Recalls - fillable forms or checklists?

RAQADeviceMfg

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I'm not sure if anyone could help me with this or not. I'm fairly new to RA/QA and took over our complaint handling and processing last July. We're about to conduct a mock recall and in doing so I'm also updating our Recall Procedure following the FDA's latest guidance, Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C.

Thankfully, we have not had to recall any of our devices in the past which makes this mock recall and updating our procedure a little bit more difficult with no previous examples in our company (especially considering being fairly new to this world). Our current procedure requires developing a Strategy Report upon determining that a recall is the appropriate course of action. The report needs to be approved and signed by the Strategy Team and signed by our company's President before submitting reports, notifying direct accounts etc. I'm wondering if other companies require reports like this beforehand and if so the best way to compile the report? Does anyone have any fillable form or checklist examples/templates?

I've found tons of information on mock recalls through the FDA website and through here, I even took a course through Oriel STAT A MATRIX, but I'm still having a little bit of a hard time. Any help is EXTREMELY appreciated! :)
 
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