Summary of Regulations, Standards and Requirements


OSHA PSM 1910.119

OSHA's Process Safety Management rule contains requirements for the management of hazards associated with processes using highly hazardous chemicals. OSHA 1910.119 establishes procedures for process safety management that will safeguard employees by preventing or minimizing the consequences of chemical accidents involving highly hazardous chemicals. Employees have been and continue to be exposed to the hazards of toxicity, fires, and explosions from catastrophic releases of highly hazardous chemicals in their workplaces. The process safety management requirements in this standard are intended to eliminate or mitigate the consequences of such releases. The following elements are addressed in this document:

  • Introduction to Process Safety Management
  • Employee Involvement in Process Safety Management
  • Process Safety Information
  • Process Hazard Analysis
  • Operating Procedures and Practices
  • Employee Training and Contractors
  • Pre-Startup Safety
  • Mechanical Integrity
  • Non-routine Authorizations
  • Managing Change
  • Investigation of Incidents
  • Emergency Preparedness
  • Compliance Audits

Document Links

  • 1910.119, Process safety management of highly hazardous chemicals.
    • App A: List of Highly Hazardous Chemicals, Toxics and Reactives (Mandatory).
    • App B: Block Flow Diagram and Simplified Process Flow Diagram (Nonmandatory).
    • App C: Compliance Guidelines and Recommendations for Process Safety Management (Nonmandatory).
    • App D: Sources of Further Information (Nonmandatory).

SAE Recommended Practice J1739

This document provides guidance on the application of the Failure Mode and Effects Analysis (FMEA) Technique, and was developed by Chrysler, Ford & General Motors. This document provides guidance on performing the Design, Process and Plant Machinery FMEA. This document outlines the design and process concepts for performing an FMEA on plant machinery and equipment, and provides the format for documenting the study. The following information is included in this document:

  • What is an FMEA?
  • FMEA Implementation
  • Format for Documenting Design/Process FMEA/Machinery
  • Development of a Design/Process FMEA
  • Suggested evaluation criteria for Severity, Detection and Occurrence of Failure

Medical Devices- Risk Management-Application of risk management to medical devices ISO/DIS 14971

ISO 14971 presents an overview of the risk management process. This document is intended to be used as part of a quality system, but could be used where a quality system is not in place. ISO 14971 specifies a procedure for the manufacturer of a medical device to incorporate the following:

  • Identify hazards associated with a medical device and its accessories
  • To Estimate and evaluate the risk associated with those hazards
  • To Control those risks
  • Monitor the effectiveness of that control

Conformance to the standard requires the following actions:

  • Establish a risk management process
  • Policy on acceptable risk
  • Hire and train qualified personnel
  • Reduce risk on design/process/personnel
  • Conduct a final risk benefit analysis and provide information on residual risk

The following Risk Analysis techniques are included in this document:

  • Failure Mode and Effect Analysis (FMEA)
  • Fault Tree Analysis (FTA)
  • Hazard and Operability Study (HAZOP)

More Standards