Grading of Management System Generic Concepts & Methodology

Transcription

1 Grading of Management System Generic Concepts & Methodology Shami S. Dua Quality Assurance Director IAEA TM on Management System Grading January 2012, Vienna, Austria

2 Grading of Management System Generic Concepts & Methodology Discussion is generic in nature & does not represent concepts /approach being used or considered for ENEC on its nuclear program

3 Grading of Management System Generic Concepts & Methodology Why do we need Grading?? Benefits, Pros & Cons Role of Classification Safety, Seismic, Environmental Grading through Standards Nuclear vs. Non-Nuclear Nuclear Pressure Boundary Components /Systems vs. Non PB Role of Risk-Informed Performance Based Concepts

4 Grading of Management System Generic Concepts & Methodology Nuclear QA standards (ASME, IAEA) recognize that requirements can be applied in a graded manner Little guidance available to apply Grading??? Grading focus is more on nuclear safety; nuclear vs. non-nuclear; safety significance, complexity & maturity; other considerations- economics, customers/stakeholders, organizational needs, nuclear experience, etc. Lack of industry standards for Grading methodologies in nuclear areas IAEA TR Series No. 328; IAEA Comparison documents with ISO 9001, NQA-1, etc. Paper on Grading of Quality Management System for Nuclear Facilities Ramesh Ghai, Brij Verma and Shami Dua, Atomic Energy of Canada Ltd., Canada, PBNC, Aomori, Japan, October 2008

5 Embedded Grading Methodology in Standards Embedded in QA Standards: ASME Section III /VIII for Pressure Boundary Components Class 1, 2 & 3 ASME NQA-1 Focus on Safety & Safety- related systems, equipment & items IAEA GS-R-3; G-3.1 / 3.5; IAEA Technical Report Series # 328 ISO 9001: 2008 series ( Captures what was earlier in ISO 9001 / 9002 /9003)

6 Grading of Management System Generic Concepts & Methodology R E Q U I R E M E N T S ASME Section III /NCA 4000 NQA-1 ISO 9001 Pressure Boundary Non- Nuclear Nuclear FACILITIES/ POWER PLANT Figure 1: QA Requirements

7 Figure 2- Example OF A Methodology for Grading the Application of Quality Assurance Requirements During Operations Step 1 Plant Class Step 2 Determine significance Could an ill-conceived or inadequately executed activity or failure of the item lead DIRECTLY to: Step 3 Consider Other Factors Step 4 Assign Grade Alpha or numeric 1 The initiation of an event beyond design basis accident? An uncontrolled radioactivity release to the environment? No A major risk of radiological/consequential hazard? A higher risk of serious injury for individuals? The functionality of the component/system affected? A major loss of power generation? Does the system/component have seismic relevance? No A failure of a system performing control functions for radiation protection? A low risk of serious injury for the worker/ people? A minor risk of radiological hazards? Plant integrity being affected? Minor loss of generation? No Consider raising the grade if: There is a need for special controls, inspection, processes, methods or equipment. The item or activity is complex, unique or novel. If the item or activity has a poor quality history. If the item is not accessible during normal operations. It is difficult to prove functionality/ reliability or perform inspection & test after installation. Yes No Yes No Yes No Noncompliance with the environmental control requirements could occur.

8 Embedded Grading Methodology in Standards Verification activates: Supervisory Review Peer Review Review by Analysis Design Review Review by Testing, etc Change Control Major changes Minor changes Minor under line control, major under the Chief Engineer Corrective Action Program

9 Embedded Grading Methodology in Standards Corrective Action Program NCR / CAR Program; Three/Four levels with Root Cause, Apparent Cause determination, Trending, etc.

10 Grading of QA Programs Current Practices Current Practices in the Industry Major Projects & Services to operating stations apply NQA-1/IAEA based QA/MS programs to all its activities Small R&D projects, other diverse business activities such as tooling, development projects, non nuclear facilities, hot cells, safeguards program, apply all the QA principles and elements but at a different level Issues raised between auditee & auditors /inspectors / customers / regulatory bodies on the level of program elements applied and required

11 Grading of Management System Generic Concepts & Methodology Safety / Safety-Related Components (SSCs) Safety Classification Methodology for assessing Grading levels / Categories Safety Classification / ASME Classes Risk Factor Assessment Program Element Method Program Element Example- Four Grading levels identified Level 1/2 : (highest) full program Safety / Safety related Level 3: basic requirements based on technical & management judgment Level 4 : Commercial Grade

12 Grading Methodology An Example

13 Grading Methodology An example

14 Grading of Management System Generic Concepts & Methodology Issues & Path Forward: Need guidance on grading if we are to use IAEA /NQA-1 based MS/QA program in the industry to cover its diverse business needs Empirical methods vs.. Safety Significance / Classification Need Regulatory input in applying the established QA documentation structure to non safety related and non-nuclear activities; Risk-Informed & Performance Based - IAEA? Industry Good Practices being applied through INPO, WANO; Check with other regulated industries aeronautical, pharmaceutical, petrochemical IAEA Guidance Grading the Application of Management System Requirements Draft 1/ a good draft document

15 ENEC Management System & QA Program Q & A

16 Thank You