Confirm that corrective and preventive actions do not adversely affect the finished device. Determine if corrective and preventive actions were effective and verified or validated prior to implementation.Determine if appropriate actions have been taken for significant product and quality problems identified from data sources.Verify that there is control for preventing distribution of nonconforming product. Determine if failure investigations are conducted to determine root cause (where possible). 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 investigation procedures are followed.Determine if results of analyses are compared across different data sources to identify and develop the extent of product and quality problems. Verify that appropriate statistical methods are employed (where necessary) to detect recurring quality problems.Verify that the data received by the CAPA system are complete, accurate and timely.
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 existing product and quality problems that may require corrective action. Determine if appropriate sources of product and quality problems have been identified.Verify that CAPA system procedure(s) that address the requirements of the quality system regulation have been defined and documented.
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