ML20043E341
| ML20043E341 | |
| Person / Time | |
|---|---|
| Site: | 07100192 |
| Issue date: | 06/05/1990 |
| From: | David Jones, Rich Smith PACIFIC NUCLEAR SYSTEMS, INC. |
| To: | |
| Shared Package | |
| ML20043E337 | List: |
| References | |
| QA-78-1, NUDOCS 9006120324 | |
| Download: ML20043E341 (19) | |
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a 10 CFR 71 QUALITY ASSURANCE PROGRAM FOR I
RADIOACTIVE MATERIAL SHIPPING PACKAGES LETTER NUMBER QA-78-1 REVISION 5 DATE:
JUNE 5, 1990 PACIFIC-NUCLEAR-SYSTEMS, INC.
1010 SOUTH 336TH STREET FEDERAL WAY, WA 98003 APPROVALS (Previous Revision Approvals on File at PNSI)
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Revision 5 b~S'90 DaYid F'. Jon Date Chairman an hief Executive G 5.So s
R. Howard Smith
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Director, Corporate Quality Assurance
.'9006120324 900603 PDR ADOCK 07100?92 C
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June 5, 1990 Lctter O.A-78-1, Rev. 5 INTRODUCTION Pacific Nuclear Systems, Inc. (PNSI) has developed a quality system to assure traceability and control the quality of all materials and processes utilized in the production of radioactive shielding,
- cask, containers and other equipment pertaining to shipping packaging for radioactive material.
The Quality Manual delineates requirements and procedures 'necessary to exercise control over design, documentation, procurement, material, fabrication, inspection, operational testing, equipment operation and use, maintenance, repair, modification, inventory, shipment and quality data retention.
The PNSI Quality System and implementing Quality Procedures are designed and administered to meet the 18 criteria of 10 CFR 71, Subpart H. is a matrix delineating the relationship between the PNSI Quality Procedures and the 18 10CFR71, Subpart H criteria.
-The Quality System is implemented throughout the company and its operating divisions.
The divisions include:
Pacific Nuclear Systems, Inc., Nuclear. Packaging, Inc., NuPac Services, Inc., PN Services, Inc., ALARON, Iric., NUTECH Engineers, Inc., and Pacific Nuclear Fuel Services, Inc.
As used in this document, PNSI includes all the listed divisions.
DESCRIPTION OF THE PNSI 10CFR]1, 8'UBPART H OUALITY PROGRAM Criterion 1, Oraanisation Full responsibility for the Quality Assurance (QA)
Program
-adherence to 10CFR71, Subpart H criteria rests with PNSI. - Quality
- Program activities include calibration of measuring equipment, NDE and materials testing.
PNSI surveys and qualifies all-organizations performing these services to assure adherence to the 18 criteria prior to their use.
All other quality activities are performed by PNSI quality personnel.
However, the responsibility of the control of quality in the other organizations continues to rest with PNSI.
- PNSI's Chairman and Chief Executive has full authority over all functions of the
- company, and delegates authority-and responsibility for selected functions to other personnel within the company.
- The administrative function includes financial,
- legal, and marketing activities.
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June 5, 1990 Letter QA-78-1, Rev. 5 Procurement department personnel perform purchasing activities and maintain supplier performance records.
The Engineering Department is responsible for research and development of shipping container technology, design of casks for licensing and fabrication and design documentation.
a The PNSI Quality Department has sufficient authority and organizational freedom to identify quality problems, implement corrective action and verify corrective action effectiveness.
Additionally, the Quality Department is independent from other organizations within PNSI and reports directly to the Chairman and Chief Executive of PNSI.
The Quality Department is headed by the Director, Corporate Quality Assurance who is responsible for the p
development, implementation and administration of the entire PNSI L
Quality Program.
He must have cufficient expertise in the field of Quality to enable him to direct the quality function in close adherence to the 18 criteria and the PNSI Quality Manual.
Responsibility for development of quality acceptance requirements, inspections and NDE activities rest with the Director, Corporate Quality Assurance.
It is his responsibility to delegate and evaluate the performance of all quality related tasks for PNSI through the authority of the Chairman and Chief Executive.
A Quality Assurance Manager who reports directly to the Director, Corporate Quality Assurance is assigned to each operating division.
m-The Quality Assurance Manager is responsit-le for implementing the Quality Assurance policies and practices as delineated in the approved PNSI Quality Assurance Manual within his division.
It is delineated in writing through the Chairman and Chief Executive that designated QA personnel have the authority to prevent the continued processing, fabrication, installation or delivery of unsatisfactory work.
g This authority also extends to the quality monitoring of special processes using PNSI equipment, personnel and procedures such as waste processing, in-service inspections, etc.
r Production responsibilities include scheduling of in-service inspection and administration of all fabrication activities, both within PNSI and at qualified suppliers.
The shipping and receiving function is also included within the responsibility.
Production activities may occur within either the Operations or the Engineering Departments.
On-site activities such as waste processing, in-service inspections, etc.
are administered as a joint effort of the operations and engineering personnel.
Quality supports these 7
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June 5, 1990 Letter QA-78-1, Rev. 5 activities with written procedures that provide methods, process controls and check points. Inspection personnel perform monitoring activities and verifications of regulatory, contractual and technical requirements during these operations.
The Director, Corporate Quality Assurance and all other quality personnel and/or organizations within, or utilized by PNSI, are fully qualified for their quality responsibilities.
Qualification records are maintained in the PNSI Quality Record File.
Typical organizational charts are shown at the end of this synopsis as Figures 1, 2 and 3.
Criterion 2, Ouality Assurance Program PNSI has established and implemented a QA Program for the control of quality in the design, fabrication, operation and maintenance of shipping containers for nuclear products.
Training and/or evaluation of personnel qualifications are required for all QA functions in accordance with written procedures.
The QA Program assures that all quality requirements, engineering specifications and specific provisions of any package design approval are met.
Those characteristics critical to safety are emphasized.
The
- Director, Corporate Quality Assurance of PNSI regularly evaluates the PNSI QA Program for adherence to - the 18 point criteria in scope, implementation and effectiveness.
Further, the PNSI Chairman and Chief Executive requires that the Quality System, including the QA Manual Policies and Procedures, be implemented and enforced on all' applicable programs at PNSI.
A Material Review Board, consisting of Engineering, Production (for PNSI fabricated items), and Quality Personnel has been established -
to disposition discrepancies or disagreements pertaining to the acceptability of material, hardware or safety related operations.
The MRB is convened when determined necessary by the division QA Manager.
Their dispositions are final and binding.
Criterion 3, Desian Control PNSI Quality Procedures (QP's) have been developed, approved and implemented to control design activities in such a manner to assure that the following occur:
(a)
Design activity is planned, controlled and documented.
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f June 5,'1990 Letter QA-78-1, Rev. 5 (b)1 Regulatory and design requirements ato correctly translated into specification, drawings and procedures.
-(c)
Design documents contain quality requirements.
(d)
Deviations from quality requirements are. controlled.
(e)
Design verification is performed by campetent engineering-personnel independent of the design activity.
- These, verifications may include tolerance'studieu, alternate calculations or tests. Qualification tests are conducted in acco'rdance with approved test programs and procedures..
(f)
Interface control is established and adequate.
(g)
Design and specification changes are reviewed and approved by the same organization (s) as the original issue.
(h)
Design errors and deficiencies are documented and corrective action to prevent recurrence is taken.
(i)
Design organization (s) and their responsibilities and authorities are delineated and controlled via written procedures.
Criterion 4.
Procurement Document Control The PNSI QA Program assures that all purchased
- material, components,- equipment and services adhere to the applicable.
requirements.
Supplier evaluation and selection, objective evidence of supplier
- quality, acclignment of quality requirements to procurement documents, including related design - documents, and source,'in-process and receiving inspection are all
.dministered and controlled in accordance with approved PNSI Quality Procedures.
All procurement activity is performed in accordance with written procedures' delineating requirements for preparation,
- review, approval and control of procurement documentation.
Emphasis is placed on assuring that revisions to procurement documentation are reviewed and approved by the same cognizant groups as the original.
Quality Assurance clause sheets are included with all requests for quote and purchase orders.
Quality Assurance personnel assign clauses from the sheets to the procurement document referencing 10CFR Part 71, Subpart H requirements appropriate to the contract.
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June 5, 1990 Letter QA-78-1, Rev. 5 In addition, material information including grade, type, size and special physical and chemical data requirements is included on the' procurement documents, other documentation and information such:
as drawings, procedures, inspection and test requirements, hold points, welding and other process qualification requirements are delineated on the procurement documents by the Quality Assurance personnel as appropriate to the contract.
PNSI Quality Assurance personnel assure that requirements for acceptance of hardware and documentation appropriate to the contract are included in procurement documentation.
PNSI Quality Assurance personnel maintain the-right of access to all supplier facilities and documentation for source inspection and/or audit activities.
A statement to this effect is included on procurement documentation when it is appropriete to the contract.
Criterion 5, Instructions, Procedures and Drawinas l
Quality planning is developed for activities requiring quality participation in accordance with PNSI QA procedures by qualified Quality Engineers and are approved by the Quality Assurance Manager.
All design documents (i.e.,
- drawings, specifications, special processes, etc.) affecting quality are reviewed by the Quality Department and referenced in quality planning as necessary to L
assure adherence to package design approvals and the applicable criteria of 10CFR71, Subpart H.
All instructions, procedures and drawings are developed, reviewed, approved,-
utilized and controlled in accordance with -the r
requirements of written quality assurance procedures.
criterion 6.
Document control Policy and procedure for review, approval, release and change control of all controlled, quality related documents are delineated in approved PNSI QA Procedures.
Provisions are provided in the QA Procedures for identification of individuals / organizations o
L responsible for
- review, approval and issuance of documents.
Document control responsibilities, facilities and distribution requirements are also addressed.
Controlled documents include, but are not limited to:
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June 5, 1990 Letter QA-78-1, Rev. 5 (a)
Design specifications (b)
Design manufacturing drawings (c)
Special process specification and procedures (d)
QA Procedures and manuals (f)
Quality planning-for receiving, in-process, source and in-service inspections (g)
Source surveillance and evaluation reports (h)
Test procedures
_(1)
Audit _ reports (j)
Operational test procedures and data When revised documents appear in other documents as references, supplements or exhibits, appropriate revisions are made to those documents concurrent with the release of the basic approved change.
Documentation listings are maintained delineating the title, number and current revision for all
- drawings,
_ procedures and specifications under the scope of our 10CFR71 QA Program.
Quality personnel assure that all required support documentation is available at the work area prior to initiation of the work
-effort.
Criterion 7. Control of Purchased Materials. Parts and Connonents Procurement documents are reviewed for acceptability of suggested suppliers based on the quality requirements of the item and the PNSI approved suppliers lists.
In addition, and as required, supplier surveys are conducted by qualified PNSI personnel to further assure supplier acceptability.
These evaluations are based on one oor all of the following criteria:
(1)
The supplier's capability to comply with the requirements of 10CFR Dart 71, Subpart H, that are applicable to the contract.
(2)
A review of previous records and performance of the supplier.
(3)
A survey of the supplier's facilities and QA program to determine his capability to supply a product which meets the design, manufacturing and quality requirements.
Results of all supplier evaluations are recorded on Supplier Evaluation forms and a_o <etained in the Quality Data File.
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June 5, 1990 IAtter QA-78-1, Rev. 5 i
Requirements are imposed on the supplier by procurement documents
]
to identify any material, item or service supplied which does not-l adhere to specified procurement requirements including the l
requirements not adhered to, as well as a requirement to provide technical justification for nonconforming items or services dispositioned by the supplier as " accept-as-is" or " repair".
Quality planning is prepared and approved by the Quality Department for performance of all source, test, shipping and/or receiving inspections in accordance with approved design requirements, applicable 10CFR71 criteria procurement document requirements and contract specifications.
Receiving inspection is performed to determine that the following, I.
as appropriate to the contract, are assured:
l (1)
The
- material, component or equipment is properly I
identified and corresponds with the identification on receiving documentation.
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(2)
Material, components, equipment and acceptance records are inspected and are acceptable in accordance with inspection instructions, prior to installation or use.
(3)
Inspection records and/or certificates of conformance attesting to the acceptance of material and components are available prior to installation or use.
(4)
Items accepted and released are identified as to their inspection status prior to forwarding them to a
controlled storage area or releasing them for further i.
work.
All described activities are delineated in approved PNSI QA procedures.
Criterion 8,
Identification and Control of Materials, Parts and Components Tte identification and control of materials, parts, components and coupleted end in-process assemblies is administered by the Quality Department in accordance with approved PNSI QA Procedures.
These l
l procedures address qual. ty status tags, maintenance of material identification and traceability, part identification and related documentation.
Some of the details of these procedures follow:
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~ June 5, 1990 Letter QA-78-1, Rev. 5 (1)
Material identification procedures included in inspection planning and-fabrication drawings require that-identification of. material, components and/or hardware be maintained at all stages of production on the item or in traceable records to prevent use of incorrect or defective items.
(2)
When; appropriate, due to contractual or safety related requirements, Quality Assurance personnel assure that identification is traceable to materials, components, specifications, procurement documents, manufacturing and inspection records, discrepancy reports and material test data.
(3)
Quality Assurance personnel assure, via drawings and inspection planning requirements, that identification locations do not affect the fit, interfacing capability, function,' performance or overall quality of the finished product. Identification, in accordance with drawings and inspection planning requirements, is verified prior to-releasing the item for further processing or delivery Criterion 9.
Control of Special Processes PNSI' approved QA Procedures delineate the policies and procedures established to control such special processes as:
welding, heat
- treating, lead
- pouring, non-destructive examination, waste processing, etc. in accordance with applicable codes, standards, specificatio..s, 10CFR71 criteria and other requirements.
Special processes developed by PNSI' suppliers and by PNSI are documented.
All procedures for special processes and the personnel required to
~ perform them are qualified under the cognir.ance of the Quality Department in-accordance with applicable
- codes, standards, specifications and. contract requirements.
All qualification records and support data are retained in PNSI quality files, and are maintained in a current status by Quality Assurance personnel.
These. documents are controlled as delineated in criterion 6 of this Quality System description.
Criterion 10. Inspection All receiving,
- source, in-process and in-service inspection activities are performed in accordance with approved PNSI QA 8
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June 5, 1990 Letter QA-78-1, Rev. 5 4
procedures.
All inspection personnel and/or-organization qualifications are reviewed and accepted by the Quality Assurance i
Manager prior to performance of the inspection activity.
The inspection activity is performed in strict accordance with approved quality planning prepared by qualified ' QA personnel (See also criterion 5 discussion).
Quality Inspection personnel. are independent from all other organizations within PNSI and report directly to the Division Quality Assurance Manager.
Inspection personnel qualifications are based on their capability to perform the required inspection functions in accordance with applicable codes, standards, professional society progrsms such as the American Society for Quality Control. and PNSI training programs.
Qualification reviews are performed periodically to maintain personnel proficiency and assure current qualification.
Mandatory hold points, inspection equipment requirements, accept-reject
- criteria, personnel requirements, characteristics to
- inspect, variable / attributes recording instructions, reference documentation and other requirements are included in the inspection planning.
The Quality Assuranco department assures that any replacements, modifications or repairs performed after final acceptance of material, components or hardware are inspected in accordance with the original inspection criteria.
Criterion 11, Test Control A test control program, as it applies to quality, is addressed in approved PNSI QA Procedures and assures, via required planning, that all required testing, such as proof and acceptance tests, are identified and performed in accordance with test procedures, design requirements and limitations.
Prerequisites, accept / reject l
- criteria, data recording criteria, instrumentation calibration, environmental conditions, documentation and evaluation requirements, etc. are delineated in the test procedures.
Changes to the test procedures are required to be reviewed / approved by the same organization (s) as the original issue.
Whenever equipment, components and/or assemblies require modification, repairs or replacement which could result in i;
requirements for re-test or additional testing, Quality Assurance
- personnel assure that original or new test inspection planning is prepared and adhered to as appropriate.
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June 5, 1990 Letter QA-78-1, Rev. 5 In any case, test results are documented, evaluated and accepted by qualified personnel as required by the test inspection plan prepared for the test under the cognizance of Quality Assurance personnel, criterion 12, control of Measurina and Test Ecuinment i
Administration of the calibration of measuring equipment and instrumentation is performed by the Quality Department in accordance with approved PNSI QA Procedures.
The calibration system assures that all standard measuring instrumentation (SMI) are used in the acceptance of material, equipment, and assemblies are calibrated and properly adjusted at specific intervals to maintain accuracy within pre-determined limits.
calibration is performed using equipment traceable to national standards when such standards exist.
When such standards do not exist, the basis of calibration is documented.
All calibrated equipment is identified and is traceable to the calibration test data.
Whenever SMI are found to be out of calibration, all items inspected during that period are submitted for review action for possible re-inspection or other appropriate corrective action.
priterion 13. Handlina, Storace and Shiccina PNSI approved QA Procedures require that handling, storage and shipping requirements adherence verification criteria be included in quality planning.
These requirements are designed to prevent damage or deterioration of material and equipment.
Information pertaining to shelf life, environment, packaging, temperature, cleaning, handling, preservation, etc., is included as required to meet design, NRC package approval and/or U.S.
Department of Transportation shipping requirements.
Shipping documentation preparation is also addressed in the planning, when applicable.
The requirements in quality planning pertaining to shipping must be met prior to release for shipment.
3 criturion 14. Inspection, Test and operatina Status The use of inspection status tags, quality inspection stamps and other means to indicate inspection and test status at, or for, PNSI are delineated in approved PNSI QA Procedures.
The clarity of the status indication, prevention of inspection and/or test step by-passing, and prohibition of removal or 10
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June 5, 1990 Letter QA-78-1, Rev.,5 modification of status indications, except with Quality Department approval / Material Review disposition is assured via these procedures.
The Quality Assurance Department assures via Quality Procedure, interoffice memoranda, training sessions and audit that all PNSI personnel are aware of and understand the meaning and uses of status tags on all hardware, material and test setups.
(see also Criterion 15 discussion).
Criterion 15, Mon-conformina Material, Parts or components PNSI approved QA Procedures require that material, components and equipment that do not conform to requirements are controlled to prevent their inadvertent use.
Identification, segregation, l
discrepancy reporting, disposition of non-conforming items by
[
authorized individuals and re-inspection activities are performed and controlled in strict accordance with these procedures.
I Quality Discrepancy Reports (QDR) are utilized by the PNSI Quality Department to identify discrepant items, describe the discrepancy, provide disposition and re-inspection requirements.
The signature of authorized cognizant personnel are placed on the QDR to signify l
approval of the disposition.
These personnel must be approved by the Division Quality Assurance Manager and must be from the same
^
groups approving the original design.
In conjunction with repair or re-work dispositions, quality assurance personnel provide supplemental inspection planning to' verify proper implementation of the QDR disposition.
This assures that the item is re-tested l
and/or re-inspected to a degree at least equal to the original acceptance activity.
1 Criterion 16, Corrective Action Significant and/or repetitive
- failures, malfunctions and deficiencies in material, components, equipment and services are identified and reported to the
- Director, Corporate Quality-Assurance using a Corrective Action Report (CAR).
The cause of the condition and corrective action necessary to prevent recurrence is identified, implemented and then followed up to verify corrective action effectiveness.
Detail requirements for this activity are delineated in approved PNSI QA Procedures.
Criterion 17, Ouality Assurance Records A quality records system is in effect at PNSI and is administered in accordance with approved PNSI QA procedures.
The purpose of the quality record system is to assure that documented evidence pertaining to quali ty _related activities is maintained and 11
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i June 5, 1990 Letter QA-78-1, Rev. 5
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'available for use by PNSI, its customers, and/or regulatory agencies as applicable.
Quality Records include, but are not l
lims ted to, inspection and test records, audit reports, quality l
personnel qualifications, design
- reviews, quality related procurement data, supplier evaluation reports, etc.
Records are identified by work _ order number, part number,' contract number, or drawing number oc appropriate to the record type.
A complete list of all quality records is maintained and provides cross reference between the different identity methods described above and identifies the record location.
y Design related records such as calculations, drawings, research and development - test reports,
'etc.,
are retained in the Quality Assurance records system for the life of the shipping package.
All i
other quality related records are retained for a minimum of two years, but no more than five years unless otherwise specified by c7ntract.
Inspection records retained in the Quality Assurance records systems provide the following data when applicable:
'D (1)
Inspection type, i.e.,
in-process, in-service, testing, o
i receiving and shipping.
(2)
Evidence of completion and verification of manufacturing, inspection or test operation.
(3)
The date and results of.the inspection or test.
(4)
Information related to noted discrepancies.
(5)
Inspector or duta recorder information.
(6)
Evidence of acceptance, criteria 18, Audita Quality program audits are performed on a periodic, scheduled basis o
by personnel without direct responsibilities in the areas being i
audited.
Audit team leaders are certified quality assurance lead auditors who have met all requirements of ANSI N 45.2.23.
Written audit plans and check lists are utilized.
Audit results including noted findings are reported to management, in writing, and are retained in the quality assurance record file.
Responsible management personnel are requirei. to respond to audit findings with the necessary' action to correct the noted deficiencies.
Current PNSI practice is to audit all quality functions on an annual basis.
Areas found to be deficient during audits are reaudited to verify 12
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7gh June 5, 1990 Letter-QA-78-1, Rev. 5 corrective action implementation and effectiveness.
Management audits of all division Quality Assuranco Managers are conddcted on an' annual basis by the Director, Corporate Quality Assurance.
Details of the PNSI Audit System are delineated in approved PNSI s
QA Procedures.
References s
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(
(1) 10 CFR 71, Subpart H, Criteria 1-18 dated August 4,
- 1983, s
" Quality Assurance Criteria for Shipping; Packages for Radioactive Material."'
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(2)
PNSI Corporate Quality Manual, dated Harch 23, 1990.
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3 (1)
" organization Chart of Pacific Nuclear Systems, Inc."
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" Typical Division Organization Chart."
(3)
" Typical Organization Chart, Quality Assurance Department."
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" Quality Requirements Matrix - 10 CFR 71, Subpart H, -Criteria 1 -18 1
vs. PNSI Quality Procedure Numbers 1-17".
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June 5, 1990 Letter QA-78-1, Rev. 5 Figme 1 ORG ANIT ATIQN Chat 1T PActFIC NUCLEAR SYSTEliE. INC.
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ATTACHMENT 1 QUALITY REQUIREMENTS NATRIX E
10 CFR vs. PNSI y
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'PNSIl Corporate Quality Manual 10 CFR 71, Subpart H 3
J.
I.
Organization Chart-Quality Program &
Organization Chart-QP 1 - Quality Control Manual QP.14 - Quality Assurance 6
Training
. Quality Assurance Program Same as.above' II.'
III. Design Control QP 2 - Design Review.
~
l QP 15 - Engineering Holds L
i QP 17 - Design Control IV.
Procurement Document Control QP 4 - Procurement Control
.QP 15 - Engineering Holds 1
V.-
Instructions, Procedures and QP 3 - Document Control Drawings QP 5 - Quality Planning QP 15 - Engineering Holds I
L VI..
Document Control QP 3 - Document Control l
QP 15 - Engineering Holds l
i p
VII. tintrol of Purchased-QP 4 - Procurement Control-lp
~Aaterial, Equipment QP 12 - Material Control L
'blo Services
.VIII. Identification and Contr'ol QP 3 - Document' Control-of Materials, Parts QP 12 - Material Control:
},
and Components i
at
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- IX.. Control of-Special Processes QP 4 - Procurement Control' QP 5 - Quality Planning-
~OP 6 - Inspection and b<
f.
Verification l
QP 16 - Special Process
. Qualifications and v
control
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O June 5, 1990 Letter QA-78-1, Rev. 5 X.
Inspection QP 6 - Inspection and Verification XI.
Test Control QP 5 - Quality Planning QP 6 - Inspection and Verification QP 15 - Engineering Holds-XII. Control of Measuring and QP 11 - Calibration Control Test Equipment XIII. Handling, Storage and QP 12 - Material Control Shipping XIV. Inspection, Test and QP 6 - Inspection and operating Status verification XV.
Nonconforming Materials, QP 7 - Discrepancy Parts or Components Reporting and Control VXI. Corrective Action QP 8 - Corrective Action XVII. Quality Assurance Records QP 1 - Quality Control Manual QP 9 - Quality Records QP 10 - Quality Forms Control XVIII. Audits QP 13 - Audits