INTEGRATION OF QA/ISM

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

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

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

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

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

6. Scope of Work Analyze Hazards • Organization • 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 ISM Quality Assurance Perform Work • Inspection • Packaging, Handling, Shipping, and Storage • Inspection, Test, and Operating Status • Audits Feedback/Improvement • Control of Nonconforming Items and Activities • Corrective Action System • Quality Improvement 11

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

9. CONCLUSION/PATH FORWARD • 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 • EFCOG/QAWG Path Forward ????