ML19309F565
| ML19309F565 | |
| Person / Time | |
|---|---|
| Site: | Vallecitos, 07100170 File:GEH Hitachi icon.png |
| Issue date: | 03/31/1980 |
| From: | GENERAL ELECTRIC CO. |
| To: | |
| Shared Package | |
| ML19309F563 | List: |
| References | |
| 16022, QAP-1, QAP-1-R1, NUDOCS 8004300056 | |
| Download: ML19309F565 (33) | |
Text
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80 04300 O%
0 GENERAL ELECTRIC - VALLECITOS (71-0170)
Request for Additional Information 1.
Describe how GE's QA organizaticn interfaces with his contractors to j_j,;.
assure proper direction of the QA program and resolution of QA problems.
2.
Identify the level of management responsible. for establishing GE's QA 1-1.2 policies goals, and objectives.
g 3.
Identify the position who retains overall authority and responsibility 1-1.2 for the QA program.
4.
Describe the qualification requirements for the principal QA/QC management 10-1.4j positiens.
1 5.
Provide a statement that designated QA individuals have the responsibi-lity and authority, delineated in writing, to stop unsatisfactory work 1-1.1 and control further processing, delivery, or installation of noncenfonn-ing material.
6.
Identify the management level (i.e., above or outside the QA organi:ation) that regularly assesses the scope, status, implementatten, and effective-1-1.2 ness of the QA program to assure that the program is adequate and ccmplies with.10 CFR Part 71, Appendix E criteria.
7.
Provide a statement that measures are provided by GE to assure that trained, qualified personnel within the..GE_crganization.are assigned to determine that 1-1,1 functions delegated to contractors are being properly acccmplished.
8.
Give a brief summary of GE's QA policies, goals, and objectives.
10,11-2.
9.
Provide a statement that. provisions are established to control the distri-bution of the QA manuals and revisiens thereto.
10.
Provide a statement that provisions are established for ccmnunicating to all responsible organizations and individuals that qualMy policies, QA manuals, and procedures are mandatory requirements.
11.
Provide a listing of the QA precedures plus a matrix of these procedures cross referenced to each criterien of Appendix E to 10 CFR Part 71.
11-2.
- 12. Provide a statement that GE reviews and documents agreement with the QA prcgram provisions of his contractors to the extent that he :an be assured that Appendix E will be impleinented.
- 13. Describe hcw disputes involving quality, arising frcra a di?ference of opinien between QA/QC personnel and other department (engineering, precurement, manufacturing, etc.) persennel are resolved.
14 Provide a statement that an indoctrination and training program is estab-lished such that:
c
-2
~
a.
Personnel responsible for performing quality-affecting activities are instructed as to the purpose, scope, and implementation of the quality-related manuals, instructions, and procedures.
11-2.
b.
Personnel performing quality-affecting activities are train'ed and qualified in the principles and techniques of the activity being performed.
c.
The scope, the objective, and the method of implementing the indoctri-nation and training program are documented.
d.
Proficiency of. personnel perfonning quality-affecting at.tivities is maintained by retraining, reexamining, and/or recertifying.
15.
Provide a statement that quality standards are specified in the design 15-3.1 documents, and deviations and changes from these quality standards are
)
controlled.
16.
Clarify that when a test program is used to verify the adequacy of a design, a qualification test of a prototype unit under adverse design conditions shall be used.
15-3.2 17.
Provide a statement that individuals or groups responsible for design i
verification are other than the original designer and the designer's immediate supervisor.
)
18.
Provide a statement that design and specification changes, including field changes, are subject to the same design centrols and approvals that were 15-3.3 acplicable to the original design unless GE designates another qualified respcnsible organization.
19.
Provide a statement that errors and deficiencies in the design, including the design process, that could adversely affect safet.y-related structures, systems, and components are documented; and corrective action is taken to preclude repetition.
- 20. Provide a statement that materials, parts, and equipment which are standard, ccmmercial (off the shelf) or which have been previcusly approved for a 15-3.1 different application are reviewed for suitability prior to selectien.
21.
Provide a statement that measures are established for the selection of suitable materials, parts, equipment, and processes for safety-related structures, systems, and components which include the. use of valid industry standards and specifications.
- 22. Clarify that the review of procurement documents determines that quality requirements are correctly stated, inspectable, and controllable; there are adecuate acceptance and rejection criteria; and the procurement docu-ment has been prepared, reviewed, and approved in accordance with QA pro-gram requirements.
23.
Provide a statement that the review and approval of precurement documents i
are documented prior to release and available for verification.
3-
- 24.. Provide a statement that procurement documents identify the applicable 10 CFR Part 71, Appendix E requirements which must be complied with and described in the supplier's QA program. This QA program or portions thereof shall be reviewed and concurred with by qualifted personnel in QA prior to initiation of activities affected by the program.
~
25.
Provide a statement that procurement documents contain or reference the design basis technical requirements including the applicable regulatory requirements, material and component identification requirements, draw-ings, specifications, codes and industrial standards, test and inspection requirements, and special process instructions.
25.
Provide a statement that procurement documents ijentify the documentation (e.g., drawings, specifications, procedures, inspection and fabrication plans, inspection test records, personnel and procedure qualifications, and chemical and physical test results of material) to be prepared, main-tained, and submitted to GE for review and approval.
16-4.
- 27. Provide a statement that procurement documents identify those records to be retained, controlled, and maintained by the supplier, and tnese delivered to GE prior to use or installation of the hardware.
28.
Provide a statement that procurement documents contain the procuring agency's right of access to supplier's facilities and records for source inspection and audit.
- 29. Provide a statement that procurement documents for spare er replacement parts of safety-related structures, systems, and compomnts are subject to controls at'le'ast equivalent to those used for the original equipment.
- 30. Provide a statement that provisiens are established which clearly delineate the sequence of actions to be acecmplished in the preparation, review, approval, and control of instructions, procedures, and drawings.
17-5.
31.
Provide a statement that methods for complying with each of the 18 criteria of 10 CFR Part 71, Appendix E are specified in instructions, procedures, and drawings.
- 32. Provide a statement that the QA organization reviews and concurs with inspec -
tien plans; test, calibration, and special process procedures; drawings, and 17-6.
specifications; and changes thereto or acceptacle alternatives are described.
33.
Identify those individuals or groups responsible for reviewing, approving, 18-6.
and issuing documents and revisisns thereto.
34 Provide a statement that changes to documents are reviewed and approved by the same organi:ations that performed the original review and approval or by other qualified responsible organi:atiens delegated by GE.
17-6.
35.
Provide a statement that approved changes are included in instructions, crecedures, drawings, and other documents prior to imolementation of the change.
a
4
- 36. Provide a statement that documents are available at the location where
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the activity will be performed prior to comencing the work.
- 37. Provide a statement that a' master list or equivalent is established to identify the current revisien number of instructions, procedures, speci-fications, drawings, and procurement documents. This list is updated and distributed to predetermined, responsible personnel to preclude use of superseded documents.
38.
Identify the documents that are controlled under.this program.
As a minimum this should include; a.
Design specifications.
b.
Design, manufacturing, construction, and installation drawings.
17-6.
c.
d.
QA manuals.
6.
Design criteria documents.
f.
Manuf acturing, inspection, and testing instructions.
g.
Test procedures.
h.
Design change requests.
1.
Nonconformance reports.
- 39. Provide a statement tha* qualified personnel evaluate the supplier's capa-bility to provide acceptable quality services and products before the award of the procurement order or contract. The QA and engineering groups participate in the evaluation of those suppliers providing critical com-ponents.
40.
Provide a statement that the evaluation of suppliers is based on one or more of the following:
a.
The supplier's capability to comply with the elements of 10 CFR Part 71 Acpendix E that are applicable to the type of material, equipment, or 19-7.
service being procured.
b.
A review of previous records and performance of suppliers who have pro-vided similar articles of the type being crocured.
A survey of the supplier's facilities and QA program to determine his i
c.
capability to supply a product which meets the design, manufacturing,
j and quality requirements.
al.
Provide a statement that the results of supplier evaluations are documented and filed.
e e
42.' ' r'ovidh S 's~tatement that surveillance of suppliers during fabrication -
~~
^
~
P inspection, testing, and shipment of materials, equipment, and components is planned and performed in accordance with written procedures to assure conformance to the purchase order requirements. These procedures provide for:
~
a.
Instru.tions that specify the characteristics or processes to be wit-nessed, inspected or verified, and accepted; the method of surveil-lance ano the extent of documentation required; and those responsible for implementing these instructions.
b.
Audits and surveillance which assure that the supplier complies with 19 7, the quality requirements. Surveillance,is performed on those items where verification of procurement requirements cannot be deteruined upon receipt.
- 43. Provide a statement that the supplier furnishes the following records as a minimum to GE:
-a.
Documentation that identifies the purchased material or equipment and the specific procurement requirements (e.g., ecdes, studards, and specifications) met by the items.
b.
Documentation that identifies any procurement requirements which have not been met together with a description of those nonconformances
'dispositioned " accept as is" or " repair."
The review and acceptance of these documents shall be described in GE's QA program and as a minimum shall be undertaken by a respensible QA indivi-dual.
44 Provide a statement that supplier's certificates of conformance are periodi-20-7.
cally evaluated by audits, independent inspecticns, or tests to assure they are valid.
- 45. Provide a statement that receiving inspection of the supplier-fumished material, equipment, and services is performed to assure:
19,20-7.
a.
The material, component, or equipment is properly identified and corresponds with the identific.cion en receiving documentation.
b.
Inspection records or ce; cificates of conformance attesting to the acceptance of mateiai, components, and equipment are available at Vallecitos prior to installation or use.
Items accepted and releas'ed are identified as to their inspection c.
status prior to forwarding them to a controlled storage area or releasing them for installation or further work.
46.
Provide a statement that the effectiveness of the centrol of quality by sucoliers is assessed by GE at intervals censisten: with the importance, 20-7.
ccmplexity, and quantity of the item.
l
-5
- 47. Provide a stater.ent that identification of materials and parts 'important to the function o' safety-related structures, systems, and components can be traced to the appropriate documentation such as drawings, spectff cations, purchase oNers, manufacturing and inspection documents, deviation reports, and physical and chemical mill test reports.
0-8.
- 48. Provide a statement that the location and the method of ideatification de not affect the fit, function, or quality of the item being identified.
- 49. Provide a statement that cor"ect identification of material, parts, ar[d components is verified and documented prior to release for fabrication, assembling, shipping and installation.
- 50. Provide a statement that inspection personnel are independent from the individuals performing the activity being inspected.
- 51.. Provide a statement that inspectica ?rocedures, instractions, and check lists provide for the following:
a.
Identification of charactr.ristics and activities to be inspected,
- b.. Identification of the individuals or groups responsible for performing 21-10.
the inspecticn operatien.
c.
A description of the method of inspection.
d.
Recording evidence of ecmpleting and verifying a manufacturing, inspection, or test operation.
e.
Recording inspector or data recorder and the results of the inspection operation.
52.
provide a statement that inspectors are qualified in accermee with aopli-cable codes, standards, and ccmpany training programs; i."' t.1eir qualifica-tions and certifications are kept current.
53.
Provide a statement that modifications, repairs, and replacements are inspected in accordance with the original design and inspection requirements or acceptable al ternati ves.
22-10.
54 Provide a statement that provisions are established for indirect cer.crol by monitoring processing methods, equipment, and personnel if direct inspecticn is not possible.
55.
Provide a statement that modificatiens, repairs, and replacements are tested in accordance with the original design and testing requirements or acceptable al ternatives.
22-11.l
- 55. Provide a statement that written test procedures incorporate or reference:
The requirements and acceotance limits c:ntained in apol'icable design and a.
I b.
Instructions for performing the test.
c.
Test prerequisites such as:
9 Calibrated instrumentation.
8 Adequate and appropriate equipment.
I e Trained, qualified, and licensed or certified personnel.
- 22-11.
l 8 Completeness of item to be tested.
9 Provisions for data collection and storage.
l d.
Mandatory ins;:ection hold points for witness by cwner, centractor, or 4
l inspector.
i
- e. ' Acceptance and rejection criteria.
I f.
Methods.cf. documenting or recording test data and results.
57.
Identify the individual or group who determines the acceptability of test results.
- 58. Provide a statement that procedures describe the calibration technique and frequency, maintenance, and control of the measuring and test equipment (instruments, tools, gages, fixtures, reference and transfer standards, and nondestructive test equipment) which is used in the measurement, inspection, and monitoring of safety-related ccmponents, systems, and structures.
59.
Provide a statement that measuring and test equipment is identified and trace-able to the calibration test data.
- 50. Provide a statement that measuring and test equipment is labeled or tagged to indicate date of the next calibration.
- 51. Provide a statement that measuring and test instruments are calibrated at specified intervals based on the required accuracy, purpose, degree of usage, 23-12' stability characteristics, and other ccnditions affecting the measurement.
- 52. Provide a statement that measures are taken and documented to deter nine the validity of previous inspectibns performed when measuring and test equipment is found to be out of calibration.
53.
Provide c statement that calibrating standards have an uncertainty (error)
-aquirement of no more than 1/4th of the tolerance of the equipmen : being calibrated.
A greater uncertainty may be acceptable when limited by the "stata-cf-the-a rt. "
54 Provide a statement that the ccmolete status of all items uncer the calibra-tion system is recorded and maintained.
- 65.
Provide a statement that procedures are prepared which control 'the cleaning, handling, storage, packaging, shipping, and preservation of materials, components, and systems in accordance with design and specification require-23-13 ments to preclude damage, loss, or deterioration by environmental conditions such as temperature or humidity.
i 66.
Provide a statement that bypassing of required inspections, tests, and other 24-14*
critical operation,s is procedurally controlled under the cognizance of the QA organization.
67.
Provide a statement that the identification, documentation, segregation.
l review, disposition, and notification to affected organizations of noncon-feming materials, parts, comoonents, or services are procedurally controlled.
68.
Provide a statement that documentation identifies the nonconforming item; l
describes the nonconformance, the disposition of the nonconformance, and the inspection requirements; and includes signature approval of the disposi-tion.
69.
Provide a statement that nonconforming items are segregated from acceptable items and identified as discrepant until properly dispositioned.
24-15.
70.
Provide a statement that acceptability of rework or repair of materials, parts, components, systems, and structures is verified by reinspecting and retesting-the item as originally inspected and tested or by a method which is at least equal to the original inspection and testing method.
Inspection, testing, rework, and repair procedures are documented.
)
71.
Provide a statement that nonconfomance reports dispositioned " accept as is" or " repair" are made part of the inspection records and forwarded with the hardware to G.E. for review and assessment.
i 72.
Provide a statement that nonconformance reports are periodically analyzed to show quality trends, and the results are reported to management for review and assessment.
73.
Provide a statement that evaluation of conditions adverse to quality (such as nonconfonnances, failures, malfunctions, deficiencies, deviations, and 24-16.'
defective material and equipment) is conducted to determine the need for corrective action in accordance with established procedures.
74 Provide a statement that follow-up reviews are conducted to, verify precer implementation of corrective actions and to cicse out the corrective action 25-16.
documentation.
75.
Provide a statement that QA records include qualification of personnel, procedures, and equipment; and other documentatien such as drawings, speci-25-17.,
ficaticns, procurement documents, calibration procedures and _ reports; ncn-i conformance reports; and correc ive ac icn recorts, 1
t 9-
- 76. Frovide a statement that requirements and responsibilities for record tr0nsmittals, retention (such as duration, location, fire protection, and ass ?gned responsibilities), and maintenance subsequent to completion of work are consistent with applicable codes, standards, and procurement documents.
77.
Provide a statement that record storage facilities are constructed, located.
25-17.
and secured to prevent destruction of the records by fire, flooding, theft, and deterioration by environmental conditions such as temperature or humidity t i
78.
Provide a statement that audits are performed in accordance with preestablished written procedures or check lists and conducted by trained personnel not having direct responsibilities in the areas being audited.
79.
Provide a statement that responsible management takes the necessary action to correct the deficiencies revealed by the audit.
80.
Provide a statement that deficient areas are reaudited on a timely basis to verify implementation of corrective actions which minimi:e r,ecurrence of deficiencies.
81.
Provide a. statement that audits include an objective evaluation of quality-related practices, procedures, and instructions and the effectiveness of 25,18.
implementation.
82.
Provide a statement that audits include the objective evaluation of work areas, activities, processes, and items, and the review of documents and records.
83.
Provide a statement that audits to assure that procedures and activities are meaningful and comply with the overall QA program are performed by:
The QA organi:ation, to provide a comprehensive independent verification a.
and evaluation of quality-related procedures and activities.
5.
G.E. and its contractors, to verify and evaluata their suppliers' QA programs, procedures, and activities.
24.
Provide a statement that audit data are analy:ed and the reports, which indicate quality trends and the effectiveness of the QA program, are reported to manage 26-18 ment for review and assessment.
160'C
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OAp.1 REVISION 1
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QUALITY ASSURANCE PROGRAM'
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VALLECITOS NUCLEAR CENTER 4
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l QUALITY ASSURANCE PROGRAM FOR SHIPPING PACKAGES FOR RADI0 ACTIVE MATERIAL DOCUMENT NO. QAP-1 REVISION 1 DATE ISSUEC: MARCH 28,1980 GENEPAL ELECTRIC COMPANY VALLECITOS NUCLEAR CENTER PLEASANTON, CALIFORNIA ISSUED BY:
M CW Quality Assurance
)
i APPROVED BY:
Manager, Irradiation Processing Operation 16Cm
TABLE OF CONTENTS Page LIST OF ABBREVIATIONS
-iv-INTRODUCTION
-V-1.
ORGANIZATION 1
2.
QUALITY ASSURANCE PROGRAM 10 3.
DESIGN CONTROL 15 4.
PROCUREMENT DOCUMENT CONTROL 16 5.
INSTRUCTIONS, PROCEDURES, AND DRAWINGS 17 6.
DOCUMENT CONTROL 17 7.
CONTROL OF PURCHASED MATERIAL, EQUIPMENT, AND 19 SERVICES 8.
IDENTIFICATION AND CONTROL OF MATERIALS, PARTS, 20 AND COMPONENTS 9.
CONTROL OF SPECIAL PROCESSES 20 10.
INSPECTION 21
- 11. TEST CONTROL 22 12.
CONTROL OF MEASURING AND TEST EQUIPMENT 23
- 13. HANDLING, STORAGE AND SHIPPING 23 14.
INSPECTION, TEST AND OPERATING STATUS 24 15.
NONCONFORMING MATERIALS, PARTS, OR COMPONENTS 24 16.
CORRECTIVE ACTION 24
- 17. QUALITY ASSURANCE RECORDS 25 18.
AUDITS 25 i
-iii-
LIST OF ABBREVIATIONS AFL Advanced Fuels Laboratory CFR Code of Federal Regulations D&TE Design & Test Engineering DR Deviation Report E&MS Engineering & Manufacturing Services ECN Engineering Change Notice GE General Electric GETR General Electric Test Reactor IR Inspection Report IPO Irradiation Processing Operation MR Material Request MRB Material Review Board NEBG Nuclear Energy Business Group NET 0 Nuclear Energy Traffic Operatian NRC Nuclear Regulatory Comission NS&QA Nuclear Safety & Quality Assurance NST Nuclear Safety Technology OPG Organization & Policy Guide P&QA0 Nuclear Energy Product & Quality Assurance Operation QA Quality Assurance QC Quality Control RP&S Radioactive Products & Services R&EP Radiological & Environmental Protection RI Reactor Irradiations R&U0 Relations & Utilities Operation RHO Remote Handling Operation RFQ Request for Quotation SO Shop Operations VNC Vallecitos Nuclear Center l
l 1
-iv-l l
n.
INTRODUCTION A quality assurance program is provided by General Electric Company, Vallecitos Nuclear Center (VNC) to assure the compliance with requirements of 10CFR71, Appendix E.
The program will assure the required management efforts, equipment, and procedures are directed toward satisfying the quality objectives of the Nuclear Energy Business Group for providing safe and re-liable systems and components, and to assure compliance with applicable codes and regulations of governing regulatory agencies.
The program described herein is structured in accordance with the 18 criteria of 10CFR71, Appendix E.
It will become applicable when its acceptability is determined by the Nuclear Regulatory Commission (NRC).
Packaging and shipping for quantities of licensed materials in excess of Type A quantities or fissile materials exceeding fifteen (15) grams are governed by this program. The program will be applied to activities affecting the packaging in a graded approach to an extent con:istent with the impor-tance to radiological safety and performance of the pacKayii.g. Those activ-ities include designing, purchasing, fabricating, handling, shipping, storing, cleaning, assembling, inspecting, testing, operating, maintaining, repairing, find modifying.
Changes to this program are initiated by Irradiation Processing Operation (IPO) Quality Assurance and require approval by the same organizations as for origination.
-V-
1.
ORGANIZATION 1.1 GENERAL This section describes the organizational structure and functional responsibilities for the Quality Assurance Program. Persons and organizations assigned quality related responsibilities have sufficient authority and organizational freedom to identify, evaluate, and recom-mend solutions to quality and safety-related problems; verify imple-mentation of corrective action; to stop unsatisfactory work and control further processing, delivery, installation or utilization of noncon-forming items until proper dispositioning has been established.
The program is implemented by or at the direction of GE-IPO. Activ-ities such as design, fabrication, testing, or others as appropriate, may be performed by contractors to GE specifications.
GE assigns appropriately trained and qualified personnel to determine that those functions performed by contractors are properly accomplished.
The organizational structure and functional responsibility assignments are such that:
(1) attainment of quality objectives is accomplished by individuals responsible for specifying quality or performing work to specifications, and (2) verificati>. J quality requirements is accomplished through audits performed by Quality Assurance per Section 18.
An abbreviated organization chart showing those components concerned with implementing this program is presented in Figure 1-1.
1.2 STAFF ORGANIZATION FUNCTIONS The Vice President and Group Executive of the NEBG is responsible for establishing the QA policies, goals, and objectives.
Division level managers report directly to the NEBG Group Executive. The Manager, IPO, reporting directly to a Division level manager, has overall responsibility and authority for the establishment and execution of this QA program.
P&QAO, a staff organization reporting directly to the NEBG Group Executive, is responsible for auditing the QA program for adequacy and compliance with 10CFR71, Appendix E Criteria at VNC.
1.3 LINE ORGANIZATION FUNCTIONS A.
Radioactive Products and Services (RP&S) Equipment Engineering The RP&S Equipment Engineering component has overall responsibility for completion of the work scope involving new designs and modifi-cations to existing desi ns for shipping containers assigned to b
RP&S which are governed by this QA program.
For those assigned containers, RP&S Equipment Engineering:
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- i.ican,s flGURE 11. VAttECITOS NUCLE AR CENTER ADMINI$iR AllVE ORG ANIZ ATION CilARI I"OUTIN 8EI3EWAI*
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t 1.3 LINE ORGANIZATION FUNCTIONS (continued)
A.
1.
Is responsible for the preparation of fabrication specifications.
2.
Is responsible for the approval of maintenance procedures.
3.
Is responsible for the preparation of fabrication procurement 4
and/or process specifications and performance of technical liaison with outside suppliers.
4.
Conducts design reviews and publishes design review meeting minutes.
5.
Is responsible for the identification, preparation, issuance, and maintenance of the documents or procedures required in Section 5.
6.
Approves new designs and modifications to existing designs.
B.
RP&S Remote Handling Operations (RHO)
RHO is responsible to:
1.
Inspect containers prior to each use in shipment.
2.
Assemble shipping containers according to written instructions.
3.
Prepare maintenance procedures.
4.
Document critical assembly steps for shipping containers.
5.
Maintain design, fabrication, and maintenance records as l
required in Section 17 for containers assigned to RP&S.
6.
Review shipment records and packaging conformance and authorize shipments.
7.
Request or perform routine maintenance on the shipping containers for radioactive material.
C.
Engineering & Manufacturing Services, Design & Test Engineering (D&TE)
When requested, D&TE:
1.
Provides assistance in design functions as necessary to assure the container is in compliance to applicable regulatory require-ments.
2.
Provides assistance in the preparation of fabrication specifi-cations or instructions.
1.3 LINE ORGANIZATION FUNCTIONS (continued)
C.
3.
Analyzes cask designs for structural and thermal capabilities and prepares analysis reports.
4.
Conducts design reviews as necessary.
D.
Reactor Irradiations (RI)
The RI engineer has overall ' responsibility for containers assigned to RI for completion of the work scope involving new designs and modifications to existing designs for shipping containers governed by this QA program.
For those assigned containers the RI engineer:
1.
Is responsible for the preparation of fabrication specifica-tions.
2.
Is responsible for the preparation of maintenance procedures.
3.
Is responsible for the preparation of procurement documents and performs liaison with outside vendors.
4.
Schedules and conducts design reviews and publishes design review meeting minutes.
5.
Is responsible for the preparation, issuance, and maintenance of the procedures required in Section 5 for containers assigned to RI.
6.
Approves new designs and modifications to existing designs.
7.
Maintains design, fabrication, and modification records as required in Section 17.
E.
Reactor Irradiations, General Electric Test Reactor (GETR) Operations RI-GETR Operations is responsible for maintaining all shipping records 'cor GETR shipments as required in Section 17.
1.
Inspect containers prior to each use in shipment.
2.
Assemble shipping containers according to written instructions.
3.
Document critical assembly steps for shipping containers.
4.
Provides assistance in the preparation of fabrication specifi-cations or instructions.
5.
Reviews GETR shipment records and packaging for conformance and authorizes GETR shipments.
6.
Provides maintenance on containers assigned to RI.
! i
O l.3 LINE ORGANIZATION FUNCTIONS (continued)
F.
Advanced Fuels Laboratory (AFL)
The Energy System & Technology Division's Advanced Fuels Laboratory (AFL) has overall responsibility for completion of the work scope involving new designs and modifications to existing designs for shipping containers assigned to AFL which are governed by this QA program. For those assigned containers AFL:
1.
Is responsible for the preparation of fabrication specifications.
2.
Is responsible for the preparation of maintenance procedures.
3.
Is responsible for the preparation of fabrication, procurement and/or process specifications and performance of technical liaison with outside suppliers.
4.
Conducts design reviews and publishes design review meeting minutes.
5.
Is responsible for the identification, preparation, issuance, and maintenance of the documents or procedures required in Section 5.
6.
Approves new designs and modifications to existing designs.
7.
Inspects containers prior to each use in shipment.
8.
Assembles shipping containers according to written instructions.
9.
Documents critical assembly steps for shipping containers.
- 10. Maintains design, fabrication, and maintenance records as required in Section 17 for containers assigned to AFL.
11.
Reviews shipment records and packaging conformance and author-izes shipments.
12.
Requests or performs routine maintenance on the shipping con-tainers for radioactive material.
G.
Fabrication Organization (s) 1.
Plan fabrication activities to include establishing schedules and procedures.
2.
Fabricate components and assemblies as required by engineering definition documents.
3.
Fabrication planning documents :
1.3 LINE ORGANIZATION FUNCTIONS (continued)
G.
3.
(continued) a.
Provide space as required for the technicians who perfonned the work to verify that they have followed the prescribed instructions.
b.
Specify essential controls and hold points for approval as defined by the engineering definition document.
These are steps in the plan which provide for an independent assess-ment that the work was performed as prescribed.
c.
Contain steps inserted by Quality Assurance for quality checks so that an independent assessment of the container quality can be accomplished.
4.
Include special instructions for handling and movement of parts within or from the fabrication facility.
H.
Quality Assurance Quality Assurance (QA) is responsible for establishing overall quality programs and for assuring that quality-related activities are performed in accordance with these programs. QA is organiz-ationally independent of the operating functions; has delegated authority and responsibility to identify and evaluate quality problems; to recommend and assure implementation of corrective actions; and to stop unsatisfactory work and control further pro-cessing, delivery, installation, or utilization of nonconforming items until proper disposition is established. The components of QA and their duties are:
1.
QA Engineering a.
Interpret quality requirements for established specifications.
b.
Prepare Quality Assurance Plans, c.
Coordinate quality-related activities.
d.
Provide the performing components with technical assistance on quality problems.
e.
Establish the need for quality control records and quality control inspection points to be included in specifications and detailed work procedures of the performing components.
f.
Review and approve procedures of perfonning components to assure inclusion of quality requirements.
g.
Issue procedures for inspection work performed by QA. -
e 1.3 LINE ORGANIZATION FUNCTIONS (continued)
H.
1.
(continued) h.
Conduct Material Review Board (MRB) evaluations on non-confonning items.
- i. Perfonn audits on the quality systems to verify product quality and compliance with specifications and procedures.
- j. Verify that follow-up actions are completed when recomended by audits, customer complaint investigations, and MRB de-cisions.
k.
Distribute audit results to appropriate management for evaluation and action.
1.
Maintain files on supplier quality capability.
m.
Perform supplier quality capability evaluatian and sur-veillance as required in accordance with established QA procedures.
n.
Approve procurement documents as required by established QA procedures.
o.
Approve supplier documents, as required, which are pertinent to fabrication activities such as welder qualification and inspector qualification.
p.
Provide specific receiving inspection instructions when required on MR's.
q.
Specify quality requirements to assure specifications are satisfied.
r.
Witness or verify supplier activities, as appropriate, to assure conformance with procurement requirements.
2.
Quality Control Inspection a.
Provide destructive and nondestructive inspection services at the request of the performing components or when spec-ified by governing procedures.
b.
Perform, witness, or verify inspection activities in accordance with approved procedures or in*,tructions at VNC or in the field.
c.
Document the results of inspections on appropriate report forms.
1.3 LINE ORGANIZATION FUNCTIONS (continued)
H.
2.
(continued) d.
Document nonconforming items in accordance with established QA procedures.
e.
Request receiving inspection services from Facilities for electrical equipment as required.
f.
Conduct Material Review Board evaluations on those non-confonning materials documented by QC Inspection.
g.
Establish requirements and maintain records of qualifica-tions of inspection personnel.
I.
Nuclear Safety Technology, Radiological & Environmental Protection, and Licensing Quality-related responsibilities for the NST, R&EP, and Licensing components are:
1.
Interface with regulatory agencies on matters pertaining to licensing and nuclear safety.
2.
Review radioactive material shipping container designs for compliance with the appropriate regulations, license require-ments, and G.E. policies, and recommend the necessary correc-tive action to resolve areas of conflict.
3.
Provide an independent review of safety-related issues con-cerning the design and planned use of the shipping container (s).
This review is carried out in accordance with documented pro-cedures issued by Nuclear Safety Technology. Records of these reviews are maintained.
4.
Review operating procedures to ensure applicable radiological safety requirements are included.
5.
Survey packaged products to assure that external radiation and contamination levels do not exceed limits established by regu-latory agencies for shipping radioactive materials.
Survey results are documented in appropriate records.
6.
Perform audits, as necessary, to assure compliance with estab-lished radiological safety requirements.
J.
Vallecitos Purchasing Purchasing performs activities involved with procurement of materials and services required from outside suppliers. The procedures followed by Purchasing are specified in Purchasing Operating Procedures.
Purchasing duties are summarized as follows:
o 1.3 LINE ORGANIZATION FUNCTIONS (continued)
J.
(continued) 1.
Procure materials and services to meet specifications provided by the requesting component. Changes are approved in the same manner as the original specification.
2.
Evaluate supplier qualifications when specific supplier is designated by the requestor.
3.
Obtain QA approval of alternate supplier when requestor desig-nated supplier is not QA approved.
4.
Provide the supplier with complete specifications and quality requi rements.
5.
Represent the supplier when nonconforming materials are re-viewed by MRB.
6.
Return rejected materials and negotiate replacement or com-pensation.
7.
Maintain records of purchases.
8.
Establish and maintain records of supplier performance.
9.
Request QA services for clarification of quality requirements.
K.
VNC Warehousing and Distribution Warehousing and Distribution is responsible for on-site and off-site movement, shipping and receiving materials. These activities are performed in accordance with written procedures issued and main-tained by the Nuclear Energy Traffic Operation (NETO).
Special handling instructions are specified in the implementing instructions.
issued by the organization requesting the service. Specific responsi-bilities are:
1.
Make arrangements with outside carriers to transport products in a manner intended to meet customer schedule requirements.
2.
Verify shipping documents and package labeling before the ship-ment leaves the site.
3.
Provide follow-up on each shipment to destination as necessary.
4.
Interface with transport carriers regarding shipping problems and schedules.
5.
Maintain appropriate shipping records.
l
-9
l 0
1.3 LINE ORGANIZATION FUNCTIONS (continued)
K.
(continued) 6.
Maintain awareness of applicable codes, policies and regula-tions for transporting radioactive materials, and provide the necessary measures to assure modes of transport are in com-pliance with those requirements.
7.
Match quantities ordered and received with procurement documents.
8.
Inspect materials for obvious shipping damage.
9.
When discrepancies arise in (7) or (8) above, notify the requestor as instructed by NETO procedures.
10.
Forward material to requestor or other specified functions.
- 11. Maintain appropriate receiving records.
1.4 QUALITY ASSURANCE PERSONNEL QUALIFICATIONS Following are the minimum qualifications for principal QA/QC personnel:
Manager, Quality Assurance.
B.S. degree or equivalent qualdications plus five years experience in managerial or project type assignments involving a combination of such fields as engineering, manufacturing, and quality assurance.
Inspection Supervisor.
B.S. degree plus three years experience in quality control or five years experience in quality control.
2.
QUALITY ASSURANCE PROGRAM An overall QA program is established, documented and implemented which en-compasses those activities which are necessary to meet quality objectives.
This program is applicable to GE-VNC licensed containers used for shipping materials in excess of Type A quantities or fissile materials in excess of fifteen (15) grams.
The program applies to activities affecting the components of the identified packaging to an extent consistent with their importance to safety. Those activities include designing, purchasing, fabricating, handling, shipping, storing, cleaning, assembling, inspecting, testing, operating, maintaining.
repairing and modifying.
QA policy and system documentation is structured from the GE Corporate Product Quality Policy down through each organizational level of the NEBG.
Figure 2-1 identifies the key policies, procedures and instructions which are estab-l.
lished to meet this objective.
l,
2.
QUALITY ASSURANCE PROGRAM (continued)
GE Corporate Product Quality Policy (No. 20.9) states quality considerations and requirements applicable to all GE business components. The policy spec-ifically requires that e6ch product-determining component issue, maintain and operate in accordance with a product quality policy.
NEBG Product Quality Policy (No. 70-1) interprets the Corporate Product Quality Policy and provides implementing direction to the NEBG organizations.
It is the policy of the NEBG to achieve and maintain a reputation in the nuclear energy business for timely and effective compliance with all appli-cable quality requirements.
NEBG Standard Quality System Requirements (No. 70-11) supplements NEBG Policy No. 70-1 and establishes the minimum quality system requirements to be implemented by NEBG organizations.
NS&QA Product Quality Guide (No.104) establishes quality policy for IPO.
It provides for development of a quality system to meet applicable require-ments of GE Corporate Policy, NEBG Policy, customers, and regulatory agencies.
QA Procedures, quality plans, performing component plans and procedures are documents which implement the IPO policy on quality.
Distribution of QA policies and procedures is accomplished in accordance with formal document control systems. This provide? for comunicating to responsible organizations and individuals the mandatory requirements of quality policies, manuals, and procedures. Table 2-1 is a cross-index showing the relationship of the key quality related document system, manuals, plans or procedures with each of the criteria of 10CFR71, Appendix E.
Should any portion of the QA program be delegated to others, the agreement is documented to provide assurance that the applicable portions of 10CFR71, Appendix E, 4111 be implemented.
In the event differences of opinion involving quality arise between QA/QC personnel and other personnel the issue (s) is brought to the attention of appropriate levels of management for resolution.
Training and experience qualifications are defined for each position in GE.
In addition, the program provides for indoctrination and training of personnel performing activities affecting quality in order to provide assurance that appropriate proficiency is achieved and maintained. This indoctrination and training is carried out through various documented proccdures, personnel con-tacts and meetings. The purpose of the training is to assure that personnel responsible for quality-related activities are instructed as to the purpose, scope, and implementation of the quality-related manuals, instructions, and procedures.
Personnel performing quality-related acti ities are trained and qualified in the principles and techniques of the ac".vity being performed.
GENERAL ELECTRIC COMPANY GE ORGANIZATION
& POLICY GUIDE 20-9
" PRODUCT QUALI'IY" NUCLEAR ENERGY BUSINESS GROUP e
NEBG ORGANIZATION &
NEBG ORGANIZATION &
POLICY GUIDE 70-1 POLICY GUIDE 70-11
" PRODUCT QUALITY"
" STANDARD QUALITY SYSTEMS" '
IRRADIATICN PRCCESSING OPERATICN NS&QA ADMINISTRATIVE PROCEDURE 104 QA PROCEDURES "PRCDUCT QUALITY GUIDE" PRCDUCT QUALITY PLANS PERFORMING CCMPCNENT PLANS & PROCEDURES FIGURE 2-1.
QUALITY ASSURANCE COMPUANCE TREE POLICIES, PRCCIDURES, AND INSTRUCTICNS j
THAT GOVERN QUALITY FILATED ACTIVITIES 12
TABLE 2-1 CROSS-INDEX TABLE SHOWING 0F QUALITY RELATED DOCUMENTS TO EACH CRITERION OF 10CFR71, APPENDIX E 1.
ORGANIZATION NEBG-0PG SECTION 150, ORGANIZATION SECTION 160, FUNCTIONAL DIRECTIVES QA PROGRAM SECTION 1, ORGANIZATION 2.
QUALITY ASSURANCE PROGRAM QA PROCEDURE N0. 2.1, PRODUCT QUALITY PLAN QA PROGRAM ALL SECTIONS 3.
DESIGN CONTROL QA PROCEDURE NO. 2.5, PROJECT DESIGN REVIEWS QA PROGRAM SECTION 3, DESIGN CONTROL 4.
PROCUREMENT DOCUMENT CONTROL QA PROCEDURE NO. 8.1, QUALITY CONTROL OF PURCHASED MATERIAL QA PROGRAM SECTION 4, PROCUREMENT DOCUMENT CONTROL 5.
INSTRUCTIONS, PROCEDURES AND DRAWINGS NS&QA ADMINISTRATIVE N0. 150, DOCUMENT CONTROL QA PROCEDURE N0. 1.1, QA PROCEDURES-GENERAL PERFORMING COMPONENTS SOP's QA PROGRAM SECTION 5; INSTRUCTIONS, PROCEDURES AND DRAWINGS 6.
DOCUMENT CONTROL NS&QA ADMINISTRATIVE N0. 150, DOCUMENT CONTROL QA PROCEDURE NO. 5.5, ENGINEERING CHANGE NOTICE PERFORMING COMPONENTS SOP's QA PROGRAM SECTION 6, DOCUMENT CONTROL 7.
CONTROL OF PURCHASED MATERIAL, EQUIPMENT AND SERVICES QA PROCEDURE NO. 8.1, QUALITY CONTROL OF PURCHASED MATERIAL QA PROCEDURE N0. 8.2, VENDOR QUALITY CAPABILITY SURVEY 8.
IDENTIFICATION AND CONTROL OF MATERIALS, PARr', rTfD CBMPONENTS QA INSTRUCTION N0. 1055, INFrrdi'Gs iEPORTING QA INSTRUCTION N0. 1056, REJEi???
- SPECTION PERFORMING COMP 0NENTS SOP's QA PROGRAM SECTION 8, IDENTIFICATION AND CONTROL 0F MATERIALS, PARTS AND COMP @ ENTS TABLE 2-1 (continued) 9.
CONTROL OF SPECIAL PROCESSES PERFORMING COMPONENTS SOP's QA PROGRAM SECTION 9, CONTROL OF SPECIAL PROCESSES 10.
INSPECTION QA INSTRUCTION MANUAL INSTRUCTIONS FOR QC INSPECTION QA PROGRAM SECTION 10, INSPECTION
- 11. TEST CONTROL QA PROGRAM SECTION ll, TEST CONTROL 12.
CONTROL OF MEASURING AND TEST EQUIPMENT QA INSTRUCTION NO. 2015, GAGE & INSTRUMENT CONTROL QA PROGRAM SECTION 12, CONTROL OF MEASURING &
TEST EQUIPMENT 13.
HANDLING, STORAGE AND SHIPPING PERFORMING COMPONENT SOP's QA PROGRAM SECTION 13; HANDLING, STORAGE AND SHIPPING 14.
INSPECTION, TEST AND OPERATING STATUS QA INSTRUCTION MANUAL INSTRUCTIONS FOR QC INSPECTION PERFORMING COMPONENT SOP's QA PROGRAM SECTION 14; INSPECTION, TEST & OPER-ATING STATUS
CORRECTIVE ACTION NS&QA ADMINISTRATIVE N0. 155, CORRECTIVE ACTION SYSTEM 17.
QUALITY ASSURANCE RECORDS QA PROGRAM SECTION 17, QA RECORDS
DESIGN CONTROL 3.1 GENERAL Design control applies to the following items: Criticality physics, radiation shielding, stress, thermal, hydraulic, and accident analyses; compatibility of materials; accessibility for inservice inspection, maintenance and repair; features to facilitate decontaaination, and delineation of acceptance criteria for inspections and tests. Quality standards are specified in the design documents, and deviations and changes from these quality standards are controlled.
Regulatory require-ments which provide the bases for design methods, material evaluation and process control are identified in the design specifications.
Measures are established for the selection of suitable materials, parts, equipment and processes for safety-related structures, systems, and components which include the use of valid industry standards and specifications. Materials, parts, and equipment which are standard, commercial (off the shelf) or which have been previously approved for a different application are reviewed for suitability prior to selection.
Errors and deficiencies in the design, including the design process, that could adversely affect safety related structures, systems, and components are documented; and, corrective action is taken to preclude repetition.
3.2 DESIGN VERIFICATION Verification or checking of design adequacy is performed using one or more of the following: design review, the use of alternate or simplified calculational methods, or the performance of a suitable qualification test.
Design reviews normally include representatives from engineering and Quality Assurance.
Individuals or groups responsible for design verifi-cation are other than the original designer and the designer's immediate supervisor, but who may be from the same organization.
When a test program is used to verify the adequacy of a design, a qualification test under adverse design conditions is used. A proto-type unit is used or actual components may be tested if the test does not cause degradation.
3.3 DESIGN CHANGE CONTROL Design and specification changes are subject to design control measures commensurate with those applied to the original design.
4.
PROCUREMENT DOCUMENT CONTROL Material and services purchased from outside suppliers are requested on a Material Request (MR) form.
Review and approval of procurement documents for safety related material and services is performed by QA prior to release i
and is available for verification.
l Review of procurement documents for safety related material and services de-termines that qual f requirements are correctly stated, inspectable, and controllable; there are adequate acceptance and rejection criteria; and the procurement document has been prepared, reviewed, and approved in accordance with QA program requirements.
Procurement documents for spare or replacement parts of safety-related structures, systems, and components are subject to controls commensurate with those used for the original equipment.
The following information is included in procurement documents as deemed appropriate by QA or the responsible engineer:
e Identification of the applicable QA requirements which must be com-plied with and described in the supplier's QA program. As necessary, the supplier's QA program or a portion thereof is reviewed and concurred with by qualified personnel in QA prior to initiation of activities affected by the program.
Design basis technical requirements including the applicable regu-e latory requirements, material and component identification require-ments, drawings, specifications, codes and industrial standards, test and inspection requirements, and special process instructions, Identif1 cation of the documentation (e.g., drawings, specifications, e
procedures, inspection and fabrication plans, inspection test records, personnel and procedure qualifications, and chemical and physical test results of material) to be prepared, maintained, and submitted to GE for review and approval.
Identification of those records to be retained, controlled, and e
maintained by the supplier, and those delivered to GE prior to use or installation of the hardware.
e Provisions for access to the supplier's facilities and records for source inspection and audit.
l
5.
INSTRUCTIONS, PROCEDURES, AND DRAWINGS The design, fabrication, assembly, testing, use and maintenance of applicable shipping containers for radioactive material is performed in accordance with approved instructions, procedures or specifications.
These instructions, procedures, or specifications include the appropriate quantitative or quali-tative acceptance criteria as a basis to evaluate the satisfactory performance of specified activities.
Provisions are established which clearly delineate the sequence of actions to be accomplished in the preparation, review, approval, and control of instruc-tions, procedures, and drawings. Activities affecting quality, including methods of complying with 10CFR71, Appendix E, are specified in instructions, procedures, and drawings.
6.
DOCUMENT CONTROL Each of the organizations listed in Section 1 generates documents in the course of perfonning their assigned tasks.
Procedures are established de-scribing the document control system in each organization. These measures provide assurance that documents, including changes, are reviewed and approved prior to implementation and are distributed for use at the location where the prescribed activity is performed.
Changes to documents are reviewed and approved by the same organizations that approved the original documen+ ualess other organizations are specifically designated by appropriate n.:n gement.
QA concurrence is obtained for inspection plans; test calibration, and special process procedures; drawings, and specifications; and changes thereto. This is accomplished by such QA actions as participation in design i
reviews; issuance of QA procedures and instructions; and review of operating i
component procedures, fabrication plans, or procurement documents.
Through established distribution and communication systems, those participating.
in an activity are apprised of current applicable instructions for performing the activity.
These measures are established to assure use of the proper docu-ments and to preclude use of superseded documents.
Table 2-1 and Table 6-1 identify the types of quality related documents con-trolled under this program.
l l
TABLE 6-1 KEY QA PROGRAM DOCUMENTATION APPROVAL AND ISSUANCE AUTHORITY
- NEBG Division Dept.
Oper./Manuf.
Document Type Group Level Level Engr.
QA Component Document Type Executive Managers Managers Managers Managers Managers NEBG Policy & Instructions X
Division Level Policies &
X Procedures Department Level Procedures X
QA Program X
QA Procedures & Instructions X
Design Criteria X
Desig1 Documentation X
5 Manufacturing / Operating Procedures X
Inspection.& Honconformance Reports X
- Approval And Issuance Authority May Be Delegated By The Respective Managers.
7.
CONTROL OF PURCHASED MATERIAL, EQUIPMENT, AND SERVICES Procedures and practices are established to provide assurance that purchased items and services conform to procurement documents. Qualified personnel evaluate the supplier's capability to provide acceptable quality services and products before the award of the purchase order or contract. As approp-riate, QA, engineering, and/or manufacturing personnel will participate in the evaluation of those suppliers providing safety-related components. The evaluations are documented and filed.
Evaluation of suppliers is based on one or more of the following:
e The supplier's capability to comply with the elements of 10 CFR Part 71, Appendix E that are applicable to the type of material, equipment, or service being procured.
e A review of previous records and performance of suppliers who have provided similar articles of the type being procured.
e A survey of the supplier's facilities and QA program to determine his capability to supply a product which meets the design, manu-facturing, and quality requirements.
Source inspection or surveillance is performed as necessary during fabri-cation, inspection, testing, and shipment of materials, equipment, and com-ponents to assure conformance to the purchase order requirements. These are performed in accordance with written procedures or instructions which specify the characteristics or processes to be witnessed, inspected or verified, and accepted; the method of audit or surveillance and the extent of documentation required; and those responsible for implementation.
Source inspection or surveillance is perfonned on those items where verification of specific procurement requirements is necessary but which cannot be determined upon receipt.
As a minimum, supplier furnished documentation includes:
e Identification of the purchased material or equipment and the specific procurement requirements which have been met.
e Identification of procurement requirements which have not been met together with a description of those nonconformances dispositioned
" accept as is" or " repair".
Receiving inspection is the responsibility of QA personnel and provides assurance that:
e Supplier furnished documents meet specified requirements.
e Material, component, or equipment is properly identified and corresponds with the identification on receiving documentation.
7.
CONTROL OF PURCHASED MATERIAL, EQUIPMENT, AND SERVICES (continued) e Inspection records or certificates of confonnance attesting to the acceptance of material, components, and equipment are available at Vallecitos prior to installation or use.
e Items accepted and released are identified as to their inspection status prior to fomarding them to a controlled storage area or
)
releasing them for installation, use, or further work.
i Periodically, supplier's certificates of conformance are evaluated by audits, independent inspections, or tests to assure they are valid. The effectiveness of the control of quality by suppliers is assessed by GE at intervals consistent with the importance, complexity, and quantity of the item.
8.
IDENTIFICATION AND CONTROL OF MATERIALS, PARTS,'AND COMPONENTS Procedures and systems are established for the identification, inventory and traceability of raw materials, in-process materials, and finished components.
Identification of materials and parts important to the function of safety-related structures, systems, and components are traceable to the appropriate documentation such as drawings, specifications, purchase orders, manufacturing and inspection documents, deviation reports, and physical and chemical mill test reports.
Measures are taken to assure that the location and method of identification do not affect the fit, function or quality of the item being identified.
Correct identification of material, parts, and components is verified and documented prior to release for fabrication, assembling, shipping and installation.
9.
CONTROL 0F SPECIAL PROCESSES W.? required by engineering specifications or planning documents, fabri-cation processes are accomplished under controlled conditions in accordance with applicable codes, standards, specifications, or other engineering criteria using appropriately qualified personnel and procedures. Special processes as a minimum include welding, heat treating, and nondestructive testing.
e Procedure Qual #ication Qualification of a,'roduction process is achieved by performing the process under control'ad conditions on samples and then analyzing the output to determine 'cceptability. When the process can be dupli-l cated on a repetitive basu by holding essential variables constant, the process is considered qualified.
Qualifications are performed 9.
CONTROL OF SPECIAL PROCESSES (continued) e Procedure Qualification (continued)
~
to written instructions (or an appropriately issued standard operating procedure) based upon engineering specifications and include essential variables.
Process procedures derived from qualification specifications may then be issued for routine production use. Approp-riately issued standard operating procedures are considered to be qualified.
e Personnel Qualification The management of each organization ensures personnel capabilities at all levels in each specific organization are adequate to perform assigned duties. Where personnel evaluation is delegated, the manage-ment ensures adequate instructions are properly conveyed to assure qualification review is commensurate with assigned responsibilities.
Where personnel qualification includes quality-related activities and specialties, each organization maintains current, auditable records of such qualifications.
10.
INSPECTION Inspection is performed for each work operation where it is necessary to assure quality and is executed in accordance with QA approved plans, pro-cedures, or instructions.
Inspection personnel are independent from the individuals perfonning the activity being inspected. They are qualified in accordance with applicable codes, standards, or company training programs; and their qualifications and certifications are kept current.
The QA approved plans, procedures, or instructions provide for the following, where applicable:
e Identification of characteristics or activities to be inspected.
Identification of the individuals or groups respor.sible for performing e
the inspection operation.
e The method of inspection.
Recording evidence of completing or verify.ng a manufacturing, e
inspection, or test operation.
Recording inspector or data recorder and the results of the Inspection e
operation, e Mandatory hold points beyond which work cannot proceed without
~
appropriate inspector action.
10.
INSPECTION (continued) l Modifications, repairs, and replacements are inspected in accordance with the original design and inspection requirements or acceptable alternatives.
Where it is not possible to perform direct inspection, provisions are j
established for indirect control by monitoring processing methods, equip-ment, and personnel.
1
- 11. TEST CONTROL Written test programs are established to assure all testing requ' ired is performed to demonstrate that the packaging components perform satisfac-torily. As required, modifications, repairs, and replacements are tested in accordance with the original design and testing requirements or accept-able alternatives.
l Test procedures incorporate or reference, as appropriate:
e The requirements and acceptance limits contained in applicable design and procurement documents.
s The requirements of 10CFR71 e Acceptance limits contained in the package approval, o Instructions for performing the test.
e Test prerequisites such as:
Calibrated instrumentation
- Adequate and appropriate equipment
- Trained, qualified, and licensed or certified personnel Completeness of item to be tested Provisions for data collection and storage e Mandatory inspection hold points for witness by owner, contractor, or inspector.
e Acceptance and rejection criteria.
e Methods of documenting or recording test data and results.
Test results are evaluated by engineering to determine acceptability.
i l
l.
12.
CONTROL OF MEASURING AND TEST EQUIPMENT Each component or subcontractor responsible for measuring quality para-meters is responsible for the inventory, identification, and calibration of all gages and instruments used for such inspections.
Procedures describe the calibration technique and frequency, maintenance, and control of the measuring and test equipment (instruments, tools, gages, fixtures, reference and transfer standards, and nondestructive test equip-ment) which is used in the measurement, inspection, and monitoring of safety-related components, systems, and structures.
Calibration and maintenance of measuring and test equipment are performed at specified intervals based on the required accuracy, purpose, degree of usage, stability characteristics, and other conditions affecting the measure-ment. Measuring and test equipment is labeled, tagged, or otherwise iden-tified to provide traceability to the calibration test data and to indicate the next calibration date.
Calibration measures are not employed for rulers, tape measures, and other such devices where-their use is limited to rough measuring functions.
Calibrat'ons are traceable to nationally recognized standards.
If no national standards exist, the basis for calibration is documented.
Cali-brating standards have an uncertainty (error) requirement of no more than 25% of the tolerance of the equipment being calibrated. A greater uncer-tainty may be acceptable when limited by the " state-of-the-art".
When inspection, measuring, and test equipment is found to be significantly out of calibration (as determined by the responsible engineer from the area where the suspect equipment was last used) measures are taken and documented to detennine the validity of measurements previously taken with the equipment.
The status of all items under the calibration system is recorded and main-tained.
- 13. HANDLING, STORAGE AND SHIPPING Procedures are prepared which control the cleaning, handling, storage, packaging, shipping, and preservation of materials, components and systems in accordance with design and specification requirements to preclude damage, loss, or deterioration by environmental conditions such as temperature or humidity.
Established radiation safety requirements for handling, storage and shipping of packages containino radioactive material are followed.
These packages are not released for shipment until all tests, certifications, final inspec-tions and acceptance have been completed.
14.
INSPECTION, TEST AND OPERATING STATUS The inspection, test, and operating status are indicated by the use of markings such as stamps, tags, labels, routing cards, or other suitable means. Uritten instructions define which method is to be used.
Bypassing of required inspections, tests, and other critical operations is procedurally controlled under the cognizcnce of the QA organization.
Measures are also established to indicate the operating status of ccmponents such as tagging valves and switches to prevent inadvertent operation.
- 15. NONCONFORMING MATERIALS, PARTS, OR COMPONENTS Procedures are established to provide for the identification, documentation, segregation, review, disposition, and notification to affected organizations of nonconfonning materials, parts, components, or services. A Deviation Report is issued for nonconfonning items which requires convening of a Material Review Board. This provides the documentation which identifies the nonconforming itam; describes the nonconformance, the disposition, and the inspection requirements; and includes signature approval of the disposition.
Nonconforming items are segregated from acceptable items and are identified as discrepant until properly dispositioned. Rework or repair of materials, parts, components, systems, and structures is verified by reinspecting and retesting the item as originally inspected and tested or by a method which is at least equal to the original inspection and testing method.
Inspection, testing, rework, and repair proeddures are documented.
For procured items, nonconformances dispositioned "use as is" or " repair" are made part of the inspection records and evaluated by GE prior to use of the item (s).
Deviation Reports are periodically analyzed to show quality trends, and the results are reported to management for review and assessment.
l l
- 16. CORRECTIVE ACTION Procedures are established for the evaluation of conditions adverse to quality (such as nonconformances, failures, malfunctions, deficiencies, deviations, and defective material and equipment) to determine the need l
for corrective action. Necessary corrective actions are identified, docu-i mented, and implemented in a manner appropriate to the cause and importance I
of the deficient condition.
Documentation may be by formal letters, audit reports, or special forms such as the Customer Complaint form or Corrective Action Request form. The cause and corrective action for adverse quality l
conditions is reported to appropriate management and, when warranted, to customers or regulatory agencies.
- j
l e.
16.
CORRECTIVE ACTION (continued)
Followup reviews are conducted to verify proper implementation of corrective actions and to close out the corrective action documentation.
- 17. QUALITY ASSURANCE RECORDS Procedures are established to provide assurance that sufficient records are maintained to furnish documentary evidence that the quality of items is satisfactory. The requirements and responsibilities for record transmittals, retention (such as duration, location, fire protection, and assigned responsi-bilities), and maintenance subsequent to completion of work are consistent with applicable codes and regulations.
The records include qualification of personnel, procedures, and equipment; and other documentation such as drawings, specifications, procurement docu-ments, calibration procedures and reports; nonconformance reports; and corrective action reports.
Facilities are provided to prevent destruction of the records by fire, flooding, theft, and deterioration by environmental conditions such as temperature or humidity.
- 18. AUDITS A system is provided for the performance of audits in accordance with pre-established written procedures or check lists and conducted by trained per-sonnel not having direct responsibilities in the areas being audited.
Audits are conducted on a scheduled or random unscheduled basis, as approp-riate. Audit results are documented and transmitted to responsible manage-ment in the area audited so that necessary action to correct deficiencies can be taken.
Deficient areas are reaudited on a timely basis to verify imple-mentation of committed corrective actions.
Audits are perfomed by QA to determine the following, as appropriate:
o The adequacy of quality related practices, procedures and instructions.
o Compliance with the quality related practices, procedures and :'nstruc-tions.
o The adequacy of work areas, activities, processes, items, and the review of documents and records.
Audits are also performed by GE and its contractors to verify and evaluate l
suppliers' QA programs, procedures and activities. ;
l
- 18. AUDITS (continued)
Audit data are periodically analyzed and the reports, which indicate quality trends and the effectiveness of the QA program, are reviewed and assessed by appropriate management.
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