Preventive Maintenance Requirements - ISO 9001

[Helmut Jilling]

Re: Seek advice on preventive maintenance under ISO 9001

Perhaps I see the TC 176 ruling differently than you do. It tells me that records are not required for maintenance. The exception would be when an organization chooses to keep records.

The requirement for keeping records for maintenance does not come from element 6.3.

And it doesn't come from 4.2.4 either. "Records established to provide evidence of conformity . . ." If records are not established they do not need to be controlled. Who gets to determine if records need to be established? Except for the places in the standard where 4.2.4 are cited, THE ORGANIZATION GETS TO DECIDE. Auditors don't have a say it that.

I agree. However, it is incumbent on the organization to demonstrate evidence that systems are effective and meet requirements. In this case, that maintenance is suitable. This may cause them to decide to maintain records.

 

[Big Jim]

Re: Seek advice on preventive maintenance under ISO 9001

I agree. However, it is incumbent on the organization to demonstrate evidence that systems are effective and meet requirements. In this case, that maintenance is suitable. This may cause them to decide to maintain records.

I absolutely agree.

And if they decide not to keep records, that makes an auditor's job harder. He may need to observe their practice. He may need to look at equipment to see if it is obviously falling apart. He may need to ask question about how and when maintenance is performed.

Is this the preferred way? In my opinion it is not, but we need to play the hand that is delt.

 

[ISO 9001 Guy]

Re: Seek advice on preventive maintenance under ISO 9001

Precisely, Jim! If management has established records requirements, then the STANDARD REQUIRES that those records are maintained and controlled. So, if management has established record requirements, THESE RECORDS ARE WITHIN THE SCOPE OF A QMS AUDIT. So, an auditor SHOULD verify that records are being maintained AS REQUIRED.

 

[Jim Wynne]

Re: Seek advice on preventive maintenance under ISO 9001

I agree. However, it is incumbent on the organization to demonstrate evidence that systems are effective and meet requirements. In this case, that maintenance is suitable. This may cause them to decide to maintain records.

Perhaps I see the TC 176 ruling differently than you do. It tells me that records are not required for maintenance. The exception would be when an organization chooses to keep records.

The requirement for keeping records for maintenance does not come from element 6.3.

And it doesn't come from 4.2.4 either. "Records established to provide evidence of conformity . . ." If records are not established they do not need to be controlled. Who gets to determine if records need to be established? Except for the places in the standard where 4.2.4 are cited, THE ORGANIZATION GETS TO DECIDE. Auditors don't have a say it that.

I absolutely agree.

And if they decide not to keep records, that makes an auditor's job harder. He may need to observe their practice. He may need to look at equipment to see if it is obviously falling apart. He may need to ask question about how and when maintenance is performed.

Is this the preferred way? In my opinion it is not, but we need to play the hand that is delt.

Precisely, Jim! If management has established records requirements, then the STANDARD REQUIRES that those records are maintained and controlled. So, if management has established record requirements, THESE RECORDS ARE WITHIN THE SCOPE OF A QMS AUDIT. So, an auditor SHOULD verify that records are being maintained AS REQUIRED.

What about objective evidence? 6.3 requires maintenance of infrastructure, and if "the organization" has its own documented requirements for machine maintenance, how does an auditor verify that the maintenance has been done if there are no records? The fact that a machine is operating normally (or it's not "obviously falling apart") is evidence, but not objective evidence.

Look at it this way: say a company has, for a particular product, a documented requirement for final inspection, but the requirement doesn't explicitly call for records to be kept.. On the day of the audit, that product isn't running, so it's not possible to actually see inspection being done. Given the opinions here on maintenance, we should apply the same logic and say that we can just assume that inspections were done because there's no history of rejections for the product in question.

So the question is: how does an auditor verify a documented requirement in the absence of objective evidence?

 

[Brunetta]

Wouldn't the same techniques for auditing an undocumented process apply?
Couldn't an auditor pointedly ask from several auditees when the maintence occurred?
If the answers are the same, coupled with the evidence mentioned before, then wouldn't this be a body of objective evidence?

 

[Stijloor]

Wouldn't the same techniques for auditing an undocumented process apply?
Couldn't an auditor pointedly ask from several auditees when the maintence occurred?
If the answers are the same, coupled with the evidence mentioned before, then wouldn't this be a body of objective evidence?

Yes.

From ISO 19011:

3.3
audit evidence
records, statements of fact or other information, which are relevant to the audit criteria (3.2) and verifiable

Statements of fact (auditee responses) are valid objective evidence.

Stijloor.

 

[Big Jim]

Re: Seek advice on preventive maintenance under ISO 9001

What about objective evidence? 6.3 requires maintenance of infrastructure, and if "the organization" has its own documented requirements for machine maintenance, how does an auditor verify that the maintenance has been done if there are no records? The fact that a machine is operating normally (or it's not "obviously falling apart") is evidence, but not objective evidence.

Look at it this way: say a company has, for a particular product, a documented requirement for final inspection, but the requirement doesn't explicitly call for records to be kept.. On the day of the audit, that product isn't running, so it's not possible to actually see inspection being done. Given the opinions here on maintenance, we should apply the same logic and say that we can just assume that inspections were done because there's no history of rejections for the product in question.

So the question is: how does an auditor verify a documented requirement in the absence of objective evidence?

I think I see what you are getting at Jim, but you chose a poor example. There is a requirement to keep records for inspection.

 

[ISO 9001 Guy]

Re: Seek advice on preventive maintenance under ISO 9001

Correct, there is no requirement for records in 6.3. But that doesn't mean that records of maintenance are not required. Record requirements reside in 4.2.4. If an organization has requirements to perform maintenance, 4.2.4 requires records are maintained to demonstrate conformity to these maintenance requirements. If an organization has no requirements for maintenance, then records are not required.

I also disagree (with myself). I should have said, "If an organization has requirements to retain maintenance records, 4.2.4 requires records are maintained to demonstrate conformity to these maintenance requirements. If an organization has no requirements for maintenance records, then records are not required."

 

[samsung]

Yes.

From ISO 19011:

Statements of fact (auditee responses) are valid objective evidence.

Stijloor.

But IMO, Jim was referring to 'Objective Evidence' which is what the auditor needs to aim at. Even if all (auditees) are telling the same thing, how can it become an objective evidence. All can unanimously tell a lie to invalidate the 'statement of fact'. These 'facts' are valid until proved otherwise by the auditor through analysis, measurement, observation or some sort of research to ensure the validity of the statement.

 

[Jim Wynne]

But IMO, Jim was referring to 'Objective Evidence' which is what the auditor needs to aim at. Even if all (auditees) are telling the same thing, how can it become an objective evidence. All can unanimously tell a lie to invalidate the 'statement of fact'. These 'facts' are valid until proved otherwise by the auditor through analysis, measurement, observation or some sort of research to ensure the validity of the statement.

There's a difference between evidence (objective or otherwise) and proof. While several auditees might tell the same lie, it's also possible that documents have been falsified in concert with the verbal prevarications. Whether there's evidence for something or a lack thereof, an eternal auditor has to work with what he's given or what he can discover in a limited amount of time and understand that there's very little absolute proof in any case.