Frequently Asked Question

Manufacturing readiness means the process can repeatedly produce conforming product at the planned rate with known controls. Review tooling maturity, fixtures, gauges, material flow, cycle time, operator instructions, maintenance, spare parts, and reaction plans.

Use representative materials and geometry in pilot evidence. An easy prototype process may not be representative of the production process.

Traceable product-development method

Product-development work should connect the customer need to a measurable requirement, design output, manufacturing control, and objective evidence. For Manufacturing Readiness and Tooling Review, define the function, stakeholders, inputs, constraints, failure risks, verification or validation method, acceptance criterion, and accountable owner. Keep assumptions and unresolved risks visible instead of hiding them in status language.

This is a prioritization aid, not a physical law. Use the project’s approved rating definitions and treat safety, regulatory, and single-point risks explicitly.

Worked example

If a seal requirement is leakage below 1.0 mL/min, the evidence plan should identify the production-intent seal, pressure and temperature cycle, measurement resolution, sample size, acceptance rule, and disposition for an outlier. “Tested” is incomplete without those details. A design change that alters the seal interface should trigger impact review of requirements, DFMEA, verification, PFMEA, and control plans.

Gate discipline: make the reviewed configuration, decision, open action, owner, due date, and residual risk explicit.

Engineering check

For Manufacturing Readiness and Tooling Review, maintain traceability from requirement to risk, design output, evidence, and approval. Record the configuration, acceptance criterion, test or analysis conditions, open actions, and residual risk. A method is not complete when the document is filled in; it is complete when the evidence supports the decision and affected controls are updated.