Reaction, Recommendation, Conclusion Paper

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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 problems have been identified. Confirm that data from these sources are analyzed to identify existing product and quality problems that may require corrective action. 3. Determine if sources of product and quality information that may show unfavorable trends have been identified. Confirm that data from these sources are analyzed to identify potential product and quality problems that may require preventive action. 4. Challenge the quality data information system. Verify that the data received by the CAPA system are complete, accurate and timely. 5. Verify that appropriate statistical methods are employed (where necessary) to detect recurring quality problems. Determine if results of analyses are compared across different data sources to identify and develop the extent of product and quality problems. 6. Determine if failure investigation procedures are followed. Determine if the degree to which a quality problem or nonconforming product is investigated is commensurate with the significance and risk of the nonconformity. Determine if failure investigations are conducted to determine root cause (where possible). Verify that there is control for preventing distribution of nonconforming product. 7. Determine if appropriate actions have been taken for significant product and quality problems identified from data sources. 8. Determine if corrective and preventive actions were effective and verified or validated prior to implementation. Confirm that corrective and preventive actions do not adversely affect the finished device. 9. Verify that corrective and preventive actions for product and quality problems were implemented and documented. 10. Determine if information regarding nonconforming product and quality problems and corrective and preventive actions has been properly disseminated, including dissemination for management review.   

 

 
Corrective and Preventive Actions
(CAPA)
Narrative
Purpose/ImportanceThe purpose of the corrective and preventive action subsystem is to collect information, analyze information, identify and investigate product and quality problems, and take appropriate and effective corrective and/or preventive action to prevent their recurrence. Verifying or validating corrective and preventive actions, communicating corrective and preventive action activities to responsible people, providing relevant information for management review, and documenting these activities are essential in dealing effectively with product and quality problems, preventing their recurrence, and preventing or minimizing device failures.One of the most important quality system elements is the corrective and preventive action subsystem.| 1. Verify that CAPA system procedure(s) that address the requirements of the quality system regulation have been defined and documented. Review the firm's corrective and preventive action procedure. If necessary, have management provide definitions and interpretation of words or terms such as "nonconforming product", "quality audit", "correction", "prevention", "timely", and others. It is important to gain a working knowledge of the firm's corrective and preventive action procedure before beginning the evaluation of this subsystem. The CAPA...
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