Use case · Quality and SOP change
A controlled SOP change rarely stops at the SOP
For quality teams in medical-device manufacturing, one revised obligation or deadline can create a review problem across work instructions, checklists, training, and related procedures.
Inspectable claims. Declared scope. Human accountability.
The familiar workflow
A Quality Systems specialist receives a revised SOP, reviews redlines, searches for references, asks subject-matter experts what depends on the change, records an impact assessment, and follows actions through the existing quality process.
- The difficult part is not seeing that text changed.
- The difficult part is establishing which meaning changed, where it propagates, what remains uncertain, and why each decision is defensible.
Synthetic case: 30 days becomes 15, and may becomes must
QMS-SOP-014 v4.1 says the Quality Investigator may initiate an investigation within 30 calendar days. Version 4.2 says the investigator must initiate it within 15 calendar days.
- Semantic Delta: OPTIONAL → MANDATORY
- Timing: WITHIN 30 CALENDAR DAYS → WITHIN 15 CALENDAR DAYS
- Potentially affected: WI-08 and CL-04
- Review required: TR-22 inferred training relationship
- Bounded unaffected: FRM-11
- Not evaluated: stale SOP-21
Text, meaning, and impact are different records
Move through three levels. Each level keeps its own evidence basis and does not silently become the next.
- Changed text exact evidence
- Semantic Delta reviewed interpretation
- Downstream impact dependency-based inference
Level 1 · exact evidence
Text diff
Version 4.1The Quality Investigator
mayinitiate the investigation within30 calendar daysof intake.
Version 4.2The Quality Investigator must initiate the investigation within 15 calendar days of intake.
This establishes: which exact source characters differ. It does not establish normalized meaning or downstream impact.
Level 2 · reviewed interpretation
Semantic Delta · SD-SYN-001
- Actor
- Quality Investigator
- Action
- initiate investigation
- Modality
OPTIONAL→ MANDATORY- Timing
WITHIN 30 CALENDAR DAYS→ WITHIN 15 CALENDAR DAYS
This establishes: the normalized meaning accepted for this synthetic narrative. It does not establish which downstream objects depend on that meaning.
Level 3 · dependency-based inference
Downstream impact
| Object | Relationship state | Bounded outcome |
|---|---|---|
| WI-08 | confirmed | potentially affected |
| CL-04 | confirmed | potentially affected |
| TR-22 | inferred — review required | review required |
| FRM-11 | evaluated | no relevant impact found within evaluated scope |
| SOP-21 | blocked | not evaluated |
This establishes: outcomes supported by eligible paths inside the declared evaluation. Text comparison alone did not produce these findings.
Declared boundary: A result applies only to this declared synthetic portfolio, frozen graph, applicability policy, and evaluation budget.
Inspect the path, not just the outcome
Select a target to inspect its node, relationship basis, evidence, lifecycle state, version, and bounded impact reason.
Choose a target
Target node · WI-08
Investigation Work Instruction
- Source evidenceQMS-SOP-014 v4.2
- Semantic DeltaSD-SYN-001
- Relationshipreferences and restates
- TargetWI-08
- Object
- WI-08 · Investigation Work Instruction
- Type
- Controlled work instruction
- State
- confirmed
- Reason
- The work instruction repeats both changed fields.
- Source
- QMS-SOP-014, Section 6.2, paragraph 2
- Evidence
- Section 2 cites QMS-SOP-014; section 4.1 repeats the 30-day initiation window.
- Relationship
- references and restates
- Origin
- exact reference plus structural match
- Method
- deterministic reference rule v1
- Lifecycle state
- confirmed
- Graph version
- GRAPH-SYN-2026-09-15-01
- Comparison
- CMP-SYN-2026-09-15-01
Target node · CL-04
Investigation Intake Checklist
- Source evidenceQMS-SOP-014 v4.2
- Semantic DeltaSD-SYN-001
- Relationshipimplements
- TargetCL-04
- Object
- CL-04 · Investigation Intake Checklist
- Type
- Controlled checklist
- State
- confirmed
- Reason
- The acceptance criterion contains the previous deadline.
- Source
- QMS-SOP-014, Section 6.2, paragraph 2
- Evidence
- Checklist item 7 asks whether initiation occurred within 30 calendar days.
- Relationship
- implements
- Origin
- field-to-claim match
- Method
- policy rule v3
- Lifecycle state
- confirmed
- Graph version
- GRAPH-SYN-2026-09-15-01
- Comparison
- CMP-SYN-2026-09-15-01
Target node · TR-22
Investigator Refresher Training
- Source evidenceQMS-SOP-014 v4.2
- Semantic DeltaSD-SYN-001
- Relationshiptrains
- TargetTR-22
- Object
- TR-22 · Investigator Refresher Training
- Type
- Training module
- State
- inferred — review required
- Reason
- The content is semantically related, but the relationship is not yet confirmed.
- Source
- QMS-SOP-014, Section 6.2, paragraph 2
- Evidence
- Module 3 teaches investigation initiation timing but does not cite the SOP identifier.
- Relationship
- trains
- Origin
- semantic candidate
- Method
- bounded candidate classifier v2
- Lifecycle state
- inferred — review required
- Graph version
- GRAPH-SYN-2026-09-15-01
- Comparison
- CMP-SYN-2026-09-15-01
Declared boundary: A result applies only to this declared synthetic portfolio, frozen graph, applicability policy, and evaluation budget.
What the prototype can support
Inside a declared synthetic portfolio, the current basis supports exact old/new semantic change evidence, versioned dependency candidates, bounded impact paths, explicit uncertainty, and accountable review states.
- It does not claim a complete organizational dependency graph.
- It does not claim production-scale recall or a customer outcome.
- It does not close the controlled change in the current M0–M4 baseline.
A historical replay starts from existing records
A first evaluation can begin from one completed change case, its known downstream review set, and the decisions already recorded in the governed quality process. The synthetic scenario does not represent a specific integration or transfer system-of-record responsibility.
Systems of record
QMS · DMS · GRC · ALM · requirements · workflow
Controlled content and approvals remain here.EvidView
Scoped versions → governed findings
No implemented connector is implied.Next step