Hi there,

If someone in your org'n purchases a custom part from a vendor, and does this to an uncontrolled drawing, can this comply with ISO 9001:2000?

If so, what measures could/should be taken to preserve revision history/control?

I ask this because we are rolling out Document Control, but only for customer drawings, and certain internal drawings (product, key mfg and test tooling).

It seems to me this could present a problem if these drawings are uncontrolled, as traceability then falls on the Purchase Order originator.

This suggests that everyone purchasing to an uncontrolled document has to maintain their own file of rev history, and that they'd need to ID their uncontroleld document with a drawing # and date at minimum.

Should we set a policy requiring controlled drawings associated with POs?

Is this atypical?

Long-time lurker, first-time poster,

Andrew

If you are purchasing a custom part that is defined by a drawing you created, that drawing must be controlled.

"The organization shall ensure the adequacy of specified requirements contained in the purchasing documents prior to issuing to them to the supplier"

The best way to ensure adequacy and maintain revision status is the a Document Control syste.

If you are purchasing a custom part that is defined by a drawing you created, that drawing must be controlled.

"The organization shall ensure the adequacy of specified requirements contained in the purchasing documents prior to issuing to them to the supplier"

The best way to ensure adequacy and maintain revision status is the a Document Control syste.

This is a good question, as we're currently going through the same pains, Our purchasing department downloads the latest revison from our configuration management system and sends it out with a PO, or request for quote if the drawing changes they send out an admenment to the PO is this acceptable?

"if the drawing changes they send out an admenment to the PO is this acceptable?"

As long as the change has been process through Configuration Management.

Congratulations, Andrew, on finally registering with the Cove and making your first post!:bigwave:

The First Commandment of Quality: Thou Shalt Not Panic!

Before you get all tied up in knots, consider what you mean by "Controlled Document" - in most cases, it means the organization has put together a system to "store, retrieve, and protect a document from unauthorized revision or modification." What most organizations forget to consider is that the control only lasts while the document is actually under the organization's control.

The control can be

physical (locked in a filing cabinet or password protected electronic file)
or
contractual (whoever receives a copy signs an agreement [the contract] not to modify the document without permission or release it to others.)
There are lots of legitimate reasons to give an uncontrolled copy to a supplier - here are just a few:

long lead times may require the supplier work on a preliminary version with final tweaking when the final, approved, and controlled version is ready.
the actual final revision is based on making the drawing to fit the prototype as built by the supplier (because of some manufacturing exigencies.)
suppliers often work with "redline" copies of documents which contain all the details of a final copy, but in the interests of efficiency, the supplier makes the product simultaneously while the redline goes through the process of formal approval and subsequent release and control.
the ONLY controlled copy is the one which resides electronically on the organization's computers - all hard copies are "uncontrolled" by definition (simply means someone shall compare the uncontrolled copy to the controlled copy before relying on the uncontrolled copy for manufacture, assembly, or other use.)
often, the customer specifies fit and function; the form is left to the supplier - in such cases, the customer adopts the final drawing of the supplier as its own to incorporate in its controlled documents.
In my opinion, it is pennywise and pound-foolish to leave important documents out of a control system. I have a hunch, however, the primary problem here is one of clear definition of what "control" means in your organization. (Note there is a distinction between "control" and "management" - it is relatively easy to manage documents whether they are controlled or not. It is impossible to control documents unless they are managed.)

In all cases, including traceability issues, it is important for the organization to keep a record of all transactions (manage) which affect the customer directly or indirectly. Surely, the organization's copy of a purchase order to a supplier would include a copy of the drawing given to the supplier as well as a notation whether the drawing was controlled or uncontrolled.

Tell me what you are most worried about with your present system.

"if the drawing changes they send out an admenment to the PO is this acceptable?"

As long as the change has been process through Configuration Management.
All document/drawing changes are approved through our CMS, no document/drawing can be used or sent out until it is approved by all applicable parties and released through the CMS. This is mandated in our QP and by Executive Management.

:agree1:

Wes brings up a good point about controlled and managed.

I'm not sure I agree with sending "uncontrolled" documents to a supplier. It is better to have appropriate levels of control defined for each stage of development.

Say at an early (prototype) stage the only change approval need is the cognizant engineer, at the production stage you would require approval from Engineering, Planning, Manufacturing Engineering, Purchasing, Quality Engineering, Program Management, Component Engineering, customer and a host of others.