Risk Management and an Approach to Validation

User Requirement Specifications

Risk Assessment

  • Low — Failure would have a minor impact on patient safety or product quality.
  • Medium — Failure would have a moderate impact on safety and quality processes.
  • High — Failure would severely impact safety and quality processes.
  • Horizontal columns — Represent safety, severity and quality.
  • Vertical rows — Represent probability, frequency and detectability.
  • Find the system function categories and add them to a risk assessment table. These categories are determined by reviewing the URS and assessing how each of the requirements correlate to a similar system function (i.e., grouping).
  • Determine the risk associated with each URS function in terms of potential failure or if the function/system is not available (i.e., offline or nonfunctioning).
  • Determine the severity, safety and quality impact on the associated failure.
  • Determine the frequency, probability and detectability of the possibility of failure.
  • Use the acceptance criteria chart to identify overall risk.
  • Place the overall risk into one of the three risk classes: high, medium, low.
  • Complete the same risk assessment on each of the functional items listed in the URS.

Validation Priority Level

  • High Risk — Complete, comprehensive testing required. All system and sub-systems must be thoroughly tested according to a scientific, data-driven rationale. This is similar to the classic approach to validation. Also, it may be necessary to enhance the detectability of failure via in-process production controls.
  • Medium Risk — Testing the functional requirements per the URS and FRS is required to ensure that the item has been properly characterized.
  • Low Risk — No formal testing is needed, but presence (detectability) of the functional item may be required.

Validation Test Plan

  • Stage 1: Process design — The commercial process based on experience gained from development and scale-up.
  • Stage 2: Process qualification — The reproducible, commercial scale is confirmed on the basis of process design.
  • Stage 3: Continued process verification — To show that the process is in a state of control during routine production.
  • Determine and understand the process variations.
  • Detect the process variations and assess their extent.
  • Understand the influence on the process and the product.
  • Control variations depending on the risk they represent.

Stage 1: Process Design

Stage 2: Process Qualification

  • Qualification activities regarding facilities and equipment.
  • Performance qualification (PQ).
  • Test description.
  • Acceptance criteria.
  • Schedule of validations.
  • Responsibilities.
  • Protocol with pre and post approval.
  • Change control.
  • Results.
  • Continued validation stage.

Stage 3: Continued Process Verification

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