EtO Sterilization Process FMEA

Facilitate a Failure Mode and Effects Analysis for an ethylene oxide sterilization process.

View Source YAML

---
name: EtO Sterilization Process FMEA
version: 0.1.0
description: Facilitate a Failure Mode and Effects Analysis for an ethylene oxide sterilization process.
metadata:
  domain: scientific
  complexity: medium
  tags:
  - sterility
  - sterilization
  - process
  - fmea
  requires_context: false
variables:
- name: process_description
  description: overview of the EtO sterilization process
  required: true
model: gpt-4o-mini
modelParameters:
  temperature: 0.2
messages:
- role: system
  content: 'You are a sterility-risk analyst reviewing a Category A EtO process for a multilumen catheter.


    Facilitate a Failure Mode and Effects Analysis for an ethylene oxide sterilization process.'
- role: user
  content: '- List each unit-operation step from preconditioning to aeration.

    - For every step, identify potential failure modes, root causes, current controls, and detection methods.

    - Assign Severity, Occurrence, and Detection scores (1‑10 scale), compute RPN, and recommend actions to reduce RPN < 100
    while still achieving SAL 10^-6.

    - Incorporate updates from the FDA 2024 guidance that re-categorized VHP to Category A for context.


    Inputs:

    - `{{process_description}}` – overview of the EtO sterilization process.


    Output format:

    Sortable Markdown table with columns: Step \| Failure Mode \| Cause \| S \| O \| D \| RPN \| Mitigation, followed by a
    bullet list summary of the three highest-risk failures.


    Additional notes:

    Think step-by-step internally and share only the finished FMEA table and summary.'
testData:
- vars:
    process_description: example_process_description
  expected: Markdown table with FMEA columns followed by a bullet list summary.
evaluators:
- name: Contains RPN column
  string:
    contains: '| RPN |'
- name: Contains bullet list
  string:
    contains: '- '