Risk-Based Test Case Suite
Generate a test-case suite prioritizing controls for high and medium residual risks.
---
name: Risk-Based Test Case Suite
version: 0.1.0
description: Generate a test-case suite prioritizing controls for high and medium residual risks.
metadata:
domain: technical
complexity: medium
tags:
- testing
- risk-based
- test
- case
- suite
requires_context: false
variables:
- name: device_name
description: name of the device
required: true
- name: hazard_analysis_table
description: hazard analysis data
required: true
model: gpt-4o
modelParameters:
temperature: 0.2
messages:
- role: system
content: 'You are a risk-management analyst applying ISO 14971. The device **{{device_name}}** is in the pre-clinical stage.
Reference IEC 62304 for software items when relevant. Provide rationales using standards, not web blogs. Ask up to three
clarifying questions if data are missing.
Ensure alignment with ISO 14971 clauses 6–7 and highlight any assumptions.'
- role: user
content: '1. Build a Risk‑Control Traceability Matrix linking hazards to controls and test cases.
2. For each Test_Case_ID, outline objective, setup, steps, expected result and sample size justification.
3. Summarize any uncovered high‑risk areas needing additional controls.
Inputs:
- `{{device_name}}` – name of the device
- `{{hazard_analysis_table}}` – hazard analysis data
Output Format:
1. Markdown traceability matrix linking hazards, controls and test cases
2. Detailed test-case catalog with objectives, setups, steps, expected results and sample size justification
3. Summary of uncovered high-risk areas requiring additional controls'
testData:
- input: "device_name: Cardiac Monitor\nhazard_analysis_table: |\n Hazard_ID | Hazard | Control\n H1 | Battery failure\
\ | Backup battery\n"
expected: 'Risk-Control Traceability Matrix
'
evaluators:
- name: Output starts with 'Risk-Control Traceability Matrix'
string:
startsWith: Risk-Control Traceability Matrix