CAPA Process

The CAPA process can support your business, removing problems and issues and increasing effectiveness


Most businesses face some degree of issues, failures, and nonconformances. All too often, issues arise in the form of production errors, process failures, or 3rd party supplier issues.  

When these issues happen, businesses require a disciplined process, at the heart of their Quality Management system. One that not only aims to identify what has occurred but also examine why it did, and what measures need to be deployed to prevent it from recurring.   

Without such a methodology, businesses can see impacts on both costs and performance.

While methods like this should be considered best practice, it is also regarded as mandatory, and legislated for, in some industries.

In today’s article, we’ll be looking at one such method, the CAPA process.

What is the Capa process

CAPA consists of two main elements and is an acronym that stands for 

  • Corrective Action (CA)
  • Preventative Action (PA)

The CAPA process is utilized to both identify and then irradicate the recurrence of issues and problems.  

The CAPA process has a variety of attributes which include:

  • The CA process, which is a reactive process targets corrective action around problems and issues,
  • The PA process is a proactive process and targets preventing issues from occurring
  • The two elements do not have to be utilized in series (i.e. CA then PA) they are two distinctly separate activities
  • CAPA is not an isolated toolset and contains some familiar problem-solving tools such as 
    • Root Cause Analysis
    • Fishbone Analysis
    • etc
  • The process involves capturing and assessing data in order to make quantitative decisions.

Where is the CAPA process used

The CAPA process is used in a variety of business environments including (but not limited too):

  • Manufacturing,
  • Food processing,   
  • Design
  • Medical device development
  • Logistics
  • Healthcare/Pharmaceuticals

As we stated in our introduction, in some industries, it’s a legislative requirement for it to be embedded within a companies Quality Management System; for example, in the USA the Food & Drug Administration includes it within standard FDA 21 CFR 820.100.

The CAPA process in detail

Now we know that the CAPA process is built from two processes, let’s take a look at each one in more detail.   

As we stated in the introduction, each element can be defined as:

1/ Corrective Action (CA)

Corrective action aims to:

  • Locate the root cause.
  • Put steps in place to resolve the root cause.

2/ Preventative Action (CA)

Preventative action aims to:

  • Communicate to the business
  • Prevent the issue from returning. 

Do not underestimate the power of communication; it is of vital importance and a key benefit of the method. By educating the business about the issue via a standardized process, the organization is then able to react and utilize this crucial data for future continuous improvement activities.

Now let’s look at some more detail.

Corrective Action

The corrective action phase aims to articulate the issue in such a way to facilitate the identification of the root cause.  

It requires the capture, documenting, and removal of the nonconformities root cause, thus preventing the problem from recurring.

Once identified the business can set about the implementation of permanent corrective action.

Typical steps of this phase include:

1/ Issue identification

2/ Articulating the problem statement

3/ Deploying containment action

4/ Probable causes identified

5/ Problem Description articulated based on data collected

6/ Probable causes reviewed, refined and reduced

7/ Root cause articulated

8/ Determine of corrective action by utilizing root cause data

9/ Implementation of corrective action

As you can see, this process contains a range of steps.

Corrective action typically utilizes standard problem-solving tools like fishbone analysis, 8d, 5 why to facilitate the required problem-solving.

Preventive Action

Preventative action steps include:

  • Implementation of steps that help the mitigation of potential issues and problems
  • Capturing & storing problem statements & permanent corrective action so that it can be useful to the organization in the future.
  • Utilizing lessons learned to identify other processes and systems that may benefit from data captured to either prevent issues or drive improvements. 
  • Analyzing data and trend analysis
  • Update associated organizational documents (including elements such as work instructions and FMEA’s).
  • Creating checklists that help process adherence
  • Implementing preventative maintenance plans for equipment that might drive nonconformance.
  • Conducting lesson’s learned

Building and deploying the CAPA process

Unsurprisingly, the root cause for many issues within a business is often it’s policies, practices, and processes. They may be weak or perhaps non-existent or perhaps they are simply not adhered too by its workforce.

Accounting for process maturity is an essential consideration up front of any CAPA system/process design.  

While the core of the process is standard, most organizations will look to put their own slant on the process during the design phase. 

When looking at designing and deploying the CAPA process, an excellent place to start is a standard that calls it out. We mentioned earlier the regulation FDA 21 CFR 820.100 and the stated objectives of a robust CAPA implementation. (for those outside of the US, this specification is from the Food & Drug Administration). The regulation lists several requirements for a CAPA process. Which the FDA Website summarises as:

  1. Verify that CAPA system procedure(s) that address the requirements of the quality system regulation have been defined and documented.
  2. Determine if appropriate sources of product and quality problems have been identified. Confirm that data from these sources are analyzed to identify existing product and quality problems that may require corrective action.
  3. Determine if sources of product and quality information that may show unfavorable trends have been identified. Confirm that data from these sources are analyzed to identify potential product and quality problems that may require preventive action.
  4. Challenge the quality data information system. Verify that the data received by the CAPA system are complete, accurate and timely.
  5. Verify that appropriate statistical methods are employed (where necessary) to detect recurring quality problems. Determine if results of analyses are compared across different data sources to identify and develop the extent of product and quality problems.
  6. Determine if failure investigation procedures are followed. Determine if the degree to which a quality problem or nonconforming product is investigated is commensurate with the significance and risk of the nonconformity. Determine if failure investigations are conducted to determine root cause (where possible). Verify that there is control for preventing distribution of nonconforming product.
  7. Determine if appropriate actions have been taken for significant product and quality problems identified from data sources.
  8. Determine if corrective and preventive actions were effective and verified or validated prior to implementation. Confirm that corrective and preventive actions do not adversely affect the finished device.
  9. Verify that corrective and preventive actions for product and quality problems were implemented and documented.
  10. Determine if information regarding nonconforming product and quality problems and corrective and preventive actions has been properly disseminated, including dissemination for management review.

(* As per https://www.fda.gov/corrective-and-preventive-actions-capa)

Having taken a look at these, let’s review what the foundations of a good CAPA system should offer:

  • A standardized process that identifies non-conforming products by analyzing company information like procedures, quality records, customer returns, audit data, using this information to also highlight potential causes of future issues.
  • A route of examining nonconformance within the organization
  • A way of recognizing the actions required to both correct and prevent recurrence of nonconformance
  • A method of validating the effectiveness of corrective and preventative actions.
  • A route to implementing change (whether that’s around processes, work instructions, organization or other) in order to prevent quality escapes.
  • A methodology that facilitates communication to the organization to ensure quality and prevent issues arising.

The key point to remember is that your CAPA process is not fixed and should be reviewed as part of your continuous improvement process. Find what works, what does not through evaluation and analysis, and then look to improve.

Benefits of the Capa process

Hopefully, as we’ve described the process you’ve seen for yourself the multitude of benefits that it can provide, we’ve summarised some of them below:

  • Forms part of an integrated Continuous improvement cycle
  • Helps meet legislative requirements
  • Provides a standard problem-solving toolkit
  • Utilizes data to make quantified AND qualified assessments
  • Can be utilized by the whole organization.

Issues with the CAPA process

As with all methods and toolkits, there are some things to watch out for, common problems include:

  • Access to data supporting the evaluation of non-conformances
  • CAPA Process not adhered to within the organizaiton.`
  • Root cause analysis methods overruled by stakeholders who think they know better
  • Lesson’s learned from identified issues are not communicated within the business
  • Once documented the CAPA process is not routinely evaluated to ensure it’s continued effectiveness

Summary

As you can see, there are huge benefits from a developed and integrated CAPA process. Considering the importance of both corrective and preventive phases within your quality management system (and it’s criticality in certain industries), if you haven’t done so already, I’d certainly recommend investigating its deployment.

We hope you enjoyed this article, as ever we’d love your feedback, you can message us on Twitter or simply use the comments section below.

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