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OOS Investigation Workflow ​

Out-of-Specification investigations are long-running quality processes. When lab results fall outside limits, the investigation must be replayable and attributable.

Investigation Phases ​

Phase I: Laboratory Investigation ​

  1. Immediate assessment of raw data and calculations
  2. Supervisor review
  3. Route on the recorded finding:
    • obvious error → QA review
    • non-obvious → durable parallel analyses

Phase II: Manufacturing Investigation ​

If Phase I does not identify a lab error:

  • process, equipment, and material review
  • root-cause analysis with CAPA

Implementation ​

dart
final oosDefinition = Workflow<OosInput, OosResult, OosFailure>(
  code: 'quality.oos',
  version: 1,
  input: oosInputSchema,
  output: oosResultSchema,
  failure: oosFailureSchema,
);

final oosHandler = oosDefinition.implement(
  fingerprint: 'quality.oos:v1',
  execute: (workflow, input) async {
    final assessment = await workflow.request(
      initialAssessment,
      input,
      id: 'assess',
      title: 'OOS initial assessment',
      audience: Audience(roleIds: ['qc_supervisor']),
    );

    if (assessment.finding == Finding.nonObvious) {
      await workflow.parallel(
        id: 'phase-1-analyses',
        branches: {
          'repeat': (branch) => branch.request(
            labAnalysis,
            input,
            id: 'repeat',
            title: 'Repeat analysis',
            audience: Audience(roleIds: ['qc_analyst']),
          ),
          'fresh': (branch) => branch.request(
            labAnalysis,
            input,
            id: 'fresh',
            title: 'Fresh analysis',
            audience: Audience(roleIds: ['qc_analyst']),
          ),
        },
      );
    }

    final qa = await workflow.request(
      qaReview,
      input,
      id: 'qa',
      title: 'QA review',
      audience: Audience(roleIds: ['qa_reviewer']),
    );

    if (qa.confirmed && qa.requiresCapa) {
      await workflow.perform(createCapa, input, id: 'capa');
    }
    return qa.confirmed ? OosResult.confirmed() : OosResult.invalidated();
  },
);

Parallel analyses are named durable branches, not token splits. QA review is assigned work. CAPA creation is a versioned operation.

Compliance ​

  • Two-phase investigation with recorded decisions
  • Mandatory assigned reviews
  • Append-only history for every completion
  • Idempotent operations for CAPA writes

See Also ​