Hi I am opinion seeking here

I am going to internally QSIT audit the complaint dept, currently they can and have closed complaints by:

Creating a ECR/ECO

Placing issue in either a live project... or putting in a listing that gets looked at when projects are started, and PM's evaluate what (if anything) will be included in the project from this list.

Having a commitment from software creation that a bug fix will be created in next version e.g. 2.1

Do not take this out of context if there was a serious safety issue then it would be dealt with straight away (I hope.. I will know more after audit), I think this is the action taken for less important/lower impact complaints.

I believe this is done so that the figures show that complaints are getting closed, but in IMHO this is not right.

Just in prepping for the audit I have discovered that some of the ECR/ECO's for a complaint have been cancelled and the complaint is closed.. so I know that we are in non conformance city here... I guess what I am looking for is whether it is an acceptable practice for this to happen with right controls e.g. trigger mechanisms to prevent the above example.... or what I would prefer the complaint to stay open until evidence is shown that it should be closed.

This choice "apperently" may cause a complaint to stay open for 2+ years as a project could take that long... I personally see these as strangers rather than the norm...

Your thoughts and insight would be greatly appreciated

:soap:

I am going to internally QSIT audit the complaint dept... What's QSIT?

...I would prefer the complaint to stay open until evidence is shown that it should be closed.
This is the correct approach, but you should define what constitutes "evidence."

QSIT = Quality System Inpection Technique (FDA Model for auditing)

Evidence = proof that the cause of the complaint has been addressed and prefferably has been shown to be effective... (testing has demonstrated that the issue cannot be repeated)

Hi
I guess it could depend on who complained and what will be the complaint closure communication between the complaintant and the company to ensure that you are in complaince with 21CFR280.198. Can you close your complaint or is the customer wanting to know what actions the company is doing to prevent it again?

I currently work in a service industry and when a customer calls to complain (i.e. wrong part sent) we take care of issue immediately (correct part sent) however, if during the investigation of why the error occured was maybe a process issue (procedure needs to be revised) what benefit is gained by keeping the complaint open untill procedure is revised and implemented? Customer doesn't care that we are revising our procedures - they got the correct part the next day. The CAPA system will monitor the procedure to be revised. I can close out the complaint file.

I believe the methodology that your company is doing is acceptable. Don't hesitate to contact me directly via elsmar if you want to discuss in detail.

Lisa

It sounds as if the complaint system may need to be reviewed.

Having complaints open for 2 years may be appropriate, but it is unlikely to be the best way.

If the customer is satisfied by the commitment to fix the issue in a future update, which would not necessarily be launched anytime soon, arguably that is the complaint closed there and then.



Careful project management then needs to take place to ensure that the fix is created (and if it turns into a no-go, then some feedback to the original complainant would likely be justified).


You have already indicated that urgent issues are handled separately, so your company already has two complaint systems.


A favourite question I ask in audits is how customer "whinges" are dealt with. These are customer feedback items that are not true complaints, but where the customer is nonetheless dissatisfied.

For example, the customer mentions in passing to the sales guy that a product arrived 1 day late. There was a lead time of 12 weeks so in the scheme of things, it is no big deal, and the customer hasn't seen the need to raise a formal complaint - "it was only one day".

But this is negative feedback. Who captures the information, does it get forwarded to the right people, who evaluates it, and makes the decision that a complaint should or should not be entered into the system anyway?

After all, this may be a symptom of a wider problem, additionally sometimes small issues can snowball into something nastier.


In the case you describe, you actually will have "serious whinges", i.e. the customer has identified software issues that need fixing, but not necessarily any time soon.