The FDA had issued a warning letter to this global cardiovascular stent manufacturer. The focus of the FDA’s audits centred on manufacturing processes and the Corrective and Preventive Action (CAPA) system.
An engineering team from PA Consulting Group had initially been engaged by the client to characterise, standardise and improve manufacturing processes, when it became apparent that the client was failing to bring their CAPA system under control.
PA was engaged to close the backlog of CAPA projects, and implement an effective and sustainable CAPA process.
PA aligned the CAPA process with the company’s Six Sigma problem-solving discipline, and implemented a programme management office focused on proactive elimination of risks to deliver sustainable solutions.
The systematic improvement of the CAPA process performance was pivotal in restoring the company's reputation with the FDA and a key element in the subsequent lifting of the warning letter.
Three months after implementing the proactive management approach, CAPA initiatives were closed in an average 42 days, down from 98 days.
The improved performance allowed the facility to tighten the acceptable CAPA cycle time from 60 to 45 days. As result of increased visibility, the number of new CAPA projects increased from two per month to more than five per month.
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