Complaint and Investigation Desk

Fernhollow Botanicals

One gritty tin is a reply. Three on one lot is a reply and a question.

Twelve contacts arrived this week as email, web forms, retailer notes and transcribed calls, on one regime: every line here is an over the counter drug product. The agent reads each one, qualifies it in the words the complainant used, and hands the rest to the code. The urgency follows the defect category, the due date follows the qualification, the recurrence is counted per lot, per defect category and per origin, and an investigation opens only on a trigger the counter established. Three complaints on one lot is a recurrence to examine, not a cause found, and the reply to the customer goes out while it is examined. It never says how serious an adverse event is. It cites the rule that says who does.

Measured here, end to end on the whole queue: run one and watch. That covers intake qualification on both lanes, the QMS record pre-fill, the recurrence count and the investigation record. It does not sample, does not inspect a returned unit or a retained sample, does not review a batch record on the floor, does not determine a cause, does not close anything and reports nothing to any regulator.

What this shows

The problem
Complaints arrive as free text through four channels. Somebody has to qualify each one the same way every time, on two lanes that run together, pre-fill the QMS record from what the contact actually said, notice the three independent reports that share a lot, and open the examination before the recurrence reaches the annual report.
The result
The run below is real and is recorded: twelve contacts qualified, the urgency, the due date and the routing computed from the procedure, the recurrence counted per lot, per defect category and per origin, and every line carrying the reference it came from.
What is simulated, and what is not covered
The maker, the twelve contacts, the six lots, the laboratory report and the two internal procedures are invented. The two public rules are not: 21 U.S.C. 379aa and 21 CFR 211.198 are quoted verbatim with their source, and every product on this desk is an over the counter drug product, which is the one regime they govern. Purely cosmetic lines sit under another regime with another definition of a serious adverse event and are out of scope here. There is no QMS connection, no ERP, no scanned document. Sampling, physical inspection and batch record review on the floor are outside this desk, so is any determination of how serious an adverse event is, so is any finding of cause, and nothing here is submitted to any regulator.
What a pilot would need from your side
A sample of real complaints with the names removed, your complaint and investigation SOPs in whatever form they exist today, and one person who can say whether a qualification is right.
Who built it
Frederic de Lavenne de Choulot, The AI Pipe. Built as a demonstration, not sold as a quality or regulatory product.

Intake this week

Batch register

Procedures and rules

Fictional desk. Do not paste real complaint, patient or quality records.
Enter to send, shift and enter for a new line. Live tool use over twelve contacts, six lots, two procedures and two public rules.