AI Quality Response Letter Drafting Agent

How Cassidy automates using AI

Step 1: Trigger on audit report upload

The Workflow activates when a quality system owner uploads an audit report or NC statement to the designated channel—whether from email, eQMS, or direct file upload.

Step 2: Parse and classify nonconformities

Cassidy extracts each NC's requirement, evidence seen, and statement text, then classifies severity (Major/Minor/OFI) and calculates submission deadlines based on IATF Rules 6th Edition timelines.

Step 3: Pull context from Knowledge Base

The agent searches your Knowledge Base for relevant PFMEA sections, Control Plans, procedures, training matrices, and prior CAPA records to inform the response with your specific process documentation.

Step 4: Guide structured root cause analysis

Cassidy prompts users through 5-Why and Ishikawa frameworks, ensuring both occurrence and escape point causes are documented with validation evidence and linked to systemic control gaps.

Step 5: Draft correction, containment, and CAPA plan

The Workflow generates the complete response letter—restated NC, immediate correction and containment actions with clean point dates, systemic corrective actions with owners and measurable acceptance criteria, and VOE planning.

Step 6: Generate document redlines and evidence checklist

Cassidy produces draft updates for PFMEA severity/occurrence/detection rankings, Control Plan revisions, procedure changes, and LPA questions—plus a checklist of required evidence attachments.

Step 7: Human-in-the-Loop review and approval

The draft routes to the quality manager for review, with flagged areas requiring additional input or evidence before management approval.

Step 8: Export CB-ready submission package

Cassidy formats the final response letter and attachments for your certification body's portal requirements, ready for submission within the 15-day deadline.