Process Approach
Good Idea, Marc. This is an interesting topic for me, as you may have noticed already and I just voted on this poll.
Unfortunately, I am not (yet) in the premium group of members and I do not have access to the premium directory.
What is (or will be) really your "upgraded" document on this subject?...
My views so far are that the new ISO certainly recommends a process approach but is not entirely successful in clearing explaining how to actually do it:
- The figure representing the process (the continuous improvement cycle) is indeed very interesting and we are now seeing it in every new ISO literature, but is only the start of the matter, a view in a broad perspective; when it comes to really implementing the system we face some questions for which ISO 9001 does not have clear answers. For instance:
How many processes? How many procedures? Which processes? Which procedures?
- Of course, we know that ISO only claims for 6 documented procedures but...how many of us have other kind of procedures? And how many of us have in fact only 6 procedures?...
- My personal opinion is that we should strive to keep the processes as few as possible, in order to avoid an "inflation" of processes and therefore, consider only one or two main processes in each of the groups other than Product Realization, i.e., identify one or two processes in clauses 5, 6 and 8 and of course some more in clause 7, but the total not exceeding a dozen or so.
- Then, we are faced with the need to document those 6 required procedures and must put ourselves the question: Did we include them already as processes or not? - If yes, no problem, but if not, then comes another question: Should we include them as processes as well or we can just considder them as "independent" activities and portrait them in separated or combined procedures, without any concern of having a corresponding process?
In fact, I believe we should answer "Yes" to both questions, because it will be very difficult in the case of those (6) requirements or at least some of them (e.g. Control of documents; Control of records) to illustrate them in a flowchart (as we should do with any process) and perhaps even more difficult to show their interaction, as ISO recommends, since they are "crossing-system" processes and therefore common to other clauses and phases within the system.
These are my views at present, but we are always changing and I hope yours and perhaps some other views will continue adding good value to this interesting and certainly controversial subject!
Henrique (formerly Henrique DaSilva, but I changed my E-mail address and the only way I found of having it right was to change my nickname as well...)