Preventive Maintenance Requirements - ISO 9001

[samsung]

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.

Yes I agree with the fact that even documents can be manipulated as quoted by one of the Cover's in his post today, yet I feel that, if time is not a constraint, an auditor may get to the facts. e.g. the evidence of maintenance in the absence of records can be verified by looking at the records of resources consumed such as stores & spares, man power, overtime record etc.

Still it is a fact that the auditors have to do a lot of job in the given time that prohibit them from going into minute details.

Thanks for the response.

 

[Crusader]

I am now tasked and going down that road to establishing "something" to meet 6.3b of ISO 9001:2008.
Because we have zero.

Now, I've only been in the new job 3 months and I've been ruffling feathers right and left. I have no fear!

Now, not to but here's my take:

I read through most posts here and I feel compelled to create a "something" that is controlled/documented with records to support what we say we will do to meet 6.3b in regards to all equipment which is ultimately related to contributing to product conformity.

And in saying that above, I feel that the above is a significant contribution to "continuous improvement" and "ensuring customer satisfaction" which is what we all strive for in the end.

 

[faisalr]

thanks mastah for your info

i understand what all of you mean

 

[Rahul26692]

We have conducted an Internal Audit in our company onto which we have found a Non conformity regarding Predictive Maintenance is not going on as per schedule from past 6 month as well as data is pending from past 6 months. Maintenance People have missed out it due to their negligence so do suggest me best root cause as well as what corrective action should i write for this which can satisfy the Auditor.

 

[Jim Wynne]

Maintenance People have missed out it due to their negligence so do suggest me best root cause as well as what corrective action should i write for this which can satisfy the Auditor.

Satisfying an auditor should be the least of your concerns when a significant process has completely broken down. The first question you might want to ask is how this went for a full year without anyone discovering it.

 

[Ninja]

Corrective action: PM not performed as planned and instructed. Root cause analysis being investigated. When known, the root cause will be addressed. Missed PM has been prioritized.
Done (for the auditor). Call it out as a self-discovered problem...and address it. That's how the system is supposed to work.

Now agreeing with Jim...move on to finding the root cause and fixing it...that's the real problem. Lack of PM can shut down you line...the auditor costs you money, the line makes you money...prioritize keeping the line running, the auditor is in fourth place.

 

[Big Jim]

First of all, be aware that ISO 9001:2015 doesn't require that you keep maintenance records unless you want to. Ask yourself if there is really a need for maintenance records, and if not, make sure your documentation does not require them.

 

[Big Jim]

Corrective action: PM not performed as planned and instructed. Root cause analysis being investigated. When known, the root cause will be addressed. Missed PM has been prioritized.
Done (for the auditor). Call it out as a self-discovered problem...and address it. That's how the system is supposed to work.

Now agreeing with Jim...move on to finding the root cause and fixing it...that's the real problem. Lack of PM can shut down you line...the auditor costs you money, the line makes you money...prioritize keeping the line running, the auditor is in fourth place.

This isn't really good structure for answering a nonconformance. There are three parts to that reply, Correction, Root Cause, and Corrective Action. ISO 9000 defines Correction as the action taken to resolve a nonconformance. It also defines Corrective Action as the action taken to overcome the CAUSE of the nonconformance. You do the correction first. Then following element 10.2 you evaluate the need for action to eliminate the CAUSE of the nonconformity. So you don't need to move forward to find the root cause unless you determine that there is a need to do so. What is important though is that you don't perform corrective action until you find the root cause. It is also very important to note that corrective action ONLY SPEAKS TO THE CAUSE and is not a repeat of the correction.

The way you outlined it would never fly as a completed nonconformance response.

 

[Ninja]

The way you outlined it would never fly as a completed nonconformance response.

Totally agreed...and that's OK (for now) since it is not yet completed. Your description of the completed is one I fully agree with.

 

[Johnnymo62]

What type of corrective action tools do you use? 8D with 3 Legged 5Why? I recommend it.

I think, part of the initial investigation should be to determine if any incorrect parts went to any customers, unknowingly.

I think the root cause of of not performing the PMs will boil down to someone not using the PM system in place, for whatever reason.

I also think the reason it wasn't discovered or the systems broke down will probably be an ineffective Management Review.

This is my guess of course.