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My apologies to all of you who received my junky attachment. I admit the mistake, I learned from it, so hopefully the rest of you will not beat up me so much.
So, to start over.
Our Document Change Order process is too cumbersome to explain on this list. We are ISO certified, and a medical company that follows many FDA regulations. Our system is designed to be a Catch 22. The DCO process takes too long, and the rules change daily!
I am including questions that our technical writing department (2 of us) compiled. Respond to me directly, or to the list if you think topic is appropriate for others.
Questions about an Engineering Change Order (ECO) or Document Change Order (DCO) system:
1. What is the basic process your manuals must go through for ECO/DCO approval?
2. How many approval signatures are required?
3. Are you responsible for completing the ECO/DCO paperwork that accompanies the manual?
4. How long does it usually take to get a manual through the approval process (that is, ready for printing)?
5. Do your printed manuals get inspected for their appearance (e.g., size, type of binding, presence of typos, etc.) or only for content?
6. If your manuals do get inspected for appearance, is this due to some regulation (e.g., ISO9000, FDA, etc.), or is it at the discretion of your company (e.g., your company's QC program)?
7. Do your specifications for the process include printing specs?
8. Are you allowed to work with the printer (vendor) yourself?
9. What are the biggest problems (if any) with the approval system?
10. Has your company ever revamped the ECO/DCO approval system - what were the basic changes and has it helped?
Thanks.
Lynda Shindley
lshindley -at- angieon -dot- com
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