No company can improve its performance if it does not fundamentally recognize and understand its errors and failures. This approach entails a change of mindset under which failures should not be regarded as disasters but instead reframed as areas ripe for improvement.

Here is where implementing an effective Corrective and Preventive Action (CAPA) program can be beneficial on many levels. A well-designed CAPA program can cut costs, reduce the administrative burden on your most highly qualified and valuable staff, and enhance and improve a company’s relationships with its clients and vendors.

An effective CAPA program is driven by critical thinking, strong problem solving and organizational control from the outset. In the normal run of things, it is the final stage of a CAPA management process that confirms that whatever remedy is put in place is 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 root causes.

A Plan of Action

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

Subscribe to the MedTech Intelligence weekly newsletter to stay up-to-date on the latest news and information in medical device development and regulation.One compulsory part of CAPA management is risk analysis, which is critical for patient safety and identifies the business impact if a failure should result. As part of this, you need to identify:

• Which stakeholders need to be involved in any investigation,
• How any situation should be graded (from minor to critical) and by what criteria
• Set out a strict but realistic timeline for any required actions.

Communication—identifying, involving and informing the right people who can give the investigation accurate information—is crucial at every level. This will allow you to get to the root of the issues involved and ensure that they are resolved more effectively. A CAPA management system is useful here, as it provides 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.

Looking Beyond Human Error

CAPA investigations frequently blame failures on human error, but the reasons why people make mistakes also need to be discovered for improvements to be made. So, look more closely at the context of the incident. Technology, for instance, can impact human performance, 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.

It is not always possible for an organization to address symptoms and problems as and when they arise, but it is important to plan for any actions that might need to be implemented once you have identified an issue. The actions that need to be taken 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 are directed towards improving processes so that problems don’t occur in the first place.

Analyze the Trends

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 complaints management. If data analysis shows that problems keep occurring in the same areas despite corrective actions having been taken, this indicates that the effectiveness check has failed.

Effectiveness checks are performed to ensure that the preventive action does, in fact, prevent noncompliance from happening again. Verification consists of actions taken beforehand to ensure that remediation plays out as expected. Validation is done after implementation to ensure the solution worked. Requirements and methods for evaluating the effectiveness of the actions taken should be clear, simply laid out and easy to understand should there be staff changeover.

Trend analysis has a very important role here in highlighting whether previous actions taken by the company result in substantive improvements to the service or were only effective in the short term.

Quality investigations and improvements are too often limited to the middle manager level, but senior management has an important role to play in investigations, ensuring that the highest levels of the company are alerted to any gaps. Nevertheless, the quality system itself should not be dependent on personnel but rather based on the right tools and infrastructure, 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. 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.

Streamlining processes and removing routine administrative tasks is a good first step that enables staff to focus on quality rather than process. It may take time and effort, but the end result is greater patient safety and an improved reputation for the business.