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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,

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