GxP Lifeline

Is Your CAPA Process Providing Adequate Return on Investment? If Not, Why Not?

2021-bl-effective-failure-investigation_715x320Corrective action and preventative action (CAPA) is often identified as the heart of the quality management system (QMS). It links to every area of the business yet it is often considered an expense rather than an opportunity to increase revenues. If you really think about it, systemic failures that require failure investigations to root cause can be very costly. They require resources – people, time, and money – but if managed properly, an effective CAPA system will reduce the cost of poor quality and increase overall revenues.

Over the past several years, the U.S. Food and Drug Administration (FDA) has increased focus on the effectiveness of failure investigations during inspections. I looked at this data several years ago and recently examined the last three years of data. Unfortunately, this review of the 483 observations still identifies CAPA as the number one reason for non-compliance. Further evaluation identifies continued concern for effective investigation of the failure to identify root cause. In many cases, this is also linked to having inadequate procedures and/or training for the process. Effective failure investigation to true root cause is the heart of the CAPA system.

Another recent change in the quality regulatory environment is the increased focus on risk management. The introduction of risk based decision making for business processes (ISO 9001:2015 and ISO 31000) and the updated ISO 14971:2018 document for product and process risk provide extra guidance for the increased emphasis.

As we all know, the purpose of having regulated products is to ensure the safety and effectiveness of the products in the market. The expectation is to integrate risk activities into all processes within the QMS. Implementing effective corrective actions adds greater focus on the safety and effectiveness of the products.

A key expectation of a QMS is demonstration of capability to achieve intended results. The organization is expected to analyze data to demonstrate this effectiveness. When your organization identifies the same non-conformances over and over, it indicates the system is not effective or capable of achieving intended results. This is where the risk management processes integrate with the CAPA system.

If the product and process risk assessment has been performed and is being “maintained” (updated regularly), then volume of complaints and reports to the regulatory agency should decrease. In fact, I believe we really shouldn’t have any recalls or reportable incidents if the risks are properly assessed.

As such, risk management must be integrated into all of the QMS processes:

  • Complaint Analysis – If we did the appropriate product/process risk assessment, why did the complaint occur? Did we miss something? Did the control measure that was put in place fail? Did we validate that the control measure would be effective?
  • Change Management – Does this change introduce any new risk? Does it change any risk that we have already identified? Does it have an impact on the control measures already in place?
  • CAPA – Did the failure analysis identify true root cause? Was the effectiveness check properly performed?

In addition to integrating risk management into the CAPA process, CAPA and risk management should also be integrated to post-market surveillance activities. As countries move forward with harmonization of regulations and standards, CAPA becomes even more critical.

One approach that I find works well is the implementation of a Corrective Action Review Board. This means identifying a team of leaders to review, approve and assign resources as necessary. It allows the business to prioritize and assign resources more effectively than trying to get everything completed at the same time. Trying to do that stretches all resources so thin that it would actually cost more than working on them based on impact (quality and financial). This prioritization also gives flexibility to make changes in priorities as necessary to meet the business needs.

The owner of the CAPA presents the plan, resource needs and financial consideration to the review board on a regular basis.

So how do you estimate financial impact or cost of poor quality?

  • Estimate the resources spent as a result of the issue. # failures * average # hours to investigate the issue * average hourly wage for individual investigating. (i.e. 50 complaints * 4 hours to investigate* $35/hour = $962000)

  • This is a basic cost of poor quality calculation. If you don’t eliminate the problem you are basically throwing away money. If you eliminate this problem, then you do not have to apply the resources to investigate/solve. This would increase the basic revenue.

Industry must really take implementation and maintenance to heart. Build the business foundation on continuous improvement and CAPA activities. Consider these 5 simple steps:

  • Analyze your current CAPA process.
    • What does the data show?
    • Is my process effective?
    • Do we include a cost of poor quality calculation?
    • Are we solving issues at the root cause or just putting Band-Aids on things?
  • How well is the CAPA process integrated throughout the other processes?
    • Risk Management – are we preventing/solving issues?
    • Complaints.
    • Planning - there are many requirements for planning throughout the standards.
  • Keep it simple.
    • Don't over complicate.
    • Assign adequate resources.
    • How do you prioritize these activities?
  • Choose the correct tool.
    • There is no one size fits all for determining root cause
    • Invest in education for all involved to understand the tools ang how to get to root cause and solve the issue and prevent recurrence
  • Educate your staff.
    • Leadership – the importance of the CAPA process and not just putting a Band-Aid on the problem hoping it will go away
    • Investigators – the staff investigating the root cause of the problem must know how to use the investigation tools and how to select the appropriate tool
    • All employees – enable them to be more engaged and understand the “why” behind what they do not just “check the box!

While CAPA is a 4 letter word, it is not one of the bad ones!


Christine Park is a solution-focused, results-oriented Business Executive with extensive Business Development/Quality Systems/Regulatory Affairs Executive. An independent consultant and experienced trainer she has demonstrated success and business acumen to integrate quality into daily business activities while reducing costs. She takes a pragmatic, common sense approach to defining and establishing good business practice to achieve goals with quality and assurance to regulatory compliance. Christine has experience with Medical Device, Pharmaceuticas, Biologicals, Food Safety as well as general quality management systems. See more information on her website.

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