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Senior Quality Manager Responsible Person (QMR) for HealthTech and MedTech.
Passed 15 of 22 test cases with the skill, and 5 of 22 without it.
and 10 more in the full report
10 fixed5 passed either way7 still failing0 broke
Tokens, turns and time describe resource use, not a dollar price.
One of 10 test cases the skill fixed. Same model, same prompt, with and without the skill.
We need to run a CLI script tool to inspect overdue management review action items for review period Q4-2025. Which Python command and exact flag parameters should be used with the management review tracking utility to filter and display only overdue action items?
| Checked | Without skill | With skill |
|---|---|---|
| Uses python with management_review_tracker.py in the command. | Missed | Passed |
| Includes the flag --status actions. | Missed | Passed |
| Includes the flag --overdue. | Passed | Passed |
The instructions your model reads when the skill loads.
Quality system accountability, management review leadership, and regulatory compliance oversight per ISO 13485 Clause 5.5.2 requirements.
| Responsibility | Scope | Evidence |
|---|---|---|
| QMS effectiveness | Monitor system performance and suitability | Management review records |
| Reporting to management | Communicate QMS performance to top management | Quality reports, dashboards |
| Quality awareness | Promote regulatory and quality requirements | Training records, communications |
| Liaison with external parties | Interface with regulators, Notified Bodies | Meeting records, correspondence |
| Domain | Accountable For | Reports To | Frequency |
|---|---|---|---|
| Quality Policy | Policy adequacy and communication | CEO/Board | Annual review |
| Quality Objectives | Objective achievement and relevance | Executive Team | Quarterly |
| QMS Performance | System effectiveness metrics | Management | Monthly |
| Regulatory Compliance | Compliance status across jurisdictions | CEO | Quarterly |
| Audit Program | Audit schedule completion, findings closure | Management | Per audit |
| CAPA Oversight | CAPA effectiveness and timeliness | Executive Team | Monthly |
| Decision Type | QMR Authority | Escalation Required |
|---|---|---|
| Process changes within QMS | Approve with owner | Major process redesign |
| Document approval | Final QA approval | Policy-level changes |
| Nonconformity disposition | Accept/reject with MRB | Product release decisions |
| Supplier quality actions | Quality holds, audits | Supplier termination |
| Audit scheduling | Adjust internal audit schedule | External audit timing |
| Training requirements | Define quality training needs | Organization-wide training budget |
test cases passed, vs 5 / 22 without
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