Risk Management Program Quality Assurance Program Plan David R. Taylor US EPA Region 9 Quality...
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Risk Management Program Risk Management Program Quality Assurance Program Quality Assurance Program
PlanPlanDavid R. TaylorDavid R. Taylor
US EPA Region 9US EPA Region 9
Quality Assurance OfficeQuality Assurance Office
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Products and Services Covered by Products and Services Covered by the New Quality Policythe New Quality Policy
• Data and Information produced for public use
• Data and information produced for internal Agency activities
• Products and services produced by organizations external to EPA for EPA use
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CIO 2106 ScopeCIO 2106 Scope• Environmental Data and Technology• Environmental Information• Assessments• Reports• Peer Review• Scientific Research• Regulatory Development• Information Technology to support services
that collect and provide access to data & information
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Quality Management Plan
R9's Quality System Umbrella
Quality System
QAPjP
SOP
QAPrP
SAP
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Quality Assurance Program PlanQuality Assurance Program Plan
• Describes the QA System for an environmental program like the Clean Water Act, Clean Air Act
• Program usually based on environmental regulations
• Contains details like a QA Project Plan, but at a organization wide or program level
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Risk Management ProgramRisk Management ProgramOrganizations Using, Storing or Transporting
Hazardous Material must:
Comply with the General Duty Clause (CAA112(r)(1))– Identify Hazards– Design and maintain a safe facility– Follow codes, standards and other business
practices– Minimize the consequences of a release
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Risk Management ProgramRisk Management ProgramOrganizations Using, Storing or Transporting
Hazardous Material must:• Implement Chemical Accident Prevention
(CAA 112(r)(7))– Do a Hazard Assessment– Develop a Prevention Program– Establish an Emergency Response Program
• Prepare a Risk Management Plans
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Risk Management Program Federal Regulations
EPCRA - Emergency Planning and Community Right-to-Know Act (aka SARA Title III) Sections 302-312
CERCLA - Comprehensive Environmental Response, Compensation and Liability Act, Section 103
CAA 112(r) - Clean Air Act Section 112(r)(7), Chemical Accident Prevention Provisions and Risk Management Plans; and Section 112(r)(1) General Duty Clause (1990)
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R9 Risk Management ProgramR9 Risk Management ProgramIssuesIssues
• Hawaii Inspector needed Federal credential
• No QA Documentation (except R9 QMP)
• No QA Guidance available
• Not an Environmental Data Collection Activity, but
• Environmental Information collected
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Risk Management PlanRisk Management Plan• Summarizes key elements of a Facility’s Risk
Management Program
• Submitted to the U.S. EPA and put in the Central Data Exchange (CDX)
• Contains certification of accuracy and completeness
• Contains a brief “Executive Summary”
• Available to the public at “Reading Rooms”
• Companion Emergency Response Plans available to EPA upon EPA request
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RMP Quality SystemRMP Quality System
• Review of Risk Management Plans based on National Guidance ensures consistency
• Training and Certification
• Audits
• Administrative and Enforcement Action
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Training and CertificationTraining and Certification
• Basic Inspector Training– Federal Inspection Credential
• Risk Management Program Training
• Confidential Business Information Training
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Risk Management Program Risk Management Program AuditsAudits
Follow one of several checklists:
• Program Level 1, 2 or 3 Checklist
• Audit Checklist from “Guidance for Auditing Risk Management Plans/Programs under Clean Air Act Section 112(r)”
• EPCRA/CERCLA Inspection Checklist for R9
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RMP AuditsRMP Audits• Has facility planned satisfactorily for
incidents and releases?
• Is it implementing the RMP as described?
• Does plan cover all chemicals and processes subject to CAA112(r)(1) (GDC) or CAA112(r)(7) (ARR)
• Does facility meet Mechanical Integrity, Process Safety and Emergency Response Requirements?
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Shut-off valve
Off
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ConclusionsConclusions
• New Quality Policy will require flexibility
• Existing systems must be respected
• New approaches will be required by the QA Community
• Documentation is key