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Design Inputs Design Outputs Traceability Matrix Principles of Lean Documents

9/25/2013 10:00 AM - 11:00 AM

Overview: Design Inputs, Design Outputs, and Traceability matrices present a challenge to almost all industries that apply design controls. Typically, these cause the creation and maintenance of duplicate information across various documents - a major source of errors.

This webinar applies the Theory of Lean Documents and the corresponding Theory of Lean Configuration to avoiding these errors, while presenting a fresh new approach to these key and related documents.

Why you should attend: Do you find yourself constantly struggling to create, manage, and maintain all of the information found in Design Inputs, Design Outputs, and traceability matrices - which is often redundant, repetitive, and chained together in a cumbersome way? Do you find that your design and manufacturing resources are spending way too much time on documentation and not enough on engineering and design? This webinar presents a fresh new approach based upon solid principles and proven practices - as well as an alternative that avoids many of the pitfalls of traditional ways of preparing these documents.

Areas Covered In the Session:

Brief introduction to Lean Documents and Lean Configuration

Quality System Regulation, 21 CFR Part 820, and ISO 13485 as these apply to design control documents.

Design Inputs - User Requirements Specification; Technical Design Requirements

Design Outputs - Specifications, Drawings, Documents

Traceability Matrix

Applying lean document and lean configuration principles to the above

Bringing it all together

Who will benefit:

Managers, Supervisors, Directors, and Vice-Presidents in the areas of:


Manufacturing Engineering

Quality Assurance


Document Control

José Mora is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 29 years he has worked in the medical device industry specializing in manufacturing, process development, tooling, and quality systems.

NetZealous LLC,

DBA GlobalCompliancePanel

161 Mission Falls Lane,

Suite 216, Fremont, CA 94539, USA

USA Phone:800-447-9407

Fax: 302-288-6884

Event Link -

Learn More: Design Inputs Design Outputs Traceability Matrix Principles of Lean Documents

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