About the Author
Proxima CRO Team
Taylor Lunsford, MGA
Regulatory Associate II
Taylor is fluent in Mandarin Chinese and has a strong background in medical interpreting and translating medical documents. Before joining Proxima, Taylor served in the Army as an intelligence analyst, instructor, translator and small-unit leader.

When assessing your CAPA process, it needs to follow the FDA’s inspectional objectives. 

The Inspectional Objective follows:  

  1. Verify that CAPA system procedure(s) that address the requirements of the quality system regulation have been defined and documented. 
  • The CAPA procedure should include procedures for how the firm will meet the requirements for all elements of the CAPA subsystem. 
  1. Determine if appropriate sources of product and quality problems have been identified. Confirm that data from these sources are analyzed to identify existing products and quality problems that may require corrective action. 
  • This analysis should include data and information from all acceptance activities, complaints, service, and returned product records. 
  • Examples of other sources of quality data include quality audits, installation reports, lawsuits, etc. 
  1. 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. 
  • This can be accomplished by reviewing historical records such as trending data, corrective actions, acceptance activities: component history records, process control records, finished device testing... and other quality system records for unfavorable trends. 
  1. Challenge the quality data information system. Verify that the data received by the CAPA system are complete, accurate and timely. 
  • Determine if the data received by the CAPA system is complete, accurate, and timely. 
  1. 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. 
  • The analysis of product and quality problems should include appropriate statistical and non-statistical techniques. 
  • The analysis of product and quality problems should include the comparison of problems and trends across different data sources to establish a global (not isolated) view of a problem. 
  1. 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. 
  • Review the firm's CAPA procedures for conducting failure investigations. 
  • Determine whether the depth of the investigation (where possible) is sufficient (root cause) to determine the corrective action necessary to correct the problem. 
  1. Determine if appropriate actions have been taken for a significant product and quality problems identified from data sources. 
  • Where appropriate, this may include recall actions, changes in acceptance activities for components, in-process and finished devices, etc. 
  1. 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. 
  • Determine the effectiveness of these corrective or preventive actions. This can be accomplished by reviewing product and quality problem trend results. 
  1. Verify that corrective and preventive actions for product and quality problems were implemented and documented. 
  • To determine if corrective and preventive actions for product and quality problems and changes have been documented and implemented it may be necessary to view actual processes, equipment, facilities or documentation. 
  1. Determine if information regarding nonconforming product and quality problems and corrective and preventive actions has been properly disseminated, including dissemination for management review. 
  • This can be accomplished by determining which records in a recent CAPA event were submitted for management review.  
  • Review the raw data submitted for management review and not the actual results of a management review. 

Corrective and Preventive Actions (CAPA) system activities consist of verifying or validating, communicating, documenting, and providing relevant information for management review, which are all essential in dealing effectively with product and quality problems. It’s also important when preventing reoccurring issues and preventing or minimizing device failures.

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