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How Deviation and CAPA management can breed success out of failure

How Deviation and CAPA management can breed success out of failure


Errors sometimes occur during drug development, but if pharma companies apply only a temporary solution to the problem, they risk repeating the same mistakes. Helen Lowe at Arriello outlines a best-practice approach that ensures the errors of the past are not repeated.
Editor: PharmiWeb Editor Last Updated: 03-May-2022

For companies to improve their performance, they have to understand their failures. But deep understanding requires more than just making a bit more effort – it needs a change of mindset where failures are not seen as problems but as opportunities for improvement.

Establishing a Corrective Action Preventive Action (CAPA) programme benefits a company in many different ways. A well-designed CAPA programme can enhance and improve a company’s relationships with its clients and vendors, at the same time as cutting costs and reducing the administrative burden on your most highly qualified and valuable staff.

For a CAPA programme to be effective, it needs to be driven by critical thinking, strong problem solving and organisational control from the very beginning. In an ideal situation, CAPA measures should be strong enough from the outset for the final effectiveness check to succeed every time.

Analyse the risks

A best-practice approach means you need to create a clear, well-structured action plan for the CAPA process from the beginning and then follow it to the letter. The process also needs to ensure that each step leads to the next in a logical sequence.

Risk analysis, which is critical for patient safety and identifies the business impact for the organisation if a failure should occur, is a compulsory part of CAPA management. When undertaking this analysis, you need to identify which stakeholders need to be involved in any investigation, set the criteria for grading any situation (from minor to critical), and set out a strict but realistic timeline for any actions that need to be undertaken.

At every level, you need to identify, involve and inform the 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 you cannot put a dedicated CAPA management system in place, you need to involve Quality staff who have skills in project management, including planning and time management.

Analyse the incident

Human error often gets the blame in CAPA investigations but people make mistakes for a reason, so look closely at the context. Poor technology, for instance, can impact people’s performance, and performance levels can also be impacted by factors such an individual’s knowledge of the subject, work satisfaction, work-life balance, or interaction with peers and leaders.

It is also important that the CAPA management process isn’t seen as an impediment to meeting regulatory requirements or to responding to audits quickly. An organisation may not always be able to address symptoms and problems when they arise – but it is important to plan ahead for any actions that might need to be taken.

There are three main categories of actions: 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 and preventing problems from occurring.

Any trends that arise should be looked at from multiple perspectives to see whether previous actions taken by the company actually resulted in improvements to the service or were only effective in the short term.

Involve the C-suite

Senior management should be involved in investigations. Quality investigations and improvements too often tend to be limited to middle manager level, but without the involvement of senior personnel, the problem is likely to keep recurring.

Nevertheless, the quality system itself should not be dependent on particular personnel but needs to be 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.

Effectiveness checks

Effectiveness checks ensure that the preventive action does, in fact, prevent non- compliance from occurring again. Requirements and methods for evaluating the effectiveness of actions should be clear; easy to understand in case there is staff changeover; and should validate if the issue has reoccurred and/or if it could reoccur in the future. 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.

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