A Feasibility Study applying the latest KEPIC Nuclear QA requirements applying the latest KEPIC...

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A Feasibility Study applying the latest KEPIC Nuclear QA requirements (KEPIC-QAP, 2011 Addenda)

1655, Bulguk-ro, Yangbuk-myeon, Gyeongju-Si, Gyeongsangbul-do, Korea 38120 Tel.054-704-2114

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TABLE OF CONTENTS

1 Meaning of R&D

2 Background and Research Overview

3 Status of Implementation

4 Obstacles & Lessons to overcome

5 Achievements & Future tasks

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Meaning of R&D 1

Establishment of a pre-emptive countermeasure against the revision of the NSSC(Nuclear Safety & Security Commission) Notice.

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1. Meaning of R&D

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Establishment of cooperation system

between KHNP's QA Department and

quality related Departments(Offices).

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Benchmarking of US Nuclear Quality Assurance Requirements for comparative analysis between KOREA and the United States.

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1. Meaning of R&D

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Gap analysis of KEPIC-QAP(2005 vs 2011)

for QAM adaption.

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Building trust between KHNP and KINS[Korea Institute of Nuclear Safety], which will have a positive effect on KHNP’s future quality assurance activities

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Perfect QA system

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Background & Research Overview

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BACKGROUND

It is necessary to review the impact of ‘Licensing &

Permits’ on the revision of the latest quality assurance

requirement approval notice[July 25, 2016]

QA requirement endorse KEPIC-QAP 2011 Add.

e-Book 시스템 개요

SUMMARY

Consigned research institute : KAE[Korea Electric Association]

Research Period : ’16.8.16 ~ ’17.7.15(11 months)

Main Contents

The application status of the latest quality assurance

requirements in the US nuclear industry

Gap analysis of major changes(KEPIC-QAP, 2005 vs 2011)

Analyzing the impacts of licensing documents against

regulatory requirements & Set up the implementation strategy

2. Background &

Research Overview

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Status of Implementation 3

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The latest quality assurance requirements (ASME NQA-1 2008 Ed. & 2009 Add.) apply from the beginning of the new construction period and require a considerable preparation period (at least 3 years).

US Nuclear Power Plants applied previous QA requiremets(ASME NQA-1 1994 Ed. & 1995 Add.).

Supplier is optimizing several types of previous / latest quality assurance plans to meet the requirements of the contractor.

Regulator(NRC) basically regulates

‘Licensing & Permits’ only.

3. Status of Implementation

2016.7.25, Nuclear Safety & Security Commission

Notice No. 2016-13 [Detailed Requirements for

Quality Assurance of Nuclear Reactor Facilities]

- KEPIC-QAP accepts from 2000 Ed. to 2011 Add.

OR

- ASME NQA-1 accepts from 1994 Ed. to 2009 Add.

KEPIC-QAP issued edition every five years.

- KEPIC-QAP is divided into 2010 edition (ASME NQA-1

1994 Ed. & 1995 Add.) and 2011 Addenda(ASME NQA-1

2008 Ed. & 2009 Add.)

- KEPIC-QAP 2000 ~ 2005 Edition also corresponds to the 2010

Ed. of ASME NQA-1 1994 Ed. & 1995 Add.


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KEPIC-QAP 2000~2005 KEPIC-QAP 2011 Add. (Full Revision)

Reference

Standard ASME NQA-1

(1994 Ed. & 1995 Add.) ASME NQA-1

(2008 Ed. & 2009 Add.)

Application

Notice NSSC Notice 2014-23 NSSC Notice 2016-13

QAP-1

1. GENERAL 2. BASIC REQUIREMENTS 3. SUPPLEMENTARY REQUIREMENTS 4. NONMANDATORY GUIDANCE

1. INTRODUCTION 2. REQUIREMENTS

QAP-2

1. GENERAL 2. FACILITY APPLICATION 3. NONMANDATORY GUIDANCE

1. INTRODUCTION 2. FACILITY

APPLICATION

QAP-3 - NONMANDATORY

APPENDICES

QAP-4 - NONMANDATORY APPENDICES(New)


Direction of Review

Analyzing the effect of ‘Licensing & Permits’ and

applicability of each requirement of KEPIC-QAP 1 & 2

Gap analysis of "KEPIC-QAP 2005 Ed. vs 2011 Add."

(Total 710 items)

- Selection of "new / revised / deleted" items for review

- Items that have the same or similar requirements are not

included in this review

Review from the technical point of view

(data based on judgment, meaning of requirements, implications, etc.)

& Difficulty (upper / middle / lower) is classified

according to the effect of ‘Licensing & Permits’

upper middle lower

Can be applied Step-by-Step before and after ‘Licensing & Permits’

Can be applied when ‘Licensing & Permits’

are granted

Immediately applicable


Results of Review

‘Licensing & Permits’ impact analysis results

- Configuration management,

Commercial Grade items and services, and

Software requirements are difficulty of

Upper & Middle effectiveness

‘Licensing & Permits’

Effectiveness Requirements

Upper 11 items including Configuration Management of Operating Facilities

Middle 7 items including The qualification of Lead Auditors

Lower 692 items including The same or similar requirements


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Configuration management

QAP-1 2000~2005 QAP-1 2011 Add.

400 TERMS AND DEFINITIONS

Configuration: the physical, functional, and

operational characteristics of the structures, systems,

components, or parts of the existing facility.

Configuration management: the process that

controls the activities, and interfaces, among design,

construction, procurement, training, licensing,

operations, and maintenance to ensure that the

configuration of the facility is established, approved,

and maintained.

Configuration item(software): a collection of

hardware or software elements treated as a unit for

the purpose of configuration control.

Upper


Add

4. TERMS AND DEFINITIONS

(None)

3.4.1 KEPIC-QAP Gap Analysis 3. Status of Implementation

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3.4.1 KEPIC-QAP Gap Analysis

QAP-1 2000~2005 QAP-1 2011 Add.

601 Configuration Management of

Operating Facilities

Procedures implementing configuration

management requirements shall be established and

documented at the earliest practical time prior to

facility operation. These procedures shall include the

responsibilities and authority of the organizations

whose functions affect the configuration of the facility

including activities such as operations, design,

maintenance, construction, licensing, and

procurement.

601.1 …….

3S-1

(None)


Upper


Add


Expert TFT review results

In-depth analysis is required in conjunction with QAP-2 Subpart 2.7

software quality assurance requirements and the configuration

management requirements of design management.

It is reflected in the current operation QAM and is being partially

performed. The application to the construction nuclear power plant

should be reviewed.

Gradual application is required for systematic application from

construction to operation.

Site QA Team Opinion

Since it is necessary to apply to a wide range of fields(Procedures

and Implementation) from construction to operation source,

gradual application is desirable.



Plant Engineering & Management Department Opinion

In the case of operating nuclear power plants, many parts are

being applied through the configuration management procedures

including the standard management procedures for configuration

management, but further review and supplementation are needed.

(In consultation with the link between construction and operation)


Construction Engineering Department Opinion

It is desirable to utilize the latest IT technology (data-base design,

etc.) from new nuclear power plants (Chunji 1 & 2) because it

affects all business processes during the construction phase

(design, purchase, production, construction and test).

It is necessary to discuss between the participanting Suppliers of

the nuclear power plant when defining the configuration

management.



Regulator(KINS) Opinion

This requirement is applied to the operation nuclear plant and is

not a requirement for the construction of nuclear power plants.

However, it is necessary to establish comprehensive management

plan for configuration management information (construction →

operation).

☞ This requirement is expected to be reviewed/

implemented when establishing

the configuration management for construction

of Chunji unit 1 & 2.


Commercial grade service

QAP-1 2000~2005 QAP-1 2011 Add.

INTRODUCTION

4. TERMS AND DEFINITIONS

(None)

INTRODUCTION

400 TERMS AND DEFINITIONS

Commercial grade service: a service that was not provided in accordance with the requirements of this Standard.

3S-1, 3. DESIGN PROCESS

(2) Identify assembles and/or components

that are part of the item being designed.

When such an assembly or component

part is a commercial grade item,

characteristics to be verified and

acceptance criteria of characteristics for

acceptance shall be documented.

요건 3, 300 DESIGN PROCESS (C) (3) identify assemblies and/or components that are part of the item being designed. When such an assembly or component part is a commercial grade item, the critical characteristics of the item to be verified for acceptance and the acceptance criteria for those characteristics shall meet the requirements of QAP-2 Subpart 2.14, Quality assurance Requirements for Commercial Grade Items and Services.

Upper

Commercial grade service

Add



Commercial grade service needs to analyze the impact of

application as a new requirement.

The acceptance of items and services must be reviewed in

conjunction with QAP-1 Requirement 7 and QAP-2 subpart 2.14.

Particularly, it is necessary to review special situations in such

cases where the item (CGI) and service (CGS) are mixed.

It is necessary to apply step by step because it requires sufficient

discussion and consultation in order to review the application

scope and essential characteristics of Commercial grade services

and to establish detailed procedures.


Structures are required to be excluded because they can not be

designed and constructed with non-nuclear power requirements.


e-Book 시스템 개요 It is necessary to thoroughly examine the connections between

Commercial grade items and services.



In the application of the Commercial grade service to the

domestic nuclear power industry, KHNP needs to check & refer

to the results of the EPRI Report cited in the revision of

10 CFR part 21 in the US and establish QAM, procedures.

☞ Further difficulties are expected due to the definition, scope, and characteristics of Commercial grade services. Therefore, continuous review is required.

Construction Engineering Department & Plant Engineering & Management Department Opinion


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SOFTWARE DESIGN CONTROL

QAP-1 2000~2005 QAP-1 2011 Add.

(None)

Requirement

Add

Requirement 3,

800 SOFTWARE DESIGN CONTROL

The requirements of section 800 apply

to computer software design control and

shall be used instead of section 200,

Design Input; section 300, Design

Process; section 500, Design Verification;

and section 600, Change Control.

801 Software Design Process

802 Software Configuration

Management

Upper



This requirement applies to the contractor who designed the

safety system computer software.

It is necessary to review the application of each item and situation

according to various types of contracts and characteristics of the

contractor.

Gradual application from important items such as controllers to

other items is needed


Reflection from the application date of the latest quality assurance

requirement is necessary.

(Ex : Previously installed S/W)


e-Book 시스템 개요 Software configuration management procedures for Operating

nuclear power plants are being applied, but additional review and

supplementation is required according to the revised notification

standards.

e-Book 시스템 개요 It is necessary to add the information transfer requirement to

develop the construction S/W configuration management

procedure so that the S/W design input and change management

history information can be transferred from the contractor in terms

of S/W purchaser and operator.

Construction Engineering Department Opinion

Plant Engineering & Management Department Opinion




Configuration management for firmware requires continuous

consultation between KINS and KHNP.

☞ This requirement is expected to be reviewed/

implemented when establishing a configuration

management for construction of

Chunji unit 1 & 2


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Quality Assurance Program

QAP-1 2000~2005 QAP-1 2011 Add.

2. Quality Assurance Program

The program shall identify the activities

and items to which it applies. The

estabilishment of the program shall

include consideration of the technical

aspects of the activities affecting quality.

Reinforce

Requirement

100 BASIC

The program shall provide control over

activities affecting quality to an extent

consistent with their importance. The

program shall include monitoring

activities against acceptance criteria in a

manner sufficient to provide assurance

that the activities affecting quality are

performed satisfactorily. Middle

☞

Lower



The existing surveillance is carried out by monitoring and

observation.

However, in carrying out specific quality activities, it is necessary to

further review of exceptional items of "monitoring activities against

acceptance criteria in that manner ".


It is considered appropriate to exclude "monitoring activities

against acceptance criteria in that manner " because it is difficult to

make a judgment on the result.



This clause is a declarative meaning, and it is performed by KHNP

QA system now.

☞ Modify difficulty from ‘Middle' to Low'


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Quality Assurance Program(Continue)

QAP-1 2000~2005 QAP-1 2011 Add.

3.3 Audit Partitipation

The prospective Lead Auditor shall have

participated in a minimum of five Quality

assurance audits as auditor within a

period of time not to exceed 3 years prior

to the date of qualification, one audit of

which shall be a nuclear quality assurance

audit within the year prior to his

qualification.

Alternative

Requirement

Add

303.3 Audit Participation. Participation in independent assessments including team assessment activities such as operations readiness reviews and regulatory inspections/surveys may be used to satisfy up to four of the five required quality assurance audits, provided that the activities can demonstrate the following: (a) independence from the functional areas being assessed (b) planning that establishes the scope of the activities and associated evaluation criteria (c) performance by technically qualified and experienced personnel (d) results that are documented and reported to management (e) appropriate corrective action initiated and tracked to resolution

Middle



The application of substitute requirements is inadequate because

survey careers can not be identified with audit careers.

It is necessary for a consensus on the eligiblity criteria of substitution

requirements because significant confusion is anticipated.


Since the suppliers can apply the substitution requirements by

misapplication or intentionally mitigate them, it is necessary to

clarify the requirements and establish the consensus of suppliers,

and it is reasonable to exclude them because there is a possibility

of misuse in the domestic industry.

The Contractor Quality Verification team and the Manufacture

Quality Assurance Team are conducting training and seminars on

partner companies throughout the year and will continue to

mentor with sufficient time.




Additional review of Reg. Guide 1.28 Rev.5 (Draft) which is

regarding lead auditor qualification requirement is required.

NRC Reg. Guide Draft ML16180A264

Prospective lead auditors, with comparable industry experience,

may satisfy the lead auditor qualification requirement of

participating in a minimum of five QA audits within a period of 3

years prior to the date of qualification by alternatively

demonstrating the ability to properly implement the audit process,

effectively organize and report results, and participate in at least

one nuclear audit within the year preceding the date of qualification.

☞ KHNP will not apply(will be maintained), but there is a possibility that the supplier may misapply. Therefore, sufficient mentor is required.


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Obstacles & Lessons to overcome

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4. OBSTACLES

The increase in the impact of the new nuclear power plant QAM according to the revision of the NSSC Notice (No. 2016-13)

Inadequate revision history management for new issuance of KEPIC-QAP

Nuclear power quality assurance requirements in the US need to be confirmed

Difference in viewpoints of KHNP's quality assurance department and KINS

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4. Obstacles & Lessons

Issues

• Current: NSC Notice No. 2015-13 (KEPIC-QAP, 2000 Edition)

• Revision: NSC Notice No. 2016-13 (KEPIC-QAP, 2011 Addenda)

• - Regulator: ANSI / ANS 3.2 comparative analysis is required

as well as KEPIC-QAP Gap Analysis

Over- come

Results • Gap Analysis, KEPIC-QAP 2000 ~ 2005 Ed. vs 2011 Add.

- Completion of impact of licensing through Gap Analysis

Good&

Bad

• [Good] We reduced burden of analyzing / applying new

requirements when implementing new QAM

• [Bad] No ANSI / ANS 3.2 analysis applied to

Operation QAM

• [To Improve] It is need to comprehensive analysis of

KEPIC-QAP and ANSI / ANS 3.2

A feasibility analysis to ensure the applicability of the latest KEPIC-QAP and establish pre-emptive countermeasures

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• Through a field survey in the US, we confirmed that the preparation period is necessary when applying the ASME NQA-1 '08 Ed with the identification of the application status.

• Considerable preparation period[more than 3 years]

• [Good] Explaination of benchmarking results(Status of US

Nuclear QA application) to the Sites & Regulator

• [To Improve] Subsequent Operation / Construction QAM

requires a large number of units to be

established, it is necessary to establish the

sub-procedures in line with the 'upper and

middle' items

• Concerns over the timing for securing applicability between KINS and US NRC

Benchmarking the application status and major issues of the US nuclear industry's latest quality assurance requirements


Issues

Over- come

Results

Good&

Bad

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Analyzing the effect of ‘Licensing & Permits’ and applicability of each requirement of KEPIC-QAP 1 & 2

- Items that have the same or similar requirements

are not included from the review

• Completion of Gap analysis, KEPIC-QAP 2005 vs 2011

- Difficulty (upper / middle / lower) is classified according to the effect of

licensing & Permits

• [Good] Based on the Gap analysis, we reviewed the

evidential information, requirements and

implications

• [To Improve] Continuous KEPIC-QAP revision

history DB establishment is required

• With the revision of KEPIC-QAP, the analysis of the differences between the new and old versions (new, revised, and deleted) when applying QAM on KHNP's operation and construction is difficult in reality


Issues

Over- come

Results

Good&

Bad

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• Inadequate experience in applying the latest nuclear quality assurance requirements

• Lack of pre-emptive response to regulation

• [Good] Problem solved through joint efforts (explanation,

question and answer, etc.)

• [To Improve] It is necessary to promote QA joint workshops,

‘KHNP and KINS’

We have secured a channel of communication through the briefing session of regulatory agencies through a rearch project.

• Confirmation of the basic position of the regulator(KINS)

(Applying the latest version of the new nuclear power plant)

• Despite difficulties in applying the QAM to the latest quality assurance requirements, the regulator(KINS) is making a positive change in KHNP's commitment to making a lot of efforts such as conducting research projects.


Issues

Over- come

Results

Good&

Bad

Achievements & Future tasks 5

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5. Achievements &

Future tasks

Nuclear Safety Law Survey and Analysis

Benchmarking of US QA Requirements application status

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Gap Analysis

Participation of regulator(KINS) to build trust 4

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Chunji unit 1 & 2 construction QAM

• The results of KEPIC-QAP Gap analysis(KEPIC-QAP, 2005 Ed. Vs 2011 Add.) have been applied to ‘Chunji unit 1 & 2 construction QAM. (Revision 0, 2017.5.30)’

- Requirements : configuration management, S/W configuration management, commercial grade item/service • Configuration management - The configuration shall be established and approved at the beginning of construction and maintained for the life of the facility. - The configuration shall include, as applicable, characteristics derived from regulatory requirements, calculations and analysis, design inputs, installation and test requirements, supplier manuals and instructions, operating and maintenance requirements, and other applicable sources. - Interface controls shall include the integration of activities of organizations that can affect the approved configuration. - Methods and procedures shall be established to ensure that proposed changes to the configuration are evaluated for their conformance to the design bases. - The implementation sequence for approved configuration changes shall be reviewed to determine that the configuration conforms to the design bases.

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5. Achievements &

Future tasks

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Chunji unit 1 & 2 construction QAM(Continue)

• Configuration management(Continue) - The configuration of the plants shall be documented in drawings, specifications, procedures, and other documents and changes to design criteria shall be approved by the original designer before implementation. • Software Configuration Management - The software design procedure must be approved and documented by the responsible design organization. - The status of the configuration items resulting from software design shall be maintained currently. • Commercial Grade Items and Services - KHNP may replace safety related items or services with commercial grade items or services in the following cases (a) a commercial grade item is specified in a design document that performs the given function and is determined to meet the design requirements (b) can not obtain a supplier that meets the quality requirements when purchasing materials, components, spare parts or services

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5. Achievements &

Future tasks

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Chunji unit 1 & 2 construction QAM(Continue)

• Commercial Grade Items and Services(Continue) - Commercial grade items or services that are replaced by safety related items or services should be identified in the procurement documents - If commercial grade items or services are to be applied, the procurement organizations shall verify that the contractor’s verification plan and program to ensure that the contractor has verified by inspection, testing or analysing and supplementing by one or more of the following dedication methods, (a) commercial grade survey of the supplier’s items or services ※ source verification of the items or services (b) an acceptable historical performance analysis

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5. Achievements &

Future tasks

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Efficient use of research results

We will supplement ‘Operation / Construction QAM’ with reference to the required results.

Enterprise-wide efforts for quality innovation

It is necessary to collaborate with the related department (office) for the issuance of new sub-procedures and revisions.

Enhance the capabilities of the personnel for pre-emptive and preventative quality control

By strengthening basic and professional education (KEPIC-QAP, ASME, ANSI / ANS, etc.), we will enhance the capabilities of quality related to personnel.

Perfect QA system

5. Achievements &

Future tasks

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