Corrective and Preventive Actions (CAPA)
Contents |
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 [1]. 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 [2]
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.
CAPA in quality management
Quality management is the coordinating of activities to control an organization with regard to quality[3]. A typical way of controlling quality is through a QMS. A QMS consists of procedures, instructions, forms, and documentation for the organizations activities to ensure conformity.
Project quality management
CAPA projects are related to quality management of a product/system. Project quality management includes the processes for incorporating the organization’s quality policy regarding planning, managing, and controlling project and product quality requirements in order to meet stakeholders’ objectives[4]. In the guide to the Project Management Body of Knowledge (PMBOK), project quality management is divided into three categories. 1) Plan Quality Management; 2) Manage Quality; 3) Control 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[3] and is categorized under plan quality management in PMBOK[4].
Continuous improvement
Project Quality Management also supports continuous process improvement activities</ref> and is categorized under plan quality management in PMBOK[4]. 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 [3].
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.
| Corrective Action | Preventive Action | |
|---|---|---|
| Type of activity | Reactive | Proactive |
| Role in ISO 13485, FDA, IATF 16949, European Pharmaceutical GMP | Assessment of root cause and action plan to prevent recurrence | Assessment of root cause and action plan to prevent recurrence |
| The majority of ISO management system standards | Assessment of root cause and action plan to prevent recurrence | Replaced by risk-based thinking and improvement. |
The FDA require that CAPA procedure includes:
- identifying existing and potential causes of nonconforming product, or other quality problems;
- identifying the cause of nonconformities relating to product, processes, and the quality system;
- identifying action(s) necessary to correct and prevent a recurrence of the problem(s);
- verifying/validating the corrective and/or preventive action(s);
- implementing and recording change needed to correct and prevent the identified problem(s);
- ensuring information related to the problem is shared with those directly responsible for assuring the quality;
- summitting relevant information for the management review;
- all activities above and their results, shall be documented [6].
The ISO:13485 requirements is somewhat similar to the FDA. The CAPA should system includes procedures for: reviewing nonconformities, finding the root cause of the problem or determining potential nonconformites, evaluate the need for action to eliminate the nonconformity, plan and document action implemented, verifying the action does not adversely affect the ability to meet applicable regulatory requirements or the safety and performance of the product, and reviewing the effectiveness of corrective or preventive action taken[7].
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 [2], [8]. 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. 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 [1].
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 [9]. [10].
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 [9]. Here answering the following questions can be helpful.
| What | When | Where | Who | How much |
|---|---|---|---|---|
| Explain what happened or what you want to happen. | When did the problem occur/was discovered | Where was the problem found? (process, region, department, etc.) | Who is the problem affecting? | How much of a process, product, batch, etc. is affected? |
Information about the problem will often be provided form different parts of the organization, and it can therefore be helpful to develop a standard procedure for collecting this data, and trying to reduce the work load for the employees[11]. A well-defined problem statement is essential for the later work and the effectiveness of the CAPA process [8]. As the cited quote from Charles Kettering emphasizes “a problem well-stated is a problem half-solved”.
Step 2: Evaluation
In step 2 the problem is evaluated to determine why the problem is a concern, and the impact and risk associated with the problem. This can be the possible impact on costs, function, product quality, safety, reliability, customer satisfaction, etc. [8]. The risks can be evaluated based on the probability/impact matrix.
The evaluation is used to decide the priority of the actions as well as the level of investigation. It makes it possible for management to better prioritize encountered complaints, deviations, nonconformance, corrections, and removals [8]. In some cases immediate corrective action is necessary until a thorough investigation have been conducted and permanent solutions have been implemented. The immediate corrective actions can in some cases be enough to correct the problem which eliminate the need for step 5 and 6 [9]. In other cases, it is assessed that no action is required. If this is the conclusion a justification must be documented.
Read more about impact and probability in risk assessment here
Step 3: Investigation
In step 3 a procedure for the investigation (analysis) if formulated. High-risk investigations will have priority over low-risk situations [1]. The purpose of the procedure is to ensure that noting is overlooked in the investigation. The procedure should include information about, but not limited to: the objective for the actions, which resources is required (money, time, testing equipment, personnel, etc.), who is responsible for conducting the investigation, which data is collected, and instructions for determining the causes of the problem including a timeline [8], [9]. The procedure require a review of all circumstances related to the problem and must consider the following:
- External factors
- Software
- Training
- Design
- Procedures
- Personnel
- Materials
- Equipment
The level of investigation is determined based on the risk evaluation results or trend analysis results [8].
Step 4: Analysis
In step 4 the investigation procedure is used to investigate the root cause of the problem as well as other contributing factors. This is done by collecting all relevant data and investigating all possible causes through a Root Cause Analysis (RCA). A RCA is a systematic approach to finding the underling (main) cause of a problem. When a root cause is proper managed the problem stops recurring [8]. In many pharmaceutical processes determining the actually cause of a problem can be a very demanding exercise. This is often due to a significant number of interactive issues [12]. Different tools can therefore be helpful to support this step. The most typical tools include, 5xwhy and fishbone diagram.
Five whys is a simple and very popular tool for RCA. To find the root cause one has to ask what cause the problem, and question the answer five times[13]. The five whys approach can quickly be adapted and applied to most problems. There are three fundamental elements to effectively using the five whys: 1) a good clear statement; 2) honesty and competencies to answer the questions; 3) determination to find the problem[13]. The second method is the fishbone diagram (also known as the cause and effect diagram), which can be used by itself or together with the five whys. The fishbone diagram is used to identify different elements that could be the root cause, divided into different areas. The fishbone diagram are useful if many factors affect the problem [11]. Here can the investigation team brainstorm of contributing factors to the problem in each category. Human factors should not be identified as a root cause, rather as a symptom of a underling problem. In many pharmaceutical processes determining the actually cause of a problem can be a very demanding exercise. This is often due to a significant number of interactive issues [12].
Step 5: Action plan
When the root cause is identified an action plan needs to be developed. The action plan determine what actions will be initiated, how, by who, when and so on. The documentation of that actions are initiated is important to have an effective follow-up [8]. Examples of actions that can be initiated includes: documentation/forms/instruction changes; procedure changes; employee training; or new equipment. A monitoring system or controls also need to be implemented to prevent the problem for recurrent. An example of a CAPA action plan can be seen in figure 6.
