Operators Manual update to product in the field

I_Moy

Starting to get Involved
My company is hoping to update the product's Operators Manual to make a change to the user steps allowing easier use. Internally I'm good with the Engineering Change Process and can relabel product still in our warehouse under my ECO. But there is product in the field that the company wants to also update with the new Ops Manual. Anyone know of a mechanism for doing this? Its not a field action per normal definition as there is no risk to using the product as is. (For context product is FDA registered, Class II 510K exempt). Thanks in Advance!
 

Randy

Super Moderator
Yep, simple and it saved a manufacturer untold millions of dollars for a nonconformity I wrote a few years ago............Put notifications out and make updates available on a public website......I wrote a major about final product testing, it was going to have potential serious implications globally and someone said "have they changed the manual?"..........DUH!. The involved test equipment manual had actually been updated years earlier and nobody had ever taken the time to occasionally look
 

yodon

Leader
Super Moderator
I would probably document your risk assessment as part of the change management process and consider what the most effective means for getting the updates in the hands of the actual users. If you distribute directly, it would be a good opportunity to re-connect with the users and even initiate feedback! Reinforcing the updated material with actual discussion would likely be more effective than just mailing new copies and/or posting on your website (which I'm not saying shouldn't be done). If you go through distributors, it gets less direct but reconnecting with them and having them re-connect with their customers would still be good.
 
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