ML17284A379

NEI 17-06 Introduction

ML17284A379
Person / Time
Site:	Nuclear Energy Institute
Issue date:	10/10/2017
From:	Nuclear Energy Institute
To:	Office of Nuclear Reactor Regulation
Wilkins L
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ML17291B302	List: ML17284A379 ML17284A380
References
NEI 17-06
Download: ML17284A379 (6)

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Page i of ii NEI 17-06 DRAFT October 10, 2017 TABLE OF CONTENTS 1 INTRODUCTION ...................................................................................... 1 1.2 PURPOSE .........................................................................................................................1 1.2 REGULATORY BASIS ....................................................................................................1 1.3 ACCEPTANCE OF SAFETY INTEGRITY LEVEL AS-VERIFICATION OF DEPENDABILITY CRITICAL CHARACTERISTICS ...........................................3 1.4 ACRONYMS ....................................................................................................................4 2 SAFETY INTEGRITY LEVEL (SIL) .........................................................

2.1 DESCRIPTION

OF THE THIRD PARTY CERTIFICATION PROCESS FOR PERFROMANCE OF SAFETY FUNCTIONS OF A PARTICULAR SAFETY INTEGRITY LEVEL (SIL)

2.2 DESCRIPTION

OF THE CRITICAL DEPENDABILITY CHARACTERISTICS PER NRC-ENDORSED EPRI-TR 106439 3 ACCEPTANCE OF COMMERCIAL GRADE DIGITAL EQUIPMENT FOR SAFETY APPLICATIONS CERTIFIED TO A PARTICULAR SIL ..............

3.1 APPLICATION OF THE THE SIL CERTIFICATION PROCESS ..............................................

3.2 TECHNICAL EVALUATION

3.3 ACCEPTANCE METHOD ....................................................................................................

4 PURCHASERS QUALITY ASSURANCE PROGRAM...............................

4.1 ORGANIZATION.................................................................................................................

4.2 PROCUREMENT DOCUMENT CONTROL ...........................................................................

4.3 CONTROL OF PURCHASED MATERIAL, EQUIPMENT, AND SERVICES .............................

4.4 CONTROL OF MEASURING AND TEST EQUIPMENT ..........................................................

4.5 CORRECTIVE ACTION.......................................................................................................

5 US NUCLEAR INDUSTRY REVIEW OF THE SIL CERTIFICATION PROCESS ...............................................................................................

5.1 TECHNICAL EVALUATION

OF SIL CERTIFICATION REQUIREMENTS AND PROCEDURES ....................................................................................................................

5.2 OBSERVATION OF TRAINING ............................................................................................

Page ii of ii NEI 17-06 DRAFT October 10, 2017 5.3 OBSERVATION OF A MUTUAL RECOGNITION ARRANGEMENT MEETING ......................

5.4 OBSERVATION OF PEER EVALUATIONS 6 US NUCLEAR INDUSTRY OVERSIGHT OF THE SIL PROCESS ............

6.1 ORGANIZATION.................................................................................................................

6.2 VERIFICATION THAT THE SIL CERTIFICATION PROCESS CONTINUES TO BE CONSISTENT WITH NRC ACCEPTED PRACTICES ............................................................

6.3 VERIFICATION THAT IMPLEMENTATION OF THE SIL CERTIFICATION PROCESS CONTINUES TO BE CONSISTENT WITH NRC ACCEPTED PRACTICES .............................

6.4 OPTIONAL ACTIVITIES .....................................................................................................

APPENDIX A - QUALITY ASSURANCE PROGRAM TEMPLATE ..................

END OF GUIDELINE ATTACHMENT A - NRC FINAL SAFETY EVALUATION REPORTATTACHMENT A-1 ATTACHMENT B - NRC RAIS AND NEI RESPONSES .... ATTACHMENT B-1

Page 1 of 4 NEI 17-06 DRAFT October 10, 2017 1 INTRODUCTION 1.2 PURPOSE The purpose of this supplemental guidance is to provide an acceptable approach for procuring and accepting commercial grade digital equipment for nuclear safety applications that have a safety integrity level (SIL) certification by an accredited third party SIL certification body. Making use of internationally accredited SIL certification services benefits licensees and their suppliers through reduced cost, expanded access to expert services, improved standardization on equipment quality evaluations, and improved regulatory confidence.

This approach takes advantage of the internationally recognized SIL certification process when accepting commercial grade digital equipment for use in safety applications for the nuclear industry. Purchasers (licensees and suppliers of basic components) that procure commercial grade equipment for safety applications are able to rely on the third party SIL certification process in lieu of conducting a review of the manufacturers design and manufacturing processes (through a commercial grade survey) to provide the necessary evidence of dependability critical characteristics described in EPRI Technical Report 106439, Guideline on Evaluation and Acceptance of Commercial Grade Digital Equipment for Nuclear Safety Applications. The third party SIL certifiers are companies with accreditation by an accreditation body (AB), such as the American National Standards Institute [ANSI]), that are signatories to the International Accreditation Forum [IAF]. The net result will be a substantial reduction in duplication of effort for accepting commercial grade equipment across the industry, while ensuring that the identified dependability critical characteristics defined in EPRI TR-106439 continue to be met.

1.2 REGULATORY Basis Items and services used in safety related applications at US commercial nuclear power plants are designated as basic components and are required to be provided in accordance with 10 CFR Part 50, Appendix B, Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants.

It is not always possible or practical to procure items and services directly from suppliers that implement quality assurance programs that meet 10 CFR Part 50, Appendix B. Therefore, the NRC established requirements in 10 CFR Part 21 Reporting of Defects and Noncompliance that permit the use of commercial grade items and services in nuclear safety related applications through a commercial grade dedication process. Although the suppliers of commercial grade items and services are not required to comply with 10 CFR Part 50, Appendix B requirements, the commercial grade dedication activities must be performed under a Quality Assurance Program that meets the requirements of 10 CFR Part 50, Appendix B.

The process for accepting items and services for use as basic components from commercial suppliers is known as commercial grade dedication. The NRC has endorsed EPRI TR-106439 as an acceptable method for dedicating commercial grade digital equipment for use in nuclear power plant safety applications and meets the requirements of 10 CFR Part 21.

Page 2 of 4 NEI 17-06 DRAFT October 10, 2017 EPRI TR-106439 contains guidance on all aspects of commercial grade dedication of commercial grade digital equipment. EPRI TR-106439 identifies a unique type of critical characteristics for commercial grade digital equipment called dependability. The following excerpts from EPRI TR-106439 are germane to the scope of third party SIL certification [underling added for emphasis]:

a third type of critical characteristics, referred to in this guideline [EPRI TR-106439] as dependability, becomes significantly more important when dedicating digital equipment including software This is the category in which dedication of digital equipment differs the most from that of other types of components. It addresses attributes that typically cannot be verified through inspection and testing alone and are generally affected by the process used to produce the device The dependability attributes, which include items such as reliability and built-in quality, are generally influenced strongly by the process and personnel used by the manufacturer in the design, development, verification, and validation of the software-based equipment...

The dependability of a digital device also can be heavily influenced by designed-in elements, including robustness of the hardware and software architectures, self-checking features such as watchdog timers, and failure management schemes such as use of redundant processors with automatic fail-over capabilities. Evaluation of these attributes requires that the dedicator focus on more than just the development and QA processes. It may require gaining an understanding of the specific software and hardware features embodied in the design, and ensuring that they are correct and appropriate in light of the requirements of the intended application. Accordingly, a survey team may need to include specialists who understand the device design, the software, and the system in which it will be applied, in addition to quality assurance and programmatic issues.

The dependability category captures those critical characteristics that must be evaluated to form an appropriate judgment regarding built-in quality of a software-based device. It also includes characteristics related to problem reporting and configuration control. Verification of these characteristics typically involves a survey of the vendor's processes (Method 2 [of NP-5652]), and review of the vendor performance record and product operating history (Method 4) Source inspections would not be used in verifying built-in quality of pre-existing software, because the software development has already occurred.

A commercial product may be judged to have sufficient quality, even if its development process lacked some of the rigorous steps of modern software engineering and/or some formal documentation.

Reaching a reasonable level of assurance of quality of a commercial grade digital item typically involves making a judgment based on a combination of the product development process and its documentation, operating history, testing, review of design features such as failure management, and other factors noted in the critical characteristics matrix, Table 4-1 [in EPRI TR-106439].

Page 3 of 4 NEI 17-06 DRAFT October 10, 2017 This supplemental guidance document describes a method for using the accredited SIL certification process as evidence of verification of the EPRI TR-106439 dependability critical characteristics within the commercial grade dedication process. This supplemental guidance is applicable to dedicating entities subject to the quality assurance requirements of 10 CFR Part 50, Appendix B (e.g., 10 CFR Part 50, 10 CFR Part 52, 10 CFR Part 71 and 10 CFR Part 72 licensees and affected suppliers).

1.3 ACCEPTANCE OF SAFETY INTEGRITY LEVEL AS-VERIFICATION OF DEPENDABILITY CRITICAL CHARACTERISTICS Third party SIL certification, provided by international bodies accredited by such accreditation organizations as ANSI, is a commercial grade service. The supplemental guidance within this document describes an approach to rely on third party SIL certifications, by companies accredited by ANSI and other signatories to IAF, in lieu of a commercial grade survey to verify the EPRI TR-106439 dependability critical characteristics. The approach used to develop this guidance was to compare the third party SIL certification process with the EPRI TR-106439 dependability critical characteristics to evaluate their equivalence and determine whether any additional actions are necessary to address differences.

Section 2 describes the third party SIL certification process, and Section 5 provides the US nuclear industrys evaluation of the third party SIL certification process including a comparison with NRC accepted practices (i.e., EPRI TR-106439). Section 6 describes the approach for the US nuclear industry to provide continued oversight of the third party SIL certification process in order to confirm that the third party SIL certification process can continue to be used in lieu of commercial grade surveys for the purpose of verifying the EPRI TR-106439 dependability critical characteristics.

Based upon the conclusion that the third party SIL certification process is essentially equivalent to a commercial grade survey verifying the EPRI TR-106439 dependability critical characteristics, it has been determined that the third party SIL certifications, by companies accredited by IAF signatories, can be used. This conclusion requires procurement documents to include a few requirements. Section 3 describes how Purchasers of commercial grade digital equipment should use the third party SIL certifications as part of their commercial grade dedication activities. It is noted that this supplemental guidance should be used in conjunction with the overall guidance on commercial grade dedication (i.e.,

EPRI TR-106439 and EPRI 3002002982). In addition, Section 4 describes information that Purchasers should ensure is included in their Quality Assurance Programs.

The following are the actions and steps that are necessary in order for a Purchaser to accept third party SIL certification of commercial grade digital equipment, by companies accredited by IAF signatory organizations, in lieu of performing a commercial grade survey to evaluate the EPRI TR-106439 dependability critical characteristics. Additional detail on performing these steps is discussed in subsequent sections of this guidance.

1) The method to use a third party SIL certification by a company accredited by a signatory to IAF in lieu of a commercial grade survey (alternative method) for verification of EPRI TR-106439 dependability critical characteristics is documented in the Purchasers QA program.

2) The method the Purchaser needs to follow, and document in their QA Program, consists of:

Page 4 of 4 NEI 17-06 DRAFT October 10, 2017

1. A documented review of the third party SIL certifiers accreditation is performed and includes a verification of the following:

a. The third party SIL certifier holds accreditation by an accrediting body that is a signatory to IAF.

b. The published scope of accreditation for the third party SIL certifier covers IEC 61508 SIL certification.

2. The purchase documents require that:

a. A copy of the SIL certificate for the commercial grade digital equipment being purchased be provided

b. The IEC 61508 Systematic Capability SIL be identified in the certificate

c. SIL certification precautions and limitations be included in the SIL certificate or in the safety manual

d. A certificate of conformance that the third party SIL certifier is accredited by a signatory to IAF.

e. The customer must be notified of any condition that adversely impacts the third party SIL certifiers ability to maintain its SIL certification accreditation or the scope of accreditation.

3. It is validated, at receipt inspection, that the commercial grade digital equipment supplier documentation certifies that:

a. The commercial grade digital equipment matches that defined in the SIL certificate provided

b. The purchase orders requirements are met 1.4 ACRONYMS AB - Accreditation Body CFR - Code of Federal Regulations EPRI - Electric Power Research Institute IAF - International Accreditation Forum IEC - International Electrotechnical Commission NEI - Nuclear Energy Institute NRC - Nuclear Regulatory Commission NUPIC - Nuclear Procurement Issues Committee QA - Quality Assurance QC - Quality Control SIL - Safety Integrity Level