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Preventive / Corrective Actions (CAPA ... - RMBIMedical

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.

Assessment of Risk Using the result of the impact evaluation, the seriousness of the problem is assessed. The level of risk that is associated with the problem may affect the actions that are taken. For example, a problem that presents a serious risk to …

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