Documentation from Vendors

COMPUTER SYSTEM VALIDATION (CSV) SCADA AND PLC's
#1

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

Hope this list helps

[FONT=Arial]Regards[/font]

#2

Under the schematics heading, we try to obtain the PLC ladder drawings.

Hope this is of some help.

#3

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.

#4

[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.

#5

escrow account? Please explain.

#6

Hi Waynem

As follows

Backup and Contingency plans

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.

Entire article is here

http://www.askaboutvalidation.com/featured_articles_expanded.php?uid=22

It’s good to see that these articles are coming in handy.

Regards
Graham

#7

Thanks gokeeffe. Interesting.

#8

Graeme,

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.