[quote=meyert]Does anybody categorize their deviations? Major, Minor, Fatal, etc…then base who has to approve based on the category.
I agree Meyert categorization is important, how do you handle what is a major and what is a minor fault. Does it depend on the system in question? sometimes its hard to get agreement on what poeple see as major and minor deviartions. I find that some people try and justifty a minor deviation when it is a major one just to cut down on the work load involved.
[quote=meyert] What about type of failure, protocol generation error(PGE), executor error (EE), RAG (random act of God), AC failure. I have seen some really complex deviation procedures, and I prefer the simple yet somehow I think a lot of information is missing in the simple.
Agree again type of failure is important, I [FONT=Verdana]Intentionally left this example simple so that people could add in their own specific details, from company to company there is no overall template that can be used. [/font]
Also, any thoughts on a Deviation Log…we use that so that deviations don’t just disappear.[/quote]
Yes a deviation log is an essential document providing a snapshot of all the deviations assocaited with the system
What about having QA approve all deviations? Or just some? Then which ones?[/quote]
It’s like as if you are on the same project as me at the moment, I have always harped on about getting quality involved in all deviations from the start. If this does not happen then Quality end up slowing doen the review process as they dont understand the deviation and as a result will not sign off the protocol. I find that it can be useful to have a meeting with the interested parties to explain all the deviations before the review process begins
What type of deviation requires approval before proceeding with execution?[/quote]
Any deviation that is deemed critical and prevents the next stage of the execution taking place.
Thats my 2 cents