INTEGRATION OF QA/ISM

J. R. YanekChair, EFCOG ISM Working GroupApril 13, 2000

INTEGRATION OF QA & ISM

AnalyzeHazards

Develop/Implement Controls

Confirm Readiness/

Perform Work

DefineScope

FACILITY

TASK

CORPORATE

Feedback/Improvement

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ISMISM

OSHA Process OSHA Process Safety Mgmt (PSM)Safety Mgmt (PSM)

Enhanced Work Enhanced Work Planning (EWP)Planning (EWP)

Voluntary Protection Voluntary Protection Program (VPP)Program (VPP)

EPA Risk Mgmt Plan (RMP)EPA Risk Mgmt Plan (RMP)

ISO 14001ISO 14001

Chemical Manufacturers Association Chemical Manufacturers Association (CMA) Responsible Care (CMA) Responsible Care qq

Quality AssuranceQuality Assurance

(QA)(QA)

Conduct of OperationsConduct of Operations(CONOPS)(CONOPS)

Work PlanningWork Planning

QA CRITERIA/ISMS FUNCTIONSISMS FUNCTIONS

QA RULEDefine Scope of Work Analyze

HazardsDevelop and Implement

controlsPerform work safely Feedback and Improvement

MANAGEMENT

1. Program

2. PersonnelTraining andqualification

3. QualityImprovement

4. Documents andRecords

PERFORMANCE

5. Work Processes

6. Design

7. Procurement

8. Inspection andTesting

ASSESSMENT

9. ManagementAssessment

X10. IndependntAssessment

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QA CRITERIA/ISMS PRINCIPLES

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ISMS Guiding Principles

QA RULE

Line ManagementResponsibility for

Safety

Clear Roles andResponsibilities

CompetenceCommensurate with

Responsibilities

Balanced Priorities Identification of SafetyStandards

and Requirements

Hazard ControlsTailored to the Work

Being Performed

OperationsAuthorization

MANAGEMENT1. Program

2. PersonnelTraining andqualification

3. QualityImprovement

4. Documents andRecords

PERFORMANCE5. Work Processes

6. Design

7. Procurement

8. Inspection andTesting

ASSESSMENT9. Management

Assessment

10. IndependentAssessment

X X X X

XX X X

XXXXX

X X X XXX

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ISMISMQualityQuality AssuranceAssurance

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

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

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.

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 ????