The CAPA (“Corrective and preventive action”) process is an essential element in a QM-system of a manufacturing company. Its basics are laid down in the standard ISO 13485 and also in the FDA regulations 21 CFR 820. The main objective is to identify and eliminate the causes of quality defects in medical devices. For that purpose, it is important to have all data available relevant to the quality of a medical device.
CAPA procedures and why they are important
Procedures for CAPA often consist out of several steps. During the process each step must be implemented effectively and fully compliant to the CAPA program. It is important that every action taken is documented thoroughly, for proper documentation provides important data for a continuous quality improvement. Further, the actions taken are essential for any product that must meet regulatory requirements. Thus, CAPA is important to contribute to regulatory requirements, since both the FDA and ISO 13485 require an active program as an essential element of the quality system. Further, the results of the implementation also add to customer satisfaction, for it is possible to correct existing problems or implement controls to prevent potential problems. The same is true for good business practice, for quality problems can have a significant financial impact on a company. With the system procedures the requirements of the regulation are addressed.
The CAPA is part of the following areas of the life cycle processes of a medical device:
- Production and process controls
- Equipment and facility controls
- Records, documents and change controls
- Material controls
- Design controls
During the CAPA process the actual scope of the problem needs to be determined as well as causes and detection methods. Transparent planning of corrective and preventive measures is important to ensure an effective implementation and in a last step control success objectively. To apply the CAPA correctly, it is crucial to understand the difference between a correction, a corrective action and a preventive action, which will be explained in the following paragraphs.
Corrective actions denote the process of reacting to an existing product problem, customer complaint or other nonconformity and fixing it. Thus, actions need to be taken to eliminate the cause of an existing non-conformity, defect or other undesirable situation in order to prevent recurrence. The actions also focus on causes of errors that have already occurred.
During the corrective action process problems or nonconformities need to be reviewed and defined, in particular, the cause of the problem. An action plan will be developed, followed by implementation and evaluation of its effectiveness.
Preventive actions depict a process for detecting potential problems or nonconformities and eliminating them. Actions are taken to remove these causes and to prevent their occurrence. The process includes the initial identification of the potential problem, finding the cause, developing a plan to prevent occurrence, finally implementing it followed by review of the plan effectiveness. The difference to corrective actions here is, that the preventive actions deal with problems that have not occurred yet, therefore it is an action that is supposed to prevent future events. Another aspect is that corrective actions focus more on the cause of problems whereas preventive actions just aim to identify obstacles in general.
Correction vs. corrective actions
The term “correction” refers to the process of repairing or adjusting a product and relates to the elimination of an existing nonconformity, whereas a “corrective action” relates to the elimination of the causes of a nonconformity. In other words, if any nonconformity occurs a manufacturer will want to remove this nonconformity purposefully. With a correction the resulting nonconformity is addressed, and the product is made acceptable again. A corrective action, on the other hand, will take a closer look at the process why the nonconformity evolved and will then try to find the root cause for it and remove it.
For instance, one component is manufactured, and its length is not acceptable, for it does not fit the construction of the overall product. A first investigation of this problem shows that the part was manufactured correctly according to the drawing, but the dimension was non-conforming. The correction here would be to rework the component to the correct length and correct the drawing, so that future produced components will have the right length. For a corrective action the main cause needs to be investigated to see why the drawing was incorrect in first place. Whatever the outcome of this investigation is (missing step, existing step carried out wrong), the method to resolve it will be a corrective action.
Tools such as 8D-Report or a CAQ software can be used to obtain an effective CAPA process.
The steps of the CAPA process according to 21 CFR 820.100
The FDA regulation specifies a CAPA plan consisting of seven steps. These should include:
- Analysis: perform a thorough assessment, every possible cause is identified, and appropriate data is collected. Results of the data collection need to be documented. Primary goal: find the root cause of the problem. List of all possible causes form the basis for collecting relevant information. Collected data must be organised and determines the effectiveness of the analysis. Data is used to complete a root cause analysis. Finding the primary cause is essential for determining appropriate CAPA
- Investigation: develop a plan to research the problem and cause of nonconformities, written document of problem investigation should include objectives for action, investigation strategy, assignment of responsibility and required sources. The objective is a statement of the desired outcome of the corrective/preventive action. Instruction to determine the causes of the problem, all circumstances related to the problem must be considered. Responsible person needs to be assigned.
- Identification: clearly define the problem, should include: the source of the information, detailed explanation of the problem (complete and concise), documentation of the available evidence that a problem exists. Identify the necessary actions.
- Verification/validation: corrective and preventive actions need to be verified and validated to ensure their effectiveness. These actions should have no adverse effect on the finished device. Actions need to be evaluated and evaluation must verify the successful completion of identified tasks. All results need to be verified, validated and documented.
- Implementation: if changes in methods or procedures occur, they should be implemented and recorded. This needs to correct and prevent identified quality problems. All changes must be documented.
- Ensure: responsible persons must be provided with all information related to quality problems and nonconforming products. These persons must assure the quality of the products or the prevention of problems.
- Submission: relevant information on identified quality problems needs to be submitted for management review. The same holds true for the corrective and preventive actions.
On a final note
Now, when it comes to CAPA it is very important to be aware of the difference between a correction and corrective actions. Bearing this in mind, the system will work more efficiently when corrective actions are only applied to systematic problems. We, the seleon gmbh, can support you in developing and implementing your CAPA system the most effective way.
Please note that all data and listings do not have the claim of completeness, are without guarantee and serve the pure information.