ISO 9001 Control of Production Equipment - CNC Machines

[auditorsos]

Hi All

We are a Design and Manufacturing Company, currently complying with the ISO9001:2008 standard until next year. My QM wants me to take on a more involved role (he is looking at becoming a silent partner ((I think)).

We have a Company procedure relating to Control of Production Equipment; we have three CNC machines in operation.
The machinists are responsible for the day to day checks on these, ensuring they are oiled and the coolant levels are maintained etc. But I am unsure as to whether there is a requirement to maintain or show additional records under this section.
The machines are not serviced annually, but the guy comes in to fix the machines when there is an issue, so will obviously carry out basic operational checks.

Do we need to be doing anything else.

Thanks in advance.

 

[Ninja]

How are you controlling your programs?
It is considered necessary to do so from a risk standpoint?
How do you know the program running hasn't been corrupted?

Sounds like you are on top of having the machines work...but are they making the right parts?

 

[dsanabria]

Hi All

We are a Design and Manufacturing Company, currently complying with the ISO9001:2008 standard until next year. My QM wants me to take on a more involved role (he is looking at becoming a silent partner ((I think)).

We have a Company procedure relating to Control of Production Equipment; we have three CNC machines in operation.
The machinists are responsible for the day to day checks on these, ensuring they are oiled and the coolant levels are maintained etc. But I am unsure as to whether there is a requirement to maintain or show additional records under this section.
The machines are not serviced annually, but the guy comes in to fix the machines when there is an issue, so will obviously carry out basic operational checks.

Do we need to be doing anything else.

Thanks in advance.

From a machine point of view - follow the guidelines of the manufactures for maintenance and frequency. It looks like you are servicing your CNC but you don't have a good preventive maintenance program. If you do, that maintenance guy should not be visiting you. Part of preventive maintenance requires to replace filters or add filters to any opening in which air passes through.

...and finally, identity who is doing the work and the frequency - this helps to visually determine what and when it was doe - plus is a good step in the program.

On your programming - make sure that the programs are properly secure and that limited access is implemented. In your procedure you must identify what to do when a program is updated and if you need to perform a first article inspection to determine that the process is effective before continuing with manufacturing

 

[Coury Ferguson]

From a machine point of view - follow the guidelines of the manufactures for maintenance and frequency. It looks like you are servicing your CNC but you don't have a good preventive maintenance program. If you do, that maintenance guy should not be visiting you. Part of preventive maintenance requires to replace filters or add filters to any opening in which air passes through.

...and finally, identity who is doing the work and the frequency - this helps to visually determine what and when it was doe - plus is a good step in the program.

On your programming - make sure that the programs are properly secure and that limited access is implemented. In your procedure you must identify what to do when a program is updated and if you need to perform a first article inspection to determine that the process is effective before continuing with manufacturing

Hi All

We are a Design and Manufacturing Company, currently complying with the ISO9001:2008 standard until next year. My QM wants me to take on a more involved role (he is looking at becoming a silent partner ((I think)).

We have a Company procedure relating to Control of Production Equipment; we have three CNC machines in operation.
The machinists are responsible for the day to day checks on these, ensuring they are oiled and the coolant levels are maintained etc. But I am unsure as to whether there is a requirement to maintain or show additional records under this section.
The machines are not serviced annually, but the guy comes in to fix the machines when there is an issue, so will obviously carry out basic operational checks.

Do we need to be doing anything else.

Thanks in advance.

As stated...it appears that the process is missing a "Preventative Maintenance" program. It also appears that you fix things when they break down without looking at the whole picture which is trying to prevent the breakdown.

When the CNC breaks down, you have machine downtime, which in turn can affect both Internal Delivery and Customer Delivery.

What is your machine downtime data, if any, say on a monthly basis?

Just my opinion.

 

[auditorsos]

Thanks everyone, you have been most helpful.

OK, we didn't have a maintenance records folder perse, so I have created a folder, segregated by machine with records going back as far as possible (our procedure states for the life of the equipment).

I have now created a maintenance checksheet which is a visual on each CNC Mill / Lathe showing critical checks lube / oil etc. What type is used as per the manufacturers recommendations. The Machinist is responsible for completing this.

CNC Programs are controlled and maintained as per our procedures - we don't have any issues there.

You are quite right we have no preventative measures in place, we are a small business and the powers that be won't hear of carrying out any preventative maintenance, unless absolutely necessary! which is really frustrating.
However, we do use two suppliers (machine shops) who can take on the task should we have a breakdown. Not ideal but.....

 

[Big Jim]

It should be noted that ISO 9001 does not require that you keep maintenance records.

Best practice probably is to keep maintenance records though.

You are required to maintain the infrastructure though.

You are on the right track. Determine a maintenance schedule based on the equipment manufactures recommendations and temper it with your own experienced based on your use. In spite of what management says, this is preventive maintenance.

Keeping track of breakdowns can help realize when a failure could be approaching and preventive maintenance is learning when to replaced parts as they approach the end of their life before they fail. That is preventive maintenance, or some may call it predictive maintenance.

Taking it a bit further is determining what spare parts you are likely to need and keep them on hand as critical spares.

Best of luck with your management.