What Are the Benefits of a Robust and Compliant CAPA System?

Effectively managed CAPAs can benefit a company in its quest to remain compliant. However, they can also be made overly complex, be allowed to remain open for too long, or be too complex for staff to understand. We look at how a robust and compliant CAPA system can benefit a company and we provide useful tips on ensuring that your CAPA system performs for your company.

Pharma biotech companies around the globe are struggling to juggle numerous priorities and challenges. One of their biggest struggles is to effectively manage CAPAs.

Let’s begin by using this 5-step checklist.

1. Do you use a scored risk assessment process to determine the need for an investigation and CAPA?
2. Do fewer than 10 percent of your investigations conclude human error as the root cause?
3. Do you maintain and use metrics on how your CAPA system is performing?
4. Do you perform effectiveness checks that include objective and measurable criteria?
5. Do fewer than 25 percent of your CAPAs need extensions?

Unless you answered YES to all the questions, your CAPA system may not be as robust and compliant as you think.

Pharma biotech companies that lack robust and compliant CAPA systems may be struggling with one or more of the following common problems:

• Employees focus on closing the CAPA to release the batch rather than applying a systemic approach to resolve and remediate the problem and prevent it from happening again
• CAPA actions address symptoms but do not fix the underlying root causes
• There is a lack of expertise in developing, implementing, and maintaining (and sometimes enhancing) a CAPA system that integrates compliance into business practices and quality systems
• The CAPA system may be good, but personnel do not use, or do not have the knowledge and expertise to effectively use, the CAPA system to improve profitability by decreasing the cost of quality
• The CAPA system doesn’t use effective checks and thereby results in unintended consequences
• The CAPA actions add unnecessary complexity and inevitably lead to non-compliance with local procedures

A CAPA system is not just a formal tracking system, it is the central component that encompasses all the mechanisms and data sources that a sound quality system uses to monitor the quality of people, processes, products, and problems. The CAPA system is an overarching umbrella – all control points flow through to the CAPA system.

There is a fine line between having too many vs. not enough CAPAs, so one should strive towards a Goldilocks model – where you have the number of CAPAs that are just right. A facility must have appropriate mechanisms in place to determine when a situation merits the issuance of a CAPA. It must be understood that not all investigations will result in a CAPA. One example may be an investigation in which the root cause has not yet been determined. Some companies in this situation will initiate a CAPA anyway, which is not value-added. CAPAs initiated at this stage will divert resources to complete the action plans but will not reduce the failure rate. Sometimes it is necessary to wait until there are several non-conformances before a pattern that points to the root cause can be identified.

Once the root cause is identified, you should evaluate the CAPA. Some CAPAs will be quick and easy to implement whereas the others may have long lead times, e.g. equipment redesign. If the CAPA remains open for a longer period, the CAPA system should track the status and document the milestones. It is not good practice to leave a CAPA open long with no indication of activity.

Time can pass quickly and at times a CAPA deadline is missed. The first solution to this problem is to set realistic timelines for completion; too many people are overly optimistic about the time needed to implement improvements. However, when it becomes clear that the deadline will not be met, it is a good idea to include a system for CAPA extensions. It is recommended that you have an escalating level of approvals for extensions – for example, the first extension requires department approval while the last extension may require executive level approval. The system should have the ability to capture status information and milestones as well as a rationale for the extension and the risk of not closing as per the original date.

Pharma biotech companies can improve their CAPA processes by:

1. Implementing a CAPA system that is simple, easy to follow, risk-based and easily integrated throughout the organization
2. Implementing a standard set of root cause analysis tools
3. Using data analysis tools and processes within the CAPA system
4. Configuring data so similar problems can be categorized to facilitate trending and further data analysis > Determining the frequency of data analysis and metric review
5. Identifying adverse trends in real-time and intervening before they deteriorate into non-conformances

During the CAPA process, if you discover a new piece of information or come across a new learning, evaluate, and communicate it. Also ensure that it cascades through and eventually gets implemented to other products, quality systems, and across the organization as appropriate.

While trying to develop or enhance a robust and compliant CAPA system, companies sometimes overdo things and end up adding unnecessary elements in their CAPA system. These elements start strangling the company and thereby cause the death by CAPA effect.

Companies need to be very careful as they can easily fall into this overkill trap. They can suffer death by CAPA by having either too many CAPAs or an overly complicated system. An effective system requires a balanced approach. You do not want to develop a CAPA program that ends up requiring a CAPA!

• Use a risk-based filter and prioritize events according to size, scope, and severity
• If possible, develop and use a scoring system
• Adequately train qualified personnel
• Get advice from experts

Our experts work with the largest and most dynamic pharma biotech companies globally helping them to manage GMP compliance issues. Here, we have provided several articles written by our experts that further look at issues relating to CAPAs.

Discover 5 Ways to Make Your CAPAs More Effective: We look at five ways to make CAPAs more effective and to ensure that they resolve quality and regulatory issues.

Moving Beyond Human Error in Biopharma Operations and CAPA Programs: We joined industry experts from AstraZeneca, Takeda, and Biogen to look at important topics related to human performance in pharmaceutical operations.

White Paper: Hierarchy for CAPA Effectiveness: Have you ever reviewed an investigation report and wondered whether the proposed corrective and preventive action (CAPA) would be effective? We propose our CAPA hierarchy to help investigators select an appropriate corrective/preventive action that is most likely to deliver the desired outcome.

We can help your company with any issues relating to CAPAs including consultancy and training for your teams. Complete the form below and we will get in touch with you.