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.
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.