Complaint Handling & MDR Kit: Intake, Investigation, 21 CFR 803 Reportability Decision Tree, Trending Log

Not eligible for NQT documentation review.

Complaint Handling & MDR Kit: Intake, Investigation, 21 CFR 803 Reportability Decision Tree, Trending Log

Intake and investigation forms, a 4-step 21 CFR 803 reportability decision tree with the clocks, and a log that sets 30-day and 5-workday due dates with overdue flags. Monthly category trending per 1,000 units with an alert rule.

What's inside:

- 00_Start_Here_README.pdf

- 01_Complaint_Intake_and_Investigation_Forms.docx

- 02_MDR_Reportability_Decision_Tree.docx

- 03_Complaint_Log_and_Trending.xlsx

Written by Matt Norman: 15 years as a U.S. Navy aviation structural mechanic, then 3 years at SpaceX as a Falcon 9 quality inspector and QA supervisor, with hands-on experience working under ITAR and DoD compliance requirements. Norman Quality Tools is Veteran-Owned & Operated.

License: one company, all sites. Word/Excel 2016+, Microsoft 365, LibreOffice. No macros.

Templates, not regulatory advice.

Norman Quality Tools is not affiliated with or endorsed by the U.S. FDA, or any other standards body, government agency or company named in this description. Standards are cited by number only; buy the official standard from its publisher.

Not affiliated with or endorsed by SpaceX or any other current or former employer of the author.

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