ML20137B763

Notice of Nonconformance from Insp on 850711-12 & 0805-09

ML20137B763
Person / Time
Issue date:	01/10/1986
From:	NRC OFFICE OF INSPECTION & ENFORCEMENT (IE)
To:
Shared Package
ML20137B728	List: ML20137B722 ML20137B748 ML20137B763 ML20137B792
References
REF-QA-99901005 99901005-85-01, 99901005-85-1, NUDOCS 8601160071
Download: ML20137B763 (5)

Text

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APPENDIX B Air Balance Incorporated (ABI)

Docket No. 99901005/85-01 NOTICE OF NONCONFORMANCE Based on the results of an NRC inspection conducted on July 11-12, 1985 and August 5-9, 1985, it appears that certain of your activities were not conducted in accordance with NRC requirements.

A.

Criterion I, " Organization," of Appendix B to 10 CFR Part 50 states, in part:

"..The authority and duties of persons and organizations perform-ing activities affecting the safety related functions of structures, systems, and components shall be clearly established and delineated in wri ti ng... The persons and organizations performing quality assurance functions shall have sufficient authority and organizational freedom to identify quality problems; to initiate, recommend, or provide solutions;.

and to verify implementation of solutions. Such persons and organizations performing quality assurance functions shall repnrt to a management level such that this required authority and organizational freedom, including sufficient independence from cost and schedule...are provided. Because of the many variables involved... The quality assurance program may take various forms provided that the persons... assigned the quality assurance functions have this required authority and organizational freedom...."

1.

Section 3, " Organization," of ANSI N45.2-1977, which is committed to by ABI in their QA manual, states, in part:

... Persons... performing quality assurance functions shall have sufficient authority and organizational freedom...The person... responsible for defining and measuring the overall effectiveness of the quality assurance program shall be...

sufficiently independent from the pressures of production, shall have direct access to responsible management at a level where appropriate action can be required...."

Contrary to the above, the ABI Quality Assurance Manager who performs all of the ABI quality assurance / quality control (QA/QC) functions, does not have adequate organizational freedom or sufficient independence from cost and schedule as revealed by the following (85-01-03):

a.

The ABI QA Manager is also the ABI Purchasing Agent for the entire manufacturing facility at Wrens, Georgia.

b.

The QA Manager reports to the Wrens, Georgia, Plant Manager approximately 90% of the time while acting as the Wrens facility Purchasing Agent.

8601160D71 86D110 PDR GA999 Ef'fVAIRB 99901005 PDR e

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. c.

Annual performance evaluaticns for the QA Manager are performed by the Wrens facility Plant Manager.

2.

Section 2, " Quality Assurance Program," of ANSI N45.2-1977 states, in part:

...The program shall... clearly delineate the responsi-bility and authority of the various personnel and organizations involved...."

Section 3, " Organization," of ANSI N45.2-1977, states, in part:

"The organizational structure, functional responsibilities, levels of authority, and lines of internal and external communication for management, direction, and execution of the quality assurance program shall be documented...The authority...of persons...

performing activities affecting ouality shall be clearly established...."

Contrary to the above, as of August 9, 1985, the various personnel positions, lines of communications, and responsibilities as depicted in the ABI-QAM organizational chart are not accurate as follows (85-01-04):

a.

Only seven out of eleven management positions indicated on the organizational chart, contained in the ABI-QAM, had their responsibilities and authorities delineated.

b.

Two ABI management personnel, within the nuclear section, had job titles for which responsibilities and authorities were not delineated. These titles were Vice President-Engineering and Assistant Product Manager.

B.

Criterion II, " Quality Assurance Program," of Appendix B to 10 CFR Part 50 states, in part:

...The program shall provide for indoctrination and training of personnel performing activities affecting quality as necessary to assure that suitable proficiency is achieved and maintained...shall regularly review the status and adequacy of the quality assurance program. Management of other organizations participating in the quality assurance program shall regularly review the status and adequacy of that part of the...

program which they are executing."

Paragraph 2.4 of the ABI Quality Assurance Manual (QAM) states, in part:

"The President of Air Balance, Inc. shall be responsible for the review and approval of the Quality Assurance Program on an annual basis. All management organizations participating in the Quality Assurance Program shall review annually the status and adequacy of that part of the Quality Assurance Program for which they have been designated responsibility...."

Contrary to the above, as of August 9, 1985 (85-01-05):

I

. 1.

Records could not be produced to show that an annual QA program review and approval was performed by the ABI President, with the exception of a July 15, 1982 QAM approval by the President.

2.

Records could not be produced to show that adequacy and status reviews were performed by any ABI management organization at any interval, for that part of the QA program which was their responsibility.

3.

No QA program indoctrination had been accomplished for any ABI management personnel at either Air Balance facility.

C.

Criterion V, " Instructions, Procedures, and Drawings," of Appendix B to 10 CFR 50 states:

" Activities affecting quality shall be prescribed by documented instructions, procedures, or drawings, of a type appropriate to the circumstances and shall be accomplished in accordance with these instructions, procedures, or drawings.

Instructions, procedures, or drawings shall include appropriate quantitative or qualitative acceptance criteria for determining that important activities have been satisfactorily accomplished."

Paragraph 7.2.4 of the ABI-QAM states: "All documents to be used in the shop will be a part of the shop traveler.

Project engineering makes the shop traveler which includes applicable drawings, specifications, inspection form, test procedure, welding procedure, inspecting procedures and their forms. The Traveler is reviewed by the QA Department for the inclusion of additional QA requirements."

Paragraph 11.4 of the ABI-QAM states, in part:

"...QC Inspectors will perform final inspections by using the inspection procedure issued by the QA Manager...."

Contrary to the above, as of August 9,1985(85-01-06):

1.

The QA Manager issues the manufacturing shop traveler with the production requirements, in lieu of Project Engineering.

Therefore, the traveler is issued and reviewed only by the QA Manager.

2.

No procedures for the QA/QC final fire damper inspection activities had been written or issued by the QA Manager.

D.

Criterion X, " Inspection," of Appendix B to 10 CFR Part 50 states, in part:

...A program for inspection of activities affecting ouality shall be... executed by...the organization performing the activity...."

Criterion XVII, " Quality Assurance Records," of Appendix B to 10 CFR Part 50 states, in part:

" Sufficient records shall be maintained to furnish evidence of activities affecting quality. The records shall include at least...results of insnections, tests, audits, monitoring of work performance...."

_ ~

Paragraph 11.1 of the ABI-QAM, states, in part:

" Inspection shall be conducted by the Quality Control Inspector for all phases of manufacture... Inspection reports shall be completed for:

1.

Receiving, 2.

In process, 3.

Final, 4.

Shipping.... Receiving and in-process inspection will be done by attribute sampling based on MIL-STD 105D."

Paragraph 11.3 of the ABI-QAM states, in part:

"The QC Inspector will... inspect orders in-process, note date, and initial the in-process inspection report...."

Contrary to the above, as of August 9,1985(85-01-07):

1.

The ABI inspection program was not implemented or documented for any nuclear in-process activities, nor were any QA/QC in-process inspection reports in evidence.

2.

No inspections, based on MIL-STD-1050, were accomplished in the areas of receiving and in-process activities, as required by the ABI QAM.

E.

Criterion XV, "Nonconfcrming Materials, Parts, or Components," of Appendix B to 10 CFR Part 50 states, in part:

" Measures shall be established to control materials, parts, or components which do not conform to requirements in order to prevent their inadvertent use or installation. These measures shall include, as appropriate, procedures for identification, documentation, segregation... and notification to affected organizations...."

Criterion XVI, " Corrective Action," of Appendix B to 10 CFR Part 50 states, in part:

" Measures sha!! be established to assure that... deficiencies, deviations, defective material...and nonconformances are promptly identified and corrected...."

Paragraph 16.1 of the ABI-QAM states, in part:

"All non-conforming items, at any stage of inspection, shall/be put on " hold"...A log shall be kept of all nonconformance rep:frts.

The log will be audited periodically...During receiving, in-p.ocess, and final inspection, tags shall be used to identify items under repair, hold, rejected...

status."

Contrary to the above, as of August 9,1985(85-01-08):

1.

Hold tags are not utilized for control of nonconforming itens as observed during a final QA/QC inspection for a licensee order.

2.

QA/QC " Hold Tags" could not be produced to assure that the tags were available for nonconforming item tagging.

3.

A nonconformance report log could not be produced to assure that nonconformance report logging was being performed.

F.

Criterion XVIII, " Audits," of Appendix B to 10 CFR Part 50 states, in part:

"A comprehensive system of planned and periodic audits shall be carried out to verify compliance with all aspects of the quality assurance program and to determine the effectiveness of the program.

The audits shall be performed in accordance with the written procedures or checklists..."

Partgraph 19.1 of the ABI-QAf1 states, in part:

...An audit team member shall be appointed by either the President or the Manager, Engineered Products to audit QA activities. Audits are performed at least annually...to evaluate the adequacy of the activities in complying with the standards and codes applicable to the program..."

Contrary to the above, periodic audits have not been performed at the Wrens, Georgia, facility as required by the ABI-0AM. Within the last five years, only one audit report was in evidence for the review of QA/QC related activities at the Wrens, Georgia, facility (85-01-09).

G.

Criterion VII, " Control of Purchased Material, Equipment and Ser/ ices,"

of Appendix B to 10 CFR Part 50 states, in part: " Measures shall be established to assure that purchased material... conform to the procure-ment documents.

These measures shall include provisions...for source evaluation..."

Paragraph 8.1 of the ABI-QAM states, in part:

" Vendors shall be selected from an approved vendors list.

Vendors shall be placed on the approved vendors list after an audit of their facility's QA program..."

Paragraph 8.2 of the ABI-QAM states, in part:

...An approved vendors list shall be maintained and distributed...by the Purchasing Manager..."

Contrary to the above, an accurate and up-to-date approved vendors list was not maintained. A review of survey sheets and other records indicated that three out of eight vendors on the list did not have a QA program as required by ABI's QAM (85-01-10).

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