Is it necessary to document a shop floor system?

S

sheryljuco

#1
:bigwave: recently, our company bought a new shop floor system which affects almost all of our major processes (from planning up to shipping). I am tasked to review the operational manual of the said shopfloor system against the ISO9001:2000 standard. The company is expecting me to check the compliance of the said system against the ISO standard. With this I would like to clarify some things, such as: (1) is it necessary to include in our established procedures for our major processes (such in the case of planning)the change in our shop floor system. (2) the project team who established this shopfloor system provided an operational manual and a system manual for this "do we have to register this manuals?" (3) do we have to distribute a copy of this manuals to all sections? (4) how are we going to controll this document?
 
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E

energy

#2
sheryljuco said:
:bigwave: recently, our company bought a new shop floor system which affects almost all of our major processes (from planning up to shipping). I am tasked to review operational manual of the said shopfloor system against the ISO9001:2000 standard. The company is expecting me to check the compliance of the said system against the ISO standard. With this I would like to clarify some things, such as: (1) is it necessary to include in our established procedures for our major processes (such in the case of planning)the change in our shop floor system. (2)
Was it just Equipment and location? Did it enhance/modify some processes? :smokin:
 
S

sheryljuco

#3
To give you a clearer view, this shop floor system is used in most of our transactions with our internal and external suppliers and customers (internal-customers/ suppliers within the company dept. to another dept. ; external-customers/ suppliers coming from external parties). Sittuation: Customer sends an order through the system, this will automatically generate data for all concerns (planning, engineering, production, warehousing).
 
#4
sheryljuco said:
Sittuation: Customer sends an order through the system, this will automatically generate data for all concerns (planning, engineering, production, warehousing).
It sounds to me as if this system will have a major influence on several of your processes as well as a major change, so imo:

1: You definitely need to refer to this system in your procedures.
2: Register the system manuals? Not necessarily, but the above goes here too.
3: You need to see to it that everyone has the instructions they need. See 7.5.1b.
4: Acc. to your usual document control procedures? What do they say

/Claes
 

lindal

Involved In Discussions
#5
Hmmmm

sheryljuco said:
To give you a clearer view, this shop floor system is used in most of our transactions with our internal and external suppliers and customers (internal-customers/ suppliers within the company dept. to another dept. ; external-customers/ suppliers coming from external parties). Sittuation: Customer sends an order through the system, this will automatically generate data for all concerns (planning, engineering, production, warehousing).
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.
 

Wes Bucey

Quite Involved in Discussions
#6
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."
 

Randy

Super Moderator
#7
Short answer to the original question...NO!

Next answer.....YOU SHOULD!

Or better yet....WHY NOT?

Documentation, understanding that it CAN be taken to the EXTREME, lends itself to insuring consistency of action. Isn't that what we want? With adequate documentation the potential for error is reduced and we can be somewhat assurred that the same thing will occur tomorrow and next week even, that happened today (taking for granted it was the correct thing).

In the end it is the organization itself that will have to decide what and how much documentation to create and maintain.
 
A

Al Dyer

#8
sheryljuco said:
:bigwave: recently, our company bought a new shop floor system which affects almost all of our major processes (from planning up to shipping). I am tasked to review the operational manual of the said shopfloor system against the ISO9001:2000 standard. The company is expecting me to check the compliance of the said system against the ISO standard. With this I would like to clarify some things, such as: (1) is it necessary to include in our established procedures for our major processes (such in the case of planning)the change in our shop floor system. (2) the project team who established this shopfloor system provided an operational manual and a system manual for this "do we have to register this manuals?" (3) do we have to distribute a copy of this manuals to all sections? (4) how are we going to controll this document?
1: Was the system reviewed at all for compliance to ISO before it was purchased?
2: Were you involved in the purchase?
3: I would say incorporation depends on the extent of the change on the processes. If it is a tool to assist in already documented practices I think the procedure inclusion would be minimal.
4: As to the manual I think it should be some part of a controlled dodument system since it seems to be a major input/tool on your processes.
5: If applicable, distribute to those personnel that will need to use it.
6: I'm not sure about your control methodology for similar documents, but I would think that they need to be controlled. If there is a change to the document from the supplier all departments with a copy need to be notified.

Al...
 
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