ISO 9001 - 7.1.3 Infrastructure - questions concerning evidence

Mr Roo

Registered
Re-reading 7.1.3, it does not state that an organization is required to "retain documented information as evidence of...". Only "... shall determine, provide and maintain ...". On one hand, I think it was an over-reach on the side of the auditor as (IMHO) the organization had fulfilled the requirement of 7.1.3. On the other hand, I have used an auditors finding to force the owners of a process to do what they are supposed to be doing per their own procedure. So i get it. Bottom line, if we state what we do & do it, there should be no findings.
I appreciate everyone's feedback & discussion.
 

Ninja

Looking for Reality
Trusted Information Resource
Bottom line, if we state what we do & do it, there should be no findings.
Correct...but my contention and reply to Jim above is that the auditor is there to verify that you did do it. It's not just doing it, it's also enabling verification.

I agree with the statement above (I think also Jim's) that a person stating "Yeah, I do that every Monday" should be adequate...but I've found checklists to simply be easier...
 

Sidney Vianna

Post Responsibly
Leader
Admin
Re-reading 7.1.3, it does not state that an organization is required to "retain documented information as evidence of..."..
the word evidence is not present in 9001. And, as I mentioned, evidence can have many forms other than a documented record.

Audit evidence is a cornerstone of what auditing is all about and audit conclusions HAVE TO be based on evidence.
 

Tagin

Trusted Information Resource
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...”.

I think the auditor should be querying you: how do you know that the maintenance is being carried out as planned, if you do not maintain records of it?
That is, it seem correct for the auditor to probe for compliance with 7.1.3, but should have placed the burden on you to demonstrate how the organization can assure the auditor of compliance rather than inventing a requirement for records.

This, I think, is a general weakness in the standard: whereby on one hand compliance must be demonstrable (if auditing is going to be at all meaningful), while on the other hand the standard attempts to be flexible by not specifying the acceptable form(s) of demonstrability.

The lack of any kind of a PM record or other feedback mechanism might be considered a risk: if, say, the experienced person who currently performs PM on machine X leaves, how do you know that a new person replacing him is performing that PM? Also, what happens if a person goes on vacation or is sick - how do you know PM is still getting done? From an RBT perspective (A.4, 6.1), it seems worthy of being addressed.

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?

Perhaps, if a lack of PM would inevitably and immediately cause the machinery to fail in a detectable way. But that's a pretty weak approach to quality.

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...)

I think the evidence of compliance with 'determined' is the end product: the list of machines that need PM, types of PM, frequency, etc. I don't think there is a requirement to "show your work", as to how you developed that list.

That said, it could certainly be useful and practical to maintain justifications (e..g., mfr PM schedule recommendation documents) for future reference. The person(s) who determined the PM schedule might change and that reference material is organizational knowledge (7.1.6) that could get lost in the mists of time.
 

Johnnymo62

Haste Makes Waste
I think that a very low equipment downtime may be used to justify your claim of equipment being maintained. Conversely, any equipment downtime would be evidence of of not maintaining the equipment.

Assuming your company tracks downtime.
 

Ninja

Looking for Reality
Trusted Information Resource
weekly equipment preventive maintenance (PM) required by the organization
I think that a very low equipment downtime may be used to justify your claim of equipment being maintained.

I'm not seeing it...weekly is weekly, and arguably means "every week"...the organization did not determine that a certain % uptime is required...
 

Johnnymo62

Haste Makes Waste
Equipment downtime is a common measure used by Production and Management that is usually tracked by the Plant Manager or someone who cares. My experience is that it is tracked and discussed in staff meetings every week. I was just offering it as an optional form of evidence for this case.
 

Ninja

Looking for Reality
Trusted Information Resource
As a form of evidence of % uptime, I'll buy it gladly.
As a form that weekly PM was done...I'm still not seeing it.

If the company decides that % uptime is required, and weekly PM is not...I'm totally on board...but I don't see evidence of that so far in the chain.
It's a plausible recommendation, though. Good add.
 

Johnnymo62

Haste Makes Waste
As a form of evidence of % uptime, I'll buy it gladly.
As a form that weekly PM was done...I'm still not seeing it.

If the company decides that % uptime is required, and weekly PM is not...I'm totally on board...but I don't see evidence of that so far in the chain.
It's a plausible recommendation, though. Good add.


A period of weeks with no downtime on a press, for example, for equipment failure may mean it was maintained well enough to keep running. Then an equipment failure would mean it was not maintained well enough to keep running.
 

Big Jim

Admin
Don't forget 7.5.1 a & b, particularly b.

"The organization's quality management system shall include:

a) documented information required by this International Standard:

b) documented information determined by the organization as being necessary for the effectiveness of the quality management system."

So according to b, if the organization has determined that records for a particular activity is needed then it is needed and it is fair game for an auditor to go after.

In other words if the organization says in their procedures or even orally that records for maintenance including preventive maintenance are needed auditor can and do write nonconformances for it.
 
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