When inspecting a firm’s CAPA process, the FDA publishes the following 10 inspection objectives as a flowchart for their inspectors to follow and make determination as to whether a firm’s CAPA process meets regulatory requirements:
This is to ensure that the firm has met the basic requirement of 21 CFR 820.100(a) which requires medical device manufacturers to establish and maintain CAPA procedures.
Here, inspectors are confirming that manufacturers are meeting the requirements of 820.100(a)(1) for existing problems and corrective actions by analyzing existing quality audit reports, quality records, service records, complaints, returned products, and other sources of quality data to determine if the firm is appropriately utilizing the data sources to identify existing causes of nonconforming product or other quality problems.
Taking this a step further, inspectors are digging into the firm’s ability to implement preventive measures from the identified data sources to ensure that potential causes of nonconforming product or quality problems are being addressed to adequately mitigate risk of unrealized issues from occurring.
By step 4 in the flowchart, the inspector is still ensuring that the requirements of 820.100(a)(1) are fully met, which requires scrutiny of the identified data sources, such as process, work operations, concessions, quality audit reports, quality records, service records, complaints, returned products, and any other data sources that might be available. The firm needs to be prepared to furnish the inspector any available records and to have them scrutinized for completeness and accuracy.
This inspection item is to ensure that the manufacturer is meeting the requirements of 820.250, which requires, where appropriate, that the manufacturer establish and maintain procedures for identifying valid statistical techniques required for establishing, controlling, and verifying the acceptability of process capability and product characteristics, and that sampling plans, when used, are based on valid statistical rationale, such as establishing an AQL based on ANSI/ASQ Z1.4-2008. Firms often make the mistake of thinking that they are too small, or that their high-mix, low-volume situation absolves them of responsibility to understand statistical sampling and process capability, but they often find that the inspectors do not agree and end up with findings during their inspection.
This one is a big one; put in place to ensure that manufacturers meet the requirements for 820.100(a)(2) – investigating the causes of nonconformities in the quality system – and of 820.90(b), which dictates how nonconforming material is properly reviewed, dispositioned, and documented, including any rework, which would require documented re-evaluation including a determination for any potential adverse effects of the work in the DHR. Firms should expect inspectors to spend a lot of time digging into how they react to defects to ensure that proper control of all nonconforming and reworked material is maintained and documented and that root cause investigation is taking place.
With data sources firmly identified and the inspector having had plenty of time to scrutinize the firm’s records, they then confirm the actual actions taken, as reported and documented by the manufacturer. 820(a)(3) requires that, following the root cause investigation, corrective and preventive action be identified prior to implementation. Here, the inspector will be challenging the adequacy of the identified corrective and preventive actions to ensure that they appropriately correlate with the identified root causes and associated risk.
Implementing corrective and preventive actions can sometimes have adverse effects elsewhere in the quality system. 820.100(a)(4) requires manufacturers to verify and validate corrective and preventive actions to ensure that they are effective and that they do not have other adverse effects. Firms should expect for the inspector to look for evidence that corrective and preventive action activity had been verified and validated prior to final implementation to ensure that the actions would effectively eliminate or reduce the risk of recurrence and that the actions are not presenting undue risk elsewhere in the system that might outweigh the benefits of implementation or put an end-user at risk.
Remember, if it wasn’t documented, it didn’t happen. Changes, including corrective and preventive action activity resulting from quality problems, need to be documented. This is, of course, important for many reasons – providing an audit trail or history, for lessons learned and read-across activity, etc. Generally, any changes to your quality system need to be documented; firm’s should expect inspectors to verify that this is the case.
Correlating with the requirement to document changes, these changes and activities need to be effectively communicated. Engineers need to be aware of changes so they can be employed in future product and process designs. Production workers or other employees responsible for product quality need to be aware of changes as they’ll likely affect their daily work. Managers need to be aware of changes so they can adequately understand the impact or use the information for future planning. Plus, CAPA information is a requirement for management review in 820.100(a)(7). CAPA data needs to be available to the right people at the right time for many reasons.
Can you say that your current CAPA system would effectively pass an FDA inspection? If you’re looking for a solution to help capture CAPA data such as root cause analysis, corrective actions taken, effectiveness reviews, verification and validation activities, and trend and recurring issue reporting and analysis, reach out for a demo of our PRRQuest module for Problem Reporting and Resolution to let us show you how we can help you meet the FDA requirements outlined in the QSR and effortlessly illustrate compliance during your next FDA inspection.