ML20216D996
| ML20216D996 | |
| Person / Time | |
|---|---|
| Issue date: | 08/15/1997 |
| From: | Black S NRC (Affiliation Not Assigned) |
| To: | Dunlap W AFFILIATION NOT ASSIGNED |
| Shared Package | |
| ML20216E002 | List: |
| References | |
| NUDOCS 9709100055 | |
| Download: ML20216D996 (5) | |
Text
_ _ _ _ _ _ _ _ - __ -______-_ -
=
fp aa%>,
y"
-4 UNITED STATES i
.j NUCLEAR REGULATORY COMMISSION o,
'g WASHINGTON, D.C. 2055H001 August 15, 1997 Mr. W.H. Dunlap President / Chief Executive Officer Continental Technical Services of Georgia, Inc.
P.O. Box 830127 Stone Mountain, Georgia 30083
SUBJECT:
RESPONSE TO REQUEST FOR INFORMATION RELATED TO THE IMPLEMENTATION OF 10 CFR PART 50, APPENDIX B
References:
Letter to Mr. W.H. Dunlap, from Ms. Suzanne C. Black, NRC, dated November 1,1996
Dear Mr. Dunlap:
l in addition to the information previously transmitted to you in the referenced letter, the following response is provided to address your questions (Enclosure 1) conceming implementation of Appendix B to Part 50 of Title 10 of the Code of Federal Reoulations.
- 1. The typical method that would be used by a utility to invoke the requirements of Appendix B to 10 CFR Part 50, and 10 CFR Part 21, on a supplier or contractor is through a procurement document. Procuremt.nt document is defined in 10 CFR 50.2 and 10 CFR 21.3 as "a contract that defines the requirements which facilities or basic components must meet in order to be considered acceptable by the purchaser."
ANSI N45.2.13-1976, " Quality Assurance Requirements for Control of Procurement of items and Services for Nuclear Power Plants," elaborates on that definition, defining procurement documents as purchase requisitions, purchase orders, drawings, contracts, specifications or instructions used to define requirements for purchase.
The requirements related to the procurement process are derived primarily from Criterion IV, " Procurement Document Control" of Appendix B to 10 CFR Part 50. Criterion IV states that " Measures shall be established to assure that applicable regulatory j\\
s requirements, design basis, and other requirements which are necessary to assure
\\
adequate quality are suitably included or referenced in the documents for procurement of
\\
material, equipment, and services, whether purchased by the applicant or by its contractors or sub-contractors. To the extent necessary, procurement documents shall require contractors or subcontractors to provide a quality assurance program consistent
- with the pertinent provisioris of this appendix."
Each licensee has its unique processes and procedures to assure adequate quality in order to meet the requirements in Appendix B to 10 CFR Part 50.
L TIFT D CM f
9709100055 970815 PDR ORO NRRA hj{
ms
,;,,s
Mr. W H. Dunlap -
- 2. Each nuclear utility may have unique commitments embodied in their quality assurance (QA) program description for the certification of QA/QC personnel. The prerequisites and requirements imposed on a supplier of quality verification personnel who will be performing work activities under the cognizance of a ut:lity's OA program would typically be specified in the licensee's procurement document. This procurement document should be detailed enough to identify the applicable quality and technical provisions necessary to accomplish the speci' led activities in accordance with the licensee's QA Program described or referenced in the Final Safety Analysis Report. These requirements may be referenced or invoked and may include industry standards such as ANSI N45.2.61978,
" Qualification of Nuclear Power Plant inspection, Examination, and Testing Personnel" as i
endorsed by Regulatory Guide 1.58, Revision 1, or the equivalent reference to NOA l 1983 as endorsed by Regulatory Guide 1.28, Revision 3. It is the responsibility of the licensee to impose the necessary conditions on a contractor / vendor.
The NRC cannot provide a list of all relevant prerequisite and requirements as those are determined on a case-by-case basis by the licensee.
- 3. The regulatory requirements for a contractor supplying quality verification personnel to a utility who will be working under the contractor's QA program, vcould typically be the same as those required of the licensee. However, the licensee may impose additional requirements on the contractor as specified in its procurement document. Specifically, it is the responsibility of the licensee to meet its commitments and communicate the necessary requirements to their vendors.
The NRC cannot provide a list of all prerequisites and requirements as those are determined on a case-by-case basis by the licensee.
- 4. The prerequisites and requirements associated with the process for amending or modifying a contractual agreement between a licensee and a supplier of quality related parts or services would typically be addressed in the licensee's procurement document.
From a QA perspective, the specific requirements associated with the administrative controls process employed by a licensee to initiate modify or amend a contract would focus on their obligation to maintain adherence to the commitments contained in their NRC-approved QA program which demonstrates compliance with the requirements of Appendix B to 10 CFR Part 50.
The NRC cannot provide a list of prerequisites and requirements as those are determined on a case-by-case basis by the licensee.
- 5. With respect to the level of detail necessary for inclusion in the licensee's procurement document, the NRC expects this document to contain enough specificity to properly identify the applicable quality and technical provisions necessary for the vendor to accomplish the pertinent activities. Typical provisions related to the content of procurement documents are described in ANSI N45.2.13-1976 and RG 1.123. These provisions are invoked by the licensee as necessary and include considerations for the
f Mr.- W.H. Dunlap 3-l scope of work, technical requirements, quality assurance program requirements, right of access by the purchaser, documentation requirements, and control of nonconformances.
As previously described in item 2 above, these provisions may be referenced or invoked by the licensee in its procurement document. However, the NRC's regulations do not specify the content of procurement documents beyond requiring them to maintain adherence to the requirements in Appendix 8 of 10 CFR Part 50, and the associated commitments contained in the licensee's QA program description.
- 6. Each licensee establishes unique provisions with respect to which personnel are authorized to approve safety-related purchase orders. The provisions related to the issuance, revision or modification of documents for POs involving safety-related services are derived, in part, from Criterion VI, of Appendix B,10 CFR Part 50. Specifically, Criterion VI states that: " Measures shall be established to control the issuance of documents such as instructions, procedures and drawings, including changes thereto which prescribe all activities affecting quality. These measures shall assure that documents, including changes, are reviewed for adequacy and approved for release by authorized personnel [ emphasis added) and are distributed to and used at the location where the prescribed activity is performed. 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."
Additionally, the amplifying information contained in ANSI N45.2.13, Section 3.1, states that "The purchaser shall establish measures to assure that applicable regulatory requirements, design basis, and other requirements (including specific issue dates and applicable addenda) which are necessary to assure adequate quality are included or invoked by reference in the documents for procurement of items and services.
Procurement document changes shall be subject to the same degree of control as utilized in the preparation of the original documents." Further, Section 3.3 of ANSI N 45.2.13 states that reviews of procurement documents "shall be performed by personnel who have access to pertinent information and who have adequate understanding of the requirements and intent of the procurement documents.."
Licensee procurement organizations routinely issue Purchase Orders (POs) and changes thereto. Licensee controls related to the issuance, revision or modification of procurement documents would be govemed by licensee administrative procedures which reflect their commitments contained in the QA program description.
- 7. The licensee would be required to comply with the provisions of Appendix B to 10 CFR Part 50, including their QA program commitments and implementing procedures as discussed in item 6 above, wheri modifying or amending a PO associated with a safety related activity or service. In an instance where the licensee's initial authorizing officialis no longer with the company, subsequent revisions to the goveming PO must be authorized by appropriately designated and qualified personnel in accordance with the licensee's administrative control procedures.
Mr. W.H. Dunlap 8. The requirements of Appendix B to 10 CFR Part 50 encompass all safety-related activities performed by licensees including the oversight and control of services provided by contractors. The specific requirements related to auditing of suppliers are derived from Cnterion XVlli, " Audits" of Appendix B to 10 CFR Part 50 and the guidance provided in ANSI N45.2.12-1977, " Requirements for Auditing of Quality Assurance Programs for Nuclear Power Plants," or the equivalent reference to NOA-1-1983, as endorsed by Regulatory Guide 1.28, Revision 3. These requirements direct licensees to perform planned and periodic audits to verify compliance with all aspects of the QA program and to determine the effectiveness of the process. Additionally, ANSI N45.2.131976 provides amplifying information related to the selection of procurement sources based on evaluation of the supplier's capability to provide items or services in accordance with the requirements of the procurement documents. These source evaluation processes include, but are not limited to, the conduct of audits of suppliers' facilities. Therefore,
&pending on the specific itcms or services being procured, the history of the supplier ad the provisions of the controlling procurement document, the licensee may elect to aucit the contractor's facility to verify appropriate QA program implementation. Typically, licensee POs discuss the Right of Access for licensee staff to perform activities such as audits, at vendor facilities.
- 9. White not an explicit NRC requirement, the candidate's suitability evaluation by a Level lli examiner, would typically include an examination of qualifications which should be contained in their r6 sum 6. Industry standards related to the certification of a prospective Level 11 Inspector / Examiner are contained in ANSI /ASME N45.2.6-1978, " Qualification of Inspection, Examination, and Testing Personnel for Nuclear Power Plants", as endorsed by Regulatory Guide 1.58, Revision 1.
Specifically, as stated in Section 1.3 of ANSI N45.2.6-1978, "It is the responsibility of each organization participating in the project to assure that only those personnel within their respective organizations who meet the requirements of this Standard are permitted to perform inspection, examination, and testing activities covered by this Standard that verify conformance to quality requirements." Also, Section 2.2 of ANSI N45.2.6, which addresses the determination of capability for personnel states that "The capabilities of a candidate for certification shall M initially determined by a suitable evaluation of the candidate's education, experience, training. test results, or capability demonstration."
10.
Appendix B to 10 CFR Part 50, defines the quality assurance requirements for the design, construction, and operation of structures, systems, and components that prevent or mitigate the consequences of postulated accidents that could cause undue risk to the health and safety of the public. Licensees are required to prepare a QA program which describes how they willimplement the requirements of Appendix B to 10 CFR Part 50.
The QA program is reviewed for its acceptability in light of the guidance provided in NUREG-0800 chapters 17.1,17.2 and 17.3.
Mr. W.H. Dunlap Relative to 10 CFR Part 50 licensees and suppliers, the term "QA Plan"is synonymous with the term "QA Program." However, the term "QA Specification"is not specifically defined in the context of Appendix B program implementation.
11.
Subsequent to the award of a PO, the typical method for modifying the terms or conditions of that document would involve the issuance of a revision to the PO. However, the licensee's administrative controls related to this contractual process may vary depending on the specific licensee and their implementing procedures. The NRC does not require an " official change order form" to accompany this activity.
12.
Pelative to the resolution of audit findings, the requirements of Criterion XVI," Corrective Actions," of Appendix B, direct that the auditing organization evaluate the adequacy of corrective actions. The determination of the acceptability of proposed corrective actions, which may include on-site verification at the vendor's facility, is the responsibility and prerogative of the licensee.
We hope the information contained in our responses to your inquires will prove helpful to you in your future interactions with nuclear utilities. Should you have additional questions related l
to these matters, please utilize the established point of contact in the Office of General Council, Mr. Charles Mullins, (301)415-1606.
Sincerely, M % w.c Suzann C. Black, Chief Cuality Assurance and Maintenance Branch Division of Reactor Controls and Human Factors Office of Nuclear Reactor Regulation
Enclosure:
Facsimile from Mr. William Dunlap to Mr. Charles Mullins, OGC dated March 6,1997 4