ISO 9001:2015 8.3.4 & validation of new equipment

[AndyN]

I disagree. I have completed retrospective validations that caught issues that have been hidden for years.

For die cut products? Since IQ/OQ/PQ is for "special" processes, that's likely to happen. For simple products which can be sampled, not so much.

 

[Candi1024]

Hi Candi,

No, there doesn't appear to have been one done at the time, I've spoken with the customer and they have pretty much laid out what you have said. They're not going to request that we go back and redo everything but that we show we have considered the NC and will act on it now for any future events of validation

Oh good, That seems to be a very reasonable request.

 

[Candi1024]

For die cut products? Since IQ/OQ/PQ is for "special" processes, that's likely to happen. For simple products which can be sampled, not so much.

Ok fine, you got me, I know nothing about the die cutting process.


I simply meant in general. Many medical device companies would expect an IQ/OQ whether it was a special process or not. It's the PQ that would be dependent on that.

 

[John Broomfield]

I disagree. I have completed retrospective validations that caught issues that have been hidden for years.

Candi,

Would you please describe some of those hidden issues for us.

Many thanks,

John

 

[Deli88]

While I agree with your sentiment, Andy, this was apparently a customer auditor so I think the push back should be a little more gentle.

I would certainly push back on the NC and express that this is not a special process and you verify the output of the equipment though appropriate sampling and/or monitoring.

Have you done any IQ/OQ on any of your other equipment? Is the customer that wrote this up in the regulated world (drug, device, auto, aero, etc)?

Hi ScottK,

The customer is in the medical device world along with most our customers. We have never carried out formal IQ/OQ on any machinery, most of the equipment has been in operation for 30 years, and the outputs are measurable.

Our procedure is fairly weak on how to address validation, we mostly follow customer requirements for guidance when qualifying new products. The procedure needs a complete overhaul, however I don't want to tie ourselves up in knots and over complicate the procedure. If you have any advice or guidance on how to carry out IQ and OQ on new equipment I'd appreciate any input.

 

[Marc]

Here are some legacy discussions which may help (food for thought):

IQ/OQ/PQ Literature - Learning and implementing IQ/OQ/PQ procedures at my facility
IQ, OQ, PQ and Process Validation Sequence

site:elsmar.com iq oq at DuckDuckGo - For lots more conversations here related to IQ, OQ and PQ.