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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.

An Evaluation of the magnitude of the problem and potential impact on the company. 3. The development of an Investigation procedure with assignments of responsibility. ... thorough investigation and a permanent solution is implemented. If remedial actions are necessary, the actions and the resources required are listed. The steps that must be taken

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