ML20093H678
| ML20093H678 | |
| Person / Time | |
|---|---|
| Site: | Byron  |
| Issue date: | 10/04/1984 |
| From: | Farrar D COMMONWEALTH EDISON CO. |
| To: | James Keppler NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III) |
| Shared Package | |
| ML20093H664 | List: |
| References | |
| 9268N, NUDOCS 8410160348 | |
| Download: ML20093H678 (18) | |
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/[^'N, oneCommonwealth
' First Nabonal Edison Plan, Chicago. manon i i
! T ",) Addr;ss Reply 10: P;st Offica Box 767 l N, ,/ Chicago. lilinois 6%90 October 4, 1984
- Mr. James G. Keppler Regional Administrator U.S. Nuclear Regulatory Commission Region III 799 Roosevelt Road Glen Ellyn, IL 60137 Sub ject: Byron Generating Station Unit 1 IE Inspection Report No. 50-454/84-40 NRC Docket No. 50-454 Reference (a): August 31, 1984 letter from R. L. Spessard to Cordell Reed
Dear Mr. Keppler:
Reference (a) provided the report of an inspection at Byron Station and corporate offices by Mr. H. A. Walker in June and July, 1984. During that inspection, it appeared that certain activities were in violation of NRC requirements. Attachment A to this letter contains Commonwealth Edison's response to the Notice of Violation appended to Reference (a).
Attachment B to this letter addresses weaknesses identified during the inspection as requested in Reference (a).
Please address further questions regarding this matter to this office.
Very truly yours, 7 /2.
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Te D. L. Farrar Director of Nuclear Licensing A t tachraents 9268N 8410160348 841011 DRADOCKoSooopg OCT gggy L ._ , _ . _ _ _
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l ATTACHMENT A RESPONSE TO NOTICE OF VIOLATION VIOLATION As a result of the inspection conducted on June ll-15, July 5-6,.
July 9-12, July 16-17, and August 16-17, 1984, and in accordance with the General Policy and Procedures for NRC Enforcement Action, (10 CFR Part 2, Appendix C), the following violation was>
identified:-
10 CFR 50, Appendix B, Criterion XVIII, as implemented by the Commonwealth Edison Operations Quality Assurance Program including a commitment to ANSI N45.2.12 and ANSI N45.2.23, requires that a comprehensive system of planned and periodic audits be carried out in accordance with written procedures or check lists by appropriately trained personnel to verify compliance with all aspects of the quality assurance program and to determine the effectivenss of the program.
Contrary to the above, certain deficiencies were identified in i the audit program being per? armed by the Byron Station quality assurance organization as follows:
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h,; 1. l Audit Procedures:Q.P. 18-51, Q.P. 18-52, and Q.P. 18-1 which Fwere being' used did not -address a number of the ANSI N45.2.12
. and'N45.2.23~ requirements.
2ib.(2)(e). During the review of ' project QA ~ audits, the .
following observations were made:
- l. . Audit procedures Q.P. 18-51:and Q.P. 18 (Operations QA_ audits) and Q.P. 18-1 (Construction and Supplier audits) were-found to 1
. generally address the requisite requirements of ANSI N45.2.12 and N45.2.23, with the exception
.noted below.
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- a. Paragraph 4.4.6 of ANSI N45.2.12 requires that recommendations for correcting program i' deficiencies be included in the audit report.
- b. Paragraph 4.2.2 of ANSI N45.2.12 describes I the mandatory audit responsibilities for lead auditors.
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c.- Paragraph 5.2 of ANSI N45.2.12 and Regulatory Guide 1.144 specify audit record
! requirements.
- d. Paragraph 2.3.4 of ANSI N45.2.23 specifies audit participation time requirements as a i basis for lead auditor qualification.
I i e. Paragraph 2.3.2 of ANSI N45.2.23 requires an
, evaluation of both written and oral communication skills for lead auditor l qualification.
$ The inspector's review was not performed to the depth which would ensure that all line items in
- ANSI N45.2.12 and N45.2.23 were procedurally 3 addressed. Accordingly, the corrective action I with regard to this item should include an indepth review of the procedures to ensure inclusion of the appropriate requirements.
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- CORRECTIVE ACTION TAKEN AND RESULTS ACHIEVED Although the Program and implenenting Quality Procedures have for a long time committed to and resulted in the implementation of these two ANSI Standards covering auditing, the Quality Assurance Department took prompt action to review in depth and revise procedures Q.P. 18-1, Q.P. 18-51 and Q.P. 18-52 to procedurally address the details of ANSI N45.2.12 and N45.2.23.
Revisions to the procedures were prepared, approved, and issued with a revision date of 8-15-84 to include more requirement details of ANSI N45.2.12 and N45.2.23. These revisions were made available to the inspector on 8-16-84.
CORRECTIVE ACTION TAKEN TO AVOID FURTHER NONCOMPLIANCE Item 2,b(2),(e)l,a:
It has been Commonwealth Edison's policy in the past not to provide recommendations in the audit report for correcting deficiencies as the auditee would often only do what was deemed necessary to satisfy the auditor. It is our position that the audited organization has the responsibility to establish corrective action followed by concurrence of the Quality Assurance Department as to the acceptability of the response to correct the deficiencies. Where the corrective action is agreed upon during the audit, however, it is stated in the audit report as a commitment. On the uther hand, the method to achieve corrective action or identify the root cause may take extended effort.
Recommending the corrective action needed in the audit may not resolve the root cause and prevent recurrence. The use of this approach permits the audited organization to elect the method best able to meet requirements under its management systems and methodologies. Then the Quality Assurance Department exercises strong control to assure that the jointly concurred corrective action between the audited organization and Quality Assurance has been acceptably completed. This approach meets the requirements of ANSI N45.2.12 and it is felt that the licensee is in compliance.
Item 2,b,(2),(e)l,b:
The Quality Procedures es previously mentioned have been revised to include the detailed responsibilities of the Lead Auditor. In addition, Quality Requirement 18 was revised to further delineate Lead Auditor responsibilities in accordance with the requirements of the Standards. The implementation aspects of these Standards are demonstrated through the various established system, training, testing, and certification measures utilized to establish qualified, and certified auditors and Lead Auditors.
The overall responsibility for an audit is that of the Lead Auditor who serves as the team leader or the sole auditor.
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O Item 2,b,(2),(e)1,c:
Quality Requirements No. 17.0 provides that audit reports are lifetime records. Also, Quality Assurance Memorandum No. 1 identifies the retention time for audit and other records.
Item 2,b,(2),(e)l,d:
Quality Procedure 18-1, which is referenced in Quality Procedure 18-51, has been further revised to include more detail of requirements for Qualifications of Auditor and Lead Auditors as required by ANSI N45.2.23.
Item 2,b,(2),(e)l,e:
Prospective Lead Auditor's communication skills, including written and oral, have been attested to in the past and documented on our qualification and certification form which is patterned to that in ANSI N45.2.23. The term " communication skill" as used in ANSI N45.2.23 has always meant both oral and written skills in the evaluation of prospective Lead Auditors.
However, each skill will be separately indicated on the Qualification Form.
DATE WHEN FULL COMPLIANCE WILL BE ACHIEVED:
Changes were achieved for Item 2.b.(2)(e) 1 on 8-15-84 when revisions to Quality Procedures were issued detailing requirements of ANSI N45.2.12 and N45.2.23.
- 2. Audit plans were not prepared for project audits as required by Paragraph 4.2.1 of ANSI N45.2.12.
2.b.(2)(e)2 Audit plans required by Paragraph 4.2.1 of ANSI N45.2.12 were not being prepared for operations QA internal audits of the Byron Station. This problem was not noted in construction audits.
CORRECTIVE ACTION TAKEN AND RESULTS ACHIEVED An " Audit Plan" format has been developed which will be completed prior to the audit and will become part of the audit package. The Audit Plan will include statements on the purpose of the audit, the scope and reference used for the audit, a schedule of the time frame over which the audit is planned to be conducted including time of entrance and exit meeting, and finally the station organizations who will be involved and notified. The
audit plan will be verba11.y presented to the audited organization.
Depending on the scope and complexity of the audit, this may vary from informal discussions with personnel directly involved to a formal entrance meeting held with the management personnel responsible for the areas audited. Also, written or telecommunication notification when the audit is to be conducted and a general description of what areas are to be covered by the audit shall be provided to the audited organization just prior to the date the scheduled audit is to start (within 72 hours8.333333e-4 days <br />0.02 hours <br />1.190476e-4 weeks <br />2.7396e-5 months <br />) . This audit plan together with the developed checklist conform to the requirements of Paragraph 4.2.1 ANSI N45.2.12.
CORRECTIVE ACTION TAKEN TO AVOID FURTHER NONCOMPLIANCE Quality Procedure No. 18-51 Attachment A was revised to clarify the requirements of the audit plan to meet Paragraph 4.2.1, of ANSI N45.2.12 on August 15, 1984.
DATE WHEN FULL COMPLIANCE WILL BE ACHIEVED Achieved on August 15, 1984.
- 3. Lead Auditors were not performing all audit related activities as required by Paragraph 4.2.2 of ANSI N45.2.12.
2.b.(2)(e)3: Lead Auditors were assigned as Lead Auditor for several audits simultaneously. As a result, some of the duties specified in Paragraph 4.2.2 of ANSI N45.2.12 for a lead auditor were not being performed. For example, lead auditors did not actively participate in the performance of many of the audits, and there is no objective evidence that other activities required for lead auditors (e.g., coordination of the audit) were being performed. In most cases, audits appeared to be performed with little participation, guidance or supervision by the lead auditor. The impact of this problem appeared to be minimal in the construction QA area.
CORRECTIVE ACTION TAKEN AND RESULTS ACHIEVED As indicated in the response to Item 1 of the violation, Q.P. 18-1, Q.P. 18-51 and Q.P. 18-52 have been reviewed and revisions made to ensure that the requirements of ANSI N45.2.12 are addressed.
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. CORRECTIVE ACTION TAKEN TO AVOID FURTHER NONCOMPLIANCE The main ~ concern expressed in this item is that the span of control of individual Auditors and their audits is too great for a Lead Auditor. There is no questioning that the standard
. ANSI N45.2.12 does provide for use of team leaders to cover several auditors (one or more). It has always been the licensee position that the standard permitted the use of a Lead Auditor in
.this made of operation. The practice of utilizing a Lead Auditor as a team leader for several audits simultaneously will continue.
To address the concern on span of control, the auditor qualifications of the Byron Operation QA Group were re-evaluated.
Two people met the requirements of paragraph 2.3 of ANSI 45.2.23 and were made Lead Auditors. Six of twelve of the Byron Operation QA group are now at the Lead Auditor level. These two new positions of Lead Auditors w'ill greatly facilitate the scheduling of multi personnel audits and will reduce the number c" audits a Lead Auditor has to be involved with thus addressing the concern on span of control.
DATE WHEN FULL COMPLIANCE WILL BE ACHIEVED j Full compliance has been achieved.
1 4. Corrective or remedial action was not required for all audit
! items noted as deficient, as required by Paragraph 4.5.1 of ANSI N45.2.12.
4 2.b.(2)(e)A: During the review of records for operations QA Audit 84-17, the inspector noted that checklist items indicated as discrepant were not adequately addressed. Two items indicated as discrepant were not covered by findings or observations and records provided no
, explanations. The checklist for this audit indicated seven discrepant items. Two findings and one observation were issued which addressed only five of the seven discrepant items. This was not in accordance with Paragraph 4.5.1 of ANSI N45.2.12. Similar deficiencies were not noted in the other 12 operations audit reports which were part of this review. Additionally, similar problems were not evident in the construction QA audits.
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r CORRECTIVE ACTION TAKEN AND RESULTS ACHIEVED The sub ject '0perations .QA Audit 6-84-17 was reviewed. As a result, seven deficiency ' items identified in the objective evidence'of the checklist have been referenced to the specififc findings or the observation originally stated in the audit report and there were no changes in the number of findings or observations. (Also, refer to the previous response (Item 3 herein) which delineates the Team Leader's responsib311 ties relative to completed audit checklists.) <
CORRECTIVE ACTION TAKEN TO AVOID FURTHER NONCOMPLIANCE Byron Operation QA personnel have received additional training in the requirements of ANSI N45.2.12, with specific instruction to include on the audit checklist the reference of the observation or finding to the applicable checklist question.
DATE WHEN FULL COMPLIANCE WILL BE ACHIEVED Full compliance has been achieved.
- 3. Audit reports did not identify participating auditors as required by Paragraph 4.4.2 of ANSI N45.2.12.
1.b.(2).(e)5: Audit reports did not identify auditors participating in the audit as required by-Paragraph 3.2 of Attachment C of Procedure QP 18-51 and Paragraph 4.4.2 of ANSI N45.2.12.
Similar problems were not evident in the construction QA audits.
RESPONSE
A review of 1984 Operations QA audits did identify that Audit 06-84-53 was signed only by the Lead Auditor and not also by the auditor. An additional case was found in an operations audit done in 1982 that was signed by the auditor as QA Engineer. At that time this QA Engineer was the only person assigned to this organization. These are isolated cases of one auditor not signing and the other not using the title Lead Auditor. No corrective action is needed as the Quality Procedure requires the auditor to be identified and the Lead Auditor and a Supervisor to review and approve the audit reports as well.
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- 6. An audit finding was closed without appropriate corrective action as required by Paragraph 4.5.1 of ANSI N45.2.12.
2.b.(2)(e)6: During the review of Audit Finding No. 1 from Operations QA Audit 84-15, the inspector noted that the finding was closed without the benefit of appropriate corrective action. Although more than 20 percent of the records reviewed were deficient, the finding was closed without requiring a review of the balance of the respective records. This was not in accordance with Paragraph 4.5.1 of ANSI N45.2.12. Of the 13 operations audits reviewed, this was the only instance where failure to take appropriate corrective action was identified.
i CORRECTIVE ACTION TAKEN AND RESULTS ACHIEVED The issue in this violation concerns the use of a data sheet indicating that there was a double verification that jumper leads had been removed from electrical panels. The problem identified during the audit was that the data sheet had not been completed for a number of work requests. As corrective action, Quality Assurance required an additional sample be made of work requests by the station. Also, a field verification of the panels in question was made by the Station Electrical group and Quality Assurance. The field verification identified that the work had been completed properly and no jumper leads were found. This was accomplished as an audit follow-up dated June 21, 1984.
CORRECTIVE ACTION TAKEN TO AVOID FURTHER NONCOMPLIANCE Additional training has been given to the Operation Quality Assurance personnel at Byron in the area of adequate sampling and corrective action.
DATE WHEN FULL COMPLIANCE WILL BE ACHIEVED Full compliance has been achieved.
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. . 1 ATTACHMENT B OTHER WEAKNESSES 2.a.(2)(b) During .the review of Quality Assurance Department Memorandum No. 7, dated April 1984, the inspector noted that in some cases the procedure allowed training to be substituted for the experience levels specified by ANSI N45.2.6-1978. This procedure was revised and reissued and is now acceptable. The inspector has no further questions regarding this matter.
CECO QA personnel performed a review of certification records of personnel who were qualified to Memorandum No. 7. The review was performed to determine if QA personnel had been certified to the minimum experience requirements specified by ANSI N45.2.6. Two separate surveillance reports, generated as a result of this review, were reviewed by the NRC Inspector. One of the surveillance reports addressed the certification of Byron QA personnel and the other dealt with the certification of QA personnel at other CECO nuclear facilities. A review of the surveillances by the NRC Inspector did not indicate a problem with QA personnel assigned to Byron; however, the certifications of some personnel assigned to other projects appeared to be questionable. A subsequent review of selected certification records at the Corporate QA Office failed to resolve the issue because some of the resumes did not contain sufficient detail. This matter is unresolved pending further review (454/84-40-01).
RESPONSE
Upon further review of all resumes, three resumes were identified as requiring revision.- They have been updated and expanded to document sufficient detail requirements. In addition, new QA personnel will be required to follow a new format for writing
-resumes to provide sufficient detail. Corrective action has been completed.
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2.a.(2).(d) During a review of QA personnel certification records the inspector noted that one of the QA engineers had not been recertified in one NDE discipline. The QA Supervisor was not aware that the engineer's certification was not current and had not established a method to ensure that only qualified personnel were assigned to work in respective NDE disciplines. There was no indication that the QA Engineer had performed work in the uncertified discipline. This matter is unresolved pending review of a controlled method to ensure assignment of qualified personnel to specific work assignments (454/84-40-03).
RESPONSE- ,
The certifications are controlled by the System Materials Analysis Department (SMAD), Lead Level III, who has the i- responsibility-~of. notifying, and does notify, individuals 60 days before the date their certifications and eye exams expire. Also, the Quality Assurance Department has instituted a certification status quarterly report for use by each QA Supervisor to assure the certifications are kept current for his people. Corrective action was taken September 13, 1984.
I 2.b.(2)(a) The inspector reviewed the three corporate audits of
- the Byron project conducted during the past two l years. The audits appeared to be comprehensive in scope and depth; however, the inspector noted that the Byron project QA organization was not included within the scope of the audit conducted on August 8-12, 1983. This item is unresolved pending further review of periodic corporate audits to verify that they include, within their scope, review of the Byron QA organization (454/84-40-04).
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RESPONSE
In the case of the August 8-12, 1983 Comprehensive Audit of all site organizations, the overall thrust of this audit was in part, to verify that the Byron Construction Site Quality Assurance group was effective in identifying problems involving these site organizations and included activities involving Site Quality Assurance. In fact, Site Quality Assurance received two citations against them during the audit. Consequently, it has to be concluded that Site Quality Assurance was a part of the audit.
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2.b.(2).(b): During the review of auditor certification records for. Operations.QA auditors, the inspector noted that certain personnel had limited nuclear quality assurance experience. Most were recent college graduates with short term quality experience at the Byron Station. This is an open item which will tue reviewed at a later date (454/84-40-05).
RESPONSE-The array of related experience for ten of the twelve Operations Quality Assurance Auditors averages 12.79 years per person and ranges from 31 years.to 2.25 years (1-31 years, 1-25, 1-29, 1-16.5, 1-10.65, 1-8.5, 1-5.5, 1-3.25 and 2 with 2.25 years) involving NDE, power plant operations, Navy nuclear, engineering, construction and Quality Assurance experience. Moreover, special attention has been given to staffing this group with experienced people and graduate engineers needed to cover the various activities. The other two are graduate mechanical and nuclear engineers, respectively, with one being new and the other having been at Byron for fifteen months. These two provide technical needs for this group. The licensee has a very agressive interview program in selecting college graduates and other technically experienced people for assignments to various Edison Departments, which includes the Quality Assurance area. Once a person is selected by the Manager Quality Assurance for assignment to the QA Department, he or she is put through a structured training program within the Department. This includes a 40 hr. department orientation program, 16 hr. class on audit training, minimum of 24 hrs. of on-the-job training in the technique of auditing. The progress of the individual in performing audits is then monitored by their Lead Auditor, the Supervisor of Operations QA and the Director of Operations.
During the first year in the department the areas an individual can audit are limited, and only as the person completes qualification requirements can he or she audit additional areas.
In addition, the person is put through structured training which includes ASME Code and Standards, Welding, and Non-Destructive Testing and could also receive other training such as in maintenance, coatings, plant systems, etc. during their first year.
2.b.(2)(d) In reviewing Construction QA Audit No. 6-84-05, which was conducted on Westinghouse pipe support calculations, the CECO auditor determined that two errors were found in each of the two calculations had been checked and used in pipe support design.
An observation was issued as a result of the
7-problem. .This observation was closed with the following statement: "Due to he fact that none of these errors were significant no further action is required. This item is considered closed." This observation was closed without requiring action by Westinghouse to review additional calculations for errors or to address reasons that persons checking calculations did not detect the errors. ,
No additional calculations were reviewed by the auditors. The licensee's action taken does not appear to be adequate. This item is unresolved pending NRC review of the calculation errors .
(454/84-40-07).
RESPONSE '
It is the practice for construction auditors to review a sampling of numerical calculations and computations. When errors are found, the auditor determines if the errors have an affect on the final results. If the errors have no significance on the design requirements, no further action is taken except to identify that they were found. For the case of QA Audit 6-84-05, this was
- the case. However, the results of the observation were rechecked l and over 600 other computations were checked. It was concluded l that the auditor was correct in his disposition of the two l computational errors initially identified.
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l 2.b.(2)(c) During the review and discussion of project QA audit schedules for operations QA for 1983 and 1984, the inspector noted that there was no system to assure that required technical specifications items are audited periodically as required by the technical specifications. The inspector was informed that this system would be prepared in the near future when personnel experienced in operations were available.
l Currently, audits of technical specifications l requirements verify that the applicable requirements
! have been included in procedures. This was because the Byron technical specifications have neither been approved by the NRC nor implemented by the licensee. This item is open pending review of the audit scheduling system and the conduct of audits that verify technical specifications compliance
, subsequent to plant operation (454/84-40-06).
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RESPONSE
To assure that all required technical specification items are audited periodically as required by the technical specifications, the licensee uses a Technical Specification Matrix at all its operating stations. Such matrix has not been formulated yet at Byron. However, once the Technical Specifications are approved by the NRC for Byron Operations, QA will develop the matrix for use in their audits. The matrix is used as a tool by QA and is not a mandatory requirement. The matrix is developed to insure the necessary aspects of the technical specification are audited.
2.b.(2).(f) Concerns noted during the review of project QA audits were as follows:
- 1) The three audit procedures (Q.P. 19-1, Q.P.
18-51 and Q.P. 18-52) were not complete and were difficult to follow. The documents were not consistent in content. For example, the operations QA audit procedures (Q.P. 18-51 and Q.P. 18-52) did not describe or define the documents or methods used to report audit findings and audit observations. These issues are defined in Q.P. 18-1. This is an open item pending further procedural review (454/84-40-09).
RESPONSE
Procedures Q.P. 18-1, Q.P. 18-51 and Q.P. 18-52 were revisad to ensure items in ANSI N45.2.12 and N45.2.23 were procedurally addressed. As to the revision, Section 5,
" Procedure", of Q.P. 18-1 was expanded to include details for the audit system. Appendix B, " Instructions for Audit Implementation", has been revised to include the requirements for Preparation, Performance, Reporting and Follow-up of audits.
Audits conducted pursuant to Q.P. 18-51 and Q.P. 18-52 are referred to Q.P. 18-1, Section 5 for audit performance requirements and audit implementation. Also, the Definition section of Q.P. 18-51 has been revised to provide clarifying definitions of our identi fication method for audit deficiencies and to provide for audit rindings and observations to be reported in accordance with the detailed requirements in Q.P. 18-1.
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2.b.(2)(f)- .2) In most cases, Project Operations QA internal audits verified programmatic requirements but did not verify implementation of those requirements during pre-operational testing activities. In other cases where verification of implementation seemed to be required, the verification was not performed. For example, checklist Item Number 8 of Audit 84-04 asks the question, "Is distilled water used to refill station batteries?" The auditor verified the requirement was included in the appropriate procedure; however, there was no actual verification that distilled water was used to refill station batteries. This is an open item pending review on a subsequent inspection (454/84-40-10).
RESPONSE
The basic issue raised in this concern is the need to establish a balance between product and programmatic audits in that verification of implementation is verified. For along time, the need to perform such verification has been stressed in training for auditors, in QA personnel meetings, and through the review and approval of completed audit checklists by QA management. Also, our Program's system of surveillance adds to this balance. Surveillances are an important part of our methodology of verifying implementation of activities as they are being performed rather then have the audited organization perform a special process function for the auditor which in many cases may not be meaningful. In this case such a demonstration would have been meaningless. We feel the auditor used acceptable judgement, as part of the audit, not to require a demonstration that distilled water was used to fill the batteries but rather do a verification at a time the refilling process was being done.
2.b.(2)(f) 3) Checklists contained general questions with no details as to sample size or methods of verification. These are left to the discretion of the auditor during the audit. In some '
cases this appears to result in inadequate verification of checklist items. This is an open item to be reviewed in a subsequent inspection (454/84-40-11).
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RESPONSE -
Auditors are instructed in their training as to proper sample size and methods of verification to obtain the proper objective evidence during audits. Also, the conduct of an audit covering the audit plan and specific instructions is discussed
-with the respective auditors prior to and during the audit by the Lead Auditor to ensure the Audit is carried out as intended. The audit / surveillance sample size specified in Q.P. 12-3, Section 4.8 is followed. It is our position that to specify a sample size or methods of verification in a checklist would reduce the auditor's flexibility and effectiveness in obtaining the information needed to support his objective evidence either that the station is meeting the requirements of the question or to support a deficiency if they are not. The auditors are trained to perform in-depth evaluations and be thorough in their investigations. To establish prescribed methods and not know the specific circumstances would inhibit the audit process and result in inadequate results. Futhermore, the completed checklists are reviewed by the Lead Auditor, QA Supervisor and QA Director of Operations. If these reviews uncover any inadequate verification of a checklist item, the auditor is required to readdress the question. The key point is not to inhibit the auditor but to provide the freedom and requirement for the auditor to thoroughly investigate the various aspects of any general checklist questions to ensure requirements are being fulfilled.
2.b.(2)(f) 4) In some cases, audit records (i.e., reports or checklists) did not indicate if the audits were performed by reviewing records, verification of hardware or witnessing of work performed. The inspector noted this in the records for Audit 83-33. This is an open item pending further review of current audits (454/84-40-12).
RESPONSE
In a training session, Byron Operational QA personnel were again instructed, that in developing their objective evidence, to answer the audit question so that the method of verification is specified. This will delineate if the verification was by procedure, data sheets or in-process examination.
2.b.(2)(g) The auditor certification files at the Byron Station were reviewed to determine if the certifications were adequate. There were two items that could not be fully evaluated.
- 1) A copy of the lead auditor qualification examination required by Paragraph 4.2 of ANSI N45.2.23 was not included in the auditor certification files at the site. Copies of the examinations were on file in the training flies of the individuals which are maintained at the Corporate QA office.
- 2) Evidence that auditor training courses completed (as indicated in the certification records) included the specific training required by Paragraphs 2.2.1 and 2.2.2 of ANSI N45.2.23 was not included in the certification file at the site.
This is an open item pending further review of the Byron Station auditor cerification records (454/84-40-13).
RESPONSE
- 1. As stated in Paragraphs 4.2 of ANSI N45.2.23, the " Integrity of the examination shall be maintained by the employee....through appropriate confidentiality of the files." " Copies of the objective evidence regarding the type (s) and content of the examination (s) shall be retained by the employer." The intent of this standard is met by the following:
- a. The examination documentation of auditors are maintained and controlled in the official files which is located in the Quality Assurance General Office to ensure integrity of the records and the credibility and confidentiality of the various testing materials.
- b. A copy of the auditor certification is documented in accordance with the recommended guidance of Paragraph 5.1 and 5.2 of ANSI N45.2.23 and such certification is controlled and administered in the Quality Assurance General Office.
- 2. The evidence of the auditor training course completion is self evident on the auditor certification documentation. Also, a letter is published after the auditor training course which states who has passed and what Regulatory ANSI Standards and ASME Code requirements have been met.
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We believe the method of control and administration of testing and certification of Quality Assurance personnel at the Quality Assurance General Office provides a credible system and prevents personnel from having possible access to exam questions as well as meets the requirements for maintaining documentation supporting the certification of auditors. As a result, we feel we are in compliance with the Standard.
2.C.(2) Results of Inspection During the review, the inspector noted that Byron Operations did not have a procedure for trending of discrepancies by cause or discrepancy type. The inspector was informed that Byron personnel were aware of the need for this procedure and it will be developed in the near future. This matter is unresolved pending further review (454/84-40-14).
RESPONSE
F This item was identified by Corporate Off-Site Audit 6-84-I, Observation 1, which stated, " Evidence that Discrepancy Records have been reviewed for cognizance of problems or trends and for identification of significant trends as required by Q.P.
15-53, Paragraph Sa and 5b was not available." The audit was performed April 24 through April 27, 1984.
The station is developing a program which is being tracked by Operations QA.
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