P13 · Approved guidanceReviewed 2026-09-17

When does a factory change affect COP or certification?

01

Direct answer

Direct answer

Do not draw a conclusion from the phrase “factory change” alone. Identify exactly what changes: the legal manufacturer, production site, process, tooling, supplier, material, quality controls or product characteristics. Then map the change to the relevant type approval or certificate, COP and dossier requirements to determine whether an update, assessment, testing or other action may be required.

02

Questions to answer

  • Does the manufacturer named in the approval change?
  • Is the production site within the current dossier/COP scope?
  • Do the process, tooling, material or supplier change?
  • Do any product characteristics change?
  • Are the control plan, inspection, traceability and calibration controls equivalent?
  • Does the approval mark or documentation require updating?
03

Basis

LEGAL REQUIREMENT: The mandatory action depends on the applicable QCVN, procedure, certificate/approval and specific COP requirements. There is no general rule that every factory change requires retesting or that no factory change requires retesting.

04

Expert analysis

EXPERT INTERPRETATION: Treat a factory change as a regulatory change-control event with an established baseline, identified delta, affected requirements, evidence and decision log.

EXPERIENCE-BASED INSIGHT: LotusTSE performs an impact/gap analysis before concluding that supplementary testing, COP action or another procedure is needed. Its COP review prioritizes change control, traceability and production evidence.

05

Risks

Transferring production while retaining the old dossier without review; supplier or tooling changes without assessment; traceability that cannot connect the two sites; a nominally unchanged product whose process-sensitive characteristics have changed.

06

Approach

1. Define the old and new baselines.

2. Build the change matrix.

3. Map the impact on requirements.

4. Identify evidence gaps.

5. Verify the required action against the specific regulation and approval.

6. Update the controlled dossier.

07

LotusTSE support

Change-impact assessment; COP readiness; dossier-update planning; evidence review.

08

Knowledge Graph

Related: Product Changes; COP; Actual Configuration.

QCVN/Circular/UNECE: according to the product and approval.

09

NEEDS VERIFICATION

Notification, extension, audit, testing and document-update requirements must be verified against the specific certificate/approval and procedure.

KG

This content does not replace a case-specific legal or technical assessment.

LotusTSE

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