Corrective Action and Preventive Action (CAPA) Process
Automate compliance with standardized, auditable corrective and preventive action procedures.
When organizations set out to create a set of processes for conducting their work, the focus is on getting things done to meet their customers' requirements, reduce customer complaints, and ensure that the process is efficient and cost-effective.
At the start of a new process, things usually work well, but in time, circumstances change, such as new types of products or services are added, international customers are added, and new staff is recruited. When the process no longer aligns with these changing circumstances, process compliance is compromised and problems creep in. These may include orders not being processed correctly or goods and services not being shipped correctly for specific customers.
When this happens, it is called deviations from the process or non-conformance. We can document, track, and fix these problems with quality management or risk management methodology called the corrective action process.
But what is the meaning of corrective action? How can you write a corrective action plan? And what are examples of corrective action, or types of corrective actions? In this post, we’ll answer these questions and more.
Corrective Action Definition
Corrective action is realizing and defining a problem, determining its cause, and taking appropriate measures to prevent it from happening again.
Exact corrective action definition from ISO 9001
Corrective action is realizing and defining problems, determining their causes, and taking appropriate measures to prevent their recurrence.
The Corrective Action Process (CAP) then helps to document, create, implement, and verify the actions taken.
We apply "corrective action thinking" in our everyday lives but do not formally consider it in that way. A good example is when we find roadworks on a daily commute, after experiencing the frustration of the first journey, we find an alternative route. What we have done is identified a problem and found a solution that meets our needs.
The difference in an organization is that the problem does not just affect one individual. The consequences of not addressing the issue may be much more significant and more costly to the organization, hence having a formal process. The CAP's output is an action plan that sets out the problem, the root cause, and the resolution.
The concept of corrective action grew out of customer audits of suppliers. Problems, also known as non-conformities or deficiencies, would require corrective actions. The manufacturing industry has long provided suppliers with formats for problem-solving. This same approach has been adopted more broadly into the business process area and incorporated explicitly into the BPM methodology.
We should not forget that the CAP is affected when a variant of the process has already occurred. You may ask why the process was set up with known problems in the first place? When developing or reviewing procedures, the objective is always to consider all the potential scenarios for possible deviations and incorporate them into the process. However, given the pace of change, it is a given that change in business circumstances will lead to a deviance from the established process.
When it comes to problem-solving and the CAP, there are a few other techniques used in various circumstances or specific industries. These techniques include:
These techniques complement the corrective actions process.
There are several variants for applying corrective actions to problem-solving, but essentially, they all follow a common approach. One type of corrective action – in fact, the most popular of these – is formalized under the ISO 9001 quality management system. This system is detailed below.
ISO 9001 based: Seven-Step Corrective Action Process:
As highlighted, there are some variants of these steps (refinements to suit specific industries or organizations. The steps may be a simple list or built into sophisticated software solutions. Like all tools, the value is in using them effectively. Simple tools in a craftsman's hand are better than complex software-based solutions that are not fully understood.
If your organization is not using this methodology, then guidelines and checklists can be tailored to a company-specific format for the process when someone makes a corrective action request.
An example of corrective action is this: A popular alternative to the corrective action steps is the 8D Method for problem-solving. This was initially developed by the US Defense Department but was tailored for the automotive industry by Ford. The steps for this are shown in the diagram below:
Another term you may come across as synonymous with the correction process is Corrective and Preventive Action or CAPA.
A typical example format of a Corrective Action Plan is given below:
A popular alternative to the corrective action steps is the 8D Method for problem-solving. This was initially developed by the US Defense Department but was tailored for the automotive industry by Ford. The steps for this are shown in the diagram below:
Another term you may see as synonymous with the correction process is Corrective and Preventive Action or CAPA.
This is a CAPA process built with Integrify's workflow automation platform; the process begins with the reporting of an issue with details and documentation and continues through the investigation and corrections, including review and approval.
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There are numerous examples of corrective actions in various industrial and business applications. These range from:
A corrective action process is a quality management methodology that allows for formal documentation and assessment of industry and business problems.
We recognize that the corrective action process provides a formal documented means of problem-solving. However, we should remember that solid, lasting corrective actions involve more than filling out a template but require disciplined, practical application of the CAPA process.
Finally, let us remember that this methodology helps, but this may be costly after the event has occurred in some circumstances. Think of the major incidents and other safety applications and the potential of something going wrong. So, when developing solutions, whether they may be equipment or process-related, we should endeavor to apply a preventive approach (get it right the first time) and avoid using the corrective actions process.
Integrify is a robust process automation platform that allows you to design and deploy your own custom corrective action process including:
To learn more, schedule a demo to see a live automated process in action and learn more about our platform
To see how quickly you can begin automating your business processes, including CAP. Request a demonstration or trial of Integrify.
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