ML20133D154
| ML20133D154 | |
| Person / Time | |
|---|---|
| Issue date: | 07/19/1985 |
| From: | Newton C NRC |
| To: | Hedges D NRC |
| References | |
| REF-WM-1 NUDOCS 8508070248 | |
| Download: ML20133D154 (23) | |
Text
DOE F 1325'3 (12-84) l United Stat:s Governmant D p;rtm:nt of Ennrgy
' memorandum DATE:
JUL 10 1985 REPLY TO ATTN OF:
RW-23
SUBJECT:
l Report of July 9-11, 1985 Quality Assurance Audit l
l Jeff Neff To:
l Attached is the report of the quality assurance audit conducted i
by HQ-0GR of the Salt Repository Project Office July 9-11, 1985.
Please provide your written response to the nine findings and two
(
observations within 30 days of your receipt of this memorandum.
l-Your response should include a statement of the root cause for each finding, the specific corrective action you propose to take and a schedule for completion of all corrective actions.
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Purcell
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Associate Director for Geologic Repositories, Office of Civilian Radioactive Waste Management
Attachment:
Audit Report 85-S-1 l
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Page 1 of 17 AUDIT REPORT 85-S-1 DATE OF AUDIT: July 9-11,1985 PROJECT NAME: Salt Repository Project Office
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ACTIVITY AUDITED:
SRP0 QA Activities, Columbus, Ohio AUDIT SCOPE:
Implementation of SRPO Quality Assurance Manual AUDIT TEAM:
Carl Newton, DOE-HQ, Team Leader Craig Walenga, NRC, Observer Ed Sulek, Weston, Member Dale Hedges, NRC, Observer John Malvin, Weston, Member h'
EXECUTIVE SUM 4ARY:
The three major concerns identified during the audit were the lack of definition of the QA Program, incomplete or inconsistent implementation of the Program, and inadequate training.
The inadequate definition of the QA Program results from the failure to address some of the requirements of the NRC Review Plan and, in some cases, the failure to define "how" an activity is to be performed.
Findings 2, 3, 4, l
6 and 7 are examples.
Incomplete and inconsistent implementation of the program is indicated by the l
following:
(1) nonconformance and corrective action procedures are not being implemented; (2) the QA records system is not being used; and (3) the method l
for documenting the SRP0 Chiefs' and QA Manager's review of procurement documents is inconsistent. Examples are found in finding numbers 4 and 5 and in observation number 1.
The indoctrination and training program described in SRPO procedures does not provide for the training of personnel performing activities affecting quality in the purpose, scope, and implementation of quality related procedures. This l
is considered to be a significant factor in assuring effective and consistent implementation of the QA Program. An example is found in finding number 8.
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Page 2 of 17 PURPOSE:
The purpose of the audit was to assess the status and adequacy of the SRP0 QA program and the effectiveness of its implementation.
The audit covered SRP0 activities described in the following QA criteria of Appendix B to 10 CFR part 50:
I - Organization II - Quality Assurance Program III - Design Control IV - Procurement Document Control V - Instructions, Procedures & Drawings VI - Document Control VII - Control of Purchased Material, Equipment, and Services XV - Nonconforming Materials, Parts and Components XVI - Corrective Action XVII - Quality Assurance Records XVIII - Audits CHRONOLOGY OF AUDIT:
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Preaudit Meeting.
A preaudit meeting was held at 8:30 a.m. on Tuesday, July 9,1985 to inform SRP0 of the scope and purpose of the audit. The audit team members were introduced including the two NRC observers. The SRP0 project manager introduced the project personnel. A list of project personnel to be interviewed by the audit team and approximate times for the interviews was then finalized. The project manager next provided a briefing on the project organization and a progress report on the status of project activities. Attendees at the preaudit meeting are identified on the attendance sheet which is page 4 of this report.
Conduct of Audit.
Following the preaudit meeting, the audit team was divided into two groups.
Ed Sulek led one group and Carl Newton the other.
Each group was accompanied by one NRC observer and by one SRP0 representative escort.
The groups then conducted interviews of the identified project personnel using the checklist questions as a guide.
All SRP0 persons contacted during the audit were courteous and professional in their response l
l to the auditors' questions. The list of project personnel contacted and interviewed are identified on page 5 of this report.
Exit Meeting: An exit meeting was held at 3:00 p.m. on Thursday, July 11, 1985, to advise SRP0 of the audit findings and observations. A draft audit report was furnished to the project manager and other attendees and the findings and observations were discussed. A total of nine findings and two i
j observations were reported. The list of attendees at the exit meeting is on page 6 of this report.
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o Page 3 of 17 POSITIVE FEATURES:
The audit team observed a number of positive features in the SRP0 Program during the audit.
Among these are:
(1)
SRP0 has added a full-time QA Manager; (2)
Quality Assurance audits, especially those conducted recently, are very well documented and appear to meet all applicable requirements; (3)
SRP0 is doing an eff"tive job of controlling distribution for documents that are being controlled.
SRP0 has documented their internal distribution of the DOE-HQ baselined documents and is effectively controlling internal distribution; (4)
SRP0's review of the early (drilled) conceptual design of the i
repository shaft appeared to be thorough and well documented. SRP0 0
is now closely controlling the new (mined) conceptual design of the exploratory shaft through documented reviews of many inte aediate technical deliverables; g.
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(5)
Reviews of technical documents submitted to the Siting Branch are being carefully carried out under a component procedure developed for use within the Branch; and (6)
A complete revision of the QA Manual is underway and a number of implementing procedures are being developed.
AUDIT RESULTS:
Nine findings and two observations were identified during the audit and are described on pages 7 through 17 of this report.
These should be taken as being representative of deficiencies observed by the auditors, but may not be all inclusive.
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/ AUDIT TEAM MEMBER
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AUDIT TEAM LP.ADER DATE i -
7 Page 4 of 17 ATTENDEES AT PREAUDIT MEETING DATE: July 9,1985 NAME ORGANIZATION TITLE 1.
Carl Newton DOE-HQ QA Manager 2.
Edward W. Sulek Weston QA Manager 3.
John H. Malvin Weston QA Spec.
4.
Tilak R. Verma NRC-Col s Senior License Rep.
5.
Andrew Avel SRP0 Engineer
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6.
William C. Sidle SRP0 Geochemist 7.
Bob Waters SRP0 Project Engineer 8.
Sarah Starr SRP0 Information Management Spec.
9.
Michael Ferrigan SRP0 Geophysicist 10.
Leo Page SRP0 Hydrologist 11.
Ram B. Lahoti SRP0 Chief, Engineering & Technology f
- 12. Jesse L. England SRP0 Chief, Contracts & Administration 13.
Gordon Appel SRP0 Geologist 14.
Dale Hedges NRC-WM QA
- 15. Phil Van Loan SRP0 Chief, Budget & Project Control 16.
J.0. Neff SRP0 Project Manager
- 17. Jay G. Jones SRP0 Geologist 18.
Loren 0. Ramsett CER Consultant (QA) 1
- 19. Jerry Reese SRP0 QA Manager Chief, Site Evaluation
- 20. Jo-Ann Sherwin SRP0
- 21. Jeff Williams SRP0 Physical Scientist j
22.
Susan L. Buchanan SRP0 Geologist l
23.
Robert Wunderlich SRP0 Deputy Manager f
24.
G.G. Walenga NRC QA Specialist
r Page 5 of 17 PERSONNEL CONTACTED DURING AUDIT DATE: July 9-11,1985 NAME ORGANIZATION TITLE 2
1.
Ram Lahoti SRPO Chief Engineering & Technology Branch 2.
Xeith Robinette SRP0 Program Engineer 3.
Jo-Ann Sher $1n SRPO Chief, Site Evaluation Branch j
I 4.
Susan Buchanan SRPO Staff Geologist 5.
Jerry Reese SRP0 Quality Assurance Manager r
<5.
Robert Wunderlich SRP0 Deputy Manager, SRPO F
- 7. ' "Jsff Neff SRP0 Manager, SRP0 8.
Jesse England SRP0 Chief, Contracts & Administration Branch 9.
Loren Ramsett CER Quality Assurance 10.
Sara.Starr SRP0 Information Manageme,nt Specialist 11.
, Roger Wu
'SRP0 Waste Package - Profect Manager 12.
Leslie Casey SRP0 Systems Engineering - Project Manager i
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ATTENDEES AT EXIT MEETING Date: July 11,1985 I
Name Organization Title Carl Newton DOE-HQ QA Manager Edward W. Sulek
/
Weston QA Manager John H. Malvin Weston QA Specialist R.B. Lahoti DOE-CH-SRP0 Chief, Engineering and Technology D.K. Robinette DOE-CH-SRP0 Program Engineer Teek Verma NRC-Columbus Sr. Licen. Rep.
J.0. Neff DOE-CH-SRP0 Project Manager S.E. Starr DOE-CH-SRP0 Information Management Analyst Lorren Ramsett CER Consul tant JdhAMSherwin DOE-CH-SP0 Chief, Site Evaluation T.J. RAese DOE-CH-SRP0 QA Manager R.C. Wunderlich DOE-CH-SRP0 Deputy Manager Dale Hedges NRC QA C.G.'Walenga NRC QA J.L. England DOE-CH-SRP0 Chief, Contracts &
Administration S.L. Webster DOE-CH-SRP0 Project Engineer A.P. Avel DOE-CH-SRPO Project Engineer G.J. Marmer ANL Physicist P. A. Green MAXIMA Project Manager R. S. Waters DOE-CH-SRP0 Project Engineer J.G. Jones DOE-CH-SRP0 Geologist K.K. Wu DOE-CH-SRPO Waste Package Project Manager
Page 7 of 17 AUDIT FINDING NUMBER 1 REPORT NO.:
85-S-1 DATE OF AUDIT: July 9-11,1985 3
AUDITOR: Carl Newton FINDING DISCUSSED WITH: Ram Lahoti, Chief Engineering &
Technology Branch SIGNED BY:
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REQUIREMENT:
The NRC QA Review Plan, Appendix A, Paragraph 3.2, states:
" Performance requirements are specified for repository system components to support:
establishment of a graded QA approach...p'(a) identification of which items are im FINDING:
Performance requirements are not specified for repository system components as required by the NRC Review Plan.
Also, the items which are important to waste isolation have not been identified nor has a graded approach to QA been established.
Page 8 of 17 AUDIT FINDING NUMBER 2
.g REPORT NO.:
85-S-1 DATE OF AUDIT: July 9-11,1985.
AUDITOR:
Carl Newton FIleING DISCUSSED WITH: Jo Ann Sherwin, Chief, Site Evaluation Branch SIGNED BY:
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- REQUIREMENT:
The NRC QA Review Plan, Appendix A, Paragraph 3.6, states:
" Procedures require that design drawings, specifications, criteria, and analyses be l
reviewed by the QA organization to assure that the documents are prepared, reviewed, and approved... "
FINDING:
The required QA reviews are not required by the SRP0 QAPs and are not being performed by SRP0.
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Page 9 of 17 AUDIT FINDING NUMBER 3 REPORT NO.:
85-S-1 DATE OF AUDIT: July 9-11,1985 AUDITOR: Carl Newton FINDING DISCUSSED WITH: Jerry Reese, Manager, Quality Assurance SIGNED BY:
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REQUIREMENT:
Section 15 of the NRC QA Review Plan requires that a nonconformance procedure be established. Section 16 requires that a corrective action be established.
FINDING:
The procedure for documenting and controlling non-conformances does not meet the requirements of the NRC QA Review Plan and is not effectively implemented.
The procedure for corrective action, likewise, neither meets the requirements nor is being effectively implemented, s
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Page 10 of 17 AUDIT FINDING NUMBER 4 REPORT NO.:
85-S-1 DATE OF AUDIT: July 9-11,1985 AUDITOR:
Carl Newton FINDING DISCUSSED WITH: Jerry Reese, Manager, Quality Assurance SIGNED BY:
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The NRC QA Review Plan, in Paragraph 17 of Appendix A, requires that a QA Records System be implemented and specifies:
(1) that the scope of the records program be described; (2) that responsibilities for implementation be defined and; (3) that suitable storage facilities be described and utilized.
FINDING:
SRP0 has not implemented a QA Records System that meets the requirements of the NRC QA Review Plan.
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Page 11 of 77 AUDIT FINDING NUMBER 5 REPORT NO.:
85-S-1 DATE OF AUDIT: July 9-11,1985 AUDITOR:
Carl Newton FINDING DISCUSSED WITH: Jerry Reese, Manager, Quality Assurance SIGNED BY:
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i i if-REQUIREMENT:
Appendix A of the NRC QA Review Plan requires the following:
(a)
That audits be perfonned of representative subcontractors (Paragraph 18.1)
(b) That audit findings be trended (Paragraph 18.6)
(c) That in resolving findings the root cause of the finding be identified (Paragraph 18.8)
Also, NQA-1 requires:
(d)
That lead auditors have participated in at least five QA audits within the past three years (Supplement 25-3, Paragraph 3.3).
FINDING:
The SRP0 auditing program does not meet the above requirements of the NRC QA Review Plan and of NQA-1.
Page 12 of 17 AUDIT FINDING NUMBER 6 REPORT NO.:
85-S-1 DATE OF AUDIT: July 9-11,1985 AUDITOR:
E.W. Sulek FINDING DISCUSSED WITH: Jerry Reese, Manager, Quality Assurance SIGNED BY:
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REQUIREMENT:
The NRC QA Review Plan, Appendix A, Paragraph 2.2 requires the QA Program [
to include a commitment that development, control and/or use of computer programs will be performed in accordance with the QA Program.
FINDING:
The SRP0 QA Program does not include such commitment for the control of computer programs and procedures describing the controls have not been provided.
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Page 13 of 17 AUDIT FINDING NUMBER 7 REPORT NO.:
85-S-1 DATE OF AUDIT: July 9-11,1985 AUDITOR:
E.W. Sulek FINDING DISCUSSED WITH: Jerry Reese, Manager, Quality Assurance SIGNED BY:
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REQUIREMENT:
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The NRC QA Review Plan, Appendix A, Paragraph 2.7 requires the QA Program F
to provide a description of how management (above or outside the QA organization) regularly assesses the scope, status, adequacy, and compliance of the QA Program to 10 CFR 50, Appendix B.
FINDING:
The SRP0 QA Program does not require the assessments to be made by management above or outside the QA organization.
There is no evidence that management assessments have been made by individuals above or outside the QA organization.
Page 14 of 17 AUDIT FINDING NUMBER 8 REPORT NO.:
85-S-1 1
DATE OF AUDIT: July 9-11,1985 t
AUDITOR:
E.W. Sulek FINDING DISCUSSED WITH: Jerry Reese, Manager, Quality Assurance SIGNED BY:
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'M REQUIREMENT:
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The NRC QA Review Plan, Appendix A, Paragraph 2.8 requires indoctrination,,
training and qualification programs to be established such that:
- Personnel responsible for performing quality-related activities are instructed as to the purpose, scope and implementation of quality related procedures.
- Personnel verifying activities affecting quality-related activities are qualified.
- Appropriate management monitors the performance of individuals involved in activities affecting quality to determine the need for retraining.
- Qualified personnel are certified.
FINDING:
The required indoctrination, training and qualification programs have not been established.
Page 15 of 17 AUDIT FINDING NUMBER 9 REPORT NO.:
85-S-1 DATE OF AUDIT: July 9-11,1985 AUDITOR:
E.W. Sulek FINDING DISCUSSED WITH: Jesse England /L. Ramsett
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V REQUIREMENT:
h The NRC QA Review Plan, Appendix A, Paragraph 7.2 requires the SRP0 QA
. Program to describe the involvement of the QA Organization in supplier selection and bid evaluation.
FINDING:
The SRPO QA Program does not describe the involvement of the QA l
Organization in supplier selection and bid evaluation.
Page 16 of 17 AUDIT OBSERVATION NUMBER 1 REPORT NO.:
85-S-1 4
DATE OF AUDIT: July 9-11,1985 AUDITOR:
E.W. Sulek OBSERVATION DISCUSSED WITH:
J. England, Chief, Contracts & Administration Branch; L. Ramsett, CER SIGNED BY:
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REQUIREMENT:
SRP0's QAP 4.0, Paragraph 5.2, requires the QA Manager and cognizant SRP0 Chief to review and approve procurement documents for compliance with specified criteria.
OBSERVATION:
In reviewing the Battelle contract and modifications and the Parsons-Redpath contract and modifications, evidence that such reviews had been performed was not always available in the files of the chief of contracts and administration.
In addition, the evidence of approvals, I
when available, was inconsistent in format.
l AUDITOR COMMENT A form has been developed and is recently in use to document these reviews and approvals.
This form should be documented in SRP0 procurement document control procedures.
Page 17 of 17 AUDIT OBSERVATION NUMBER 2 REPORT NO.:
85-S-1 l
DATE OF AUDIT: July 9-11,1985 b
AUDITOR: John Malvin OBSERVATION DISCUSSED WITH: Jerry Reese, Manager, Quality Assurance
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REQUIREMENT:
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The NRC QA Review Plan, Appendix A, Paragraph 18.6, states:
"A tracking system for audit findings is established to help assure that all findings are appropriately addressed and to trend audit findings."
OBSERVATION:
The SRP0 does not have an audit tracking system. Audit tracking is performed by ONWI, but documentation of the results is not routinely provided to the SRPO.
Also, no trending has been performed to date.
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United St:tzs Gov:rnm:nt Dep:rtm:nt cf En:rgy
- memorandum 3yL i 91985 DATE
REPLY To ATTN oF:
RW-23
SUBJECT:
Quality Assurance Coordinating Group (QACG) Meeting Sally Mann, CRPO To:
Jeff Neff, SRPO Don Vieth, NNWSI Lee Olson, BWIP The OACG will meet in Columbus, Ohio on July 30 through August 1, 1985.
The meeting will be held in Battelle Project Management m
Division's (BPMD) Building No. 13, Conference Room No. 13-6-080 (6th Floor PCC).
Badges may be picked up in the lobby of Building 13 which is located at the rear of tl. main building at 505 King Avenue.
(Easiest access to building 13 is f rom the Fif th Avenue entranc4 to the parking lot.)
The objective of the meeting is to exchange information and develop a consensus on several program-wide QA activities.
Discussions will be held on the results of HQ QA audits of the project offices, status of development and implementation of project office QA programs, proposed methodology for designating non 0-list quality classes and approaches to graded QA. _A presentation will be made by M.E. Lanagston on the OCRWM Quality Management Policies and Requirements Document.
The meeting will also serve as a workshop for reaching consensus on eight key quality issues:
(1)
Computer Software Control (2)
Control of Measuring and Test Equipment (3)
QA Records (4)
Reliability of Existing Data (5)
Peer Review (6)
QA for R&D (7)
Oversight of Field Actitivies (8)
Significant Problem Reporting The attached agenda includes comments received from QACG members on the draft agenda that was telefaxed to them on June 24.
It is expected that we will complete the agenda items by 5:00 pm on August 1 and travel plans may be made accordingly.
s Should additional information be required, please contact Carl Newton.
Ralph Stein, Director Engineering & Licensing Division Office of Geologic Repositories
Attachment:
Agenda for QAGC Mtg.
cc: w/
Attachment:
Pierre Saget, BWIP John Clark, BWIP
,-r Mike Nicol, RHO i
Jim Blaylock, WMPO Stan Klein, SAI Jerry Reese, SRPO E.
Patzer, BMPD W.
Kehew, CRPO D.
Lozier, BMPD M.
Flannigan, DOE-CH E. Langston, RW-43 E.
Sulek, Weston Ralph Stein, RW-23 Charles Head, RW-23 VBale Hedges, NRC Harold Steinberg, RW-33
6 M
Ag:nda j
.QACG Meeting July 0 - August 1, 1985 Columbus, Ohio July 30 1.
Opening Remarks Chairman 8:30-9:00 o
General Comments o
Status of Q-List Methodology o
DOE /NRC Resolution of QA Independence o
Status for QA Program at HQ 2.
Threshold Point for Application of 10 CFR 21 C. Newton 9:00-9:30 J. Reese 3.
Review Action Items From Previous Meeting Sec retary 9:30-10:00 Break 10:00-10:15 4.
Report on HQ QA Audits of P.O. 's Chairman 10:15-11:00
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5.
Status of W R Document E. Langston 11:00-12:00.
Lunch 12:00-1:00 6.
Report on SCP Preparation (QA Section)
BWI P 1:00-2:00 NNWSI o
Status SRPO o
Problems / Issues-7.
Status of Project Office QA Program Projects 2:00-3:30 o
Procedures o
Implementation Break 3:30-3:45 8.
Proposed Methodology on Sulek 3:45-5:00 Quality Levels for Non Q-List Items.
l Followed by Open Discussion L
July 31 i
9.
Next QACG Meeting Secretary 8:30-9:00 o
Presentation on Central Location
- Accommodations
- Prices o
Establish Location & Dates o
Identify Proposed Agenda Items All 9:00-9:30 i
, - ~ - - - -...,--- ---- -.---.
- 7. v July 31
- 10. Workshop on QA Program Requirements 9:30-5:30 (a) Computer Sof tware Control D. Lozier 9:30-10:45 Break 10:45-11:00
( b) Control of Measuring & Test Equipment M. Nicol 11:00-12:00 Lunch 12:00-1 00 (c) QA Records C. Williams 1:00-2:30 Break 2:30-2:45 (d) Reliability of Existing Data J. Blaylock 2:45-4:00 (e) Peer Review M. Nicol 4:00-5:30 August 1
- 10. Workshop on QA Requirements (Cont.)
(f) QA for RED J. Blaylock 8:30-10:00 Break 10:00-10:15 (g) Oversight of Field Activities E. Sulek 10:15-11:30 Lunch 11:30-12:30 i
(h) Significant Problem Reporting E. Sulek 12:30-2:00
- 11. Review and Recap All 2:00-4:00 l
Identification of Action Items All 4:00-5:00
- 12. Adjourn l
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