Comparison of International Atomic Energy Agency

Safety Requirements on Management Systems, GS-R-3 to ASME NQA-1-2008/NQA-1a-2009

Presented at the IAEA “National Workshop on Improving the Management Systems for the National

Nuclear Industry”Harbin, Heilonjiang, China

April 26-30, 2010

Gustave (Bud) Danielson, U.S. Department of Energy

IAEA Project Objectives

• A new IAEA Safety Report to guide regulators and users of either GS-R-3 and NQA-1

• Support implementation of the new Management System Requirements, GS-R-3

• Provide a user of one of the standards with similarities and differences of the requirements in the other standard

• Achieve integration of and compliance with both standards

NQA Committee Project Objectives

The NEW NQA-1, Part IV Application Guide will be consistent with IAEA Safety Report (both are comparison guidance documents)

Why Two Guides?

Overview of GS-R-3

Requirements to ensure protection of people and the environment

Regulatory language to enable adoption into national laws and regulations

Required for IAEA funded projects Comprehensive management system for;

- safety, health, environment, security, quality and economic elements

Replaces IAEA 50-C-Q, Quality Assurance, 1996, which is modeled after DOE and NQA-1

Applies to all nuclear facilities and activities Imposed by regulation or contract

-

Imposed by regulation or contract

Overview of NQA-1-2008/NQA-1a-2009

Define requirements to establish, implement and assess a QA Program to achieve nuclear safety

Applies to activities that could affect the quality of nuclear material applications, structures, systems and components

Reflects industry experience and current understanding of QA requirements

Imposed by regulation or contract

International Regulatory Adoption of IAEA GS-R-3

UN Member State adoptions proceeding: Argentina, Canada, Chile, Iran, The Philippines,

Spain, Ukraine, United Arab Emirates, United Kingdom; and Others

Western Europe Nuclear Regulators Association (WENRA) adapted portions of GS-R-3 requirements: Specifically, the reference Level C, Management

System (see www.wenra.org for details)

International Regulatory Adoption of NQA-1

• Nuclear Facilities across the globe (UAE, Japan, Korea, and Others)

• U.S. Department of Energy – 10 CFR 830

• U.S. Nuclear Regulatory Commission – 10 CFR 50 Adoption in progress via RG-1215

• U.S. Environmental Protection Agency Evaluating benefits of NQA-1-2008/9 edition

• ASME Code Section III Adoption approved, awaiting publication

IAEA Project Team

• Project Leader: J. Majola (IAEA, Scientific Secretary) • Sponsor: Pal Vincze (IAEA, Section Head, NQA Contributing

Member)• Consultancy Group:

Bud Danielson, Chair (DOE and NQA, US) Shamsher Dua (AECL, Canada) Marco Beher (AREVA, NP, Germany) Michael Hille (AREVA, NP, Germany) Franc Pribac (Nuklearna Elektarna Krsko, Slovenia) Ramon Sabate (Westinghouse, Spain) Graham Watson (Consultant to IAEA, UK) Duli Agarwal (DOE and NQA, US) Chris Marden (Energy Solutions and NQA, US) Ken Sowder (ITER and NQA, NQA Project Manager, US)

IAEA Project Status

• Time Line: Project initiated @ IAEA (June 2008) Consultancy Group recommended for IAEA approval

(July 2009) IAEA management and safety committee reviews (In

Progress)

• Deliverables and Status: IAEA “Safety Report”, in support of GS-R-3, to be

published in 2010

NQA-1 Project Team

• Ken Sowder, Project Team Lead, NQA Standards Committee & Subcommittee (SC) on Applications

• Duli Agarwal, NQA SC on Application• Nissen Burstein, NQA SC Interface and Administration• Bud Danielson, Vice Chair of NQA Committee, & Chair

of Executive Committee• Edward Jordon, NQA SC Software Quality Assurance

• Chris Marden, NQA SC on Assessment and Verification• Ron Schrotke, Chair of NQA Committee

NQA-1 Project Status

• Time Line: Project approved by NQA (October 2008) Transfer of IAEA drafts (July 2009) Draft guide for NQA review (August 2009) NQA informal review (September 2009) Ballot & comment resolution (October 2009) ASME Board ballot approved (March 2010)

• Deliverables and Status: A NEW Part IV Application Guide (2010 Addenda)

Areas Where The Standards are Similar?

• While differences exist, they are compatible, complimentary and easily integrated in the following ways:

IMS concept & requirements in GS-R-3 are compatible with NQA-1 QA Program requirements

Management & improvement in GS-R-3 compliment NQA-1 Item & Service

Process management in GS-R-3 can be integrated into NQA-1 Design Control & Procurement

Areas Where NQA-1 Differs From GS-R-3

Areas Where GS-R-3 Differs From NQA-1

An Example Where GS-R-3 Addresses NQA-1

NQA-1a-2009 GS-R-3 and Recommendations

1 Organization

1-100 BASIC

Key words:

Responsibilities, organizational structure, functional responsibilities, levels of authority, and lines of communications.

GS-R-3 Requirements 2.8, 3.12 and 3.14.

1-200 STRUCTURE AND RESPONSIBILITY

201 General

Key words:

(a) management expectations, (b) quality achieved and maintained by, (c) quality achievement is verified by, (d) sufficient authority, direct access, organizational freedom, access to work, independence, verification functions.

202 Delegation of Work

GS-R-3 Requirements 2.1, 2.2, 2.4, 3.12, 3.13, 3.14, 5.7, 5.10, and 6.5.

Recommendations.

GS-R-3 users should address organizational freedom, independence of verification activities, and the following verification functions:

(1) identifying quality problems

(2) initiating, recommending, or providing solutions to quality problems through designated channels

(3) verifying implementation of solutions

(4) assuring that further processing, delivery, installation, or use is controlled until proper disposition of a nonconformance, deficiency, or unsatisfactory condition has occurred.

Example Where GS-R-3 Does Not Address NQA-1

NQA-1a-2009 GS-R-3 and Recommendations

2-300 QUALIFICATION REQUIREMENTS

Key words:Designate activities that require qualification,written procedures.

301 Nondestructive Examination (NDE)302 Inspection and Test303 Lead Auditor303.1 Communication Skills.303.2 Training.303.3 Audit Participation.303.4 Examination.303.5 Maintenance of Proficiency.303.6 Requalification.304 Auditors305 Technical Specialists

No corresponding requirement.

Recommendations

GS-R-3 users should ensure the responsibleorganization designates those activities thatrequire qualification. The minimumrequirements for personnel to verify qualityand auditing are specified in paragraphs 301through 304 of this Requirement. Consultrelevant parts of NQA-1a-2009 for guidanceon implementation of this requirement.

GS-R-3 NQA-1a-2009 and Recommendations

2.1-2.10 Management System

General Requirement

2.1 A management system shall be established, implemented, assessed and continually improved. It shall be aligned with the goals of the organization and shall contribute to their achievement. The main aim of the management system shall be to achieve and enhance safety by: Bringing together in a coherent manner all the requirements for managing the organization; - Describing the planned and systematic actions necessary to provide adequate confidence that all these requirements are satisfied; Ensuring that health, environmental, security, quality and economic requirements are not considered separatelyfrom safety requirements, to help preclude their possible negative impact on safety.

NQA-1a-2009 Requirements 1 and 2.

Recommendations.

NQA-1a-2009 users should ensure that health, safety, environmental, security and economic requirements will be implemented as part of continual improvement of the management system.

Example where NQA-1Addresses GS-R-3

Examples where NQA-1Does Not Address GS-R-3

GS-R-3 NQA-1a-2009 and Recommendations

2.1-2.10 Management System

General Requirement

2.3 The management system shall identify and integrate with therequirements contained within this publication:- The statutory and regulatory requirements of the Member State;- Any requirements formally agreed with interested parties (also known as ‘stakeholders’);- All other relevant IAEA Safety Requirementspublications, such as those on emergency preparednessand response and safety assessment;- Requirements from other relevant codes and standards adopted for use by the organization.

No corresponding requirement.

Recommendations

NQA-1a-2009 users should addressthis GS-R-3 requirement. Consult GSG-3.1 2.1-2.6 and GS-G-3.1 AppendixI for guidance on implementation ofthis requirement.

Benefits for the User Community

NQA-1 and GS-R-3 will be used globally.

The value of the Comparison Guidance Documents: Contain common comparisons Provides a common acceptance basis for regulators Provides a common acceptance basis for contracts Enhances understanding Facilitates international trade Increases market acceptance Timely – in support of new power generation Increased awareness of integrated safety/quality culture

Summary

• IAEA Safety Report has been completed and will be available in 2010.

• ASME NQA-1, Part IV is completed and will be published in 2010 addenda as subpart IV

Additional Information:• NQA-1 and GS-R-3 currently have an approved

comparison document to ISO 9000. The addition of this Comparison Guidance Document serves to broaden the acceptance of different standards

Thank you for your time and attention!

Comments and Questions?