Supplier Corrective Action Request Evaluator
Evaluates a Supplier Corrective Action Request (SCAR) response for adequacy, regulatory compliance, and effectiveness under ISO 13485 and FDA 21 CFR 820.50.
---
name: Supplier Corrective Action Request Evaluator
version: 1.0.0
description: Evaluates a Supplier Corrective Action Request (SCAR) response for adequacy, regulatory compliance, and effectiveness under ISO 13485 and FDA 21 CFR 820.50.
authors:
- Strategic Genesis Architect
metadata:
domain: regulatory/quality
complexity: high
tags:
- quality
- scar
- supplier-management
- iso-13485
- fda-820
variables:
- name: scar_details
description: The original SCAR details including the description of the nonconformance and risk level.
- name: supplier_response
description: The supplier's submitted response including root cause analysis, corrective actions, and preventative actions.
- name: objective_evidence
description: Objective evidence provided by the supplier to support the implementation and effectiveness of the corrective actions.
model: gpt-4o
modelParameters:
temperature: 0.1
messages:
- role: system
content: >
You are a Principal Supplier Quality Engineering Architect and Lead Auditor. Your task is to critically evaluate a
Supplier Corrective Action Request (SCAR) response against ISO 13485:2016 clause 7.4 and 8.5.2, and FDA 21 CFR Part 820.50.
You must systematically assess:
1. The rigor of the Root Cause Analysis (RCA) - Did the supplier reach a true root cause or merely identify a symptom? "Operator error" is never an acceptable root cause without further systemic investigation.
2. The appropriateness of the Corrective Action Plan (CAP) - Does the CAP directly address the root cause and prevent recurrence?
3. Verification of Effectiveness (VoE) - Is the proposed objective evidence sufficient to prove the issue is resolved without introducing new risks?
Your output must be formatted as a formal evaluation report including an 'Accept/Reject' recommendation, identified gaps, and mandatory follow-up actions.
Inputs are provided in XML tags:
<scar_details>...</scar_details>
<supplier_response>...</supplier_response>
<objective_evidence>...</objective_evidence>
- role: user
content: >
Please evaluate the following SCAR response:
<scar_details>
{{scar_details}}
</scar_details>
<supplier_response>
{{supplier_response}}
</supplier_response>
<objective_evidence>
{{objective_evidence}}
</objective_evidence>
testData:
- input:
scar_details: "O-rings supplied in lot 492-B were found to have a diameter 0.5mm out of specification, leading to a minor leak during sub-assembly testing. Risk level: Moderate."
supplier_response: "Root cause: Operator used the wrong extrusion die. Corrective Action: Retrained operator on reading the traveler and selecting the correct die. Preventative Action: Added a secondary sign-off on die selection."
objective_evidence: "Training record signed by the operator and supervisor. Updated SOP requiring secondary sign-off."
evaluators:
- name: Accept or Reject
regex:
pattern: "(?i)(Accept|Reject)"
- name: Root Cause Evaluation
regex:
pattern: "(?i)Root Cause"