crreli Keywords: EPRI TR-102260 Procurement Project Q101-43 Dedication Final Report ‘Commercial grade item March 1994 Materials testing Materials specification Critical characteristics Supplemental Guidance for the Application of EPRI Report NP-5652 on the Utilization of Commercial Grade Items Prepared by Cygna Energy Services Atlanta, Georgia and Gilbert’Commonwealth, Inc/United Energy Services Corp. Reading, PennsylvaniaEPR] stents, INTEREST CATEGORIES Nuclear plant operations and maintenance Nuclear plant life extension Quality engineering KEYWORDS Procurement Dedication Commercial grade item Materials testing Materials specification ritical characteristics Ree GeO eo UMM Any Supplemental Guidance for the Application of EPRI Report NP-5652 on the Utilization of Commercial Grade Items Significant industry activity has occurred in the area of commercial grade dedication since the publication of EPRI NP-5652 in 1988. This document evaluates these activities and provides updated information which can further assist utilities in reducing the engineering and procurement costs associated with commeroial grade items (Gls) intended for nuclear safety-related applications. BACKGROUND _ In 1988, EPRI published “Guideline for the Utilization of Com- mercial Grade Items in Nuclear Safety-Related Applications, (NCIG-07)," (NP-5652) in response to a growing industry concem over an effective methodology to ensure the proper dedication of CGls used in safety-related applications. This guideline received industry-wide acceptance. Since the issuance of NP-8652, several industry and USNRC activities have ‘occurred which have indicated the need for further clarification and guidance regarding the implementation of the process for dedicating commercia grade items for safety-related applications. This document was developed by EPHI's Plant Support Engineering (PSE) Program at the request of its member utilities, OBJECTIVES ‘To assimilate the events that have occurred and to collect additional information that has become available since the publication of EPRI Report NP-5652 * To provide supplemental guidance regarding the implementation of the process for dedicating commercial grade items for nuclear safety-related applications. APPROACH A project task group of nuclear power plant licensees, architect engineers, consultants, and nuclear suppliers reviewed industry activites, NRC. actions, and documents published since 1988 to identify CGI issues warranting ‘additional guidance. For each issue, tne group developed a consensus position to assist utilities in implementing an improved commercial grade dedication process. ‘The task group developed examples, where appropriate, to illustrate the “lessons learned” through utility implementation experience. RESULTS This document provides consensus positions on issues related to achieving “reasonable assurance,” performing technical evaluations, implementing the generic acceptance process, dedicating services, evaluating supper dedication programs, using Acceptance Method 4 (Acceptable Supplier/item Pertormance Record), sampling during the dedication process, and maintaining item traceability ‘The document contains “lessons learned” scenarios on issues such as attaining confidence in the correctness of technical information from suppliers, selection of critical characteristics for acceptance, and the use of postinsiallation testing. Examples are provided on issues including sampling and the use of Acceptance Method 4. EPRI TR-102260s Electric Power Research instituteEPRI PERSPECTIVE Prior to the development of viable options for the acceptance of commercial grade items, utilities tended to procure items intended for safety-related applications from 10CFR 50, Appendix B sup: pliers. These items were often expensive (reflecting the cost a supplier incurs to maintain the nuclear quality assurance program) and required ‘a large lead time for supply. The various commercial grade dedication ‘options presented in EPRI Report NP-5652 and this supplemental guid- ance document will assist utilities in reducing the costs associated with the use of commercial grade items in safety-related applications. PROJECT 101-43 Project Manager: Fran Rosch Nuclear Power Division Contractors: CYGNA Energy Services; Gilbert/Commonweatth, Inc. For further information on EPRI research programs, call EPRI Technical Information Specialists (415) 855-2411.Supplemental Guidance for the Application of EPRI Report NP-5652 on the Utilization of Commercial Grade Items TR-102260 Final Report, March 1994 Prepared by CYGNA ENERGY SERVICES 41200 Ashwood Parkway Suite 160 Allanta, Georgia 30338, and GilbertiCommonwealth, inc / United Energy Services Corp. P.O. Box 1498 Reading, Pennsylvania 19603, Principal Investigators William E. Craig Louie O. Lavender Michael P. Tulay Frank J. Yurich Prepared for Electric Power Research Institute Plant Support Engineering 1800 Harris Boulevard Charlotte, NC 28262 EPRI Project Managers Tom J. Mulford Fran C. Rosch Plant Support Engineering Program Nuciear Power DivisionDISCLAIMER OF WARRANTIES AND LIMITATION OF LIABILITIES THIS REPORT WAS PREPARED BY THE ORGANIZATION(S) NAMED BELOW AS AN ACCOUNT OF WORK SPONSORED OR COSPONSORED BY THE ELECTRIC POWER RESEAACH INSTITUTE, ING. (EPRI. NEITHER EPRI ANY MEMBER OF EPR, AKY COSPONSOA, THE ORGANI2ATIONGS) NAMED BELOW, NOR ANY PERSON ACTING ON BEHALF OF ANY OF THEME (f) MAKES ANY WARRANTY OR REPRESENTATION WHATSOEVER, EXPRESS OR MPLED, () WITH RESPECT TO THE USE OF ANY INFORMATION, APPARATUS, NETHOD, PROCESS, OF SIMILAR ITEM DISCLOSED IN TH'S REPORT, INCLUDING MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. OR (i) THAT SUCH USE DOES NOT INFRINGE ON OR INTEAFERE WITH PAVATELY OWNED AIGHTS, INCLUDING ANY PARTY'S INTELLECTUAL PAOPERTY, OR li) THAT THIS REPORT IS SUITABLE TO ANY PARTICULAR USERS CIRCUMSTANCE; OR (®) ASSUMES RESPONSIBILITY FOR ANY DAMAGES OR OTHER LIABILITY WHATSOEVER INCLUDING CONSEQUENTIAL DAMAGES, EVEN IF EPRI (OR ANY EPA REPRESENTATIVE HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES) RESULTING FROM YOUR SELECTION OR USE OF THIS REPORT OR ANY INFOAMATION, APPARATUS, METHOD, PROCESS, OR SIMILAR TEM O'SCLOSED IN THIS REPORT. ORGANIZATION(S) THAT PREPARED THIS REPORT: CYGNA ENERGY SERVICES GILBERT/COMMONWEALTH / UNITED ENERGY SERVICES CORPORATION ORDERING INFORMATION Requests for copies of this report should be directed to the EPRI Distribution Center, 207 Coggins Drive, P.O. Box 23205, Pleasant Hill, CA 94523 (510) 934-4212. There is no charge for reports requested by EPRI member utlities and affiliates. Electric Power Research Institute and EPAI are registered service marks of Electric Power Research Institue, Inc. Copyright © 1994 Electric Power Research Institute, Inc. All rights reserved.ABSTRACT EPRI Report NP-5652, "Guideline for the Utilization of Commercial Grade Items in Nuclear Safety-Related Applications, (NCIG-07)" was issued by the Electric Power Research Institute in June 1988. The document was developed and issued in response toa growing industry concern over an effective methodology to ensure that commercial grade items (CGls) used in safety-related applications were properly "dedicated" as discussed in 10CFR21.3. The original document received considerable acceptance within the nuclear industry. During the period subsequent to the issuance of EPRI Report NP-5652, several industry and NRC actions occurred which indicated that clarification may be appropriate to effectively and consistently implement the guidance provided in the Report for nuclear facilities and suppliers. These actions have included NRC Generic Letters, NRC Inspections and Assessments, and the NUMARC Procurement Initiative. ‘The purpose of this document is to assimilate the events and available information since the publication of EPRI Report NP-5652, and to provide the purchaser of commercial grade items with supplemental guidance regarding the implementation of the process for the use of commercial grade items in nuclear safety-related applications. Specific objectives of the document are to provide detailed guidance on: + the defi tion and concept of "Reasonable Assurance” + the intent of EPRI Report NP-5652 with respect to the veri requirements versus verification of safety-related functions ication of original design + application of EPRI Report NP-5652 generic dedication process including the CGI acceptance methods + the application of Method 4, "Acceptable Supplier /Item Performance Record’ + the acceptance and dedication of CGIs by 10CFR50, Appendix B suppliers, third party suppliers and NSS suppliersACKNOWLEDGMENTS The following individuals were ongoing members of Plant Support Engineering's Supplemental Guidance to NP-5652 Task Group. As such, they have made significant contributions to the development of this guide by attending the majority of the task group meetings, reviewing /commenting on various drafts, and writing portions of the document. Kenneth Peveler, Chairperson Kevin Cellars, Vice-Chairperson Theodore Bernard Charles Vincent Clyde McCullough Jim Spina Edward Martin William Barnhardt Michael Mirchich Charles Tyrone William Houston Tom Mulford Fran Rosch George Regal Michael Tulay Frank Yurich Allan Soni Rory Segan Robert Pettrey Dennis Weaver Eugene McNatt Darlene Stimart Larry Templeton Lawrence Patterson K.D, Ramsey Douglas Aaron Ed Kahler Mark Shaw Mansoor Sanwarwalla Marlin Hutson Joe Kiwak Daniel Maret Joseph Webb William Craig Robert Geier Iowa Electric Light & Power Co. Baltimore Gas & Electric Co. ABB Combustion Engineering ‘ABB Impell Arizona Public Service Co, Baltimore Gas & Electric Co. Commonwealth Edison Co. Duke Power Co, Duquesne Light Co. Entergy Operations, Inc. EPRI Plant Support Engineering EPRI Plant Support Engineering EPRI Plant Support Engineering Florida Power & Light Co. Gilbert/Commonwealth Gilbert/Commonwealth Gulf States Utilities Co. Limitorque Namco Controls Niagara Mohawk Power Corp. Northeast Utilities Norther States Power Co. Northem States Power Co. ‘Nutherm International On Site Engineering Pacific Gas & Electric Co. Pacific Gas & Electric Co. Rochester Gas & Electric Co. Sargent & Lundy Engineers S.E.A. Consultants, Inc. Sequoia Consulting Group Sequoia Consulting Group Tennessee Valley Authority United Energy Services Corp. isconsin Electric Power Co. iiiCONTENTS Section Page 1.0 INTRODUCTION 1.1. Development of EPRI Report NP-5652 and Status of Industry Actions 1.2 Document Purpose and Objectives. 1.3 Premises . - 1.3.1 Basic Premises of EPRI Report NP-5652. 1.3.2 Basic Premises of EPRI Report NP-6406. 1.3.3 New Premises for this Guideline. 2.0 EPRI REPORT NP-5652 IMPLEMENTATION GUIDANCE 24 22 Achieving Reasonable Assurance .. 2.1.1. Achieving Assurance of the Performance of Plant Components and their Replacement Items 2-2 Use of Major Process Elements in Achieving Reasonable Assurance .... a . 2.1.3 Clarification of "Item Received is the Item Specified’ . 2.1.4 Reasonable Assurance in the CGI Acceptance Process. 2.1.5 Factors Required to Achieve Reasonable Assurance in the Context of CGI Acceptance 2.1.6 Example. Issues Relating to the Technical Evaluation of Replacement Items (TERI) During the Use of EPRI Report NP-5652 .. 2.2.1 Technical Evaluation of Replacement Items versus Acceptance of Commercial Grade Items...Section 3.0 vi 2.3 24 25 2.6 2.2.2 Obtaining Technical Information from Suppliers. 2.2.3 Equipment Qualification versus CGI Acceptance Process. 2.2.4 Design Verification versus Establishment of Critical Characteristics for Acceptance 2.2.5 Like-For-Like Determination 219 2-20 Issues Related to the Generic Process for Acceptance of Commercial Grade Items ....... 2.3.1 Determining Safety-Related Function of the Iter 2.3.2 Identification and Selection Of Critical Characteristics Acceptance Methods .... 2.4.1 Method 1 - Special Test and Inspection Activities .. 2.4.2 Method 2 - Commercial Grade Survey . 24.3 Method 3 - Source Verification Application of Method 4 - Acceptable Supplier/item Performance Record. 2.5.1 Additional Guidance .......0 2.5.2 Compilation of Performance Data 25.3 Established Industry-Wide Performance 25.4 Manufacturer's Controls ... 2.5.5 Evaluation of Performance Record. 2.5.6 Examples. Traceability. 2.6.1 Issue 2.6.2 Guidance SUPPLIER DEDICATION ISSUES. 34 Supplier Dedication. 3.1.1. Introduction 3.1.2 Issue... 3.1.3. GuidanceSection 4.0 3.2 3.3 3.4 35 Supplier Methodology for Accepting Commercial Grade Replacement Parts .... 3.2.1 Design Contra... 3.2.2 Acceptance Process 3.2.3 Examples... Supplier Methodology for Accepting Individual Parts Provided in Complete Components 3.3.1 Issue... 3.3.2 Guidance Third Party Organizations .. Acceptance of Replacement Parts Installed as Part of Repair Services 35.1 Issue...... 35.2 Guidance COMMERCIAL GRADE SERVICES 44 42 43 Issue Guidance. .. 4.2.1 General... 4.2.2 Safety Classification of Services. 4.2.3 Confirming the Service Meets the Commercial Grade Item Definition 4.2.4 — Selecting the Method of Procurement 4.2.5 — Identify Critical Characteristics ... 4.2.6 Select the Acceptance Method... Example... viiSection 5.0 DEFINITIONS... APPENDIX A SAMPLE OF A POTENTIAL SUPPLIER/ITEM PERFORMANCE RECORD EVALUATION... APPENDIX B INDUSTRY SURVEY METHODOLOGY AND RESULTS... Bet viiiILLUSTRATIONS Figure/Table Figure 1-1 Figure 2-1 Figure 2-2 Figure 2-3 Figure 2-4 Table 2-1 Figure 2-5 Figure 2-6 Figure 2-7 Figure 2-8 Figure 2-9 Figure 2-10 Figure 2-11 Figure 2-12 Figure 2-13 Figure 2-14 Figure 2-15 Figure 3-1 Figure 3-2 Figure 3-3 Generic Process for Acceptance of Commercial Grade Items Used in Safety-Related Applications ... Key Elements to Achieving Assurance of Plant Component Performance. oo Utilization of Commercial Grade Items. Achieving Assurance in the Context of CGI Acceptance Relationship Between Technical Evaluation for Replacement Items and CGI Acceptance Process .......c-ese-210 Recommended Supplier Sources of Information... Relationship Between Equipment Qualification and CGI Acceptance Process .. Factors Determining a Like-For-Like Procurement .. Like-For-Like Procurement. Alternative Item Procurement Proper Relationship of Critical Characteristics Verifying All Critical Characteristics for Design Inadequate Selection of Critical Characteristics for Acceptance. Process for Establishing Critical Characteristics ... Typical Method 1 Acceptance Testing Equipment... Relationship Between Lot Homogeneity and Sample Size... . Possible Actions Resulting From Negative Operational Feedback of a CGl...... How Different Types of Commercial Grade Items are Accepted By Suppliers After Receipt... ‘Two Different Ways Original Equipment Manufacturers Can Control Items Intended for Use in Safety-Related Equipment... Methods Suppliers Employ to Accept Commercial Grade Items.....Figure/Table Figure 4-1 Table 4-1 Figure 4-2 Figure A-1 Figure B-1 Figure B-2 Process for Acceptance of Commercial Grade Services.. Examples of Potential Failures in the Performance of Services . : Procurement Options for Safety-Related Services. Sample of a Potential Supplier/Item Performance Record Evaluation Interpretation and Implementation Issues Acceptance Process Issues .1.0 INTRODUCTION 1.1. Development of EPRI Report NP-5652 and Status of Industry Actions In June 1988, the Electric Power Research Institute (EPRI) issued EPRI Report NP-5652, Guideline for the Utilization of Commercial Grade Items in Nuclear Safety Related Applications (NCIG-07). The document was developed and issued in response to a growing industry concern over an effective methodology to ensure that commercial grade items (CGls) used in safety-related applications were properly “dedicated” as discussed in 10CFR21.3. As stated in NP-5652, the intent was to provide guidance to the industry but not to be prescriptive in the manner normally found in an industry standard or regulatory document. This guideline received widespread acceptance within the nuclear industry. Subsequent to the issuance of EPRI Report NP-5652, several industry and US Nuclear Regulatory Agency (NRC) actions occurred which indicated that clarification may be appropriate to effectively and consistently implement its guidance at nuclear facilities and suppliers. Specific actions which have occurred since the issuance of EPRI Report NP-5652 include: * NUMARC endorsement of EPRI Report NP-5652, March 1989 * Generic Letter 89-02, NRC conditional endorsement of EPRI Report NP-5652, March 1989 * NRC Inspections performed between June 1988 and December 1989 * SECY-90-304 "NRC Announcement of Additional Assessment” + NUMARC 90-13, Nuclear Procurement Program Improvements, also known as the NUMARC Comprehensive Procurement Initiative, June 1990 * NRC Generic Letter 91-05, "Licensee Commercial Grade Procurement and Dedication Programs", April 1991 LtEPRI Licensed Material EPRI Plant Support Engineering + NRC, "Assessments of the Procurement and Commercial Grade Dedication Programs" of eight utilities, February 1991 through December 1991 + NUPIC Surveys and Audits which provide vendor /supplier feedback, January 1990 through present * SECY 91-291 Resumption of the NRC Procurement Inspection Program, December 1991 + NRC Pilot Inspections of 5 utilities + NRC Commercial Grade Procurement and Dedication Workshop held in Dallas, Texas on April 21 and 22, 1993 + NRC Inspection Procedure 38703, "Commercial Grade Procurement Inspection” The industry and regulatory issues addressed in these activites and the lessons learned in implementing EPRI Report NP-5652 created utility interest in further clarifications. This interest prompted the EPRI Plant Support Engineering (PSE) Program member utilities to direct that this guideline be developed. The methodology used to develop this guideline consisted of the following actions: 1. Task scoping by EPRI Plant Support Engineering 2. Consultant Selection Utility Task Group Formed composed of utility, supplier and consultant representatives 4. Survey of Nuclear Industry Utilities and Suppliers to determine specific issues to be addressed in the guideline (See Appendix B) Guideline Development 1.2. Document Purpose and Objectives The purpose of this document is to assimilate the events and to collect additional information that has become available since the publication of EPRI Report NP-5652. The objective is to provide supplemental guidance regarding the implementation of the process for dedicating commercial grade items for nuclear safety-related applications.EPRI Licensed Material ‘Supplemental Guidance for the Application of EPRI Report NI Specific objectives of the document are to provide detailed guidance on: * The definition of the concept of "Reasonable Assurance" and demonstration of implementation guidance on achieving reasonable assurance. * The clarification of the intent of EPRI Report NP-5652 with respect to the verification of original design requirements versus verification of safety-related functions. © The EPRI Report NP-5652 generic process application and acceptance method implementation. * The application or enhancement of "Method 4 - Acceptable Supplier/Item Performance Record” in EPRI Report NP-5652 to the various utility scenarios encountered in accepting CGls for safety-related application. © The application considerations identified through solicitation of "Lessons Learned” scenarios. * The acceptance and dedication of CGls by 10CFR50, Appendix B suppliers, third party suppliers, and NSSS suppliers. 1.3 Premises This guideline was developed under the same premises as those contained in EPRI Report NP-5652, Section 1 and EPRI Report NP-6406, Section 1. These premises have been restated here for clarity. Additional premises for this document are also included. 1.34 Basic Premises of EPRI Report NP-5652 1.3.1.1 Design of Commercial Grade Items. This guideline assumes that the design requirements of the item have been satisfactorily translated into specification requirements as reflected in the procurement document. The purpose of the technical evaluation is to assure that the specification requirements are correct. The acceptance process reasonably assures that an item received is the item which was specified in the procurement document. 1.3.1.2 Equivalent Performance. Equivalent performance is confirmed by conducting the technical evaluation to ensure the item specified meets design requirements. Acceptance assures that the item received is the item which was specified in the procurement document. The combination of the two activities, therefore, assures that the item received and accepted will perform in an equivalent fashion to the item being replaced. Neither activity need be conducted with theEPRI Licensed Material EPRI Plant Support Engineering intention of improving the expected performance of a replacement commercial grade item. 1.3.1.3 Part Number Verification, Part number verification is an integral step in the acceptance of commercial grade items and is included in each of the four acceptance methods. Verification of a part number and the utilization of the acceptance methods in this guideline provide assurance of acceptability. Since suppliers furnish commercial grade items for general industrial use, they may change the product design or the manufacturing process, and not the part number. These actions are taken without concern for the nuclear end user's design requirements. The methods described in this guideline provide various means to accept a commercial grade item without sole reliance upon part number verification, 1.3.1.4 Guideline Consistency with Regulatory Requirements. The methods in the guideline are in conformance with existing regulatory requirements. The methods for accepting commercial grade items are consistent with the provisions of Criterion VIL of Appendix B to 10CFR50 which states: "Measures shall be established to assure that purchased material, equipment, and services, whether purchased directly or through contractors, conform to the procurement documents. These measures shail include provisions, as appropriate, for source evaluation and selection (Method 2), objective evidence of quality furnished by the contractor or subcontractor (Method 4), inspection at the contractor or subcontractor source (Method 3), and examination of products upon. delivery (Method 1)." Each acceptance method identified in EPRI Report NP-5652 is depicted in brackets after the specific regulatory justification for that method. The acceptance methods provided in the guideline are: Method 1 - Special Tests and Inspections Method 2 - Commercial Grade Survey of Supplier Method 3 - Source Verification Method 4 - Acceptable Supplier /Item Performance Record 1.3.1.5 Uniformity and Flexibility. This guideline provides the detailed guidance that will permit the establishment and implementation of uniform nuclear industry practices for the acceptance of commercial grade items. The guideline permits flexibility in the selection of the most appropriate method or combination of methods to accept commercial grade items. This flexibility allows utilities to incorporate this guideline into their individual procurement, quality assurance, and engineering practices. 14EPRI Licensed Material ‘Supplemental Guidance for the Application of EPRI Report NI 652 1.3.1.6 Acceptance Documentation. This guideline emphasizes that the acceptance process and the acceptance of an item must be documented. The flow diagrams for each acceptance method designate when acceptance documentation should be developed. 1.3.2 Basic Premises of EPRI Report NP-6406 1.3.2.1 Design Changes Versus Equivalency. EPRI Report NP-6406 assumes that a plant initiated design change or modification does not occur if the equivalency of the form, fit, function, and interchangeability (including seismic and environmental qualification requirements) of a replacement item has been established. The basis for this premise is that the plant, system, or component's design has not been altered. However, when evaluating alternate replacement items, plant specific commitments may require the processing of design change documentation including safety reviews as required by 10CFR50.59. The documentation required to establish system and component configuration should be maintained regardless of the vehicle (i.e., design change, plant modification or other documentation) utilized to implement the technical evaluation for replacement items process. 1.3.2.2 Maintenance and Surveillance Activities. When performing the technical evaluation of replacement items, it is assumed that all required maintenance (preventive and corrective) will be performed in accordance with the proper procedures. The technical evaluation and acceptance processes for a replacement item can not compensate for improper maintenance practices (i.e., poor installation, parts missing, use beyond qualified life, inappropriate application, etc.). Surveillance requirements (such as operability checks, technical specification requirements, post maintenance testing, etc.) are also assumed to be performed per requirements and plant procedures. 1.3.2.3 Q-List and Component Safety Classification. The technical evaluation for replacement items assumes that a "Q-List” identifying the safety-related systems and components in the nuclear power plant exists. EPRI Report NP-6406 is not intended as a stand alone guide for developing Q-Lists. It does, however, provide guidance for establishing functional safety classifications for components and parts when the Q-List does not contain sufficient detail to specify the safety classification or safety-related functions. [Note: EPRI Report NP-6895 provides additional information on safety classification.} 1.3.2.4 Engineering Judgment. Many of the decisions required in the performance of the technical evaluation processes in this document will be based on the knowledge and expertise of the personnel performing the evaluation. Individuals performing these evaluations must have appropriate experience and /or training in design, 15EPRI Licensed Material EPRI Plant Support Engineering manufacturing, equipment operation, maintenance, quality assurance and regulatory requirements to make these engineering judgments. This document provides guidance for the accomplishment of relevant tasks, but is not intended to eliminate the need for sound technical decisions and judgment. The basis of engineering judgment made in the conduct of these evaluations should be documented. 1.3.2.5 Quality of Parts. Manufacturers and suppliers are motivated to provide high quality and reliable products which meet published specifications. During these technical evaluation processes, the technical data in these published specifications must be used to determine suitability of application for a replacement item. However, suppliers must be carefully evaluated to assure that only reputable suppliers are utilized. The acceptance process is then used to verify that the item received is the item specified. 1.3.2.6 Technical and Quality Requirements. The amount of evaluation effort required and the extent to which specific technical and quality requirements are specified should be commensurate with the importance to safety of the item being evaluated. 1.3.2.7 Repetitive or Ongoing Item Procurement. When adequate technical and quality requirements for an item in a specific application have been established, it is not required to re-perform the evaluation unless a change has occurred in the item or its application. 1.3.2.8 Supporting Procedures. EPRI Report NP-6406 should be implemented by detailed procedures specific to the utility's quality assurance program requirements. 1.3.3 New Premises for this Guideline 1.3.3.1 Relationship to 10CFR50, Appendix B. The guidance provided in EPRI Report NP-5652 and this document is consistent with the requirements of 10CFR50, Appendix B. The design /design basis of the systems, components and structures is developed under Criterion III, “Design Control" at the inception of plant design and maintained through the modification process. Subsequently, the technical and quality requirements from the design /design basis are translated in the specifications, drawings, and other procurement documents to procure these systems, components and structures under Criterion IV, "Procurement Document Control”. Criterion VII "Control of Purchased Material, Equipment and Services’ then controls the process by which purchasers verify (or provide reasonable assurance) that the technical and quality requirements have been met. Therefore, for commercial grade items, Criterion VILis implemented by EPRI Report NP-5652 through the use of the four methods. 1.3.3.2 Relationship to USNRC Regulatory Guide 1.33 (Endorsement of ANSI 18.7). The guidance provided in this document and EPRI Report NP-5652 is. 146EPRI Licensed Material ‘Supplemental Guidance for the Application of EPRI Report NP-5652 consistent with the requirements contained in ANSI N18.7, paragraph 5.2.13, Procurement and Materials Control, which states in part: "Measures shall be provided for procurement, documentation and control of those materials and components including spare and replacement parts necessary for plant operation, refueling, maintenance and modification. These measures shall utilize American National Standard Institute's Quality Assurance Requirements for the Control of Procurement of Items and Services for Nuclear Power Plants, N45,2.13-1976. The Appendix to ANSI N45.2.13 is particularly useful in determining the quality assurance requirements depending on the complexity or safety of the item. [15]. Procedures shall be established and implemented to ensure that purchased materials and components associated with safety- related structures or systems are: (1) Purchased to specifications and codes equivalent to those specified for the original equipment, or those specified by a properly reviewed and approved revision. (In those cases where the original item or part is found to be commercially “off the shelf,” or without specifically identified quality assurance requirements, spare and replacement parts may be similarly procured but care shall be exercised to assure at least equivalent performance"; (2) Produced or fabricated under requirements at least equivalent to that of the original equipment, or those specified by a properly reviewed and approved revision; (3) Packaged and transported in a manner that will ensure that the quality is not degraded during transit; (4) Properly documented to show compliance with applicable specifications, codes and standards; (6) Properly inspected, identified and stored to protect against damage, deterioration or misuse; (6) Properly controlled to ensure the identification, segregation and disposition of non-conforming material. [Guidance in this document and EPRI Report NP-5652 is intended to assist in implementation of this requirement} 17EPRI Licensed Material EPRI Plant Support Engineering “In those cases where the QA requirements of the original item cannot be determined, an engineering evaluation shall be conducted by qualified individuals to establish the requirements and controls. This evaluation shall assure that interfaces, interchangeability, safety, fit and function are not adversely affected or contrary to applicable regulatory or code requirements.” [Guidance in this document and EPRI Report NP-6406, Guidelines for the Technical Evaluation of Replacement Items in ‘Nuclear Power Plants, is intended to assist in implementation of this requirement.] “The results of this evaluation shall be documented,..." 1.3.3.3 Use of EPRI Report NP-5652 and this Guideline for Purchase Specifications. EPRI Report NP-5652 and this document were developed to be used as guidance in implementing the controlling regulatory and industry standards. Therefore, purchasers of commercial grade items should not use EPRI Report NP-5652 and this document as specifications or purchase order attachments. These documents can be used as references for specific methods and issues. 1.3.3.4 Validity of EPRI Report NP-5652 Generic Process and Acceptance Methodologies. This document was developed to be consistent and compatible with EPRI Report NP-5652 and to provide additional guidance on implementation of the CGl acceptance process. The generic process (ref. Figure 1-1) and acceptance methods defined in EPRI Report NP-5652 are valid. No conflict exists between the two guidelines. 1.3.3.5 Use of EPRI Report NP-5652 and This Guideline for New Design. While the major emphasis of EPRI Report NP-5652 is to address replacement and spares, the guidance is also applicable to new designs. For the new design the responsibility for ensuring that the design meets the plant licensing requirements is the design engineer. The technical evaluation and acceptance processes are then based on the new design requirements delineated by the design package. 1.3.3.6 Use of the Examples Contained in Guideline. The examples used in this guideline are for illustrative purposes only. The examples were selected and modified to illustrate a specific point within the text where the example is used. The examples are not comprehensive and should not be copied or reused except within the context of the illustration. 1.3.3.7 Use of the Issue and Position Statements Contained in this Guideline. The guidance provided in this document is provided on an issue oriented basis. The 1-8EPRI Licensed Material ‘Supplemental Guidance for the Application of EPRI Report NP-5652 user of the guideline should take care not to separate position statements and "Lesson Learned" from the issue under consideration in order to maintain the context and clarity of the guidance. 1.3.3.8 Graded Approach. A fundamental concept from 10CFR50, Appendix B is that "the Quality Assurance program shall provide control over activities affecting the quality of the identified structure, system, and components, to an extent consistent with their importance to safety". This graded approach may be applied throughout the CGI dedication process (eg., selection of critical characteristics, and determination of acceptance methods, and acceptance criteria). The use of engineering judgment and the concept of reasonable assurance are accepted techniques in the application of the graded approach. 19EPRI Licensed Material EPRI Plant Support Engineering TDENTFY REQUIRED TTEW BY MEANS OF TECHNICAL EVALUATION | URETO NO ITEM MEET CRITERIA OF CG PROGURE TEM AS] gum BASIC COMPONENT] "NG phere Geteaton CAITICAL 1 Tesepance CHARACTERISTICS | ‘DOCUMENT RESUI | ‘SELECT ACCEPTANCE METHOD METHOD] [WETHOD] [weTHOD] [METHOD] FomswaTion oF] 1 2 sl 4 TWO OR MORE (OF THE FOUR METHODS TEM ACCEPTED’ “Deficiency reporting responsibilty accepted. Figure 1-1 Generic Process for Acceptance of Commercial Grade Items Used in Safety-Related Applications 1-102.0 EPRI REPORT NP-5652 IMPLEMENTATION GUIDANCE This section provides the user with supplemental guidance for the effective implementation of the generic process for the acceptance of commercial grade items as described in EPRI Report NP-5652. The scope of the issues discussed resulted from an industry survey of nuclear utilities and suppliers conducted in early 1992. A prioritized listing of issues, which summarizes the results of the survey, is provided in Appendix B of this document. Other issues are also included throughout this, document in response to the direction provided by the task group. Section 2.1 discusses achieving reasonable assurance, and the relationship between 10CFR50, Appendix B, Criteria III, IV and VII with elements which assure the quality and performance of items. The section also puts the CGI acceptance process in perspective with other processes contributing to the assurance of the quality of procured items. This section describes how each of these processes (not just criterion VII) contributes to the assurance of the accepted items ability to perform its safety function (i.e, the item received is the item specified does not assure performance of safety function by itself). All these processes contribute to this assurance. Sections 2.2 and 2.3 provide guidance on issues regarding the generic processes for the technical evaluation of replacement items (TERI) and CGI acceptance respectively. The user should recognize that the fundamental principles of the technical evaluation were initially discussed in EPRI Report NP-5652 and were presented as part of the CGI acceptance process. Although further guidance for TERI was provided in EPRI Report NP-6406, this document recognizes the close relationship between the two processes, and attempts to provide supplemental guidance in response to industry direction. Sections 2.4 and 2.5 discuss issues related to the implementation of the four acceptance methods described in NP-5652. Section 2.6 discusses the need for item traceability both before and after the Commercial Grade Item Acceptance Process. The implementation guidance is applicable to both nuclear utility personnel as well as suppliers. Additional implementation guidance for suppliers regarding commercial grade acceptance can be found in Section 3.0 of this document, recognizing their approaches to CGI acceptance, procedures, and terminology may differ somewhat from the utility's. 24EPRI Licensed Material EPRI Plant Support Engineering 2.1 Achieving Reasonable Assurance Five related issues are presented below to assist the user in understanding the concept of reasonable assurance. For each issue, appropriate supplemental guidance is provided. 2.1.1. Achieving Assurance of the Performance of Plant Components and their Replacement Items 2444 Issue. How do the procurement process elements contribute to achieving, an overall assurance of plant component performance? 21.1.2 Guidance. The concept of achieving assurance of the quality of products or services is the fundamental principle of 1OCFR50, Appendix B. 10CFR50, Appendix B states that "quality assurance comprises all those planned and systematic actions necessary to provide adequate confidence that a structure, system, or component will perform satisfactorily inservice. Quality assurance includes quality control, which comprises those quality assurance actions related to the physical characteristics of a material, structure, component, or system which provide a means to control the quality of the material, structure, component, or system to predetermined requirements. ‘Asses Suabity or Applicaton por ANSI Nas.2 tO (Gocton 2122.1) Design & Equipment ualfcaton Supplier's Product JOCFRSO, App B Contre Erteron ti Aaauos Copa equrements Techical Evaluation (Sexton 2122.2) S0GFRSO, App 3 Grrenon iP Acceptance sOCFRSO, Gitenon vi Assutes the tem In Combination, ecewed Mess Asso Eouvatnt Requremens ANSINTa? (Geoton 2122.3) (Section 21.224) Figure 2-1 Key Elements to Achieving Assurance of Plant Component Performance 2-2EPRI Licensed Material ‘Supplemental Guidance for the Application of EPRI Report NP-5652 This concept is not new, and attaining the level of assurance necessary (commensurate with an item’s complexity, safety-related function, and performance) is achieved by consideration of several actions or "elements". Relative to plant components and their replacement items, key elements contributing to achieving overall quality assurance are depicted in Figure 2-1. These elements are the supplier's product controls, the design and qualification of equipment, the utility's technical evaluation and acceptance, and the user's post receipt and installation quality controls. Proper implementation of these actions enables the user to cumulatively achieve a level of assurance that the procured item will perform satisfactorily in service once installed, recognizing that the degree each process contributes may vary from procurement to procurement, 10CER50, Appendix B encompasses each of the actions shown in Figure 2-1 and allows each to contribute to attaining the overall assurance of quality. As such, no single element should be relied upon to achieve the overall level of assurance necessary. The 10CFR50, Appendix B actions depicted in Figure 2-1 apply to both licensees as well as suppliers maintaining a nuclear QA program. Section 3 provides guidance to suppliers on how these processes are effectively implemented. 2.1.2 Use of Major Process Elements in Achieving Overall Assurance 24.24 Issue. What does each of the process elements contribute, either individually or in combination, to the overall assurance of plant component performance? 2.1.2.2 Guidance 1, Each element or combination of elements (ref. Figure 2-1) provides a different type of assurance. Proper implementation of design and equipment qualification assures suitability of equipment for its intended application. The design /design basis of plant systems, components, and structures is developed under Criterion III, "Design Control” and is maintained through the modification process. Criterion III requires "the selection and review for suitability of application of materials, parts, equipment, and processes that are essential to the safety-related functions of the structures, systems, and components” Determination of item suitability of application was performed at the time the original design and procurement technical and quality requirements were established for the original plant equipment. Specification of technical and quality requirements which must be met for an item to be suitable for its application is a design process. The specifications and drawings which were prepared during this design process also established the technical and quality requirements to be met for an item to be considered suitable for application under the plant design basis. 23EPRI Licensed Material EPRI Plant Support Engineering The specifications developed during the design process established suitability for application by invoking design codes and standards, specifying functional requirements to be met, and identifying test, inspection, and certification requirements. In some cases, material or design requirements not included in referenced codes and standards were explicitly stated in the specification. In general, a wide latitude was left to the equipment manufacturer to establish specific subcomponent and part level requirements as long as the overall functional and performance requirements of the equipment specification were met. ANSIN18.7-1976 recognizes that the result of the specification development process in some cases resulted in the specification of a commercial grade item for use in safety-related applications. In such cases, commercially "off the shelf" replacements are acceptable, with care exercised to ensure at least equivalent performance. The "care" necessary is the proper implementation of both the technical evaluation and acceptance processes which are discussed in Paragraph 4 of this section. 2. A technical evaluation as defined in EPRI Report NP-5652 and EPRI Report NP- 6406 (or "engineering evaluation" per ANSI N18.7) assures that the correct technical and quality requirements for an item are specified in a procurement document, The technical and quality requirements from the design/design basis are translated in specifications, drawings, and other procurement documents to procure plant systems, components, and structures under Criterion IV, "Procurement Document Control”. Section 2.2 provides supplemental guidance for conducting technical evaluations for replacement items, and Section 1.0 may be used to reference ANSI N18.7. 3. Acceptance provides reasonable assurance that the item received meets specified requirements. The process for verifying that technical and quality requirements of the received item have been met is controlled under Criterion VII, "Control of Purchase, Material, Equipment, and Services’. The concept of achieving reasonable assurance in EPRI Report NP-5652 was conveyed in the definition of acceptance, as it related to commercial grade items. Reasonable assurance, though not defined in EPRI Report NP-5652, described the level of confidence one had in assuring the commercial grade item received met specified requirements The word "reasonable" connotes a level of confidence which is justifiable but not absolute. In the context of product or service quality, "reasonable assurance" of performance must be based on facts, actions, or observations (objective evidence). While these bases are objective and measurable, the inference of adequacy drawn from them ~- the decision that "reasonable assurance" has been attained ~- is inherently subjective and the judgment of reasonability may varyEPRI Licensed Material ‘Supplemental Guidance for the Application of EPAl Report NP-5652 between different observers. These judgments are commonly referred to as “engineering judgment’ and should be typically documented. A technical evaluation for replacement items and an acceptance process in combination "assure that the item received and accepted will perform in an equivalent fashion". Equivalent performance is meant to encompass performance of an item's plant-specific design functions. From an end-user's viewpoint, these plant-specific design functions envelope nuclear safety-related functions. From a supplier's viewpoint, an item’s performance capabilities may exceed design functions necessary for any plant-specific application. These two processes (shown in bold outline on Figure 2-1) are key elements of the nuclear procurement function. EPRI Report NP-5652 emphasizes that for commercial grade items the "technical evaluation in combination with an appropriate acceptance process provides assurance that the specified item is adequate to meet 10CFR50, Appendix B requirements” (ref. Figure 2-2). Ina more general sense any given item's performance is assured through the proper implementation of the design, technical evaluation, and acceptance processes (Criteria IIf, IV, and VII). Commercial Grade Item | Technical Acceptance Evaluation + Process | Dedicated Item Purchased as a Commercial | = | Basic Component to 10CFR50, Grade Item Appendix B Requirements Figure 2-2 Utilization of Commercial Grade Items Additional assurance may also be achieved for any item through reliance on the supplier's product controls. Supplier's product controls can provide confidence that the item is manufactured to meet design requirements. Reliance upon and contribution of the supplier's product controls will increase based on the extent to which the documented quality program activities are implemented. 25EPRI Licensed Material EPRI Plant Support Engineering 6. The user's post receipt and installation quality controls add assurance that the item performs as designed under normal operating conditions. These controls, include preventive maintenance testing, post maintenance testing, surveillance testing and other tests or inspections which verify the material condition and operating status of plant equipment. 2.1.3 Clarification of "Item Received is the Item Specified" 24.34 Issue. As the term "acceptance" is defined in EPRI Report NP-5652, what is meant by "the item received is the item specified"? 2.1.32 Guidance. As stated above, reasonable assurance describes the level of confidence one has in assuring the commercial grade item received meets specified requirements. This assumes that an adequate technical evaluation is performed which translates design criteria into technical and quality procurement requirements. Thus the item is specified correctly to maintain current plant-specific design requirements, The acceptance focuses on the right hand side of Figure 2-2. The term "the item specified” is meant in a broad, generic sense and should not be literally taken to mean that each and every technical requirement of a given item communicated (i.e. specified) ina procurement document needs to be verified to meet 10CFR50, Appendix B, Criterion VII. Conversely, more critical characteristics for acceptance may be selected for verification than appear as technical requirements in the procurement document. Therefore a direct correlation between specified technical requirements and verified critical characteristics for acceptance is not necessary to be reasonably assured the item received meets specified requirements. The user should take care not to oversimplify the acceptance process by attempting to rely solely on part number verification as the means to accept CGls for safety- related use. The acceptance process for CGIs should be implemented as described in EPRI Report NP-5652 using the generic process and implementing the four acceptance methods either individually or in combination. 2.1.4 Reasonable Assurance in the CGI Acceptance Process 24.44 Issue. In the context of CGI acceptance, what is the user reasonably assured of? 2.1.4.2 Guidance. In the context of CGI acceptance, the procurer is attempting to be reasonably assured that the received item meets specified requirements. As depicted in Figure 2-2 and as discussed in preceding sections, the assurance of item performance of safety function results from the combination of the technical evaluation and the acceptance processes.EPRI Licensed Material ‘Supplemental Guidance for the Application of EPRI Report NP-5652 Reasonable assurance for acceptance of CGIs in nuclear safety-related applications is always achieved under the procurer's 10CFR50, Appendix B Quality Assurance Program and varying levels of supplier quality assurance depending on the acceptance method(s) used. 2.1.5 Factors Required to Achieve Reasonable Assurance in the Context of CGI Acceptance 21.54 Issue. What factors should be considered in achieving reasonable assurance in the context of CGI acceptance? 21.5.2 Guidance. Several factors should be considered in achieving reasonable assurance as depicted in Figure 2-3. The primary factor is the selected critical characteristics for acceptance to be verified. This factor may consider the number of ctitical characteristics selected as well as the type (i.e. product identification, physical, and performance). Section 2.3.2 discusses critical characteristics in detail. A second factor to consider in achieving reasonable assurance is the adequacy of the sample size of items chosen for verifying selected critical characteristics for acceptance. EPRI Report NP-7218 provides detailed guidance on sampling for the acceptance of commercial grade items. What is the degree of verification of any critical characteristic for acceptance? Was an adequate sample of items chosen for verification? — _— Were the proper critical characteristics for acceptance selected for verification? Engineering Judgment ™—~~™_ “Reasonably assured’ the item received meets specified requirements. Figure 2-3 Achieving Reasonable Assurance in the Context of CGI AcceptanceEPRI Licensed Material Another factor to be considered in achieving reasonable assurance is the degree of verification of each selected critical characteristic deemed necessary. For accepting commercial grade items, the degree of verification for a given critical characteristic corresponds to the acceptance criteria to be met, and may vary from item to item based on each end-use application. When a given critical characteristics is not verified, justification to support the decision should be provided. Once reasonable assurance has been achieved, the user should ensure the adequacy of the documentation of the acceptance process. This documentation provides the objective evidence that the process was implemented, as well as the results of the acceptance. 2.4.6 Example Example 2-4 is provided to demonstrate achieving reasonable assurance in the context of CGl acceptance. Because the example also demonstrates the selection of critical characteristics for acceptance, it follows Section 2.3.2 2.2 Issues Related to the Technical Evaluation of Replacement Items (TERI) During the Use of EPRI Report NP-5652 The technical evaluation process was introduced in EPRI Report NP-5652 as the process by which the required technical input necessary (ie., the safety classification, functional analysis, and technical and quality requirements) to perform the acceptance of commercial grade items could be obtained. The technical evaluation process was generically described in Appendix A of EPRI Report NP-5652 and developed in detail in EPRI Report NP-6406, Guidelines for the Technical Evaluation of Replacement Items in Nuclear Power Plants. Utilities and suppliers have experienced difficulty in determining the interfaces between the two processes. In general, suppliers were not intended to perform the technical evaluation process except in those cases where the utility has delegated the plant design authority to the supplier (e.g., NSSS vendors or other suppliers where the product application has been communicated). 2.2.1 Technical Evaluation of Replacement Items versus Acceptance of Commercial Grade Items 22.4.1 Issue. The industry has experienced difficulty in determining the differences between the activities covered by a “technical evaluation’ as described in EPRI Report NP-6406 and the "acceptance of commercial grade items" covered by EPRI Report NP-5652. The differences between critical characteristics for acceptance and critical characteristics for design have complicated this issue. 28EPRI Licensed Material ‘Supplemental Guidance for the Application of EPRI Report NP-5652 2.2.1.2 Guidance. Figure 1-1 of this document depicts the generic process for acceptance of commercial grade items used in safety-related applications nearly as it appeared in EPRI Report NP-5652. The solid line represents, in a general sense, where the Technical Evaluation Process ends and the Acceptance Process begins. The flow diagram was depicted in this manner to demonstrate that the technical evaluation process was not an integral part of the acceptance of commercial grade items but that certain technical information was necessary as input to fully implement acceptance. Figure 2-2 of this document further illustrates the interface between these two processes. The purpose of the technical evaluation process is to identify, through specified technical and quality requirements, the correct item for a given application or set of, applications. The purpose of the acceptance of commercial grade items process is to provide reasonable assurance that the item received meets the specified requirements. It should be noted here however that neither the technical evaluation process or the acceptance process are a substitute for the design and equipment qualification activities covered by Criteria III of 10CFR50, Appendix B. The design control and equipment qualification processes establish the design basis and performance criteria for the plant specific equipment application. The technical evaluation process translates the design criteria into procurement technical and quality requirements. Where the technical and quality requirements are already available in existing specifications, a formal technical evaluation may not be necessary. During the technical evaluation process the user deals with CRITICAL CHARACTERISTICS FOR DESIGN which are “those properties or attributes which are essential for the item's form, fit and functional performance. Critical characteristics for design are the identifiable and/or measurable attributes of a replacement item which provides assurance that the replacement item will perform its design function" (EPRI Report NP-6406). The critical characteristics for design result from the functional performance requirements and the optional credible failure analysis of the item's application in service (see EPRI Report NP-6406). They are then translated into technical and quality requirements for the generation of a specification or purchase document. The break point between the "technical evaluation” and “acceptance process" occurs at this point. Once the item is specified, the user begins the process of acceptance by determining the CRITICAL CHARACTERISTICS FOR ACCEPTANCE defined as “identifiable and measurable attributes/oariables of a commercial grade item, which once selected to be verified, provide reasonable assurance that 29EPRI Licensed Material EPRI Plant Support Engineering the item received is the item specified" (EPRI Report NP-5652 and EPRI Report NP-6406). This selection process is discussed in detail in Section 2.3.2 of this document. Therefore the user should be aware that technical evaluation and acceptance processes are distinct as further illustrated in Figure 2-4. TERI Process CGI Acceptance Process Regulatory 10CFR50, Appendix B, Criteria IV; 10CFRS50, Appendix B, Basis: ANSI N18.7 Criteria Vil Guidance: EPRI Report NP-6406 EPRI Report NP-5652 Reasonably —_The correct requirements are The item received meets Assures: specified in the procurement specified requirements document Method: Evaluation/specification of technical Verification of selected critical | and quality requirements characteristics | | | Results In: Technical and quality procurement Dedicated CG! documented in | requirements documented ina an acceptance document purchase document Figure 2-4 Relationship Between Technical Evaluation for Replacement Items and CGI Acceptance Process 2.2.2. Obtaining Technical Information from Suppliers 22.24 Issue. In order to implement the commercial grade acceptance process, technical information related to the commercial grade item must often be obtained. This information may be solicited from the original equipment supplier, original equipment manufacturer, a distributor, or the part manufacturer. Guidance is needed on how to obtain and document the different types of information provided by these suppliers. How to attain confidence that the information provided is correct also needs additional guidance. 2-10(2) EPRI Licensed Material ‘Supplemental Guidance for the Application of EPRI Report NP-5652 Guidance. The two ways technical information can be obtained follows: Published or Supplier Controlled Documents Where possible, supplier technical information should be obtained from the appropriate edition of published or controlled documents. These sources can include: + Part drawings + Assembly drawings + Supplier catalogs + Supplier technical manuals + Supplier product specifications + National codes and standards These are reliable sources of information issued by the supplier or national standards organizations. Supplier Technical Information Obtained From Other Than Controlled or Published Documents In many cases, technical information must be obtained from suppliers’ representatives by telephone or in supplier meetings. Attaining confidence the information provided is correct is accomplished by assuring the information is obtained from a knowledgeable supplier representative and by requiring formalized documentation, where appropriate. For certain types of technical information, further confidence is attained through the implementation of the commercial grade item dedication process. When determining how to attain confidence in the correctness of supplier provided technical information, the following four factors should be considered: A. Types of technical information B. _ Who provides the data C. Method of documentation D. Engineering judgment A 9 Technical Information The six major types of supplier technical information follows. 241EPRI Licensed Material EPRI Plant Support Engineering 2-12 ifi yut Purchasers often solicit information from the 10CFR50, Appendix B original equipment manufacturer on the design function of parts within the safety-related host component. In many cases, the original equipment manufacturer has made its own safety classification determination at the part or sub-component level. This information is used strictly as input by the utility's engineering organization to make its own safety classification decision. (This information might also be obtained from a responsible third party organization that represents the original equipment manufacturer or has purchased the product rights.) ‘Whether the item meets the commercial grade item definition The primary input the supplier would provide is whether the item is used in industries other than the nuclear industry. If the same item is used in other industries but additional technical requirements are imposed (ie., specific materials, hardness ranges, liquid penetrant testing, tighter tolerances), this should not preclude the item from being considered commercial grade. Purchaser imposition of special requirements on a commercial item to meet its specific needs is a common commercial practice. ritic acteristics of an It The original equipment manufacturer or part manufacturer should have the best understanding of how the item is designed and intended to function in the host component. Information on an item's critical characteristics and how they can be verified may be requested by the purchaser. The purchaser's engineering organization would consider the supplier's input during its, engineering evaluation and factor in plant specific considerations before finally selecting the appropriate critical characteristics for acceptance. nce Cri ‘The purchaser needs to identify the acceptance criteria for each critical characteristic for acceptance to implement Acceptance Method 1. When the acceptance criteria information is obtained from the supplier, the purchaser is responsible for evaluating the input and deciding on the actual acceptance criteria to be used for commercial grade item acceptance. When using Acceptance Methods 2 and 3, acceptance information can be obtained or examined during the plant visit.EPRI Licensed Material ‘Supplemental Guidance for the Application of EPR! Report NP-5652 Form: s An original equipment manufacturer's, part manufacturer's, and/or distributor's lot formation practices are important when the purchaser verifies critical characteristics through special tests and inspections utilizing sampling plans. EPRI Report NP-7218 provides information on different types of lot formations. Used in Speci I The purchaser should provide a detailed description of the item in the purchase order to assist in assuring the correct item will be supplied. Who Provides the Data The source of information is the most significant factor in attaining confidence that the technical information provided by the supplier is correct. The contact to obtain needed technical information will vary from supplier to supplier based on. organizational responsibilities. When possible, information should be obtained from the technical source responsible for the information or activity. For example, information related to drawing acceptance criteria or the function of a part should normally be obtained from the supplier's engineering organization. Many suppliers, however, designate sales, sales service, or contracts personnel as the principal interface with the purchaser. These individuals take purchaser questions to the appropriate technical organizations for answers. The purchaser must decide whether information obtained in this manner can be relied upon. Past history of the correctness of information provided is the best indicator as to the validity of information obtained from these non technical sources. Table 2-1 lists recommended supplier sources for different types of technical information. 2-13EPRI Licensed Material EPRI Plant Support Engineering 214 c : Recommended Supplier Source of __Types of Technical Intormation Information 1 Safety Classification Input | Supplier's Engineering Organization 2 Whother the Item Meets the CGI Definition | Supplier's Engineering, QA, or Production Organizations 3.__ Critical Characteristics of an item ‘Supplier's Engineering Organization 4. Acvoptance Criteria ‘Supplier's Engineering, QA, or Production Organizations 5. Lot Formation Practices ‘Supplier's Engineering, QA, or Production | organizations 6. Information Used in Spectying an item | Suppliers Engineering, QA or Production | organizations Table 2-1 Recommended Supplier Sources of Information Method of Documentation When the technical information is provided by the supplier, formal documentation of how the information was obtained is a good practice, but not required. The purchaser should document its final technical decision in accordance with its procedures. For example, a utility may document a part's safety classification decision on a safety classification work sheet. Information a supplier might have provided on the part's function or potential failure modes would be documented on the safety classification work sheet. Formal documentation of supplier furnished technical information, however, has some benefits. Such a practice clearly documents the source of the information, what information was obtained, and who received the information from the supplier. One way of formally documenting the information is to have it confirmed in writing by the supplier's representative. Alternatively, the purchaser's technical representative could document in a telephone conference memorandum: + the supplier + the name of the representative providing the information * the technical information providedEPRI Licensed Material ‘Supplemental Guidance for the Application of EPRI Report NP-5652 + the date A practice followed by some purchasers is to send the telephone conference memorandum to the supplier representative so any miscommunication can be identified. D. — Engineerin; ment The efforts and documentation needed to attain confidence in the correctness of supplier provided technical information is a matter of engineering judgment. Assuring the technical information is provided by a credible supplier source normally provides reasonable assurance to the purchaser's technical representative that the information is correct. Discrepancies in information received are almost always due to miscommunication. This, problem can be minimized by assuring documentation of the information provided is sent to both parties. Specific visits to the supplier to verify the information obtained is correct is considered unwarranted. If experience, however, reveals that the supplier's information has been incorrect, then actions should be taken to determine the source of the errors. These actions might include a visit to the supplier. 2.2.2.3 Lessons Learned. For certain types of technical information, the acceptance process may identify if incorrect technical information has been provided. Examples include information on acceptance criteria and lot formation practices. For example, if the supplier incorrectly identifies a bushing material as 304 stainless steel and it is really manufactured from 316 stainless steel, this discrepancy would typically be discovered during the alloy identity test. Lot formation information will be further confirmed by receipt inspection identification checks and the commercial grade item acceptance process where attributes and variables for sampled items can be compared for similarity. Purchase order line items from one heat number, batch number, or production lot would be expected to have very similar test and inspection results. Purchase order line items from one product manufacturer would be expected to have relatively similar test and inspection results because of the manufacturer's production controls. Purchase order line items from multiple or unknown product manufacturer's would be expected to have variations in, test and inspection results although all the values should be within the purchaser specified acceptance criteria. 2-15EPRI Licensed Material EPRI Plant Support Engineering ‘There may be instances when the acceptance criteria is not available from the supplier over the telephone or through the mail (ie., proprietary information). The party performing the dedication has several methods to obtain the information including: + Facility Visit: Although the vendor refuses to provide the requested information over the phone or through the mail, they may make it available if the requesting party visits their facility, + Procure the Information: Suppliers may agree to supply the information ifa utility agrees to purchase it. + Release Agreement: Certain suppliers may release the information if the requester signs a proprietary agreement stating how the information will be used and that it will not be divulged to other sources. + Reverse Engineering: An evaluation which could consist of testing, research of codes and standards, and /or inspection may be performed to obtain the item's design, physical and performance characteristics. 222.4 Example. Example 2-1 provides an illustration of how confidence is attained in the correctness of technical information obtained from a supplier. Example 2-1 Attaining Confidence in the Corre ical Information From Suppliers SCENARIO ‘The original, 10CFR50, Appendix B Qualified Valve Manufacturer, "No Leak Valves", declared Chapter 11 in 1989, with the drawings, calculations, design data and equipment obtained by Scavenger Service, Inc. Scavenger Service, Inc., a 10CFR50, Appendix B qualified supplier, in 1990 also declared Chapter 11. As a result, the butterfly valve drawings, calculations, design data and equipment for 20" and smaller butterfly valves were procured by C. C. Service and Repair, Inc. The larger valve design information and equipment was sold to. Jamison, Inc. During an attempted procurement of several replacement 20" valves and valve parts as, well as several 24” valves and valve parts, it was determined that C. C. Service and Repair, Inc. and Jamison, Inc,, did not have Quality Assurance Programs in accordance with 10CFR50, Appendix B. Jamison, Inc. does maintain a Quality Control Program, but that program does not meet 10CFR50 Appendix B. C. C. Service and Repair, Inc. does not maintain a formal QA or QC Program. 2-16EPRI Licensed Material ‘Supplemental Guidance for the Applic ion of EPRI Report NP-5652 During the development of the dedication activities it was determined that no details were on site for either the internals of the 20" or for the internals of the 24" butterfly valves. The procurement engineer developing the dedication packages considered some of the dimensions as critical characteristics for the internal parts being procured. ACTION The Procurement Engineer contacted both companies’ Engineering Departments and requested copies of their drawings for the purpose of developing the dedication packages for each of the subject valves. Both companies supplied copies of the original valve manufacturer's (No Leak Valves) drawings for the internal parts identified as needed. The Procurement Engineer prepared an Engineering Memorandum (EM) and forwarded the EM and drawings to the utilities’ Design Engineering Department for approval. After the EM was approved, the Procurement Engineer completed the dedication packages and forwarded them with the EM to the appropriate supervisor for approval. The technical information (i.e., drawings) was considered correct because it was provided by the responsible Engineering Department at both companies. The drawings with the designated dimensional acceptance criteria constituted written confirmation of the acceptance criteria, 2.2.3 Equipment Qualification versus CGI Acceptance Process 2.2.3.4 Issue. Some suppliers, vendors, and utilities are substituting the equipment qualification process (both seismic qualification and environmental qualification) for the CGI acceptance process. This appears to result from the similarity in the testing or acceptance methods used to perform CGI acceptance and equipment qualification. Failure to recognize the differences could result in the use of inadequately qualified equipment or over specification of acceptance requirements. 2.2.3.2 Guidance. Equipment Qualification is a part of the design process covered under 10CFR50, Appendix B Criterion III which demonstrates either through the testing of a prototype, by engineering analysis of a prototype, or by historical performance demonstration of an item of the same design under corresponding parameters, that an item exhibits design characteristics allowing it to function or survive a set of environmental conditions and /or seismic spectra. The technical evaluation process translates the design criteria established under Criteria III into procurement specifications as delineated in Criterion IV of 10CFR50, Appendix B. When the design criteria for the plant application contains equipment qualification requirements, these requirements are translated in the procurement specification along with any other technical and performance criteria, When the specified item meets the commercial grade item definition, performance of commercial grade acceptance is the 217EPRI Licensed Material EPRI Plant Support Engineering transition point from Criteria IV to "Control of Purchased Items" described in 10CFR50, Appendix B Criterion VIL. The commercial grade acceptance process as described in EPRI Report NP-5652 is the same when used to accept an item where the application has equipment qualification requirements as it is for applications which do not have equipment qualification requirements. The purpose of CGI acceptance is to provide reasonable assurance that an item meets specified requirements. Therefore, for applications which have equipment qualification requirements, these equipment qualification requirements simply become an input to the commercial grade acceptance process, when the selection of critical characteristics for acceptance is performed. The critical characteristics for design which relate to the equipment qualification requirements should be weighted heavily when critical characteristics for acceptance are selected. The user should note that the testing or other acceptance methods used in achieving "reasonable assurance that an item meets specified requirements" does not necessarily demonstrate that an alternate item (not identical to the original or current design) is, adequate with respect to its equipment qualification. The adequacy of design of an alternate item can only be determined through the design modification /control requirements contained in 10CFR50, Appendix B, Criteria IIT and/or as described in EPRI Report NP-6406, Guidelines for the Technical Evaluation of Replacement Items in ‘Nuclear Power Plants, and EPRI Report NP-7484, Guideline for the Seismic Technical Evaluation of Keplacement Items for Nuclear Power Plants. Figure 25 illustrates the distinct difference between these two processes. Equipment Qualification CGI Acceptance Process Regulatory 10CFRS50, Appendix B, Criteria Ill; 10CFR50, Appendix B, Basis: 10CFRS0.49; 10CFR100 Criteria Vil Guidance: IEEE 344; IEEE 323 EPRI Report NP-S652 Reasonably The equipments adequate for _—_‘The item received meets. Assure: these application(s) specified requirements Method: Testing, analysis, or history Verification of selected critical demonstration that an equipment —_characteristics, design is suitable for its intended application Results In: Qualification report resulting from Dedicated CGI documented testing, analysis, or historical in an acceptance document demonstration Figure 2-5 Relationship Between Equipment Qualification and CGI Acceptance Process 218EPRI Licensed Material Supplemental Guidance for the Application of EPRI Report NP-S652 2.2.3.3 Issue. Equipment qualification requirements are usually established at the component or system level. However, replacement items are frequently parts within a qualified component or system. Therefore it is difficult to determine critical characteristics both for design and for acceptance at the part level as they relate to the components or system's equipment qualification requirements. 2.2.3.4 Guidance. Replacement parts within a qualified component or system are usually based on a "replacement in kind” philosophy where the replacement part is, identical to that in service. Many qualification reports provide "Bills of Materials’ or parts lists of the items on which the qualification was based. Where this information is not available, heavy reliance on the equipment manufacturer or supplier must be made. Where the identity of the original part cannot be determined, an engineering analysis up to and including complete requalification may be required to demonstrate the replacement material will continue to maintain the qualification of the parent or host component. In most cases, however, the engineering analysis can determine the impact on the component by evaluating the specific qualification parameters against the purpose of the qualification. For example, replacing metallic parts within a component, qualified to meet radiation, temperature, and humidity related degradation parameters on the component's polymer-based parts, will have no effect on the qualification report. However, when a polymer-based part's original identity can not be determined, an engineering analysis, or test can evaluate the ability of the replacement material to pertorm in the application's environmental parameters. EPRI Report NP-7484, Guideline for the Seismic Technical Evaluation of Replacement Items for Nuclear Power Plants, provides detailed guidance on the evaluation of replacement items with seismic considerations. The selection of critical characteristics for acceptance for these parts then becomes a matter of focusing on the results of the technical evaluation. Where the replacement part is identical and minimal technical evaluation is performed, the user should focus on critical characteristics for acceptance which ensure the part meets its specified requirements. 2.2.4 Design Verification versus Establishment of Critical Characteristics for Acceptance 2.2.44 Issue. Some utilities and suppliers are experiencing difficulty in determining the extent to which the design verification process described in ANSI N45.2.11 applies to the commercial grade acceptance process described in EPRI Report NP-5652. This difficulty has resulted in design verification reviews exceeding the regulatory requirements being applied to the commercial grade and procurement acceptance process. 2-19EPRI Licensed Material EPRI Plant Support Engineering 2.2.4.2 Guidance. EPRI Report NP-5652 Section 1.3.1 states "This guideline assumes that the design requirements of the item have been satisfactorily translated into specification requirements as reflected in the procurement document. The purpose of the technical evaiuation is to assure that the specification requirements are correct.” EPRI Report NP-6406, Section 1.4.1 states "This document assumes that a plant initiated design change or modification does not occur if the equivalency of the form, fit, function, and interchangeability (including seismic and environmental qualification requirements) of a replacement item has been established. The basis for this premise is that the plant, system, or component's design has not been altered." It should be concluded that the Technical Evaluation and the Commercial Grade Acceptance Process described in EPRI Report NP-6406 and EPRI Report NP-5652 are not a substitute for a design change/modification process. In fact, the TERI process was to provide the user process for ensuring the design basis of a plant, system, structure, or component is maintained. ANSI N45,2.11, Quality Assurance Requirements for the Design of Nuclear Power Plants, paragraph 6.2 states "Where the design of a particular structure, systemt or component has been subjected to the verification process in accordance with this standard, the verification process need not be duplicated for identical designs.” This guidance applies to technical evaluations performed for parts within a compenent as well as evaluations performed at the component level. Caution should be taken to ensure that the component's ability to perform the plant specific design functions is not degraded, Therefore, the process of performing the technical evaluation and the commercial grade acceptance is not intended to be a design change mechanism and as such does not require a design verification. It is prudent however that the user of EPRI Report NP- 5652 institute a peer or supervisor review of commercial grade dedication documentation for accuracy and consistency of these evaluations. Once a technical evaluation has been performed, it is not necessary to repeat the review for repetitive purchases as long as the bounding conditions of the applications remain the same. For plant configuration purposes, plant records should be updated to reflect the installed equivalent components and parts. 2.2.5 Like-For-Like Determination 2.2.51 Issue. Guidance is needed to clarify the purpose of the like-for-like determination and factors to be considered when procuring a replacement item. 2.2.5.2 Guidance. The term like-for-like was used in EPRI Report NP-5652 and EPRI Report NP-6406 to describe a procurement scenario in which a minimal technical 2-20EPRI Licensed Material ‘Supplemental Guidance for the Application of EPRI Report NP-5652 evaluation was required for a replacement item. A like-for-like replacement was defined as a "replacement of an item that is identical’. The like-for-like determination was made primarily to ascertain the degree of engineering evaluation necessary to specify the item correctly. As defined, the term like-for-like was clearly associated with the technical evaluation process and not the acceptance process. The like-for-like procurement was based on the premise that the original item was designed correctly, satisfied its intended design basis, was suitable for its intended end-use application, and was specified correctly with the proper technical and quality requirements. In specifying technical and quality requirements for subsequent procurements, the previously specified technical and quality requirements need not be reevaluated unless negative feedback is received during the procurement or receipt inspection process. (See Example 2.3 for further clarification). The extent to which one could obtain and document reaffirmation during the technical evaluation that the replacement item had not undergone changes has been an issue requiring additional guidance. Figure 2-6 depicts varying factors which may contribute to determining a like-for-like procurement. These factors are generic in nature and should be considered for any procurement of a replacement item. On the other hand, the user should recognize that these factors should not be considered as criteria necessary to justify proceeding with a like-for-like procurement. The figure also depicts that the confidence one has in the replacement item being identical impacts the degree of further engineering evaluation that may be required. 221EPRI Licensed Material EPRI Plant Support Engineering Same Manufacturer? supple ratns ro | changes in material, ' design, ft, form, ee function of interchangeabiity? a a Confidence level the item will be identical (Like-for-Like procurement) ‘Adequate supplier controls of the ‘manufacturing and —____ procurement processes? a / Degree of engineering evaluation deemed necessary supplier controls of design change process? ‘Supplier Performance? Same published product description of the item? Figure 2-6 Factors Determining a Like-for-Like Procurement EPRI Report NP-5652 states "If the purchaser has assurance through planned coordination with the supplier that the design of the item has not been changed by the manufacturer or supplier, a like-for-like procurement should be implemented without performing an engineering evaluation”. If the purchaser has achieved a high confidence that the replacement is identical to the original, because there is reason to believe no changes had occurred with the item's material, design, fit, form, function or interchangeability, 1) the procurement is called like-for-like, 2) the item is specified with the same technical requirements (design criteria) as the original, and 3) a minimal technical evaluation is required to specify the item. Figure 2-7 portrays this scenario. 2-22EPRI Licensed Material ‘Supplemental Guidance for the Application of EPRI Report NP-5652 High confidence level Factors were considered ‘the item will be Minimal and purchaser has no identical technical reason to believe changes (Like-for-Like evaluation had occurred (ref. Fiegure 2-6) procurement) required Planned Confidence Degree ot Coordination Level engineering Evaluation * Item will typically be specified with existing technical and quality requirements, and will not require an equivalency evaluation. igure 2-7 Like-for-Like Procurement If the purchaser has low confidence that the replacement item is identical, because there is reason to believe changes have occurred with the item's material, design, fit, function or interchangeability, 1) the procurement is called an alternative item procurement, 2) the item may be specified with different technical requirements, and 3) a technical equivalency evaluation is required. Figure 2-8 portrays this scenario. Factors were considered Low confidence and purchaser has reason 10 believe changes Identical have occurred (ref. Figure 2-6) Equivalency evaluation required Planned Confidence eee of Coordination Level ngineering Evaluation Figure 2-8 Alternative Item Procurement 2.23EPRI Licensed Material EPRI Plant Support Engineering 2.2.5.3 Example. Examples 2-2 and 2-3 are provided to illustrate typical like-for- like procurement determinations. Example 2-2 Like-for-Like Determination Utility X must procure a replacement gland. Utility X has determined that the gland performs a safety-related function in the intended applications in their plant. The supplier, Valve Inc., has informed Utility X that the gland will be furnished as a CGI and Utility X confirms that the item meets the CGI definition. Utility X must determine whether the gland can be procured like-for-like, because if it cannot, an equivalency evaluation will be required. A procurement engineer from Utility X contacts a representative from Valve Inc. and inquires if there have been any changes in the item's form, fit, function, material, interchangeability, or design. Valve, Inc. states there have been no changes and acknowledges their reply by signing a copy of the telephone conference memorandum prepared by the Utility X procurement engineer. The engineer also considered the fact that this same supplier has performed adecuately in the past by consistently furnishing items that met specified requirements. Since a commercial grade survey of Valve, Inc. has not been conducted, no objective evidence regarding their controls of procurement and manufacturing processes or design change control exists. Based on the above factors, the engineer proceeds with a like-for-like procurement with a minimal further technical evaluation. The procurement is graphically conveyed below to illustrate the various factors considered. The item is specified correctly and because it is a CGI intended for safety-related use, is accepted utilizing the methods described in EPRI Report NP-5652. 2.24EPRI Licensed Material ‘Supplemental Guidance for the Application of EPRI Report NP-5652 Same Manufacturer? Success accepting this YES supplier in the past? YES | Complexity of Supplier reatfirms no N\ the item changes in material, ‘SIMPLE METALLIC. design, fit, form, PART function, or interchangeability?* YES Adequate supplier controls of the ———— manufacturing and procurement provesses?™ INDETERMINATE ey High Confidence Level the item will be identical once properly accepted Minimal technical evaluation requit Adequate supplier control of design change process? INDETERMINATE Supplier Same published product Performance description of the item? Goop YES * The confidence the purchaser has resulting from supplier controls willbe affected by the type and degree of prior evaluation of supplier quality assurance programs/practices. Example 2-3 Like-for-Like Determination Utility Y has a need for a 3/8 inch, ASTM A-105, three way manifold valve, containing, a single flange, in a safety-related instrumentation application. This valve is used to isolate the pressure sensing lines and for use during the calibration of the instrumentation. The valve's safety function is pressure retention and Utility Y confirms that the item meets the CGI definition. Utility Y must determine whether the valve can be procured like-for-like, because if it cannot, a technical equivalency evaluation will be required. This replacement item was previously purchased from the original manufacturer using the catalog description as technical procurement requirements, and was accepted using Method 1, Special Test and Inspection. Criteria verified included part number, weight (for seismic considerations), dimensions (for fit), seat leak check and hydrostatic test (pressure integrity), and body material. The verifications for weight, dimensions, seat leak check, hydrostatic testing per ANSI B31.1 (1.5 times design pressure) in the open and closed positions, and a verification of 2-25EPAI Licensed Material EPRI Plant Support Engineering body material through the use of an alloy analyzer were completed to accept the valve manifold. During the initial receipt inspection for the replacement, concerns were identified with the part number of the item received matching the part number contained in the suppliers catalog. During communications with the supplier by the engineering personnel, it was determined that the catalog was in error. This error was corrected in both the purchase specification and acceptance criteria. The engineer also considered the fact that this same supplier had performed adequately in the past by consistently furnishing items that met specified requirements. Since a commercial grade survey had not been conducted, no objective evidence regarding the manufacturer's controls of manufacturing processes or design change control existed. Subsequent purchases of these valves were made using the corrected specification, and the previously specified technical and quality requirements. Based on the above factors, the engineer proceeds with a like-for-like procurement with minimal further technical evaluation. The engineer assures that the original technical evaluation remains valid until such time that negative feedback is obtained through responses to requests for quotations or changes identified by the receiving inspection process. The procurement is graphically conveyed below to illustrate various factors considered. The item is specified correctly and because it is a CGI intended for safety- related use, is accepted utilizing the methods described in EPRI Report NP-5652 2-26EPRI Licensed Material ‘Supplemental Guidance for the Application of EPRI Report NP-5652 ‘Same Manufacturer? Success accepting this YES supplier in the past? vo Complexity of ‘Supplier reaffirms no the item changes in material, "ASSEMBLED ITEM design, fit, form, function, or interchangeabllity?” NO ‘Adequate suppiier controls of the ——=— manufacturing and procurement processes?” INDETERMINATE Lo Adoucate suppor / High Confidence Level the item will be identical ‘once properly accepted Minimal technical controt of design change process?* INDETERMINATE Supplier Same published product Performance description of the item? GOOD _YES, EXCEPT PART NUMBER. * The confidence the purchaser has resulting from supplier controls will be affected by the type and degree of prior evaluation of supplier quality assurance programsipractices. 2.3 Issues Related to the Generic Process for Acceptance of Commercial Grade Items ‘This section of the document provides application guidance specific to the steps of the generic process for acceptance of commercial items depicted in Figure 1-1. No attempt has been made to change the original intent of EPRI Report NP-5652, but to simply clarify issues raised during its application in the nuclear industry. 2.3.1 Determining Safety-Related Function of the Item 23.44 Issue. EPRI Report NP-5652, EPRI Report NP-6406, and EPRI Report NP- 6895 each provide guidance on determining the safety-related function of an item. EPRI Report NP-5652 states that "this evaluation is optional and need not be performed if itis assumed that the component or all items within the component are safety-related”. It is difficult to perform technical evaluations and commercial grade acceptance where the safety functions of items have not been identified. It is also cost prohibitive to perform acceptance processes to the level discussed in EPRI Report NP-5652 on items that can be shown to be nonsafety-related. 2.27EPRI Licensed Material EPRI Plant Support Engineering 2.3.1.2 Guidance. During the generation of EPRI Report NP-5652, it was determined that many utilities did not have safety classification systems which extended to the part level. For these utilities, many times the conservative assumption was made that all parts within a safety-related component were safety-related. In addition, many utilities did not have a breakdown of a component's safety-related functions and as such, performance requirements for most items were based on a “worst case” scenario (ie. all functions are safety-related). Since both of these assumptions were conservative from a safety standpoint, the statement that the safety- related function identification was optional was technically sound. While this is adequate from a safety classification standpoint, it does not provide the individual preparing the technical and quality requirements for procurement or individuals preparing commercial grade acceptance requirements adequate information to develop the relationship between safety function and critical characteristics. Also the economics of performing commercial grade item acceptance on items which could be classified as nonsafety-related is becoming cost prohibitive and does not provide any additional safety benefit to the product, component, system, or nuclear facility. In addition to the imposition of unnecessary requirements, suppliers of safety-related equipment cannot be expected to perform classification of parts within their components unless the safety application and functional requirements have been communicated to them by the purchaser. To preclude these conditions, the users of EPRI Report NP-5652 should determine the safety classification and safety-related functions of items during the technical evaluation process. It should be noted that while most classification evaluations are application specific, many commodity type items can be evaluated on a generic basis using a set of bounding conditions. These types of evaluations many times allow utilities to classify whole groups of items (such as gaskets, conduit, etc.) safety-related /nonsafety-related, and handle the few specific applications to the contrary on an exception basis. Although it is not a regulatory requirement, depending on an item's complexity and importance to safety, the safety-related function of the item may be documented to facilitate the development of critical characteristics for acceptance and provide the link to item safety function. 2.3.2. Identification and Selection of Critical Characteristics This section of the document provides application guidance specific to the steps of the generic process for acceptance of commercial items depicted in Figure 1-1. No attempt has been made to change the original intent of EPRI Report NP-5652, but to simply clarify issues raised during its application in the nuclear industry.EPRI Licensed Material ‘Supplemental Guidance for the Application of EPRI Report NP-5652, 2.3.24 Issue. As part of the generic process for CGI acceptance, technical personnel must identify and select certain critical characteristics that will be verified. Additional guidance regarding the selection of critical characteristics for acceptance is needed. 23.2.2 Position. Itis only necessary to identify and verify the appropriate critical characteristics which provide reasonable assurance that the item received meets specified requirements. 2.3.2.3 Background / Basis. In EPRI Report NP-5652 (1988) the term "critical characteristics” was defined as those "measurable and identifiable attributes variables of a commercial grade item, which once selected to be verified, provide reasonable assurance that the item received is the item specified". In EPRI Report NP-6406 (1989) an attempt was made to differentiate those critical characteristics selected for verification and those that more fully described the design of the item relating to its plant-specific design function(s). Thus, the original definition from EPRI Report NP- 5652 was used to describe “critical characteristics for acceptance", and a broader definition was provided for “critical characteristics for design”. EPRI Report NP-6406 describes critical characteristics for design as "those properties or attributes which are essential for the item's form, fit and functional performance...identifiable and /or measurable attributes of a replacement item which provides assurance that the replacement item will perform its design function’. The two definitions were consistent and compatible because: (1) EPRI Report NP-6406 addressed all replacement items, not only CGIs. (2) The original intent of EPRI Report NP-5652 was to select “critical characteristics for acceptance” from a larger population of “critical characteristics for design’. (3) The item's particular safety-related function(s) were key considerations in determining both groups of critical characteristics because both groups of critical characteristics were application specific. (4) The selection of critical characteristics for acceptance was "based upon the complexity, intended safety-related function, and performance of the CGI’ using engineering judgment. EPRI Report NP-5652 stressed that “it is only necessary to identify and verify the appropriate critical characteristics which provide reasonabie assurance that the item received is the item specified”. 2.3.2.4 Additional Guidance. Additional guidance regarding the relationship of critical characteristics is graphically conveyed in Figure 2-9. The figure is not drawn to 2:29EPRI Licensed Material EPAl Plant Support Engineering eee any scale and does not attempt to compare the number of critical characteristics in any circle or oval. Critical Item Characteristics Characteristics for Design (2) Critical Characteristics for Acceptance (3) Characteristics including Product Identification Characteristics (1) (1) Other characteristics are inherent to the item's design but are not required/used in the purchaser's application (2) These characteristics are application spacific and include physical and Performance characteristics. (3) All must be verified once selected. Justification why an identified critical characteristic for acceptance is not veritied should be documented, Figure 2-9 Proper Relationship of Critical Characteristics Regarding critical characteristics for acceptance, EPRI Report NP-5652 states that “critical characteristics that could be identified are physical characteristics of an item, identification markings, or performance characteristics of the item". EPRI Report NP- 6406 states that "critical characteristics for acceptance are generally a subset of the critical characteristics for design". EPRI Report NP-6406 also states that "critical characteristics for design include physical and performance characteristics of the item but not product identification characteristics". Figure 2-9 accurately depicts this relationship. The critical characteristics for acceptance that are physical and performance characteristics are depicted by the cross-hatched segment in Figure 2-9. This cross- hatched segment represents the subset of the larger population of critical characteristics for design stated in EPRI Report NP-6406. Selected critical characteristics essential for 2:30EPRI Licensed Material Supplemental Guidance for the Application of EPRI Report NP-5652 the item's safety-related functional performance would be included in those represented by the cross-hatched area. Physical or performance characteristics of the item that may have been specified in the original equipment specification and affect the item's safety-related functional performance should be considered as those selected for verification. If the original equipment specification did not specify technical and quality requirements at the item level, then the critical characteristics selected for verification during the acceptance process should be based upon “the complexity, intended safety-related function, and performance” of the item. Critical characteristics for acceptance should include both physical and performance characteristics as well as product identification characteristics. Thus, as depicted in Figure 2-9, they should include some number of "critical characteristics for design" as well as product identification characteristics such as part number. Once the critical characteristics for acceptance have been selected for a commercial grade item, each one should be verified using one or a combination of the four acceptance methods discussed in EPRI Report NP-5652. Verification of the selected critical characteristics for acceptance should provide the purchaser confidence that the remaining characteristics of the item are also conforming to the item design. It was not the intent of either EPRI Report NP-5652 or EPRI Report NP-6406 to require verification of all critical characteristics for design in order to achieve reasonable assurance that the item received met specified requirements (ref. Figure 2-10). In achieving reasonable assurance, it is assumed that if the properly selected critical characteristics for acceptance are conforming, then the remaining critical characteristics for design were also adequately controlled by the supplier. ‘Additionally, obtaining objective evidence of the acceptability of every critical characteristic for design related to safety function via the acceptance process would be inconsistent with the existing guidance of N18.7 (ref. to Section 2.1.2). On the other hand, EPRI Report NP-5652 clearly recognized that sole reliance on part number verification was inadequate to reasonably assure the CGI received met specified requirements (ref. Figure 2-11), Similarly, reliance only on the verification of product identification characteristics is generally inadequate to reasonably assure the CGI received met specified requirements. 231EPRI Licensed Material EPAl Plant Support Engineering tem Characteristics Critical Characteristics for Acceptance Characteristics including Product Identification Characteristics Critical Characteristics for Design Figure 2-10 Verifying All Critical Characteristics for Design (Not the intent of EPRI Report NP-5652) Item Characteristics Catical Characteristics for Design Critical Characteristics for Acceptance part number (Characteristics including Product Identification Characteristics Figure 2-11 Inadequate Selection of Critical Characteristics for Acceptance 2:32EPRI Licensed Material ‘Supplemental Guidance for the Application of EPRI Report NP-5652 EPRI Report NP-5652 stated that "the item's part number by definition is a critical characteristic," because by definition it is an identifiable attribute of an item which once verified, provides some assurance that the item received meets specified requirements. ‘The user should recognize that many items are uniquely identified by means other than bya part number. This may affect the selection of product identification critical characteristics for verification during the acceptance process. Caution should be used when relying on part number as contributing to the item acceptance if there is no basis for knowing that the part number has been correctly applied to the item. 2.3.2.5 Lessons Learned. (1) Ifadequate technical and quality requirements for the item are available from existing design basis information, then they may be used to establish critical characteristics for acceptance without performing a new determination of critical characteristics for design. ANSINI8,7 requires that replacement parts be purchased to specifications and codes equivalent to those specified for the original. Technical and quality requirements which applied to procurement of the original item must either be met when procuring a replacement item, or revised through a properly reviewed and approved revision. Original item specifications (or current approved revisions) are the preferred source for determination of critical characteristics for design, where such specifications are available or can reasonably be obtained. Specifications used to identify critical characteristics for design must be at the appropriate level of detail for the item being procured. For example, if an entire replacement valve is being procured, then the valve specification may be the appropriate specification for determination of critical characteristics for design. Specifications at this level of detail are most often available in utility records. However, if a replacement valve stem is being procured, then the valve specification alone may not completely define the stem’s technical and quality requirements. Additional design information may be available from the valve supplier. If this information can be reasonably obtained, it is the preferred source of information from which to determine critical characteristics for design. If adequate design information cannot be obtained at the level of detail necessary, then determination of critical characteristics for design based on an analysis of safety functions and failure modes and effects may be performed. ‘This evaluation (see process described in (2) below) is an appropriate method for performing the engineering evaluation required by ANSI N18.7 when the technical and quality assurance requirements of the original item cannot be determined. 2-33