Design controls turn user requirements, the voice of the customer, into technical design inputs, which then form the design specification, or design output. Because design controls require tracing requirements backward and forward to show they are met, many companies end up keeping duplicate information across controlled documents, a major source of inconsistencies and errors.
This 90-minute webinar applies the Theory of Lean Documents and its corollary, the Theory of Lean Configuration, to these linked, cascading documents. You'll get a brief introduction to both theories, see how the Quality System Regulation (21 CFR Part 820) and ISO 13485 apply to design control documents, and learn how to bring design inputs, outputs and the traceability matrix together.
If creating and maintaining design inputs, design outputs and traceability matrices feels redundant and awkward, or your engineers spend more time on paperwork than on design and manufacturing, this session offers a different approach built on established principles and practices.
It suits managers, supervisors, directors and vice presidents in manufacturing engineering, design assurance, quality assurance, operations and document control.
Managers, Supervisors, Directors, and Vice-Presidents in the areas of:
If creating and maintaining design inputs, design outputs and traceability matrices feels redundant and awkward, or your engineers spend more time on paperwork than on design and manufacturing, this session offers a different approach built on established principles and practices.
It suits managers, supervisors, directors and vice presidents in manufacturing engineering, design assurance, quality assurance, operations and document control.
Managers, Supervisors, Directors, and Vice-Presidents in the areas of:
Jose Ignacio Mora
Jose Mora is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 30 years he has worked in the medical device and life sciences industry specializing in manufacturing, process development, tooling, and quality systems. Prior to working full time as a consulting partner for Atzari Consulting, José served as Director of Manufacturing Engineering at Boston Scientific and as Quality Systems Manager at Stryker Orthopedics, where he introduced process performance, problem solving, and quality system methodologies.During that time he prepared a white paper on the application of lean manufacturing methods to the creation and management of …
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