ISO 9001 Regarding Preventative Maintenance

QC_Queen

Registered
I recently switched jobs from an inspector to quality engineer and have been tasked with implementing a QMS for a small company that consists of 9 people. Me being the only one in inspection. (This side of manufacturing is all new to me and I’m just trying to keep myself to a timeline. ) Currently, I’m being told to create a preventative maintenance sheet for each of the 18 machine we have detailing what needs to be checked weekly and quarterly. I think that’s a bit excessive as I didn’t see anywhere while reading ISO9001 that it’s required to keep any records of maintenance. So I guess my question is, what is the easiest way for me to go about this. Should I suck it up create a generic sheet that can be filled out weekly and quarterly for the entire year, or can I not put in our Qms that we document and just get away with creating a procedure for P.M. for the employees to follow?
You have to not just consider the ISO requirements, part of OHS requirements where you are located, may require you to keep documentation.

Also, in regards to creating a document and procedure, how are you proving these checks are indeed being completed? If an external company comes in to do the PM's you could invoices and service records, if it is being completed by internal employees ISO is going to ask for proof that the PM's were completed.

Rule of thumb when it comes to any QMS, if its not documented, it never happened.

You can avoid using paper forms by utilizing Microsoft Forms, or Google Suite, whichever platform you use. Both have great options.

When creating the procedures, ensure you cover the process for deviations/non-conformances, and what warrants a lock/out tag out. You would then need a Lock/Tag Out Procedure.

I STRONGLY suggest you look into taking an introduction to quality or ISO course, as the information you have requested is entry level, and developing an ISO system from scratch with little to no quality experience is a challenge.
 

QC_Queen

Registered
And then you end up with documentation overkill. :)

But I can document things that never happened as well.
Like I said it is a rule of thumb. There are ways of documenting without going overboard.

And documenting things that never happened is falsifying documents, and can be regarded as fraud.

This is why I highly recommend in the case of PM keeping service receipts or invoices, or go with an electronic QMS with forced processes, that prevents the falsification of records.
 

ChrisM

Quite Involved in Discussions
So I have to ask. If you never had to make a record before, why do you have to make a record now?
For one thing, for insurance/legal purposes in case there is an incident and we need evidence that we had checked the operation or performance of something.
 

Mike S.

Happy to be Alive
Trusted Information Resource
There are lots of good reasons to keep maintenance records. I keep records on the maintenance of each vehicle and major power equipment I have not because a standard tells me to, but because I cannot remember when to do things, what has been done prior, etc. without them.

I have one vehicle still in-warranty and I need the records to prove, should something go wrong, that it was not due to failing to do the required maintenance.
 

Morellijoe

Starting to get Involved
Thank you all for your input. All of you have been helpful and insightful, some more than others. I have decided to include the P.M. routine in the employee training, as well as implementing a generic template that will include weekly fluid checks along with a quarterly maintenance for greasing, cleaning, filter replacement, and hose checks. Another sheet will be included that will detail any major breakdowns/maintenance. I plan on keeping the sheets attached to each machine on a clipboard and replace yearly.

Now in regards to a lock-out tag out procedure, can I just reference the manuals for that, or is that another procedure I have to write to implement P.M. checks? If I don't reference this procedure, can I get a non-conformance since it doesn't mandate in 9001 that I need a procedure? I understand the benefits, and if we get to a point where it can be more beneficial to us, I have no problem amending the QMS at a later time to show that.
 
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Mike S.

Happy to be Alive
Trusted Information Resource
I know little about LOTO except that from a safety and liability standpoint the folks I know using it take it VERY seriously and do initial training and frequent refresher training including graphic videos of people injured when it was not used correctly. It's one thing if a machine breaks down due to lack of maintenance, it's orders of magnitude different if a person is injured.
 

Golfman25

Trusted Information Resource
Thank you all for your input. All of you have been helpful and insightful, some more than others. I have decided to include the P.M. routine in the employee training, as well as implementing a generic template that will include weekly fluid checks along with a quarterly maintenance for greasing, cleaning, filter replacement, and hose checks. Another sheet will be included that will detail any major breakdowns/maintenance. I plan on keeping the sheets attached to each machine on a clipboard and replace yearly.

Now in regards to a lock-out tag out procedure, can I just reference the manuals for that, or is that another procedure I have to write to implement P.M. checks? If I don't reference this procedure, can I get a non-conformance since it doesn't mandate in 9001 that I need a procedure? I understand the benefits, and if we get to a point where it can be more beneficial to us, I have no problem amending the QMS at a later time to show that.
Lockout/tagout is a standard in and of itself. May or may not be required to do simple PM checks -- all depends. Generally speaking though, you should have a procedure for each machine of what to LO/TO. We keep a laminated card attached to each machine. In your case, if you have specific PM procedures, you may want to review and determine whether LO/TO would be required and then reference that in the PM procedure.

No way I would let an ISO auditor even come close to asking about LO/TO as it's an independent animal itself (Had one try). Requires a whole different expertise.
 
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