ML20035B031
| ML20035B031 | |
| Person / Time | |
|---|---|
| Issue date: | 03/25/1993 |
| From: | Norrholm L Office of Nuclear Reactor Regulation |
| To: | Rossi C Office of Nuclear Reactor Regulation |
| References | |
| NUDOCS 9303310018 | |
| Download: ML20035B031 (35) | |
Text
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'o UNITED STATES
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NUCLEAR REGULATORY COMMISSION n
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E WASHINGTON, D. C. 20555
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March 25, 1993 MEMORANDUM FOR:
Charles E. Rossi, Director Division of Reactor Inspection l
and Licensee Performance Office of Nuclear Reactor Regulation FROM:
Leif J. Norrholm, Chief Vendor Inspection Branch Division of Reactor Inspection and Licensee Performance Office of Nuclear Reactor Regulation
SUBJECT:
COMMERCIAL GRADE PROCUREMENT AND DEDICATION WORKSHOP Enclosed is the proposed revision to NRC Inspection Procedure 38703,
" Commercial Grade Procurement Inspection, which also contains guidance on key dedication issues (Appendix A).
This document will be discussed at the upcoming workshop in Dallas on April 21-22, 1993. Appendix A of the proposed procedure incorporates feedback from our meeting with five utilities, NUMARC, and EPRI. As a result, we have modified our initial guidance on several of the issues to clarify their intent and to provide more flexibility in achieving 10 CFR Part 50, Appendix B compliance in dedication process.
Also enclosed is a set of dedication examples that we intend to discuss at the workshop breakout sessions. These examples are not directly related to dedication packages reviewed during the pilot inspections since certain parameters have been altered to focus on specific dedication issues.
Reference to this memorandum has been made in Federal Reaister notice i
58 FR 15167, entitled " Commercial Grade Procurement and Dedication Workshop,"
i dated March 19, 1993.
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Leif J.
Jorrholm, Chief Vendor Inspection Branch l
Division of Reactor Inspection and Licensee Performance Office of Nuclear Reactor Regulation
Enclosures:
1.
Inspection Procedure 38703 (March 22, 1993, Draft) 2.
Examples for Commercial Grade Dedication Workshop (March 24, 1993) 280094 9303310018 930325
((9/
1 DRAFT lMR 2 21993 l
NRC INSPECTION MANUAL RviB f
INSPECTION PROCEDURE 38703 i
COMMERCIAL GRADE PROCUREMENT INSPECTION
!a i
PROGRAM APPLICABILITY: 2515 l
SALP FUNCTIONAL AREA:
ENGINEERING l
38703-01 INSPECTION OBJECTIVE This procedure is provided in two sections and is intended to cover: (A) reactive inspections (38703A) in response to the failure or malfunction of dedicated commercial grade items (CGIs), and (B) inspections of the implementation of a licensee's process (38703B) for dedicating CGIs to determine if it meets the requirements of Appendix B of 10 CFR Part 50, and ensures that CGIs will perform l
their intended safety functions.
l 38703A-01 REACTIVE INSPECTION OBJECTIVES l
Determine whether the failure of a system, structure, component, (SSC) or part to perform its intended safety function was the result of a deficient CGI dedication process. A failure resulting from inadequate dedication, in general, may occur when the important design, material, and performance characteristics that are necessary to ensure that the dedicated CGI will perform its intended i
safety function, are not addressed during dedication.
387031.-02 REACTIVE INSPECTION REQUIREMENTS 02.01 Schedulina the Inspection and Contactino Licensee.
This. inspection l
procedure should be considered for implementation when there is reason to believe -
l that the failure of a SSC, or part to perform its intended safety function was the result of an inadequate CGI dedication.
This inspection procedure may be implemented independently or it may be used as a supplement to inspections such l
as an Augmented Inspection Team investigating failures. or other major team inspections such as those for maintenance, modificatien, or system specific l
inspections where review of failed SSCs or parts is appropriate.
l 02.02 Pre-Insoettion Activities. Review the circumstances associated with the j
failure including any identified root cause analysis by the licensee. It may be-l appropriate to contact the licensee and obtain additional information prior to j
determining if an inspection is required. If it is determined that the item did not perform its intended safety function because of a hardware failure, determine if the failed item was purchased as a CGI and dedicated for its safety-related application.
If the failed item was dedicated, then this inspection procedure' j
}
Issue Date: XX/XX/XX
-I-38703 l
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02.03 On-Site Conduct of the Insoection. Contact licensee personnel responsible for defining procurement requirements, and if not previously performed, determine if the failed item was procured as a CGI and dedicated for safety-related applications. If the failed item was dedicated, obtain the complete procurement and dedication records.
Typical records included in a dedication package are described in Section 03.02(b) of 337038.
02.04 Determine if the Failure was the Result of an Inadecuate Dedication.
Review and discuss with licensee personnel the failure analysis for the failed CGI.
Once the failure mode and cause of failure have been postulated or determined, review the dedication process to see if the critical characteristics identified encompassed the characteristics associated with the failure.
Section 1 of Appendix A to Inspection Procedure 38703 provides methods for determining if the important critical characteristics related to the failed item were identified.
If the critical characteristics associated with the failure are determined to be adeqe tely addressed in the dedication package, determine if the methods used for verifying / accepting those critical characteristics are acceptable. The following should be considered when reviewing the methods used to accept the critical characteristics related to the failure.
a.
Where receipt inspection along with testing of the item (Method 1) was the method for accepting the critical characteristics, Sections 02.04 and 03.04(a) of 38703B should be used for determining the acceptability of receipt inspection and testing activities.
Proper calibration of measuring and test equipment, the use of approved vendors to perform tests, and use of qualified personnel should also be considered.
b.
Where a commercial grade survey (Method 2) was the method used to accept a critical characteristic, Sections 02.04 and 03.04(b) of 38703B should be used for determining the acceptability of the commercial grade survey.
c.
Where a source verification (Method 3) was the method used for accepting a critical characteristic, Sections 02.04 and 03.04(c) of 38703B should be used for determining the acceptability of the source verification.
d.
Where supplier history (Method 4) was the method used for accepting a critical characteristic, Sections 02.04 and 03.04(d) of 38703B should be used to determine the acceptability of the use of the supplier's history.
e.
Any documentation that is furnished with the item and is relied on by the licensee to accept critical characteristics, should be validated by a commercial grade survey, source verification, or methods discussed in Section 6 of Appendix A to Inspection Procedure 38703.
02.05 Generic Considerations.
If it is determined that the dedicated item failed as the result of certain critical characteristics not being identified and/or properly accepted, the inspector should perform the following assessments:
a.
Determine if other CGIs from the same accepted lot or batch as the failed dedicated CGI have been similarly dedicated and installed in other safety-related applications.
If yes, determine if the licensee has evaluated the operability of the systems or components where these CGis are installed.
38703 Issue Date:
XX/XX/XX
DRAFT b.
In an effort to determine if a full program inspection (38703B) is aecessary, the inspector should select and review at least three other dedicated CGIs having similar applications and critical characteristics as the CGI(s) that resulted in the identified failures. Section 02.02 of 38703B should be used in selecting these dedication packages.
c.
If, after performing (b) above, it is determined that other CGIs were inadequately dedicated, regional management should determine whether it is appropriate to perform a more comprehensive inspection of the licensee's dedication process in accordance with 38703B of this procedure, or if the inspector should review those portions of the dedication program most pertinent to the deficiencies already identified.
38703A-03 REACTIVE INSPECTION GUIDANCE Guidance for the inspection requirements is contained in the guidance section for 38703B.
38703A-04 REACTIVE INSPECTION RESOURCE ESTIMATE 04.01 Inspector Resources. The typical reactive inspection will be conducted by one inspector either independently or in conjunction with other NRC inspection efforts.
04.02 Estimated Inspection Hours. The following are estimates of the inspection effort needed to complete this inspection.
Pre-inspection in-office review
-4 inspection hours On site inspection
- 24 inspection hours 36703A-05 REFERENCES Refer to 38703B-05 for the appropriate references.
38703B-01 PROGRAM INSPECTION OBJECTIVES Verify that the licensee's process for dedicating CGIs, as implemented, meets the requirements of 10 CFR 50, Appendix B, and ensures that CGIs will perform their intended safety function.
38703B-02 PROGRAM INSPECTION REQUIREMENTS 02.01 Schedulino the Inspection and Contactino Licensee. Coordinate with the appropriate NRC and licensee personnel to schedule the inspection.
When practical, inform the licensee of the objectives of the inspection 4-6 weeks before the inspection is to begin.
Request that the licensee prepare a list, prior to the inspection, consisting of items that the licensee purchased as commercial grade and subsequently dedicated for' use in safety-related applications within the past two years.
If time permits, prior to the beginning of the on-site inspection, the inspector should request and review the licensee's program and procedures to become familiar with the licensee's procurement and dedication process.
Issue Date: XX/XX/XX 38703
DRAFT In addition, explore with the licensee the possibility of obtaining a list of recent component failures. Request this list only if the licensee states this type of information would be easily retrievable. The list of component failures can be used by the inspector during the selection of dedication packages described in section 02.02.
02.02 Selection and Content of Dedication Packaaes. From the list of dedicated items provided by the licensee, the inspector should select approximately twenty dedication packages for review. Additional inspection guidance for the selection of packages for review is contained in Section 03.02(a) of 387038.
After the selections have been made, the inspector should request that the licensee compile a complete package of all the procurement and dedication records for each item. Inspection guidance on the contents of these dedication packages is provided in Section 03.02(b) of 38703B.
02.03 Review of Prooram and Procedures.
Review the licensee's program and procedures for the procurement and dedication of CGIs so the inspector understands the basic operation of the licensee's program.
Specifically, the inspectors should become familiar with the licensee's procedures that control:
procurement activities; material control; the dedication of commercial grade items, including receipt inspection and acceptance testing; audits and surveys of commercial grade suppliers; classification of components; training of personnel; trending of supplier performance; and equipment failures.
The inspectors should attempt to identify any apparent weak areas to concentrate on during the evaluation of the program implementation.
If plant equipment performs reliably and there are no identified failures of dedicated components, then there should be no need for the inspector to further examine the licensee's program and procedures beyond the initial review for familiarization. However, if after evaluation of the program implementation, it is determined that a full review of program and procedures is warranted, then Section 03.03 of 38703B provides guidance for this review.
02.04 Review of Dedication Packaces.
Review the dedication packages selected in Section 02.02 and perform a detailed review as described below and as per Section 03.04 of 38703B, depending on the dedication method (s) used.
The inspectors should perform the following steps to assist in the review.
- Determine the safety-related function of the item for its intended use in the plant by reviewing the technical evaluation portion of the package including, as applicable:
- classification of the item;
- consideration of credible failure modes; and,
- item equivalency / substitution evaluations.
- Determine if the important design, material and performance characteristics relevant to the safety function have been identified. Determine whether the licensee verified the characteristics necessary to provide reasonable assurance that the item will perform its intended safety function.
If appropriate, take into account post installation testing and periodic surveillance testing and inspection.
- Determine whether the item is a like-for-like replacement, or a new item replacement of an oosolete item.
38703 Issue Date: XX/XX/XX
DRAFT
+ Determine if the item is or may be used in a different safety-related application than previously evaluated for, where different design, material, and performance characteristics may be applicable.
This is especially applicable for generic dedications of bulk items and stock material.
Determine if the dedication assures those design, material, and performance characteristics relevant to the most critical safety application.
- Determine why the item is being replaced. Have there been repeated failures?
Is the degraded performance a result of adverse environment?
Did it fail because it was a refurbished or fraudulent item? Additional information on these activities is provided in ANSI N45.2 - 1977, " Quality Assurance Program Requirements for Nuclear Power Plants," Section 17, " Corrective Action."
. Determine how the identity of the item is controlled from the time it is receipt inspected up to when it is installed. Additional information in this area is provided in ANSI N45.2 - 1977, Section 9,
" Control of Parts and Components."
. Determine whether information learned during the dedication process is fed back to the appropriate persons to evaluate existing stock items, or installed items, and for future use in surveys and source verifications.
This information could include positive and adverse findings obtained during surveys and source verifications. Additional information on these activities is provided in ANSI N45.2.13 - 1976, " Quality Assurance Requirements for Control of Procurement of Items and Services for Nuclear Power Plants,"
Section 9, " Corrective Action."
02.05 Review of Trainina Effectiveness. If the inspectors review of commercial grade dedication activities indicates there are weaknesses in the way these activities are being performed, the inspector should investigate further to determine if the licensee has established an effective training program. Section 03.05 of 38703 provides additional guidance. Additional information in this area is provided in ANSI N45.2 -1977, Section 2, " Quality Assurance Program."
38703B-03 PROGRAM INSPECTION GUIDANCE General Guidance. The procurement of safety-related spare and replacement parts for operating plants in the nuclear industry has changed considerably over the past several years. Because of a decrease in the number of qualified nuclear-grade vendors, the NRC staff is aware that there has been a change in the industry's procurement practices.
Ten years ago, licensees procured major assemblies from approved vendors who maintained QA programs pursuant to Appendix B of 10 CFR Part 50 (Appendix B). Currently, due to the reduction in the number of qualified nuclear-grade vendors, licensees are increasing the numbers of commercial grade replacement parts that they procure and dedicate for use in safety-related applications. This is a substantial change from the environment in which Appendix B was promulgated.
Licensees are required to maintain procurement and dedication programs that adhere to the requirements of Appendix B, and thus assure the quality of items purchased and installed in safety-related applications.
Since commercial grade dedications have increased in number, the NRC has developed this inspection procedure (JP) to provide guidance to assist the inspector in completing the inspection requirements.
This IP applies to the review of commercial grade procurement and dedication activities with regard to the technical and acceptance requirements of Appendix B.
It is not intended to provide a detailed, step-by-step, checklist for the inspection.
Issue Date: XX/XX/XX 38703
DRAFT The guidance discussed belou is intended to assist the inspector to assess the effectiveness of the implementation of the licensee's commercial grade procurement practices. The evaluated areas should help the inspector discern any developing trends or emerging problems in the implementation of the program.
The Vendor Inspection Branch, NRR, is available to assist with specific questions that arise during the performance of this procedure.
03.01 No inspection guidance 03.02 Selection and Content of Dedication Packaoes.
a.
Selection of Dedication Packaoes:
The selection process should be performance-oriented; weighted toward the review of dedication packages for equipment, components or parts that have experienced failures.
To accomplish this, the inspector should select approximately twenty packages for review using the two step approach described below:
Sten 1: Review the licensee's records available at the plant site to identify recent failures (approximately the last two years) of equipment, components or parts. Review these failures to determine if any were CGIs dedicated for use in safety-related applications.
If available, select approximately 75% of the total sample from CGI failures.
Step 2: From the list of dedication packages supplied by the licensee, select the remainder of packages for review.
The total sample size including packages from step 1 and step 2 should be approximately twenty packages.
However the inspector can select a larger or smaller sample depending on the complexity of the packages and the time available. The inspector should select these packages based on the following considerations:
The inspector should select packages for items whose failure would have the most impact on the ability of the plant to safely operate, safely shutdown from an adverse condition, or maintain a safe shutdown condition.
The plant specific probabilistic risk assessment (PRA), individual plant examination (IPE), and risk based inspection guides (RIGS) provide information on the risk significance of safety-related plant equipment.
The inspector should take a performance oriented approach to the selection process by including in the sample packages those items that have been problems in the past.
The inspector should review available sources of information to identify any known failures of CGIs that were used in safety-related applications. These sources of information could include:
Component failure lists or lists of items requiring frequent maintenance or replacement as provided by the licensee.
Misrepresented or fraudulent items reported in NRC Information Notices.
Licensee trending of equipment and supplier performance.
Previous history of component failures or malfunctions as 38703 Issue Date:
XX/XX/XX
DRAFT reported in licensee event reports, plant nonconformance reports, or NRC morning reports.
The inspector should include both simple and complex packages in the sample as well as packages that include a variety of dedication methods (i.e., Methods 1,2,3, and 4) described in guidance Section 03.05a through 03.05d.
In addition to selecting packages based on the above considerations (safety significance, complexity, and failures) the inspector should attempt to select samples from each of the following areas:
electrical, instrumentation and control, mechanical equipment, and materials.
b.
Contents of Dedication Packaoes:
The dedication packages compiled by the licensee may contain the following items, as applicable, depending on the item chosen and the dedication methods used.
Purchase requisitions and purchase orders.
Other pertinent vendor / licensee correspondence.
Design specifications - original and updated to verify certain important parameters, such as original design pressure of a system or degraded pick-up voltage of a solenoid or relay.
Catalog specifications.
Procurement basis evaluation - Like-for-like, equivalency, plant design change packages, drawing and specification updates.
10 CFR Part 50.59 safety evaluation, if required.
=
Material receiving reports, packing lists / invoices and other shipping documents.
Receipt inspection reports and any related test reports.
Other documents to trace the item from the time it was dedicated to a
the time it was installed, tested and accepted.
Certificates of Conformance/ Compliance / Quality.
Vendor test and inspection reports.
=
Third party or subvendor test and inspection reports.
Shelf life information.
Vendor dedication / partial dedication information.
Design / material / process change history information.
Completed ccmmercial grade dedication document including:
identification of safety functions / application requirements Issue Date: XX/XX/XX 38703
DRAFT identification of critical characteristics identification of verification methods and acceptance criteria for the critical characteristics evaluation of credible failure modes Any deviation from design, material and performance characteristics relevant to the safety function (Nonconformance dispositions).
Documents showing objective evidence:
Special test and inspection procedures and results Commercial grade survey reports - item, design, material and performance characteristic specific (relevant to safety function)
Source inspection reports Completed post installation test procedure and results.
Completed stock or material issue forms and installation work orders or reports.
Historical performance information.
03.03 Review of Program and Procedures. Conduct a familiarization tour of the angineering, receipt inspection, component testing, and warehouse areas.
Contact, as necessary, systems engineers, procurement engineers, receipt inspectors, quality assurance engineers and inspectors, and warehouse personnel in order to gain an understanding of:
How processing of CGI procurement documents is controlled under the QA program and receive QA review and approval.
Additional information on these activities is provided in ANSI N45.2.I3 - 1976, Section 3,
" Procurement Document Preparation, Review, and Change Control."
= How technical personnel participate in the preparation, review, and approval process of purchase requisitions and purchase orders.
How consistency and coordination is maintained between corporate level, engineering / support
- level, and site level programs and implementing procedures.
03.04 Review of Dedication Packaoes. The goal of the review of the procurement and dedication packages is to ensure that the CGIs being dedicated by the licensee for safety-related applications will perform their intended safety functions. The inspectors should not place an over emphasis on the review of documentation. Inspection results should be directed towards the identification of inadequate dedications of CGIs that could potentially render SSCs or parts inoperable. The inspectors should use the " Operable / Operability: Ensuring the functional Capability of a System or Component," section of NRC Inspection Manual Part 9900, " Technical Guidance," for the review of licensee operability determinations for inadequately dedicated CGIs that could affect the SSCs or parts operability.
Appendix A to this procedure contains a discussion of significant dedication 38703 Issue Date:
XX/XX/XX
DRAFT issues that can be used during the review of dedication packages. The following specific guidance is included for the review of CGIs dedicated using any of the four methods listed below.
a.
Method 1 - Special Tests and Inspections Additional information on these activities is provided in ANSI N45.2.13 -
1976Property "ANSI code" (as page type) with input value "ANSI N45.2.13 -</br></br>1976" contains invalid characters or is incomplete and therefore can cause unexpected results during a query or annotation process., Section 10, " Acceptance of Item or Service."
Use the following approach to review packages that were dedicated using Method 1:
Attempt to witness receipt inspections and tests of the design, material, and performance characteristics relevant to the most critical safety application.
Review receiving records and associated tests and inspections.
=
Review post-installation test records.
Verify that the tests and inspections specified for acceptance, adequately verify performance and suitability for all intended applications.
Verify that sampling plans are controlled and have adequate technical basis, considering lot traceability and homogeneity, complexity of the item, and adequacy of supplier controls.
Verify that CGI receiving inspection activities are adequately
=
controlled under the QA program regardless of whether they are being done in conjunction with other plant QA receipt inspection activities.
Verify that receipt inspection activities establish and maintain traceability of CGIs by capturing and appropriately relating traceability documents through identification and monitoring of CGis.
b.
Method 2 - Commercial Grade Survey Use the following guidance to review packages that were dedicated using Method 2:
Determine if the guidance of Generic Letter (GL) 89-02, or an appropriate alternate, is included in the appropriate procedures.
Specifically, that (1) the documented commercial quality program was effectively implemented, and (2) the surveys were conducted at the location necessary to verify that adequate controls were exercised on distributors as well as manufacturers.
Determine if the persons who perform vendor audits and surveys are knowledgeable in the following:
The use of performance-based audits, Screening third-party audits and surveys.
Processing and evaluating adverse findings resulting from the review of third party audits and surveys to ascertain if those findings impact CGls al ready installed or stored in the Issue Date: XX/XX/XX 38703
DRAFT warehouse awaiting future installation.
Additional information on these activities is provided in ANSI N45.2.12 - 1977, " Requirements for Auditing of Quality Assurance Programs for Nuclear Power Plants," and ANSI N45.2.23 - 1978,
" Qualification of Quality Assurance Program Audit Personnel for Nuclear Power Plants."
Verify that the supplier's commercial quality controls are imposed in the procurement documents.
Determine if design, material, and performance characteristics relevant to the safety function that are to be verified by the survey team are accurately and completely incorporated in the survey plans.
Determine if the validity of supplier cocumentation relied upon in the dedication of the item, is verified during the survey.
Determine if surveys of commercial grade suppliers are performance-
=
based as opposed to broad-based programmatic audits. Specifically, verify that selected
- design, material, and performance characteristics relevant to the safety function for the CGIs being surveyed are controlled by the supplier's quality activities.
Determine if survey teams include technical and quality personnel that are knowledgeable in the operation of the item (s) and the associated critical characteristics to be verified, including any special processes such as welding and heat treatment that are specific to the critical characteristics.
Determine if surveys are conducted at appropriate times relative to
=
the procurement.
Are surveys required to be updated on a regular basis to support dedication?
Determine if the control of subvendors is adequately addressed by the surveys so that the supplier has an adequate basis to accept test results and certifications from the subvendor.
Determine if pertinent information about a supplier or his products
=
is used to plan, conduct, and report results of surveys and source verifications.
Such information could have been available from source verifications, raceiving inspections, the dedication process and supplier / product performance history or outside sources such as (NRC Information Notices and Bulletins, NPRDS reports, or NUPIC joint audit or commercial grade survey reports'.
c.
Method 3 - Source Verification Additional information on these activities is provided in ANSI N45.2.13 -
1976Property "ANSI code" (as page type) with input value "ANSI N45.2.13 -</br></br>1976" contains invalid characters or is incomplete and therefore can cause unexpected results during a query or annotation process., Section 10.3.2, " Acceptance by Source Verification." Use the following approach to review packages that were dedicated using Method 3:
Determine if source verifications involve witnessing the supplier performing quality activities on the actual items being procured, and adequately verify the design,
- material, and performance characteristics relevant to the safety function.
38703 Issue Date:
XX/XX/XX
DRAFT Determine if personnel who participated in the source verification surveys had technical backgrounds.
Determine if appropriate hold points are imposed in the purchase orders. This would include a hold point to verify design, material, and performance characteristics relevant to the safety function, that can not be verified after the item has been completely manufactured.
Determine if the results of the source verifications were adequately documented.
d.
Method 4 - Acceptable Supplier / Item Performance Record Use the following guidance to review packages that were dedicated using Method 4:
Determine if the guidance of GL 89-02, or an appropriate alternate, has been incorporated. Specifically, (1) the established historical record is based on industry-wide performance data that is directly applicable to the item's critical characteristics and the intended safety-related application, and (2) the manuf acturer's measures for the control of design, process, and material changes have been adequately implemented as verified by audit (multi-licensee team audits are acceptable).
Determine if information pertinent to the CGI's quality of performance, obtained from outside sources (e.g. OER, NRC, VETIP, INP0 etc.) and from commercial grade Surveys, source verifications, receipt inspections, previous dedication or qualification and operational history, is factored into the dedication process.
Determine if the item or manufacturer is included in the licensees performance trending program.
03.05 Review of Trainina Effectiveness. Select and review the training records for individuals involved in the following areas:
. Determining the safety classification of an item.
- Specifying design, material and performance characteristics relevant to the safety function and establishing the acceptance criteria for these characteristics.
- Specifying or performing commercial grade surveys, source verifications, and tests and inspections, including enhanced post-receipt verification testing or inspection.
The preparation and review of purchase orders.
Through observation, interviews and a review of records of work performed by the individuals:
- Determine if the individuals selected have adequate knowledge to perform the specific tasks assigned to them. Attend a training course, if available, or review the lesson plans for selected training courses.
Determine whether training inadequacies contributed to any of the deficiencies Issue Date: XX/XX/XX 38703 J
t DRAFT which may be identified during the inspection.
- Determine if the personnel are familiar with the program requirements and procedures and if they have been properly trained in the dedication process.
38703B-04 PROGRAM INSPECTION RESOURCE ESTIMATE 04.01 Insoection Resources.
The typical procurement and commercial grade dedication program inspection will consist of two or three inspectors for one week.
The inspectors should be knowledgeable of procurement requirements and include at least one mechanical engineer and ono electrical / instrumentation and control engineer.
04.02 Estimated Inspection Hours. The following are estimates of the inspection effort needed to complete this inspection.
In-office review of program and procedures - 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> / inspector = 72 hours8.333333e-4 days <br />0.02 hours <br />1.190476e-4 weeks <br />2.7396e-5 months <br /> On-site inspection
- 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> / inspector = 120 hours0.00139 days <br />0.0333 hours <br />1.984127e-4 weeks <br />4.566e-5 months <br /> Total for inspection = 192 hours0.00222 days <br />0.0533 hours <br />3.174603e-4 weeks <br />7.3056e-5 months <br /> 38703B-05 REFERENCES The following documents are listed for the inspectors information only and are not considered regulatory requirements unless the licensee has formally committed to implementing any of these documents. The inspector may wish to review these documents to become familiar with commercial dedication issues.
= Generic Letter 89-02, " Actions to Improve the Detection of Counterfeit and Fraudulently Marketed Products."
(microfiche 48960-001)
= Generic Letter 91-05, " Licensee Commercial Grade Procurement and Dedication Programs."
(microfiche 57468-264)
- American National Standards Institute (ANSI) N45.2 - 1977, " Quality Assurance Program Requirements for Nuclear Power Plants," as endorsed by NRC Regulatory Guide (RG) 1.28 Revision 2.
ANSI N45.2.12 - 1977, Requirements for Auditing of Quality Assurance Programs for Nuclear Power Plants."
" Quality Assurance Requirements for Control of Procurement of Items and Services for Nuclear Power Plants,"
. ANSI N45.2.23 - 1978, " Qualification of Quality Assurance Program Audit i
Personnel for Nuclear Power Plants."
l
= SECY-90-304, "NUMARC Initiatives on Procurement" (microfiche 55277-049)
- SECY-91-291, " Status of NRC's Procurement Assessments and Resumption of Programmatic Inspection Activity" (microfiche 59490-079) i
= NUMARC 90-13, " Nuclear Procurement Program Improvement" EPRI NP-5652, " Guidelines for the Utilization Of Commercial-grade Items In 38703 Issue Date:
XX/XX/XX
DRAFT
~
Nuclear Safety Related Applications (NCIG-07)"
. EPRI NP-6406, " Guidelines for the Technical Evaluation of Replacement Items in Nuclear Power Plants (NCIG-II)"
EPRI NP-6629, " Guidelines for the Procurement and Receipt of Items for Nuclear Power Plants (NCIG-15)"
EPRI NP-6630, " Guidelines For Performance-Based Supplier Audits (NCIG-16)
= EPRI NP-6895,
" Guidelines for the Safety Classification of Systems, Components, and Parts Used in Nuclear Power Plant Applications (NCIG-17)"
EPRI NP-7218, " Guideline for the Utilization of Sampling Plans for Commercial Grade Item Acceptance (NCIG-19)"
END Appendix A.
Dedication Issues B.
Definitions Issue Date:
XX/XX/XX 38703
DRAFT APPENDIX A DEDICATION ISSUES j
\\
l l
1.
Basis for the selection and verification of critical characteristics.
a.
Consideration of Item's Safety Function Critical characteristics should be based on the item's safety function.
The licensee is responsible for identifying the important design, I
material, and performance characteristics which have direct impact on the I
item's ability to accomplish its intended safety function, establishing l
acceptance criteria for these characteristics, and providing reasonable assurance of conformance to these criteria. When an existing equipment specification is available that contains adequate technical requirements for the item being purchased, that specification can be used to establish the critical characteristics for this item.
Criterion II of Appendix B provides for the application of quality control over activities affecting the quality of structures, systems, and components to an extent consistent with their importance to safety. This graded approach can be used in the selection of critical characteristics and acceptance criteria for commercial grade items, b.
Consideration of Failure Modes An evaluation of credible failure modes of an item in its operating environment and the effects of these failure modes on the item's safety function may be used in the safety classification of an item and as a basis for the selection of critical characteristics.
c.
Reasonable Assurance The dedication process is not a substitute for Appendix B.
Rather, it represents a method of achieving compliance with Appendix B with the purchaser assuming many of the responsibilities for assuring quality and I
functionality of an item which had previously been the responsibility of the vendor.
In this context, reasonable assurance consists of the purchaser controlling the activities affecting the item's quality to an extent consistent with the item's importance to safety or assuring that these activities are adequately controlled by the supplier.
For more complex items, dialogue with the original equipment manufacturer may be necessary to identify the design and functional parameters of specific piece parts. Upon the completion of the dedication process, the quality assurance and/or other measures applied to those aspects of the item which directly affect its safety function should result in the same level performance as for a like item manufactured or purchased under an Appendix B program.
d.
Engineering Judgement Engineering judgement can be used in selecting those important design, i
material, and performance characteristics which are identified as the item's critical characteristics. The bases for engineering judgement for this application should be documented.
Issue Date: XX/XX/XX A-1 38703 i
I
DRAFT 2.
Samplina.
a.
Established Heat Traceability (materials)
When heat traceability of material has been established and each piece of the material is marked with the material heat number, all analyses and tests required to verify the identified critical characteristics may be performed on one piece of this material.
b.
Established Lot / Batch Control When Lot / Batch (defined as units of product of a single type, grade, class, size and composition, manufactured under essentially the same conditions, and at essentially the same time) control is established through a commercial grade survey or other means, the party performing dedication can use sampling prescribed by standard statistical methods which are based on homogeneous product lots. Such sample plans should be identified and should provide for the verification of the critical characteristics with confidence level consistent with the item's importance to safety.
c.
Items With No Lot / Batch Control When Lot / Batch traceability can not be established, sampling plans need to be considered on individual, item-specific basis and assure that they are capable of providing a high level of assurance of the item's suitability for service.
There may be situations where each item needs to be tested.
3.
Traceability.
a.
Material / Items Purchased from Distributors Traceability can be defined as the ability to verify the history, location, or application of an item by means of recorded identification.
Where the item's acceptance is based entirely or partially on a certification by the manufacturer, the traceability must extend to the manufacturer.
In situations where intermediaries (distributors) are included in thc supply chain and have physical possession of the item during the procurement
- process, their capability of maintaining traceability should be assured by audit or surveys.
Distributor audits or surveys do not need to be performed on item-specific basis but should demonstrate that the distributor has adequate traceability controls in place for the type of items being supplied.
4.
Commercial Grade Surveys.
a.
Verification of Vendor's Control of Specific characteristics A commercial grade survey should be specific to the scope of the commercial grade item or items being purchased. The vendor's controls of specific critical characteristics to be verified during the survey should be identified in the survey plan.
The verification should be accomplished by reviewing the vendor's program / procedures controlling these characteristics and observing the actual implementation of these controls in the manufacture of items identical or similar to the items Issue Date: XX/XX/XX A-2 38703
DRAFT being purchased.
b.
Identification of Applicable program / Procedures The vendor must have a documented program and/or procedures to control the critical characteristics of the item or items being procured which are to be verified during the survey.
When many items are being purchased, a survey of a representative group of similar items may be sufficient to demonstrate that adequate controls exists. If the vendor's controls are determined to be satisfactory, purchase orders for these items should invoke these controls as contract requirements by referencing the applicable program / procedure and revision.
Upon completion of the work, the vendor should certify compliance with the purchase requirements.
c.
Documentation of Survey results Commercial grade survey documentation should include the identification of item or items for which the vendor is being surveyed, identification of the critical characteristics of these items which the vendor is expected to control, identification of the controls to be applied (program / procedure and revision) and a description of the verification activities performed and results obtained.
Deficiencies identified during the survey which may affect control of the identified critical characteristics should be addressed by requiring the vendor to institute additional controls or by utilizing other verification and acceptance methods.
5.
Like-For-like Replacements.
a.
Like-for-Like Verification If it can not be demonstrated that the replacement item is identical with the item that it replaces, or if differences between the items are identified, an evaluation is necessary to determine if any changes in design, material, or manufacturing process could impact the item's critical characteristics and its ability to perform the intended safety function.
6.
Acceptance Of Certified Material Test Reports (CMTRs)
And Certificates Of Compliance (C0Cs).
a.
Validity Verified Through Vendor / Supplier Audit or Testing The validity of vendor CMTRs and CoCs should be verified.
This can be accomplished through a commercial grade survey or, for simple items, periodic testing of the product upon receipt. Such verifications should be conducted at intervals commensurate with the vendor's past performance.
If the item's supply chain includes a distributor who has physical possession of the items during the procurement process, the verification survey should include warehousing and/or traceability controls at the distributor's facility. The purchaser may develop other means to accomplish this verification consistent with its QA program commitments.
Issue Date:
XX/XX/XX A-3 38703
DRAFT APPENDIX B DEFINITIONS The following terms are listed to provide the inspectors with working definitions of important terms used during the procurement and dedication of commercial grade items (CGIs). These terms are defined only in the context of the CGI dedication process and are solely to aid the inspector in the inspection process.
Acceptance - The employment of methods to produce objective evidence that the CGI will perform its intended safety function.
Commercial Grade Item - An item satisfying all three of the f llowing criteria:
1.
Not subject to design or specification requirements that are unique to nuclear facilities; and 2.
Used in applications other than nuclear facilities; and 3.
Is to be ordered from the manufacturer / supplier on the basis of specifications set forth in the manufacturer's published product description (i.e. catalog).
Commercial Grade Survey - Activities conducted by the purchaser or its agent to verify that a supplier of CGIs controls, through quality activities, the critical characteristics of specifically designated CGIs, as a method to accept those items for safety-related use.
Critical characteristics - Are those important design, material, and performance characteristics which have direct impact on the CGI's ability to accomplish its intended safety function.
Dedication - Is the process which assures the suitability of commercial grade parts, materials and services intended for safety-related applications by identifying, and obtaining assurance with respect to, the important design, material, and performance characteristics which are relevant to the intended safety function.
Eauivalency Evaluation - A technical evaluation performed to confirm that an alternate replacement
- item, not identical to the original
- item, will satisfactorily perform its intended safety function once in service.
Like-for-like Replacement - The replacement of an item with an item that is identical.
Reasonable Assurance -
In the context of dedication of a CGI, reasonable assurance consists of the purchaser controlling the activities affecting the item's quality to an extent consistent with the item's importance to safety and providing adequate justification that the SSC or part will perform its designed safety function.
Issue Date: XX/XX/XX A-4 38703
DRAFT Source Verification - Activities witnessed at the suppliers' facilities by the purchaser or its agent for specific items to verify that a supplier of CGls controls the critical characteristics of that item, as a method to accept the item for safety-related use.
Special Tests and Inspections - Activities conducted during or after receipt of a CGI to verify certain critical characteristics as a method to accept the item for safety-related use.
Technical Evaluation - An evaluation performed to assure that the correct requirements for an item are specified in the procurement document.
Traceability - Is the ability to verify the history, location, or application of an item by means of recorded identification.
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I Issue Date:
XX/XX/XX A-5 38703
N i
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EXAMPLES FOR-t
. COMMERCIAL GRADE DEDICATION WORKSHOP.
(March 24, 1993).
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PAGE I.
INADEQUATE IDENTIFICATION / VERIFICATION OF l
CRITICAL CHARACTERISTICS i
Example No. I, Woodruff Key..................... 'I Example No. 2, Elbow....
3 II.
USE OF DOCUMENTED ENGINEERING JUDGEMENT Example No. 3, Valve. Actuator Spring...............
5 Example No. 4, Beam Clamp....................
.7 j
III. VERIFICATION OF CRITICAL CHARACTERISTICS AND-THE USE OF NON-PROCUREMENT ACTIVITIES FOR CGI DEDICATION Example No. 5, Wire Rope (Cable) 9 IV.
USE OF SAMPLING Example No. 6, (Various Items) 11
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V.
-USE OF COMMERCIAL GRADE SURVEYS Example No. 7, (Various Items)..................
13 -
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Example I i
INADEQUATE IDENTIFICATION / VERIFICATION OF CRITICAL CHARACTERISTICS - METHOD I Dedicated CGI:
Woodruff Key, connecting the valve stem to the actuator lever arm.
Applications:
Installed in an active air operated isolation
-l valve.
4 CGI Safety Function:
Ensures full engagement of the valve stem and actuator arm (full engagement is required to ensure full stroking of the valve).
Credible Failure Modes:
Shear Fracture / Deformation Failure Consequences:
A severely worn or broken Woodruff key would allow the actuator lever arm to partially.
disengage from the valve stem and prevent full closing of the valve.
Available CGI Specially Hardened ASTM A-304, Gr. 8630H steel.
Specification:
i Purchase Order:
The CGI purchase order (P0) specified drawing
'?
number, part number, and material (Specially Hardened ASTM A-304, Gr. 8630H steel).
The P0 was issued to the original equipment manufacturer (0EM)
USER SELECTED CRITICAL CHARACTERISTICS AND ACCEPTANCE METHODS NOTE: The following critical characteristics were verified during receiving inspection by the licensee.
Part Number, Dimensions, Verify acceptance against manufacturer's
}
and Configuration:
drawing, manual, or other published document l
requirements.
Material:
Verify that material is magnetic.
Dedication Deficiency In the absence of a validated Certified Material Test Report, the critical characteristics and acceptance methods should have included verifying the i
material (i.e., chemistry) and the material heat treated condition (a hatiness test would have been acceptable to verify heat treatment in this case).
~
f b !
Other Considerations (To determine the sianificance of the deficiency)'
The extent of installation testing, periodic testing, and inspection requirements that' the licensee has in place will. influence the safety significance of the deficiency including any potential effect on operability.
The NRC inspection' report should reflect the significance of ~the dedication deficiency taking into account the types of the considerations mentioned above and appropriate follow-up inspection performed.
- Note
- In this actual failure, licensee inspection revealed that 3 normal leakage past a valve (having a Woodruff key from the accepted batt i of keys discussed in this example) was experienced in system operation.
Upc disassembly it was discovered that the Woodruff key had failed allowing the silve actuator arm to disengage from the valve stem preventing proper valve posi ioning.
Failure analysis showed the key to be manufactured from SAE 1035 c rbon steel in mill annealed condition. This material in mill annealed condit on did not have sufficient strength to withstand normal service loads.
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Example-2.
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INADEQUATE. IDENTIFICATION / VERIFICATION OF CRITICAL CHARACTERISTICS - METHOD I Dedicated CGI:
Elbow f
i Application:
Installed upstream of the throttle valve in the j
steam line to the auxiliary feedwater pump l
turbine.
.I I
I CGI Safety function:
Forms part of the pressure boundary for steam flow to the auxiliary feedwater pump turbine.
Credible failure Modes:
Fatigue, Deformation, Burst, Wall Thinning (corrosion / erosion), and Propagation of Manufacturing Defects.
Failure Consequences:
A failed elbow would result in-the turbine driven auxiliary feedwater pump being partially or totally inoperable (depending on the extent of the failure).
Available CGI Construction Code - ANSI B31.1 -1984 Edition, l
Specification; Material Specification - ASTM A-234,' Gr. WPB Size - 6 inch, schedule 80, 90 degree elbow.
j i
Purchase Order:
The purchase order for the elbow was identical to the above Available CGI Specification dectription. The PO was issued to a distributor of commercial pipe fittings.
l USER SELECTED CRITICAL CHARACTERISTICS AND ACCEPTANCE METHODS I
~
Note: The following critical characteristics were verified by the licensee during receiving inspection.
Markings, Dimensions, Verify acceptance against the requirements
(
and Configuration:
of Specification A-234, Gr. WPB.
Material Chemistry:
Using an alloy analyzer, verify that the-chemical requirements (excluding carbon) meet ASTM A-234. Gr. WPB.
I 1 i
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q B
Dedication Deficiency
. In the absence of a validated Certified Material Test Report, the critical i
characteristics should include verifying for acceptance the following:
Material Chemistry:
-ANSI B31.1, Paragraph 124.2(c) and ASTM A-234,-
Section 7 and Table 1, restrict the maximum amount of carbon. Carbon content should be verified.
l l
Material Tensile Properties: The tensile properties of the elbow should conform to the requirements of Section_8 and i
Table 2 of ASTM A-234' for Gr. WPB. -Tensile i
properties should be verified.
[
Dimensions:
During the dedication of the: elbow, the user l
only verified the end-dimensions of the elbow adjacent to the weld prep areas.
No wall thickness measurements were taken along the arc _
of the elbow to ensure. that minimum wall was -
present in areas other than the elbow ends.
l
(
Reference:
ANSI B31.1, Section 104.2.2)
NOTES:
Tensile tests should either be performed using a prolongation obtained from the end of the elbow or using an elbow from the same heat. Material heat traceability of the test specimens and elbow l
to the same material heat should be established by audit, survey, j
or source surveillance regardless of where the tensile specimens-were obtained.
For dedicated commercial grade pipe and other fittings in this-system, the dedication activities should' verify critical characteristics similar to those verified for the elbow.
l Other Considerations The use of a commercial grade survey, source surveillance, or a licensee approved testing laboratory could have been the_ method selected to. verify the-critical characteristics for the elbow.
{
If all of the critical characteristics were not verified, consider programs in place, such as corrosion / erosion, inservice inspection,' and surveillance of the steam supply line, to determine the safety significance and potential effect on auxiliary feedwater pump operability.
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i Example 3 j
l IDENTIFICATION / VERIFICATION OF CRITICAL CHARACTERISTICS AND USE AND DOCUMEr cD OF ENGINEERING JUDGEMENT Dedicated CGI:
Actuator Spring Application:
Installed in a normally open control valve.
.f
'l CGI Safety function:
Forces the valve to its fail safe close position.
Credible Failure Modes:
Fracture / Deformation Failure Consequences:
A broken or deformed actuator spring would not provide the force required to ensure that the j
control valve fails in its fail-safe closed position.
j Available CGI Item is obsolete, and unavailable from OEM.
i Specification:
Specification requirements for this example are unknown.
Purchase Order:
The purchase order was issued to a licensee and_
requested the transfer of a spring installed in a spare valve. This valve was the same model as the valve having the broken-spring.
i User Selected Critical Characteristics and Acceptance Methods 1
The selecting of the following critical characteristics and acceptance methods, in part, were based on documented engineering judgement that addressed not verifying critical characteristics such as the spring constant (it was not known)..The basis for not verifying the spring constant was i
obtaining a replacement actuator spring from another licensee, who removed the actuator spring from an actuator of the same type and from the same OEM as the i'
existing actuator with the failed spring.
Marking, Identification, Visual Inspection - Compare the existing spring and Configuration:
and the replacement spring.
Both springs must appear identical (performed at receiving inspection).
Material Hardness:
Measure the hardness of both. springs (existing and replacement) through an approved test laboratory and compare the values.
Both springs must have the same hardness'(performed at i
receiving inspection).
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- Material Chemistry:
Analyze both existing and replacement springs by an approved test laboratory and compare' the j
values. The chemical composition of both springs must be similar.
l
- Dimensions'(diameter, Measure the existing and replacement' springs and free length, thickness) compare the values.
The-dimensions must-be nominally the same, j
Surface Condition:
Perform a penetrant examination on all accessible areas of the replacement spring per j
plant procedure.
General Comments 3
The above dedication is considered acceptable based on the documented engineering judgement and acceptance of critical characteristics for this j
specific application.
The reason that the original spring failed in service was not identified. It-
}
may have been appropriate for the licensee to determine the cause(s) of the failure and consider them in the dedication process.
Other Considerations The verification of all of the above identified critical characteristics may not be necessary provided that other suitable controls exist to' assure that the item will perform its intended-safety function'(eg. functional performance history of springs ' fabricated by the 'same spring manufacturer and surveillance i
testing and trending of.the valve's~ performance.
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Example 4 l
IDENTIFICATION / VERIFICATION OF CRITICAL CHARACTERISTICS AND USE AND I
DOCUMENTATION OF ENGINEERING JUDGEMENT - METHOD I i
i Dedicated CGI:
Beam Clamp (7/8 inch)
Application:
Supports conduit having a dead load of approximately 10 pounds (inside a control room cabinet).
CGI Safety function:
Provide mechanical fastening of conduit to a f
cabinet beam.
Credible Fa re Mode:
Fracture, due to over loading i
Failure Consequences:
A failed beam clamp may result in the clamp and conduit falling on or coming in contact with components within the cabinet, thus causing an electrical failure (short circuit) or physical damage to components within the cabinet.
l Available CGI Beam Clamp, Type 15-500 (See Manufacturer's Specification:
Published Literature)
Purchase Order:
The purchase order for the beam clamp specified Beam Clamp, Type 15-500, and the Manufacturer's catalog number and revision.
The PO was issued to a distributor.
User Selected Critical Characteristics and Acceptance Methods The selecting of the following critical characteristics and acceptance methods, in part, were based on documented engineering judgement such as verifying material of construction using a magnet test. This documented engineering judgement addressed considerations such as the following:
When installed, this type of beam clamp supports a dead load of approximately 10 pounds.
Based on the relatively low loading and the environmental conditions of the installation (a control room cabinet) i the clamp was selected as being suitable for the intended end use. The 1
clamp is of simple design and material.
Based on this, the acceptance methods chosen are relatively simple in scope and complexity.
The manufacturers published literature indicates that the item is i
fabricated from ductile iron and is zinc plated. A verification of the items magnetic properties would provide some assurance that the material
{
is iron.
It is not probable that there is any other weaker material i -!
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i that is magnetic ~. The low commercial _ cost (under one dollar each) provides no economic incentive for' fraud. The visual inspection of the
]
coating provides assurance that the' item.is zinc plated.
j The standard receipt inspection procedure requires a visual inspection j
for evidence of damage or deterioration. This'will assure that the clamp is not cracked or damaged.
l Note: The following critical characteristics were verified by the licensee during receiving inspection, j
Physical Dimensions, Visual Inspection and measurement in l
Configuration, Marking:
accordance with approved engineering sketch.
t Material:'
Verify that the clamp exhibits magnetic attraction.
l Color:
Verify that the clamp is silver in color, and i
that galvanizing uniformly covers all areas.
Threaded Dimensions:
Using appropriate thread gauges, verify male and l
female threads are in accordance with approved engineering sketch.
l 6
General Comment The above dedication is considered acceptable based on the documented f
engineering judgement and acceptance of critical characteristics for this i
specific application.
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4 Example 5 I
I.
General Information i
Dedicated CGI:
Wire Rope (Cable) for Yale Hoist Application:
Refuel Platform Auxiliary Hoist, used for various refueling activities such as supporting tools used for_ manipulating and uncoupling control rod blades and core support plates.
l CGI Safety Function:
The cable was classified as safety-related by
-[
the licensee based on the various refueling activities performed by the auxiliary hoist.
i Failure Modes:
The cable is subject to stress and an environment having moisture and concentrated boric acid. Tensile fracture and corrosion are likely failure modes.
CGI Specification:
The HSSS specification required that the cable i
be unlubricated stainless steel, and the original equipment manufacturer (0EM) specified non-rotating, non-lubricated, 1/4 inch diameter f
wire rope (19 x 7 classification - weave).
Purchase Order:
The purchase order requirements are the same as j
the Available CGI Specification description (above), and identified the specific drawing and-part number.
The PO was issued to the OEM.
II.
User Selected Characteristics and Acceptance Methods - Methods 1 and 3 The licensee identified and accepted critical characteristics for the cable as follows:
Part Number:
Visual Inspection at Receipt Configuration:
Visual Inspection at Receipt Dimensions:
Visual Inspection at Receipt Material Strength:
Source Surveillance to Witness the Destructive Testing of a Rope Sample III. NRC Concerns Expressed in Inspection Report The NSSS specification required that the cable be unlubricated stainless steel; however, material was not identified as a critical characteristic.
The source inspection confirmed the breaking strength of the cable as !
3
b q
-t 5550 pounds. However, a carbon steel cable of the same diameter and i
configuration has a published breaking strength of 5540 pounds
-(exceeding the published breaking strength of stainless steel which is 5400 pounds)~
l i
l The source surveillance report did not indicate that_the supplier and I
tester of the cable (Yale Hoist) performed any independent overchecks to support the validity of the material listed on its Certificate of l
Conformance.
t i
IV.
Re-Evaluation of NRC Concerns i
Subsequent to the issuance of the inspection report, the licensee met j
with representatives from the NRC staff to discuss generic dedication i
issues and the inspection report.
The licensee emphasized that, in addition verifying the identified critical characteristics for the cable, when corrosion is an concern for cables, inspections are performed to verify the cable's integrity prior to its use, and that shiftly checks for excessive wear _and corrosion are performed on the cable in the refuel platform auxiliary hoist.
The NRC staff did not review the licensee procedure used to inspect the cable.
However, if sufficient cable length is inspected for various types of deterioration periodically during its use, then the dedication activities performed by the licensee, along with the periodic inspections, should provide reasonable assurance that the cable will perform its required safety function.
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Example 6
)
SAMPLING i
I.
General Discussion During the conduct of the assessment and pilot inspections, the NRC staff identified several CGI dedications that used sampling to verify i
selected critical characteristics.
In general, sampling was performed without a documented basis for the sample size selected and specific procedure requirements for these activities had not prepared.
t Also, throughout the assessments and inspections, the need to have a homogenous population, when using certain sample plans based on a homogenous population, was a topic discussed in detail.
In addition to the guidance for sampling provided in the proposed revision to NRC Inspection Procedure No. 38703, the following philosophy may be considered for selected CGIs when trying to establish a sampling plan.
THE QUALITY HISTORY AND DEGREE OF STANDARDIZATION OF THE ITEM The ability.to use historical data in evaluating the quality experience of an item is based in part upon the degree of j
standardization of the item.
If a manufacturer has been producing a particular standard item for a long period of time, using essentially the same controls, and if the operational quality i
history of the item indicates that its significant characteristics perform satisfactorily, the quality assurance program may be tailored to reflect this satisfactory performance history.
Additionally, the satisfactory performance history, lieu of a-commercial grade survey, could be used to support a general product homogeneity over the years and the use of sampling to accept certain product characteristics. When this philosophy is used, it should be documented and substantiated by objective evidence.
l Conversely, if certain characteristics are determined to be unsatisfactory based on operational data, additional quality assurance effort may be required to correct these deficiencies.
F i
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.l II.
Examples' l
The following are examples.cf sampling that'were identified by the NRC staff as questionable because the basis for the selected sample size was j
not documented.
-}
F 1.
0-Rings used in the standby liquid control level transmitter
-[
junction box.
Critical characteristics identified were dimensions i
and material.
t Of the 100 0-Rings received, 2 were laboratory tested (for l
dimensions and material).
There was no indication that any tests or inspections.were performed on the remaining 98 0-Rings. There was no identified basis for the sample size selected, no procedure requirements for sampling, and lot homogeneity had not been addressed.
j
)
t 2.
Adapter (tube end male) for use in various pressure transmitters.
Critical characteristics identified were dimensions, marking, configuration, and material.
l Of the 50 adapters received, material analysis was performed on 2.
[
There was no identified basis for the sample size selected, no procedural requirements for sampling, and lot homogeneity had not
.j
.been addressed.
t 3.
Cap screws-(5/8 inch diameter x l-3/4 inches long, socket head,,
11 UNC CL 3A threads, ASTM A574 steel material) used in various j
safety-related applications._ Critical characteristics identified
-)
were dimensions (thread, pitch diameter, body diameter, ' length, width across flats and head' height), material, and configuration i
(as depicted in ANSI B18.3).
r All of the critical characteristics were verified by sampling with a sample size equal to 25 percent of the sample size required by Mil-Std-105E. There was no identified basis for the sample size selected, no procedural requirements that addressed this sampling plan, and had not been addressed.
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Example 7 i
i COMMERCIAL GRADE SURVEYS l
I.
General Discussion i
Two basic criteria must be met when conducting a commercial grade survey. The purchaser must confirm that the selected commercial grade item's critical characteristics are controlled under the scope of j
commercial quality system activities, and the purchaser must-also be j
reasonably assured that the commercial supplier's quality system requirements are being effectively implemented.
5 In addition to the guidance on the use of commercial grade surveys provided in the proposed revision to NRC inspection Procedure No. 38703, j
the following philosophy may be considered for selected CGIs when establishing the requirements for the use of commercial grade surveys.
A.
THE COMPLEXITY OR UNIQUENESS OF THE ITEM i
i In developing specific commercial grade surveys for a particular r
item, the item's complexity and uniqueness should be considered.
The extent of controls by the manufacturer. needed to assure the quality of those characteristics (necessary for proper functional 1
and long-term performance) that are to be. evaluated during the survey may depend heavily upon the items complexity and the industry experience, or lack of, in accomplishing the quality i
related activity.
Items which require a complex manufacturing.
plan may require extensive control over important characteristics.
The control over important characteristics should extend beyond the manufacturing phase when it is necessary to preclude damage to those characteristics during packaging, shipping, handling and l
storage.
In determining the extent of controls to be applied past experience in the development and/or manufacturer of similar items should be considered. An item developed for the first time will probably require much more control over important characteristics i
than one which has had a past history of successful' performance.
The complexity or uniqueness of the item may also affect the extent of personnel training and indoctrination required.
{
B.
THE NEED FOR SPECIAL CONTROLS AND SURVEILLANCE OVER PROCESS AND i
EQUIPMENT Certain work operations may require the use of special processes such as welding, non-destructive examination, brazing and soldering, hardness and tensile testing, protective coating and heat treatment.~ Special processes may also include certain in-process operations such as chemical batch process, plating operations, and electric insulation impregnation. The survey j
should provide assurance that these processes are accomplished i
! i
under specially controlled conditions. Controlled conditions-include the use of. appropriate equipment, suitable environment conditions, definitive procedures,. qualified personnel and assurance that prerequisites have been satisfied.
II.
Examples The following are examples where the use of commercial grade surveys are considered unacceptable.
1.
' A third party commercial grade survey of a manufa'cturer's facility in California was used to accept certain critical characteristics of an item fabricated by the same manufacturer, but at the manufacturer's facility in Georgia.
The use of this survey is unacceptable because the manufacturer's controls at its Georgia facility were not evaluated.
2.
An audit report for a supplier of commercial grade fasteners was used to
[
accept certain critical characteristics of bolts and nuts purchased as L
commercial grade and dedicated. The audit report's scope and i
documentation indicated that the purpose of the audit was to a review the supplier's ASME Section III quality assurance program for compliance to ASME Section III, NCA-4000 and NCA-3800, requirements.
The audit-i report did not address the supplier's commercial grade quality controls.
The use of this audit report for accepting critical characteristics
(
is considered unacceptable because the purchase order for the fasteners did not invoke the quality assurance program controls reviewed during l
the conduct of the audit, and there was no documented objective evidence.
that the audit team had reviewed the supplier's controls for' commercial quality fasteners.
3.
A commercial grade survey of a manufacturer was used to accept material chemical and physical properties of replacement' items for control valve and its operator.
The survey report indicated that i
the auditors had reviewed the manufacturer's commercial quality systems manual'and documented several-implementing procedures that were reviewed during the conduct of the audit. All procedures and l
processes reviewed during the survey related to in-house-activities performed by the manufacturer, including a review of I
procedures for the purchase of materitl and parts. The survey did not document any reviews or evaluations of contracted services 4
such as calibration and material testing or the control of l
laboratories performing such services.
l This survey was used to accept the physical and chemical properties of the fasteners used to attach the valve yoke to the valve bonnet. The use of this survey report for accepting the i
physical and chemical properties of the fasteners is-unacceptable because the survey did not confirm that the valve manufacturer l
adequately controlled its subsuppliers.
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The following =are examples where the use of commercial grade surveys are considered acceptable.
i 1.
A commercial grade survey was used to accept the proper heat treatment of a valve stem. The survey report clearly indicated that the manufacturer's controls had been confirmed to be adequate. : Included in the. survey' report was documentation that (1) heat treatment procedures, practices and controls had been reviewed and observed; (2) hardness procedures and; testing had been reviewed and observed; (3) calibration controls had been_ reviewed; and (4) actual testing of a valve stem to verify that the finished material has a Brinnell hardness between _165 and 195 had been observed.
Based on the reviews and observations it was j
concluded that the manufacturer adequately controlled the heat treatment of.the valve stem.
i 2.
A' commercial grade survey was used to accept the critical l
characteristic, material (EPDM compound), of a nonmetallic 0-ring.
the survey report clearly indicated design controls, procurement controls, receipt inspection controls, processing controls, and material controls l
for the EPDM compound were examined during the survey. Also, during the i
conduct of the survey the auditors witnessed the control of batch material from which 0-rings were fabricated, and the mixing and fabrication process. The survey report indicated that the 0-ring manufacturer conducts chemical analysis and destructive testing on a sample basis using a qualified test laboratory audited by the 0-ring i
manufacturer. Also, the survey report indicated that the auditors selected 0-rings from the fabricated batch of 0-rings manufactured from the EPDM compound and forwarded them to their qualified test laboratory.
The results of these independent tests were acceptable.
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