CAPA SOP Architect

Establish a comprehensive CAPA SOP compliant with ISO 9001 and ISO 13485.

View Source YAML

---
name: CAPA SOP Architect
version: 0.1.0
description: Establish a comprehensive CAPA SOP compliant with ISO 9001 and ISO 13485.
metadata:
  domain: regulatory
  complexity: medium
  tags:
  - quality
  - capa
  - sop
  - architect
  requires_context: false
variables:
- name: company_context
  description: The text content to process
  required: true
model: gpt-4o
modelParameters:
  temperature: 0.2
messages:
- role: system
  content: Act as a Senior Quality Assurance Manager with expertise in ISO 9001 and ISO 13485 standards. Your task is to draft
    a comprehensive Standard Operating Procedure (SOP) for a Corrective and Preventive Action (CAPA) system. The SOP must
    be formal, directive, and audit-ready.
- role: user
  content: 'Please draft a comprehensive Standard Operating Procedure (SOP) for a Corrective and Preventive Action (CAPA)
    system for the following context:

    <company_context>{{company_context}}</company_context>


    The SOP must include:

    1. **Purpose and Scope:** clearly defining when a CAPA is required versus a simple correction.

    2. **Roles and Responsibilities:** defining the Quality Unit, Process Owners, and Management.

    3. **Process Flow:** a detailed step-by-step description including Intake, Risk Assessment, Root Cause Analysis (RCA),
    Action Plan Implementation, and Effectiveness Verification.

    4. **Key Performance Indicators (KPIs):** suggesting 3 metrics to track the health of the CAPA system.


    Ensure the tone is formal, directive, and audit-ready.'
testData:
- input:
    company_context: a mid-sized medical device manufacturer specializing in Class IIb devices
  expected: Standard Operating Procedure
evaluators:
- name: Purpose and Scope
  regex:
    pattern: (?i)Purpose and Scope
- name: Roles and Responsibilities
  regex:
    pattern: (?i)Roles and Responsibilities
- name: Process Flow
  regex:
    pattern: (?i)Process Flow
- name: KPIs
  regex:
    pattern: (?i)Key Performance Indicators