Understanding the general Philosophy with Complaints and CAPAs

[QACen]

Looking to understand general philosophy with Complaints and CAPAs and get the opinion of how other QA Gurus handle it within their companies.

We generated a CAPA to capture the trend of complaints for an issue. If we receive service calls afterward that is related to the same issue. Must we transfer the service call to a complaint, route the complaint for closure in reference to the CAPA?

Thoughts?
Thank you.

[Randy Lefferts]

In Reply to Parent Post by QACen

Looking to understand general philosophy with Complaints and CAPAs and get the opinion of how other QA Gurus handle it within their companies.

We generated a CAPA to capture the trend of complaints for an issue. If we receive service calls afterward that is related to the same issue. Must we transfer the service call to a complaint, route the complaint for closure in reference to the CAPA?

Thoughts?
Thank you.

Correction fixes complaint.
Corrective action fixes cause of complaint.

I am probably misunderstanding what you are asking. If you are continuing to get complaints on something that has had a corrective action assigned and closed then either a system breakdown is occuring or the correct root cause of the complaint hasn't been identified and handled.

Either way, something is amiss if you are continuing to get complaints on an item that was supposed to have been fixed by a prior corrective action.

[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.

[v9991]

In Reply to Parent Post by QACen

We generated a CAPA to capture the trend of complaints for an issue. If we receive service calls afterward that is related to the same issue. Must we transfer the service call to a complaint, route the complaint for closure in reference to the CAPA?

even if its related to same issue; we need to assess the service call... for eg.,
1)whether its report_able... (regulatory requirements)
2) whether its occurring in the areas/customers after implementation of last/previous corrective&preventive actions? (here point is whether RCA was effective are not!!!)
3) if service call is coming from new area? ( here point is whether CAPA was effective...otherwise you would not have received the call on same problem)


and depending upon above assessment, you would see if there is another investigation required, or whether CAPA needs to be strengthened...etc.,

hope this helps.

[Randy Lefferts]

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.

[QACen]

Thanks Randy and v9991. Great advice and believe that will help me. There are many changes I need to make to our SOPs based on last audits so I plan to definitely throw this in their.

[NikkiQSM]

If you continue to receive a service call on a known issue, why not send out an advisory notice of some kind. Get information from the customers before they call you?

[Deep Krothapalli]

On a cautious note, make sure that CAPA scope also includes service calls, as it relates to the same issue.

I think you can reference CAPA in complaint files for closure, but you would still want to include all the basic investigation details: state the issue, samples evaluation, risk assessment, MDR evaluation. You could conclude the complaint referencing that increasing trend will be addressed by CAPA.

Since you are referencing CAPA in complaint files, you would want to make sure that CAPA is addressed in timely manner.

Deep