The ICH Q9 guideline, Quality Risk Management, provides a list of methods widely used in the industry for risk management. With so many great tools at your disposal it is sometimes easy to become overwhelmed and unclear as to what tool is the best fit for a given circumstance.

In this article we will outline all of the common risk tools used in industry today and some of the potential areas of use.

We would like to encourage you to use the comments box below this article to add your own favorite risk tools and areas where you have used them before.

1. Basic risk management facilitation methods (flowcharts, check sheets,cause and effect diagram etc.)

  • Organize data and facilitate decision making in the areas of failure investigations and root cause analysis

2. Failure Mode Effects Analysis (FMEA)

  • Prioritize risks
  • Monitor the effectiveness of risk control activities
  • Equipment and facilities
  • Analyse a manufacturing process to identify high-risk steps or critical parameters

3. Failure Mode, Effects, & Criticality Analysis (FMECA)

  • Utilized on failures and risks associated with manufacturing processes

4. Fault Tree Analysis (FTA)

  • Establish the pathway to the root cause of the failure
  • Investigate complaints or deviations to fully understand their root cause
  • Ensure that intended improvements will fully resolve the issue and not lead to other issues
  • Evaluate how multiple factors affect a given issue

5. Hazard Analysis and Critical Control Points (HACCP)

  • Identify and manage risks associated with physical, chemical and biological hazards
  • Useful when process understanding is sufficiently comprehensive to support identification of critical control points (critical parameters / variables)
  • Facilitates monitoring of critical points in the manufacturing process

6. Hazard Operability Analysis (HAZOP)

  • Manufacturing processes
  • Equipment and facilities
  • Evaluating process safety hazards
  • Primarily as starter of a HACCP
  • Operator error (“use error”)

7. Preliminary Hazard Analysis (PHA)

  • Useful in analysing existing systems or prioritizing hazards
  • Evaluate the types of hazards for the general product type, then the product class and finally the specific product
  • Most commonly used early in the development of a project when there is little information on design
    details or operating procedures; thus, it will often be a precursor to further studies

8. Risk ranking and filtering

  • Used to prioritize manufacturing sites for inspection/audit by regulators or industry
  • Particularly helpful in situations in which the portfolio of risks and the underlying consequences to be managed are diverse and difficult to compare using a single tool
  • Evaluate both quantitatively-assessed and qualitatively-assessed risks within the same organizational framework

9. Supporting statistical tools

  • Monitors critical parameters
  • Provides information to determine Process capability, Variability and Control
  • Some charts are dealing with warning limits or trend analysis