Process for closing complaint records after a period of inactivity?

Mark Meer

Trusted Information Resource
#1
Another thread to throw out there for discussion...

Going through our complaint records, I've realized that many of them have been open for some time, pending response and/or decision from the customer.

As such, I'd like to revise our complaint-handling system procedure to provide allowance for closing these records if customers become unresponsive.

So, open to discussion:
  1. Is this acceptable in the medical device industry? I know it's common practice in a lot of general consumer-product companies, but I'm concerned that closing out records simply due to customer unresponsiveness may be inappropriate for medical devices. Regulations (ISO13485, FDA QSR), don't seem to indicate either way...
  2. If practiced, what is an appropriate length of time to wait? I'm thinking wording something like: "if no response from customer within 4-weeks, in which period attempts were made to contact the customer, then the complaint record can be closed." (though in general consumer companies, I've seen this period be a low as 72 hours)

Love to hear how others handle this... :read:
 
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NikkiQSM

Quite Involved in Discussions
#2
Another thread to throw out there for discussion...

Going through our complaint records, I've realized that many of them have been open for some time, pending response and/or decision from the customer.

As such, I'd like to revise our complaint-handling system procedure to provide allowance for closing these records if customers become unresponsive.

So, open to discussion:
  1. Is this acceptable in the medical device industry? I know it's common practice in a lot of general consumer-product companies, but I'm concerned that closing out records simply due to customer unresponsiveness may be inappropriate for medical devices. Regulations (ISO13485, FDA QSR), don't seem to indicate either way...
  2. If practiced, what is an appropriate length of time to wait? I'm thinking wording something like: "if no response from customer within 4-weeks, in which period attempts were made to contact the customer, then the complaint record can be closed." (though in general consumer companies, I've seen this period be a low as 72 hours)

Love to hear how others handle this... :read:
I work for a company that supplies plastic for medical device manufacturers.

This is just my opinion based on my experience, but I see no problem with closing complaints after a period of time where there is no actions. In fact, I have had to close out complaints for that reason before.

Why keep following up over and over and wasting your time tracking a potentially "dead" complaint?

I use a time frame of 30 days. If I dont hear anything for that amount of time, the complaint gets closed out and scanned into our system.

If the customer suddenly decides to further the investigation / complaint, simply re-open the complaint.

Just my :2cents:
 

Mark Meer

Trusted Information Resource
#3
Why keep following up over and over and wasting your time tracking a potentially "dead" complaint?
I guess my concern has to do with the implications for regulatory reporting, and product NC records.

I could easily foresee an email correspondence as follows:
CUSTOMER: "The device we bought 2 years ago fell off the table during a session and broke."
COMPANY: "How did it happen? Was it secured properly? What is the serial number? Was anyone hurt? The warranty is expired, so we'd have to charge for servicing."
CUSTOMER: (no reply...)

In this example, we'd just have to use our "best guess" as to reportability determination, and have insufficient details to make any determination as to product non-conformance.

I agree, that it makes no sense to keep records open indefinitely if customers become unresponsive.

But open to discussion is: What is the (generally) expected level of diligence you should document in terms of trying to pry details from the customer? (e.g. 1 week with no attempts, 30 days with one attempt, 2 months with multiple attempts....etc.?)
 
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