Reaction, Recommendation, Conclusion Paper
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
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