Table of Content: Guidance for the use of Risk Assessment in Validation


  1. Application
  2. Responsibility and Authority
  3. Safety and Process Specific Information
  4. Procedure
  5. Risk Assessment
  6. Describe the product and proces
  7. Describe the intended use of the product
  8. Construct a flow diagram
  9. Identify steps in the process that may impact on safety and product quality
  10. Qualitative and/or quantitative evaluation of the presence of hazards
  11. Severity Test
  12. Probability Test
  13. Detectability Test
  14. Defining the class and priority of the hazard
  15. Establishing Critical Control Points (CCP)
  16. Determine the level of Validation or Verification required

Sample Content


This procedure details the standard methodology used to perform GMP/Quality Risk Assessments during Validation activities.


The Validation Supervisor is responsible for appointing personnel to and coordinating Risk Assessments. The Validation Momager will be responsible for the development of the Validation Risk Management plan, the implementation/execution of the plan and the documentation of the activities associated with the plan.


All safety requirements for relevant areas at any GMP facility must be followed at all times.


  • Risk Assessment

The Risk Assessment shall be conducted to determine the level of inherit risk within a given process or product. The Risk assessment should be developed to suit the type of Validation undertaken and should be used to determine the level at which Validation is performed. Validation should not be conducted where steps in a process do not impact the safety or quality of the final product and no perceivable risks are identified.

  • Describe the product and process

A full description of the product and the process should be drawn up, including relevant quality information such as the composition, physical/chemical properties, structure, pH, temperatures, method of cleaning, bactericidal/bacteriostatic treatments (e.g. heat-treatment), drying, screening, mixing, blending, packaging, and the storage conditions. The method of distribution and transport should also be described.

  • Describe the intended use of the product

The intended use should be based on the expected uses of the product by the end user or consumer. The end use of the product can have a significant impact on the severity of any hazards that are identified and the extent to which Validation may be applied.

  • Construct a flow diagram

A flow diagram should be constructed and should cover all operations and decisions in a process. When applying risk assessment to a given operation, the steps preceding and following that operation should also be considered. A block-type diagram may be sufficiently descriptive.

  • Identify steps in the process that may impact on safety and product quality

List all the hazards that may be reasonably expected to occur at each step from production, testing and distribution up to the point of use. A hazard analysis should then be conducted to identify which hazards are of such a nature that their elimination or reduction to acceptable levels is essential.

A thorough hazard analysis is required to ensure an effective assessment of all potential risks. A list of the potential hazards which may be introduced, increased or controlled in each step should be drawn up.