No Cross Functionality
CAPA is generally a process that medical device
companies own for their quality functions. Quality
is actually responsible to determine when exactly
CAPA is needed as it plays a vital role in the
implementation and effectiveness of the quality
management system.
Is it justified for a quality function to categorize
the nonconformities as CAPA without considering
all the aspects and inputs? Definitely not!
Do organizations collect data and information
from the resources to take decisions on
categorization? It is doubtful due to a lack of
transparency and commitment among the
departments.
In fact, most of the medical devices company
don’t have their trustworthy source of truth that
could enable them to make informed decisions.