Transition from QA to IMS

1. Transition from QA to IMS Robert (Bob) Lavoie Management System Specialist Atomic Energy of Canada Limited 2010 November UNRESTRICTED / ILLIMITÉ

2. Agenda • Maintain Safety Focus • Management System Expectations and Requirements • Move from QA / QM to IMS • Consolidate requirements • Status of current integration • Implementation Plan • Conclusions UNRESTRICTED / ILLIMITÉ

3. Maintain Safety This approach reduces the risk by addressing the interfaces as all processes, activities or actions are important and can impact on safety safety quality economics health environment safety UNRESTRICTED / ILLIMITÉ

4. Maintain Safety • When moving to new standards and/or new management system know the steps to ensure that: • Safety and quality of products and services are not compromised • Safe operation is maintained • Equipment reliability is maintained • ….. UNRESTRICTED / ILLIMITÉ

5. Management System Expectations • Expectations: What are the national, international and widely accepted management system standards: • Quality • Environment • Health and Safety • Security • Economics • Corporate Governance • Others • Regulatory bodies • Acceptance of IMS • Canadian Nuclear Safety Commission (CNSC) • Support IMS and will require as licence condition UNRESTRICTED / ILLIMITÉ

6. Harmonization of Requirements • Look at comparison between widely accepted standards: • ISO 9001 • …. • …. • US 10CFR50 App.B / NQA-01 • …. • …. • Key messages from the comparison studies: • IAEA comparison documents: • ….. • ….. • NQA-01 comparison documents UNRESTRICTED / ILLIMITÉ

7. SUPPLIER REGULATOR IAEA SS Manag. Systems ISO 9001:2000 + add. requirements ACTIVITIES FACILITIES Satisf. Req. Application of IAEA and ISO Standards UNRESTRICTED / ILLIMITÉ

8. Move from QA/QM to IMS • Do you have a QA/QM system in your organization ? • What are the national and international standards supporting your current QA /QM system ? • Do you have other management systems / programs ? • Environmental Management System (EMS) • Safety Management System (SMS) • Radiation Protection Program • Security and Fire Protection…. UNRESTRICTED / ILLIMITÉ

9. Move from QA/QM to IMS • Are you considering to move towards an IMS based on GS-R-3 • Constraints, Enablers and Challenges ? • Business processes defined? • Safety Culture? • Process and methodology to move to IMS ? UNRESTRICTED / ILLIMITÉ

10. Move from QA to IMS • Identify and evaluate your existing QA / programs against IMS requirements • Tools / Information available for comparison ?? • What are their status ?? • Customer Contracts • May require work to a specific QA program • Regulatory commitments / Licenses • May require operations to a given QA or MS standard • Others ?? UNRESTRICTED / ILLIMITÉ

11. Move from QA /QM to IMS • Other Considerations • Senior management and /or executive sponsorship of IMS project in place • Know how to influence senior management to support IMS • Status of Safety Culture • Status of process management • Good understanding in place? UNRESTRICTED / ILLIMITÉ

12. Move from QA /QM to IMS • Common Difficulties: • Define the gaps between existing system in the corporation and IMS • Acceptance from top management • Alignment between internal organizations • Use of common processes (e.g., audits, document control) • Acceptance by the regulatory bodies/other applicable regulations • Acceptance by the customers • Alignment with suppliers and contractors UNRESTRICTED / ILLIMITÉ

13. Consolidate IMS Requirements UNRESTRICTED / ILLIMITÉ

14. Status of Current Integration UNRESTRICTED / ILLIMITÉ

15. Example - Utility Supply Chain IMS UNRESTRICTED / ILLIMITÉ

16. Option – for GS-R-3 UNRESTRICTED / ILLIMITÉ

17. Compliance Matrix UNRESTRICTED / ILLIMITÉ

18. Implementation Plan : Transition Process to IAEA GS-R-3 Develop and implement new MS Documentation and supporting Processes, etc. (Integrated Management System (IMS)) transition transition 2008/2009 Implement Continue working to existing programs and systems 2009/2010 2010/2011 2011/2012 Key Steps: 1. Familiarization of IMS standard (e.g., GS-R-3) - Participate in IMS meetings, workshops, etc. - Discuss with key stakeholders and regulatory authorities 2. Develop IMS - Implement IMS elements as they become available 3. Manage transition / change over to IMS - Training / Awareness sessions - Gap analysis and develop implementation / improvement plans 4. Celebrate completion and implementation of IMS

19. Transition from QA to IMS • Conclusions: • Build upon and go beyond compliance model to include performance using IMS methodology • Safety must remain paramount • IMS must be led and supported by top management • IAEA GS-R-3 provides an excellent IMS framework • Participate and attend workshops on IMS • Engage your Management in IMS activities, Ownership of IMS • IMS is a business imperative for industry to compete and enhance its market share UNRESTRICTED / ILLIMITÉ

20. Questions? UNRESTRICTED / ILLIMITÉ

21. CASE STUDY • See handout • Objective • Produce a process model for the management system for an organization • Five Steps: • Identify to business • Identify processes and activities • Define the process hierarchy • Develop a process model • Prepare to present your model to the group UNRESTRICTED / ILLIMITÉ

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