Six Decision GatesMove from supplier claims to reviewable project evidence.
The output of one gate becomes the input to the next. A certificate, sample or laboratory report is useful only when its identity, scope, version and project relationship are clear.
Gate 1 · SupplierQualify identity, roles and evidence access
Separate the U.S. coordination role from the manufacturing site, then record facility identity, scope, current documents, quality contacts and disclosure limits.
24-point supplier qualification checklist →
Review dated factory-verification evidence
Gate 2 · RFQMake formulas and quotes comparable
State the active, serving design, gummy base, target market, package, test scope, volume stage and delivery basis so suppliers are not evaluating different projects.
Open the gummy manufacturer RFQ template + Excel workbook →
Translate the label target into formula-space arithmetic · Compare two quotes by delivered, accepted bottle
Gate 3 · RequirementsConvert the concept into controlled acceptance criteria
Define identity, assay, physical, microbiological, packaging, sampling and change-control expectations before treating a prototype or COA as approval.
Build the product specification →
Reconcile label and artwork
Gate 4 · TransferControl what changes from sample to commercial batch
Record the approved sample, known scale differences, first-batch checks and change triggers instead of assuming a hand sample proves production equivalence.
Plan sample-to-batch scale-up →
Review packaging change control
Gate 5 · ReleaseMatch reports and records to the released batch
Confirm sample identity, method suitability, units, specifications, batch linkage and review status before using a report or COA as claim support.
Review COA and batch records →
Evaluate a third-party lab report · Check stability evidence
Gate 6 · Follow-UpKeep investigation and claim evidence reviewable
Preserve containment, related-batch review, original data, disposition and corrective-action evidence. Keep external claims tied to the exact evidence approved for disclosure.
Review complaint and OOS investigations →
Open the project evidence register