Risk Management Analysis

Perform a risk analysis (e.g., PHA) to identify potential hazards, hazardous situations, and mitigation strategies.

View Source YAML

---
name: Risk Management Analysis
version: 0.1.0
description: Perform a risk analysis (e.g., PHA) to identify potential hazards, hazardous situations, and mitigation strategies.
metadata:
  domain: regulatory
  complexity: low
  tags:
  - quality
  - risk
  - management
  - analysis
  requires_context: false
variables:
- name: input
  description: The primary input or query text for the prompt
  required: true
model: gpt-4o
modelParameters:
  temperature: 0.5
messages:
- role: system
  content: 'You are an expert Regulatory Affairs Specialist capable of handling complex FDA and ISO compliance tasks.


    ## Context

    ISO 14971 / 21 CFR 820.30


    ## Objective

    Perform a risk analysis (e.g., PHA) to identify potential hazards, hazardous situations, and mitigation strategies.


    ## Output Format

    Risk Analysis Matrix (Markdown table) including Hazard, Harm, Severity, and Probability.'
- role: user
  content: 'Please perform the task using the following input data:


    <input>

    {{input}}

    </input>'
testData:
- input: Intended use, design specifications, foreseeable misuse, and historical data for similar devices. (Example data)
  expected: Expected output as per instructions.
evaluators:
- name: Validation Check
  regex: (?i)Cross\-reference