ML20215M652
| ML20215M652 | |
| Person / Time | |
|---|---|
| Issue date: | 10/28/1986 |
| From: | Grimes B NRC OFFICE OF INSPECTION & ENFORCEMENT (IE) |
| To: | Browning R NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| References | |
| REF-WM-16 1453, NUDOCS 8611030132 | |
| Download: ML20215M652 (7) | |
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'hjc'um to N623Tf MEMORANDUM FOR:
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" Division ~of Waste Management Office of Nuclear Material Safety and Safeguards FROM:
Brian K. Grimes, Director Division of Quality Assurance, Vendor, and Technical Training Center Programs Office of Inspection and Enforcement
SUBJECT:
REVIEW 0F SALT REPOSITORY PROJECT QA PLAN In response to a request from the Repository Projects Branch, the QA Branch reviewed the Salt Repository Project Office (SRP0) " Quality Assurance Plan,"
Revision 0, dated December 4,1985 against the " Criteria for QA Program (High-Level Waste Repository Program)," (Appendix A of Enclosure 'l to the Browning to
.Bennett letter of June 29,1984). This review resulted in th enclosed request
- for additional information (RAI).
Sections 1.0 through 18.0 of the plan each have a Subsection 4, " Requirements."
These subsections were thought to. serve the same purpose as NNWSI-50P-02-01, "QAPP Requirements for Participating Organizations and NTS Support
. Contractors." My August 18, 1986 memo to you indicated we had reviewed
~
NNWSI-SOP-02-01 against NQA-1 as well as against the NRC review' plan, and we started to take the same approach with these subsections. We found,
.however, that NQA-1 requirements are not all reflected in the plan.
For example, the plan does not address SNT-TC-1A as required by Supplement 2S-2 of 4
NQA-1. Nor does it.specify certification documentation required by Supplements
.~
2S-1 and 2S-3 of NOA-1. Thus we did not complete our review ~of the plan vs.
NQA-1, and the enclosed RAI. includes no items from NQA-1.. Although the NRC has not endorsed NQA-1, SRP0 should be asked to explain as a point of information why the " Requirements" subsections do not include the basic and supplemental requirements of NQA-1 which are specified by the OCRKM as "the basic OA e
requirements standard." -(
Reference:
Section 5.2, DOE /RW-0032, " Quality Assurance Management Policies and Requirements," October-1985.)
The' enclosed RAI should lead to a QA program description in compliance with NRC regulations which, when properly implemented, will meet DOE's programmatic QA responsibilities regarding the DOE Chicago Operations Office waste storage investigations. We suggest the enclosed RAI be forwarded to DOE for response.
We also suggest a working meeting between SRP0 personnel and NRC so that we can
Contact:
J. Spraul, X-24530
% U030I32 1A As3o
Enclosure Page 1 of 5 REQUEST FOR ADDITIONAL INFORMATION SALT REPOSITORY PROJECT OFFICE QUALITY ASSURANCE PLAN REVISION 0, December 4, 1985 1.
The SRP0 Quality Assurance Plan was written prior to the following NRC June 1986. draft generic technical positions (GTPs):
a.
Peer review.
b.
Qualification of existing data, c.
Items and activities subject to QA requirements..
An evaluation should be made against the draft guidance of these GTPs, and differences between the plan and the draft GTPs should be addressed.
2.
Section 1.3 of the plan indicates that SRPO delegates some authority for the QA program to Prime Contractors.
Identify the SRP0 Prime Contractors and describe the major delegation of work involved in establishing and implementing the QA program.
(1.2)*
3.
Clarify whether the Prime Contractors and other participants under direct contract to DOE for Salt Repository Project work report to DOE-HQ, DOE-CH, or DOE-SRP0.
(1.3) 4.
Section 1.3.1 of the plan states: "The Project Manager, SRP0 executes his QA responsibilities by approving this QA Plan and the implementing Quality Assurance Administrative Procedures (QAAPs) which set forth the requirements of the SRP0 QA Program." Revise this sentence to clarify that the Project Manager, SRP0 also performs other activities to execute his QA responsibilities, as discussed in the remainder of the section.
5.
Section 1.3.3 of the plan indicates the SRP0 verifies effective implementation of the QA program.
Clarify that this includes at least an annual audit of the Prime Contractors.
(1.4) 6.
Show the location (e.g., onsite or offsite) of the organizational elements shown on Attachments A and 8 to Section 1.0 of the plan. This should also be required of other SRP organizations.
(1.7) 7.
Describe how the extent of SRP0 QA controls is determined.
(1.8)
- The number in parenthesis after an RAI refers to the specific guidance in the NRC review plan.
e Enclosure Page 2 of 5 8.
Sections 1.3.3. and 1.4.1.2 of the plan address stop work. Describe how stop work requests are initiated and completed, and clarify the retention -
time of records of stop work requests.
(1.12) 9.
Identify items and activities covered by the QA program. Clarify whether importance to safety and importance to waste isolation are defined as numerical performance objectives and standards. Justify why not if not.
(2.1)
- 10. Section 2.4.1 of the plan addresses computer software control. Provide a commitment in the plan that SRP0 computer activities will meet the commf $a.nts of Section 2.4.1 and the guidance of NUREG-0856.
(2.2)
- 11. Section 1.3.3.1 of the plan indicates the Chief, Quality Assurance, is responsible for the development, maintenance, issue, and control of Quality Assurance Administrative Procedure (QAAPs).
Clarify that these responsibilities include the review and documented concurrence with all SRP0 quality-related procedures relative to QA requirements.
(2.4) 12.
Identify existing and proposed SRP0 QAAPs and detailed technical procedures reflecting that each criterion of 10CFR50, Appendix B, appropriate to specific items and activities will be met.
(2.6)
- 13. Describe measures by SRP0 which ensure that applicable regulatory requirements and design bases are reflected in design, procurement, and procedural documents. Also, describe measures which ensure that performance goals are specified for repository subsystems and components to support the establishment of data gathering and analysis needs.
Discuss the timeliness of specifying these requirements. At the latest, planned performance allocation should be addressed in the SCP consistent with agreements reached in NRC/ DOE meetings of April 17, 1981 and September 26 and 27, 1985 on this matter.
(3.2) 14.
Describe organizational responsibilities for preparing, reviewing, approving, verifying, and validating design and design information documents.
(3.3) 15.
Describe measures which ensure that design drawings, specifications, criteria, and analyses are reviewed by a QA organization to assure that the documents are prepared, reviewed, and approved in accordance with documented procedures and QA requirements. Also clarify what is meant by
" design reports" in Section 3.3.2.4.a of the plan.
(3.6)
- 16. Section 3.4.5 of the plan addresses design verification. Describe measures which ensure that design checking, which includes such things as confirmation of the numerical accuracy and computations and the accuracy of data input to computer codcs, will be performed.
(Confirmation that the correct computer code has been used is part of design verification.)
Design verification should be performed by persons other than those performing design checking. Clarify whether personnel performing design verification can be associated with the responsible design organization.
(3.7;
=
Enclosure Page 3 of 5
- 17. Section 3.4.9 of the plan addresses design changes. Clarify whether a configuration control system is in place such that design changes, including field changes, are analyzed to ensure they are required, are subject to the same design controls as the original design, are communicated to all affected groups and individuals, and are considered for changes to procedures and training.
(3.10)
- 18. Section 4.3.2.1 of the plan requires that integrated contractor task agreements include the " applicable requirements of this Section," whfie Section 4.3.2.1 requires that procurement documents and interagency agreements are in accordance with the " applicable requirements of Section 4.4."
Similarly, Section 4.3.2.1 indicates the Chief, Budget and Project Control, is responsible for preparation and implementation of QAAPs, while the Chief, Contracts and Administration, shall ensure that QAPPs are developed and implemented.
Clarify the significance of these differences in handling the different types of procurement documents.
Also clarify why Section 7.3.1.2 of the plan requires incorporation of applicable requirements of Section 7.4 in procurement 0AAPs while Section 7.3.1.3 does not have a comparable requirement for integratad contractor task agreement QAAPs.
- 19. Section 5.3 of the plan indicates that SRP0 retains overall responsibility for assuring that the doers implement the instructions, procedures, and drawings which prescribe activities that affect quality.
Identify who (by position title) within SRP0 has this responsibility and describe how this responsibility is met.
(5.1)
- 20. Section 6.4.1.a of the plan gives examples of the types of documents controlled in accordance with the document control system. Clarify that the responsible QA organization reviews and concurs with these documents with respect to quality-related aspects.
(6.2)
- 21. Section 7.3.1.e of the plan indicates that SRP0 Chiefs are responsible for accepting delivered items. Clarify the responsibilities of the SRP0 Chiefs (including the Chief, Quality Assurance) for receipt inspections.
(7.2) 22.
Describe measures which ensure that suppliers' certificates of conformance are periodically evaluated by audits, inspections, or tests to assure they are valid and the results documented.
(7.4)
- 23. Section 9.2 of the plan includes a number of processes.
Differentiate items in the list between processes that will be classified as special processes and those that will not.
If necessary, expand the list to provide such examples.
(9.1)
7 y
Enclosure Page'4 of 5
~24.
Sections 10.3, 9.3, and 8.3 of the plan state that SRP0 retains the overall responsibility for ensuring that " documents... are controlled.... " Clarify each of these sections to show that SRP0 has more:than document control responsibilities in the areas of inspection, process control, and item identification and control.
- 25. Section.10.3.1.2 of the plan indicates involvement of SRP0 QA in the QA planning function. Clarify whether SRP0 requires similar QA involvement
-in the inspection planning activities required by Section 10.4.1 of the plan.
(10.1)
- 26. Section 10.4 of the plan addresses inspection requirements. - Clarify that Section 10.4 is met by SRP0 in its inspection activities. Section 10.4.5 of the plan. addresses inspector qualification and permits inspections by personnel outside QA organizations. The inspection function may be part
-of the line organization provided that the QA organization perfonns periodic surveillance to confirm sufficient independence from the individuals who performed the activity. Clarify section 10.4.5.c
-accordingly.
(10.2)
- 27. _ Section 10.4.5 also refers to personnel-with "special" expertise.
Describe QA's involvement in determining the expertise required commensurate with the technical complexity of the inspection function and the acceptability of the qualifications of the inspector. -(10.3)
- 28. Describe measures which ensure that, when practicable, tests of structures, systems, and components shall be at conditions which simulate both normal and anticipated off-normal operations.
(11.5)
- 29. Section 15.1 of the plan refers to activities and items which do not confonn to the SRP0 QA Program requirements. Clarify that the purpose of Section 15.0 is to also address activities and items which do not conform to SRP0 technical requirements. Also clarify the first sentence of Section 15.3.2.1.b of the plan which indicates that "use-as-is" and
" repair" dispositions will correct the nonconforming condition.
- 30. Describe measures which ensure that the significance of each nonconformance is assessed to determine whether corrective action is required to prevent recurrence.
Identify the organization responsible for this assesment, and identify the management level of DOE responsible to review and assess significant results of nonconformance trend information.
(15.4)
- 31. Clarify that the SRP0 responsibilities regarding corrective action (Section 16.3 of the plan) include the verification of activities to preclude recurrence and the establishment of root causes. Identify (by position title) who is assigned these responsibilities for CARS issued to or received by SRPO. Also clarify in section 16.4.1.1 of the plan that significant quality problems are documented.
(16.4)
N Enclosure Page 5 of 5
- 32. Section 16.0 of the plan uses the following terms:
a)-
Significant condition adverse to quality (defined in Section 111) b)
Condition adverse to quality c)
Significant quality problem d)
Trends adverse to quality e)
Significantly adverse trend Clarify the meaning of and the relationship between these terms.
Identify (by position title) who is responsible to determine when something adverse or a problem is significant and thus requires formal, documented, Corrective Action Reports.
- 33. Describe the scope of the record program.
That is, identify by type of data what records will be maintained within the records management system. (17.1)
- 34. Describe the responsibilities of the prime contracture' QA organizations in the records management system. Also, identify (by position title) who in the SRP0 organization is responsible for meeting the requirements of Section 17.4 of the plan.
(17.2)
- 35. Supplement 4 of the OGR QA Plan addresses QA records, and it introduces the concept of " post-closure" records. Address SRP0 requirements for maintaining records after closure of the repository.
- 36. Section 18.4.11 of the plan addresses follow-up activities by auditing organizations.
Clarify that these include analysis of audit data by the QA organization with the results being reported to responsible management for review, assessment, and appropriate action.
(18.4)
- 37. Clarify that technical audits which provide a comprehensive independent verification and evaluation of procedures and activities affecting quality are included in the audit program, that audit team membership includes personnel (not necesarily from ;he QA organization) having technical expertise in the areas being audited, and that audit team leaders are from the QA organization.
(18.9)
- 38. The last sentence of Section 18.4.9 of the plan requires that the audit team leader obtains agreement from the audited organization regarding the validity of audit findings.
Clarify what is required when such agreement cannot be obtained.
p D
Robert E. Browgiing develop a firm understanding of the functioning QA relationships and QA respon-sibilities for the Salt Repository Project. We have found such meetings to be 1
most beneficial when they are held after draft responses to RAIs have been prepared. We have several editorial comments which can also be discussed at the suggested working meeting.
Your staff or DOE representatives should contact J. Spraul' before the suggested meeting if further clarification the enclosed I is desired.
4 d
M rian K. Grimes, frector Division of Quality Assurance, Vendor, and Technical Training Center Programs i
Office of Inspection and Enforcement
Enclosure:
RAI i
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