Risk Check for First Order: Contract Manufacturing Guide

Sample approval does not guarantee that the first commercial order will be repeatable. Material lots, operators, packaging and process conditions can change. Record these differences in the control plan before placing the order.

Evidence before the first order

For contract manufacturing guide, check these records against the product revision and target market:

• Released specifications and process flow
• Material-lot traceability and batch records
• Capacity assumptions, changeover time and a pilot-run report

Define the pilot order

Specify the pilot quantity, material lots, process settings, inspection points and acceptance criteria. Keep sample, pilot and series-production approvals separate; approval at one stage does not replace the next.

Stop and correction rules

Hold shipment for critical nonconformities, missing traceability or unapproved material changes. Define who can authorize correction, reinspection or a concession. Verbal reassurance is not a release record.

Keep an approval record

Store the approved specification, inspection results, commercial terms and accepted exceptions together. Specify who can approve changes and how their price or delivery effects will be assessed.

Frequently asked questions

Should I place an order if evidence is missing?

Assess what the missing evidence affects. If safety, market requirements or the core product specification cannot be verified, request adequate evidence from the responsible person before approval.

What does a pilot order verify?

A pilot order tests whether the approved specification is repeatable under actual production conditions, and whether inspection and delivery assumptions hold.