Using Risk-Based Thinking To Manage Nonconformances And Deviations

The CAPA process has eight distinct steps. Each step has specific requirements that should be followed to ensure successful resolution of quality issues, including:

  1. Problem identification – describe the problem and its source
  2. Impact assessment – what products, processes, or systems may be affected
  3. Remedial action/containment – place product on hold, recall, quarantine, etc.
  4. Investigation/root cause analysis – determine what caused the issue
  5. Corrective action – actions taken to address the root cause of the problem
  6. Implementation – the deployment of corrective action(s)
  7. Verification of effectiveness – the plan, criteria, and requirements to ensure the problem will not recur or have other adverse effects.
  8. Closure – ensuring the corrective action(s) were effective; this should include a disposition record of any products or materials affected.

These concepts can be readily applied to virtually any industry as best practices. How have you used them in your industry and what was the result?

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