Make: production batches, QA release, and lot genealogy

What Make holds

Make turns an approved formula version into a batch record: steps, consumption, in-process checks, and batch testing, tied back to the specific formula version and the supplier lots it consumed.

Release is a gate, not a formality. A batch with an open blocking quality event does not release without a signed, reasoned override from someone holding the elevated permission, recorded in the audit trail.

What's in it

• Batch lifecycle with steps, ingredient consumption, in-process checks, and batch tests.
• Second-person verification enforced by role: the person who verifies a step is never the person who performed it.
• A nine-point QA release gate, with a signed, reasoned override required to bypass a blocker.
• Potency-adjusted dispense math computed from the operator-confirmed assay.
• Forward and backward lot genealogy, recall blast-radius calculation, and a timed mock-recall drill.
• Per-lot reserve sample records with disposal tracking under 21 CFR 111.83.

Who reaches for it

Production runs the batch record. Quality Control performs in-process checks and second-person verification. Quality Assurance owns the release decision and any override.

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