ML20151T661
| ML20151T661 | |
| Person / Time | |
|---|---|
| Issue date: | 04/25/1988 |
| From: | Voltura N NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Kennedy J NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| References | |
| REF-WM-1 NUDOCS 8804290097 | |
| Download: ML20151T661 (12) | |
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1 MEMORANDUM TO:
J. Kennedy, Section Leader APR 2 51933 QA Section j
4 Operations Branch, DHLWM' FROM:
N. Voltura, Proiect Manager QA Section l
1 Operations Branch, DHLWM i
SUBJECT:
QA STAFF REVIEW OF DRAFT OCRWM QA DOCUMENTS i
9 A) QA REQUIREMENTS FOR THE HIGH-LEVEL NUCLEAR WASTE l
REPOSITORY PROGRAM - REV. E, 2/5/88 l
i B) QA PROGRAM DESCRIPTION FOR HEADQUARTERS (OCRWM) -
i REV. C, 2/5/88 i
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l Per your direction on February 29, 1988, QA staff personnel have reviewed the i
subject, draft QA documents.
Limited reviews were conducted by both W.-Belke 4
and A. Duncan and their comments are incorporated with the results of my review.
As established in the Task Description for this activity, these plans were f
I reviewed utilizing the following criteria:
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- 1) NRC Standard QA Review Plan (June-1984) i
- 2) Nov. 27, 1987 Letter to DOE on OCRWM Director's Statements i
- 3) Feb. 12, 1986 Letter to OGR Commenting on HQ QA Documents
- 4) QA Issues List
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- 5) Jan. 28, 1987 Letter to OGR Commenting on OGR/B-3
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- 6) GTP on Qualification of Existing Data for High-level Nuclear i
Waste Repositories l
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- 7) GTP on Peer Review for High-Level Nuclear Waste Repositories l
- 8) Technical Position on Items and Activities in the High-Level
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j Nuclear Waste Repository Program Subject to QA Requirements l
4 Although DOE stated that they did not expect NRC to submit review comments on
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these Oraft documents, the staff review was conducted so that DOE could address i
any staff concerns in its subsequent revisions of the documents.
Per our i
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conversations, you have indicated that the results of this review will be i
j oresented verbally to DOE.
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The following comments are submitted for the referenced documents:
a) QA Requirements for the High-Level Nuclear Waste Repository l
j Program - Rev. E, 2/5/88 (Draft) j i
Section: Introduction i
J 1.
The first paragraph, entitled ' General', clearly identifies and includes OCRWM and Project management as being responsible to i
participate in the QA program planning and implementation and to j
comply with the requirements of the QA Requirements documents as j
described in their respective QA Program Descriptions.
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. Comment:
This appears to differ from the definition provided for "Program Participation (Pg. iii) which specifically excludes OCRhM and the Project Office, by stating:
"All contracted organizations performing activities associated with the Program, including prime and subcontractors, national laboratories, other government organi-zations, etc., but excluding OCRhH and the Project Office (s)."
Additionally, the term "Program" is defined as:
"For purpose of clarification and uniform understanding and use, ' Program', when used, shall mean the U. S. Department of Energy Civilian Radioactive Waste Management Program."
Since both OCRhN and the Nevada Project Office conduct activities that implement QA program requirements, the exclusion of these organ-irations as Program Participants seems contradictory.
Clarification is required.
2.
' Purpose and Applicability' - first sentence needs clarification to include:
performance assessment, performance confirmation and decommissioning.
Additionally, this paragraph endorses NQA-1, 1986 Edition; NRC, to date, has only endorsed NQA-1, 1983.
3.
' Definitions' - Clarification is needed on last sentence which states:
"...Where differences between this document and other documents exist, I
the definitions in this document shall take precedence."
There are several areas where the document differs from NRC GTPs; for example: (a) Activities that Affect Quality; (b) Peer Review; (c) Technical Review; (d) Q-List; and, there are differences with NQA-1; for example: (3) Verification (listed here as ' Quality Verification' -
however, the new definition excludes those aspects of verification discussed in NQA-1, and (f) Nonconformance - the definition is grammati-cally incomplete in its listing of examples:
...therfore, and/or.."
These need clarification.
Section I - Organization 1.
Clarify that GA responsibilities include the requirement listed as item (4) under NQA-1, Basic Requirements "...(4) assure that further i
processing, delivery, installation, or use is controlled until proper disposition of a nonconformance, deficiency, or unsatisfactory cond' tion has occurred.
2.
Clarify last sentence in 1 1.(A):
"Persons and organizations with the authority shall be identified..." Clarification on what type of authority is implied here needs to be adied.
3.
Clarify where/how the following NRC Standard QA Review Plan (SRP) j criteria are addressed:
1 1.2; 1.3; 1.4; 1.5; 1.6; 1.7; 1.8; 1.10; 1.11; & 1.15.
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j Section II - QA Program j
l 1.
1 A - Planning - Clarify, by organizational position title, who is I
responsible to review and approve the Program Descriptions.
i 2.
1 A(2) Clarify to include:
... based on their importance to public radiological health...."
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1 A(3) Clarify to address that justification must be provided for less than a full 18-criteria program, i
1 3.
1 B(2):
Definition of Quality Level 2 has the same implications as described in the NRC letter of 11/27/87 (ref. review criteria #2).
l This definition now states:
...QL 2-designated items and activities may support licensing but are not required to comply with the QA l
requirements of 10 CFR Parts 60, 71 and 72, and are not Q-listed..."
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As stated in the staff letter of 11/27/87 and in the staff's review comments on the CDSCP, Comment 104, the NRC staff believes it is j
prudent to classify those items, activities and data which may be j
relied on in the licensing process as Quality Level I.
In addition, l
j the GTP on Qualification of Existing Data for High-Level Nuclear i
Waste Repositories states in part:
...NRC regulations (10 CFR 60, i
l Subpart G) require that DOE implement a QA program that applies to 1
all systems, structures and components important to safety, to design j
and characterization of barriers important to waste isolatico, and to t
i activities related thereto.
The activities include the development vf site characterization data which will be used in support of the DOS l
license application...."
l 4.
1 B(3) Definition of Quality Level I - la!,t sentence in first paragraph i
needs to clarify:
".. public radiological health, safety and waste j
isolation.
Underlined words not in this DOE document.
5.
1 C - Personnel Selection, Indoctrination, Training & Certification Clarify the types of documentation that are to be maintained as a record of this activity Clarify whether these records are to be maintained separate from 1
other confidential personnel records so that access is not hindered j
during audits, surveillance etc.
1 j
Editorial Clarification:
Clarify next to last sentence of subparagraph (3):
...an evaluation l
of education and experience and compared to..."
Word choice seems j
inappropriate - (as underlined.)
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Does not address SRP 1 2.8 a thru e.
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1 0. QA Surveillance Clarify who is to receive reports on QA surveillances of QL1 and QL2 items and activities.
7.
1 E QA Program Review Clarify subparagraph (3):
"QA program reviews shall verify, as a minimum, that... (3) indoctrination and training have been completed for individuals conducting overviews:...
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- this does not address indoctrination & training that must be com-W pleted for those individuals performing quality-related activities; SRP 1 2.8(a), (b), (c), (d), (e).
8.
1 F. QA Program Assessment Clarify last sentence:
"... Management assessments shall be performed regularly and reported at least annually to the highest management position identified by the organization's QAPD."
As worded, this sound as though management assessments are done more often than they are reported to higher management - If so, why?
Section III - Design Control 1.
Does not address the Standard Review Plan (SRP) paragraphs:
3.1, 3.2; 3.3; 3.4; 3.6; 3.7; 3.8; 3.9; 3.10 2.
1 A - Control of Scientific Investigations Clarity the following sentences which appear to conflict with 10 CFR 50, App. 8 - Criterion VI "... Changes to documents shall be reviewed and approved by the same organizations that performed the original review and approval unless the applicant designates another responsible organization."
Section III, 1 A states:
".. Procedures for conducting scientific investigations and their implementation shall be reviewed for tech-nical adequacy and approved by qualified persons other than those who prepared the procedures.
Changes to procedures for conducting scientific investigations shall be reviewed and approved by qualified persons familiar with the original procedure and the purpose of the investiagion is fulfilled."
a) The DOE document neither maintains the independence of the reviewers in its discussion of changes to procedures for conducting scientific investigations, nor does it maintain that reviews and approvals of changes are to be performed by the same organizations that performed the original review and approval unless the applicant designates another responsible organization.
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1 A - Control of Scientific Investigations Clarify the use of "peer reviews" as discussed in the SRP 1 3.8:
Peer review is defined as:
"For design or design-activities which involve use of untried or state-of-the-art testing and analysis procedures and methods or where detailed technical criteria and requirements do not exist or are being developed,-a peer review should be conducted...A "peer review" is a critical review per-formed by personnel who are' independent of...those who-performed the work..."
Per the DOE document, it states:
... Development activities to develop or establish new methods or procedures for conducting scientific investigations...The results shall be reviewed for adequacy and approved by qualified persons."
4.
1 8(5) - Control of Erroneous Data Clarify whether ' erroneous data' is controlled via the nonconformance control system established in Section XV.
If not, why not? What about:
identification; segregation; dis-position; documentation; notification of affected organizations -
These must be addressed if Section XV controls are not invoked.
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1 B(6) - Evaluating and Reporting Results Clarify whether "uncertainty limits" are always a factor to consider.
As written, this suggests that all data must have an "uncertainty-limit" assigned to it.
If so, are there specified criteria for establishing these limits or must the criteria be developed?
6.
1 B(7) - Qualification of Data with Indeterminate Quality Does not meet GTP on Qualification of Existing Data Definitions not included (i.e., corroborating data, confirmatory testing, qualified data etc.)
Contains only partial listing of attributes for qualification process Documentation of the decision process - not included Does not provide for auditable trail of all factors used in the choice of the qualification method 7.
1 C - Peer Reviews Does not meet GTP on Peer Reviews - i.e:
Staff position on applicability of peer reviews -
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. Definition of "peer review" and "technical review" - (00E document (Pg.11) states:
... Peer reviewers shall document their findings...
and whether the work conforms to specified requirements." However, the GTP makes the distinction in the differences between a ' peer review' and a ' technical review' by stating that:
...In contrast to ' peer review', the term ' technical review', as used in this GTP,.
refers to a review to verify compliance to tredetermined require-ments; industry standards; or common sciencific, engineering and i
industry practice.
l Does not address the details for acceptability of peers; Does not address the peer revi w process to include: (a) validity of assumptions; (b) alternate interpretations; (c) uncertainty of results and consequences, if wrong; (d) appropriateness and limitations of methodology and procedures; (e) adequacy of appli-cation; (f) accuracy of calculations; (g) validity of conclusions; and, (h) adequacy of requirements and criteria; Does not address details described for the "Peer Review Report";
Does not address QA involvement, by conducting surveillances, of the peer review process (i.e., from selection of group members M issuance of report).
8.
1 D - Computer Software Control Clarify second sentence as it is not clear what is being addressed.
1(1) - Identify the position title that is responsible for the review and approval of the description of the Software Design, Test and Con-figuration Management System.
Section IV - Procurement Document Control 1.
Clarify the involvement of the QA organization in the review of procure-ment documents to include all of the detail in SRP 1 4.1 2.
Clarify how the document addresses the detail included in SRP 1 4.2 Section V - Instructions,-Procedures & Drawings 1.
Clarify how the document addresses the detail included in the SRP 1 5.1(2), including the last sentence.
2.
1(A) - Clarify the statement:
"Formal QA and attendant work activities...", as written, this implies that there may be "informal QA and attendant work activities" that may be conducted.
Clarify the position title that is responsible to review and approve the QAAP's and Technical Procedures.
l l Section VI - Document Control 1.
Clarify the ' scope' of the document control program as required by SRP 1 6.1; 2.
Clarify how the document addresses SRP 1 6.2, 6.3, 6.4, 6.5 and 6.6.
Section VII - Control of Purchased Items & Services Clarify how the document addresses SRP 1 7.1; 7.2; 7.3(a), (b), (c) and the last sentence; 7.4
"...and the results documented"; and 7.5.
Section VIII - Identification and Control of Materials, Parts, Components and Samples 1.
Clarify how the document addresses SRP 18.2 requirement that states
"...or on records traceable thereto."
2.
Clarify how this document addresses SRP 1 8.3.
Section IX - Control of Processes 1.
Clarify how this document addresses SRP 1 9.1; 9.2; 9.3; 9.4 and 9.5 Section X - Inspection 1.
Clarify how this document addresses SRP 1 10.1; 10.2; 10.3; 10.4-(portions of); 10.6 and 17.3.
Section XI - Test Control 1.
Clarify how this document addresses SRP'1 11.1; 11.2; 11.3;_11.4 (portions of); 11.5 for both "tests" & "tests to collect data."
2.
Clarify use of the following terms, as defined in first paragraph on Pg. 20:
- confirmatory testing qualification testing The definition used for ' confirmatory testing' does not meet the definition established in the GTP on Qualification of Existing Data; The definition used for ' qualification testing' is not familiar as to its basis / source; please clarify.
3.
1(f) Test Records - Does not address SRP 1 17.3(c).
e Section XII - Control of Measuring & Test Equipment Clarify how this document addresses SRP 1 12.1; 12.2; 12.3 (last_ sentence);
12.4 ("...and to provide traceability to calibration test data'); 12.5, 12.7 (last sentence).
Section XIII - Handling, Storage, Transport and Shipping Clarify how this document addresses SRP 1 13.2:
...to preclude damage, loss or deterioration by environmental conditions such as temperature or humidity."
Section XIV - Inspection, Test and Operating Status to comments jsection XV - Control of Nonconforming Items Clarify how this document addresses SRP 1 15.1:
"Procedures are established
?or... tracking,... reviewing...of nonconformances.
- lection XVI - Corrective Action i
1.
1 (A) - Trend Analysis:
Clarify how this document addresses SRP 115.4 which requires quality trends to be reported to "... upper management for review and assessment."
Describe the upper management position which will receive this information and review & assess.
Describe the review & assessment process and what will be required as follow-up/ corrective action.
Identify the organization responsible to conduct this analysis.
2.
1 (B) - Unusual Occurrence Reports (VOR) provide definition clarify whether an NCR is to be generated, and if not, then QA involvement in the UOR process needs to be the same as in 1 XV A.(1) and (2).
clarify, if NCRs are not generated along with UOR, what methods are used to tag, segregate or, otherwise identify, similar items (if appropriate) so as to preclude continued use.
3.
1 (c) - Significant Quality Problems
- 1. Item (4) discusses "significant quality problems / deficiencies in design and construction practices..."; Provide clarification on the types of activities which would qualify during the current ' site characterization phase'.
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1 (D) Corrective Action 1.
Clarify what actions are needed when either a "significant quality problem" or an "unusual occurrence" exists.
As written, it appears that both:
a UOR and CAR are written for unusual occurrences; only a CAR is written'for "significant quality problems";
but, in neither case is an NCR written when discrepant / indeterminate materials or items, etc. may be involved and would require tagging or segregation.
2.
Clarify subparagraph (5) to. address that QA concurrence on the adequacy of corrective action should occur prior to implementation of corrective action that is recommended.
3.
Clarify how this document addresses SRP 116.4 as far as management's review and assessment.
XVII QA Records
- r 1.
Clarify how this document addresses SRP 1 17.1 - as a minimum.
2.
1 (A):
Clarify whether every "record" requires an "approval" signature and define what that "approval" means.
3.
1 2(f):
Clarify / define the' term "... modifying..." as used in this sentence. This term is not discussed in the Glossary,Section III, XV, XVI.
4.
1 3:
Clarify whether the second sentence means:
...shall be retained for at least 3 years after initiation of repository operation or 3 years from the completion of the activity, whichever is longer."
As written, after the repository is in operation beyond the 3 year point, "nonpermanent" records are not maintained at all.
Clarify whether this was the purpose.
5.
1 (F) Records Management Plan:
Clarify the organizational position title responsible for review and approval of the Records Management Plan.
1 (F) does not address:
SRP 1 17.2 which states:
"QA and other organizations are iden-tified and their responsibilities are described for the definition and implementation of activities related to QA records.
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1 (G) Temporary Record Storage:
Clarify the first sentence which implies that controls on records cease once they are placed in the permanent storage facility.
Clarify the "environmental control" parameters for a single storage facility.
7.
1 (H) List of Typical Post-Closure Records:
Clarify whether ' Site Characterization Reports' are inclusive of the ' Site Characterization Plan'.
XVIII Audits 1.
1 (A):
Clarify the last sentence which suggests that the QA program is not fully developed yet.
The QA program should be in' place prior to start of site characterization activities, which have already.
begun.
2.
1 (D&F):
Paragraph (D) states "...QA Audit deficiencies shall be documented as Findings and Observations (see glossary for definitions)."
However, both the Glossary and 1(F) address ' observations' as requiring less action than for a ' finding'.
If ' observations' are deficiencies in the program, then they need to be corrected.
Clarification is needed.
Appendix I Instructions for Preparation of a QA Program Description-1.
1 17.1.1.3 - Paragraph is not consistent with SRP 1 1.12 in assigning responsibilities for stop work.
Also, as written, there is the option to "stop work or control further processing, delivery, installation, or use of nonconforming items...", this is less than is required by the SRP 1 1.12.
2.
1 17.1.7.1(5) - Clarify the term "meaningful".
3.
1 17.1.10.1 - Clarify how or where the QAPD is to describe / identify any mandatory sampling or inspection holdpoints that require witnessing or inspection, by 00E, beyond which work may not proceed.
These criteria are only addressed in 117.1.10.2 within the context of the waste form producer requiring such witness or inspection activities.
Note:
Due to the extensive nature of the comments generated from this review, the QA Program Description for Headquarters (OCRWM) Rev. C, 2/5/88 (Reference B),
was not reviewed since at a minimum, the program areas which need clarification
APR 2 5 '1988
- in the QA Requirements document would generate similar clarification in the QAPD for OCRWM.
It must be emphasized.that since these DOE-HQ documents establish the^ basic program requirements implemented by NNWSI, the changes proposed'by the revisions in these documents may impact the current staff reviews of NNWSI QA Program Plans.
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Nancy Voltura, Project Manager QA Section Operations Branch, DHLWM cc:
B. J. Youngblood R. E. Browning M. J. Bell W. Belke A. Duncan DISTRIBUTION:
B. J..Youngblood HLOB R/F R. E. Browning N. Voltura M. Bell h3SS R/F R. Ballard Central Files J. Bunting P. Prescholt 0FC :HLOB/DHLWM:
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DATE:04/Af/88 0FFICIAL RECORD COPY l
3ccanen] kne: : NEMO KEMEbY DOCUMENT PREPARATION CHECKLIST DIVISION OF HIGH-LEVEL WASTE MANAGEMENT This checklist is to be submitted with each document sent for typing or for distribution 1.
Is this document a draft?
Yes do 2.
If it is a draft, does it have the concurrence'bf a Branch Chief or higher?
Yes No 3.
Is this a ticketed item? If Yes, ticket number 4.
DISTRIBUTION:
(Names on concurrence and the standard B anch lists need not be listed; they will be included automatically.)
[ Attach labels for other than standard distribution)
ANY OTHERS?
PDR Yes No LPDR Yes No_ /
CNWRA Yes No v,
LSS Yes No v' Proprietary Yes No 5.
CC's k d[tl : & &, hawM,blE 00e but.tu--.
y y
U V'
I 6.
CONCURRENCES:
Please list the names of all individuals who should be on concurrance:
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Date Originated: 'l[20/f(f Date Due or Needed
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8.
Task Assigned to:
Date Completed and _4 off fs sent to 4-C-20
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REQUIRED ONLY FOR LSS DOCUMEliTS-------------------
9.
Date DID'ed to INRC0304/IRMTLSS [ NOTE: Send only if LSS box is marked Yes above]
- 10. TLSS:
Returned by Date Approved by Date
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