Hi Everybody!

I'm looking for help on this issue: Currently we are creating process instructions related with shop floor operations, we are not close to create flow diagrams neither control plans/pfmeas. What is the best way to audit manufacturing process having just process instructions?
We are working to meet ISO 9001:2000 certification.

Thanks

Anerol C:thanks:

Anerol - it would help if I knew what you made. That being said, here is a simplistic & generic list.

To make a "part" you have to order (purchasing) material/components, etc.; how is that done?

You need to "receive" the material/component into your plant, how is that done, what is checked upon receipt, what happens if the metal/coponent is nonconforming?

Where does this material/component go after receiving? What checks are performed to ensure conforming product? What happens if it is nonconforming; reworked? how?; scrapped? how?, who authorizes, etc.

Keep walking to each place/machine this material/component goes through your plant until you ship the product; how do you make sure the product is conforming that goes to your customer?

As I said, this is simplistic and if it were me, I would generate a generic process flow following the product. (A very basic example of a flow on a shop floor: receiving, test, die cast, trim, heat treat, shot blast, CNC, wash, final audit, shipping.)

Thanks Valeri,

We are a metal-mechanic organization that makes subweldments for construction machinary; I had thought and suggested to engineering create simple flow diagrams for each different product.
Some one has suggested to use/create Value Stream Maps, Do you think VSM are fine? I mean there is a lot of information on them and not all people in our company understands VSM.

I appreciate any advice.

Anerol C

My opinion only - it sounds like you are in the infancy stage of implementing a quality system. A lean value stream map is great when the system is established and employees are knowledgable and have embraced the culture. However, in this instance, taking baby steps would be my advice. It gives both you and the employees time to "adjust" to this new culture, and that will be your hardest challenge - change is not easy.

Anerol:

If your organization has process instructions (welding procedures etc.) then those may be sufficient to perform an audit. It's nice to have process flows (they can tie in all those process instructions) with supporting PFMEA's and control plans, but since ISO 90001 doesn't specifically require them, the other documentation may be all that's needed for quality product and therefore as a basis for an internal audit.

Value stream maps are can be very complex and are not really the basis of a QMS, although some might say they are/can be. As Valeri says, these are to find the waste/non-value added work done in an organization, not to describe the processes.

Anerol -

every ISO9001 audit I've ever done has been for companies that have not gotten beyond process instructions for the shop floor. And for ISO9001 I probably wouldn't ask for more. Heck - if I wrote "PFMEA" on a whiteboard there's only two people in my current company who could tell me what it means.
And we're having an ISO9001 registration audit in 3 weeks.

Audit to the standard. Look for the "shalls" and see that they're met.
Flow diagrams are handy, but not required.