ML20246D051
| ML20246D051 | |
| Person / Time | |
|---|---|
| Site: | 07100678 |
| Issue date: | 08/12/1989 |
| From: | Olivadoti J PACTEC, INC. |
| To: | |
| Shared Package | |
| ML20246C996 | List: |
| References | |
| QA.01.89, QA.1.89, NUDOCS 8908250238 | |
| Download: ML20246D051 (10) | |
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- .j PRCTEC,.INC. 10 CFR 71, SUBPART E,.QA FROIRAM PG 1.OF.27 R v 1, 8/89-1 l
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- 10 CFR 71, SUBPART H QUALITY ASSURANCE PROGRAM o.
FOR DESIGN AND FABRICATION
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SHIELDED TRANSPORTATION CONTAINERS l
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' LETTER NUMBER QA.01.89 REVISION 1 l
August 11, 1989 i
PacTec, Inc.-
l 11655 S.
E. 50th Place Bellevue WA 98006 l
APPROVALS l
REVISION l
PRESIDENT /DATE.
l QA DIRECTOR /DATE f
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IPXCTJC, INC. 10 CFR 71, SUBPART H, QA PROGRAM PG 2 OF 27 Rev 1, B/89 INTRODUCTION PacTec', Inc. has developed a Quality Assurance System to assure traceability and control the quality of all materials and pro-cesses utilized in the design, licensing and production of radioactive shielding, casks, containers, and reclated structures, systems-and components.
The Quality Assurance Manual delineates policies and requirements l R1 (Quality Policies) and detail procedures (Quality Instructions) necessary to exercise control over
- design, documentation, procurement,
- material, fabrication, inspection, and quality data retention.
Please also see Criterion 2,
" Quality Assurance Program" for Quality Manual Discussion.
PacTec, Inc. 's QA System and implementing Quality Procedures (QP) l R1 are designed and administered to meet the requirements of 10 CFR 71, Subpart H.
Figure' 1 is -a matrix delineating the relationship between the l R1 fifteen (15) PacTec, Inc. QPs and the 18 criteria of 10 CFR 71, Subpart H.
The following is a synopsis of the current PacTec, Inc. QA Sys-l R1 tem.
This is the basic system utilized on all 10 CFR 71, Subpart H related design, license, fabrication programs at PacTec, Inc.
DESCRIPTION OF THE PACTEC, INC. 10 CFR 71 SUBPART H QA SYSTEM Criterion L. Organization Full responsibility for the Quality Assurance (QA) Program ad-herence to 10 CFR 71, Subpart H criteria rests with PacTec, Inc..
Selected QA Program activities are performed by PacTec, Inc. QA approved suppliers. These include calibration of measur-i ing equipment, NDE and materials testing. PacTec, Inc. surveys and qualifies all organizations performing these services to assure adherence to the 18 criteria prior to their use. However, the responsibility of the control of QA in the other organiza-tions continues to rest with PacTec, Inc.
l R1 All other QA activities such as design review, quality.instruc-l R1 tion preparation, in-process and final acceptance inspections, MRB activities, data review and retention, etc.,
are performed I
by PacTec, Inc. QA directed and approved personnel.
PacTec, Inc.'s President has full authority over all functions of the company, and delegates authority and responsibility for selected functions to other personnel within the company.
l PacTec, Inc
PiCT C, INC. 10 CFR 71, SUBPART H, QA PROGRAM PG 3 OF 27 R:V 1, 8/89 s
Administrative functions include financial and legal activities.
Marketing activities are performed by senior management and technical personnel reporting directly to the President.
They are charged with the duty to identify 'and develop new business for PacTec, Inc.
Procurement functions are performed by PacTec personnel assigned l R1 to purchasing activities.
These personnel maintain supplier performance records.
i PacTec engineering personnel are responsible for research and de-l R1 velcpment of shipping and storage container technology, design of casks for licensing and fabrication and design documentation.
The PacTec, Inc. QA Department has complete authority and organ-izational freedom to identify QA problems, establish QA programs,
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implement corrective action and verify corrective action effectiveness.
1 Additionally, PacTec personnel performing QA/QC functions are l R1 assigned and approved by the QA Director and the President. They are independent from other organizations and functions within PacTec, Inc. while performing QA/QC functions and report directly to the QA Director and the President of PacTec, Inc.
The QA Department is headed up by the QA Director who is respons-l R1 f
ible for the development, implementation and administration of 1
the total PacTec, Inc. QA Program and all related activities and l
functions.
The QA Director must have sufficient expertise in the entire field of Quality to enable him to direct the entire QA function in close adherence to the 18 criteria and the PacTec, Inc. QA Manual.
The QA Program and supporting QA Manual and procedures developed by the QA Director are approved by the President of PacTec, Inc.,
Please also see Criterion 2,
" Quality Assurance Program" for Quality Manual Discussion.
j Responsibility for development of QA acceptance requirements, inspections, and NDE activities rest with the QA Director. It is also his responsibility to delegate and evaluate the performance of all QA related tasks for PacTec, Inc. through the authority of the president.
In written direct #ves, the OA Director designates PacTec personnel l R1 l
with authority to perform QA functions that prevent the continued processing, fabrication, installation or delivery of unsatis-factory work.
QA authority also extends to the monitoring of special processes utilizing PacTec, Inc. equipment, personnel and procedures such as testing, field erection, in-service inspections, etc.
PacTec, Inc
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PACTCC,:INC. 10 CFR 71, SUBPART H, QA. PROGRAM PG 4 OF 27 Rev 1,-8/89
-Production responsibilities include scheduling of in-service l.' R1-inspection'and administration of all fabrication activities, both within.PacTec, Inc. and at qualified suppliers.
The shipping and Lreceiving function is also the responsibility of personnel cognizant of the production activity but is performed through the
-Procurement activity.
On-site activities such as in-service inspections, field testing programs, 'etc. are administered as a joint effort of the QA and engineering personnel of PacTec, Inc. and QA approved contractors-as requiredc The PacTec, 'Inc.
QA Department supports these 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 QA Director and all PacTec personnel assigned by the Director. l R1 to QA functions within, or utilized by PacTec, Inc., are fully qualified for their QA responsibilities.
Qualification records are maintained in the PacTec, Inc.'QA Record File.
Figures - 2A and 2B provide general PacTec, Inc. Organization l R1 Charts for the company and the QA function.in particular.
Criterion-h Ouality Assurance Procram PacTec, Inc. has established and implemented a QA Program for the control of quality in the design, testing and fabrication of shielded transportation containers for nuclear products. The QA Program is documented in the PacTec, Inc. QA manual.
The QA Manual is comprised of two separate but interrelated documents as follows:
QUALITY POLICY (QP):
This document is relatively brief and includes a series of QPs.
The intent of it is to provide an official PacTec, Inc. overview of what QA is to the company, and who has the responsibilities for it.
It is informative and concise.
The basic 18 criteria of 10 CFR 71, Subpart H are addressed in sufficient detail to assure accurate and complete dissemination of the QA requirements to all PacTec, Inc. personnel, its customers and suppliers.
The QPs provide a standard reference for QA that all person-nel and suppliers receive and refer to for basic information on the PacTec, Inc. QA process.
PacTec, Inc
l l-l PACTEC, INC. 10 CFR 71, SUBPART H, QA PROGRAM PG 16 OF 27 Rev 1, 8/89 L
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- PacTec, Inc.
QA personnel assigned to QA/AC functions are l R1
' independent from all other organizational activities while reporting to the QA Director.
QA Inspection personnel qualifications are based on their cap-ability to perform the. required inspection functions in accord-ance with applicable codes, standards, professional society pro-grams such as the ASQC quality technician certification, AWS QC1, SNT-TC-1A and PacTec, Inc.
training programs.
Qualification reviews are performed periodically to maintain personnel profi-ciency and assure current qualification.
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Mandatory inspection hold points, inspection equipment require-l.
ments, accept-reject criteria, personnel requirements, character-l istics to inspect, variables / attributes recording instructions, reference documentation and other requirements are included - in the QA Inspection Planning.
The QA Inspection Planning, when completed, also includes results and supporting information such as variables and attributes data, test results, NDE records, welding information, certified ma-terial test reports and/or certifications, special process data, discrepancy reports and related MRB dispositions and resultant re-inspection data, etc.
Enforcement of mandatory inspection hold points assures that in-process work does not proceed beyond the point where it can be l
properly inspected or verified.
They also prevent unsatisfactory in-process work quality by specifying hold point buyoff by QA personnel before further processing.
J The QA Department assures that any replacements, modifications,
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or repairs performed after final acceptance of material, compo-nents or hardware are inspected in accordance with the original or new QA Inspection Planning as appropriate.
l Criterion & Test Control Test control, as it applies to quality, is addressed in approved PacTec, Inc. QA Procedures. It assures, via QA Inspection Plan-ning,' 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 and data recording criteria, instrumentation cali-bration, environmental conditions, documentation and evaluation requirements, etc. are delineated in the test procedures.
PacTec, Inc. QA personnel assure, during test procedure reviews l
prior to release, that, whenever practical, the normal and an-l ticipated off-normal operational performance described in appli-cable design, regulatory and contractual documents are re-created during the testing activity.
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PacTec, Inc l
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l PACTEC, INC. 10 CFR 71, CUBPART H, QA PROGRAM PG 23 OF 27 rov 1, 8/89 Corrective action may include, but not be limited to: personnel evaluation and training, procedural re-evaluation, changes or I
enforcement, facility re-design, etc.
Please also see Criterion 16, " Corrective Action".
After completion of these steps, all audit results and agreed to corrective actions, Audit Trend Analysis reports delineating Quality Trends and QA Program Effectiveness and any additional input resulting from the post audit review are forwarded to the PacTec, Inc. President.
The President reviews the complete audit and supporting data for information and any additional action as appropriate.
References (1) 10 CFR 71, Subpart H,
Criteria 1-18:
" Quality Assurance Criteria for Shipping Packages for Radioactive Material".
(2)
PacTec, Inc. Quality Assurance Manual Attachments Figure 1:
" Quality Requirements Matrix - 10 CFR 71, Subpart H, Criteria 1-18 vs. PacTec, Inc. Quality Policy Numbers 1 through 18".
Figure 2A:
PacTec, Inc.: General Organization Chart, Dated 04/14/89.
Figure 2B:
PacTec, Inc.: QA Functional Organization Chart, Dated 08/11/89, l R1 l
l PacTec, lru:
a.,
.hr FACTEC, INC. 10 CFRL71, SUBPART H, QA PROGRAM PG 24 OF 27 Rev 1, 8/89' FIGURE 1 OUALITY ASSURANCE MATRIX: la CEB Vi PACTEC, INC, QA POLICIES 10.CFR 71, SUBPART H
-l TACTEC, INC. QA POLICY l 1 R1 I.
ORGANIZATION QP MANUAL, PG 1: QUALITY PROGRAM QP 1: QUALITY ORGANIZATION II.-
QUALITY ASSURANCE PROGRAM QP 2:-QUALITY MANUAL CONTROL 1 QP 14: QUALITY-TRAINING III.
DESIGN CONTROL QP 5: DESIGN REVIEW AND CONTROL IV.
PROCUREMENT. DOCUMENT CONTROL QP 4 : PROCUREMENT CONTROL.
1
.V.
INSTRUCTIONS, PROCEDURES &
QP 3: DOCUMENT CONTROL DRAWINGS QP 6: QUALITY PLANNING VI.
DOCUMENT CONTROL QP 3: DOCUMENT CONTROL
-VII.
CONTROL OF PURCHASED QP 4: PROCUREMENT CONTROL MATERIAL, EQUIPMEN7' &
QP 8: MATERIAL CONTROL SERVICES VIII. IDENTIFICATION & CONTROL QP 3: DOCUMENT CONTROL OF MATERIALS, PARTS &
QP 8: MATERIAL CONTROL COMPONENTS IX.
CONTROL OF SPECIAL PROCESSES QP 4: PROCUREMENT CONTROL QP 6: QUALITY PLANNING QP 7: INSPECTION & VERIFICATION QP 9: SPECIAL PROCESS CONTROL X.
INSPECTION QP 7: INSPECTION & VERIFICATION PacTec, Inc
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- 'PACTEC, INC. 10 CFR 71, SUBPART H, QA PROGRAM PG 25LOF 27 Rev'1, 8/89 f.-
FIGURE 1.(CONTINUED) 10 CFR 71, SUBPART H l PACTEC, INC. QA POLICY l R11 XI.
TEST CONTROL QP 6: QUALITY PLANNING QP 7: INSPECTION ~& VERIFICATION-XII.
CONTROL OF MEASURING QP 11: CALIBRATION. CONTROL
& TEST' EQUIPMENT XIII. HANDLING, STORAGE QP 6: QUALITY PLANNING
& SHIPPING QP 7: INSPECTION & VERIFICATION
.QP 8: MATERIAL CONTROL XIV.
INSPECTION, TEST &
QP 7: INSPECTION & VERIFICATION-OPERATING STATUS XV.
NONCONFORMING MATERIALS QP 10: DISCREPANCY REPORTING PARTS OR COMPONENTS XVI.
CORRECTIVE ACTION XVII. QA RECORDS QP 2: QUALITY MANUAL CONTROL QP 12: QUALITY RECORDS QP~13: FORM CONTROL XVIII. AUDITS QP 15: AUDITS PacTec, Inc
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- FACTCC,'INC. 10 CFR'71, SUBPART H, QA PROGRAM PG 27 OF 27 Rav 1, 8/89' FIGURE 2B QA FUNCTIONAL ORGANIZATION l
l Approved:
R. 7. Heelsig, President PacTec, Inc.
August 11, 1989 QA DIRECTOR INSP5CTION QUALITY ENGINEERING QUALITY AUDIT l
l Receiving Process QA Internal In-Process Design QA External Testing Docunent CA Final Procurement GA l
Shipping CA Records l
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