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Quality Management – Enabling Localization of Nuclear New Build 19-March-2013 Presented to: Nuclear Africa 2013 Mark Mitchell EON Consulting [email protected]

Quality Management – Enabling Localization of Nuclear New Build

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Quality Management – Enabling Localization of Nuclear New Build

19-March-2013

Presented to: Nuclear Africa 2013

Mark MitchellEON [email protected]

19-March-2013 / 2 © 2013– EON Consulting (Pty) Ltd19-March-2013 / 2 © 2013– EON Consulting (Pty) Ltd

Quality Management – Enabling Localization of Nuclear New Build

• What is the role of Quality Management in enabling the Nuclear New Build?

• How is Nuclear Quality Management different to what we know?

• How do we start preparing ourselves?• As individual companies• As NIASA

Nuclear Quality Management will be a key to our participation in the new-build. Industry

through NIASA has a leading role to play here.

19-March-2013 / 3 © 2013– EON Consulting (Pty) Ltd

Quality Management Enables Nuclear New Build

What is the landscape:• Building a 9,600MW nuclear fleet is a huge job. All industry will

have to be involved to make this a success• We will target high levels of local supply – 30-50% for the first

units.• South Africa has many companies that are technically capable,

that is not enoughWhat is missing:• Organizations must be qualified to provide equipment and

services to a Nuclear Project

Nuclear quality management is a key enabler

19-March-2013 / 4 © 2013– EON Consulting (Pty) Ltd

What are the main elements of Nuclear Quality Management

• Regulatory Requirements• National Nuclear Regulator Act, (Act No 47 of 1999) to provide for the protection of

persons, property and the environment against nuclear damage through the establishment of safety standards and regulatory practices. South African NNR (RD-0034), Other regulatory directives and guides

• International good practice (IAEA NS-R-1)• Occupational Health and Safety Act - Pressure Equipment Regulations (PER)• Incorporated Health and Safety Standards

• Standards, depends on code of construction either imposed on or selected by reactor vendor• ASME NQA-1 (2012), QSE-1, NSQ100, ISO-9001

• Client Requirements• Further to Regulated requirements – meeting Clients standards and requirements

• The impact of jurisdiction• Combination and interaction of requirements• start developing a standard base - easy to adjust a requirement develop

This means that the final quality management requirements are Internationally Recognised with a truly South African approach

19-March-2013 / 5 © 2013– EON Consulting (Pty) Ltd19-March-2013 / 5 © 2013– EON Consulting (Pty) Ltd

NQA-1 Quality Assurance Requirements for Nuclear Facility Applications (2012)

NQA-1 Establishes:• Approved Quality Assurance Program • Controls such as Procedures, Documents and

Processes to provide consistent quality results

• Qualification of Personnel • Inspectors and Testing Personnel• Welders• NDE Examiners• Auditors

Alternative or complimentary to ISO9001 or IAEA GS-R-3

19-March-2013 / 6 © 2013– EON Consulting (Pty) Ltd

What do the requirements in NQA-1 Address

1. Organization2. Quality Assurance Program3. Design Control4. Procurement Document Control5. Instructions, Procedures, and

Drawings6. Document Control7. Control of Purchased Items and

Services8. Identification and Control of

Items9. Control of Special Processes

Responds to the requirements defined by the US-NRC in 10 CFR 50 Appendix B

10. Inspection11. Test Control12. Control of Measuring and Test

Equipment13. Handling, Storage, and Shipping14. Inspection, Test, and Operating

Status15. Control of Nonconforming Items16. Corrective Action17. Quality Assurance Records18. Audits

NQA-1 is one of the most specific Quality Management System Standards – A system based on it would still need to be tailored for South African use

19-March-2013 / 7 © 2013– EON Consulting (Pty) Ltd19-March-2013 / 7 © 2013– EON Consulting (Pty) Ltd

RD-0034 Quality and Safety Management Requirements for Nuclear Installations (2008)

NNR Requirements prescribe:• Consideration of Quality and Safety Culture

requirements• Requirements throughout the supply chain• Requires a Graded Approach

• Originally Based on ISO 9001 and IAEA Safety standards and elements of NQA-1.

19-March-2013 / 8 © 2013– EON Consulting (Pty) Ltd

What do the RD-0034 Quality and Safety Management Requirements for Nuclear Installations Address?

• The Integrated Management System Approach– Structure of an Integrated Management System

(IMS)– Safety Management System and Safety Culture

Implementation (Level 1) – Quality Management System (Level1 and 2)

• General Requirements on Organisation and Documentation– General Requirements on Organisation (Level 1, 2) – General Requirements on Organisation (Level 1) – General Requirements on Documentation

• Management Responsibility– Management Commitment – Management Priorities, Policy and System Planning – Management Responsibility, Authority and

Communication

RD-0034 provides 134 requirements, split into 6 main areas.

• Resource Management– Overall Requirements (Level 1, 2) – IMS Requirements (Level 1)

• Process Realisation– Planning and Management of Processes – Licensing related Processes – Design and Development – Procurement– Production and Service Provision

• Measurement, Analysis and Improvement– Monitoring and Measurement of the

Management System– Control of Non-conforming Products– Analysis of Data – Improvement

While not as specific as NQA-1 it does have broader scope – for example the inclusion of safety culture.

19-March-2013 / 9 © 2013– EON Consulting (Pty) Ltd

How does Nuclear QA differ from what we are doing today

• More prescriptive• Not just that you do something but how, you do it and how you demonstrate that you

have done it

• More integrated• Requirements come from multiple sources• Technical and quality requirements mix required to be integrated to be effective• Technical work and quality work mix • Expanded to include Safety Culture

• How you demonstrate compliance• Chain of accountability back to the license holder• Purchasers qualify suppliers• Generally qualification not achieved through a third party certification agency - alone• A Quality Management System certificate is not good enough

• It is a culture• Safety culture is cascaded down the supply chain (questioning attitude)• Graded approach – to focus on safety and risk issues.

Most of the people at this meeting have a quality management system in place

If it is not documented – it did not happen

19-March-2013 / 10 © 2013– EON Consulting (Pty) Ltd

Role of Quality Management in qualifying as a supplier

As a first step to qualify as a supplier to the nuclear industry is to demonstrate that you are technically capable of working within the applicable standards• Quality assurance standards are an important gatekeeper

Nuclear Localization Capability Capacity Quality

- Systems- Culture- Qualification

- People- Technical

Availability

- Skills- Experience- Infrastructure

and Equipment- Technology

partners

Nuclear quality management is a key gatekeeper

19-March-2013 / 11 © 2013– EON Consulting (Pty) Ltd

What to do: Establishing Nuclear Quality management in South African industry

• Preparing• We do not need to wait to do this, Start Preparing now, this is a long lead

activity but need not be high intensity.

• Leadership – NIASA• Use the industry body to lead the process. This can be done in two areas:

• Standardization: • Select a standard set of nuclear quality requirements for industry• Address the regulatory requirements such as RD-0034

• Shared Audit:• Learn from the US, establish a shared audit system such as Nuclear Industry

Assessment Committee (NIAC) or Nuclear Procurement Issues Committee (NUPIC)

• Improve efficiency and pool experience

• Influence• A unified industry will enable us to influence the approach to Localization.

It will also simplify and align the approach that the vendors need to take.• Question and understand the requirements and how they affect your

business

19-March-2013 / 12 © 2013– EON Consulting (Pty) Ltd

The Nuclear Industry and localization needs you – Take Action now

• Understand the Regulatory framework applicable to your business

• Start to implement - get the business to practice the requirements

• Qualify your staff and create a skills base

• Create history and depth of implementation

• Test the your system via Peer and Benchmark reviews

What can you do?