Simplify CAPA in 7 Steps

List the specific information available that demonstrates the problem exists. For example, the evidence for a product defect may be a high percentage of service requests or product returns, while the evidence for a potential equipment problem may be steadily increasing downtime. A CAPA request form is commonly used to initiate a CAPA action and collect preliminary information. At minimum, these forms should include fields to record the following information:

• Date of the CAPA request.
• Source of the request.
• Description of the problem.
• Evidence observed.
• Initiator of the preliminary assessment of potential impact and/or risk action.

The situation that has been described and documented in the “Identification” step must be evaluated to determine the need for action and the level of action that is warranted. The potential impact of the problem and the actual risks to the company and/or customers must be assessed. Essentially, the reasons that the problem is a concern must be documented.

An important part of any evaluation is a specific explanation of precisely why the documented problem is a concern. This may include possible repercussions the problem may have in terms of costs, function, product quality, safety, reliability, and customer satisfaction.

Using the result of the impact evaluation, the seriousness of the problem can be assessed. The level of risk associated with the problem may affect subsequent actions that are taken. For example, a problem that presents a serious risk to the function or safety of a product may be assigned a high priority and require immediate remedial action. On the other hand, an observation that a particular machine is experiencing a rising level of downtime each month may have a lower priority.

Based on the outcome of the impact and risk evaluations above, stakeholders may determine that immediate remedial action is needed to remedy the situation until a thorough investigation is conducted and a permanent solution is implemented. If remedial actions are necessary, the actions and the resources required should be documented. Any expedient actions taken to avoid further adverse effects must be explained, and the actions taken then recorded. This documentation will become part of the “Action Implementation” and “Follow- Up” steps of the CAPA. In some instances, you may decide that the remedial action is all that is needed. In such cases, you should always document:

• The rationale for that decision.
• Evidence that appropriate follow-up was done (see the “Follow-Up” section below).
• A record that the CAPA was closed out.

Specialized forms are commonly used to explain the remedial steps that must be taken to avoid any further adverse effects. These “Remedial Action Required” forms typically include fields to record the following information:

• Identifying number for the CAPA action.
• Date the form was issued.
• Indication of corrective or preventive action.
• Description of the problem.
• Evidence observed.
• Potential impact of the problem.
• Remedial action(s) required.
• Date remedial action was completed.
• Name of person(s) who completed the remedial action.

For a CAPA process to be embedded long-term, it must align with business initiatives and empower employees to solve a variety of problems.

The investigation process should establish a well-grounded method for accomplishing work within the organization. A formal reporting system must be in place for accountability and documentation purposes. All departments and business functions involved must be aligned if the desired result is to be achieved. When alignment is lacking, personnel tend to revert to familiar, ineffective methods.

Training on any new process steps should be provided at the appropriate level. It’s unlikely that new skills can be implemented into old systems, nor can the new systems and processes be properly supported using the old approaches. Teach the right skills to those who need and will use them. Ensure that they understand the new skills and can apply them, and confirm that proficiencies are task appropriate (e.g., internal investigators need greater proficiency in cause analysis than the operators who answer investigators’ questions).

The likelihood that personnel will use any new skills that they’ve been trained upon is low without ongoing coaching, support, accountability for effective investigations, and reliable corrective actions. One powerful reinforcement approach is to appoint an appropriately trained individual to be a cause analysis process advisor. Most importantly, equip key employees who have been trained in root cause analysis with tools that enable them to conduct investigations and implement corrective actions. To institute a truly closed-loop problem- solving approach, the system must be flexible and tie all quality processes together, from the initial nonconformance to the corrective action.

• An objective for the actions that will be taken.
• The procedure to be followed.
• The personnel that will be responsible.
• Any other anticipated resources that may be needed.

Every action must have a goal. The first step in conducting the investigation is to state an objective for the action. Whereas in the “Identification” phase, the problem was defined and the current situation was documented, the objective is a statement of the desired outcome of the CAPA. State what the situation is expected to be when the action is complete. The statement should generally explain that the problem will be corrected, all effects of the problem identified and rectified, and controls will be put in place to prevent the situation from occurring again.

Specific instructions should be devised to outline what must be done to determine the contributing and root causes of the problem. The investigation procedure will vary depending on the circumstances, but it must incorporate a comprehensive review and analysis of all the circumstances related to the problem. Consider equipment, materials, personnel, procedures, design, training, software, and any external factors.

A critical element of the investigation procedure is assigning responsibility for conducting each aspect of the investigation. Any additional resources that may be required should also be identified and documented. For example, specific testing equipment or external analysis may be necessary.

The forms used to collect investigation procedure information are the basis of the written action plan for the investigation into the problem. These forms should include the overall objective and instructions for conducting the investigation, as well as the person(s) responsible for the investigation and an expected completion date. They should include specific fields to capture the following:

• Identifying number for the CAPA action.
• Date the investigation was initiated.
• Objective of the action.
• Basic instructions.
• Name of the assigned investigator(s).
• Expected completion date.
• Approver.
• Date of the investigation procedure approval.

By considering all possible causes, appropriate information and data can be collected and ultimately used to determine the root cause of the problem.

This step may involve combining the results of various tests and a review of records, processes, service information, design controls, operations, or any other data that may lead to a determination of the fundamental cause of the problem. The resulting documentation should be complete and address all the possible causes that were previously determined. This information is used to zero in on the root cause of the problem.

Determining the root cause often requires answering a series of “Why?” questions and digging deep until the fundamental reason for the problem is found. For example, if an investigation reveals that the operator had not been properly trained and had forgotten an essential step in a machining process, the improperly trained operator is the immediate cause of the problem. However, the operator may not be the root cause. Continue asking questions like, “Why was the operator not trained properly?” “Are the existing training programs adequate?” “Are trainings being implemented properly?” Further investigation may reveal that the operator was on vacation when the training was given and, therefore, did not receive the proper training when other operators did. The root cause of the problem is a lack of follow-up in the training program since no mechanism existed to cross-check training records to ensure that a missed training session was rescheduled.

List all the activities and tasks that must be accomplished to either correct the existing problem or eliminate a potential problem. For a CAPA program to be effective, it is important to take a global approach, so make sure to identify all actions that will be required to address everything related to the situation. For example, in the training situation described above, the root cause was a flaw in the training program. One of the actions that should be taken is to review all previous training records to determine if this problem resulted in other employees not receiving the necessary training.

List any documents to which modifications will be required and describe the modifications in general terms.

Describe any changes to processes, procedures, or systems that will need to be made. Enough detail should be included so that it is clearly understood what must be done. The expected outcome of these changes should also be explained.

Employee training is an essential part of any change that is made and, as such, should be a vital part of the action plan. To ensure that the actions taken will be effective, any modifications made to documents, processes, etc., must be effectively communicated to all persons or departments that will be affected.

If necessary, the action plan should include any controls or monitors that are put in place to prevent the problem’s occurrence or recurrence.

This document should include a list and summary of all the activities that were completed as outlined in the action plan step.

List all documents or other specifications that have been modified. This documentation is typically attached to a final report on the CAPA action, which facilitates the verification of the changes in the next “Follow-up” step.

The implementation and completion of all changes, controls, training, etc., must be verified, and the evidence that this has been done must be recorded. Appropriate information should be compiled as documentation that all actions have been completed successfully.

Another key aspect of any CAPA is verifying that the actions taken were effective. A thorough evaluation should be conducted to ensure that:

• The root cause of the problem has been solved.
• Any resulting secondary situations have been corrected.
• Proper controls have been established.
• Adequate monitoring of the situation is in place.