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PQ validation qualification - Asked to write a PQ protocol

#1
Hello,

I'm new to a lot of this but have some time lurking here. My question revolves around a recent process qualification for a customer. We were asked to write a PQ protocol. This protocol had an acceptance criteria in it. The criteria required involved an X% requirement of yield at each work station. We were well within those "planned results" (ISO13485).

When we discussed the results of the PQ the customer stated that we failed because we had failures in our output. The customer divided the failures by component induced and process induced. There were some of both. They said that because some of the failures were process induced we failed the PQ and would need to run it again.

It seems to me that we met the criteria of acceptance and are now being asked to meet a different acceptance criteria.

What am I missing? I have been told to back off from the customer but I would like to learn from this failure.
 
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Marc

Fully vaccinated are you?
Staff member
Admin
#2
Were any of their PQ requirements in contract review? That is, when was acceptance criteria communicated with you? Did your customer review and approve your protocol at some time?
 

Ajit Basrur

Staff member
Admin
#3
Hello,

I'm new to a lot of this but have some time lurking here. My question revolves around a recent process qualification for a customer. We were asked to write a PQ protocol. This protocol had an acceptance criteria in it. The criteria required involved an X% requirement of yield at each work station. We were well within those "planned results" (ISO13485).

When we discussed the results of the PQ the customer stated that we failed because we had failures in our output. The customer divided the failures by component induced and process induced. There were some of both. They said that because some of the failures were process induced we failed the PQ and would need to run it again.

It seems to me that we met the criteria of acceptance and are now being asked to meet a different acceptance criteria.

What am I missing? I have been told to back off from the customer but I would like to learn from this failure.
Did you not obtain customer approval for the PQ protocol?
 

Ajit Basrur

Staff member
Admin
#6
They said as long as there was a process breakdown, the qualification/validation is consider a failure.
The "breakdown" has to be analyzed to determine if additional controls are required to make the process robust and repeatable. In my view, to just cover under a process breakdown and label a failure is not a right thing to do. As you mentioned in your first post, the acceptance criteria was met so technically not a failure. Even to mark this validation exercise a failure, what will you attribute the failure to?
 

indubioush

Quite Involved in Discussions
#7
It seems to me that there might be a miscommunication regarding acceptance criteria. For example, let's say the PQ is for a bonding process. If the operator accidentally applies an inadequate amount of glue during the process, and rejects that one unit, that is scrap (accounted for in the yield). After the appropriate number of units have been manufactured for the PQ, the bond strength is tested on those units. If any of the bonds do not meet the bond strength criteria, the whole PQ is a failure.

Not sure if this correlates at all to what you are doing, but I think there is some miscommunication here. I think your customer just didn't review the PQ protocol and made some incorrect assumptions. Since you are posting in the med device section, I assume your customer is a medical device company. Reading this guidance might help:

http://www.imdrf.org/docs/ghtf/fina...g3-n99-10-2004-qms-process-guidance-04010.pdf
 
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