Ra Qm Skills
When to use
Use this skill for ra qm skills when you need to choose a regulatory or quality workflow. The expected result is a regulatory quality work plan.
Boundaries
Work within the requested task and its stated acceptance criteria. Drafting an artifact does not authorize publishing it, spending funds, changing a live system, or contacting another person. Identify any such action separately before taking it.
Inputs
Inspect product type, market, lifecycle stage, responsible person, and immediate decision. Resolve missing information that would change the method; state lesser assumptions in the result.
Method
- Diagnose. Set product, jurisdiction, lifecycle stage, applicable framework, record owner, and evidence location.
- Decide. Route the task to the relevant regulatory, risk, audit, or document process.
- Produce. Build a regulatory quality work plan from the inspected material; keep assumptions distinguishable from observed facts.
Decision rules
- Trace each requirement to the risk it controls and the documented proof that the control works. Mark missing or outdated evidence.
- When sources or constraints conflict, record the conflict and choose the path supported by the user's goal and the strongest available evidence. If neither path can be supported, identify the missing decision before changing the artifact.
Domain rules
- Preserve traceability between requirement, risk, control, and validation evidence.
- Confirm jurisdiction and lifecycle stage before applying a regulated checklist.
Verification
Verify the chosen framework and flag qualified review. Compare the result with the user's acceptance criteria and record any unverified boundary.
Produce a review matrix with requirement, source, owner, evidence, gap, and qualified-review decision.
Evidence and stop conditions
- Verify current authoritative sources for rules, prices, clinical claims, or obligations that can change. Distinguish fact, interpretation, and assumption.
- Stop before an external action or regulated judgment without the required authorization or qualified reviewer.
- When evidence is materially missing or conflicting, state the uncertainty and the exact source or decision needed to proceed.
Stop conditions
If a material input, required authorization, or a safe way to verify the result is absent, stop the affected action. Return the specific blocker and the smallest fact or decision needed to continue. Do not report an unrun check as passed.
Output
Provide a regulatory quality work plan. Include the decisive evidence and actual verification result. Name any artifact location and unresolved issue that affects its use.
