Originally posted by isodog:
But it makes a BIG difference if I create a procedure and control it than if I just write a memo about how I am going to do something like contract review.
doesen't it?
Dave
Answer? Controlled memo (quality record).
You document what you need to document. Check against requirement. Ask: Do I need anything else?
The point of all this is that you have to be able to explain how people know what to do. If the folks on the dock all know that chemical product X-1235f1-4QQ cannot be shipped unless it's at least 45 degrees F outside because if 'spoils' if it is exposed to temperatures of less than 38 degrees F, then you don't need a procedure. As an auditor I'll pull 2 to 4 aside and ask about this product. "It's January and you have to ship product X-1235f1-4QQ to Genrad. What is the procedure?" I'll expect something like "...product X-1235f1-4QQ is temperature sensitive. In January it's typically cold so we require a heater reefer." Auditor: What is the requirement?" Auditee: "...If it's less than 45 degrees F outside, we require a reefer." Auditor: "...How do you know when it's below 45 degrees out side?" Auditee: "...We have a thermometer outside on the dock." Now if the employee really wanted to impress s/he could say "...I check the weather channel in the mornings and know what the predicted weather is along the route. So even if it's 48 degrees here and I'm shipping to Toronto, I know Toronto is expecting 15 degrees - So I order a reefer..." I won't go into whether the wearther channel is
calibrated, but I think you get the idea. Does the employee understand the requirement
and does the employee understand the implications of a screw up with respect to product thermal stability.
Quickly, I want to say I define a procedure as a way of doing something whether it is documented or not documented. No more, no less. Again, I do not define 'documented' as requisite to a methodology being called a procedure. If you ask how I start my car, I tell you how I do it. It is a procedure. It is my procedure. May be I derived it from my owners manual (that thing the manufacturers ensure are comprehensable to total idiots {...Do not start the car while in gear...}). It is my procedure - I don't need a flow chart. I know how to do it.
Let's face it. There have to be some road maps. How far and how deep you document is a function of how well employees are trained with respect to aspects such as process complexity, employee turn over rate for the position and numerous factors.
You simply

determine what systems you have to document while considering you company.
If you're
12 souls and your
turnover rate is
0 for the last
10 years (I actually had a client like this - no kidding), every one knows what to do so documented systems is not a big deal. Auditor asks and everyone can tell exactly what to do.
If you have
20,000 employees you are going to have many master systems documented (road maps). And in any given facility with respect to any local process and also with respect to aspects such as employee turn over rate, you have to determine what has to be documented and what does not. And you have to be ready to explain why you document what you do document and why you do not document what you do not document.
What you do not document, you must train.
Get out of the 'required procedures' trap.
Comments welcome.
[This message has been edited by Marc Smith (edited 22 April 2000).]