Document Control.

Hi all. I am the Quality Manager at a Sub Contract Precision Machining Company. I have limited knowledge of ISO9001:2015,(so please be kind).We have 30 plus CNC machines of various type's Lathes, Mills, Grinders, Wire erodes all of which have a Maintenance / Preventative Maintenance checklist magnetically located on each and all machines. During an IA it was noted that these checklists are not part of DC. My question is do i have to produce a Document of each type of machine and place them in the DC register.

 

From your description it seems to me that these checklists are critical to the maintenance of the equipement and therefore "7.5.1.b documented information determined by the organization as being necessary for the effectiveness of the QMS" applies, so it would be wise to have these as controlled documents.
For example; What if the checklist is updated and new checks are included or removed? How can you be sure that the checklist you are using is the correct version etc.

See clause 7.5 for more information.

 

If there are unique items that need to be checked for each type, then you may opt to keep a standard checklist for each. ISO 9001 doesn't specifically require documenting a maintenance checklist or even having a registry of documents. The necessity of having them is for your organization to determine.

 

Thanks for your reply Evers.
My thoughts are i can produce one Document that refers to all the checklists on the shop floor.
That way i can control the one Document with issue and version numbers. The checklist are unlikely to change and are only visible to ensure the tasks are being carried out to schedule.

 

Thanks tony s

 

Personally, I'd control this via a database on your intranet system for interaction with those involved (Maintenance/Engineers)

That way you don't have to worry about:

1. Creating documents and keeping them updated, the collection and actual maintenance of the physical completed documents
2. Wastage of paper
3. You get a referenceable data base (Just use excel, access or what ever else you have) to quickly search up information rather than looking through mountains of paperwork that you accumulate over the years.

 

Hi MonsterEnergy22

thanks for your input, makes perfect sense to create database.

Hi Andy,
The purpose of the visible checklist is to satisfy the foreman/manager that the machine manufactures maintenance checklist is being carried out to schedule and by whom.
the checklist also has provision for highlighting machine faults which triggers maintenance dept to rectify.

you have a very good point the IA didn't mention the effectiveness of the data generated and to be fair I didn't either.

 

Who keeps the master copy of the checklist? How and where? Aren’t they controlled by that guy? What about the filled out checklists? How does your maintenance process work?

 

Hi Guys thanks for the reply's.
Golfman25,
Each section has its own checklist blank once filled in another one is copied and placed on the machine. As far as I'm aware the filled out copy is shredded. As Andy has implied we are not aware of how effective the checklist are.
Hi Andy,
You are correct. The IA stumbled over the checklist. However in fairness the scope of the Internal Audit was to cover our QMS for compliance to the standard prior to a main outside Audit

 

Well I think you can do one of two things. Either each section has the ability to ensure the current version is used, i.e.; it is kept on their computer, with rev level, etc. Or you can put the blank checklists into your more formal doc control system. The later will likely give your auditor less to question.

 

Don't forget that once the checklists are filled out, they become records and also need to be controlled.