> It is written, but not documented.
By this I assume that (for example) building drawings have wiring routing indicated but how the route was determined was not in accordance with a documented procedure.
The question is then: How far do you go in documenting a system and it's sub-systems (processes). And how does this fit in with requirements of Design within the standard.
This depends upon many factors including the size and complexity of your company. Most companies, as they get larger, tend to have defined procedures for plant upgrades. Looking at a large plant of say 1500 employees with a medium-complex set of processes, one would expect a relatively complex system which involves bringing together manufacturing, maintenance, and whatever other 'functional areas' ar necessary to plan the change.
On the other hand, if you're a mom and pop of 14 employees and you're having a LAN installed it will probably be seat of the pants. It may be that you have a local retailler install and provide equipment. Or - you may call Dell or some other major playr and they may do the design and such.
By the time you reach a few hundred employees you're looking at a relatively comlex planning situation for 'infrastructure changes' with respect to IT. ISO doesn't require you to follow the design requirements within - those are aimed at product design, but Planning does come into play here. So - look at it from this direction.
As a last comment - remember that some things are not done according to a procedure. You have to determine the need for a procedure. And how much detail you need. An example is a plant manager. Whilst s/he may follow certain procedures, most of what s/he does is not readily definable in detail in a procedure. Design is like this. You can lay out a 'standard plan' for designers to follow, but much of what they do is done because of their education and/or experience. As an aside: If you look at the requirements for Design in 7.3, these are nothing more than the basics that (in my opinion) any college graduate with a degree in engineering should know and understand as the basics of a design project. A good design process is nothing more and nothing less than a good planning process.
> They have a plan on how to create those things, that's why
> when there's a problem they could easily troubleshoot,
> where could the problem arise.
If this is true, it sounds as if they have a defined planning methodology / procedure whether it is written or 'known' (the proverbial 'unwritten procedure').
> And they created a tracking database in monitoring problems.
They also have a way of addressing non-conformances in their system and such. Sounds pretty sound to me.
Comments / opinions from others?
