Corrective and Preventive Actions (CAPA)

Abstract

Corrective and Preventive Actions (CAPA) are procedures designed to handle nonconformity and other undesirable situations. In this context is corrective actions is defined as actions set in motion to eliminate an occurred nonconformities or unwanted situations, and preventive actions as actions set in motion to eliminate potential nonconformities or unwanted situations . CAPA is a mandatory part of the Quality Management System (QMS) for any pharmaceutical or medical device manufacturer reporting to the U.S Food and Drug Administration (FDA). CAPA is also an integrated part of ISO:13485 and Good Manufacturing Practice (GMP) for medical products. The FDA defines the purpose of a CAPA procedure as: collecting and analyzing information, identifying and investigating product and quality problems, and taking appropriate and effective corrective and/or preventive action to prevent their recurrence

The purpose of this article is to give the reader an overview on how to perform a CAPA and which risk to be aware of. In this article a 7 step framework is presented. The steps include 1) Identification; 2) Evaluation; 3) Investigation; 4) Analysis; 5) Action Plan; 6) Implementation; 7) Follow-up.

The context of CAPA

Project quality management

A project is an unique temporary organizational construction with a defined objective. Projects can operate under different constrains such as time, cost, quality, etc. CAPA projects are related to quality management of a product/system. Quality management is the coordinating of activities to direct and control an organization with regard to quality. The CAPA process can be used as a quality management approach when working with project management. A quality management approach is a procedure that describes how quality will be managed in a given project .

Continuous improvement

CAPA is categorized under the section measurement, analysis and improvement in ISO:13485 and closely related to continues improvement processes. CAPA can be an alternative to processes such as the plan-do-check-act (PDCA) by Shewhart (modified by Deming), or other quality improvement initiatives such as total quality management (TQM), Six Sigma, and Lean .

Regulatory authorities

CAPA is most commonly used in highly regulatory industries and is a mandatory part of a Quality Management System (QMS) for any pharmaceutical or medical device manufacturer reporting to the U.S Food and Drug Administration (FDA) or who is compliant with ISO:13485 Medical Devices as well as European Pharmaceutical GMP and IATF. Procedures for corrective actions is also mandatory to include in the QMS for the majority of ISO management systems.

Figure 1: Corrective action vs. preventive action

The purpose of an efficient CAPA process

CAPA is designed to ensure quality and continuous improvement, which is especially important in the pharmaceutical and medicine device industry since lack of control can have fatal consequences. CAPA is one of the most essential regulatory area for both the FDA and ISO in pharmaceutical quality systems and industries producing medical devices , . The CAPA system is practically always a part of the regulatory compliance audit and around 30-50 percent of nonconformance cited by the FDA is due to inadequate performance of CAPA [5]. In the worst case can the FDA withdraw their certification, which is necessary to sell production on the U.S market. The CAPA process is more demanding and rigid than other similar approaches such as the PDCA. This is to ensure that all regulatory demands are fulfilled .

The 7 steps of CAPA

The CAPA process is typically divided into 5-9 steps depending on the scope of the steps. In this article a 7 step framework is introduced. The steps include 1) Identification; 2) Evaluation; 3) Investigation; 4) Analysis; 5) Action Plan; 6) Implementation; 7) Follow-up. When CAPA is performed as a part of a regulatory requirement such as FDA or ISO:13845 documentation through each step is crucial.

Step 1: Identification

The first step of the CAPA process is to identifying, describe and document the problem. A nonconformity incident does not necessarily trigger a CAPA. However it is necessary to evaluated every nonconformance and assess what action is appropriate. Nonconformance can be identified from both internal and external sources, including, but not limited to:

• service request;
• internal quality audits;
• costumer complaints;
• quality assurance inspections;
• staff observation;
• trending data;
• risk assessment;
• management review;
• failure mode analysis;
• Audit findings . .

When a problem is discovered, a clear problem statement should be written. It is important to precisely and completely describe the situation. The problem statement should include the source of the information, evidence of the problem and a detailed explanation of the problem