ML20151H742
| ML20151H742 | |
| Person / Time | |
|---|---|
| Issue date: | 04/21/1983 |
| From: | NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION IV) |
| To: | |
| Shared Package | |
| ML20151H735 | List: |
| References | |
| REF-QA-99900905 NUDOCS 8305050258 | |
| Download: ML20151H742 (2) | |
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L APPENDIX B
. yle Laboratories W
I.'
Western Operations-I Docket No. 99900905/83-01 NOTICE.0F NONCONFORMANCE i-
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Based on the results of an NRC inspection conducted on January 17-20,1983, it appears that certain of your activities were not conducted in accordance with NRC requirements as indicated below:
i A.
Criterion I of Appendix B to 10 CFR Part 50 states, in part, "... The authority and duties of persons and organizations performing activities affecting the safety-related functions of structures, systems, and components shall be clearly established and delineated in writing...."
- r Contrary to the above, the QA manual Standing Practice Procedure (SPP)
No. 380-1-B,.does not delineate in writing the authority and duties of cognizant management personnel responsible for technical and test services affecting the ' testing of safety-related equipment.
B.
. Criterion V of Appendix B to 10 CFR Part 50 states, in part, " Activities affecting quality. shall be... accomplished in accordance with these j.
instructions, procedures, or drawings...
i The QA manual SPP No. 380-2-B, Section 2.5 states, " Management'shall conduct annual review and assessment of the Quality Assurance Program."
i Contrary to the above, management had not conducted a management audit or review and assessment of the QA program since February 1981.
C.
Criterion V of Appendix B to 10 CFR Part 50 states,-in part, " Activities.
l affecting quality shall be... accomplished in accordance with the.M j
instructions, procedures, or drawings...."
The 0A manual SPP-No. 380-4-B, Section 4.3.7 states, in part, "...
purchase authorization shall indicate... technical requirements, i.e.,
specified by reference to specific drawings, specifications, codes, standards, regulation...."
Contrary to the above, Purchase Order Nos. 3-6406 and 3-6223 that were issued to an approved radiation services facility did not specify the i
radiation requirements, such as, type of radiation source, a suggested activation energy level, or an ' upper limit for the radiation exposure (dose) rate for specimen to be irradiated in accordance with the criteria
't of IEEE Standards 323 and 278 as applicable.
t
~D.
Criterion V of Appendix B to 10 CFR Part 50 states, in part, " Activities affecting qLality shall be... accomplished in accordance with these instructions, procedures, or drawings...."
3 8305050258 830421 PDR GA999 EXIWYLE r
99900905 PDR
. The QA manual SPP No. 380-6-B, Section 6.1.3 states, "The Quality Assurance Department is responsible for monitoring compliance with this directive via random surveillance and audits in accordance with 380-18."
Contrary to the above, the QA department had not audited or maintained records of random audits made of the document controls in accordance with procedure 380-18.
E.
Criterion V of Appendix 3 to 10 CFR Part 50 states, in part, " Activities affecting quality shall be... accomplished in accordance with these instructions, procedures, or drawings...."
The QA manual SPP No. 380-7-B, Section 7.2.1 states, in part, "Those contractors doing work on a continuous basis shall be surveyed before the issuance of a purchase' order and maintained on the ' Approved Vendors List' by sampling their work at random intervals...." This sampling and evaluation of the vendor's work was defined as the Vendor's Accumulated Sampling History.-
Contrary to the above the Vendor's Accumulative Sampling History was not being maintained.
F.
Criterion V of Appendix B to 10 CFR Part 50 states, in part, " Activities affecting quality shall be... accomplished in accordance with these instructions, procedures, or drawings...."
The QA manual SPP No. 380-17-B, Section 17.4.1 states, "The records shall be stored in location (s) that meet the requirements of applicable standards, codes and regulatory agencies.
Prior to s'torage of records, a written storage procedure shall be prepared and responsibility assigned for enforcing the requirements of that procedure."
Contrary to the above, documented procedures did not describe a record storage system and did not describe the responsibilities of the persons responsible for the system.
G.
Criterion V of Appendix B to 10 CFR Part 50 states, in part, " Activities affecting quality shall be'... accomplished in accordance with these instructions, procedures, or drawings...."
The QA manual SPP No. 380-18-B, Section 18.2.2 states, in part, "The Quality Manager shall assure that Quality Audits are performed by trained personnel...."
Cor,trary to the above, personnel records that were examined indicated that certain audit team members (auditors reporting to lead auditors) had not received auditor indcctrination and training.
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