ISO 9001 Regarding Preventative Maintenance

Morellijoe

Starting to get Involved
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?
 

Golfman25

Trusted Information Resource
Honestly, I am not sure you're the right person for this project. What the heck do you know about the machines? Isn't there someone who uses the machines that might be better informed about what is needed?

But you are right, you want to keep your records easy to maintain. Daily/Weekly records have a way of getting out of hand or skipped. I have seen some people do it with a dry erase on each machine, each week. Each record is either up to date or it isn't -- pretty easy to see.
 

Morellijoe

Starting to get Involved
Honestly, I am not sure you're the right person for this project. What the heck do you know about the machines? Isn't there someone who uses the machines that might be better informed about what is needed?

But you are right, you want to keep your records easy to maintain. Daily/Weekly records have a way of getting out of hand or skipped. I have seen some people do it with a dry erase on each machine, each week. Each record is either up to date or it isn't -- pretty easy to see.
The only thing I know about machines is not to touch a lock out tag. :vfunny:. But in all seriousness the only person who could help enough to make a difference is the owner. He wants the QMS to be as bare bones as possible. He was certified "compliant" about 6 years ago but hasn't kept records of any kind. Its not that they aren't keeping up with the maintenance, its more so knowing that the operators and owner will not keep up with documentation. So I would rather not waste my time creating sheets they're going to pencil whip anyways. If I implement the idea of using dry erase boards, would this suffice to cover the maintenance portion. " Maintenance of equipment and infrastructure is conducted. Maintenance planning and instructions are maintained and scheduled based on manufacturer's recommendations and/or (Company Name) technical knowledge and experience. Maintenance activities are performed by qualified personnel."
 

Michael_M

Trusted Information Resource
It depends on what type of QMS certification you are looking for. If it is ISO9001 then I highly recommend NOT having a check list. I have gotten a few Non-conformances because the maintenance sheet was not filled out completely on one machine. It is an easy NC for an auditor to find. The way I do it now is have it as part of peoples training and keep records of the training.

I believe NADCAP does require very specific maintenance records so as I said, it depends on what type of QMS you are looking at.
 

Morellijoe

Starting to get Involved
It depends on what type of QMS certification you are looking for. If it is ISO9001 then I highly recommend NOT having a check list. I have gotten a few Non-conformances because the maintenance sheet was not filled out completely on one machine. It is an easy NC for an auditor to find. The way I do it now is have it as part of peoples training and keep records of the training.

I believe NADCAP does require very specific maintenance records so as I said, it depends on what type of QMS you are looking at.
Just trying to become ISO9001 certified, nothing more. The training is what I thought would be easiest as well. Thank you for your input!
 

John C. Abnet

Teacher, sensei, kennari
Leader
Super Moderator
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?
Good day @Morellijoe ;
Two bits of counsel if I may...
1- Don't ever do anything for ISO / for an auditor. All done should be done selfishly...serving the organization you work for. It if does not serve your organization/provide a benefit to your leadership and/or your teams, then it should be questioned as to why it is being done.
(obviously conformance to ISO 9001:2015 is required, but ISO 9001 does not prescribe HOW to achieve.).

2- Always ask the question "so what?". For example, let's say your organization ...
a) creates a PM procedure (great if NEEDED by your organization but NOT an ISO 9001 requirement),
b) creates a checklist preventative maintenance sheet (great if NEEDED by your organization but NOT an ISO 9001 requirement)...

....then "so what?" Your organization now has these items,...."so what?". If a clear benefit/answer can not be derived from that question, then why do it?

In regard to "Just trying to become ISO9001 certified".....hmmmm.
When I hear this, I 'see' (assume) the organization is reading through the standard and then creating numerous self imposed rules , documents, forms, etc.... to "...to become ISO9001 certified" . This generally results in numerous items and tasks that the organization now needs to manage and control, ;which may not add benefit to the organization.
Result?:
Jaded and bitter leadership and teammates who realize there is no answer to the question "so what?"....therefore, the "ISO" stuff is not a seamless foundation of the organization...supporting the company's goals and mission, but instead becomes this separate 'other' set of activities that is performed only for the purpose of "...trying to become ISO 9001 certified."

Summary:
Instead of looking at the organization through the lens of the standard, look instead through the EXISTING lens of the organization. In doing so, you are now reverse engineering and determining how what your organization ALREADY does may indeed already meet many of the ISO9001 requirements (this is often the case).

Hope this helps.

Be well
 

Mike S.

Happy to be Alive
Trusted Information Resource
Maintenance of the equipment IS important. If it was my equipment I'd want to be sure it was being maintained properly, like I do my vehicles.

Consider a check sheet on the machine saying when the machine is supposed to undergo maintenance and a place for the maintainer to check/initial. Let training, "owner's manuals", etc. take care of the rest.

If you give some leeway on the "when" you are less likely to get dinged or irritate the maintainer. For example, "the first week of every month" might be better than the first Monday of every month. Or, every 900-1000 hours, etc. if you have an hourmeter on the equipment.
 

Golfman25

Trusted Information Resource
Good day @Morellijoe ;
Two bits of counsel if I may...
1- Don't ever do anything for ISO / for an auditor. All done should be done selfishly...serving the organization you work for. It if does not serve your organization/provide a benefit to your leadership and/or your teams, then it should be questioned as to why it is being done.
(obviously conformance to ISO 9001:2015 is required, but ISO 9001 does not prescribe HOW to achieve.).

2- Always ask the question "so what?". For example, let's say your organization ...
a) creates a PM procedure (great if NEEDED by your organization but NOT an ISO 9001 requirement),
b) creates a checklist preventative maintenance sheet (great if NEEDED by your organization but NOT an ISO 9001 requirement)...

....then "so what?" Your organization now has these items,...."so what?". If a clear benefit/answer can not be derived from that question, then why do it?

In regard to "Just trying to become ISO9001 certified".....hmmmm.
When I hear this, I 'see' (assume) the organization is reading through the standard and then creating numerous self imposed rules , documents, forms, etc.... to "...to become ISO9001 certified" . This generally results in numerous items and tasks that the organization now needs to manage and control, ;which may not add benefit to the organization.
Result?:
Jaded and bitter leadership and teammates who realize there is no answer to the question "so what?"....therefore, the "ISO" stuff is not a seamless foundation of the organization...supporting the company's goals and mission, but instead becomes this separate 'other' set of activities that is performed only for the purpose of "...trying to become ISO 9001 certified."

Summary:
Instead of looking at the organization through the lens of the standard, look instead through the EXISTING lens of the organization. In doing so, you are now reverse engineering and determining how what your organization ALREADY does may indeed already meet many of the ISO9001 requirements (this is often the case).

Hope this helps.

Be well
Great in theory. Difficult in practice. Way too many auditors have their own biases these days on what they want to see and there is too little control pushback from the CBs to reign them in. The standard is too vague and allows for too much "discretion." Thus, you system grows and grows until it's an unworkable mess. Don't ask how I know. :)

Otherwise I agree 1000%.
 

Sidney Vianna

Post Responsibly
Leader
Admin
Maintenance of the equipment IS important. If it was my equipment I'd want to be sure it was being maintained properly, like I do my vehicles.

Consider a check sheet on the machine saying when the machine is supposed to undergo maintenance and a place for the maintainer to check/initial. Let training, "owner's manuals", etc. take care of the rest.

If you give some leeway on the "when" you are less likely to get dinged or irritate the maintainer. For example, "the first week of every month" might be better than the first Monday of every month. Or, every 900-1000 hours, etc. if you have an hourmeter on the equipment.
What Mike said. Don’t start this “project” with the mindset of how easy can I get certified. But what makes sense to manage business risks.
 

Golfman25

Trusted Information Resource
The only thing I know about machines is not to touch a lock out tag. :vfunny:. But in all seriousness the only person who could help enough to make a difference is the owner. He wants the QMS to be as bare bones as possible. He was certified "compliant" about 6 years ago but hasn't kept records of any kind. Its not that they aren't keeping up with the maintenance, its more so knowing that the operators and owner will not keep up with documentation. So I would rather not waste my time creating sheets they're going to pencil whip anyways. If I implement the idea of using dry erase boards, would this suffice to cover the maintenance portion. " Maintenance of equipment and infrastructure is conducted. Maintenance planning and instructions are maintained and scheduled based on manufacturer's recommendations and/or (Company Name) technical knowledge and experience. Maintenance activities are performed by qualified personnel."
Less is more. The hardest thing is to keep up with documentation. Luckily, for ISO 9001 maintenance is covered in 7.1.3 and doesn't specifically require any documentation. So strip it down to document only what you absolutely need.

We basically keep everything in a spreadsheet file. We review each year to hit any annual requirement like oil changes and such. Then during the year, any major maintenance activities are recorded so we know what we have done on each machine over time. Other than that, our operators are go around and lube everything as required, usually each morning. That's on the honor system -- we don't require records.
 
Top Bottom