Enhancement of CAPA’s and Audits Responses in a Medical Devices Industry
Abstract
In the regulated industry of medical
devices, different issues can compromise regulatory
certifications. The CAPA and Audit system were
presenting a situation regarding the submission of
responses; Timeliness. One of the objectives was to
reduce the quantity of extensions requested. During
the collection and presentation of data using
DMAIC, 24 CAPA’s and 7 audits were analyzed.
Identifying the quantity of extension and its
justifications. The majority of justifications were
about complete a criticality assessment in CAPA’s
and incomplete trainings in audits. After a difficulty
impact analysis, workload and decision making
could be two of the principal contributors for
timeliness. 25% of CAPA’s exceed the general rule
of requesting only two extensions. The audits does
not have a rule. One of the suggested improvement
was the implementation of a tracking system, which
could facilitate the process. Continuous monitoring
should be performed to ensure the effectiveness and
the reduction of extensions requests.
Key Terms - Audit, CAPA, Medical Device,
Timeliness.