ML20054G093: Difference between revisions

From kanterella
Jump to navigation Jump to search
(StriderTol Bot insert)
 
(StriderTol Bot change)
 
Line 2: Line 2:
| number = ML20054G093
| number = ML20054G093
| issue date = 04/30/1982
| issue date = 04/30/1982
| title = Responds to NRC 820401 Ltr Re Violations Noted in IE Insp Rept 50-334/82-01.Corrective Actions:Penetration Fire Barrier Repacked & Plans Made for Personnel Indoctrination by 820625
| title = Responds to NRC Re Violations Noted in IE Insp Rept 50-334/82-01.Corrective Actions:Penetration Fire Barrier Repacked & Plans Made for Personnel Indoctrination by 820625
| author name = Carey J
| author name = Carey J
| author affiliation = DUQUESNE LIGHT CO.
| author affiliation = DUQUESNE LIGHT CO.
Line 11: Line 11:
| contact person =  
| contact person =  
| document report number = NUDOCS 8206210087
| document report number = NUDOCS 8206210087
| title reference date = 04-01-1982
| package number = ML20054G090
| package number = ML20054G090
| document type = CORRESPONDENCE-LETTERS, INCOMING CORRESPONDENCE, UTILITY TO NRC
| document type = CORRESPONDENCE-LETTERS, INCOMING CORRESPONDENCE, UTILITY TO NRC

Latest revision as of 11:34, 14 November 2023

Responds to NRC Re Violations Noted in IE Insp Rept 50-334/82-01.Corrective Actions:Penetration Fire Barrier Repacked & Plans Made for Personnel Indoctrination by 820625
ML20054G093
Person / Time
Site: Beaver Valley
Issue date: 04/30/1982
From: Carey J
DUQUESNE LIGHT CO.
To: Starostecki R
NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I)
Shared Package
ML20054G090 List:
References
NUDOCS 8206210087
Download: ML20054G093 (14)


Text

l

  • L.. .

e' k

"hp Telephone (412) 4564000 Nuclear Division P.O Box 4 Shippingport, PA 1507N)004 April 30, 1982 United States Nuclear Regulatory Commission Office of Inspection and Enforcement Attn: R. W. Starostecki, Director Division of Project and Resident Programs Region I 631 Park Avenue King of Prussia, Pennsylvania 19406

Reference:

Beaver Valley Power Station, Unit No. 1 Docket No. 50-334, License No. SPR-66 IE Inspection Report No. 82-01 Centlemen:

In response to your letter of April 1, 1982, and in accordance with 10 CFR 2.201, the attached reply addresses the Notice of Violation which was included as Appendix A with the referenced Inspection Report. The Notice of Violation identified seven items considered to be in noncompli-ance. ,

We would like to express our concern related to the classification of Violation A as Severity Level III. Due to the existing outage condi-tion, the safety significance of this 1 :'conformance was certainly mini-mal as there was no actual or high p ential impact on public health and safety. We believe that the enforcement history, as published in the Atomic Energy Clearinghouse reports resulting from events of a similar -

nature, clearly point to an established NRC practice of classifying such events as Severity Level IV or V. Current NRC Policy for Enforcement Actions takes into consideration the actual ef fect on the margin of safety and classifies " violations that have minor safety or environmental sig-nificance" as Severity Level V.

In view of the refinements made to the Enforcement Policy as published in the Federal Register on March 9,1982 and the demonstrated past practice of the NRC regarding similar events at other facilities, we believe that there is substantial justification for the reclassification of this event as a Severity level V. This reclassification would provide a consistent NRC application of its Enforcement Policy.

We do, however, share your concern regarding repeated problems with inoperable fire barrier penetrations. We are taking steps to improve this situation with our development of modifications to the maintenance program to provide better administrative control in this area as discussed in our attached reply.

8206210087 820611 PDR ADOCK 05000334 0 PDR

~

Beaver '.illey Power Station, Unit No. 1 Docket ho. 50-334, Licence Ho. DPR-66 l IE Inspection Report No. 82-01 Page 2 If you have any questions concerning this response, please contact my office.

Very truly yours, J. J. Carey Vice President, Nuclear cc: Mr. D. A. Beckman, Resident Inspector U. S. Nuclear Regulatory Commission Beaver Valley Power Station Shippingport, PA 15077 U. S. Nuclear Regulatory Commission c/o Document Kinagement Branch Washington, DC 20555

~

COMMONWEALTH OF PENNSYLVANIA)

) SS:

COUNTY OF BEAVER )

On this < v> M day of dh+< /J , /<7 P h , before me, .

vf/uS gofer t hm- , a Notary Ptfblic in and for said Commonwealth and County, personally appeared J. J. Carey, who being duly sworn, deposed, and said that (1) he is Vice President of Duquesne Light, (2) he is duly authorized to execute and file the foregoing Submittal on behalf of said Company, and (3) the statements set forth in the Submittal are true and correct to the best of his knowledge, information and belief, s

~

/f / f W tt4 N f)

HE601 MARilN. fdOTARY PUCLIC CHIPPfW4 TC'ANSil:P, P!/3ER COUNTY MY COMMISS 0N [xPmts Jgxi gg, jeg3 Member, Pennsylvane Assocuhoa et pg,4,,cg 9

9

'l DUQUESNE LIGHT COMPANY Beaver Valley Power Station Unit No. 1 Reply to Notice of Violation-Inspection 82-01 Letter dated April 1, 1982 VIOLATION A (Severity Level III; Supplement I)

Description of Violation (82-01-09)

Technical Specification 3.7.15 requires penetration fire barriers protecting safety-related areas to be functional at all times or establish a continuous fire watch on at least one side of the penetration within one -hour.

Contrary to the above, the following penetration fire barriers were non-functional for the periods indicated and no continuous fire watch was posted:

1. Fire barrier material was removed from a conduit penetration between the AE and DF Vital Bus rooms to install temporary cable about 9:15 p.m., January 27, 1982 and not reinstalled until 11:00 a.m., January 28, 1982.
2. A four inch diameter conduit penetration between the Auxiliary Feedwater Pump Room and the West Cable Vault switchgear areas was found uncapped and not packed with fire barrier material on February 5,1982. The time at which the penetration became nonfunctional could not be established.

Corrective Action In each case, upon notification that the penetration fire barrier was found nonfunctional, the penetration was immediately repacked with fire barrier material.

Action Taken To Prevent Recurrence A maintenance program which includes use of a permit system for administrative control of opening of existing fire barrier penetrations or creation of new fire barrier penetrations will be adopted. The program is expected to be available for use by June 30, 1982. In the interim, all maintenance personnel have been instructed not to open any fire barrier penetration without approval of their supervisors. These supervisors have been instructed in the requirements for either maintaining a fire watch during the time the barrier is open or re-establishing the barrier if it is to be left unattended. The maintenance supervisor and maintenance personnel involved in the incident have been given written reprimands.

Date On Which Full Compliance Will Be Achieved Full compliance has been achieved at this time.

, Beaver Valley Power Station, Unit No. 1 Reply to Notice of Violation _

Inspection 82-01 Page 2 VIOLATION B (Severity Level V; Supplement I)

Description of Violation (82-01-06) 10 CFR 50, Appendix B, Criterion II, requires that the OQA program provide for indoctrination and training of personnel performing activities afis-ting quality as necesaary to assure that suitabic proficiency is achieved and maintained. The BVPS FSAR, Appendix A.2.2.2, states that indoctrination and training measures assure that all responsible individuals are aware of quali ty policies, procedure and manuals and have an adequate understanding l

of these requirements. QA Procedure OP-14, Indoctrination and Training, Section 14.4.1, Revision 3, requires that station personnel be trained, as l appropriate to achieve special skills required in the performance of equipment protection, process, and test procedures and that retraining will be provided as necessary to maintain adequate proficiency. _

The BVPS thintenance Kanual, Chapter 1, Section A.5.b, General Roles for Implementation, Revision 14, requires mechanics, electricians, and technicians to receive indoctrination on specific procedures in the manual and to document its completion.

Contrary to the above, as of February 3, 1982, six mechanics, electricians and technicians had not received indoctrination on twenty of the forty procedures identified by the Maintenance Manual requirements.

Corrective Action A review has been conducted to determine the status of maintenance personnel indoctrination on required procedures. Personnel requiring indoctrination will be fully indoctrinated by June 25, 1982.

Action Taken To Prevent Recurrence A review of maintenance personnel indoctrination on required procedures will be conducted on a monthly basis. The results will be given to the 3 Maintenance and Instrument and Control Supervisors for any required action.

The first monthly review has been completed. .

Date On Which Full Compliance Will Be Achieved

=

Required indoctrinations will be completed by June 25, 1982.

a m

Ecaver Valley Power Station, Unit No. 1 Reply to Notice of Violation Inspection 82-01 Page 3 VIOLATION C (Severity Level V; Supplement I)

Description of Violation (82-01-01)

Technical Specification 6.5.2.7.e requires Offsite Review Committee (ORC) review of violations of applicable statutes, codes, regulations, orders, Technical Specifications, license requirements, or of internal procedures or instructions having nuclear safety significance.

Contrary to the above, for the period June 1980 through December 1981, the ORC f ailed to review such violations identified by: (1) Operations Quality Control Nonconformance and Corrective Action Reports; (2) BVPS Licensee Event Reports (30 day); (3) BVPS Incident Reports not issued as Licensee Event Reports; and (4) Quality Assurance Department 1980 Outage Surveillance Reports. No formal method of review and referral to assure such documents were provided for the committee review had been established.

Corrective Action The ORC has approved the establishment of four Subcommittees of the ORC to work in the areas of Audits and Inspections, Operations and Maintenance, Radiological Controls and Environment, and Engineering. Each Subcommittee will operate under a written Charter which will define the scope of audit, review and analysis responsibilities assigned. The Charters have been structured so as to provide a mechanism to permit a comprehensive review of the areas of ORC review as set forth in Technical Specification 6.5.2.7. Draft Subcommittee Charters have been prepared and ORC comments are being incorporated. The Charters will be presented to the ORC for approval at its next regularly scheduled meeting. Subcommittee Chairmen have been selected and have been approved by the ORC to perform the functions described in the Charters.

In its most recent mee t ing , the ORC reviewed both the 24-hour and 30-day LERs issued in the previous review quarter and will continue this practice in the future.

Incident Reports will be indexed and those Incident Reports or summary analysis of incidents having nuclear safety significance will be reviewed by the ORC. The Operations Quality Control Nonconformance and Corrective Action Reports have been reviewed by the Chairman, ORC but formal review by the ORC has not been undertaken.

We will prepare analyses of the OQC-NCARs on a quarterly basis and this analysis will be revicead by the ORC on a quarterly basis. The first analysis will cover NCARs issued during 1982. The QA Department Outage Surveillance Reports will be analyzed and the analysis distributed to ORC members for review. QA Procedure QAI 18.3.2 has been nodified to provide that the QA Surveillance Reports will be distributed to the Subcommittee Chairman of the Audits and Inspections Subcommittee.

l Beaver Valley Power Station, Unit No.1 Reply to Notice of Violation Inspection 82-01 Page 4 VIOLATION C (continued)

Action Taken To Prevent Recurrence The establishment of the ORC Subcommittees operating under ' formal Charters will-provide the necessary administrative structure and controls to assure that the ORC conducts its review responsibilities in accordance with the Technical Specifications.-

Date Upon Which Full Compliance Will Be Achieved

a. ORC Subcommittee Chairmen have been appointed and approved by the' ORC.
b. ORC Subcommittee Charters have been written and ORC comments are being incorpo ra ted . Approval of the ORC Subcommittee Charters is expected at the next regular ORC meeting, presently scheduled for June 15, 1982.
c. ORC reviews of 30-day LERs, OQC-NCARs, Incident Reports and QA Surveillance Reports will commence with the next ORC review cycle which begins on June 15, 1982 and will end no later than September 30, 1982.

9

Beaver Valley Power Stetion, Unit No. 1 Reply to Notice of Violstion Inspection 82-01 Page 5 VIOLATION D (Severity Level V; Supplement I)

Description of Violation (82-01-02) 10 CFR 50, Appendix B, Criterion X, requires that a program for inspection of activities affecting quality be established and executed to verify confermance with documented instructions and procedures for accomplishing the activity. The BVPS FSAR, Appendix A, Operations Quality Assurance Program, Section A.2.2.10, requires establishment of such a program, including written instructions and procedures for its implementation. The BVPS FSAR, Section A.2.2.2, states that the Operations Quality Assurance Program applies to plant operations associated with safety related structures, systems, and components. The DLC Quality Assurance Policy, a part of the BVPS Quality Assurance Manual, requires, in Section 10, that a program for the inspection of activities affecting quality be established, providing for inspections during operations.

Contrary to the above, as of February 5,1982, no program or instructions /

procedures for the inspection of operating activities had been established or executed. Examples of activities affecting quality not subject to inspection include: routine plant operations such as startup, shutdown, and routine system operation; reactor engineering activities; operating surveillance tests; equipment lubrication; chemistry activities; and equipment clearance / tagging activities.

Corrective Action , 77,tg Le gp i -

A program for the inspection of operating activities is currently being formalized. Requirements for the surveillance of routine plant activities, li[a operating surveillance tests, and equipment clearance / tagging activities will O@dpubb'd be incorporated into the procedures which detail the duties of the STAS.

Surveillance of activites such as equipment lubrication, chemistry, and reactor engineering will be included in the QA audit prog ram. Technical specialists will be utilized by the QA auditors where needed.

Action Taken To Prevent Recurrence The program for the inspection of operating activities as described above should prevent recurrence of this item.

Date On Which Full Compliance Will Be Achieved Procedure changes for STA inspections will be completed by May 15, 1982.

QA surveillance of chemistry activities was included in QA audit BV-1-82-07 performed in February, 1982. Surveillance of equipment lubrication and reactor engineering will be performed prior to September 1,1982.

, Beaver Velley Powar Station, Unit No. 1 Reply to Notice of Violation Inspection 82-01 Page 6 VIOLATION E (Severity Level IV; Supplement I)

Description of Violation (82-01-03) 10 CFR 50.59(b) requires records of changes in the facility or procedures as described in the safety analysis report including a written safety evaluation which provides the bases for the determination that the change does not involve an unreviewed safety question.

The BVPS Station Administrative Procedures, Chapter 10, Onsite Safety Committee, Revision 0, Paragraph C, requires that the Onsite Safety Committee (OSC), upon direction by the Station Superintendent, provide safety evalu-ations pursuant to 10 CFR 50.59 including the bases for the determination that the change does not involve an unreviewed safety question.

Contrary to the above the OSC failed to document the bases for 10 CFR 50.59 determinations for:

a. Temporary Operating Procedure (TOP) 80-27, Filling the RWST from the Boron recovery Tanks; OSC review documented by OSC Poll dated August 15, 1980 and OSC Minutes BV-0SC-104-80 dated August 25, 1980. TOP 80-27 permitted use of a temporary hose flowpath which constitutes a change to normal system operation as described by the Final Safety Analysis Report ,
b. TOP 81-83, River Water System Operation While Dredging Near Intake; OSC review documented by OSC Minutes BV-OSC-93-81 dated August 7, 1981. TOP 81-31 permi tted continued power operation with the non-safety related Auxiliary River Wa ter System cross connected with the main River Water System in a manner not described by Final Safety Analysis Report.

Corrective Action To provide documentation of the bases for the OSC safety evaluatiens, details of the safety evaluations which were discussed extensively at OSC meetings BV-0SC-104-80 and BV-OSC-93-81 were formalized in writing and presented at OSC meeting BV-0SC-48-82 for record purposes.

Action Taken To Prevent Recurrence More detailed written safety evaluations are being done to cover changes to the facility in all necessary cases and are included in the OSC minutes to provide sufficient documentation.

Date On Which Full Compliance Will Be Achieved Full compliance has been achieved at this time.

~

Beaver Valley Power Station, Unit No. 1 Reply to Notice of Violation Inspection 82-01 Page 7 VIOLATION F (Severity Level V; Supplement I)

Description of Violation (82-01-05)

Technical Specification 6.5.2.8 requires audits under the cognizance of the Offsite Review Committee, including:

(1) Pe rf o rmance , training, and qualifications of the entire facility staf f at least once per 12 months, and (2) Perforr ance of all activities required by the Quality Assurance Program at least once per 24 months.

10 CFR 50, Appendix B, Criterion II, requires the licensee to regularly review the status and adequacy of the Quality Assurance Program. Beaver Valley Power Station QA Procedure OP-1, Revision 4, Section 1.1.9 requires this ranagement review to be conducted biennially.

Contrary to the above:

(1) QA Audit BV-1-81-4 (Training) performed March 23 - April 9,1981 to meet the requirements of Technical Specification 6.5.2.8 did not include a review of performance of any facility group or the training and qualification of key facility groups, e.g. station engineering, unlicensed operators, maintenance, chemistry, and results and test.

(2) The "1980 Hanagenent Audit" performed to satisfy TS 6.5.2.8 and QA Procedure OP-1 requirements was incomplete in that it addressed only activities subj ec t to five of sixteen major Quality Assurance Procedures.

Corrective Action Taken >

A new audit checklist has been developed to audit the performance, training and qualifications of the entire facility staf f. 'Diis checklist provides for an audit on a sampling basis of the following facility staf f organizations:

( a. Plant Operations (including unlicensed operators) l

b. Plant Fhintenance
c. Radiological Operations
d. Station Engineering l e. Chemistry l f. Plant Testing l g. Training
h. Schneider
1. Sargent Electric
j. Dick Corporation
k. Construction Department Nuclear

Beaver Valley' Power Station, Unit No. 1-

- Reply . to Notice lof Violation Inspection 82-01 Page 8 VIOLATION F (continued)

Corrective Action Taken (continued)

A new audit matrix has been developed to satisfy TS 6.5.2.8 and QA Procedure OP-1 requirements to audit the performance of activities required by the Quality Assurance Program. ' This audit matrix covers the (FL procedure requirements OP through OP-16 and Appendix C (Fire Protection) of the QA Manual and identifies the applicability of these procedural requirements to 'each of the 21 Corporate and racility staf f sections performing work at Beaverf Valley. An' audit checklist will be developed to audit the performance requirements of each QA procedure with at 1 cast one Corporate or facility staff section and to audit all 21 Corporate and-facility staff sections wi;h respect to at least one QA procedure requirement, on a sampling basis. The long term audit-schedule will provide for the auditing of every Corporate and facility staff'section for every QA procedural requirement on -

a cycle of about 6 years. g gad (ogyp o,q yIL,7 Action Taken to Prevent Recurrence The establishment of a new audit checklist for the audit of the performance, training and qualifications' of the entire facility staff was used for the current audit and will be used as the basis for developing the audit checklists for future audits. The use of this checklist will ensure compliance with TS 6.5.2.8 requirements in this area in the future.

The establishment of the audit matrix for the audit of the- performance of activities required by the Quality Assurance Program as required by TS 6.5.2.8 and QA Procedure OP-1 will permit the preparation of comprehensive audit checklists to meet technical ~

specification and programatic requirements in the future.

l TWc establishment of the Audits and Inspection Subcommittee, reporting to the ORC, s Et1 provide ef fective ORC overview of the audit responsibilities of TS 6.5.2.8 and will assure administrative and technical control of the ORC audit process.

l l Date Upon Which Full Compliance Will Be Achieved The new audit checklist to audit the performance, training and qualifications of the entire facility staff has been prepared and the audit was completed April 26, 1982.

l The new audit matrix to audit the ef fectiveness of the Quality Assurance Program has been prepared and this audit will be performed by the Cooperative Ibnagement Audit Program (CMAP), a utility cooperative auditing organization, during September or October, 1982. The formation of the ORC Audits and Inspections Subcommittee has been approved and a Subcommittee Chairman has been appointed. The Subcommittee Charter is presently before the ORC for review and comment and is expected to be approved by the ORC at its next regular meeting, now scheduled for June 15, 1982. If the Charter is approved at that time, the Subcommittee will assume its responsibilities at that time.

I

(

Beavor Valley Power Station, Unit No. 1 Reply to Notice of Violation

~Inopection 82-01 Page 9 VIOLATION G (Severity Level V; Supplement = I)

Description of Violation (82-01-04) 10 CFR 50, Appendix B, Criterion XVIII, and the BVPS FSAR, Section A.2.2.18 require a comprehensive system of planned audits, performed by appropriately trained personnel, to verify compliance with all aspects of the Quality Assurance Program.

ANSI N45.2.12-1974 (endorsed by the BVPS FSAR, Attachment to. A.2) requires that: -(a) an audit system plant be maintained, reviewed, and revised as necessary to assure coverage of the QA program; (b) audit personnel quali-fications and requirements for use of technical specialists be established;-

and, (c) auditors be selected based on experience or training which establishes their qualifications to be commensurate with the complexity or special nature of the audited activities.

ANSI N18.7-1972 (endorsed by the BVPS FSAR, Section A.2.2, via endorsement of Regulatory Guide 1.33) requires audits to include observations of opera-tions and maintenance activities.

Contrary to the above:

a. No overall audit system plan is maintained as a method of assuring coverage of the QA program. Existing plans and schedules do not include actual confirmation of audit coverage,
b. Quality Assurance Department Instruction (QAI) 2.1.2, Training of Quality Assurance Personnel, Revision 5, and QA1 2.1.3, Training and Qualification of Auditors, Revision 4, do not specify audit personnel qualifications nor requirements for use of technical specialists -

commensurate with the complexity or special nature of the audited acitivities.

c. The auditors who conducted QA Audit BV-1-81-28 of plant operations on September 21 - October 7,1981 had neither experience nor training in nuclear power plant operations.
d. QA Procedure OP-16, Audits, Revision 2, does not include requirements for observations of operations and maintenance activities during audits. No such observations were documented in reports of ' operations and maintenance audits performed during 1980-1981.

. Beaver Valley Powar Station, Unit No.1 Reply to Notice of Violation Inspection 82-01 Page 10 VIOLATION G (continued)

Corrective Action

a. QA Procedure OP-16, Revision 2, in the scope specifies that a comprehensive planned system of audits is required to verify compliance with all aspects of the Operations Quality Assurance Program. Paragraph 16.4 specifies that audits must be planned in accordance with written procedures. Quality Assurance Instruction 18.1.1 (QAI 18.1.1) identifies the system for developing an audit schedule to ensure coverage of the applicable Quality Assurance Program requirements and assigns this responsibility to the Senior Quality Assurance Engineers. While a cross reference list between the audit schedule and the eighteen criteria of 10CFR50, Appendix B, is not required by the QAI, a review of the 1981 audits was performed that showed the requirements were satisfied.
b. All Quality Assurance Auditors who serve as lead cuidtors at Beaver Valley meet the qualification requirements of N45.2.23 as committed to by our reply to Generic Letter 81-01, dated August 4,1981. Quality Assurance Instruction 2.1.4, Revision 2, specifies the audit personnel qualification requirements which are met prior to certifying an auditor.

The Quality Assurance Instructions do not specify the method used to determine when a technical specialist is required. In the past, when it was determined by the audit team leader or Senior Quality Assurance Engineer that technical expertise was required, such as for audits of Environmental Technical Specifications and Fire Protection, technical specialists were part of the audit team.

c. The plant operations audit (BV-1-81-28) conducted on September 21 through October 7,1981 was an administrative cudit, not a technical specification audit. The auditors involved in the audit were qualified as audit team leaders under the existing Quality Assurance Department qualification system.

Duquesne Light Company Quality Assurance is aware of its committment to use technical specialists when the scope of the audit is of technical nature and the Quality Assurance auditors do not possess the required technical expertise. A technical specialist was not used on this audit because of the scope of the audit and the knowledge and experience of the audit team.

Our opinion has not changed as a result of a re-evaluation of the scope and complexity of the audit in question.

' . . Beaver Valley Power Station, Unit No. 1 Reply to Notice of Violation Inspection 82-01 Page 11 VIOLATION G (continued)

Corrective Action (continued)

d. As was stated in the inspection report, ANS1 N18.7-1972, Administrative Controls for Nuclear Power Plants, Section 4.4 requires audits to include observations of operations and maintenance activities. This requirement refers to audits performed by the independent review and audit group which at Beaver Valley Power Station, Unit #1, is the Of f site Review Committee (ORC) .

These audits are not covered in OP-16 Audits, but are covered in OP-3, Administrative Cont rols, paragraph 3.4.3 which states, "The Of f site Review Committee (ORC) shall conduct technical audits of station operations including the performance of both equipment and operating personnel". OP-3 also allows the ORC to delegate the task of performing the audits to other individuals or groups.

The Quality Assurance Department conducts audits required by the Quality Assurance Program, OP-16, and has been delegated to perform ORC sponsored audits to meet the Technical Specification requirements. Audits conducted to me e t the Quality Assurance Program, OP-16 are more administrative in nature than ORC sponsored audits which are technical in nature. The audits reviewed during the inspection were audits conducted by the Quality Assurance De partment to meet the Quality Assurance Program, OP-16, requirements. The practice in the past has been to rely on the checklist for documenting the areas reviewed without providing specific items or activities that were inspected to answer a checklist question. All members of the Quality Assurance Department have been instructed to use the checklist comment sheet to document the items or activities that are reviewed during an audit.

Action Taken To Prevent Recurrence

a. To provide documented evidence that the Quality Assurance Program requirements are met, a matrix will be developed to cross reference requirements with the audit schedule. Also, QA1 18.1.1 will be revised to include the requirment for a matrix.
b. The appropriate Quality Assurance Instruction will be revised to identify the method used for determining the need for technical specialists,
c. No additional action is required.
d. The appropriate Quality Assurance Instruction will be revised to incorporate the requirement for documenting observations of activities.

Date On Which Full Compliance Will Be Achieved

a. QAI 18.1.1 will be revised and a matrix will be developed by September 30, 1982.
b. The appropriate QA1 will be revised by July 31, 1982.
c. We are in compliance at this time.
d. The appropriate QAI will be revised by July 31, 1982.

_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ - - _ . _ _ _ _ . _ . _ _