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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.

of a formal Corrective Action / Preventive Action (CAPA) program. CAPA is a major area of concern for both FDA, ISO 9000, as well as the Automotive and Aerospace industries. They have recognized that how a quality system is maintained and monitored is critical to its effectiveness.

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Transcription of Preventive / Corrective Actions (CAPA) Guidelines

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