ML20214E677
| ML20214E677 | |
| Person / Time | |
|---|---|
| Issue date: | 02/12/1986 |
| From: | Linehan J NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Purcell W ENERGY, DEPT. OF |
| References | |
| REF-WM-1 NUDOCS 8603260363 | |
| Download: ML20214E677 (9) | |
Text
P DISTRIBUTION
[-
t WM S/F 3405 BGrimes
\\
' WMRP r/f GAnkrum NMSS r/f PDR hp CF
@;hios/01/^F el JBunting MRKnapp JTGreeves JLinehan Mr. William J. Purcell RRBoyle Director SCoplan Office of Geologic Repositories JKennedy Office of Civilian Radioactive.
RCook Waste Management PPrestholt.
U. S. Department of Energy TVerma RW-20 JGiarratana Washington, DC 20545 DHedges & r/f SBilhorn
Dear Mr. Purcell:
DAltman The purpose of this letter is to provide formal comments to the Department of Energy on the draft supplements to the Office of Geologic Repositories Quality ~
Assurance. Plan. The NRC staff committed to this review in the December 4-5,
-1985 meeting on quality assurance. Oral comments relative to the draft supplements were provided in that meeting and Enclosures 1-7 to this letter provide the written formal comments.
Should you have any questions regarding these comments please contact Dale Hedges of my staff at 427-4491.
Sincerely, g pas 4 John J. Linehan, Acting Chief Repository. Projects Branch Division of Waste Management.
Office of Nuc'9ar Material Safety and Safeguards
Enclosures:
1.
General Comments 2.
NRC Comments on Draft Supplement No. 1 3.
NRC Comments on Draft Supplement No. 2 4.
NRC Comments on Draft Supplement No. 3 WM P@ct
/
- 5..NRC Comments on Draft Supplement No. 4 g,MRj'd%
06 Docket No.
6.
NRC Comments on Draft Supplement No. 5 7.
NRC Comments on Draft. Supplement No. 6 PDR v LPDR 8603260363 e60212
~
' Distribution:
$g OM U%m pyg
__l
- See previous. concurrence page.
[ Return to WM,623 SS)
}
DFC :WMRP:mkb
- WMRP
- IE
- IE
- IE H.___:____________:____________:
NAME :DH;dges*
- J i
h *
- DAltman*
- GAnkrum*
- BGrimes*
h_ __ _ : _ _ _ _ _ _ _ _ _ _ _ _ :: J Ken nedy*
DATE :02/04/86
- 02/04/86
- 0 8b
- 02/07/86
- 02/07/86
- 02/10/86 l
General Comments - The staff requires a better understanding from DOE as to how the various documents being issued by OCRWM and 0GR tie into the overall quality assurance program.
For example, how does the " Quality Assurance Management Policies and Requirements" document relate to the " Office of Geologic Repositories (0GR) Quality Assurance Plan for Siting and Site Characterization"; how does the " Systems Engineering Management Plan for the Office of Geologic Repositories" (SEMP) relate to the 0GR Quality Assurance Plan; and how do-the supplements relate to the overall~QA program. Also, it is the staff's understanding that policy can be issued by memorandum as was done to implement the NRC Standard Review Plan as a requirement for projects'to follow. A complete and comprehensive listing of the QA policies, plans, and procedures and their interrelationships will be needed for the staff to adequately review the 0GR QA program.
The OGR-QA Plan states that Headquarters (0GR), its field project offices, and their contractors shall develop, implement, and maintain a QA program that complies with the basic and supplementary requirements of American National Standards Institute /American Society of Mechanical Engineers (ANSI /ASME)
" Quality Assurance Program Requirements for Nuclear Facilities," NQA-1-1983.
Does a QA program which meets Supplement 1 of the 0GR QA plan satisfy the requirements of Supplement 2S-1, Supplement 2S-2 and/or Supplement 25-3 of NQA-17 The supplements need to clarify this.
The staff suggests a consistent format be followed for supplements. There is no consistency from supplement to supplement which leads to confusion in reading and interpretation.
In writing supplements, and in revising the six supplements discussed at the meeting, the 00E should give careful consideration to ensuring that the purpose of the supplement is clearly stated, its scope is clearly defined, and its relationship to the OGR QA Plan and other supplements is clearly delineated.
The staff noted an impreciseness of language in two of the supplements discussed at the meeting, " Calibration of Measuring and Test Equipment" and
" Computer Software QA."
Also in the supplement on " Quality Assurance Records,"
the terms " Record" and "QA Records",'while defined differently, appear to be used interchangeably.
NRC COMMENTS ON DRAFT SUPPLEMENT N0. 1 QUALIFICATION OF PERSONNEL PERFORMING AND VERIFYING ACTIVITIES AFFECTING QUALITY Comments are identified by section numbers of the supplement.
Section 1.0 Clarification is needed as to who is included in "... all personnel who are assigned to perform and verify activities affecting quality." Does this include the entire staff of OGR?
Section 1.1 Procedures are required for the qualification of personnel performing or verifying activities that affect quality.
Is it intended that those qualifications be certified?
The supplement requires certification in accordance with applicable supplementary requirements of NQA-1. The staff suggests specific reference.to section 2.7 of Supplement 2S-1 for inspection and test personnel, to section 2 of Supplement 2S-2 for nondestructive examination personnel, and section 6.2 of Supplement 2S-3 for lead audit personnel. ~ In addition, Appendices 2A-1 and 2A-3 provide non mandatory guidance which would be useful.
Section l'.3 The staff suggests that indoctrination as to the overall QA
~
program philosophy and requirements be included for all personnel assigned to the project. The supplement states:
"Those who verify activities affecting quality shall be instructed in the principles, techniques, technical objectives, and requirements of the activity being performed." The staff suggests that such instructions are also appropriate for those who perform activities affecting quality.
Section 1.4 Is it intended that on-the-job training be documented?
Section 1.5 The supplement requires performance evaluation on at least an annual basis. Clarification is needed as to how this evaluation is conducted and documented. Also, clarification is needed as to whether this is in addition to normal day-to-day supervisory performance evaluation.
Section 1.6 It 13 suggested that the requirement to record " activities to be performed" for all personnel be reconsidered.
It appears appropriate to list calibration activities a lab technician is qualified to perform, but difficult and inappropriate to list the activities a scientist is qualified to perform. The staff suggests the scientist could be certified as meeting the job description for the assigned position.
NRC COMMENTS ON DRAFT SUPPLEMENT NO. 2 OVERVIEW 0F QUALITY ASSURANCE ACTIVITIES Comments are identified by section number of the supplement.
Section 1.0 The supplement states that each 0GR project office is to develop and implement written procedures, is this to be restricted to project offices? This appears-inconsistent with the scope in Section 1.1.
This section addresses " quality plans / manuals / procedures" while Section 1.2 addresses "QA program plans / manuals and procedures."
If these differences are intentional, describe the difference; if not intentional, the differences should-be eliminated.
The term " participant" is introduced without definition.
Section 1.2 Procedures should also identify the basis of review, i.e.,
acceptance criteria, for acceptance of plans, manuals and procedures.
Section 1.5 The introduction lists four (4) review activities:
- 1) review and approval of plans / manuals / procedures; 2) surveillance; 3) audits; and 4) management assessments. The scope indicates that HQ-0GR will overview project offices.
It is not clear, therefore, why HQ-0GR's verification of the overview program is limited per section 1.5 of Supplement 2 to activities 1 (review and approval of plans / manuals / procedures) and 3 (audits).
It appears that activities 2 (surveillance) and 4 (management assessments) should be included in section 1.5.
E i
NRC COMMENTS ON DRAFT SUPPLEMENT N0. 3 CONTROL 0F MEASURING AND TEST EQUIPMENT
~
Comments are identified by section numbers of the supplement.
Section 1.4 The requirements for use of primary, secondary and working standards are not described.
Section 1.5 Is there intended to be a requirement for traceability of standards calibration to the National Bureau of Standards?
Section 1.6 Acceptability of calibration records by " Standards Laboratory personnel" is required by paragraph 1.6 Q of the supplement.
The qualifications.of those individuals,-who approve and sign what, should be specified. A requirement similar to item B in section 1.8 would be one method for specifying this.
Section 1.9 Is there to be another supplement that describes actions to be taken relative to test data when a piece of calibrated equipment used in the test is found to be outside calibration limits when returned to the standards lab? If not, this supplement needs to be expanded.
NRC COMMENTS ON DRAFT SUPPLEMENT NO. 4 QUALITY ASSURANCE RECORDS Comments are identified b. section numbers of the supplement.
Section~1.0 It is suggested that "nondocument records" be replaced with
" physical samples" since a nondocument record has been defined as a physical sample.
It is confusing to read about document records and nondocument records. Also, it is suagested that descriptive documentary material which describes the physical samples should be called " document records" and not "nondocument records" as the supplement now requires. Documentary material should also be cross-indexed to the unique physical sample being described.
Given that two types of records are being described, document and physical samples, the supplement must be expanded to describe the collection and care of physical samples. The supplement is descriptive only of the collection and care of document records.
Section 2.0 Definitions should include " physical samples."
The definition of " Record" is restricted to documents and makes no mention of "nondocument" records or physical samples. The terms " record" and " quality assurance record," though defined differently, are used interchanget.bly in the text of the supplement. This should be clarified.
Section 3.0 It is suggested that a uniform method of records indexing should be provided by Headquarters to prevent many methods and confusion during retrieval. A uniform system can reduce the amount of records retained in that duplication will not be needed.
Section 5.0 Direction should be given as to method of identifying documents and physical samples that are to become records and how they are to be temporarily stored.
Section 6.0 The supplement does nnt address how the 10CFR60 requirement for placement of records in various archives is to be met.
e..
NRC COMMENTS ON DRAFT SUPPLEMENT N0. 5 QUALITY ASSURANCE ON (R&D) EXPERIMENTS Section 1.0 The scope limits this supplement to non-licensing data collection. As stated by the staff in.a letter to Dr. D. L.
Veith ' rom Hubert J. Mi.ller, June 25, 1985, it is unlikely that DOE will know, prior to initiation of tests, whether the data to be obtained from a particular test will be used to support the licensing application.
It is likely that every piece of data available will be utilized by DOE in assessing performance and making findings. All data collected will be subject to review and challenge by NRC staff and intervening parties. The NRC staff therefore believes it is prudent to collect all data under the QA program. Thus, this supplement should be of limited use in the program.
Also, it is not clear why this one subject has been singled out to provide guidance for nor.-licensing activities, particularly since the same subject is not treated for licensing activities in any other supplement.
.o.
i NRC COMMENTS ON DRAFT SUPPLEMENT NO. 6 COMPUTER SOFTWARE Coments are. identified by section numbers of the supplement.
General - The supplement appears to have been taken from another document and not reworded to be applicable to the HLW program. As an example, the use of the term " contractor" throughout the document is either inconsistent or inappropriate. This should be corrected.
It is suggested that an appendix which lists several of the appropriate industry standards may be helpful.
Some terms and phrases were not readily understandable or well defined:
Section Term or Phrase 3.2.3 review 3.4 other technical directives 3.4.2 an evaluation of the degree of validity 1
of the model 3.7.3.2 independently reviewed The procurement / contract aspects of computer applications should be more clearly addressed.
Section 2.0 It is not clear why " developmental... applications are exempt" as stated in the last sentence of this section.
If this means that software QA requirements are applicable only during the production, as opposed to the developmental, phase of a code's evolution, the exemption appears to be inappropriate. Clearly the use of QA requirements during the production phase of a code"s life does not compensate for the absence of such requirements when the code was developed.
Section 3.2.1 The operating system dependencies, compiler version, system library changes and other issues should be addressed in this section. The hardware / software parameters of the host computer should be noted and become an integral part of the software design control, rather than just part of the documentation (Section 3.5.4).
Section 3.3.4 The word " correct" is inappropriate in the context of this paragraph and should be omitted.
e
-y,
.a 2
Section 3.5.2 The documentation requirements of Section 3.5.2 should also refer back to Section 3.4.2.
That is, documentation should be provided with sufficient detail and clarity to allow a degree of validation by the peer review process.
The responsibilities of the user / owner of codes should be better addressed throughout the document.
Section 3.1.3 A system needs to be established that can keep a record of all of the users of the specific codes'and each code use so that appropriate corrective action can be undertaken when code errors are discovered.
Section 3.2.3 The QA organization is tasked here with a specific function to perform, but not anywhere else. While QA can be tasked with this particular function, it need not be given the task. QA should be aware of all of its overall responsibilities for computer applications either here or in a separate document, but to only reference one QA responsibility within this supplement is inappropriate.
Section 3.4.1 The definition of " validation" is weak. The difference between
" validation" and " verification" should be clarified.
I
-