ML20151H745

QA Program Insp Rept 99900905/83-01 on 830117-20. Noncompliance Noted:Failure to Post Current Regulations, Insufficient Info in QA Manual & Failure to Conduct Mgt Audit of QA Program

ML20151H745
Person / Time
Issue date:	04/14/1983
From:	Agee J, Phillips H NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION IV)
To:
Shared Package
ML20151H735	List: ML20151H732 ML20151H737 ML20151H742 ML20151H745
References
REF-QA-99900905 NUDOCS 8305050262
Download: ML20151H745 (15)

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l ORGANIZATION: WYLE LABORATORIES i WESTERN OPERATIONS NORCO, CALIFORNIA REPORT INSPECTION INSPECTION NO.- 99900905/83-01 DATF(O 1/17.90/97 ON 9TTF 40llR9- Ad CORRESPONDENCE ADDRESS: Wyle Laboratories Western Operations ATTN: Mr. R. C. Sadlier, General Manager 1841 Hillside Avenue Norco, CA 91760 ORGANIZATIONAL CONTACT: Mr. L. Housteau, QA Manager TELEPHONE NUMBER: (714) 737-0871 PRINCIPAL PRODUCT: Equipment qualification engineering services.

NUCLEAR INDUSTRY ACTIVITY: The Wyle Laboratories, Western Operations Facility, provides engineering and test services to military, utility, and commercial nuclear power organizations. Approximately 40 percent of the facility's capability is currently committed to environmental qualification testing of safety-related equipment for its customers.

ASSIGNED INSPECTOR: M45g.<.4 pr/#1 F R. Agef, Equip'ent Qualification Section (EQS) Date OTHERINSPECTOR(S): D. E. Norman, Reactive & Component Program Section E. Minor, Sandia National Laboratories APPROVED BY:

H.

S.' Phillips, Chief, EQS

/f[f3 ate INSPECTION BASES AND SCOPE:

A. BASES: Appendix B to 10 CFR Part 50 and 10 CFR Part 21.

B. SCOPE: This inspection consisted of: (1) an in-office review of the QA manual relative to the 18 criteria of 10 CFR Part 50, Appendix B; (2) onsite inspection related to the implementation of 18 criteria of 10 CTR Part 50, Appendix B; and (3) verification that requirements of 10 CFR Part 21 had been fulfilled.

I PLANT SITE APPLICABILITY: DEsICNATgg cRIGINAL 50-425/426, 50-528/529/530.

certified 27 -

8305050262 830421 PDR GA999 EXIWYLE 99900905 PDR

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ORGANIZATION: WYLE LABORATORIES WESTERN OPERATIONS NORCO, CALIFORNIA REPORT INSPECTION N0.: 99900905/83-01 RESULTS: PAGE 2 of 8 A. VIOLATIONS:

Contrary to Section 206 of the Energy Reorganization Act of 1974 and its implementing regulation 10 CFR Part 21, Wyle Laboratories had not posted the current version of the regulation in accordance with paragraph 21.6 posting requirements. During this inspection, the NRC inspector verified that corrective action was accomplished (see paragraph D.3 below).

B. NONCONFORMANCES:

1. Contrary to Criterion I of Appendix B to 10 CFR Part 50, the QA manual does not delineate in writing the authority and duties of cognizant management personnel responsible for technical and test services affecting the testina of safety-related equipment.

2. Contrary to Criterion V of Appendix B to 10 CFR Part 50 and QA manual SPP No. 380-2-B, Section 2.5, a management audit or review and assessment of the QA program had not been conducted since February 1981.

3. Contrary to Crf terion V of Appendix B to 10 CFR Part 50 and QA manual SPP No. 380-4-B, Section 4.3.7, purchase orders (P0s) had been issued that did not specify technical requirements, such as, the radiation source, a suggested activation energy level, or an upper limit for the radiation exposure (dose) rate in accordance with criteria of IEEE Standards 323 and 278 as applicable.

4. Contrary to Criterion V of Appendix B to 10 CFR Part 50 and QA manual SPP No. 380-6-B, Section 6.2.3, the QA department had not audited or maintained records of random audits made of document controls in accordance with procedure 380-18.

5. Contrary to Criterion V of Appendix B to 10 CFR Part 50, QA manual SPP No. 380-7-B, Section 7.2.1, and Standard Operating Procedure (SOP) No. 518-19, the Vendor's Accumulative Sampling History was not being maintained.

6. Contrary to Criterion V of Appendix B to 10 CFR Part 50 and QA manual SPP No. 380-17-B, Section 17.4.1, documented procedures did not describe a record storage system and did not describe the responsibilities of the persons responsible for the system.

ORGANIZATION: WYLE LABORATORIES WESTERN OPERATIONS NORC0, CALIFORNIA REPORT INSPECTION N0.: 99900905/83-01 '

RESULTS: PAGE 3 of 8

7. Contrary to Criterion V of Appendix B to 10 CFR Part 50 and QA manual SPP No. 380-2-B, Section 2.4, personnel records that were examined indicated that certain audit team members (auditors reporting to the lead auditor) had not received auditor indoctrination and training.

C. UNRESOLVED ITEMS:

None D. OTHER FINDINGS OR COMMENTS:

1. QA Manual Review - The NRC inspector reviewed Wyle QA Manual, Revision B, in the NRC office prior to the onsite inspection. A checklist was used and completed to assure that all 18 criteria of 10 CFR Part 50, Ap;'endix B and 10 CFR Part 21 were described as applicable.

Organization - Only the duties, functions, and responsibilities of the QA department are adequately described. Contrary to the require-ment of Criterion I of 10 CFR Part 50, Appendix B, the QA manual did not describe the authority and duties of other cognizant persons and organizations responsible for engineering and testing activities, including the facility general manager (see nonconformance item B.1).

2. QA Program Implementation - During this inspection, the NRC inspectors evaluated the implementation of the criteria described in the QA manual. A sunnary of the inspection of each criterion, whose titles are the same as each criterion of 10 CFR Part 50, j Appendix B, is described in the following paragraphs.

a. Organization The NRC inspector verified that the organizations shown in the organizational charts were staffed as shown. Several of the

{ individuals were interviewed relative to their duties and t

responsibilities. The persons and organizations appeared to

! have sufficient authority and organizational freedom. No nonconformances were identified; however, see D.1 above.

b. QA Program - This section provides an adequate overview of the QA program. Reference to control and distribution of the QA manual by QA Form No. W-768A was substantiated. Also,

ORGANIZATION: WYLE LABORATORIES WESTERN OPERATIONS NORCO, CALIFORNIA REPORT INSPECTION NO.: 99900905/83-01 RESULTS: PAGE 4 of 8 indoctrination and training of employees were verified to be in accordance with S0P No. 518-1 by inspecting personnel files. Contrary to the QA manual SPP No. 380-2-B, Section 2.5 which states, " Management shall conduct an annual review and assessment of the Quality Assurance Program," management had not done so (see nonconformance item B.2).

c. Design Control - The facility currently designs no test fixtures, although such engineering services are available.

However, design verification functions are performed in the review, evaluation, and confirmation of customer thermal and radiation calculations. This requires approval by signature of three groups of the facility staff; e.g., the Test Qualifi-cation Plan 57650 had been signed off by the test engineer, test manager, and QA manager. Although this qualification plan (QP) had been approved, the NRC inspector identified a thermal aging formula that was incorrectly referenced twice in the QP. How-ever, in each case, the accompanying computations were completed by use of the correct formula and the results were correct for the proposed thermal aging. No nonconformances were identified.

d. Procurement Document Control - The NRC inspector reviewed the QA manual SPP No. 380-4-B, Section 4.3.7, and related P0s for calibration and radiation services, blanket Pas to vendors on the " Approved Vendors List" far repetitive services, and other P0s for one-time services to determine that 10 CFR Part 21 and applicable QA and contractural technical requirements were imposed in accordance with established procedures. Contrary to the QA manual SPP No. 380-4-B, Section 4.3.7, P0 Nos. 3-6223 and 3-6406, that were issued to a radiation services facility did not specify the radiation requirements, such as, type of radiation source, a suggested activation ener upper limit for the radiation exposure (dose)gy rate level, er an in accordance with the criteria of IEEE Standards 323 and 278 as applicable (seenonconformanceitemB.3).

e. Instructions, Procedures, and Drawings - The inspector verified that various departments are responsible for providing, approving, issuing, and maintaining procedures unique to the specific department. Procedures 50P Nos 519-1, 518-1, 518-24, and 519-2 unique to the engineering department were examined. Each had been prepared and approved in accordance with the requirements of QA manual Section 380-5-B.

ORGANIZATION: WYLE LABORATORIES WESTERN OPERATIONS NORC0, CALIFORNIA REPORT INSPECTION NO.: 99900905/83-01 RESULTS: PAGE 5 of 8 Further evidence of the implementation of the criterion was verified during the review of other criteria where procedures describing the criteria were being followed. No nonconformances were identified.

f. Document Control - A review of document files, consisting of contract Job Orders (CJ0s), Wyle test procedures, and customer test procedures was completed to verify that review, approval, and issuance complied with documented procedures. The work folder for Job No. 58644 was also reviewed to determine that current documents were included and being used at the test site.

Contrary to the procedure 380-18, the QA department had not maintained records of random audits made of document controls (see nonconformance item B.4).

g. Control of Purchased Material, Equipment, and Services -

Inplementation of the QA program for this element was evaluated by reviewing the approved vendor list and records of interviews, audits, and historical data which resulted in vendors being placed and retained on the approved list.

Receiving records, vendor Certificates of Conformance, and S0P No. 518-19 concerning the Vendor's Accumulated Sampling History were reviewed. Contrary to the procedure, the vendor accumu-lated history was not being maintained (see nonconformance item B.5).

h. Identification and Control of Materials, Parts, and Components -

Test activity during the NRC inspection, was limited; therefore, the evaluation of the implementation of this criterion consisted of verifying the identification of one test item. No nonconformances were identified.

1. Control of Special Processes - On manual SPP No. 380-9-8 and S0P No. 518-1 have been approved for use for special processes, especially welding. However, Wyle does not fabricate test fixtures for nuclear environmental qualification testing; therefore, no welders are currently qualified to standards applicable to the nuclear industry. No nonconformances were identified.

j. Inspection - Implementation of the QA manual SPP No. 380-10-8 was verified by examining QA files of CJ0s that schedule and track the testing and inspection of tests as they progress to completion. Four each Quality Report Forms and four Inspection

ORGANIZATION: WYLE LABORATORIES WESTERN OPERATIONS NORCO, CALIFORNIA REPORT INSPELi1VN NO.: 99900905/83-01 RESULTS: PAGE 6 of 8 Surveillance Record Forms were examined while tracking the inspection practices on Wyle Job Nos. 56917 and 58644. No nonconformances were identified,

k. Test Control - QA manual SPP No. 380-11-B and S0P No. 519-1 identify the mechanisms (instructions, procedures, forms) for tracking and conducting tests. QA test files for CJO NES-57641 and related data sheets were examined. All test documents had been approved and signed off by authorized personnel. No nonconformances were identified.

1. Control of Measuring and Test Equipment - The QA manual SPP No. 380-12-8 provides the basic procedures for the control of measuring and test equipment. The inspector verified that the calibration laboratory mai.ntains a program for maintenance, repair, and calibration of facility instruments. The program uses calibration procedures, calibration standards, schedules, and computer services to maintain the system. Documents examined included instrument recall records, calibration records, records of central use, consignment instruments, records of instruments outside repair and/or calibration, and records of instrument (out-of-tolerance) evaluations. Documentation was current. No nonconformances were identified.

m. Handling, Storage, and Shi] ping - A review was made of the QA manual SPP No. 280-13-6, w1ich is the procedure that delineates the requirements for the handling, storage, and shipping activities. Other documents reviewed included: Receiving Inspection Form No. W-614, Quality Record Form No. W-927, and Shipping Memorandum WL-204. These forms are the primary QA documents for handling, storage, and shipping of nuclear /

customer test specimen and/or related test fixtures. No nonconformances were identified,

n. Inspection, Test, and Operating Status - The QA manual SPP No. 380-14-8 was reviewed and compared with qualification plan (QP) 57555 for the Job No. 58644. The QP had been compiled in accordance with procedures of the QA manual and the CJO had been approved for the scheduled test. The QA Form Nos. W-927 and W-614 for tracking the test to completion had been implemented in accordance with the QA manual. No nonconformances were identified.

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ORGANIZAT10N: WYLE LABORATORIES WESTERN OPERATIONS NORCO, CALIFORNIA REPORT INSPECTION NO.: 99900905/83-01 RESULTS: PAGE 7 of 8

o. Nonconforming Materials, Parts, or Components - The inspector verified that nonconforming materials, parts, or components are identified, evaluated, and dispositioned (i.e., used, scrapped, returned to customer or se Material Review Board (MRB) action) in gregated in with accordance storage for Procedure 15.3 of QA manual SPP No. 380-15-B. No nonconformances were identified.

p. Corrective Action - Six Corrective Action Request (CAR) Forms No. W-771-8 were reviewed. Each had been reviewed, approved, and processed in accordance with Procedure 16.1 CAR, Method 7, QA manual SPP No. 380-16-B. No nonconformances were identified.

q. Quality Assurance Records - The NRC inspector reviewed the QA manual SPP No. 380-17-B, Section 17.4.1, and various QA records, personnel certifications, material receiving reports, nonconformance reports, specifications, and test reports. Also the current records, storage, and retention facilities for QA records were examined. Contrary to the above, implemented procedures did not address records and storage requirements (see nonconformance item B.6).

r. Audits _- The NRC inspector reviewed the QA manual SPP No. 380-18-B, internal and vendor audit reports, personnel auditor qualifications, audit checklists, and audit schedules to determine that audits are conducted in accordance with approved schedules and checklists, and that auditors are qualified per established indoctrination and training require-ments. Contrary to the above, personnel qualification records for auditors indicated that certain audit team members (auditors reporting to the lead auditors) had not received auditor indoctrination and training (see nonconformance item B.7).

3. 10 CFR Part 21 - Several P0s dated August 1982 and later that had been issued to approved tendors were reviewed. Each had been stamped indicating that 10 CFR Part 21 applies.

Contrary to 10 CFR Part 21, the current version of 10 CFR Part 21 was not posted at the Wyle facility (see Section A. Violation).

During the inspection, Wyle management directed the posting of current copies of the 10 CFR Part 21 regulations and Section 206 of the Energy Reorganization Act of 1974. In addition, to preclude recurrent posting

ORGANIZATION: WYLE LABORATORIES WESTERN OPERATIONS NORCO, CALIFORNIA REPORT INSPECTION NO.: 99900905/83-01 RESULTS: PAGE 8 of 8 violations, Wyle management agreed to establish procedures requiring periodic audits to verify that the subject documents are posted and current. The NRC inspector verified that the subject documents were posted; therefore, no written response to this violation is necessary.

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