Given the numerous inspectional observations citing insufficient established CAPA procedures, it’s worth revisiting what regulators expect to see from your CAPA process.
In a 2014 presentation, FDA’s Joseph Tartal described the basics of effective corrective and preventive action—a resource every company should use to evaluate against their own processes. Among many important points, one stands out as particularly useful when for ensuring FDA CAPA compliance:
“Manufacturers should consider that their corrective action and preventive action documentation can demonstrate to FDA that the manufacturer’s quality system is effective and enables the manufacturer to identify problems quickly and implement effective corrective and preventive actions (or not).”
In addition to helping manufacturers meet the broad expectations for effective CAPA, FDA also makes public its own inspectional guide, which lays out the specific objectives for investigators when evaluating a medical device CAPA system and related documentation. We’ve summarized its main points below and re-formatted its specific requirements and inspection criteria into questions for consideration.
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The Guide to CAPA & Root Cause Analysis in FDA-Regulated Industries
This should serve as your ultimate preparedness checklist when evaluating your CAPA processes for compliance with FDA regulations.
FDA Inspectional Objectives for Corrective and Preventive Actions (CAPA)
1. Verify that CAPA system procedure(s) that address the requirements of the quality system regulation have been defined and documented.
Key Questions:
• Have you clearly defined terms such as "nonconforming product", "quality audit", "correction", "prevention", and "timely"?
• Does your CAPA procedure include other procedures for meeting the requirements for all elements of the CAPA subsystem? Have all of these procedures been implemented?
• Do you have a documented and implemented system for identifying and inputting quality data into the CAPA subsystem? Does this include 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.
Key Questions:
• Do you have documented and implemented methods and procedures for inputting product or quality problems into your CAPA subsystem?
• Are product and quality problems analyzed to identify product and quality problems that may require corrective action?
• Do you routinely analyze quality data regarding product and quality problems? Does this analysis include data and information from all acceptance activities, complaints, service, and returned product records?
• Are you capturing and analyzing data from acceptance activities relating to component, in-process and finished device testing?
• Is information obtained subsequent to distribution, including 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 (quality audits, installation reports, lawsuits, etc.) being captured and analyzed?
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.
Key Questions:
• Are you identifying product and quality problems that may require preventive action? Are you doing this by reviewing historical records such as trending data, corrective actions, acceptance activities (component history records, process control records, finished device testing, etc.) and other quality system records for unfavorable trends?
• Have preventive actions have been taken regarding unfavorable trends recognized from the analysis of product and quality information?
• Are you capturing and analyzing data regarding in-conformance product?
• Are you using statistical control techniques for process controls where statistical techniques are applicable?
4. Challenge the quality data information system. Verify that the data received by the CAPA system are complete, accurate and timely.
Key Question:
• Are all data complete, accurate and entered into the CAPA system in a timely manner?
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.
Key Questions:
• Does your analysis of product and quality problems include appropriate statistical and non-statistical techniques? (Statistical techniques include Pareto analysis, spreadsheets, and pie charts. Non-statistical techniques include quality review boards, quality review committees and other methods.)
• Does your analysis of product and quality problems also include the comparison of problems and trends across different data sources (to establish a global, and not an isolated view, of a problem)?
• Are you ensuring the full extent of a problem is being captured before the probability of occurrence, risk analysis and the proper course of corrective or preventive action are determined?
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.
Key Questions:
• Do your procedures for conducting failure investigations include provisions for identifying the failure modes, determining the significance of the failure modes (using tools such as risk analysis), the rationale for determining if a failure analysis should be conducted as part of the investigation, and the depth of the failure analysis?
• Do you have an established rationale for determining if a corrective or preventive action is necessary for an identified trend regarding product or quality problem?
• Are investigations (where possible) sufficient enough to determine the corrective action necessary to correct the problem?
• Can you verify that nonconforming product and quality concessions have been made appropriate to product risk, within the requirements of the quality system and not solely to fulfill marketing needs?
7. Determine if appropriate actions have been taken for significant product and quality problems identified from data sources.
Key Questions:
• Have you confirmed that no change or changes could have extended beyond the action taken for any given significant corrective actions?
• Have you established a rationale for not extending the action to include additional actions such as changes in component supplier, training, changes to acceptance activities, field action or other applicable actions?
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.
Key Questions:
• Have you determined the effectiveness of all corrective or preventive actions taken? Are any similar product or quality problems present after implementing the corrective or preventive actions?
• Have you verified and validated corrective or preventive actions to ensure that such actions are/were effective and do not adversely affect the finished device?
• Do your corrective actions include the application of design controls if appropriate? (Good engineering principles should include: establishing a verification or validation protocol; verification of product output against documented product requirements and specifications; ensuring test instruments are maintained and calibrated; and that test results are maintained, available and readable.)
9. Verify that corrective and preventive actions for product and quality problems were implemented and documented.
Key Question:
• Have your most recent corrective and preventive actions for product and quality problems and changes been documented and implemented?
10. Determine if information regarding nonconforming product and quality problems and corrective and preventive actions has been properly disseminated, including dissemination for management review.
Key Questions:
• Has relevant information regarding quality problems, as well as corrective and preventive actions, been submitted for management review?
• Do you have a mechanism to disseminate relevant CAPA information to those individuals directly responsible for assuring product quality and the prevention of quality problems?
Next Steps
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Evaluate your current CAPA process on the criteria listed above.
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Highlight and remediate any gaps that exist between regulatory expectations and current processes.
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Follow up on all changes with necessary documentation, training, or other actions needed to implement, support, and maintain those improvements.
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Note any gaps or improvements that require third party assistance from a qualified CAPA professional and contact a firm to pair you with the appropriate resource.
"Insufficient CAPA procedures" has consistently topped the list of most common FDA inspectional observations within the medical device industry since fiscal year 2010. Its prevalence as the top problem year after year makes it clear that many device companies have issues, both known and unknown, within their CAPA programs. Ensuring your procedures are aligned with the expectations of regulators is step one toward building a CAPA program that's compliant, effective and efficient.
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