Frequently Asked Question

Controlled change

Engineering change control identifies the reason, affected configuration, risk and requirement impact, verification and validation impact, manufacturing and supplier impact, inventory impact, effective date, and approval authority. Keep proposed, approved, and obsolete information distinct. Revisit DFMEA, PFMEA, control plans, work instructions, and evidence when risk or performance can change.

Worked example

A gasket-material change requires review of leakage, compression set, temperature range, supplier capability, tooling, storage, validation samples, and inventory segregation. Approval is incomplete until the affected documents and production baseline are updated.

Engineering check

For Engineering Change Control and Configuration Management, 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.

Engineering note

For Engineering Change Control and Configuration Management, state the intended use, input range, dominant mechanism, units, boundary conditions, acceptance criterion, and evidence owner. Use an independent balance, limiting case, repeat measurement, or sensitivity check to challenge the result. Document the configuration and uncertainty so another engineer can reproduce the reasoning and determine whether the result remains valid after a design, material, boundary, or process change.

Engineering note

For Engineering Change Control and Configuration Management, state the intended use, input range, dominant mechanism, units, boundary conditions, acceptance criterion, and evidence owner. Use an independent balance, limiting case, repeat measurement, or sensitivity check to challenge the result. Document the configuration and uncertainty so another engineer can reproduce the reasoning and determine whether the result remains valid after a design, material, boundary, or process change.