HELEN LOWE
Auditing and Quality Assurance Director, Arriello, Ireland

Abstract

Pharma companies may make mistakes during drug development but if they apply only a temporary solution to the problem, this can just lead to the error being repeated. So how can we work more effectively and ensure we are not repeating the mistakes of the past? Helen Lowe at Arriello outlines a best-practice approach, showing how 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. Effectiveness checks then 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.

If a company wants to improve performance and outcomes, it also has to recognise and understand its failures. But this entails more than just making a bit more effort – it needs a change of mindset so that failures cease to be seen as problematic but are instead viewed as an opportunity to correct areas that need 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 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 that won’t happen if ...