Investigation record

The skill preserves the original OOS result, separates laboratory review from expanded manufacturing review, and routes unresolved evidence to the Quality Unit. The complete machine-readable deliverable follows.

{
  "schema_version": "1.0",
  "case_id": "DEMO-001",
  "domain": "Pharmaceutical quality control",
  "evidence_boundary": {
    "reviewed": [
      "analyst interview note",
      "assay worksheet and chromatogram",
      "sequence suitability report"
    ],
    "unavailable": [
      "retest_rationale",
      "manufacturing_review"
    ]
  },
  "evidence_ledger": [
    {
      "item": "original_result",
      "status": "OBSERVED",
      "finding": "original result is observed in the worked case.",
      "source_refs": [
        "assay worksheet and chromatogram"
      ]
    },
    {
      "item": "system_suitability",
      "status": "OBSERVED",
      "finding": "system suitability is observed in the worked case.",
      "source_refs": [
        "sequence suitability report"
      ]
    },
    {
      "item": "analyst_hypothesis",
      "status": "REPORTED",
      "finding": "analyst hypothesis is reported in the worked case.",
      "source_refs": [
        "analyst interview note"
      ]
    },
    {
      "item": "retest_rationale",
      "status": "MISSING",
      "finding": "retest rationale is missing in the worked case.",
      "source_refs": []
    },
    {
      "item": "manufacturing_review",
      "status": "MISSING",
      "finding": "manufacturing review is missing in the worked case.",
      "source_refs": []
    }
  ],
  "investigation_route": "EXPANDED_INVESTIGATION_REQUIRED",
  "batch_disposition_decision": "NOT_MADE",
  "dependency_map": [
    "Final decision depends on Quality Unit and every route-changing missing artifact."
  ],
  "next_evidence": [
    "retest_rationale",
    "manufacturing_review"
  ],
  "decision_owner": "Quality Unit",
  "limitations": [
    "No result invalidation.",
    "No batch release or rejection.",
    "No retesting into compliance.",
    "No regulatory compliance conclusion."
  ]
}

Next step: obtain the missing contemporaneous preparation evidence and approved retest rationale before any authorized disposition decision.