drawing and design control for product design consultancies

Hi all.

Regarding drawing control and design control in a consultancy. How much should we be controlling and how much should we be deferring to our clients?

For drawing control:

We have an established format for part numbering and naming
We make design changes as required, up-issue the drawings and email the new issue to the client (from first production release onwards)
We have a change record box on the drawing where we can briefly describe (and date) what the change was.

We do not ‘control’ data flow; for example we rely on the client or manufacturer to take control of removing outdated drawings from circulation and to decide whether stock / field / WIP items are affected and when to implement the changeover
We do not have a written drawing control procedure
We do not have an Engineering Change Order form showing actions required to implement etc.

For Design Control (of medical products)

We participate in some design exercises (such as risk assessments, physical testing etc) which are used by our clients as contributions towards design history files.
We do not compile DHF’s ourselves. We are not directly involved with applications for CE / FDA approval


What is our obligation as contracted design consultants? For example in the case of a client who is a medical device manufacturer being audited by MHRA / FDA, what is our expected level of responsibility as contracted designers?

Is it simply…

To record changes to documents (description and date of change, revision level, all affected docs, signatures, approval and effective dates)?
To show that we have communicated the change to all affected parties?
To have a formal, written design control procedure which demonstrates a controlled process?

My question particularly relates to controlled flow of documentation at the ‘implementation’ end…
How can we ensure that old documents owned by the client are removed and filed / discarded to prevent unintended use?
How can we ensure that documents are passed from the client to their manufacturers / suppliers?
How do we control remedial work generated by the change (i.e: to field items or warehouse stock / WIP?)
How do we reference the client’s QA procedures within our change control process?
Is this our responsibility anyway, or should we just be outlining to our clients that all of the above lies in their court?

We need to clearly and correctly divide the responsibilities between ourselves and our clients, and make sure that nothing ‘falls down the gap’.

How has everyone else approached the design of their drawing / design control systems? I’d be really interested to have your advice.