ISO 9001 - 7.1.3 Infrastructure - questions concerning evidence

[Mr Roo]

Manufacturing facility

During our most recent surveillance audit, an auditor issued a non-conformance against section 7.1.3 Infrastructure. The basis was no evidence was presented during the audit that weekly equipment preventive maintenance (PM) required by the organization is being completed as required.

I didn’t fight it because the auditor was correct in their assessment as there was “no evidence” that it was being performed. But the 9001:2015 standard does not require that an organization retain records documented evidence concerning infrastructure, only “...shall determine, provide & maintain...”.

So two questions:

Would the actuality that the lights are on, the machinery is functioning as intended and operators are operating them, be evidence that the organization has determined, provided and maintained the equipment?

Could an auditor request evidence of how an organization “determined” it needed a particular piece of equipment? (I know its a stretch, but asking hypothetically...for a friend...who is not here right now...)

Thanks & Stay Safe

 

[Ninja]

Would the actuality that the lights are on, the machinery is functioning as intended and operators are operating them, be evidence that the organization has determined, provided and maintained the equipment?

I take from your post that your organization requires weekly PM (pretty much because you said so).
If you skipped the PM and had a beer instead...the lights would still be on, and the machinery would still be functioning.
So "No", that is not evidence.
Evidence could be as easy as a check mark on a "to do" list for the maintenance guy...but there has to be some positive record that the organization performed the task that it determined needed to be preformed.

Could an auditor request evidence of how an organization “determined” it needed a particular piece of equipment? (I know its a stretch, but asking hypothetically...for a friend...who is not here right now...)

Why would they? They are measuring you against what the standard requires, and what you require of yourself.
They aren't there to question why you bought a thing...that's what the shareholders are for.
If the organization determined they wanted a left handed wrench because it's cool sounding, so be it.
If the organization then determined it had to be waxed twice a day...the auditor should look for evidence that it had been waxed twice a day...it being shiny isn't enough...the organization didn't require "shiny"...it required waxing twice a day.

Does that help you think through it?

FWIW, consider what the organization has deemed necessary...it's often good to push on that a bit in the right places. Is monthly PM good enough? Quarterly? If weekly is indeed the best approach, for good and solid reasons, "lights on" does not accomplish that.

 

[Mr Roo]

Does that help you think through it?

Yes it does and I understand.
I was looking at this from the standard's verbiage "shall determine, provide & maintain" rather than what the organization had determined and documented as being required.
Thanks for the clarity...I will drink that beer for you tonight....in quarantine...just like last night....

 

[Ninja]

FWIW, on the flip side...

If the auditor is looking at a process requiring "Shall be measured for dimensions and compared to design tolerance" (ugly working to prove a point).
and asks why the operator didn't do it...and the operator says "we don't have a tool to measure that anymore, it broke"...
That would be an issue, because the organization did not "determine, provide & maintain"

No issues with having extra fancy toys like a laser scanner that you don't really need...big issues if you don't have the needed and functioning ruler or calipers or mics...

 

[Sidney Vianna]

Manufacturing facility

During our most recent surveillance audit, an auditor issued a non-conformance against section 7.1.3 Infrastructure. The basis was no evidence was presented during the audit that weekly equipment preventive maintenance (PM) required by the organization is being completed as required.

Would the actuality that the lights are on, the machinery is functioning as intended and operators are operating them, be evidence that the organization has determined, provided and maintained the equipment?

​

It seems to me that the auditor has a misunderstanding of what EVIDENCE is comprised of. If he asks whomever is responsible for the weekly maintenance questions about the activity, he should be able to ascertain if that is happening or not. That's a typical case of where an experienced auditor should use hard data to dig into audit trails. If the auditor finds out that there are customer complaints due to late deliveries and he digs into that and finds out that the late deliveries are due to poor equipment uptime, due to excessive malfunction, caused by the lack of preventive maintenance, THEN he has evidence in his hands. Until then, he is speculating and failing to perform proper auditing investigations.

 

[Richard Regalado]

First and foremost, preventive maintenance is not a requirement. I cannot remember if it was EVER a requirement of ISO 9001. The requirement is "maintain".

Therefore, corrective and/or preventive maintenance are expected and acceptable activities under 7.1.3.

Why would an NC be raised if the infrastructure is in tip-top shape and no maintenance has been performed to-date? Strange.

 

[Jim Wynne]

An auditor should be able to ascertain whether any specific internal requirements are intended to directly support compliance to the standard. A requirement can be cited within the QMS without there being any direct relationship to requirements of the standard. That type of requirement should be considered outside the scope of a third-party ISO 9001 audit. A (tenuous) case might be made regarding the organization's internal audits, however. If there's a requirement to do weekly maintenance and no records are kept, an internal auditor should have brought the issue to light.

 

[Ninja]

Agreed with both statements in a vacuum...but...

that weekly equipment preventive maintenance (PM) required by the organization

The OP says that it was determined by the organization that it was necessary...

 

[Jim Wynne]

Agreed with both statements in a vacuum...but...

The OP says that it was determined by the organization that it was necessary...

So, what would you cite as the requirement in the standard that hasn't been fulfilled?

 

[Ninja]

I don't have a copy of the standard with me at home...where I will likely be for a while yet...

If an organization determines that an action is required (from the OP), and there is no evidence that the action was performed (from the OP)...what section is violated? That one.