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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
2
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
3
Meaning of R&D 1
Establishment of a pre-emptive countermeasure against the revision of the NSSC(Nuclear Safety & Security Commission) Notice.
4
1. Meaning of R&D
A p
re-e
mp
tive
co
un
term
ea
su
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Establishment of cooperation system
between KHNP's QA Department and
quality related Departments(Offices).
5
co
op
era
tion
syste
m
1. Meaning of R&D
A p
re-e
mp
tive
co
un
term
ea
su
re
Benchmarking of US Nuclear Quality Assurance Requirements for comparative analysis between KOREA and the United States.
6
co
op
era
tion
syste
m
Be
nch
ma
rkin
g
1. Meaning of R&D
A p
re-e
mp
tive
co
un
term
ea
su
re
Gap analysis of KEPIC-QAP(2005 vs 2011)
for QAM adaption.
7
co
op
era
tion
syste
m
Be
nch
ma
rkin
g
Ga
p
an
aly
sis
1. Meaning of R&D
A p
re-e
mp
tive
co
un
term
ea
su
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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
8
co
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tion
syste
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Ga
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an
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Tru
st
1. Meaning of R&D
A p
re-e
mp
tive
co
un
term
ea
su
re
Perfect QA system
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op
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tion
syste
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rkin
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Ga
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1. Meaning of R&D
A p
re-e
mp
tive
co
un
term
ea
su
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10
Background & Research Overview
2
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
12
Status of Implementation 3
13
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.
3. Status of Implementation
15
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)
3. Status of Implementation
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
3. Status of Implementation
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
3. Status of Implementation
18
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
Configuration management
Add
4. TERMS AND DEFINITIONS
(None)
3.4.1 KEPIC-QAP Gap Analysis 3. Status of Implementation
19
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)
Configuration management
Upper
Configuration management
Add
3. Status of Implementation
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.
3. Status of Implementation
e-Book 시스템 개요
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)
e-Book 시스템 개요
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.
3. Status of Implementation
e-Book 시스템 개요
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.
3. Status of Implementation
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
3.4.1 KEPIC-QAP Gap Analysis 3. Status of Implementation
Expert TFT review results
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.
Site QA Team Opinion
Structures are required to be excluded because they can not be
designed and constructed with non-nuclear power requirements.
3. Status of Implementation
e-Book 시스템 개요 It is necessary to thoroughly examine the connections between
Commercial grade items and services.
e-Book 시스템 개요
Regulator(KINS) Opinion
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
3. Status of Implementation
26
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
3.4.1 KEPIC-QAP Gap Analysis 3. Status of Implementation
Expert TFT review results
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
Site QA Team Opinion
Reflection from the application date of the latest quality assurance
requirement is necessary.
(Ex : Previously installed S/W)
3. Status of Implementation
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
3. Status of Implementation
e-Book 시스템 개요
Regulator(KINS) 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
3. Status of Implementation
30
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
3.4.1 KEPIC-QAP Gap Analysis 3. Status of Implementation
Expert TFT review results
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 ".
Site QA Team Opinion
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.
e-Book 시스템 개요
Regulator(KINS) Opinion
This clause is a declarative meaning, and it is performed by KHNP
QA system now.
☞ Modify difficulty from ‘Middle' to Low'
3. Status of Implementation
32
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
3.4.1 KEPIC-QAP Gap Analysis 3. Status of Implementation
Expert TFT review results
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.
Site QA Team Opinion
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.
3. Status of Implementation
e-Book 시스템 개요
Regulator(KINS) Opinion
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.
3. Status of Implementation
35
Obstacles & Lessons to overcome
4
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
36
37
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
38
• 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
4. Obstacles & Lessons
Issues
Over- come
Results
Good&
Bad
39
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
4. Obstacles & Lessons
Issues
Over- come
Results
Good&
Bad
40
• 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.
4. Obstacles & Lessons
Issues
Over- come
Results
Good&
Bad
Achievements & Future tasks 5
41
42
5. Achievements &
Future tasks
Nuclear Safety Law Survey and Analysis
Benchmarking of US QA Requirements application status
1
2
Gap Analysis
Participation of regulator(KINS) to build trust 4
3
43
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.
5
5. Achievements &
Future tasks
44
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
5
5. Achievements &
Future tasks
45
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
5
5. Achievements &
Future tasks
46
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