GMP OOS Investigation Casefile

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.