Contract Manufacturing Qualification Checklist
A contract manufacturing qualification checklist for completeness, capability, scale, timing, unknowns, and accountable handoff.
Intake completeness
Confirm the request has enough information for the intended first-pass decision.
Product defined
Product category, description, services, and SKU count are present.
Configuration defined
Primary package, size, closure, process, and relevant product traits are present or marked unknown.
Commercial basis defined
First-run volume per SKU, annual forecast, and requested date are present.
Requirements defined
Certifications, allergens, claims, sourcing responsibility, and formula stage are present.
Capability checks
Compare submitted requirements with documented plant criteria.
Category support
The product category appears in the current approved capability source.
Line configuration
The requested package and relevant features match a supported configuration.
Process support
The requested or required process is supported, or technical confirmation is assigned.
Requirement support
Required certifications, allergen controls, and relevant claims have a confirmed review path.
Scale and timing
Apply the plant’s real quantity and lead-time rules with the correct basis.
Minimum comparison
Compare first-run units per SKU with the approved minimum or review band.
Forecast context
Record the annual forecast separately from the first run.
Lead-time check
Compare the requested production date with the approved planning threshold.
Material lead times
Identify formula, ingredient, and packaging dependencies that need sourcing review.
Decision integrity
Make the result explainable, conservative, and easy to audit.
Unknowns visible
Every material missing fact is listed and assigned rather than guessed.
Conflicts specific
Every not-fit reason names the requirement and the approved criterion it conflicts with.
Evidence current
Each decisive criterion has a source, owner, and review date.
Human review preserved
Technical, quality, commercial, and scheduling decisions remain with their accountable owners.
Outcome and handoff
Close the first-pass review with a clear path forward.
Outcome selected
Choose qualified, needs review, not a fit, or incomplete.
Reason written
Summarize the decisive match, conflict, or unknown in plain language.
Owner assigned
Name the person or function responsible for the next action.
Next action dated
Record the follow-up action and due date.