omp-flow-qbd

OMP-Flow QbD

Gate Meaning

• QbD 1 challenges whether the selected problem, requirements, design, sources, and contracts are justified.
• QbD 2 challenges whether the authored work map, work Concepts, scope, ordering, and verification can realize the approved design.
• The independent auditor applies adversarial judgment. The human calibrates the result. Neither replaces the other.
• QbD is a material decision challenge, not an exhaustive search for possible refinement. Practice evidence（实践检验）outranks process completeness; anti-formalism（反形式主义）does not weaken mechanical authorization, data, false-authority, or irreversible-effect boundaries.

Procedure

Before native dispatch, only Main/coordinator may dispatch, correlate operations/receipts, obtain or record human calibration, and choose a workflow transition. Those coordinator actions are inapplicable to an already-dispatched Auditor: it must not dispatch or self-redispatch, govern, calibrate, transition, or selectively reinterpret coordinator clauses. The Auditor still owns the complete bounded independent audit and assigned audit Concept: reconstruct the concrete problem without solution jargon, challenge whether the selected problem and current principal contradiction still hold before judging architecture completeness, preserve the mechanical safety analysis, and report the required verdict, findings, evidence, and contradictions through that output boundary.

1. Identify the design or work-map entry Concept and an explicit audit output Concept. Through its useful links, bind the audit to the current decision, unacceptable consequences, current scope/change, and relevant closed findings, residual risks, and human decisions. Do not require a fixed audit-brief file or field shape; no prior findings is normal for a first audit.
2. In Main/coordinator context only, start one independent QbD operation with Bundle root, role, bounded objective, entry, output, actor ID, and optional predecessor receipt.
3. In Main/coordinator context only, dispatch one independent native qbd-auditor. Pass the paths and opaque receipt returned by the runtime by forwarding the complete returned assignment unchanged. Keep its strict v1 ompFlowDispatch descriptor as the first non-blank line, set native item id = actor_id = actorId, and use the matching descriptor role. Do not render the Bundle, reconstruct the descriptor, or prepend audit prose.
4. Require an explicit verdict with these semantics:
   • FAIL requires evidence of a critical falsehood, authorization or data violation, irreversible harm, or an unrealizable/unverifiable core path for which safe degradation is insufficient.
   • NEEDS_EVIDENCE applies only when missing evidence prevents judging whether such a material consequence exists. Unknowns alone are not blocking.
   • PASS means no unresolved blocking finding in the current scope; it may carry advisory observations, residual risk, later verification, and deferred recommendations.
5. Require each blocking finding to link evidence through cause -> concrete consequence -> affected decision, give the smallest remedy, and explain why hiding, unavailable, disabling, narrowing, refusal to write, or another safe degradation is insufficient. Findings without that chain are advisory.
6. In Main/coordinator context only, confirm the promised audit Concept exists, links to what it evaluated, and records material findings, then finish the runtime operation with the same actor ID. The already-dispatched Auditor returns that assigned audit output; it does not finish or correlate the coordinator's operation.
7. In Main/coordinator context only, present material findings and applicable governance options to the user. Only the user decides calibration; the verdict itself authorizes no repair, re-audit, or forward transition.
8. In Main/coordinator context only, record the human decision in a linked decision Concept. Do not encode approval, materiality, or risk as runtime phase or parsed state.