P SPENCE & ASSOCIATES, LLC

Capabilities

Quality Management System (QMS) consultant specializing in aerospace and medical device environments requiring AS9100 and ISO 13485 compliance. I help organizations identify operational and compliance risks within their quality systems before they become certification failures, customer escalations, or costly production issues. Through my proprietary 360° Efficiency Assessment, I evaluate how the QMS functions across leadership, quality, and production. This evaluation identifies system gaps, cross-process communication breakdowns, recurring CAPA patterns, and areas where documented procedures and operational behavior do not align. Clients receive a detailed audit report with objective evidence of conformance and nonconformance, providing a prioritized roadmap to strengthen operational visibility, reduce risk exposure, improve efficiency, and support certification readiness. Additional support includes internal audit guidance and CAPA coaching.