Classifying Defect Reports from Business Partners

J

Jim-S

#1
#1
I was hoping to get some general feedback on a topic that has turned the past few days at work into one long unpleasant series of debates and discussions regarding what should and should not be considered a complaint.

The situation is that my company manufacturered a batch of pharmaceutical product for a business partner and then shipped it to their facility. When the business partner received the material they noted that one case was missing the outer shipping case labels and reported the issue to us. I discussed the issue with two other QA managers to get their thoughts on whether this should be received in as a Complaint or a Deviation/Nonconformance investigation. (In my opinion, it didn't really matter, since both investigational paths result in an investigation, identification of root cause, and corrective actions) The two managers both felt that since the report did not come from the field that it should be handled as a Deviation/Nonconformance, so that is how we received it in.

What has followed since then has been a series of debates and discussions involving vice-presidents, directors, and managers. Hours have been spent debating the topic with people arguing that this MUST be received in as a Complaint. - I was just wondering how others would handle such a report.

I view it as something that can argued either way. The product was released by us, but the issue was caught prior to it being sent out to the market. Perhaps I'm incorrect in my thinking.
 
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somashekar

somashekar

Leader
Admin
#2
#2
Jim...
Keep it simple sir.
You are a manufacturer and what you received is a complaint.
All the simple guidelines are in 820.198
Your business linkage or the complaint not being from market are not classified for any other consideration.
The 820.198 talks about all complaint being processed in a uniform and timely manner.
There is nothing to feel shy about calling a complaint as a complaint and then addressing accordingly.
 
Ronen E

Ronen E

Problem Solver
Moderator
#4
#4
Jim-S said:
I was hoping to get some general feedback on a topic that has turned the past few days at work into one long unpleasant series of debates and discussions regarding what should and should not be considered a complaint.

The situation is that my company manufacturered a batch of pharmaceutical product for a business partner and then shipped it to their facility. When the business partner received the material they noted that one case was missing the outer shipping case labels and reported the issue to us. I discussed the issue with two other QA managers to get their thoughts on whether this should be received in as a Complaint or a Deviation/Nonconformance investigation. (In my opinion, it didn't really matter, since both investigational paths result in an investigation, identification of root cause, and corrective actions) The two managers both felt that since the report did not come from the field that it should be handled as a Deviation/Nonconformance, so that is how we received it in.

What has followed since then has been a series of debates and discussions involving vice-presidents, directors, and managers. Hours have been spent debating the topic with people arguing that this MUST be received in as a Complaint. - I was just wondering how others would handle such a report.

I view it as something that can argued either way. The product was released by us, but the issue was caught prior to it being sent out to the market. Perhaps I'm incorrect in my thinking.
Click to expand...
Hi,

What does "a business partner" mean?

If they pay you, they are your customer, hence part of your market, hence the product did go to the market and you got a customer complaint.

If they don't pay you, then one way or another they are an extension of your operations, hence the problem is internal (deviation).

The main difference between handling an external complaint and a deviation is that complaint handling has the additional aspect of damage control with the complaining party. If the source is not a customer (paying), then to stay efficient you should minimize the communication with them to getting the essential information regarding what happened and how, and (if applicable) communicating back what needs to happen in the future to avoid recurrence (corrective actions).

From a practical standpoint, if so many senior managers in your organization think it should be counted as a complaint, why not?... Someone might be concerned about a KPI not looking pretty, but the fact is that it did happen and the way to look good is to put in the work to prevent recurrence, not to play around with tags. If someone is concerned about creating a precedent, they could initiate a SOP revision to add clarifications as I stated at the beginning of this post, so next time something similar happens one could argue "it was a bit vague before so we took a conservative approach, but then it was clarified so we don't necessarily have to do the same thing again."

Cheers,
Ronen.
 
Last edited:
P

PaulJSmith

#5
#5
Your product escaped your facility before it was completed. So, it's exactly that; an escape. You should treat it as such. Call it whatever you want, but treat it as what it is.
 
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