CAPA Management is Worth Doing, and Worth Doing Well

Mistakes can occur during both drug development and after launch, but if pharmaceutical organizations apply a temporary solution to the problem, this just leads to repeated mistakes, which is a waste of time and resources. We need to work more effectively to learn from past errors, which also means looking at systemic failures in processes. Corrective action preventive action (CAPA) management provides a structure to uncover the root causes of problems, solve them, and build solutions, as well as look for potential problems that might arise in the future. And effectiveness checks allow for the review of such preventive measures to ensure that what you have put in place works for the long-term benefit of the company. Helen Lowe at Arriello outlines a best-practice approach to deviation and CAPA management.

For companies to improve, they need to understand why they sometimes fall short. But understanding the root cause of errors requires a change of mindset under which failures are reframed as areas for improvement rather than being regarded as disasters.

Here is where corrective action preventive action (CAPA) comes in. Implementing a well-designed and effective CAPA program can benefit a company in many ways. It can cut costs, reduce admin for your most highly qualified and valuable staff, and enhance and improve a company’s relationships with both vendors and clients.

A CAPA program should be driven by critical thinking, strong problem-solving, and organizational control from the outset. In the normal run of things, the final stage of a CAPA management process checks that whatever remedy is put in place is actually going to work. However, in an ideal situation, CAPA measures should be strong enough from the get-go for the effectiveness check to be successful every time — and this won’t happen if the organization fails to address the root cause of the issue. 

Logical Sequencing

Creating a clear, well-structured action plan for the CAPA process and following it to the letter is crucial to the best-practice approach. The process also needs to take account of the dependencies between all phases in CAPA management and ensure that each step leads to the next in a logical sequence. 

Risk analysis is a compulsory part of CAPA management and is critical for patient safety, as well as identifying the business impact for the organization if a failure should occur. As part of this analysis, you need to identify which stakeholders need to be involved in any investigation, determine how any situation should be graded (from minor to critical) and by what criteria, and set out a strict but realistic timeline for any required actions.

At every level, communication is crucial — identifying, involving, and informing the right people who can give the investigation accurate information. This will get to the root of the issues involved and ensure that they are resolved more effectively. A CAPA management system is useful here, to provide a clear and transparent way to share information from the start of the CAPA process to the end. It should inform relevant personnel about what input they are expected to provide, manage approvals, and trigger actions to agreed timelines. If a dedicated CAPA management system cannot be put in place, you need to involve Quality staff who have skills in project management, including planning and time management.

Causes, Not Symptoms

CAPA investigations often cite human error as the cause for the failure, but people make mistakes for a reason, and those reasons need to be discovered if you aim to make improvements. Therefore, it pays to look more closely at the context of the incident. Technology can impact human performance — for example, if an interface is unclear or badly designed — while performance levels can also be impacted by interaction with peers and leaders and by other factors, such as a person’s knowledge of the subject, work satisfaction, or work-life balance. When deciding what actions to take, it is important to separate causes from symptoms.

It’s also important that the CAPA management process isn’t seen as an impediment to meeting regulatory requirements or to responding to audits quickly. Organizations are often tempted to patch over issues rather than take actions to address both the symptoms and the root cause. It’s not always possible for an organization to address symptoms and problems as and when they arise, but it is important to plan ahead for any actions that might need to be implemented once you have identified an issue.

Actions fall into three main categories: immediate or containment actions are aimed at containing the issue quickly and making sure that processes are not disrupted; corrective actions are aimed at eliminating the root cause; and preventive actions aim to improve processes and prevent problems from occurring in the first place. 

Multiple Perspectives

Trend analysis has a very important role in highlighting whether previous actions taken by the company actually result in substantive improvements to the service or were only effective in the short term. All the different phases of CAPA management can filter into trend analysis, providing data and reporting on routine process monitoring, risk management, impact analysis, and complaint management. In addition, reports might include performance information related to personnel or vendors. If data analysis shows that problems keep occurring in the same area despite corrective actions having been taken, this indicates that the effectiveness check has failed.

Senior managers should be involved in investigations, ensuring that the highest levels of the company are alerted to any gaps. Quality investigations and improvements too often tend to be limited to the middle manager level, but, without the involvement of senior personnel, the problem is likely to keep increasing, and this could eventually jeopardize the flow of the project and even have a negative impact on relationships with clients and vendors.

Nevertheless, the quality system itself needs to be based on the right tools and infrastructure and not be contingent on the skills of particular personnel — otherwise, the system depends entirely on retaining highly skilled people. Having both good people with planning and project management skills and an effective CAPA management system helps to slash administrative overhead and reduces the potential for human error.

Repeated failures are a useful guide to where improvements should be targeted and offer your organization an opportunity to learn from its mistakes. It is all too easy to turn a blind eye to systemic problems in a company and apply repeated temporary solutions to problem areas, many of which may be only partial fixes. This is especially the case when an organization is busy focusing on getting through an audit or bringing a product to market.

If you can streamline processes and remove routine administrative tasks, this is a good first step that enables staff to focus more on quality rather than process. It may all take time and effort, but the end result is greater patient safety and an improved reputation for the business.

Effectiveness Checks

Effectiveness checks are designed to ensure that whatever preventive actions you take prevent non-compliance from happening again. Verification consists of actions taken beforehand to ensure that remediation plays out as expected, and validation is performed after implementation to ensure that the solution worked.

You should set down clear, simple requirements and methods for evaluating the effectiveness of any actions taken. These should be easy to understand in case there is staff changeover and should validate whether the issue has re-occurred and if it ever could.

Helen Lowe

Helen Lowe has over 16 years’ experience within the pharmaceutical and biological sector, with in‐depth knowledge and extensive global PV QA auditing experience involving local operating companies, affiliates, co‐developments, marketing/license partnerships, distribution, and regulatory due diligence. She has conducted numerous GCP clinical investigator site audits, medical information audits, and regulatory audits, and has assisted with computer system validation audits. She has also participated in or managed several health authority inspections (including FDA, BfArM, MHRA, AEMPS).