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Subject:RE: Org charts by title only From:"Dori Green" <dgreen -at- associatedbrands -dot- com> To:"TECHWR-L" <techwr-l -at- lists -dot- techwr-l -dot- com> Date:Mon, 6 Aug 2007 08:51:34 -0400
Dan Goldstein wrote:
We follow FDA's Quality System Regulations and ISO 13485:2003, and we
built our document-controlled org chart with only position titles, no
names. It's a common practice and it works fine -- as long as everyone's
been trained to understand where they are on the chart, how the
interrelated responsibilities work, etc.
************************
Yes, I knew that, which is why I proposed the solution I did (taking names off since they're dropping like flies -- I mean, changing frequently).
Of course, there's no reason that the org chart can't just be controlled and revised when it changes. If it changes every week, so be it. That's exactly why it should be a controlled document!
Ah, training. Sigh, it's an educational opportunity, isn't it? <pun intended> I _really_ don't want to give a negative impression about my company, but I guess it's okay to say that we're among the thousands (millions?) for whom it's an ongoing issue. We were purchased last March and the new owners have recently engaged a consulting firm to come in and look at our processes. They might not come up with the same suggestions that I did, but maybe something will be done about theirs so _something_ will happen. When we have systems, I'll be glad to document them.
As a person with some experience in document control (30 years), I am not comfortable with the distribution of an org chart without names as controlled document, and same chart with names as an uncontrolled document. But that's what's working for them and we'll let them run with it until an FDA auditor says they can't do that any more. I made my suggestions, in writing, dated. If some future interviewer wants to know why So the task at hand is to get my own perfectionism character flaw out of the way and move on in the process as well as I can.
It was a major win to get them to write down an organization chart and allow it to be controlled, even without names. So yay for me, now on to the next grapple!
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