E01-0101 Risk Management (FMECA)


Risk management is a process to Identify, Assess, Prioritise, Mitigate (CAPA) the risk. It is one of the main concepts in good practices to ensure a balance of risks against benefits. 3 examples illustrate the assessment process.



What is this process and document about?

  •  Risk management is a process to Identify, Assess, Prioritise, Mitigate, Preventive and Corrective Actions (CAPA) for the risk.
  • Risk management is at the core of most Good Engineering Practice activity such that there is a balanced evaluation of risks against benefits. Where practicable efforts should be made to design out or minimize identified risks to an acceptable level (ISPE Good Practice Guide).
  • This document addresses Risk Management using FMECA methodology.
  • Failure Modes, Effects and Criticality Analysis (FMECA) methodology is used to rate and rank risks.
  • This template includes 3 examples (Purified Water System, Cream Manufacturing and Project Risks (deliverables, quality, time and cost)) to illustrate the assessment process.

This document has 2 parts:

  • Part 1 (3 pages) – describes the rational of why this procedure or standard is required
  • Part 2 (12 pages) – the document template ·

Attachments & Forms included:

  • Risk Identification Form – a risk identified by any personnel is recorded.
  • Risk Control Form – this form guides you methodically through the risk assessment process.

Associated Industry/regulatory guidance and requirements:

  •  ASTM E2500-7 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing System and Equipment
  • ISPE Good Practice Guide: Good Engineering Practice (Core Concepts)
  • Reference only – ICH Q9 Quality Risk Management

Who needs this document?

  •  Any department who performs a process that involve a risk to product quality, safety, equipment, environment and the business.

Related Products:

  • E00-01-01 Policy Statement – Good Engineering Practice (also refer flowchart E00-01-02)
  • E01-02-01 Cost Management
  • E01-03-01 Organization and Control
  • E02 Common Practices & Systems
  • E03 Project Engineering & Management
  • E04 Operations & Maintenance


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