ML20059D993

From kanterella
Jump to navigation Jump to search
Rev 14 to, QA Policy & Procedures Manual
ML20059D993
Person / Time
Site: 07100135
Issue date: 08/24/1990
From: Haertjens B
BABCOCK & WILCOX CO.
To:
Shared Package
ML20059D988 List:
References
QA-72-1, NUDOCS 9009070257
Download: ML20059D993 (96)


Text

. __

_ _ _ ~..

THE BABCOCK & WILCOX COMPANY NUCLEAR ENVIRONMENTAL SERVICES PENNSYLVANIA NUCLEAR SERVICE OPERATIONS APOLLO, PENNSYLVANIA QUALITY ASSURANCE POLICY AND PROCEDURES MANUAL REVISION 14 DATE:

AUGUST 24, 1990 t

APPROVED:

l<

N AGER, PENNSYLVANIA NUCLEAR

~

SERVICE OPERATIONS l'

A

$/1M S _A MNNAGElt,TECHNICApONTROL 0

/f p y ITY ASSURANCE SUPEandOR I

e 9009070257 900830 ADOCK 0710 5

{DR

4MWW9A' REVISION INDEX PROCEDURE NO.

0A-72-1 REVISION NO.

14 DEPT:

SUBJECT:

QUALITY ASSURANCE QUALITY ASSURANCE POLICY & PROCEDURES MANUAL PURPOSE:

Index of intermediate changes between major revisions.

ISSUE CHANGE DATE SECTION, PAGE, PARA.

DESCRIPTION 12/2/86-All sections Complete revision 4/30/88:

All sections' Complete revision 5/ 2/89 Page 10 - Figure 1.0 Organization Chart 36, Section 7.1 10 CFR 71 Subpart E 41, Section 7.4 10 CRR 71

~

41 Section 7.4.2 Ouality Assurance Supervisor 41, Section 7.4.2 On any type of shipping container manu-factured to the above requirements will have a Certificate of Conformance from the manufacturer

" 67, Section 13.2.5 Written procedures or ITC's of all shipping containers 8/24/90 All Sections Complete Revision M

1

" ' ca d A '

i l

-REVIS10'l I EEX PROCEDURE fl0. __0A-72-1 REVIS10N t10.

I 4..

)

l DEPT:

SUBJECT:

QUALITY ASSURANCE QUALITY ASSURANCE POLICY & PROCEDURES MANUAL Index of intermediate chaIiges between major revisions.

PURPOSE:

(

ISSUE CHAtlGE DATE SECT 10tl, PAGE PARA.

DESCRIPTION llay 20,1982 All Sections Cor'olete Reuision Deleted 1.2.1.5 and Oct. 1, 1982 1.3.1.5. 1.2.1.6. 1.2.1.7 Renumbered at 1.7.1.9 1 1 7 1 A

'I Nov.10, 1982 Figure 1.0 Revised Nov.10, 1982 Section 2.9.3 (b)

Deleted B&W in last sentence.

APPENDIX I " Cross. Reference of a

Jan.21, 1983 OA Poliev & Procedure Manual 9.c Deleted " Misc. Procedurn 1311-01 opposite GP-11 and To Implementina Procedures referenced 01-1266 Section 17.0 Oct. 31, 1983 All Sections Complet.e Revision Mar. 14 / 1984 Section 4.2.6 Deleted oriainal 4.2.6 Change last sentence to include fluclear Mar. 14, 1984 Section 18.3.2 Safety'and Reculatory Supervisor -

itar. 14, 1984 Section 7.0 Entire section revised i

Delete Foreman is and add Aug. 14, 1985 Section 1.2.1.2 functions are M

Organization - Figurt 1.0 Revised Organization - Figure 1.1 Revised Section 2.41 Delete and or Foreman add or his desianee-Section2.46(1)

Delete Ouality Control Fore-an. aM n* W designee 12.2.4 Delete Manaaer, add Suoervisor 18.2.3 End of 4th sentence, add if recuired 18.2.5 End of last sentence, delete or Nuclear Safety ard Reaulatorv tonarviene 18.3.2 Same as above Appendix I Delete PAS /UAS-01-M PAS /UAS-02-fl. GP-40, QC-0!P-Series, f11-2d8, DFP-6 PfF75cr in, DF-003

- (

, ~ ~ -

w

x..-
l INTRODUCTION This manual describes the general policies and procedures established for the administration of the Quality Assurance program at the Nuclear Environmental Services (NES) and PANSO facilities of the Babcock & Wilcox. Company.

The program is applicable to support.of the Nuclear Service Company (NSC) ; the decontamination, dismantling ~and remediation of facilities / sites; i

the manufacture, procurement, utilization and repair-of certain radioactive material shipping containers; operations involving commercial decontamination of equipment; the manu.facture of nuclear reactor components; and to any other activities.where a Quality Assurance program is required by regulation or by customer order documents.

1 Detailed Quality Assurance outlines and procedures are prepared for individual contracts as necessary and are available for review by authorized persons.

Those outlines and procedures povide specific direction for implementing the' general policies set forth in this manual.

The policies and procedures contained in this manual and the-specific implementing procedures are mandatory and no deviation is. permitted without written authorization from - the Manager, PANSO, Manager, Technical control, and the Supervisor, Quality Assurance.

Docummet:

QA-72-1 hetstan No.:

14 Date:

8/24/90 Page:

1

~

i TABLE QE CONTENTS Section Title Quality Assurance Policies 1.0 Organization 2.0 Quality Assurance Program 3.0 Design Control 4.0 Procurement Document Control 5.0 Instructions, Procedures and Drawings 6.0 Document Control 7.0-Control of Purchased Material,. Equipment and Services-8.0 Identification and Control of Materials, Parts and Components 9.0 Control of Special. Processes 10.0 Inspection 11.0 Test Control 12.0 Control of Measuring and Test Equipment.

13.0 Handling, Storage and Shipping 14.0 Inspection, Test and operating Status 15.0 Nonconforming Materials, Parts, or Components 16.0 Corrective Action 17.0 Quality Assurance Records 18.0 Audits Appendix I Applicable Procedures l

l-

' Document:

QA-72-1 Revision No.,

I4 2

Date:

8/24/90 Page:

l

(

QUALITY ASSURANCE POLICIES

-1.

It is the policy of the Nuclear Environmental-Services (NES) and its Pennsylvania Nuclear Service Operations (PANSO) to-provide the highest quality parts, equipment and services' to our customers and to perform any continuing decommissioning or decontamination activities consistent with the highest quality levels.

Quality will be defined against compliance with applicable regulations, codes and standards, performance to customer specifications and achievement of established-quality objectives as defined for the products we manufacture or the services we perform for ourselves or our customers.

2.

It is the policy of NES/PANSO to insure that services performed or products provided by our operatins-are 4

consistent with the regulations established by 10 CFR 21, 10 CFR 71.50, ANSI Standards and NIST Standards.

3.

It is the policy of the NES/PANSO management to maintain a quality assurance program that thoroughly. monitors-quality related operations and provides documented evidence that the required quality levels have been achieved in - all phases of performance.

4.

It is the policy of NES/PANSO. management to insure that there is a sufficient number of qualified personnel to implement an effective and economical quality assuranca program.

Document:

QA-72-1 Revislan No.:

14 Date: 8/24/90 Page:

3

5.

It is the policy of NES/PANSO management to establish and implement on a regular basis an effective feedback system i

including internal quality audits, and to provide for prompt j

correction of all conditions adversely affecting quality.

This feedback system includes responses-from customers and l

L regulatory bodies regarding the quality level for the i-l products or services performed by NES and PANSO.

6.

It is the policy of NES/PANSO management to hold both employees who are performing a service or are producing a product, and their supervisors accountable for the quality of their work.

It shall be the respww

'.ity of management to ensure that the procedures, training, tools, equipment, computer - programs, or work practices necessary to produce quality products are available and used by employees.

7.

It is the policy of NES/PANSO management to define, measure and reduce quality costs including costs of any external or internal failures and to minimize cost escalation and insure that all quality standards are met in the most economical means possible.

4 8.

It is the policy of NES/PANSO management to review quality assurance audit findings, to assess quality accomplishments and resolve potential quality problems.

9. It is the policy of NES/PANSO Management to maintain a quality assurance function which -reports directly to staff Document:

QA-72-1 Revision No.:

14 Date-8/24/90 Page:

4

level management, and w.11ch operates independently of any operations or manufacturing responsibility.

l-l

10. It is the policy of NES/PANSO Management to take positive action to correct and record any quality deficiencies noted by customer
feedback, audit or operational record identification.
11. It is the policy of NES/PANSO Management to procure materials and services from competent and ' qualified suppliers and to insure that materials and services supplied meet the appropriate quality standards established for our industry.

12.

It is the policy of NES/PANSO Management to maintain a comprehensive quality policy manual that can be used to acquaint all employees with our commitment to quality and regulations regarding

quality, and

.to review the documentation in this manual each year.

13. It is the policy of NES/PANSO Management to provide quality control training to all personnel, focusing on improving-quality performance and reducing costs.

14.

It is the policy of _ NES/PANSO Management.to collect information which defines our customers perception of quality so that appropriate steps can be taken to improve the customers' perception of our delivered quality.

_Deewment:

QA-72-1 hvisles No.:

14 Date:

8/24/90 Page:

5

-15. 'The NES/PANSO Quality Assurance' manual and any revisions-thereof shall be approved by the PANSO Supervisor of Quality Assurance, -Manager of Technical control, and the Manager of Pennsylvania Nuclear Service Operations.

Each copy of the PANSO Quality Assurance manual is numbered and registered to individud2s receiving a copy.

Controlled copies shall be issued to all department managers, to all qualified quality assurance personnel and to others' designated by the managers of each operating department within PANSO and NES.

Document:

QA-72-1 Revision No.:

14 Date:

8/24/90 Page:

6

L-1.O ORGANIZATION l-1.1 ScoDe This section describes the organization of the PANSO Quality Assurance' Department and.the duties and responsibilities of the organizational units responsible for implementing the Quality - Assurance Program.

The overall quality policies, goals and objectives are established by Babcock & Wilcox company and operating group level management.

The respective Division Heads have

-the authority and responsiblity to issue Division policy, establish procedures and take' other actions necessary to implement the requirements of those policies.

1.2 Oraaniration The organization of NES/PANSO and its Quality Assurance Department is shown in Figures 1.0 and 1.1.

1.2.1 The duties and responsibilities of' the various-Quality Assurance Organizational elements shown in Figure 1.1 are as follows:

1.2.1.1 Quality Assurance Department Supervisor, Quality Assurance a.

The Supervisor, Quality. Assurance directs and assumes responsibility for all Quality Assurance activities necessary to olan. monit nr. cnnern1 a net Document:

QA-72-1 Revieles No.:

14 Date: 8/24/90 Page:

7

i document the quality-related performance of the NES/?ANSO.

b.

The Supervisor, Quality - Assurance has direct. access to the Manager of PAN 30 in order to address quality related activities and problems.in an appropriate manner.

Routine quality activity reports are submitted monthly to - the Manager, Technical Control and 1

topical quality reports are provided as necessary to keep management cognizant of significant quality problems.

The-Quality Assurance Supervisor and c.

the technical personnel reporting to him have the authority and freedom to implement quality programs, identify quality' problems; initiate, recommend, provide or concur with. corrective actions; to verify the implementation of corrective actions

'and to control further processing, shipment or use of nonconforming materials, products or services.

Docuamat:

QA-72-1 Revisha No.:

14 Date:

8/24/90 Page:

8

d.

The qualification requirements for this position include a level of training normally associated lwith a B.S.

degree or equivalent experience.

e.

Quality _ functions subordinate to this position include Quality control Calibration and Document Control.

1.2.1.2 Quality Control and Calibration Function The Qu'ality Control and Calibration functions are responsible for-the implementation-of quality activities related to inspection, testing, calibration and process control of; materials, equipment-and components purchased, produced or utilized by the PANSO.

1.2.1.3 Document control The Document Control function is responsible for the issuance of new or revised documents, the retri~ eval of

-l superseded-documents and ths.. control and j

issuance of contract-documents.

.A description of the Document Control program is contained in Section 6.0 of 'this manual.

Document:

QA-72-1 9

hvisten No.:

14 Date:

8/24/90 Page:

.~

t l

1.2.l'.4 Contrhetual.'Reauirements When two or more divisions are involved in providing a product and/or'evice to-a customer, the division that _eceived the order from he customer shall be responsible for communicating applicable requirements (and obtaining concurrence to meet the requirements) and shall be accountable for the quality of all products and/or services

(

supplied under such order.

The mechanism used to control this applicable requirement will be a

purchase order or purchase authorization.

l 1-1 Docuamat:

QA-72-1 hvision No.: -

14 Date: 8/24/90 Page:

10

NUCLEAR ENVIRONMENTAL SERVICES 8

xy l

o>

DEFENSE GROUP u

a N

l E

R. E. Tetramit l

l

^

Sr. V. P. & Gioup Exec.

NES l

R. V. Carlson Manager t

CONTROL'LER J. S. Maun3 i

ADMINISTRATION PA NUCLEAR

~ BUSINESS ENGINEERING s

SERVICE OPERATIONS DEVFlhPMENT E

J. J. Cepicka W. L. Coleman W. L. Coleman J. L. Hammond se Manager Manager Acting Manager Manager v

h.!

DECONTAMINATION g

PROJECTS A. E. Haase Manager s

t 8/24/90 Figure 1.0

GUALITY ASW R ANCE s.i CALISRAfl0N 00 ALITY CONTROL DOCUMENT CONTROL 1

1 l

Figure 1.1 1

e d

Document:

QA-72-1 Revision No.:

I4 Date:

8/24/90 Page:

12

k 2.0 OUALITY ASSURANCE PROGRAM 2.1 Scope This section describes the program established to monitor, evaluate and control the quality conformance of materials, processes, equipment and components to the requirements of contract documents, internal specifications and_ the i

regulations of government agencies.

2.' 2 Resoonsibilitles 2.2.1 The Quality Assurance Department is responsible for the program outlined. in this manual and implemented by additional written-policies, outlines, procedures or instructions.

The program provides for the l

performance of those activities required to insure that the manufacturing processes, products and l:

associated activities conform to all quality related contractual and regulatory requirements.

2.2.2 It shall be the responsibility of management to ensure that the procedures,

tools, equipment, computer programs, and work practices necessary to produce quality products / services are available and used by employees and are maintained in a serviceable condition.

2.2.3 Any disputes involving quality related matters shall be resolved by the Manager, PANSC or Manager, Technical Control.

Document:

QA-72-1 Revision No.:

14 Date:

8/24/90 Page:

13

m 1 :

2.3 Modifications'ADi Revisions M Ouality Assurance Manual 2.3.1 When necessary, minor revisions of this manual or its appendices may be effected through u the issuance - of individual page revisions.

Pages so revised shall continue to bear the current manual revision number, but that-number will-be f olloited by the "R"

designating-a page revision.

In addition, the page date will be changed to indicate the date the page i

revision was made.

i 2.3.2 All revisions to this manual, whether in part or total must be approved by the Manager,

PANSO, Manager, Technical control, and Supervisor of Quality Assurance.

Approval of page revisions shall be documented by nignature following the revision number indicated at the bottom of each page, t

s 2.3.3 Where required by contract or regulation, all revisions to this ' manual or its individual pages shall be submitted to the - customer' and to the appropriate regulatory agency for review and approval prior to the implementation of the changes. set forth in the revision.

2.4 Oualltv Review Board i

2.4.1 A Quality Review Board (QRB) -has been instituted for the purpose of reviewing, advising and concurring in decisions -on quality matters affecting PANSO performance.

Routine decisions on product quality, Document:

QA-72-1 Revision No.:

I4 Date:

8/24/90 Page:

I4

including production releases, are made by the cognizant Quality Assurance - Supervisor or' his designee.

TMcisions on the disposition of deviated I

materials will normally be maae by Manager. of the operating Department and the approval of the Supervisor, Quality Assurance.-

Where necessary, questions. involving the disposition of deviated materials will be referred to the QRB.

The following

-describes the function and activities of the Quality Review Board.

2.4.2 The QRB is a standing board ' consisting of the following permanent members:

2.4.2.1 Manager, PANSO 2.4.2.2 Supervisor, Quality Assurance (Chairman)

I

\\

2.4.2.3 Manager, Technical Control 2.4.2.4 Managing Supervision of the area involved.

Management Staff. members are Ad Hoc-members of the Quality Review Board; however, their attendance at QRB meetings is not mandatory.

The Chairman of _ the QRB will from time to time, as dictated by the nature of the matter being considered, appoint temporary members to the QRB.

2.4.3 The QRB shall meet as frequently as necessary to transact business under this policy..

Document:

Qi>

1 Revisten No.:

14 Date:

8/24/90 Page:

15 i

~

1 2.4.4 The Quality Review Board shall have the following 1

authority:

2.4.4.1 To review and advise on-corrective-action l

programs for preventing and correcting quality deficiencies' in operations at PANSOe 2.4.4.2 To review and advise line managers on.

qua),ity related matters.

2.4.4.3 To recommend changes in quality assurance and operational policies, procedures, and controls.

2.4.5 A QRB will be convened as quickly as practicable to i

discuss quality issues.

The procedure for convening a QRB shall be as follows:

Resoonsibility Activity Any PANSO 1.

Contacts the Supervisor, Quality Manager Assurance to request a date and time for a'QRB meeting.

l Supervisor, Quality 1.

Selects time and pla'ce for QRB and l

Assurance sets agenda (including the assign-1:

ment of responsibilities).

2.

Notifies permanent and Ad Hoc members.

3 '.

Determines and notifies temporary-Board members, if any.

1 l Document:

QA-72-1 i

i

! Revision No.:

14 Date:

8/24/90 Page:

16

L Resoonsibility Activity operations Super-1.

completes the necessary analysis and vision of the area preparation for the QRB, including as

involved, appropriate.

(a)

A review of the past history of the deficiency, including previous correceive action programs.

(b)

An assessment of the probable cause(s) for the quality deviation..

(c)

An analysis of alternative solutions for sol,ving_the quality problem.

(d)

A recommendation for the corrective action program (s).

(e)

A. schedule for corrective action.

.(f)

The assignment of responsibility for performing corrective action.

2.4.6 The following procedure will be observed during the operation of QRB meetings:

(1)

The QRB will be chaired by the-Supervisor, Quality Assurance.

In his

absence, his designee shall serve as chairman.-

l (2)

A quorum for a QRB shall consist of two permanent members.

Domment:.

QA-72-1 14 Date:

8/24/90 Page:

h viston m.:

4 (3)

Detailed minutes. of the meeting-will be taken and distributed to permanent - and. attending Ad Hoc members within five working days of the QRB meeting.

(4)

The topics covered in the QRB shall be left to

-the discretion of the chairman.

However, as a matter of practice the meeting. shall include items (a) through (f) under section 2.4.5..

(5)

Where t.ppropriate, the recommendations of the QRB may be reached in a closed meeting of:the permanent members of the QRB at the discretion of the Chairman.

2.4.7 Implementation of the Quality Review Board recommendations shall be the -responsibility -of the cognizant Manager.

Any disagreement with QRB recommendations shall be resolved 'by the Manager, PANSO. The Quality Assurance Supervisor shall review the implementation of the recommendations and l

determine the need for further action.

2.5 Maloractice Prevention Procram 2.5.1 Programs for prevention of deliberate or unintentional malpractice require constant vigilance and systematic procedures, which can detect and deter.

malpractice actions in a timely manner.

2.5.2 Preventive actions relating to management of PANSO:

l Document:

0A-72-1 hvision No.:

14 Date:

8/24/90 Par;e:

I8 1

2.5.2.1 A properly managed and well planned internal audit program ~as outlined in Section 18.0 is the primary activity implemented to detect malpractice.

2.5.2.2 Meetings of Quality Assurance and pANSO management provide opportunities to review Quality Assurance programs and policies.

These meetings-also involve presentations of current Quality Assurance and. Manuf acturing activities and provide for the review of areas conducive to malpractice.

2.5.2.3 As noted in Section 1.0 of the Quality Assurance Manual, the Quality Assurance organization is separate from the 1

Manufacturing organization, thus allowing independent checks on product quality.

2.5.2.4 Internal audit procedures and checklists allow for follow-up of discrepancies reported by internal and external audits.

2.5.2.5 Corrective action required for deficiencies detected during inspection activities are-i governed by Section 16.0 of this manual.

~

Those deficiencies detected through the implementation of the audit program will be addressed by the procedure set forth in-Section 18.0.

Document:

0A-72-1 I9 Revistan No.:

I4 Date: 8/24/90 Page:

l l

l l

2.5.3 Preventive' action relating to personnel policies:

2.5.3.1 Section 2.6 outlines-general guidelines for personnel training and ' certification which require minimum - levels of competence to be l

reached 1 and-documented for-- tests and a

l-inspections requiring. specialized skills.

2.5.4 Preventive-action relating-to procedures and-

)

l equipment

  • l 2.5.4.1 The audit program in Section 18.0 provides for crosschecks of equipment, personnel and procedures to detect potential deviations or inconsistencies.

2.6 Personnul Trainina And Certification 2'6.1 rest, inspections and quality related a'ctivities which require special skills or special ' operator

-l judgment shall be conducted only - by personnel-i qualified in such duties.

2.6.1.1 Qualification. requirements and qualifying procedures shall be defined in the appropriate operating procedures.

2.6.2 All personnel performing quality related activities i

shall be familiar with the procedures governing those-activities.

2.6.3

. Written evidence of personnel experience and qualifications to perform specific duties shall be maintained on file in the area of concern and in the Docuamet:

0A-72-1 20 Revislan No.:

I4 Date:

8/24/90 Page:

_ ~ _ _ --

Training section.

2.6.4 The existing qualification status of-QA personnel shall be updated annually, or as noted in the applicable qualification procedure, by complete requalification or audit of past performance.

i Personnel failing a retest shall be removed from the particular operations until requalified.

In addition, work performed by those personnel shall be evaluated to determine if corrective action is required.

2.6.5 Special skills which may require qualification of personnel include soil

counting, welding, weld evaluation, er other special skills specified in particular contracts.

NDT work will be performed by certified outside subcontractors.

2.6.6 When applicable and necessary to the requirements of a particular operation, personnel shall be given periodic eye examinations.

2.6.7 All PANSO personnel who perform surveillance and inspection of vendor processes or products shall be qualified in accordance with procedures appropriate for the inspection requirements.

2.7 Subcontractor Qualification 2.7.1 Subcontractor testing shall be performed by certified laboratories approved by Quality Assurance and, where l

applicable, approved by the customer.

Document:

0A-72-1 kWsien No.i 14 Dste: '8/_24/90 Page:

21

2.8 Insoection Procedures add Results 2.8.1 All inspec.+. ion and test results shall. be evaluated for conformanca to contractual specification and/or-drawing requirements by Quality Assurance.

2.8.2 All physical and chemical test methods used in operation and product evaluation.shall be described in formal procedures (Section 17.0).

Test methods shall be approved by the customer where. required by l

contract.

2.8.3 Detailed inspection and test procedures shall be kept current and revised when necessary utilizing the l

procedures described in Section 6.0, Document control, l

2.8.4 Product and' operation certifications shall be prepared and issued by Quality Assurance.

l 2.9 Ouality Assurance Activities Related M Comoliance with l

Government Reaulations 2.9.1 Various regulatory agencies have imposed certain l

requirements on organizations involved in the manu f acture,. utilization,

handling, shipaent or receipt of nuclear materials.

The involvement of 4

Quality Assurance in activities governed by those regulations may be specifically imposed by the particular regulation or may be self imposed by the reaulated organization.

-2.9.'

Specific requirements for Quality Assurance programs Document:

QA-72-1 Revislan No.:'

14 Date:

8/24/90 Page:

22

i 1

are set ~ forth in the Nuclear Regulatory Commission regulations, Title 10 CFR 71.51, 10 CFR 71 Subpart H, 10 CFR 71.91(a),

10 CFR 71.91(c) and 10 CFR 50 Appendix _B.

This manual: is desi ned to address the 7

QA program requirements of those regulations.

'I 2.9.2.1 Appendix I to.this manual provides a matrix of procedures cross-referenced to the.

sections of this manual applicable to the above regulations.

2.9.3 Other regulations impose requirements for which Quality Assurance has assumed implementing or auditing responsibilities.

Quality Assurance has prime responsibility in implementing the, p'.'ogram established for compliance with Title 10- CG Part 21-

.l (Reporting of Defects and Non-compliance).

The implementing procedure is' identified as GP-34.

2.10 Audits And Review 91.1J13 Quality Assurance Procram 2.10.1 Verification that the Quality Assurance program is adequately designed, implemented and effective in i

i assuring that the quality objectives of the company and the quality requirements of our customers are achieved is-made through routine audits of the QA-program by customer and company representatives.

2.10.1 In addition, the adequacy, implementation and~

effectiveness of the Quality Assurance program components applicable to compliance with regulatory Docannt:

QA-72-1 l

Revision No.:

14 Date:

8/24/90 Page:

23

- -. ~ - - _, _.

.l l

agency requirements will be. periodically evaluated 1

by the = PANSO Safety Advisory'. Board.

This Board is comprised of management. personnel representing Engineering,

. Technical-Control, Administration, Quality Assurance, and the Manager,-PANSO.

s t

I 1

l Docum.nt:

QA-72-1 1

I Revision No.:

I4 Date: -8/24/90 Page:

24 l

l

l 3.0 DESIGN CONTROL 3.1 Scope The design specifications and drawings of components and materials manufactured or utilized at PANSO are provided by l

our customers or by the manufacturer or designer.

Therefore, design control is not an applicable part of our Quality Assurance program.

However, the selection of l

cor.merical grade materials, parts or components for safety related systems will be reviewed for suitability by Quality Assurance through their review and approval of purchase requisitions.

Inasmuch as certain of the facility designs are unique to the nature of our activities, PANSO has an active Design Review Board that is involved in evaluation of facility design.

The Quality Assurance Supervisor is a member of this board and it is his responsibility to insure'that all customer or regulatory agency quality requirements are addressed in the design phase of facility modifications, i

Doement:

QA-72-1 Revisies No.t I4 Date:

8/24/90 Page:

25 i

4.O PROCUREMENT DOCUMENT CONTROL 4.1 Scope This section describes the procurement control procedures in use at PANSO.

Procurement is the responsibility of Purchasing. In establishing procurement procedures, the Buyer works closely with Quality Assurance and other 1

cognizant groups to assure that the requirements of those organizations are reflected in the procurement procedures.

4.2 Procurement Document Precar'ation W Anoroval 4.2.1 When required by contractual provisions, PANSO will request customer approval of subvendor Quality Assurance documents applicable to materials and components purchased for use in contract performance.

4.2.2 Customer approval, when required, will be obtained

(

prior to procurement action.

3.2.3 Responsibilities for the preparation,

review, approval, and release of procurement documents are l

defined in the Purchasing Manual.

l 4.2.4 The Supervisor, Quality Assurance shall assure Quality Assurance review of all purchase requisitions.

Purchase requisitions shall not be processed unless they have received Quality Assurance approval.

Changes made to purchase requisitions following initial Q.A.

approval and purchase requisitions issued as change notices to purchase 1

l l Documene OA-72-1 l

I Revieles No.:

I4 Date:

8/24/90 Page:

26

orders will also require Q.A. approval.

4.2.5 Requisition review by Quality Assurance shall assure that the following provisions are considered and incorporated, when required, into the purchase order:

Any or all of the following provisions may be 1

i extended to lower tier subcontractors as necessary to

)

i assure the adequacy and quality of subcontractor J

materials or services.

4.2.5.1 cuttomer ordering requirements.

4.2.5.2 PANSO and customer requirements and specifi-i cations defining the - supplier's quality assurance, inspection and certification requirements.

4.2.5.3 Applicable Regulatory Agency requirements.

(e.g.,

Title 10 CFR 21 and 10 CFR 71, Appendix E.)

l 4.2.5.4 PANSO qualification requirements, if any and approval provisions.

4.2.5.5 Applicable codes and standards, including general quality assurance program requirements.

4.2.5.6 Required quality levels.

4.2.5.7 Requirements for the generation, control, maintenance and submittal of supplier documentation to the purchaser for review I

and approval.

l Document:

QA-72-1 Revistem No.:

14 Date:- 8/24/90 Pose:

27 L

t 4.1.5.8 Specification and drawing definition.

4.2.5.9 Requirements for preoperational review and 2

approval of manufacturing processes and Quality Assurance programs.

4.2.5.10 Statement providing for purchasers right of access to the suppliers facilities and quality records for the purpose of source inspection and audit.

4.2.5.11 PANSO inspection, surveillance and release requirements.

i 4.2.5.12 Hold requirements for overinspection and release.

4.2.5.13 PANSO approval and inspection requirements 3

for subvendors.

4.2.6 As evidence of Quality Assurance review and approval of purchase requisitions, the QA reviewer shall sign and date the requisition.

4.3 Control g.1 Confiauration 4.3.1 Contract drawings, specifications and procedures originated by the customer and any revisions thereto, shall be distributed by. Document control to_ cognizant personnel.

1 4.3.2 Q.A.

and Manufacturing will review all customer originated technical documents and determine inspection and/or manufacturing modifications required.

Purchasing will notify vendors of any such Docus t:

0A-72-1 Revisten No.:

I4 Date:

8/24/90 Page:

28 Y

changes identified so that vendors can determine any necessary price changes and/or manufacturing or process changes.

4.3.3 Where required, all vendor manufacturing, process or inspection changes and associated documents will be reviewed by Q.A.

and origitiating department.

Approval of, or suggested changes to, vendor change documents shall be communicated to the vendor by Purchasing.

4.3.4 Re-identification of drawings and specifications will be done by Q.A.

This is described in Section 6.0 of the Q.A. Manual.

4.3.5 Purchasing will draft a change notico to the original purchase order detallir/g approval raidentification of drawings, specification, and vendor manufacturing and Q A. changes.

The change notice will be reviewed by Q.A. and originating department and must be approved as evidenced by the the signature of the appropriate Q.A. representative before release by Purchasing to the vendor.

4.3.6 Purchasing will distribute copies of the approved change notice to Q.A.

and originating department.

The change notice will include an acknowledgement copy which when signed and returned by the vendor will be included as part of Purchasing's vendor

files, ut:

QA-72-1

,,t-len N*.

14 Dste:

8/24/90 Page:

29

^

1 4.3.7 Changes to contract drawings, specifications and procedures initiated by PANSO or its subcontractors i

i shall be processed in the same manner as those initiated by the customer except for the following actions:

4.3.7.1 Specific and complete documentation of PANSO and/or subcontractor initiated changes will be submitted to the customer.

4.3.7.2 Document Control shall receive custemer disposition of such changes before i

distributing the changes for Purchasing, Q.A. and originating department action.

i I

1.

l l

l I

oeument:

0A-72-1 sies No.:

I4 Dste:

8/24/90 Page:

30 1

./$

5.0 INSTRUCTION

S. PROCEDURE

S & lid DRAWINGS 5.1 Scope This section describes the Quality Assurance requirements imposed during operations to assure that all quality related activities conform to contractual and regulatory requirements, and to internal procedures.

5.2 Recuirements The Document Control Section is responsible for n intenance, issuance, retrieval and initiating the periodic review of documentation.

Quality systems are built around but not limited to the following types of documentation:

5.2.1 Process Outline.LEQ.1, Defines the production process, including product definition, materials, and processing operations.

Submittal to customer for approval may be required.

5.2.2 Ooeratina Instructions.LQI,1 - Defines the operation of each piece of equipment.

Specific operating parameters, dimensions, tolerances

and, where appropriate, acceptance criteria are included.

Where necessary, drawings and flow diagrams are provided.

5.2.3 Ouality Assurance Release f.QIE 1013B Documents QA release of materials, equipment or processes.

5.2.4 Interim Procedure Revision Form li!-609-A - Documents the effected interim modifications to procedures pending formal revision.

Document:

0A-72-1 1

Revistas No.:

,I4 Dste:

8/'t4/90 Pote:

31

5.2.5 ouality Assuranct Outlines. Procedures and M Built Data Sheets i

The various types of Quality Assurance procedures are discussed in Section 17.0 of this manual.

Those procodures provide comprehensive instructicas for the performance of Quality Assurance related activities.

Where appropriate, the procedure shall include qualitative and quantitative acceptance criteria.

5.2.6 Shineina Receivina Instructions (SRI)

These procedures describe the routine activities required in the handling of radioactive materials shipments and receipts including the inspection of shipping containers, performance of radiological surveys and the preparation of shipping papers and container labels.

5.3 Copies of applicable and necessary procedures, instructions and drawings shall be available in the appropriate work area prior to the performance of any activity described in those procedures.

The Document Control Procedure which insures the currency of operating documents is described in Section 6.0 of this manual.

Document:

0A-72-1 Revision No.:

I4 Date:

8/24/90 Page:

32 4

. ~ -

i l

l 6.O DOCUMENT CONTROL 6.1 Scope i

6.1.1 This section describes the program.for controlling the preparation, receipt, issuance and revision of designated inst rtictions,

procedures,

drawings, contract documents and specifications which prescribe activities affecting quality.

6.1.2 A detailed description of Document Control activities and procedures is provided in General Procedure GP-11, " Document Control Procedure".

6.2 Reauirements 6.2.1 Document Control shall establish and implement procedures to control the issuance and revision of documents subject to this policy.

6.2.1.1 Preparation a.

Internal documents subject to this policy may be prepared by any of the departments depicted in Figure 1.0.

Any changes to these documents shall be made by the same organization which prepared the initial documents.

c.

The originator shall determine l

whether the document requires customer approval.

The originator also advises Document control of the di.stribution 1

l

Document
-

0A-72-1 Revistas No.:

I4 Date:

8/24/90 Pose:

33

requirements for each document.

6.2.1.2 Document Approval a.

Internal approvals of new or revised documents shall be obtained by Document Control prior to the issuance of the document.

b.

Approval shall be received from a

predetermined list of individuals or organizations to include at a minimum the Manager of the originating l

department and the supervisor, Quality Assurance.

customer or regulatory agency approvals, I

c.

where required, shall be obtained prior to the internal distribution of documents subject to this policy.

d.

Revisions to existing documents shall be reviewed and approved by the same organizations that performed the original review and approval.

6.2.1.3 Document Issue a.

Upon -receipt of approval (internal i

and/or external), Document control shall issue copies of the approved document to cognizant individuals on a distribution list prepared by the document i

Document:

0A-72-1 Revision No.:

14 Date:

8/24/90 Page:

34

originator.

b.

Each copy shall be serially numbered and stamped with a control number and date issued once approved.

c.

Upon receipt of the

document, the recipient is required to sign and return a

document receipt along with the superseded copy of the document where applicable.

Documents issued for use in contaminated areas are not returned, but are destroyed by the recipient.

The document receipt is marked to indicate that the destruction has been completed.

d.

Obsolete or superseded documents will be destroyed by Document Control upon receipt.

The document recipient is responsible e.

tor the distribution of the document to the appropriate work area.

f.

Douments subject to the Document control policy are not to be reproduced by the recipient and only those copies bearing an original serial number are authorized for use.

Document:

QA-72-1 Revisies No.:

I4 Date:

8/24/90 Page:

35

.i 6.2.1.4 Approved Document List a.

Lists of current, approved documents shall be_ issued to cognizant persons.

Each list will be updated as necessary to maintain it current.

6.2.1.5 Customer and Regulatory Documents a.

Customer specifications and quality related procurement documents shall be reviewed by Quality Assurance and issued through Document control to cognizant individuals as described in 6.2.1.3 above.

b.

Certain regulatory agency documents (NRC IE Bulletins, Circulars and Information Notices) are subject to the Document control program.

Those documents will be forwarded by the Technical control Department for issuance as discussed in 6.2.1.3.

6.2.1.6 Document Records a.

Copies of all controlled documents, revisions, signed document receipts'and customer approval forms shall be maintained in Document Control flies.

! Document:

QA-72-1

! Revieles No.:

14 Date:

8/24/90 Page:

36 i

l

_ -.. ~.

i b.

Current distribution lists for controlled documents shall be maintained.

c.

Records shall be maintained as necessary to provide a chronology of document approval, issue and retirement dates.

6.2.2 Proaram Audits 6.2.2.1 Internal Audits by Compliance or QA shall verify that current issues of controlled documents are in use within the audited areas.

(See Section 18.0).

Document:

QA-72-1 Revisten No.:

I4 Dste:

8/24/90 Pose:

37 J

i

=

'f 7.0 CONTROL QI EUACHASEQ MATERIAL, EOUIPMENT AliQ SERVICES 7.1 Scone 1

To assure that purchased material, equipment and services conform to specifications, and the regulatory requirements of Title 10 CFR 71 including Sub Part

'E',

evaluations of vendor capabilities are made consistent with the importance, complexity, contractual and regulatory requirements related to the product or services.

This may be accomplished through an evaluation of the vendor's quality program, review of vendor certifications or inspection of the product received.

Such reviews and approvals shall be documented and the documentation retained in QA files.

7.2 FvalitaM an ;;d Eclecticn AI Vwndors 7.2.1 Items and services which are critical to product quality will be purchased only from suppliers appearing on an Approved Vendor's Lists from 4

Commercial Nuclear Fuel Plant (CNFP), Naval Nuclear Fuel Division Research Laboratory (NNFD-RL), Alliance Research Center (ARC), Nuclear Power Division (NPD)

Lynchburg and PANSO Approved Vendors List.

These lists shall indicate the basis for approval and the nature of the material or service supplied.

7.2.1.1 Quality Assurance is responsible for designating those items and services con-sidered " critical" or safety related.

NPD Lynchburg and PANSO OA Denartment arm Document:

0A-72-1 hvision No.:

14 Date: 8/24/90 Page:

38

I responsible for determining the quality capability of proposed vendors, and PANSO QA Department is responsible for maintaining and distributing copies of the Approved Vendor List.

7.2.1.2 The Approved Vendor List shall be revised at any time new suppliers are approved or previous suppliers deleted.

7.2.1.3 The following general types of items and services may be considered as critical to product quality:

Process chemicals used directly in operations.

a.

operations.

b.

Raw materials specified by customer contract or ordering requirements, Outside laboratory services used for c.

product quality evaluation and certification.

d.

Nuclear material shipping containers.

7.2.1.4 New suppliers are approved for inclusion on the Approved Vendor List according to one or more of the following criteria:

a.

The vendor is listed on CNFP, NNFD-RL, ARC, NPD or PANSO Approved Suppliers for the particular commodity or service to be purchased.

Document:

QA-72-I hvielea No.:

14 Dste:

8/24/90 Pose:

39

act

.o l

b.

The vendor has a previous and continuous record of supplying acceptable items or services of the type and quality required.

c.

The items supplied are subject to PANSO source or receival inspection for verification of quality conformance.

d.

The supplier implements a

quality assurance or quality control program approved by PANSO and provides certification that the program has been implemented for the material provided.

e.

A supplier evaluation is performed through an on-site visit to the supplier's facility or through the review and approval of a " Vendor Quality control Questionnaire",

f.

The supplier has been approved by PANSO's customer for providing items or services of a similar type and quality, g.

Calibration services may be obtained from vendors who supplied the particular item along with initial calibration and/or have a previous and continuing record of supplying acceptable services Decument:

QA-72-1 Revielen No.:

I4 Dste: 8/24/90 Page:

40

l of the type and quality required.

7.3 Source Insnection 7.3.1 Where necessary, the Supervisor, Quality Assurance will establish procedures for QA surveillance of procured items at the source of manufacture.

This may be done when the quality of an item cannot be verified by review of certified test reports or receipt inspection. This may also be required when the items procured are extremely

complex, critical /important, or of sufficient quantity to merit source surveillance, or require special tests or processes.

Procedures for source inspection may be established in accordance with the importance, complexity, and required quality of items being procured.

7.3.2 Source inspection may be required when any of the following considerations apply:

7.3.2.1 Inspection at any other point would require uneconomical disassembly or destructive testing.

7.3.2.2 Inspection at any other point would destroy i

or require the replacement of costly packaging materials and/or containers.

7.3.2.3 Special instruments, gages, equipment or facilities required for inspection or testing are available only at the vendor's Doewment:

0A-72-1 Revielen b.

I4 Date:

8/24/90 Pese-4I

3 facility.

7.3.2.4 Loss of time due to unacceptable shipments 2

cannot be tolerated because of schedule requirements.

7.3.2.5 Inspection is necessary to verify that specific processes, test, or inspections required of the supplier were adequately accomplished and that certificates of comformance to requirements are valid.

7.3.2.5 Items are to be shipped directly from a supplier's facility to a site other than headquarters.

7.3.3 The results of inspections and surveillanu; activities shall be documented and retained on file in the Quality Assurance section. Records shall be available for review by authorized customer and t

regulatory agency representatives.

7.4 y.gnior Certification and Test Results 7.4.1 Where appropriate, the vendor shall be required to provide documented certification and/or test data to verify that the product or services conform to all specifications and regulatory requirements set forth in the procurement document.

i 7.4.2 If the purchased item or service is subject to the requirements of Title 10 CFR 21, 10 CFR 71, or Public l

Law 96-295, the vendor shall be reauired to notify Document:

QA-72-1 l4 Revish No.:

Dste:

8/24/90 Pose:

42'

the purchaser if any of the procurement specifications have not been met.

All purchase orders shall be reviewed by Quality Assurance

.,upervisor for the above requirements.

Any type of shipping containers manufactured to the above requirements will have a certificate of Conformance from the manufacturer.

7.4.3 All vendor certifications, test reports and notices of non-conformances will be reviewed and evaluated by the Quality Assurance Department.

7.4.3.1 If certifications and test results for raw materials and process chemicals are found to be satisfactory, Quality Assurance shall release the procured items as described in Section 8 (8.2.2) of this manual.

7.4.3.2 Where notice of non-conformance has been received from the vendor, the non-conforming items are segregated and placed on hold pending disposition.

Disposition shall be accomplished as outlined in Section 8

(8.2.3) of this manual.

I Document:

QA-72-1 Revista b.:

14 Dste:

8/24/90 Pooe:

43 I

l 8.0 IDENTIFICATION M CONTROL QI MATERIALS. PARTS i COMPONENTS 8.1 Scope This section describes the techniques used to identify and control materials, parts and components (hereinafter referred to only as materials) to assure that only acceptable materials, parte and components are utilized in fabrication.

8.2 Reauirements 8.2.1 Identification 8.2.1.1 Where appropriate, identification requirements shall requirements shall be specified in procure-ment documents, and internal procedures and drawings.

8.2.1.2 The identification of materials shall be maintained through the use of permanent markings where appropriate, or by documents which provide traceability of the item or material to specific inspection, process or procurement data.

Where identification markings are placed on-the

item, the location and form of such marking shall not adversely affect the
fit, function or quality of the item.

I Document:

QA-72-1 hvision No.:

14 Date:

8/24/90 Page:

44

8.2.1.3 The identification of materials and parts I

which are important to the function of safety related structures, systems or components will provide traceability to the appropriate

drawings, specifications, manufacturing and inspection documents.

8.2.2 Receiving Inspection 8.2.2.1 Plans shall be prepared for the receipt, inspection,

test, storage, release and distribution of procured itemr where deemed appropriate or required by contract.

The inspection plan shall be used to verify characteristics of the items in conformance with the appropriate specifications and ensure no shipping damage has occurred.

8.2.2.2 The following basic inspections shall be t

performed at the poia of receiving inspection:

(a)

An identity check (materials shall be identified with the purchase order, drawing number, specification number, l

heat

number, and material type

[

designation) as appropriate.

(b)

A damage check.

(c)

Review of supplied inspection data for acceptable completeness and confor-l Document:

QA-72-1

_Revieles No.:

14 Date:

8/24/90 Page:

45 I

1 1

mance with contract requirements.

(d)

Vorification that applicable drawings and specifications reflect the config-il uration of items received.

8.2.2.3 Inspection plans will specify what action is required during the actual inspection of the item (i.e., inspect, measure, test, confirm documentation, or other).

Requirements for recording measurements will be noted and data sheets for this purpose will be included.

8.2.2.4 The use of sampling inspection will be considered in the receiving inspection plan.

Individual characteristics may be classified as critical, major or minor, and appropriate acceptable quality levels (AOL's) will be included in the QC outline where appropriate.

8.2.2.5 When an item requires an acceptance test, the quality plan shall include an adequate test procedure.

Where the applicable l

specification does not reference a test 1

i procedure or does not contain sufficient i

acceptance test detail, the Superviser, Quality Assurance shall obtain the needed information front he procurer.

(

l Deemment:

QA-72-1

)4 Date: 8/24/90 Page:

46

t l

8.2.2.6 When required, revisions to the receiving inspection plan will De made by the Quality Assurance Department.

Each revision will be serialized and dated.

8.2.2.7 Whenever possible, the number of inspections i

and tests shall be established on the basis of proven statistical techniques.

Composite 4

j samples may be used to provide greater

?

coverage of the material where feasible.

8.2.2.8 Procured items shall be maintained in a

" hold" category until all required inspections have been completed.

The items awaiting processing or inspection should be stored in an area where they are protected from damage from handling or adverse environmental exposure.

8.2.2.9 Acceptable items shall be released for further utilization using Material Release Certificates QA 1013-B.

8.2.2.10 The inspection records shall be analyzed frequently to determine if the sampling plans are adequata to assure product compatibility with requirements.

overchecks may be instituted at any' time at the discretion of the Supervisor, Quality Assurance.

Where required by the Document:

0A-72-1 Revisten No.:

I4 Date:

8/24/90-Page:

47

4 appropriate contract, only customer approv d sampling plans will be used.

8.2.3 Release of Procured Materials 8.2.3.1 Procedures shall be prepared where necessary to control the movement and use of procured materials.

i 8.2.3.2 Acceptable materials shall be released for processing using the Material Release certificate.

i 8.2.3.3 Unacceptable materials shall be processed according to Section 15.0.

Material awaiting inspection shall be withheld from further processing and placed in a hold category.

Hold tags shall be used to control further movement or use of these materials.

8.2.3.4 Copies of all Material Release Certificates issued shall be maintained in Quality Assurance files to provide traceability of materials throughout all subsequent handling stages.

8.2.4 Control of Nonconforming Items 8.2.4.1 In addition to internal procedures, the i

customer may require completion of customer designed forms to report nonconforming items.

If such is the casa. tha nrne.adiira Document:

QA-72-1 Movielen No.:

14 Ds'e:

8/24/90 Pose:

48

l

~

listed in 8.2.4.9 will be f o ? ^. -

t using customer forms in add

  • t,on

'p-regular deviation requests.

8.2.4.2 If the nonconforming c ';..d i t i o n is not considered detrimental to product quality and the nonconformance does not violate contractual or regulatory requ'.rements, the material may be released for utilization in operations on " manufacturing risk".

Release shall be made by Quality Assurance via the Material Rsiease certificate, Form Q.A.

1013-B which shall indicate the extent of nonconformance and any special instructions required to assure proper processing and subsequent inspection of the material.

8.2.4.3 Customer approval shall-be required for items not conforming to contract requirements.

8.2.4.4 While awaiting final disposition, noncon-forming materials shall be under the control of Quality Assurance.

Where practicable, nonconforming items shall be immediately i

segregated from acceptable items, properly identified and processed to designated hold areas.

Except in certain cases these hold areas must be physically secrecated from

! Docuneet:

0A-72-1 L Revistas No.:

14 Dete:

8/24/90 Pogo:

49' l-

- ~~

O I

other incoming or process areas.

8.2.4.5 Quality Assurance rejected. materials shall be removed from the hold area and scrapped or returned to the vendor as soon as practicable.

The vendor shal; be notified of the rejection immediately.

The supervisor, Quality Assurance shall take necessary corrective action to prevent continuing nonconformance.

8.2.4.6 If disposition of nonconforming materials calls for repair / rework, the material records shall clearly designate the causes j

for original rejection.

Material shall not be reclassified until repair / rework and reinspection, with proven conformance, is i

completed.

Customer approval of repair / rework action shall be verified prior to reclassification.

8.2.4.7 Materials, parts or components which have been reworked or repaired-will be reinspected by the same or equal methods as were employed in the original inspection.

All rework and repair actions shall be documented.

All reinspections and tests shall be performed in accordance with Document:

QA-72-1 L

I h vistm No.:

14 Date:

8/24/90 Page:

50

1 written procedures.

l 8.2.4.8 All records relating to nonconforming materials and their disposition shall be on file and available for review by authorized customer representatives.

8.2.4.9 Corrective action may be required of the

]

vendor.

The following procedure shall be followed:

(a)

A Nonconformance Report and Notice of i

Nonconformance will be submitted to the vendor requesting a corrective action plan.

The plan shall address the probable cause of nonconformance and suggested disposition of the noncon-formance.

(b)

The vendor corrective action plan and suggested material disposition will be reviewed by Quality Assurance.

(c)

Quality Assurance will evaluate the resubmitted material and the returned nonconformance report.

The nonconfor-mance report shall identify that the items are resubmittals of previous nonconforming items and reference the previous documentation.

l Document:

QA-72-1 Revistan No.:

14 Date:

S/24/90 Page:

Si

8.2.4.10 A

more detailed description of the corrective action procedure is contained in Section 16.0 of this manual.

1 A

i l

l l

1 l

Document:

QA-72 _

1 Revislan No.

I4 Dste:

8/24/90 Pose:

52 4

l l

9.0 CONTROL QI SPECIAL PROCESSES 9.1-Scope This section sets forth the measures taken to assure that certain processes that cannot be controlled by product inspection alone are accomplished with - qualified personnel and procedures.

Quality Assurance or Operations shall be responsible for process qualification and training of personnel in the process.

Where required by contract or regulation, all special. process procedures, equipment and personnel shall be qualified in accordance with applicable c' odes, standards and specification.

9.2 Recruirements 9.2.1 During the review of contract requirements, Quality Assurance and Operations shall determine 'wr *'

operations shall be considered as special process nne i

require special' training..

1 9.2.2 Special process shall be' performed in accordance procedures which have been reviewed-and approvs-i the Supervisor of Quality Assurance. and Operati.

Supervision.

9.2.3 Records of procedure-and personnel qualification shall be maintained by the cognizant ' organization; l

i.e., Quality Assurance or Operations, to which the l

qualification is applicable.

1 l

Docuamat:

QA-72-1 hvislan No.:

I4 Date:

8,' J 4 / 9 0 Page:

-53~

9.2.4 Records of special process operations and inspections shall be-maintained by QA or operations as appropriate.

Those records shall describe the activity performed and provide data regarding the process parameters and the identification of the material or item involved.

i l

1 i

l j

i

'l i

l Document:

QA-72-1 i

Revisles No.:

I4 Date:

8/24/90 Page:

54

=

10.0 INSPECTION 10.1 Scope The. inspection program is conducted in accordance with standards and procedures which incorporate the quality requirements defined'in applicable specifications and drawings.

The procedures encompass receiving, in-process and final inspection, ' setting forth minimum requirements for acceptance.

It is.the responsibility of. Quality Ausurance to ensure that these.requirments are fulfilled.

10.2 Ensuirements 10.2.1 Inspection Provisions 0.2.1.1 A

detailed Quality Control Outline describing. the sequence. of quality assurance activities during operations is

prepared, or As Built-Data Sheet representing the applicable drawing.

10.2.1.2 Quality Assurance-shall define the necessary inspection and test points from receipt of raw materials through fabrication and shipping of. final product

(

or completion of an operation.

The Quality control outline indicates typical characteristics to on

measured, the method of examination, number of samples to be taken, type of plan to be used and

-l 1

the applicable acceptance criteria.

-c Doc.vment:

0A-72-1 hvision No.:

I4 Date: 8/24/90 Page:

55

I i

10.2.1.3 A Quality Control-Outline shall be sub-mitted for customer approval when required.

10.2.1.4 Inspection'and. test procedures and/or checklists shall be available. at. the inspection station.

Those procedures and lists-shall provide all information necessary to perform the-inspection task

-c and shall

include, where required,.
drawings, specifications and acceptance criteria.

10.2.1.5 Inspection and test personnel shall be trained and qualified in a manner appro-priate for the inspection' task as pro-vided for in Section 2.0 of'this manual.

10.2.1.6 Where materials, components or parts have been modified, repaired or replaced, the j

conformance of the item shall be verified by inspection in accordance with. the original design and inspection require-ments where applicable.

If the original inspection requirements are not applicable, a

revised inspection procedure shall be prepared.

Document:

QA-72-1 Revision No.:

I4 Date:

8/24/90 Page:

56

10.2.2 Source or Receiving Inspection Purchased items which significantly affect quality of the final product or operation shall be either source or receipt inspected by Quality Assurance.

l 10.2.2.1 Vendor certification and test reports, I

where required, will be reviewed to ascertain conformance to the purchase order requirements.

10.2.2.2 Sampling will be performed in accordance with e.n approved sampling plan designed in a manner consistent with the product quality requirement.

10.2.2.3 Any lot containing components with nonconforming conditions shall be i

processed per Section 15.0 of this manual, " Nonconforming Materials, Parts, or Components.

Nonconforming lot (s) shall not be released for utilization until the defective condition is either corrected or the deviation'is accepted in the ananner outlined in Se.cti on 15.0.

]

I 10.2.2.4 Components shall

'be inspected for

~

shipping damage upon receipt.

Such 1

damage shall be confirmed by Quality Assurance and the carrier shall be notified by.the Buyer.

Quality Assurance l-Docuawnt:

QA-72-1 Revision No.:

I4 Date:

8/24/90 Page:

57

'l may inspect any' or all parts for conformance to specification or drawing.

10.2.2.5 Purchased ' materials and components shall f

also be inspected for proper identification, and other purchase order requirements, f

i 10.2.2.6 Following the receipt and satisfactory review of all - necessary. reports, and subsequent verification that'the material-or parts are acceptable, formal 4

acceptance _ shall be made by Quality Assurance.

10.2.3 In-Process Inspection Ic-process inspections shall be performed as necessary to assure conformance to all requirements.

10.2.3.1 Each foreman is responsible for a

instruct lag personnel under his= super-vision, in the proper use of applicable process-procedures.

Each foreman is also I

responsible for the quality-' of the-t product or operation insofar as the l

1 contribution under his control are

?

I concerned.

10.2.3.2 All personnel are accountable for i

following established procedures.

i'!

q ocument:

QA-72-1 Cylston Ns.:

I4 Date:

8/24/90 Page:

58

}

l-i 1

q i.

l-1 L

l l

i 10.2.3.3 All inspection sampling shall-be l

performed in accordance with the approved l

\\

L Quality control outline or an alternate j

plan prepared and approved consistent with product quality requirements.

10.2.4 Final Inspection shall be performed on completed materials and final operations.

Inspection data shall be reviewed by Quality Assurance prior to P

storage or shipment.

10.2.4.1 Materials shall be inspected according to

-1 detailed inspection procedures prepared to insure the verification of all j

specified quality requirements.

J 10.2.4.2 All deviated components shall be treated in accordance with Section 16.0 of this manual.

.10.2.4.3 All final.

inspection data.shall be maintained and stored as. defined in Secton 17.0 of this-manual.

10.2.5-If mandatory hold points are imposed by the j

customer, such hold points will be designated in the Operations and Quality Assurance documents..

10.2.6 In addition to product inspection, a system of process. audits shall be implemented to determine the continuing adherence of operations to

'orocedures, process parameters and reaulatory Document:

QA-72-1 hvisico No.:

I4 Date:

8/24/90 Page:

59

~. -. -.- _-

l i

requirements.

These audits are performed by Quality Assurance personnel on both a formal and informal basis.

Formal audits are conducted as described in Section 18.0 of this manual.

10.2.7 Statistical Methods

-l l

10.2.7.1 The - Quality Assurance Section shall be responsible for preparing necessary statistical Quality control analyses, l

sampling

plans, and control charts.

Where required by-contract, sampling plans and revisions will be submitted to the customer for approval.

10.2.7.2 Statistical approaches shall be based on applicable contract : documents and shall use established. statistical methodology as defined by government publications, l

standard textbooks, or contract requirements.

10.2.7.3 Control charts may be employed at principal processing steps. that have a-significant effect on product. quality.

10.2.7.4 ' Statistical = data records.and control charts shall be available for review ~ by authorized customer and regulatory agency representatives.

Document:

QA-72-1 Revision No.:'

14 Date:

8/24/90 Page:

60-

11.O TEST CONTPOL 11.1 Scoce This section of the QA Manual governs the application of test control for NES/PANSO sites.

11.2 General 11.2.1 It is the purpose of this section to assure that all testing and ana]yses required to demonstrate the suitability of items processed or decontaminated by PANSO are identified and documented.

11.2.2 The cognizant department manager is responsible for.

assuring that the test requirements and ' test -

equipment are referenced when he or she ' approves the appropriate purchase authorization or procedure 11.2.3 The Supervisor of Quality Assurance

, has -

responsibility for assuring that test procedures, analyses procedures, free release procedures and data are audited on an ongoing basis.

11.3 Procedure 11.3.1 When testing, decontaminating, performing. analyses and free releasing material, all shall be done in accordance with written procedures prepared by the organization responsible for performing any of the above.

wt:

QA-72-1 violon Na,:

I4 Date:

8/24/90 Page:

61

i

~

11.3.2 Any of the above criterion shall be performed by i

certified personnel utilizing approved procedures.

All data will be documented and signed off by the individual performing. the work and the Supervisor of that department.

l Document:

QA-72-1 Revision lio.:

14 Date:

8/24/90 Page:

62 l

I

12.0 CONTROL QE HEASURING AliD TEST EQUIPMENT 12.1 Scope This section describes the system followed to assure that all measuring and test equipment used in activities affecting quality are properly controlled, calibrated and adjusted to maintain accuracy within necessary' limits.

It I-is~the responsiblity of Quality Assurance to assure that proper procedures are followed for the calibration of all in-service

gages, measuring
devices, and inspection fixtures.

l l

12.2 Eauioment Calibration and Control Standards 12.2.1 The Quality Assurance Department shall' establish and maintain a program for the calibration of instruments and gages used to determine-the conformance of materials or processes to-specifications and regulatory requirements.

12.2.2 Calibrations shall be accomplished by comparing-instrument readings against known values of standards under controlled conditions of temperature and humidity where these factors j

significantly influence the accuracy of calibration.

Standard accuracy shall be traceable via certifications to NIST Standards or to other recognized standards as described in the specific calibration procedures.

Document:

QA-72-1 RevPlos No.:

14 Date:

8/24/90 Page:

63

L 12.2.3 Standards shall be calibrated at periodic intervals 5

L established on the basis of stability, purpose, and degree of' usage.

12.2.4 The accuracy of standards shall have a tolerance no greater than 25 percent of-the allowable tolerance for the : equipment being. calibrated.

Any greater tolerance.must be approved by the Supe rvis or',

Quality Assurance and the Customer, if required by contract.

Calibration Procedures 12.2.5 Calibration procedures shall cover, but not be l

limited to, the following typical measurement tools or devices:

(a)

Balances (b)

Temperature Controllers (c)

Micrometers l

(d)

Timers (e)

Recorders (f)

Optical Measuring Equipment (g)

Radiation Measurement Devices 12.2.6 Calibration procedures-shall include the following j

considerations:

(a)

Technique for calibration j

(b)

Standard description (c)

Method for recording calibration results Document:

QA-72-1 Revisten No.:

14 Date:

8/24/90 Page:

64

(d)

Limits of accuracy 12.2.7' Each item of measuring equipment and all' standards shall be identified in a recall index maintained in the Q.A.

Calibration Laboratory and/or a computer master file. Identity shall be by item serial or code - number.

Such an identity number shall be affixed directly to the measuring equipment, when.

practical, or alternately. to.its carrying. case.

.The following additional information shall be contained either with the index or in another location such as the work area.

(In the latter

instance, the location. of records will -be l

referenced in the index):

I 12.2.7.1 Dates of the last andlnext scheduled calibration for each item.

12.2.7.2 Status of the condition of.each item.

12.2.7.3 Dates of corrections and/or repairs to the item.

12.2.8 Limits of accuracy shall be -established to determine the serviceability of. measuring tools; Single primary limits shall be employed wherever possible.

Nonconforming instruments shall be removed from service and - identified by appropriate l

labels.

In some instances, as defined'in specific calibration procedures, secondary limits may also be established, such that an item failing to meet t:

QA-72-1 levislan Nr.i

-14 '

Date:

8/24/90 Poe : 65

~

T primary limits may be continued in service for specified non-critical or restricted use.,

In these cases the index shall be modified' accordingly.

These items shall be appropriately labeled.

.12.2.9.Where a tool or other measuring device has a highly specialized function or is used only for uncommon f

and very. specific applications at in f requent:

intervals, the. device will be calibrated only = as required for a

current application.

During prolonged out-of-service periods, calibration willL be allowed to lapse and be so noted by.the'use;of-the appropriate label.

12.2.10 Calibration frequency for measuring tools shall be dependent on usage and drif t. characteristics.

Calibration results will be reviewed annually - and frequency levels adjusted where necessary.

12.2.11 All measuring and test equipment shall carry a i

label indicating the date of the last and next scheduled calibration and id. entity of the current calibrator.

Where tool size or configuration precludes attaching the label directly to the instrument, it may be attached to - the - storage: or.

carrying case.

Standard color labels shall-' signify compliance of the item within primary limits of 2

accuracy.

If the item has limited use, based-on secondary limits of accuracy, a special color label Document:

0A-72-1 Revt%e No.:

14 Date: 8/24/90 Page: 66

[

l (green - accept; red - rejectt. orange'- restricted; j

yellow. - noncalibrated) shall be used and the.use limitations clearly marked.

12.2.12 Calibration data records shall be maintained in the Calibration file or, alternately, on' file or on display in the area where the' item is used.

12.2.13 Calibr'.itions shall be performed by qualified PANSO.

persr.nnel.

Calibrations. may also be performed by-i outside qualified' agencies.

12.2.14 Vendors of measuring / test equipment shall furnish' accuracy and calibration data.

Newly purchased measuring / test equipment shall be checked to verify vendor stated - accuracy before being placed in service.

12.2.15 Instrumentation used to measure process parameters such as temperature or pressure may be subject' to calibration control when the control limits defined-

.in process procedures are restrictive.

The extent of process instrument calibration shall'be defined at the time of contract where appropriate.

-12.2.16 When calibration of process instrumentation is

{

required, instruments will be identified, labeled 4

and entered on a recall index under the cognizance of-the Quality-Assurance Calibration Group.

Procedures shall include the considerations of

- l paragraph 12.2.6.

Document:

QA-72-1 Revielen No.:

I4 Date:

8/24/90 Page: 67

12.2.17 The Quality ' Assurance Calibration Group shall' maintain a schedule for calibrations and will i

update the recall index on a weekly basis.

12.2.18 Measuring and test equipment shall be handled, stored and transported in a manner-that will not adversely affect the calibration or condition of the equipment.

12.2.19 When significant errors in inspection and testing equipment are found.during calibration, the cognizant Supervisor / Engineer shall be notified via Form 252-610A-and an investigation must be made-to determine whether items previously inspected do, in fact, meet specifications.

che investigation l

l indicates that = the items were. inspected with l

discrepant equipment, appropriate corrective action will be taken to reinspect the items or.to notify the

customer, c

i Document:

QA-72-1 hvistan No.:

I4 Date:

8/24/90 Page:

68

-+ww v

v r

+t w

-w e-iMe-W w--

w

-. - ~ -

13.0 HANDLING, STORAGE & liq SHIPPING 13.1 Scope This section provides a general outline of the program-established to control the

handling, cleanliness, preservation, packaging, shipping and storage of customer supplied materials and process end-product to prevent
damage, loss or deterioration.

Where appropriate,-

procedures shall be prepared and personnel qualified in the performance of these tasks.

13.2 Reauirements 13.2.1 Handlina Cranes, hoists, slings and industrial j

truckw used in the transfer and movement of l

radioactivo materials and finished products shall be operated by qualified personnel in accordance with written procedures.

Maintenance checklists shall also be prepared for the inspection of such equipment at specified intervals.

13.2.2 Cleanliness To reduce the probability of cross contamination, procedures shall be developed for the cleaning and inspection of the chemical processing equipment.

Reusable product containers shall be cleaned prior to use and finished components will be cleaned to the extent necessary t

to achieve conformance

.to applicable specifications.

1 Document:

QA-72-1 hviston No.:

I4 Date: 8/24/90 Page: 69

~

l J

13.2.3 Packmaina - Radioactive materials shall be packaged in authorized containers under conditions established to prevent subsequent deterioration or contamination.

Packaging methods, materials and identification requirements shall be specified by written procedure.

i 13.2.4-Preservation add Storace Customer supplied materials and operation end-products shall be protected from damage and degradation while awaiting final use or shipment.

13.2.5 Shinoina Written procedures or. ITC's shall be.

followed for the inspection of all shipping containers, load securement, proper. labeling and consignee notification to assure full' compliance with regulatory requirements and customer l

specifications, i

Docua nt:

QA-72-1 Revision No.:

14 Date: 8/24/90 Page: 70

~

14.0 INSPECTION. TEST MD OPERATING STATUS 14.1 Scope This section sets forth measures in effect to indicate the status of inspections and tests performed on individual purchased or manufactured items.

14.2 Reauirements 14.2.1 The status of operations inspections shall be i

documented in accord with the applicable Quality control outline or other applicable procedures.

14.2.1.1 Each operator shall sign off by signature and date on the data sheet for the operation performed as verification that the operation has been - completed as planned.

14.2.1.2 The performance of all inspections, tests and' analyses specified in the applicable Quality Assurance and' contract documents shall be monitored ~through a thorough review of test, inspection-and analytical l

reports by. Quality Assurance.

If circumstances prevent the performance of a particular inspection or test, the item or material affected-shall be considered to be in nonconformance and disposition will be made as' described Document:

QA-72-1 Date:

8/24/90 Page: 71 Revisten No.:

I4

in SectionL41.0 and Section 15.0 of this manual.

14.2.2 Receiving Inspection 14.2.2.1-Receiving inspection on' incoming material

~

shall. be performed as specified in the applicable QA document.

14.2.2.2 Any items determined to be nonconforming shal'l have a " Hold" label attached to the item.

Only Quality Assurance shall remove any " Hold"-label from an item.

14.2.2.3 Any item. deemed to be unacceptable shall have a " Reject" label attached to it and shall be segregated from' conforming material where possible.

14.2.3 In-Process Inspection l

14.2.3.1 Where in-process = inspection is specified in the applicable' QA document, any item or component found- - to bc nonconforming shall have a " Hold" label. ' attached '.to it indicating 'a deviation; which may require a repair or- ~ rework, reject, or "use as is" d'isposition.

Certain intermediate product may be. reworked on Operations cognizance without formal QA

" Hold"-

action.

Such rework shall be approved-by QA through approval of an " Engineering i

Wument:.

QA-72-1 1.

Walen No.:

l4 Date:

8/24/90 Page:

72

t.

I i

Release".

(a)

Where a

" Hold" label has been affixed, the label shall remain with the material until the material has been reworked and found acceptable.

]

(b)

Any component classified as reject shall have a " Reject" label attached v

to it and shall not be further f

processed.

14.2.4 Final Inspection 14.2.4.1 Material or components which have completed the final inspection operation j

shall be moved to an appropriate storage area.

14.2.4.2 Under no circumstances shall a noncon-forming component which has been processed through final inspection be-

[

shipped to a

customer or utilized l

internally,

.until-the discrepant condition has been-properly evaluated and i

a-dispositioned as described in Section 15.0 of this manual.

1 4

I Documenti QA-72-1

Revislan No.:

I4 Date:

8/24/90 Page:

73

i 15.0 NONCONFORMING MATERIAIR. PARTS. QB COMPONENTS 15.1 Scope This section sets forth the measures taken to control nonconforming materials,. parts, or components in order to prevent their subsequent use.

It is the responsibility of Quality Assurance to assure that the following requirements are fulfilled on nonconforming components.

15.2 Control 2.f Nonconformino Items 15.2.1 Section 8.0,

" Identification and Control of Material, Parts and - Components" discusses receipt inspection and control of non-conforming procured items.

Similar procedures.shall apply to material fouri to be nonconforming at in-process and final i

l inspection stages with the following exception:

15.2.1.1 Where feasible,

" Hold" areas for the storage of in-process nonconforming materials shall be separate from those used for-incoming. materials.

If the.same i

hold area is used, materials' will be identified-as to-status.

~15.2.1.2 The cognizant Operations: personnel shall be notified of all nonconforming materials by Quality Assurance.

Document:

QA-72-1 Revielen No.:

14 Date: 8/24/90 Page:

74 w.-

w-

15.2.1.3 Customer approved repair action. may be performed internally rather than at sub-j.

vendors plants.

Materials, parts or components which have been reworked or repaired (either by vendor or in-house) will be reinspected by the same or equal

~

methods as-were employed in the original inspection.

All rework or repair-inspections and tests shall be performed-in accordance with written procedures.

15.2.2 All records' (IDR's, nonconformance

reports, deviation requests, etc.) relating to nonconforming materials and their disposition at in-process and l

final inspection stages shall be on file and i

available for review.

l

)

Document:

QA-72-1 Revision No.:

I4 Date:

8/24/90 Page:

75

i l

16.0 CORRECTIVE ACTION 16.1 Scope This section describes a corrective _ action program to assure that conditions adverse to quality such as defective material, nonconformances to specifications, deficiencies and noncompliances to approved Operations or Quality-Assurance procedures are promptly identified and corrected.

It shall be the responsibility of the Quality. Assurance Department to bring to the attention of PANSO Management, any situation adverse to quality and to verify that the appropriate corrective action has been taken to preclude its re:urrence.

16.2 Corre:tive Action Procedures 16.2.1 Quality deficiencies detected during _ inspection, test or certification activities will be documented by the issuance of an Internal Deficiency Report (IDR).

(See Section '16'. 3')

16.2.2 The IDR procedure requires that a prompt response be made by the responsible individual as to the corrective action to be taken for the cause and specific deficiency.

16.2.3 Review of the completed: IDR by the appropriate l

Quality Assurance personnel and the other responsible persons shall consider the following:

Docunwnt:

QA-72-1 Revisten No.:

I4 Date:

8/24/90 Page:

76

I

)

(a)

The date corrective action will be taken and the responsible individual.

(b)

Other items which could be affected by similar deficiencies but not detected.

This includes previous shipments and in-process material.

(c)-

Previous IDR's which are related to this item which could point to a more serious problem.

16.2.4 Quality Asurance and/or Internal Compliance will follow-up each IDR to ensure that the action taken

(

was sufficient..

In addition, the items may be added to the audit checklist for subsequent follow-up during internal audits.

16.2.5 All IDR's shall.be reviewed for each major contract l

on a monthly basis.

The review will point out.

areas where additional effort is necessary to reduce.the. number of deficiencies related to specific deviations and will provide insight-into the effectiveness of the corrective action which has been taken.

The review 'can also provide guidance in updating audit checklists.

Deviations which appear with regularity can be included on audit checklists for particular attention.

.I 16.2.6 Purchased item IDR's'. will also be maintained on file in Purchasing by contract and vendor.

This I

will aid in evaluation of vendor quality i

performance.

1 l

' Document:

QA-72-1

! Revision No.:

I4 Date:

8/24/90 Page: 77

l 16.2.7 In addition, an open action IDR file will be maintained by Quality Assurance.

This file will include all' IDR's, which have not ' been closed-out l

or completed.

16.2.8 The data generated in the corrective action program will be reviewed routinely by. PANSO Management to provide data for reports to customers.

16.3 Internal Deficiorm Procedurgg-16.3.1 Internal Deficiency Reports (IDR's) shall be used on all applicable contracts.

16.3.2 The purpose-of the internal: deficiency report is-to inform responsible personnel of deficiencies-so that the proper corrective action can be taken for the following items:

16.3.2.1 Deviations from regulatory requirements, related to quality.

16.3.2.2 Deviations from customer approved procedures.

16.3.2.3 Deviations from internal ~in-process specifications.

16.3.2.4 Deviations from final inspection-and test limits.

16.3.2.5 Warning of approaching-out of..specifi-cation' conditions of any of the items listed above.

Document:

QA-72-1 i

Revision No.:

I4 Date:

8/24/90 Puge: 78 i

16.3.3 Copies:of the IDR shall be-sent immediately to the responsible Engineer,. Operations Supervision, Quality Assurance Supervisor, and other appropriate personnel as re uir3d.

v contract requirements have-16.3.4 When appropriate p.~

been violated) tac..ffected material shall be properly segregited from other material'- and appropriately tagged.

^

16.3.5 The Supervisor of Quality Assurance shall routinely i

review 'the deficiency items and the action items..

4 If_ deemed appropriate, the following actions may be-I taken:

16.3.5.1 Convene the Quality Review Board, f

16.3.5.2 Immediately stop operations in the affected area.

16.3.5.3 Take other appropriate action (Note:

If immediate curtailment of operations is necessary to protect' operations quality, l

the Supervisor, Quality Assurance.should stop operation and immediately _ notify l

higher level management).

l

.16.3.6 The individual to whom the IDR is addressed. must i

L reply within 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> or within the time specified I

on the IDR.

The necessary responses are i

categorized below:

Document:

0A-72-1 hvielen No.:

14 Date:

8/24/90 Page: 79.

16.3.6.1 Immediate corrective action for specific deficiency- - this is used to indicate the action-required to disposition material.

16.3.6.2 Long term corrective action for cause the corrective action noted here should l

be appropriate to prevent recurrence of similar deviations.

This can include changes.

to operating procedures, instructions, re-qualification of personnel and processes, etc.

(a)

There are certain production anomalies.for which no'immediate or long term corrective action can be' determined; and, in many cases, the frequency is too low to justify a

concentrated investigation into the cause, t

16.3.6.3 If the cause -of the deficiency is

unknown, the IDR should be answered stating this.

At this time, a program for determining the cause and the i

corrective action of the deficiency may t

be outlined with a target date noted for l

completion of this study.

Upon determining the-cause and corrective action, a supplemental answer to the ILR i

Docenent:

QA-72-1 7

l I Revistan No.:

14 Date:

8/24/90 Page: 80 a..--.

should be issued to Quality Assurance noting the corrective action to be taken.

16.3.7 The completed IDR form is returned to Quality i

Assurance for review and approval.

If the answer i

to the IDR is considered unsatisfactory, a new IDR may be lesued or the original IDR returned to the

.q recipient for further action.

16.3.8 There must be mutual agreement between the 1

operations and Quality organizations as to product disposition in order to use deviated material.

Where appropriate, the Quality Review Board will i

convene to determine the product disposition.

If the material violates contractual requirements and l

the internal agreement is to accept the material, then the appropriate action will be taken to inform the customer and request his acceptance.

I 16.3.9 Quality Assurance will close out the IDR when the proposed corrective action has been evaluated and approved.

The performance of corrective actions j

shall be reviewed by Quality Assurance to, insure that all corrective action commitments are implemented as stated.

t l

1 l

Document:

QA-72-1 j

Revielen No.:

I4 Date:

8/24/90 Page: 81

l 17.0 OUALITY ASSURANCE RECORDS j

17.1 Scoce This section describes measures taken to assure that adequate test and inspection records are maintained to meet all contractual and quality related regulatory requirements I

i and any additional requirements which may be considered 1

appropriate.

17.2 Etcords and Reoorts 17,2.1 Records shall be maintained to furnish documentary evidence of the performance of production and inspection activities affecting product quality.

The format of all inspection, test and certification data forms shall be reviewed and l

'pproved by Quality Assurance prior to issue.

Review shall be performed by the Quality Assurance Supervisor or his designated representative.

Revision of forms currently used shall require similar review and approval before issuance.

17.2.2 Records shall be maintained in the Quality Assurance files and will be avaliable for review by management personnel and by authorized customer or regulatory agency representatives.

17.2.3 When a

contract is completed, records shall ultimately be transferred to the ' company archives where they are' held for a specified period.

l Document:

QA-72-1

( Revistas No.:

I4 Date:

8/24/90 Poge: 82

i 17.2.4 Archive record storage areas shall be selected and maintained to provide adequate security and protection form loss due to fire, theft, flooding and deterioration.

17.2.5 A test procedure numbering system shall be main-tained by Quality Assurance.

Test, inspection and operation procedures shall be categorized in tr' following series:

17.2.5.1 Physical Test PT Series 17.2.5.2 Chemical, Spectrographic UAS or PAS /UAS l

and Metallographic Analysis Series 17.2.5.3 Detailed Inspection DIP Series Procedures 17.2.5.4 Calibration Procedures CP Series 17.2.5.5 General Procedures GP Series 17.2.5.6 Q.C. Outlines QCO Series 17.2.5.7 As-Built Data Sheets 17.2.6 Data resulting from the various test and inspection operations shall be recorded on appropriate forms.

17.2.7 In all instances data recorded shall include:

17.2.7.1 Specific part identification including drawing number and

revision, when applicable.

17.2.7.2 Specification number and revision i

applicable to definition of character-istics measurec'.

Document:

0A-72-1 Revisten No.:

I4 Date:

8/24/90 Pose: 83

17.2.7.3 Test, inspection, or operating procedure number, when applicable.

17.2.7.4 Data inspections were made and signature of inspector.

17.2.7.5 Acceptance criteria, if not defined and identical to that listed in the reference drawing or specification, where applicable.

17.2.9 Records shall be maintained by Quality Assurnce which can be used to analyze trends at critical inspection points and to analyze the results of corrective action taken on nonconforming items.

i 17.2.10 Records and/or forms (contractor forms or approved substitutes) will be completed and supplied to j

customers as required by contract.

I i

l l

i i

Document:

0A-72-1 Revision No.:

I4 Oste:

8/24/90 Page: 84 l

18.0 AUDITS 18.1 ScoDe This section describes the formal Quality Assurance Audit Program. The program is applicable to both internal and vender or supplier audit activities.

Internal audits are performed to verify the compliance

with, and the effectiveness of, the Quality Assurance Program.

Vendor audits are performed as necessary to verify the suppliers compliance with quality related requirements specified in the procurement documents and to monitor the effectiveness of the supplier's quality program.

The detailed procedure 1

l for conducting internal Quality Assurance audits is contained in General Procedure GP-19,

" Quality Assurance Audit Program."

18.2 Internal Audits 18.2.1 Audit Personnel Audits shall be conducted by persons who have received audit training.

The Quality Assurance Supervisor or Supervisor, Licensing and compliance has the prime responsibility for the administration of the audit program.

Audit personnel shall have no direct responsibility for the operations performed in the area or activity being audited.

19.2.2 Audit Documenta_ ion l

t An Audit plan or agenda shall be prepared by QA.

Document:

QA-72-1 Movisten No.:

14 Date:

8/24/90 Page: 85

~

i checklists, procedures or other appropriate forms i

shall be used to document the performance and findings of each audit.

The findings and/or recommendations resulting from the audit shall be provided in written form to the manager.of tha trea or activity audited.

The audit document shall identify the requirement (s) violated, recommend r

corrective action (s) and specify a response date.

18.2.3 Audit Schedule The Quality Assurance supervisor or supervisor of Licensing and compliance shall prepara a schedule of all formal internal audits to be ' conducted during each year.

Process audits will usually be performed on each individual process or operation once each year.

Internal audits of the applicable elements of the Quality Assurance Program should be audited at least annually or at least once within the life of the activity whichever is shorter.

In l

addition, special unscheduled audits will be conducted to verify compliance with corrective action commitments and to review the response to quality problems or potential problems as required.

18.2.4 Audit _ Performance In advance of each audit, the auditor shall review any findings of previous audits pertinent to the activity to be audited.

The auditor shall prepare Document:

0A-72-1 Revisten No.:

I4 Date:

8/24/90 Page: 86

~ _ _ _ _ _. _ _ _ _ _ _ _ _ _. _ _ _.___ __ _ _ -_

B I

i I

or obtain audit checklists or procedures describing the activities to be audited and perform the audit as assigned.

The audit will consist of an objective evaluation of quality related practices, procedures and instructions, and their effectiveness.

Audit findings and/or recommen-dations are to be recorded on the audit report form.

The auditor will discuss the results of the audit vith the personnel responsible for the 4

audited activity and issue a formal audit report to the area or activity manager.

18.2.5 corrective Action The manager of the area or activity audited is to provide a written corrective action commitment in response to identified findings and specify a completion date for the corrective action.

Recommendations by the auditor also require a written response. Audit responses and corrective action commitments will be reviewed by the auditor and the Quality Assurance Supervisor, 18.2.6 Follow-Un Audit Audits will be performed to verify that corrective actions have been implemented as specified.

Following verification, the auditor will formally close-out the audit as provided on the audit form.

The manager of the-area or activity audited shall Document:

QA-72-1 I Movision No.:

14 Dste:

8/24/90 Pove: 87

s be notified of the audit closeout.

18.3 vendor M 18.3.1 hudii; Egraonnel l

Audits shall be conducted by Quality Assurance q

personnel.

When appropriate, personnel repre-senting the Engineering, Purchasing, Technical Control or Operations organizations may assist in these audits.

Auditors shall be designated by the j

Quality Assurance Supervisor or supervisor of Licensing and Compliance.

18.3.2 Audit Documentation An audit plan or agenda shall be developed to determine compliance with the requirements i

specified by the procurement documents.

In

addition, the agenda shall
include, when applicable, a follow-up of corrective actions from previous audits and a review of current quality problems.

At the conclusion of the audit, the i

auditor shall document the performance of the audit I

and the resultant findings in a report to the Quality Assurance supervisor.

18.3.3 Audit Sshaf,Q Vendor aud:to shall be scheduled as necessary to ensure the vendors compliance with quality require-ments specified by the procurement documents.

Document:

QA-72-1 Movisten No.:

14 Date:

8/24/90 P,y:

88

F L

l l

18.3.4 Audit Performance Prior to the audit, the auditor shall provide the vendor with a description of the audit plan and schedule.

During the audit, the auditor shall review and evaluate the vendors quality performance with respect to the specifications defined in the procurement documents.

Where appropriate, the auditor may also perform preliminary inspections of starting materials, in-process and final products prior to shipment.

Upon completion of the audit, the auditor shall discuss his findings with vendor management and provide an informal report of those findings.

18.3.5 corrective Ac11pn A formal audit report, lisHng the audit findings and a request for correct'-

':tica. shall be issued to the vendor.

The vend'Or will 1,e requested to l

1 provide a

corrective action comm!tment and completion date for each finding.

If the corrective action response is considered satisfactory, the vendor shall be so notified.

If the response is not satisfactory, further negotiation will be necessary to resolve the issue.

18.3.6 Follow-Un Audits When necessary to verify the completion of f

corrective action, a

follow-up audit will be Document:

0A-72-1 Revistes No.:

14 Date:

8/24/90 Pose: 89 i

I

F scheduled.

Where the implementation of corrective action can be verified through receival inspection of the procurement material, no follow-up audit s

will be required.

t 1

I l

l l Deemment:

0A-72-1 l

Mob No.:

I4 f Dste: 8/24/90 Pooe: 90

F. __

  • l

~

Quanty Assurance Sectton sub.fect Procede es Misc. Proceduras l

9.0 Control e(Special Processes P0 series Mi series 10.0 Inspection N Series ITC Series j

s 1

GP.46

~

11.0 Test Control UAS Series 12.0 Control of Measuring and QC-CP 00-001 Test Equipment QC-CP-00-002 QC-CP Series GP-4 13.0 Handling, Storage and ITC-Series Shipping GP-46 SRI-Strtes ISI Series HMT-001 NMC-Series 14.0 Inspection. Test and GP 20 Operating Status GP-41 am Nonconfoming Materials, GP-26 Parts or Components GP-34 i

i Document:

QA-72-1 i

Revistes No.:

14 Dste:

8/24/90 Page:

91

APPENDIX !

CROSS REFERENCE OF OVALITY ASSURANCE POLICY AND PROCEDURE MANUAL SECTIONS TO IMPLEMENTING PROCEDURES.

Quality Assurance Section Subject Procedures Misc. Procedures 1.0 Organization 2.0 Quality Assurance Program GP-15 GP.34 3.0 Design Control l

4.0 Procurement Document Control GP-11 Purchasing Manual 5.0 Instructions, Pr ocedures &

GP-4 GP 1.0 Drawings GP-25 AM Series GP-46 P.O.-Series SRI Series ITC Series Mi-Series Pt)M-Series OI Series 6.0 Document Control GP-11 GP-25 GP-41

~

7.0 Control of Purchased Haterial, GP-43 Equipment & Services GP-46 8.0 Identification & Control of GP-34 Materials, Parts & Components Document:'

0A-72-1 Revielee No.:

I4 Dete:

8/24/90 Page:

92

Quality Assurance Section

_ Subject Procedures Misc. Procedures 16.0 Corrective Action GP-26 17.0 Quality Assurance Records GP-11 01-1266 GP-18 GP-20 GP-41 18.O Audits GP-19 0103-04 GP-43 0103-05 NOTE: This cross reference Appendix may be changed from time-to-time to reflect the addition or deletion of procedures bated on operational requirements.

Subsequent revisions to the Manual will reflect these changes.

Doewment:

QA-72-1 hviolas No.:

14 Date:

8/24/90 Pose:

93