The CAPA Process for Medical Devices

CAPA is an abbreviation for Corrective and Preventive Action, which translates into a corrective and preventive action. The CAPA process was first introduced in 2006 by the US Food and Drug Administration (FDA) as part of the issued Quality Systems Guidance, which later became the basis of the ICH Guideline Q10 relevant to the pharmaceutical industry. The ICH Guideline Q10 has now also been included in Part 3 of the EU GMP Guide, highlighting the implementation of the CAPA process in the pharmaceutical industry.

In the area of medical devices, the corrective and preventive measures are dealt with separately in ISO 13485 (Chapter 8.5.2: "Corrective measures" and Chapter 8.5.3: "Preventive measures"). Therefore, the standard does not explicitly mention the CAPA process as such, but rather divides it into the separate processes CA ("Corrective Action") and PA ("Preventive Action"). Normatively required are the documentation and evaluation of these improvement and preventive measures. Therefore, the implementation of a CAPA process, which unites these two separate processes, offers itself here.

A CAPA process is used to deal with deviations or errors that have occurred (correction) and to avoid future deviations and errors (prevention). Here, a distinction is made between the terms "correction" and "prevention": A corrective action always refers to an error that has already occurred. Preventive measures, on the other hand, are only those that are taken before a deviation can occur at all (for example, sufficient labeling for product-related operation). The required analysis of potential errors, deviations and their consequences can be carried out as part of a risk assessment.

Errors or deviations that occur, for example, can emerge from the assessments of the management system during the internal audit and from customer feedback or, for companies in the medical technology or pharmaceutical industry, the most serious case due to security-relevant incidents (for example triggered by faulty goods due to inadequate controls in production). A CAPA process initiated by deviations or errors therefore always starts with the actions and corrections to be taken immediately in order to limit further effects. Depending on the severity, for example, this can be an immediate stop of production and distribution in the worst case scenario.

The actual CAPA process begins after the immediate measures and can be compared in its execution with the PDCA (Plan-Do-Check-Act) cycle: It starts with a detailed error description, the problem is accurately evaluated and documented. This step can be equated with the planning phase of the PDCA cycle. Subsequently, the necessary corrective measures are determined after carrying out an error cause analysis. These may be, for example, a change in the production process or an exchange of a component important to the completion of the product. Preventative measures are also taken to avoid this error in the future. Strictly speaking, these are also corrective measures (purely preventive measures are by definition only those that are perceived before the occurrence of an error). The defined measures are implemented accordingly after their verification and validation (see "Do" phase of the PDCA cycle). At the end, the effectiveness of the measures is checked (effectiveness check) and the success evaluated accordingly.

In a phase to be compared with the "Act" phase, it justifies whether and why the CAPA process was successful (see Figure 1 below).

Figure 1

If the CAPA process was not or only partially successful, another CAPA process must be initiated. A successful CAPA process may result in a re-evaluation or addition to the risk analysis.

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