#Capa process steps how to#

In the Medical Device Industry one can implement CAPA in these 6 key areas. When should you plan to implement CAPA in a medical device manufacturing organization? Identify the actions that require quick amendments.Build a Cross Functional Team with members involved from all the departments in manufacturing facility.

#Capa process steps how to#

How to implement a CAPA plan in Medical Device Manufacturing? Outcome oriented functioningĪ CAPA should be quantifiable and must have clear metrics to evaluate the success of the entire activity. A regular overview and mapping of the resource performance is necessary to identify priorities and eliminate or optimize unused resources. The Lean Six Sigma based manufacturing facilities believe in keeping the system Lean by optimizing the human resource too. The next step is to set & evaluate proper key performance indicators. 2.Defined KPIs for continual monitoring & analysis Rather, it is to continually eliminate the cumulative errors and make the system more robust and productive. 3 Main Elements of a CAPA (Corrective Action Preventive Action) 1.A continually evolving development systemĮvery time we implement CAPA the aim is not to solve a single issue. CAPA (Corrective Action Preventive Action) refers to a set of practices adopted to correct an error that occur repetitively. Analysis of these issues and measures adopted to eliminate them is tagged under the banner of “CAPA”. These errors might look small initially, but when left unattended for a long these may lead to bigger problems. With cascaded processes involved in Medical Device Development some errors may get unnoticed over a period of time. The learnings gained over the years help in refining the processes and staying in sync with latest requirements of the Medical Device Industry.

Every new project comes with its challenges and opportunities to learn. With diversity of projects from different segments of Medical Device Industry, the possibilities of errors, risks, and upgrades are infinite.

A Medical Device Contract Manufacturing Organization is never at rest.