What to report and to whom all depends on what countries you are working in. I generally create a complaint handling/reporting flow chart for each entity that would require a report; FDA, Health Canada, competent authority, etc.
As far as organization of a system, anyone who can become aware of an incident should be trained in your incident processes. These generally include Sales, Customer or Tech Services, even receiving. Think about all the ways complaints could be received and train everyone.
In my opinion everything has to be evaluated by a competent person who can determine whether something is reportable. Your structure should depend mostly on the volume of complaints, but I feel the best way to make sure nothing "slips through" even on a weekend, is to train all people who could become aware of an event to submit as much info as they can into a central repository like
[email protected]. That way you can review each of them most likely in the 2 days minimum you would need to in the case of a sever event.
How many people need to do this and databases etc, all depends on your volume. If you have a form for sales, service, etc to completed upon becoming aware that is faxed or e-mailed to your repository, then you can review and manage each one. Just create a form, a Database and go from there. With electronic reporting available for the FDA a compatible DB might be a good idea and speed things along for you. Just make sure everyone sends all issues to the same place. Then you can go from there as far as evaluating them and sorting them out. Hope this helps out some....