Involve senior management
As a general best practice, experts believe that it's important to have management involved in CAPA programs, not just the
Quality unit. Involvement of management is crucial for several reasons, explains Parexel's O'Hara:
- Management is ultimately responsible for how the company responds to risks and the actions taken
- Management has the authority and responsibility to provide the resources (e.g., financial, staff) to ensure not only that
the company produces a product that is safe and effective, but also that the environment in which the product is produced
is safe and compliant with trained, knowledgeable staff
- Management can encourage the engagement of staff and open communication with staff, which aids in ensuring success from the
design of a product to a finished product.
"These three factors also encourage staff to anticipate issues, voice their thoughts as to why or how a deviation occurred
and to aid in the corrective and preventive actions taken," says O'Hara. "In my opinion, their knowledge and experience of
the management team is invaluable in the deviation and CAPA systems processes.
Adds Teva's Welter, "Management is ultimately responsible for the health and effectiveness of the firm's quality system. Having
management participate in the CAPA process will ensure that management is aware and can communicate across the organization
the issues that the firm is facing and will no doubt be supporting in any upcoming regulatory inspectional activities. It
is crucial that ownership and accountability for corrective actions and effectiveness of those corrective actions be solidly
with the organization owning the deviation.
1. GAO, FDA Could Strengthen Oversight of Imported Food by Improving Enforcement and Seeking Additional Authorities (May 6, 2010),
2. GAO, Improved Monitoring and Development of Performance Measures Needed to Strengthen Oversight of Criminal and Misconduct Investigations
3. FDA, Enforcement Strategy (Jul. 15, 2010),
4. GHTF SG3, Quality Management System–Medical Devices–Guidance on Corrective Action and Preventive Action and Related QMS
Processes (Nov. 2010),