Plan Do Check Act - CAPA

Maintaining Control of your CAPA system

Corrective and Preventative Actions (CAPAs) are the foundation of continuous improvement in any Quality Management System (QMS). Your CAPA system, along with the other parts of the QMS, offers great insight into the functions of your company. A lack of control in a function, or unmanaged risks, can be easily spotted through analysing the CAPA system. This is why CAPAs are high priority on an auditor’s agenda when auditing the QMS of a pharmaceutical or medical device company and well as CAPA training.

CAPA training

CAPA training is critical for success, it is often stated that staff must be regularly trained on CAPA.

Often, companies find themselves inundated with open CAPAs. This is most commonly experienced in the aftermath of an audit, where the CAPA system is used to document the issues that are identified, the investigations, the execution of corrective and/or preventative actions, and finally the closures. However, with adequate control and resources, a CAPA system can be maintained in a manageable state.

But what attributes to a situation where you have 50-100 (and growing) open CAPAs and no sign of light at the end of the tunnel? How did you get into that tunnel in the first place? And how do you get out? Here are some Dos and Don’ts to help you identify how you may be unknowingly creating a problem for yourself, as well as how to maintain control of your CAPA system.

DO understand what a CAPA is…

It is quite easy for companies to get used to overusing the CAPA system for tracking any and all issues. This is often the root cause for ever-growing CAPA numbers. Therefore, it is imperative for an organisation to clearly define the inputs that feed into their CAPA system. Sometimes, there are other avenues within a QMS (e.g. Complaints, Internal Audits, etc.) that can handle issues without being forced through a formal CAPA process, and without necessarily compromising on visibility of the issue. The key is not to be hasty, and take the time to understand the problem at hand.

Risk Assessments (RAs) play a vital role in understanding the impacts of every function within an organisation. A proactive RA can help identify areas with higher risks than others, allowing you to set the boundaries of your CAPA system.

DO create robust procedures…

In addition to making the CAPA process a risk-based process, it is essential that the CAPA procedure be simple and robust as well. The procedure must be based on the sound understanding of the inputs and outputs of the CAPA system, and include uncomplicated easy-to-follow process flows. Simple forms that allow the user to record all pertinent information are a necessary supplement to the procedure. Typically, all functions of the organisation that have an impact on quality must be trained on the CAPA procedure and forms.

DON’T be a one-department show…

Generally, RAs that are created with a cross-functional team, rather than single-handedly, tend to be more robust and paint a clearer picture of an organisation. The CAPA process should also be treated in the same way. While it is essential to have a single point of contact when it comes to assigning tasks and accountability, the robustness of a CAPA system is dependent on teamwork. This is where cross-functional communication is essential.

Communication is often underrated, despite being the biggest and most widely known cause of system failures. Very often, the Quality department is left handling CAPAs on its own. In order to ensure that the top priority issues are being adequately and robustly addressed by the CAPA system, all essential functions of an organisation must take accountability and get involved in the process.

DON’T set unrealistic deadlines…

The amount of time and effort required to address a CAPA must be commensurate with the severity of the issue and its impact on product quality and/or patient safety. Every CAPA must include a well-researched and investigated Root Cause Analysis (RCA) to determine why the problem has occurred/recurred. The RCA then helps to identify the tasks to be performed to address the problem, the person or function responsible for each task, and an appropriate deadline for the completion of each task. Setting realistic deadlines is crucial. Underestimated deadlines often lead to wasted time and effort in the extending of CAPA deadlines, whereas overestimated deadlines breed complacency and allow the numbers of CAPAs to build up to an unmanageable level.

DO ensure strong management oversight…

Management has the responsibility to oversee and ensure that the CAPA system is under control and is regularly maintained. This includes the responsibility to clearly communicate within the company the importance of the CAPA process as a means to continually improve the organisation.

Regular management reviews must be conducted to discuss occurring, recurring and potential issues, as well as the effectiveness of CAPAs implemented. It is common to compile metrics and trends as a way to quantify the effectiveness of CAPAs. It is vital that management are abreast of the real performance data for the CAPA system and react accordingly.

DO regular metrics and trending…

Keeping an eye on adverse trends can help identify issues that can be prevented and stop them from occurring or recurring, including the issue of increasing number of overdue CAPAs. Choosing the right metrics can be crucial to ensuring the success of a CAPA system. How long have the CAPAs been open? What stages are they in? Who are the CAPA owners? What are expected completion dates?

Another question to ask is: Are there more Corrective actions than Preventative actions? A positive answer to this could indicate a failure in the identification of issues in advance, where they could have been prevented before needing to be corrected. If you are putting out fires all the time, it could mean that more resources need to be employed to look for potential issues, anticipate them, and implement measures to ensure they do not have a chance of becoming actual issues.

There must be an active output from the metrics analysis, besides just a review. The analysis should record reasons, if any, for resulting in critical metrics being overdue. The organisation should then work towards addressing the root cause of overdue metrics and improve them before the next review.

DO have accountability…

The compiled metrics should aim to highlight parties responsible for overdue CAPAs. This helps to re-enforce the subject of accountability. It also ensures enough attention and assistance where appropriate is given to the smooth transition of CAPAs from the initiation stage to closure stage, and minimizes the number of CAPAs that are stuck in limbo.

DO ensure adequate resources throughout CAPA lifecycle…

Lack of resources is the most common excuse provided for an unmanageable CAPA system. It is also the lack of adequate resources that causes a CAPA system to get to an unmanageable state. A common trend in organisations with high numbers is that adequate resources are initially put into the investigation of issues and creation of CAPAs, but soon dwindle after the CAPA tasks and deadlines are set. As a result, initiated CAPAs are often neglected and remain unaddressed as priority is shifted to manufacturing schedules or sales statistics. With passing time, the bulk of the CAPAs are either swept under the carpet or placed in the too-difficult basket.

It is essential that adequate resources are maintained throughout the CAPA lifecycle, in order to ensure a continuous turnaround of CAPAs and a healthy, manageable system.

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