Validation of New Process Equipment - What are the ISO 9001 requirements?

[qualitycube]

What are the requirements, per ISO 9000, for the validation of new processing equipment? If you replace a piece of equipment with something equal to or better than the old one, is it enough to document that:
A. The equipment is properly installed per the manufacturer's instructions
B. That the guages and controllers are set to the recommended settings
C. That test material has been ran through the process and that the end
results are within stated parameters
Is there more that we are required to do per ISO?

 

[Wes Bucey]

What are the requirements, per ISO 9000, for the validation of new processing equipment? If you replace a piece of equipment with something equal to or better than the old one, is it enough to document that:
A. The equipment is properly installed per the manufacturer's instructions
B. That the guages and controllers are set to the recommended settings
C. That test material has been ran through the process and that the end
results are within stated parameters
Is there more that we are required to do per ISO?

Welcome to the Cove!
Actually, none of those things are "shalls" under ISO9001:2000.
They are all good things to note under Section 6.3 Infrastructure. The method of documenting such things is NOT prescribed in the Standard.

This may seem difficult to accept, but ISO9001:2000 is not as much about documenting everything as the previous version (1994), but more about creating an efficient work environment for the benefit of the organization, its customers, and employees.

Thus said, it is enough that the organization is satisfied that its infrastructure meets its needs and those of its customers and continually evaluates its suitability as time and circumstances change.

In TS16949 (Automotive version of ISO9001:2000), customer requirements MAY dictate you document the new equipment in the manner you suggest, but that is beyond the requirements of ISO9001:2000.

 

[GMAC16949]

May Need To Validate

There may be more to it than that Wes. It would depend on a definition of that particular new equipment. At 7.5.2 ISO does provide for "Validation of Processes..." and includes "...approval of equipment and qualification of personnel..." Of course this clause refers to specific equipment / processes; those where resulting output cannot be verified by subsequent monitoring or measurement.

We should also make note of the simple statement TS has at 7.5.2.1 "The requirements of 7.5.2 shall apply to all processes for production and service provision." I know the question deals with ISO but ISO is currently undergoing a revision. In the past the revisions made to ISO sere strikingly similar to already existent QS requirements. Who Knows?

But for the initial question, consider whether your equipment fits that definition provided at 7.5.2.

 

[Caster]

Why not shall

What are the requirements, per ISO 9000, for the validation of new processing equipment? If you replace a piece of equipment with something equal to or better than the old one, is it enough to document that:
A. The equipment is properly installed per the manufacturer's instructions
B. That the guages and controllers are set to the recommended settings
C. That test material has been ran through the process and that the end
results are within stated parameters
Is there more that we are required to do per ISO?

Hi Qcube

It sounds like you are already well on top of this.

We sometimes get so wrapped up in "lawyering" the shalls of ISO that we don't stop to think what it's all about.

As has been said TS16949 is heavy on validating process changes (including perhaps performing a complete new PPAP).

Why - cause the big 3 were sick of hearing "well, we didn't think that change was going to cause a problem" when their lines went down due to a part problem due to a "better piece of equipmet". So they demanded we make sure before we ship.

If you have done the ABC stated, you have already done due diligence, and protected both yourself and your customer...and you didn't have to be forced to by TS requirements. Good on you!

 

[antoine.dias]

Validation of equipment

The A,B & C activities you have done are the right things to do, but the validation is not yet completed with that.

The base line of validation is that validation should prove that the equipment does what it is supposed to do ( that it achieves the planned results ).
IMO This should be in several areas like:

- Quality
- Quantity or capacity
- Safety
- Ergonomics
- Environment
- Availability
- Maintainability
- .....

Hope this helps.
Best regards and success!!

Antoine

 

[qualitygoddess - 2010]

What are the requirements, per ISO 9000, for the validation of new processing equipment? If you replace a piece of equipment with something equal to or better than the old one, is it enough to document that:
A. The equipment is properly installed per the manufacturer's instructions
B. That the guages and controllers are set to the recommended settings
C. That test material has been ran through the process and that the end
results are within stated parameters
Is there more that we are required to do per ISO?

What do you need to do in order to assure that the process is functioning as designed? I would worry more about that aspect of it, than if it meets ISO 9001 requirements. Any auditor doing a process audit is going to observe the equipment as it is used in your overall process, and determine from there if you have done the things that need to be done for the overall process as it relates to 9001.

Good luck. You seem to have it well under control,.

 

[Frank34]

Validation

Some of the best information I have seen for vaildation is from GHTF. The process validation guidance from SG3 (Study Group 3) offers many suggestions on what should be checked in various situations. Additionally, the information is free to all.

www.ghtf.org