Linda LaVine said:
So can't you just incorporate your shop floor system into your DMRs for all products? The QS and the new shop floor system are really intertwined, aren't they. I think that if your DMRs cross-reference the QS documents correctly, then you shouldn't have to do a major re-write of all your entire quality system. Maybe you would only have to update your contract review, purchasing, and HSPP&D (shipping etc...) procedures to refer to the specific DMR. I would guess you'll have to update your DMRs anyway.
Of course I may be way, way wrong too.
I have reviewed such systems over many years. Some of my suppliers have them. I created my own in a previous company. I think they are great.
The question is:
"How do you fold a software system like this into your QMS?"
If you accept the prevailing view of "levels" or "tiers" in your QMS documentation, you have to ask yourself what level this software would be covered under in YOUR QMS. Some of the systems are as simple as a set of macros which trigger a slew of documents (electronic or hard copy) associated with each order. As the systems increase in complexity, they affect more and more functions within an organization. Forms and documents may include, but are not limited to:
- CofC
- shipping label
- packing slips
- traveler
- inspection forms
- bill of materials
- inventory update
- automatic reorder of commodities
- work instructions
- email notice of shipping
- invoicing/billing
Given the potential complexity, it is easy to see where confusion may arise.
Personally, I think of such systems as more in the vein of
"which version of Word, Excel, or Access do we use?" I would consider the documents and forms generated by the system the same as if I had created and typed them myself and control (or not) them accordingly.
Given that, I certainly would not incorporate the Microsoft documentation into my QMS documents except by reference
"to the most recent documentation for our then current version of Microsoft Office."