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Preventive / Corrective Actions (CAPA) Guidelines

Preventive / Corrective Actions (CAPA) Guidelines 254 College Ave SE Grand Rapids, MI 49503 616-454-9639 CAPA Facilitator Software Corrective / Preventive Action (CAPA) Made Easy ! See Page 17 2 Table of Contents Introduction .. 3 Corrective Actions .. 3 Preventive 3 Differences between Corrective and Preventive 3 CAPA Procedures .. 4 Identification .. 5 Report Source .. 5 Explanation of the Problem .. 5 Evidence of the 5 Evaluation .. 6 Potential Impact .. 6 Assessment of 6 Remedial Action .. 6 Investigation .. 7 Objective .. 7 Investigation Procedure .. 7 Responsibility / 7 7 Possible Causes / Data Collection .. 8 Results and Data .. 8 Root Cause 8 Action 8 Actions to be Completed .. 9 Document or Specification Changes .. 9 Process, Procedure, or System Changes .. 9 Employee Training.

completion of the action to the appropriate individuals or departments. This information may come from many possible sources. For example, situations that require corrective actions may come from external sources such as customer concerns or service requests. Internal quality audits, staff …

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