In Reply to Parent Post by QACen
Thanks Randy. We just initiated the CAPA to do a corrective action on the issue and still working on it with our supplier. So the issue has not been resolved yet. We are continuing to receive service calls that are tied to the issue. Such service calls are documented on a service report form not a complaint form. My question was more relating to documentation.
Technicians or Engineers will make the initial determination if the service call is a complaint. If so, they will create a complaint form. (Our QA department will review the service calls throughout the month to review if whether or not service calls should be complaints.)
If a CAPA form has been documented to capture the trend. Is it necessary to document the service call on a complaint form OR can the service report be referenced to the CAPA directly. Trying to avoid an overkill of documentation. We do not specify in our processes how such should be managed. I hope this makes sense.
I just noticed this is in the Medical Device Related Standards. I am not familiar with any of these standards and what they may require you to do.
In the ISO 9001 requirements it reads :
8.5.2 Corrective action
The organization shall take action to eliminate the causes of nonconformities in order to prevent recurrence.
Corrective actions shall be appropriate to the effects of the nonconformities encountered.
A documented procedure shall be established to define requirements for
a) reviewing nonconformities (including customer complaints),
b) determining the causes of nonconformities,
c) evaluating the need for action to ensure that nonconformities do not recur,
d) determining and implementing action needed,
e) records of the results of action taken (see 4.2.4), and
f) reviewing the effectiveness of the corrective action taken.
It would be in our procedures how we handled new issues after a formal corrective action was in place. Assuming it doesn't violate your standard, I see no reason you couldn't cross reference the new service calls with the existing corrective action. So it would be up to you to define within your procedure on how you handle this. Of course, your standard may say otherwise.