ICH Q9 provides a simple process flow of a typical risk management process.  This process includes risk assessment (risk identification, risk analysis, and risk evaluation) which leads to risk control (risk reduction and risk acceptance). Figure 1 below, extracted from ICH Q9 illustrates this process flow.

Figure 1. Adapted from ICH Q9, Quality Risk Management, Nov 2005, retrieved from ICH.org

ICH Q9 provides information on typical risk management tools (Annex I) and how these tools may be used over the product quality life-cycle (Annex II).  One tool that is commonly used for risk assessment and control is the Failure Modes and Effects Analysis (FMEA).  Performance Validation recently completed a project with a biomedical research company to provide training on the use of FMEA.  However, it is important to remember that quality tools such as FMEA, FTA, FMECA, Fishbone diagrams, etc., are not risk management, but simply tools to help the organization understand what risks are present and the significance of these risks.   These risks are then analyzed to gain understanding of which of the identified risks are acceptable “as-is”, and which of these risks require further mitigation.

FMEA is a great tool and can be used alone or in conjunction with other quality tools to:

  • Identify and eliminate concerns early in the development of a process or design
  • Predict the likely effects for product performance
  • Identify critical steps/processes
  • Identify high risk areas
  • Prioritize risk
  • Prioritize remediation actions/solutions to maximize impact
  • Provide a methodology that facilitates process improvement
  • Prevent or minimize product manufacturing related quality issues
  • Improves internal and external customer satisfaction

How do you analyze your risk?  What quality tools does your organization use for risk assessment and control?  Do you have questions on how to implement ICH-Q9 or how these quality tools can be used to improve product quality, reduce waste, or manufacturing cycle time?  If so, PV can help.  We have American Society of Quality (ASQ) Certified Quality Engineers (CQE) who can provide FMEA training, help develop an FMEA work instruction or facilitate performing a FMEA.  We can also provide refresher training on complimentary quality tools that support the risk assessment and control process such as Ishikawa or fishbone diagrams, control charts, Pareto and process flow charts.

For more information on the use of quality tools in risk management please contact:

Holly Couch
Principal Validation Engineer
Certified Quality Engineer
Performance Validation, LLC

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