Corrective Action Preventive Action (CAPA)

Corrective Action and Preventive Action (CAPA)

by | May 27, 2021 | QMS

EU MDR Compliant eQMS

Corrective action and preventive action (CAPA) comprises a set of actions aimed to improve an organization’s processes by eliminating the causes of recurring non-conformances and other unwanted situations.

CAPA’s are typically used in industries like medical devices, pharmaceuticals, biotechnology, food & beverages, biologics, chemical, and others. Therefore, various regulations and standards require an organization to take certain actions to remedy and eliminate unwanted situations.

This article discusses the concept of corrective action and preventive action (CAPA), and the differences between the two. We discuss how it can provide long-lasting support to your company and how digital tools could help manage the CAPA process.

All in all, we will cover:

NOTE
This is not a comprehensive guide on corrective action and preventive action (CAPA) for a specific industry like a medical device, pharma, etc., but a simplified overview of CAPA, with an example of various industries. Always follow the standards applicable to you and your company!

What is CAPA?

CAPA or corrective action and preventive action provide a structure for discovering the main cause of problems and resolving those problems. In addition, it verifies the conditions and solutions for future use and then looking for other possible issues and solutions.

Corrective and Preventive Action is a concept inside the Good Manufacturing Practice (GMP) and ISO 13485. CAPA concentrates on the methodical investigation of discrepancies so that their repetition can be avoided.

To guarantee that corrective and preventive actions are operative, the systematic investigation of the failure incidence is essential in recognizing the corrective and preventing actions undertaken.

For instance, a pharmaceutical or medical device company needs to have a system in place that executes corrective actions and prevents action resultant from the examination of non-conformances, product rejections, audits, deviations, governing inspections, and findings, and trends from process performance and product quality monitoring.

To determine the root cause, an organized approach to the investigation process needs to be utilized. The CAPA methodology needs to result in the product as well as process perfection and improved product and process understanding.

What Is the CAPA Process and Why It Is Important?

The CAPA process consists of numerous steps. At the time of the process, each step needs to be executed successfully and submissive to the CAPA program.

It is necessary to ensure that each action taken is documented carefully because proper documentation helps in offering vital data for continuous quality improvement.

In the case of medical devices, CAPA is part of the different areas of the life cycle processes:

  • Production & process controls
  • Equipment and facility controls
  • Material controls
  • Records, documents, and change controls
  • Design controls

During the CAPA process, the real scope of the problem should be determined along with causes and detection methods.

Why Implementation of CAPA Is Necessary For QMS?

As per FDA 21 CFR 820, ISO 9001:2015, and ISO 13485:2016, execution of corrective and preventive actions is considered as the path towards the enhancement and success of quality management systems.

Note that corrective actions are mainly the actions that are based upon the identification of the problem. Through staff suggestions, document reviews, management reviews, or internal audits, it is easy to identify non-conformance internally.

On the other hand, customer grievances/suggestions, customer refusals, non-conformities raised in customer/third-party audits & recommendations by the auditors are some of the external sources that assist in finding the root cause of the problem.

Corrective Action VS Preventive Action

Corrective action is a reaction to all the causes or non-conformance that are stated above and is divided into two phases of action:

  • Identification of root cause – To recognize the root cause, Total Quality Management (TQM) tools like Fishbone or Cause & Effects analysis can be utilized. Note that CAPA is going to be appropriate and effective only if you have effectively recognized the root cause of the problem.
  • Taking important actions – Addressing the root cause requires important and quick actions. By using an efficient approach of the PDCA (plan–do–check–act or plan–do–check–adjust) cycle, the effectiveness of the corrective action requires to be proved periodically.
PDCA Cycle

Preventive action is a prophecy of the problem and a trying method to prevent the occurrence through self-initiated actions and analysis that are related to your products or processes.

Preventive actions can be introduced with the assistance of active participation of staff members/workers through:

• Improvement teams
• Management review
• Enhancement meetings
• Customer reactions

Such an approach not only assures business growth, decreases rejections but also uses the equipment effectively.

Effective CAPA Implementation Tips

To execute the CAPA process effectively from the beginning, you should first address the problems like lack of adequate documentation and lack of adequate actions. The problems should be addressed as early as possible.

Here are some tips that can help you to implement CAPA in a better way:

  • By following the guidelines create a CAPA process quickly
  • To ensure better control, don’t forget to keep the data centralized
  • Make sure to keep your process simple to assure it’s easy to follow
  • At the very first stage of a CAPA process, you need to execute risk management

Clearly distinguish the symptoms from causes and have a clear idea about the problem so that you can reach its root cause more easily.

Steps of CAPA for Life sciences Industry

In seven basic steps, execution of a corrective or preventive action that is capable of meeting quality assurance and regulatory documentation requirements is done.

Identification

This is the first step that involves the identification of the problem. It is necessary to define the situation properly and completely as it exists now. This needs to include the source of the information, complete clarification of the problem, and accessible evidence that the problem exists.

A sample form is offered a corrective/preventive action request that can be used to initiate a CAPA action and gather the initial information.

Evaluation

The situation must be evaluated properly to determine the need for action and then the level of action needed. It is necessary to determine the possible impact of the problem and the real risks linked to the company or customers.

A remedial action plan can be used to explain the steps that need to be taken to prevent any kind of additional adverse effects.

Investigation

A written process for doing an investigation into the problem is formed. This kind of written plan ensures that the investigation is complete, and nothing is missed. This procedure mainly includes an objective for the action, investigation strategy, and assignment of accountability and required resources.

A sample investigation form is included that investigates the problem and contains the objectives and instructions that are required for investigating.

Analysis

The investigation process is used for researching the cause of the problem. The main motive of this analysis is to govern the root cause of the problem defined. Along with this, the contributing cause is also recognized.

A problem analysis form is included which helps record the information which is related to the analysis of the issue.

Action Plan

By using the results from the analysis, one of the best methods for correcting the situation and preventing a future occurrence is better determined by the action plan.

You need to know that tasks that are needed to correct a problem and avoid its reappearance is recognized and included in an action plan.

This type of plan includes changes that need to be made and allocates responsibility for the tasks. With this plan, it becomes easy to recognize a person or person who is accountable for completing each task.

Implementation

The correction and preventive action plan created should then be effectively executed. You need to know that all the required tasks that are listed and described in the action plan are introduced, accomplished, and documented.

Follow-Up

In the CAPA process, one of the most essential steps in completing an evaluation of the actions that were taken. This evaluation should validate the successful completion of the recognized tasks and evaluate the suitability and efficiency of the actions taken.

Once the follow-up is done, the CAPA is complete. It needs to be dated and signed by the authorized personnel.

Therefore, CAPA plays a vital role in the quality management system and improves its effectiveness. Apart from this, CAPA methodology also results in the product as well as process enhancements and ensures a better understanding of the product and process.

CAPA Process

In pharmaceutical and biopharmaceutical manufacturing, it is often seen that somewhere in the line something could go wrong and have an effect on the quality. When this happens, the quality issue needs to be resolved in an effective and compliant manner.

In case, the issue is small and there is a solution that can be performed directly and appropriately then the quality event can be closed with an effective correction easily. However, if the problem is substantial then it will be escalated into a CAPA.

The CAPA best practices can help in firming clinical research not only for compliance purposes but at the same time aid accelerate time to market.

Impact of Risk Management on CAPA

If you are a medical device manufacturer then risk and risk management are synonymous within your daily operations. Medical device manufacturers must bring a device to the market that will not only prove to be functional for a patient but is also safe and effective to use.

In the medical device industry, risk management is a process that is going to stay for a long time. FDA works to ensure that there is stronger risk management in which the manufacturers of the medical device need to have a clear document process for corrective action and preventive action (CAPA).

Proper CAPA processes for corrective action and preventive action (CAPA) is an important step for medical device companies implementing ISO 13485:2016. Therefore, the concept of a risk-based CAPA process has turned out to be foundational for the success of medical device companies.

CAPA Management Software

As you know, for life science organizations, maintaining full compliance with regulatory requirements, those set by ISO and the FDA are critically important to succeeding.

An integrated CAPA management software solution can help companies streamline CAPA management processes. Which typically results in enhanced product quality and safety, increased customer satisfaction, and especially, ensure compliance with the regulations, when implemented properly.

With the help of CAPA management software, it is easy to:

  • Recognize and initiate a corrective and preventive action process
  • Recognize trends
  • Conduct or link to a prevailing investigation and root cause analysis
  • Describe action plans to modify or improve
  • Assure efficacy checks with an organized verification and closure

CAPA software offers risk assessments and notifies you about the possible problems that might take place. This further permits you to changes that are required before an issue takes place.

When the problems occur, the software assists with root cause analysis to know why the issue happened and what steps can be taken to fix the problem effectively.

CAPA software is mainly used by any business that makes use of a quality control system. One of the major uses for CAPA software is by manufacturers who need to ensure that their processed and products successfully meet the regulatory ethics of their industry.

To summarize, here are some benefits of using CAPA management software:

  • Recognize product and process problems along with root cause analysis
  • Successfully solve product quality & process problems
  • Decrease risk and avert quality issues
  • Attain valuable insights into quality problems and possible risks
  • Sustain regulatory compliance for your business

Various Electronic Quality Management System vendors provide CAPA Management Software System as one of the modules of their overall solution. Although, there is no one size fits all solution that would suit every life science organization.

SimplerQMS offers a ready-to-use eQMS in which you can easily manage corrective action and preventive action (CAPA) processes. Furthermore, it seamlessly integrates with other subsystems and critical processes to regulatory compliance, including:

  • Customer complaints
  • Audit Management
  • Change Control
  • And others
Integrated CAPA System

To see our CAPA Management Software in action and learn how SimplerQMS can help your organization achieve better CAPA management processes book a free demo today!

Final Thoughts

The main purpose of CAPA is to determine the reason why quality events like deviations and non-conformances have occurred in the first place and to prevent them from happening in the future.

Corrective action and preventive action (CAPA) is used in various life science regulations and its basics are described in the regulations, standards, and guidelines like ISO 13483:2016, FDA 21 CFR 820, ISO 9001, and Good Manufacturing Practices (GMP).

CAPA processes are present within various quality systems and the data they produce. Integrated CAPA Management software allows life science organizations to streamline all the critical quality processes throughout the entire product life cycle. When implanted properly, this typically results in increased safety and product quality, enhanced customer satisfaction, and above all, ensure compliance with the regulations.

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