MICHAEL SCHAEFER
CAPA
The process for corrective and preventive actions is a key element in quality systems for medical devices. During my audits I observe, that requirements are not yet fully understood and implemented. Doing proper root cause investigations to come up with an adequate action plan remains a challenge. It is also the missing effectiveness check which triggers nonconformities during audits.
Templates for CAPA
The attached templates may be used for Corrective and Preventive Actions. Trainings are available for CAPA including workshops.
Results of a short CAPA survey 2014/2015
A non-representative and non-controlled survey was conducted by the author to gather some data from non-systematically selected medical device experts. The survey does not claim any completeness or correctness of the results. It aims to show trends and opinion within the medical device industry only. Summary: 67% reported more than 20 CAPA’s annually. The ratio of escalating early warnings up to CAPA varies widely. The median is about 1:10. The majority of participants expect an increase in CAPA. Most participants are using risk-based CAPA triggers. 5 Why’s and historical data are most often used in root cause analysis. About 60% of participants are reporting significant recurrences of failures. Recurrence rate of failures seem to be higher after 2 years compared versus 6 months after CAPA closure. Most of the participants handle failure investigations reactively. Degree of training is 75% and can be considered high.
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