1. INTEGRATION OF QA/ISM J. R. Yanek Chair, EFCOG ISM Working Group April 13, 2000

2. INTEGRATION OF QA & ISM Analyze Hazards Develop/ Implement Controls Confirm Readiness/ Perform Work Define Scope FACILITY TASK CORPORATE Feedback/ Improvement

3. 11 ISM OSHA Process Safety Mgmt (PSM) Enhanced Work Planning (EWP) Voluntary Protection Program (VPP) EPA Risk Mgmt Plan (RMP) ISO 14001 Chemical Manufacturers Association (CMA) Responsible Care q Quality Assurance (QA) Conduct of Operations (CONOPS) Work Planning

4. QA CRITERIA/ISMS FUNCTIONS ISMS FUNCTIONS QA RULE Define Scope of WorkAnalyze Hazards Develop and Implement controls Perform work safelyFeedback and Improvement MANAGEMENT 1. Program 2. Personnel Training and qualification 3. Quality Improvement 4. Documents and Records PERFORMANCE 5. Work Processes 6. Design 7. Procurement 8. Inspection and Testing ASSESSMENT 9. Management Assessment X 10. Independnt Assessment Shaded area indicates that one would not expect a driver at the intersection X X X X X X X X X X X X X X X X X X

5. QA CRITERIA/ISMS PRINCIPLES Shaded area indicates that one would not expect a driver at the intersection ISMS Guiding Principles QA RULE Line Management Responsibility for Safety Clear Roles and Responsibilities Competence Commensurate with Responsibilities Balanced PrioritiesIdentification of Safety Standards and Requirements Hazard Controls Tailored to the Work Being Performed Operations Authorization MANAGEMENT 1. Program 2. Personnel Training and qualification 3. Quality Improvement 4. Documents and Records PERFORMANCE 5. Work Processes 6. Design 7. Procurement 8. Inspection and Testing ASSESSMENT 9. Management Assessment 10. Independent Assessment XXXX X XXX XXXXX XXXX XX X XX XX X X XX X X X X X X X X X

6. 11 ISM QualityAssurance Perform Work Feedback/Improvement Scope of Work Organization Analyze Hazards QA Program Develop/Implement Controls Design Control Procurement Document Control Instructions, Procedures, and Drawings Document Control Control of Purchased Items and Services Identification and Control of Items Control of Processes Test Control Control of Measuring and Test Equipment Quality Assurance Records Software Quality Assurance Environmental Quality Assurance Inspection Packaging, Handling, Shipping, and Storage Inspection, Test, and Operating Status Audits Control of Nonconforming Items and Activities Corrective Action System Quality Improvement

7. ISM IMPLEMENTATION n Quality Assurance must be viewed as part of the total safety management system –A strong QA Program directly supports ISM implementation –QA impacts 4 of 5 ISM Functions and 4 of 7 ISM Principles –Quality Assurance is a critical element of the Feedback and Improvement function

8. WHY INTEGRATE QA & ISM ? n Ensures work is accomplished safely while minimizing potential hazards to public, site or facility workers, and environment. n QA Rule provides for a quality management system for assessing work in accordance with ISMS requirements. n The quality management system provides processes and tools to ensure ISMS achieves its objectives. n The integration of the two provides for a comprehensive system for performing work safely.

9. CONCLUSION/PATH FORWARD n Integrating QA and ISM –ensures the DOE mission is accomplished safely and such that performance can be objectively assessed –provides a more comprehensive management system for completing work n EFCOG/QAWG Path Forward ????