ISO 9001:2015 8.3.4 & validation of new equipment

[John Broomfield]

It's for die-cutting! The parts can be checked. The press has nothing to do with anything. The auditor needs to stop, engage their brain or quit auditing (for good).

Andy,

Let’s have the OP confirm the facts first then we can recommend a course of action.

John

 

[AndyN]

Andy,

Let’s have the OP confirm the facts first then we can recommend a course of action.

John

You are unfamiliar with die cutting John?

 

[John Broomfield]

You are unfamiliar with die cutting John?

Andy,

I’ve learned not to leap to conclusions.

The OP may have designed their process so as not have to verify its products.

After all, sorting good from bad product adds no value.

John

 

[somashekar]

Hi John,

Yes, it's a die cut press. We don't make or design them. We use it for cutting parts.

Your customer is drawn into something that is not translated into the appropriate clause. But that is not the main issue.
You need to just have your process capability report that would say that the machine is capable of cutting parts as required.
Some acceptable dimensions, some burr levels that meet the specification, no other abnormalities etc., and if this has not been done, its not too late to have one. The inputs can come from your ongoing production if all is well really.
I don't see any other issues, and perhaps I am not clear with all the parts you mention in your opening post here...

 

[Deli88]

Hi Scott,

Yes, customer is a medical device company. We make a small component for them.

I'm only 6 months in this position and the validation process on the machine was carried out 3 years ago. We had to replace the existing machine as replacement parts had become obsolete for it and we couldn't stand over it's reliability anymore.

The acceptance criteria and results are stated so I don't see how this non-conformance stands. The "original" hand written results from the validation exercise were not kept but there is a typed out version of them held on file. (This should be against 7.5.3.2 of ISO 9001 in my opinion).

Our validation procedure is a little vague, but it kind of needs to be as we need to be flexible from one customer to the next

 

[Deli88]

Hi John,
QC checks are carried out after die cut to verify dimensions as part of the OP for this customer.

 

[AndyN]

Andy,

I’ve learned not to leap to conclusions.

The OP may have designed their process so as not have to verify its products.

After all, sorting good from bad product adds no value.

John

It's not a leap if you know the process (well)

 

[ScottK]

Hi Scott,

Yes, customer is a medical device company. We make a small component for them.

I'm only 6 months in this position and the validation process on the machine was carried out 3 years ago. We had to replace the existing machine as replacement parts had become obsolete for it and we couldn't stand over it's reliability anymore.

The acceptance criteria and results are stated so I don't see how this non-conformance stands. The "original" hand written results from the validation exercise were not kept but there is a typed out version of them held on file. (This should be against 7.5.3.2 of ISO 9001 in my opinion).

Our validation procedure is a little vague, but it kind of needs to be as we need to be flexible from one customer to the next

I would guess that they are expecting IQ and OQ on the machine and maybe the dies. Especially if you have done this for other equipment.

I also think they are citing the wrong clause for this.

 

[AndyN]

I would guess that they are expecting IQ and OQ on the machine and maybe the dies. Especially if you have done this for other equipment.

I also think they are citing the wrong clause for this.

I think they are waaaay off base too - you can physically check a die cut part for quality. Doing IQ/OQ/PQ makes zero sense. It's really for special processes.

 

[John Broomfield]

Hi John,
QC checks are carried out after die cut to verify dimensions as part of the OP for this customer.

Deli88,

Why then would the auditor be looking for evidence of design validation?

You say that historically the machine was validated so did this requirement come from a customer or from your management?

It is not required by the standard alone.

Thanks,

John