AF risk-management-specialist
Medical device risk management specialist implementing ISO 14971 throughout product lifecycle. Provides risk analysis, risk evaluation, risk control, and post-production information analysis. Use when user mentions risk management, ISO 14971, risk analysis, FMEA, fault tree analysis, hazard identification, risk control, risk matrix, benefit-risk analysis, residual risk, risk acceptability, or post-market risk.
As a process F 31/100 · Will not run — References files that are not bundled: ../quality-manager-qms-iso13485/, ../capa-officer/, ../regulatory-affairs-head/
How to improve
- The text references files that are not there: add them or drop the references.
- Your own cases (evals/evals.json, 4–6 real requests with expected answers): the full check would then run those instead of a model-drafted suite.
- A spec.yaml with trigger phrases and assertions — a behaviour contract for CI; `skilltest init` writes a template.
Guard findings · 0
✓ No critical or high findings
Files scanned: 7. Evidence is masked. Grey chips explain why severity was lowered.
Against the Agent Skills spec
- warning
missing-refreference to a missing file: ../quality-manager-qms-iso13485/ - warning
missing-refreference to a missing file: ../capa-officer/ - warning
missing-refreference to a missing file: ../regulatory-affairs-head/ - warning
missing-refreference to a missing file: ../quality-documentation-manager/
Process rating: all ten parameters 31/100
- 0Tools and files. 4 referenced file(s) missing: ../quality-manager-qms-iso13485/, ../capa-officer/, ../regulatory-affairs-head/
- 0Inputs and preconditions. Does not say what the process needs to start
- 0Failures and branches. Linear process with no failure handling
- 0Progress reporting. Says nothing while it works
- 20When it triggers. No condition that starts the skill
- 30Running it twice. 2 mutating operations with no state check
- 40Result and completion. Does not say what the result is
- 40Consistency. Frontmatter name (risk-management-specialist) differs from the folder (risk-management-iso14971)
- 85Steps. 98 steps, 1 vague phrases
- 100Execution cost. Instruction body is 3684 tokens
- low 10 top-level sections: this looks like several domains in one skill
Everything here is measured from the skill text rather than judged by a model, so the numbers are checkable. A parameter weighs more when it is a more common reason for the process to stall.
Quality signals
- +5Description has no quoted example phrases that should trigger the skill
- +4Description does not say when NOT to use the skill (false activations)
- +3Output format is not stated: the model decides each time
- +1No license
- +2Single-language instructions
- +3Description length 413: enough signal without eating the budget
- +4Structure: 39 headings
- +3Step-by-step instructions: 98 items
- +4Has examples (3 code blocks)
- +4Reference files are cited in the instructions (3 of 3)
- +3All 1 scripts are documented
Quality base 70; lint remarks subtract, signals add up to 100. Result: 79.