A Generative AI-Based Framework for Proactive Quality Assurance and Auditing

Abstract

Generative artificial intelligence (AI) is increasingly used to support decision-making in manufacturing quality assurance (QA), but its adoption raises concerns regarding governance, traceability, and auditability. This paper proposes a proactive framework that integrates generative AI into quality management and auditing while preserving standards alignment and human oversight. The framework structures quality activities across supplier, in-process, and post-market domains and across three hierarchical levels—product, process, and operation—to link quality outcomes with documentary evidence requirements. A proof-of-concept (PoC) study in electronics manufacturing focused on New Product Introduction (NPI) planning and compared two parallel workflows: an expert QA team and a generative AI-assisted chatbot workflow. Within a fixed time window, both workflows produced an aligned Process Failure Mode and Effects Analysis (PFMEA), Control Plan, supplier Production Part Approval Process (PPAP) request package, and internal audit evidence pack. Three independent experts evaluated the integrated deliverable package using five indices covering documentation quality and audit readiness, detection and containment logic, process capability and stability, governance and provenance safeguards, and execution (time) efficiency. Compared with the expert package, the generative AI–assisted workflow produced more traceable, governance-rich documentation (ownership, versioning, clause-to-evidence links) and reduced manual audit-evidence consolidation, supporting quality planning and change-control readiness.

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