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3 PQ lots mentioned as requirement in PPAP. Is this necessary?

#1
Hi,

In the medical device industry. PPAP to supplier for an injection molded part. Many on the team have been adamant about adding the requirement of a minimum of 3 PQ lots during run-at-rate consisting of 3, complete startup/shutdowns and 8 hr runs each day. My question is, since this is a PPAP shouldn't the supplier be providing the appropriate information regarding the validation? Is it really necessary we list things out?
My thoughts are as follows:
-Validation protocols will be reviewed and approved prior to the runs being executed. This will ensure minimum 3 lot PQs.
-What makes up a lot? I hear all the time that 3 lot PQs are required and I understand why but what decides when one lot starts and another stops?
-Doesn't it go without saying that a PQ should have 3 lots minimum?
-If a run at rate is supposed to demonstrate capability to produce part as well as capacity, shouldn't it be tailored to the parts need/ forecast? (As opposed to the blanket statement of 3 lots consisting of 8 hrs each)

Apologies if this is a ramble.
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#2
Hi,

In the medical device industry. PPAP to supplier for an injection molded part. Many on the team have been adamant about adding the requirement of a minimum of 3 PQ lots during run-at-rate consisting of 3, complete startup/shutdowns and 8 hr runs each day. My question is, since this is a PPAP shouldn't the supplier be providing the appropriate information regarding the validation? Is it really necessary we list things out?

My thoughts are as follows:
  • -Validation protocols will be reviewed and approved prior to the runs being executed. This will ensure minimum 3 lot PQs.
  • -What makes up a lot? I hear all the time that 3 lot PQs are required and I understand why but what decides when one lot starts and another stops?
  • -Doesn't it go without saying that a PQ should have 3 lots minimum?
  • -If a run at rate is supposed to demonstrate capability to produce part as well as capacity, shouldn't it be tailored to the parts need/ forecast? (As opposed to the blanket statement of 3 lots consisting of 8 hrs each)
Apologies if this is a ramble.
Good day Vobro, I am sorry about the delay in this response.

For those of us in the medical device industry, it's all about risk. It is not at all unheard of to require three, four or even five PQs (or at least that many pieces for First Article Inspections). Injection molding gets such requirements in more places besides just you.

Additionally, manufacturers have a recent European Union requirement to ramp up these requirements; they naturally get passed on to you. Yes, run-at rates too. This is based on business risk of your ability to deliver good stuff on time. I think it makes sense from your view to establish blanket statements, but the manufacturer may be trying to normalize their statistics. That can be awkward for large parts. If that's the case for you, I would consult with your SQE.

I don't know how many is in a lot. I suppose it depends on size and material type. Starts and stops can involve new raw material introduction, tooling intervention and/or other factors. All could introduce risk to consistent good outputs.

I hope this helps!
 

kuyakut

Involved In Discussions
#3
We always follow the production shift pattern. If the production is running two 12 hours shift, the PQ run is 2 Lots. The idea of running multiple lots is to simulate normal production operations, unexpected interruptions and mold changeover.
 
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