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

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

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

Quality Management Plan

R9's Quality System Umbrella

Quality System

QAPjP

SOP

QAPrP

SAP

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

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

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

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)

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

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

RMP Quality SystemRMP Quality System

• Review of Risk Management Plans based on National Guidance ensures consistency

• Training and Certification

• Audits

• Administrative and Enforcement Action

Training and CertificationTraining and Certification

• Basic Inspector Training– Federal Inspection Credential

• Risk Management Program Training

• Confidential Business Information Training

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

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?

Shut-off valve

Off

ConclusionsConclusions

• New Quality Policy will require flexibility

• Existing systems must be respected

• New approaches will be required by the QA Community

• Documentation is key