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Corrective and Preventive Actions (CAPA) * Inspectional Objectives * Decision Flow Chart * Narrative * Medical Device Reporting * Inspectional Objectives * Decision Flow Chart * Narrative * Corrections & Removals * Inspectional Objectives * Decision Flow Chart * Narrative * Medical Device Tracking * Inspectional Objectives * Decision Flow Chart * Narrative
Corrective and Preventive Actions (CAPA)
Inspectional Objectives
1. Verify that CAPA system procedure(s) that address the requirements of the quality system regulation have been defined and documented.
2. Determine if appropriate sources of product and quality …show more content…

Once you have gained a knowledge of the firm's corrective and preventive action procedure, begin with determining if the firm has a system for the identification and input of quality data into the CAPA subsystem. Such data includes information regarding product and quality problems (and potential problems) that may require corrective and/or preventive action.
2. Determine if appropriate sources of product and quality problems have been identified. Confirm that data from these sources are analyzed to identify existing product and quality problems that may require corrective action.
The firm should have methods and procedures to input product or quality problems into the CAPA subsystem. Product and quality problems should be analyzed to identify product and quality problems that may require corrective action.
The firm should routinely analyze quality data regarding product and quality problems. This analysis should include data and information from all acceptance activities, complaints, service, and returned product records. Determine if the firm is capturing and analyzing data from acceptance activities relating to component, in-process and finished device testing. Information obtained subsequent to distribution, which includes complaints, service activities and returned products, as well as information relating to concessions (quality and nonconforming products), quality records, and other sources of quality data should also be captured

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