Describe the proposed change precisely
A different receiver can require a different output role even when the design is unchanged. A different material or process can change applicable constraints. A changed export setting can alter generated output without resolving design suitability.
| Observation or task | Action and evidence |
|---|---|
| Receiver changes | Confirm accepted file roles, directory requirements and acceptance contact. |
| Material or process changes | Compare applicable instructions and list design decisions requiring renewed review. |
| Output configuration changes | Have the authorized administrator verify the installed method, then inspect a controlled regenerated output. |
Example: the geometry looks unchanged
A hypothetical R03 design was reviewed for route A. The customer requests route B and says the visible geometry is identical. The designer records the new requirements, identifies which prior decisions remain supported and which need review, and issues R04 only after those questions have owners and answers.
An unchanged screenshot cannot establish suitability for route B. Changing a file extension cannot demonstrate that the required export was generated.
What the software source establishes
3Shape documents manufacturing-process selection and CAM-output method configuration in Dental System. It notes that available settings vary with the selected method. This supports checking the configured output route; it does not establish material suitability or acceptance by Pristine.
Record the installed release and process identifier for provider review. Do not copy configuration values from an unrelated lab or change shared production settings simply to obtain an export.
Acceptance checkpoint
Use the worksheet to pair each changed requirement with an owner, affected review and evidence. The receiving provider confirms the delivered roles; the responsible reviewers confirm the affected design decisions. Keep the prior package clearly superseded once the replacement is accepted.
Validation and limits
Louie validation pending — unverified locally. Louie and the receiving provider must verify installed manufacturing-method behavior, applicable material/device instructions, file-role acceptance and who renews affected approvals. No Pristine manufacturing compatibility or numeric parameters established.
Use internal references in the blank worksheet. Examples are hypothetical; applicable instructions and responsible approvals govern real work.
Source notes
Official sources checked October 6, 2026. Scope and dates below; installed applicability remains unverified. Worked examples and worksheets are original.
Prepared by Pristine Dental Design · October 6, 2026.