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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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Under the Wire

There are many organizations asking, “How do we get certified successfully?” Aside from hiring a professional such as myself, the key to a successful implementation of or transition to ISO 9001:2015 is proper planning with realistic deadlines and management providing adequate support, including the resources necessary to meet the project goals and deadlines.

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