7 Steps of CAPA for Pharmaceutical Industry

Implementing an effective corrective or preventive action capable of satisfying quality assurance and regulatory documentation requirements is accomplished in seven basic steps:
  1. Identification - clearly define the problem
  2. Evaluation - appraise the magnitude and potensial impact
  3. Investigation - make a plan to research the problem
  4. Analysis - perform a thorough assessment with documentation
  5. Action Plan - create a list of required tasks
  6. Implementation - execute the action plan
  7. Follow Up - verify and assess the effectiveness

1 - Identification - clearly define the problem

The initial step in the process is to clearly define the problem. It is important to accurately and completely describe the situation as it exists now. This should include the source of the information, a detailed explanation of the problem, the available evidence that a problem exists.

This should include:

• The source of the information

The specific source of the information is documented. There are many possible sources: Service requests, Internal Quality Audit, Customer complaints, Internal quality audits, Staff observations, Trend data, QA inspections, Process monitoring, Risk analysis, Process performance monitoring, Management review, and Failure mode analysis. This information is important for the investigation and action plan, but also useful for effectiveness evaluation and communicating the resolution of the problem.

• Detailed explanation of the problem

A description of the problem is written that is concise - but complete. The description must contain enough information so that the specific problem can be easily understood.

• Documentation of the available evidence that a problem exists.

List the specific information, documents, or data available that demonstrates that the problem does exist. This information will be very important during the investigation into the problem. For example, the evidence for a product defect may be a high percentage of service requests or product returns. The evidence for a potential equipment problem may be steadily increasing downtime.

• Corrective/Preventive Action Request form
A sample form is provided “Corrective/Preventive Action Request that can be used to
initiate a CAPA action and collect the initial information.

2 - Evaluation - appraise the magnitude and impact

The situation must be evaluated to determine both the need for action and then, the level of action required. The potential impact of the problem and the actual risks to the company and/or customers must be determined. Essentially, the reasons that this problem is a concern must be documented.

An evaluation should include:

•Potential Impact of the problem

Determine and document specifically why the problem is a concern and what the impact to the company and/or customers may be. Concerns may include costs, function, product quality, safety, reliability, and/or customer satisfaction.

• Assessment of Risk
Using the result of the impact evaluation, the seriousness of the problem is assessed. The level of risk that is associated with the problem may affect the 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 an increasing level of downtime each month may have a lower priority.

•Remedial Action that may be required
The potential impact and risk assessment may indicate a need for some immediate action to remedy the situation until a permanent solution can be implemented. In some cases the remedial action may be adequate. If so, the CAPA can then be closed, after documenting the rationale for this decision and completing appropriate follow up.

• Remedial Action form
A sample “Remedial Action” form is included. This form should be used to explain the steps that must be taken to avoid any further adverse effects.

3 - Investigation - make a plan to research the problem

A written procedure for doing an investigation into the problem is created. A written plan helps assure that the investigation is complete and nothing is missed.

This procedure should include:

• The objectives for the action
The objective is a statement of the desired outcome(s) of the corrective or preventive action.
The action will be complete when all aspects of the objective have been met and verified.

• An investigation strategy
A set of specific instructions for determining the contributing and root causes of the problem is written.
This procedure directs a comprehensive review of all circumstances related to the problem and must consider: equipment, materials, personnel, procedures, design, training, software, external factors.

•Assignment of responsibility and required resources

An important part of the investigation procedure is to assign responsibility for conducting each aspect of the investigation. Any additional resources that may be required is also identified and documented. For example, specific testing equipment or external analysis may be required.

• Investigation Procedure form
A sample “Investigation Procedure” form is included. This is a written plan of action for the investigation into the problem. It should include the overall objective and the instructions for conducting the investigation. The person or persons responsible for the investigation and an expected completion date should also be entered.

Continue to Complete Procedure of CAPA for Pharmaceutical Industry (Part II)