ISO 9001:2015 8.3.4 & validation of new equipment

[Deli88]

Hi All,

I need a little help with a NC from a customer.

The finding was put against section 8.3.4 of ISO 9001:2015 which we exempt ourselves from. They requested we carry out a validation of a new machine back in 2015. the audit has since thrown up the following finding:

The Validation of the Hawkes machine (Atom) equipment in Control room 1 contains the following deficiencies:
Part 1: No protocol exists to define upfront the acceptance criteria for the validation or to describe and justify testing required or specify the sample size
Part 2: No deficiency report process exists to recognise and document appropriately any out of specification results reported during the validation activity
Part 3: Support print outs or data were not signed or dated. Original data was not attached to the report
Part 4: Validation of process procedure OP21 Rev. 01 reviewed and found to be not fit for purpose of driving effective protocols, contemporaneous data generation and reporting or a process for dealing with out of specification data

I can provide some limited info if required

Thanks

 

[John Broomfield]

Hi All,

I need a little help with a NC from a customer.

The finding was put against section 8.3.4 of ISO 9001:2015 which we exempt ourselves from. They requested we carry out a validation of a new machine back in 2015. the audit has since thrown up the following finding:

The Validation of the Hawkes machine (Atom) equipment in Control room 1 contains the following deficiencies:
Part 1: No protocol exists to define upfront the acceptance criteria for the validation or to describe and justify testing required or specify the sample size
Part 2: No deficiency report process exists to recognise and document appropriately any out of specification results reported during the validation activity
Part 3: Support print outs or data were not signed or dated. Original data was not attached to the report
Part 4: Validation of process procedure OP21 Rev. 01 reviewed and found to be not fit for purpose of driving effective protocols, contemporaneous data generation and reporting or a process for dealing with out of specification data

I can provide some limited info if required

Thanks

Deli88,

Are you talking about a die cutting machine?

Did your company design the machine?

I’m trying to validate your auditors selection of clause 8.3.4.

Thanks,

John

 

[Deli88]

Hi John,

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

 

[Golfman25]

Is the press as important as the tool?

 

[John Broomfield]

Deli88,

Thanks.

Being as your company did not design the press it does seem that your auditor has cited the wrong clause.

But clause 8.5.1g may apply if the press is part of a process that results in products that are not or cannot be verified.

If so, that may explain why the auditor expects to see evidence that the press has been validated as we do with crimpers for example.

Please confirm if the press results in products that are not or cannot be verified.

Thanks,

John

 

[AndyN]

Deli88,

Thanks.

Being as your company did not design the press it does seem that your auditor has cited the wrong clause.

But clause 8.5.1g may apply if the press is part of a process that results in products that are not or cannot be verified.

If so, that may explain why the auditor expects to see evidence that the press has been validated as we do with crimpers for example.

Please confirm if the press results in products that are not or cannot be verified.

Thanks,

John

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).

 

[Kronos147]

It the auiditor said against 8.5.1 and added "output of"

The Validation of the "output of" Hawkes machine (Atom) equipment in Control room 1 contains the following deficiencies:
Part 1: No protocol exists to define upfront the acceptance criteria for the validation or to describe and justify testing required or specify the sample size

Perhaps this would make sense to me.

 

[ScottK]

Your auditor is incompetent. Don't waste time addressing the issue. Simply write to your registrar's operations management and reject the finding, explaining you don't want the auditor back. The finding is a load of techno-babble and not worth the time it took to write it.

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)?

 

[AndyN]

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)?

Oooops, my bad! Yup, can't do much about customer auditors and incompetence...

 

[Golfman25]

Oooops, my bad! Yup, can't do much about customer auditors and incompetence...

Take them to lunch and get them drunk.