In terms of machine or equipment maintenance what should the supplier/vendor supply to give you confidence that if something goes wrong with your equipment when production begins you have some degree of reassurance that the you will have backup.
Below is a list I have put together of possible items to look out for, the vendor at a minimum should provide documentation comprised of the following:
Machine Descriptions
Schematics/Assembly Drawings, Electrical, Mechanical, Pneumatic, etc.
Operational Instructions
Trouble Shooting Manual
Calibration Requirements, Schedules and Procedures
List of lubricants & lubrication frequency
Preventative Maintenance Schedule and Requirement Procedures
Spare parts list and recommended spare part list
Purchased Component Literature/Datasheet.
Alarm output descriptions and troubleshooting guidelines
Life expectancy analysis
Training Manuals
Critical Set-up manuals
Please add more items to this list to make it more definitive
Cleaning schedule and procedures
System “inputs” requirements (electrical, compressed air, etc.)
Operational limitations
I’ve never tried to do it, but I’ve heard of companies getting the vendor to put any software in the system in an escrow account in the event that the vendor folds or stops support on the product.
[quote=yodon]
I’ve never tried to do it, but I’ve heard of companies getting the vendor to put any software in the system in an escrow account in the event that the vendor folds or stops support on the product.[/quote]
I have seen this done aswell, it seems to be getting more common now.
The vendor must backup the software periodically, and have written procedures for making backups as well as restoring from backups. There should be a disaster recovery plan in place covering partial through total system loss, to ensure restoration of acceptable operation after a disruption. A Software Escrow Account should be in place to ensure your company gets a copy of the software and supporting documentation in the event of the vendor’s dissolution.
A lot of vendors are reluctant to make special dispensation for individual companies. When we ask for some of the items below, we usually get the standard response “no other customers ask for these things so what makes you so special etc. etc.”
A lot of suppliers providing COTS equipment and qualification activities to regulated companies still have pretty shoddy practices and documentation. The best approach we find is to try to work with them and help them improve their practices so they are in a better position to provide services to other prospective customers. This softly, softly approach seems to work okay for us but some companies get defensive. It’s a tough one.