We have begun developing a quality system in compliance with ISO9000. At present we do not have anything.

In order to organize our resources, we need to better understand responsibilities for level 2 (procedures), level 3 (work instructions), and level 4 (forms). Therefore, we would like to know what other organizations are doing.

If you wouldn't mind, could you tell me the name of your company, and also who generates the procedures, work instructions, and forms in your company.

Is it:

A- Quality (Engineering) developing/custodian for all documents, regardless of department (Purchasing, Manufacturing, Inv. Cont'l, Customer Serv., Engineering, etc.

B- Individual department developing/custodian for all documents pertaining to department. Afterwards they are submitted to Quality for review & approval against requirements.

C- Engineering developing all documents, regardless of department (Purchasing, Manufacturing, Inv. Cont'l, Customer Serv., Engineering, etc. Afterwards they are submitted to Quality for review & approval against requirements.

D- A variation of any of the above.

I would appreciate any comments above and beyond my basic question(s), but mostly we would like to mirror what successful companies (our organizations) have done.

TIA,

Rudy Bakker

We have begun developing a quality system in compliance with ISO9000. At present we do not have anything.

In order to organize our resources, we need to better understand responsibilities for level 2 (procedures), level 3 (work instructions), and level 4 (forms). Therefore, we would like to know what other organizations are doing.

If you wouldn't mind, could you tell me the name of your company, and also who generates the procedures, work instructions, and forms in your company.

Is it:

A- Quality (Engineering) developing/custodian for all documents, regardless of department (Purchasing, Manufacturing, Inv. Cont'l, Customer Serv., Engineering, etc.

B- Individual department developing/custodian for all documents pertaining to department. Afterwards they are submitted to Quality for review & approval against requirements.

C- Engineering developing all documents, regardless of department (Purchasing, Manufacturing, Inv. Cont'l, Customer Serv., Engineering, etc. Afterwards they are submitted to Quality for review & approval against requirements.

D- A variation of any of the above.

I would appreciate any comments above and beyond my basic question(s), but mostly we would like to mirror what successful companies (our organizations) have done.

TIA,

Rudy Bakker
***e-mail address removed**
www.amatrol.com (http://www.amatrol.com/)

Rudy,

If I were starting out from scratch (which I have a few different times), I would not worry too much about the levels of a documented Quality Management System. I would get representatives from the applicable functions together and flow the process identifying the functional responsibilities (i.e., process steps, major decision & possible results, etc.), the documentation (i.e., Instructions, Routings, Forms, etc.), and metrics (for determining effectiveness / efficiency of the process) associated with the process. If a turtle helps in detailing the process requirements, then generate a turtle along with the flow, remembering the flow is primarily the head - body - and tail of the turtle.

Once you have the process identified via the above activity, then you manage the process and continuously improve on it using the process documentation as a basis for understanding and controlling the process. The Cross-Functional Team that developed the process documentation works with whomever you have responsible for documentation control, so that the documentation requiring control is controlled per your control requirements.

This is how I do it. It is a time consuming process, but I have Cross-Functional interaction (and hopefully buy-in) during the process. I am not trying to create different levels of documentation (It is my belief that each level of the documentation pyramid results in its own documentation and records.).

Hope this helps!

Doug