ML20126D483
| ML20126D483 | |
| Person / Time | |
|---|---|
| Issue date: | 04/08/1980 |
| From: | NRC OFFICE OF STANDARDS DEVELOPMENT |
| To: | |
| Shared Package | |
| ML20126D461 | List: |
| References | |
| TASK-OS, TASK-RS-035-2, TASK-RS-35-2 REGGD-01.144, REGGD-1.144, NUDOCS 8005020137 | |
| Download: ML20126D483 (9) | |
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@005020 G ]
VALUE/ IMPACT ASSESSMENT ON AUDITING OF QUALITY ASSURANCE PROGRAMS FOR NUCLEAR POWER PLANTS RG 1.144 I. The Proposed Action A. Description The appl 4 cant (licensee) of a nuclear power plant is required by the Commission's regulations to establish and implement a quality assurance program. The applicant (licensee) is also required to carry out planned and periodic audits to verify compliance with the quality assurance Frogram and to determine the effectiveness of the program. The proposed action will provide updated guidance
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for establishing and implementing a system of internal and external l audits of quality assurance programs for nuclear power plants, including the preparation, performance, reporting, and followup l of audits by both the auditing and audited organizations.
B. Need Guidance on auditing of quality assurance programs is contained in NRC documents WASH-1283, " Guidance on Quality Assurance Require-ments During Design and Procurement Phases of Nuclear Power Plants,"
dated May 24,1974 (Gray Book-Revision 1) and WASH-1309, " Guidance on Quality Assurance Requirements During the Construction Phase of Nuclear Power Plants," dated May 10,1974 (Green Book-Revision 0). '
These documents use [The guidance-is premaigated-threagh ese-of]
draft standard ANSI N45.2.12 (Draft 3, Revision 4), " Requirements for Auditing of Quality Assurance Programs for Nuclear Power Plants" as their basis. ANSI N45.2.12 (Draft 4, Rev. 3) was approved as an American National Standard on November 17, 1977 and designated ANSI /ASME N45.2.12-1977. NRC guidance should be updated to reflect experience in use of present guidance and to establish an NRC staff position on the approved National standard.
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Consistent with past NRC practice, promulgation of this guidance '
will be in the form of a regulatory guide endorsing, with certain exceptions, the approved national standard which reflects further development of the draft standard contained in the WASH documents.
C. Value/ Impact of the Proposed Action
[6eidance en sediting-of quality-asserance programs-(ANSI-N45:2:42; Braft-B;-Revision-43-eentained-in-WASH-i28S-Revision-i and-Wash-1389-is presently-esed-by-the-NRE-staff-in-the evalestion-of applications-for-censtructier. permits-and-eperating-ficense appliestions as-specified-in-Sections-47:4-ane-97:2-of-the S t a nd ard- R e vi ew- Pi a n:-- E h a p t e r o f- R e g ei s to ry- 6 ei d e- 1: 707 -
uStandard-Fermat and-Eentent of-Safety-Analysis-Reports-for u
Neeiear-Pewer-Piants -fRevision-237-states-that-as-the-draft standards which-are-incieded-in-the-WASH-decements are-issued-as approved-American-National-Standards;-it-is expected-they-wili be endersed-by regeistory gaides ]
[ ANSI /ASME-N45:2:42-i977-differs-in certain-areas-in-centent-frem the-draft standard-ineerperated-in-WASH-4288-and-WASH-13097--As a-rescit-of staff reviewi-these-changes-have-been evaiented-as to-their-importance-to-safety-and-for-censistency-with present staff practice:--Regeistory-Positions-2 and-3-have-been added as a-rescit-of-this review:]
Regulatory Position 1 provides information to the user of the guide concerning applicability of referenced standards and has no impact.
l The associated Value/ Impact of Regulatory Positions 2 and 3 are addressed below:
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- a. Regulatory Position 2 has been added to state ANSI /ASME I N45.2.12-1977, subject to the exceptions of the regulatory position, should be used in conjunction with the ASME Boiler and Pressure Vessel Code, Section 1
III, Divisions 1 and 2, and Section XI for auditing of -l 1
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1 quality assurance programs where the ASME Code does -
not address the activities covered by ANSI /ASME N45.2.12-1977. l Value: The ASME Code addresses general requirements for quality assurance program audits but it does not explicitly address all the activities described in ANSI /ASME N45.2.12-1977. ANSI /ASME N45.2.12-1977 I should provide the necessary guidance for conducting audits.
Impact: The previous version (Draft 3, Rev. 4) of the N45.2.12 Standard, which is presently used by the NRC staff, does not contain the Code exclusion statement and is considered to be applicable for auditing of j quality assurance programs where the Code does not I address the activities covered by ANSI N45.2.12.
There should be no impact from present staff practice.
- b. Regulatory Position 3 has been added to describe acceptable ways of scheduling audits.
Value: The N45.2.12 Standard only states that audits ,
shall be regularly scheduled on the basis of the )
status and importance of the activities to assure the l adequacy of, and conformance with, the program.
Additional guidance is provided with regard to scheduling of audits. This should reduce the level of l uncertainty as to what the staff considers acceptable in scheduling audits. i Impact: The previous version (Draft 3, Rev. 4) of the N45.2.12 Standard, which is presently used by the NRC staff, states that applicable elements of the quality
- assurance program shall be audited at least annually or at least once within the life of the activity, .
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whichever is shorter. This statement has been con- -
strued to apply to both external and internal audits.
The guide in Regulatory Position 3 has provided further clarification of audit scheduling. This should result in reducing in the number of audits conducted when compared to the provisions of Draft 3, Rev. 4 of the N45.2.12 Standard while at the same time meeting the objectives of the audit program.
The proposed regulatory guide also addresses the "should" and "shall" problem which resulted from the uncertainty arising from the NRC's endorsement of both the requirements and guidelines contained in a standard. A letter was received from General Electric (W. D. Gilbert) to A. Giambusso, dated February 20, 1975, asking for clarification. The NRC replied (R. B. Minogue to W. Gilbert, dated May 6, 1975) to G.E. and in the reply we stated we were undertaking a reexamination of some of the regu-latory guides which endorse ANSI standards, particularly in the quality assurance area, to determine whether it might not be appropriate to qualify our endorsement of at least some of the guidelines since not all have substantive safety importance. A copy of this correspondence is attached. This evaluation has been extended to new regulatory guides endorsing ANSI standards.
Regulatory Position 4 addresses the "should" and "shall" problem. The NRC staff has evaluated each guideline (indicated by the verb "should") contained in the N45.2.12 Standard with respect to its importance to safety. Two of the total number of .
1 six guidelines were found to have substantive safety importance and consequently were included in Regulatory Position 4. These guidelines, with associated value/ impact assessments, are dis-cussed below:
- a. Section 3.5.3 - This section states that regularly sched-uled audits should be supplemented by audits for one or more of the following conditions: .
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- 1. When it is necessary to assess the capability of a contractor's quality assurance program prior to awarding a contract or purchase order.
- 2. When, after award of a contract, sufficient time has elapsed for implementing the quality assurance program and it is appropriate to determine that the organiza-tion is adequately performing the functions as defined in the quality assurance program description, codes, standards, and other contract documents.
- 3. When significant changes are made in functional areas of the quality assurance program such as significant reorganization or procedure revisions.
- 4. When it is suspected that the quality of the item is in jeopardy due to deficiencies in the quality assur-ance program.
- 5. When a systematic, independent assessment of program effectiveness is considered necessary.
- 6. When necessary to verify implementation of required corrective action.
This guideline with respect to items 3 thru [6]5 of Section 3.5.3 is important to safety and should be followed. Items 1 and 2 of Section 3.5.3 are con-sidered applicable only to external audits. Pro-visions for external audits are addressed in more detail in Regulatory Position 3.
Value: Making this guideline mandatory will ensure that audits are conducted when the listed conditions exist. This should lead to program improvements and correction of deficiencies. -
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Impact: There should be minimal impact on an effective -
quality assurance program. Normally, regularly scheduled audits will suffice and supplemental audits will be the exception and not the rule.
- b. Section 4.3.2.7 - This section states specific attention should be given to corrective action on program deficien-cies identified during previous audits. This guideline is important to safety and should be followed.
Value: An effective quality assurance program will include measures for correcting program deficiencies. The time spent in verifying correction of deficiencies identified in previous audits should be minimal; however, outstanding program deficiencies which have not been corrected between audits could be indicative of generic quality assurance program deficiencies. Thus, this action is extremely important for the amount of effort required.
Impact: As stated above, the time required in verification of correction of program deficiencies should be minimal.
It is also noted in the regulatory position that verifica-tion of correction of program deficiencies is limited to the area which is being audited.
The four guidelines which do not have substantive safety importance are discussed below:
- a. Section 1.4 - The last sentence of the definition of the term " audit" states: An audit should not be confused with surveillance or inspection for the sole purpose of process control or product acceptance."
This guideline is informational only.
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- b. Section 4.2.4 - The first two sentences state:
" Involved organizations shall be notified of a scheduled audit a reasonable time before the audit is to be performed. This notification should be in writing and include such information as the scope and schedule of the audit and the name of the audit team leader." The requirement for notification is established in the first sentence. It is not con-sidered necessary from a safety point of view that the notification be in writing.
- c. Section 4.3.2.1 - The second sentence states: "The audit checklist is intended for use as a guide and should not restrict the audit investigation when findings raise further questions that are not speci-fically included in the checklist." This guideline is considered informational. The authority and independ-ence of the auditor is covered elsewhere in the standard and provides the necessary freedom for con-duct of a comprehensive audit.
- d. Section 4.3.2.5 - This section states: "Nonconform- !
ances or quality assurance program deficiencies should be acknowledged by a member of the audited organization." l This subject is adequately covered by the requirements I l
of Section 4.3.3, " Post-Audit Conference." i Regulatory Position C.5 has been incorporated since the public comment period to provide clear guidance on auditing suppliers on behalf of more than one purchaser.
Value: The allowance of single purchaser audit of a supplier on behalf of more than one purchaser should significantly reduce both supplier and purchaser audit time reouirements.
Impact: No impact can be foreseen.
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Regulatory Position C.6 has been incorporated as a result of staff-review to reflect that 10 CFR Part 50 Appendix B Criterion XVIII allows methods other than audits to verify implementation of required corrective action.
Value: The allowance of methods other than audits to verify imple-mentation of required corrective action should provide more flexibility-in this area.
Impact: No impact can be foreseen.
D. Decision on the Proposed Action -
As previously stated updated guidance should be issued on auditing of quality assurance programs for nuclear power plants.
II. Technical Aporoach This section is not applicable to this value/ impact statement since the proposed action is an update of previously issued guidance. The technical issues have been previously discussed.
III. Procedural Approach Previously discussed.
l IV. Statutory Considerations A. NRC Authority This guide would fall under the authority and safety require-ments of the Atomic Energy Act. In particular under Crite-rion XVIII of Appendix B to 10 CFR 50, which requires, in part, i that a comprehensive system of planned and periodic audits shall l be carried out to verify compliance with all aspects of the quality assurance program and to determine the effectiveness of the program.
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. , r B. Need for NEPA Assessment -
The proposed action is not a major action, as defined by 10 CFR 51.5(a)(10), and does not require an environmental impact statement. .'
V. Relationship to Other Existing or Proposed Regulations or Policies The relationship to the proposed action to previous NRC documents (WASH-1283 and WASH-1309) is discussed in Section B of the proposed Regulatory Guide. Implementation of the proposed action is discussed in Section D of the proposed guide.
VI. Summary and Conclusions The proposed Regulatory guide on auditing of quality assurance programs for nuclear power plants should be issued.
References ANSI /ASME N45.2.12-1977, " Requirements for Auditing of Quality Assurance Programs for Nuclear Power Plants."
WASH-1283 (Revision 1), " Guidance on Quality Assurance Requirements During Design and Procurement Phases of Nuclear Power Plants." (Gray Book - Revision 1, dated May 24,1974.)
l WASH-1309, " Guidance on Quality Assurance Requirements During the Construc- )
tion Phase of Nuclear Power Plants." (Green Book - Revision 0, dated May 10, 1974.)
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Attachments l
- 1. W. D. Gilbert letter to A. Giambusso dated February 20, 1975.
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- 2. R. B. Minogue letter to W. Gilbert dated May 6, 1975.
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