instructions that require inclusion of the following quality assurance requirements, as applicable:
A.
Requirements and acceptance limits as contained in the ap-plicable design documents; B.
Detailed instructions for performing the test; C.
Test prerequisites, including, but not limited to the follow-ing:
a.
calibrated instrumentation b.
adequate and appropriate equipment c.
trained, qualified, and as appropriate, licensed and/or certified personnel d.
preparation, condition and completeness of the item to be tested e.
suitable and, if required, controlled environmental conditions D.
Mandatory inspection hold points for witness by responsible individual; E.
Acceptance and rejection criteria; F.
Method for documenting or recording test data and results; G.
Designation of the individual (s) or groups (s) responsible for evaluating and making decisions based on test results.
Test procedures shall be subject to document control as outlined in this program.
They shall be maintained current by revisions issued upon changes in specifications, documentation, drawings or contracts.
DOCUME N T REV.
SHEET QA-AD-001 B
11-1
(
j CNSO 1002,8 78
r 3
11.2 Test Records Records of tests performed shall be prepared, showing the applic-able drawing or procedure revision, identification of test per-formed, date, test data and other essential test information.
The test record shall be signed by the individual perfonning the test and any test witnesses, if so required.
Test records thall be retained.
11.3 Test Control for Procured Items Test control requirements are imposed on suppliers by procurement documents.
They identify the tests to be performed and stipulate that suppliers' test proced res be submitted for approval.
Tests are conducted by groups within the supplier's organization, and test control systems are monitored during Quality Assurance sur-veillance.
Records of tests are reviewed for acceptability during surveillance.
O 11.4 Modifications, Repairs and Replacements Modifications, repairs and replacements shall be tested in accord-ance with the original design and test requirements or acceptable alternatives approved in the same manner as the original.
O DOCUME N T REV.
SHEET QA-AD-001 B
11-2 CNSO 1002/8 78
r 3
12.0 CONTROL OF MEASURING AND TEST EQUIPMENT Measuring and test equipment with the necessary range and accuracy shall be provided to qualified personnel for the inspection, test and accept-ance of material, parts, components and systems.
Equipment accuracy shall be assured by calibration traceable to national standards or a documented alternate basis for calibration.
12.1 CNSI's Equipment Calibration and Control Inspection and test equipment shall be subjected to maintenance and calibration at periodic intervals by qualified personnel or subcontractors.
Frequency of calibration shall be based on the equipment type, historical experience and operational requirements.
Each item of measuring and test equipment shall be serialized for record and identification purposes.
A sticker shall be attached to the equipment to indicate date of calibration, due date of next (N
calibration and the stamp or signature of the person conducting the calibration.
A status file shall be maintained for all cali-brated equipment.
Measuring and test equipment shall be issued to and retained be-tween calibrations by those requiring its use.
Each user has the responsibility to ascertain, prior to use, that the measuring and test equipment calibration date has not expired and that damage or rework has not taken place since the last calibration.
Compliance with the above requirements is monitored by Quality Assurance.
12.2 Measuring and Test Equipment at Subcontractors Measuring and test equipment used by subcontractors, vendors and suppliers engaged in fabricating and furnishing materials, parts and components to CNSI shall be under the surveillance of CNSI's Quality Assurance.
The surveillance shall cover production tooling, jigs, fixtures and other fabrication equipment which con-Q trols dimensions, contours, etc., and which is used for accept-b DOCUMENT REV-SHEET QA-AD-001 8
12-1 j
CNSO 1002/8 78
r 3
ance.
Surveillance activities include checks to assure that in-spection operations are or have been perfomed with appropriate measuring and test equipment.
12.3 Inspection Validity Equipment accuracy is nomally checked prior to each use.
When measuring and test equir' ant is found to be out of calibration, mea sure s shall be taken to ensure the validity of previous measurements and tests conducted during the period when the equipment is likely to have been operating in such a condition.
O V
O
%J REV.
SHEET B
12-2 QA-AD-001 e
i CNSO 1002,8 78
r 3
3 13.0 HANDLING, STORAGE AND SHIPPING 13.1 Procured Items Measures used to control packaging, shipping, storage and handling of components and material to prevent damage or deterioration shall be documented to reflect contractual or CNSI specified re-quirements.
Procurement documents shall identify the required control measures to suppliers.
The supplier must have adequate written work and inspection in-structions for storage, preservation and packaging of shipment to protect the products from damage, loss, deterioration or substi-tution.
As required by the equipment specifications and/or pro-curement documents, these procedures may be subject to approval by CNSI.
13.2 Transport Casks Transport cask handling and operation shall confonn to the written handling and operating procedure for each licensed cask.
Prior to the shipment of a transport cask all conditions of ti.e NRC's Certificate of Compliance (specifications, tests, inspect-fons) shall be satisfied.
All required shipping papers shall be prepared and shall accompany the shipment.
Quality Assurance located at Barnwell, S.C.,
is responsible for auditing all critical cask handling, storage and shipping oper-ations conducted by Barnwell Site Operations.
Established safety restrictions concerning handling, storage and shipping shall be included in the handling and operating pro-cedures for transport casks.
OV DOCUMENT REV.
SHEET QA-AD-001 B
13-1 j
CNSO 1002/8 78
r 3
14.0 INSPECTION, TEST AND OPERATING STATUS V
14.1 Equipment Status The inspection, test and operating status of systems and compon-ents used for processing or transportation of radioactive material shall be known at all times during manufacturing and operation.
Transportation and operating procedures shall include reporting requirements which establish the equipment status at key events (af ter unloading, prior to shipment, etc.).
Equipment status will be maintained by operating personnel who are responsible for critical inspection, test and operating activi-ties.
Quality Assurance personnel shall verify equipment status and compliance with procedures.
Bypassing of required tests or other critical operations shall be procedurally controlled under the cognizance of Quality Assurance personnel with the concurrence of the Q.A. Manager.
14.2 Establishment of Examinations and Tests In-process and final examinations and tests shall be established to assure conformance with documented instructions, procedures, drawings, rules and regulations.
14.3 Hold Points The procurement documents, drawings, quality plans, transportation and operating procedures shall establish any required mandatory hold points which shall be reflected in fabrication or operational schedule.
Hold points shall be designated points in the fabri-cation or operation schedule beyond which the operations shall not proceed without the concurrence of quality assurance because of witnessing, examination or testing requirements.
O L.)
DOCUMENT REE SHEET QA-AD-001 B
M t
J CNSQ 1002,8 78
r 3
p 14.4 Check Lists of Examinations, Tests and Inspections b
Prepared check lists shall include the document number and re-vision to which the examination, inspection or test shall be per-fomed.
The check list shall have space provided for recording results of examination, test or inspection and for witness sig-natures, initials or stamp and date for activities witnessed.
14.5 Examination of Process Status Measures shall be established to indicate during receiving, fabrication and equipment operation the status of examinations and tests perfomed on items, systems and components.
These measures shall provide identification of those items which confom to examination and test requirements and those that do not confom.
14.6 Inspection Status CNSI inspection stamps or authorized Quality Assurance signature shall be applied to documentation for materials, items, systems and components to indicate the inspection status and to provide traceability to the individual performing the inspection.
A tag indicating inspection status shall nomally be applied directly to the item which has been examined.
14.7 Control of Inspection Stamps Inspection stamps shall be serialized for traceability to the in-dividual inspector.
Quality Assurance shall control and issue inspection stamps, as required, to authorized personnel.
Stamps removed from service because of loss, employee temination, etc.,
shall be retired for a minimum of three months.
O DOCUME N T REV.
SHEET QA-AD-001 B
14-2 CNSO 1002,8-78
r 3
15.0 NONCONFORMING MATERIALS, PARTS OR COMPONENTS QO Procedures for control of nonconfoming materials, parts or components assure that such materials are adequately identified and segregated from acceptable materials, if feasible, to preclude their inadvertent use.
15.1 Internal Nonconfomances CASI materials, parts and components which are detemined to be di screpant shall be identified, reported, and, when feasible, physically separated from acceptable items.
The method of identi-fication shall clearly cescribe the nature of the defect.
Non-confomance reports shall be forwarded to the designated depart-ment (s) for disposition.
A holding area with controlled access shall be provided when necessary for material and/or component segregation.
Nonconformance reports shall indicate the nature and extent of the discrepancy and the disposition Minor discrepan-cies that can be reworked shall be identified by an Inspection Tag and/or report of rejection until rework has been satisfactorily O
ss accomplished.
15.2 Subcontractor Control Subcontractors shall promptly notify CNSI of all deviations from the procurement requirements, such as deviations from the required codes or approved drawings.
A nonconfomance notice shall be initiated by the subcontractor in accordance with the subcontract-or's quality assurance program.
After detection of the deviation, further fabrication shall not be perfomed until the nonconfom-ance has been resolved.
The subcontractor shall supply records of nonconfomance reports dispositioned " accept as is" or " rep ai r".
These reports shall be made part of the inspection records and forwarded with the hardware to CNSI for review and assessment.
15.3 Verification of Rework or Repair Acceptability Acceptability of rework or repair of materials, parts, components, systems and structures shall be verified by reinspection and/or N
retesting the item to the original criteria, or by a method DOCUMENT REV.
SHEET QA-AD-001 8
15-1 q
J CNSO 1002,8 78
\\
r 3
which is at least equal to the original inspection and testing O,
method.
Inspection, testing, rework and repair records shall be documented and filed in CNSI quality records files.
15.4 Nonconformance Disposition The individuals or groups identified on nonconformance reports shall have the responsibility and authority for disposition of nonconforming items.
CNSI Quality Assurance is responsible for reviewing, approving and verifying the disposition of nonconfom-ances.
15.5 Assessment of Nonconformances Nonconfonnance reports shall be analyzed periodically to show quality trends, and the results reported to CNSI management for review and assessment.
O DOCUMENT REV.
SHEET QA-AD-001 3
15-2 CNSO 1002,8 78
O r
3 16.0 CORRECTIVE ACTION f,]\\
Conditions adverse to quality (e.g.,
nonconformances, failures, mal-functions, deficiencies, deviations, defective materials, etc.) shall be evaluated to determine the need for corrective action in accordance with established procedures.
Corrective action shall be promptly initiated when it is detemined that an existing nonconformity in a material, a process or a product is due to an assignable cause and is repetitive in nature.
The corrective action shall include:
(a )
Investigation of discrepancy (b)
Determination of cause (c )
Corrective action to be taken (d)
Evaluation of corrective action V-The appropriate departments shall be assigned the responsibility for corrective actions.
Corrective action ic.:ludes, but is not limited to, procurement or manufacturing operations, design, construction and oper-ation.
The results of corrective actions shall be documented.
Quality Assurance shall review records to verify proper implementation of cor-rective action.
Effectiveness of corrective actions shall be continu-ously monitored as a function of quality surveillance.
The corrective action shall not be complete until results have been verified by Quality Assurance.
Significant conditions adverse to quality, the cause of such conditions, and the corrective action taken fhall be reported to cognizant levels of CNSI management for review and assessment.
When corrective action requests affect a CNSI supplier, the supplier shall be required to provide the following information:
(a)
A description of factors contributing to the deficiency (b)
A description of corrective actions taken to prevent recurrence of r
the discrepancy in future production.
t DOCUM E N T REV.
SHEET QA-AD-001 B
16-1 j
CNSO 1002,8 78
r 3
(~
17.0 QUALITY ASSURANCE RECORDS 17.1 Maintenance and Access to Records The record system maintained by Chem-Nuclear Systems, Inc. includ-es the retention of those design, fabrication, inspection and sur-veillance records essential to demonstrate proauct quality.
It provides for the identification of materials and their correspond-ing manufacturing, installation, test and inspection records and certificates.
Operating records maintained will include inspect-ion, test and audit results.
All records pertaining to a specific project shall be available for review by the appropriate inspect-for agencies, the customer and/or his representative.
All records maintained according to established procedures will be identifi-able and retrievable.
17.2 Contents of Record Files It is the policy of CNSI that adequate records be maintained of all component and material inspections and tests.
Inspection and test records shall contain the following, as applicable:
a.
A description of the type of observation; b.
Evidence of completing and verifying a manufacturing, in-spection or test operation; c.
The date and results of the inspection or test; d.
Information related to conditions adverse to quality; e.
Inspector or data recorder identification; f.
Evidence as to the acceptability of the results; g.
Identification of the procedure (s) and revision (s) used.
Records shall also be maintained of supplier and subcontractor quality assurance reviews, surveillances and audits, and documents pertaining to CNSI internal quality assurance audits.
The files shall also contain procedures and specifications written for a specific project.
O DOCUME NT REV.
I SHEET QA-AD-001 B
17-1 j
CNSQ 1002,8-78
l 3
r 17.3 Permanent Records Permanent file records shall contain:
design specifications, stress reports or stress calculations, "as built" and interface control drawings, copies of material test reports, tabulation of materials for "as built" configuration, nondestructive examination reports, including examinat' ion: result's[ and disposition reports.
17.4 Non-perinanent Records All non-permanent records required to verify c'ompliance with the applicable codes and the supplier's or subcontractor's Quality Assurance Program shall be maintained until project completion,
'~
unless otherwise stipulated.
17.5 Record Storage Facilities Record storage facilities shall be constructed, located and/or secured to prevent destruction of records by fire, flocd, theft, and deterioration.
As an alternative duplicate sets of documen-tation may be maintained in separate locations.
gU O
DOCUMENT REV.
SHEET QA-AD-001 B
17-2 k
)
I CNSO 10022 8 78
7 l
~
3 f
/,,
18.0 AUDITS
\\'
P,lanned audits shall be perfomed to provide comprehensive, independent veri fication and evaluation of the CNSI or supplier activity being
' audited.
The ' audit scope shall encompass evaluation of quality system
' practices and/of procedures and the effectiveness of their implementat-ion, monitoring of operations and activitiet, and a review of pertinent documents and their control and mainter;nce.
Audit checklists shall be prepared, prior to conducting an audit.
18.1 Audit Schedule Interna'i audits shall normally be conducted once every 12 months.
- However, unscheduled audits may be performed more frequently in
, spicific, areas, if. deemed necessary by Quality Assurance and/or when the need is indi.cated by the existence of chronic problems.
. Supplier audits shall be conducted at least once every 36 months.
18.2 Audit Personnel Audits shall be perfomed by CNSI personnel with no direct line responsibili ty for the function audited.
The audit personnel shall have the required level of technical capability to ac-complish the audit functions.
When required, representatives from various CNSI departments may be called upon for technical advice
' ~
or assistance.
18.3 Audit Reports
~A verbal' presentation of the findings, conclusions and reconnen-dations of E,he audit shall be made to management personnel affect-e'd by ' the audit.
A written report containing the findings and recommendations pre-sented in the verbal report is prepared and distributed to the responsible divisions and appropriate management.
Da
\\.
/
r DOCUMENT REV.
SHEET 2
04-AD'001' B
18-1 J
w CNSO 1002/8 78
f r
3 O
Audits shall include an assessment as to how well the Quality As-d
,urance Program meets regulatory or other requirements.
18.4 Audit Follow-Up The originator of an audit report or a designated alternate is required to follow an open finding until action is taken to sati sfy the audit item.
Follow-up actions are taken to verify corrective actions are implemented and effective.
Responsible management personnel shall evaluate each audit report item and correct deficiencies as promptly as possible af ter they are revealed.
O O
COM 3 V
REV.
SHEET QA-AD-001 B
18-2 i
CNSQ 1002,8 78