design inputs - design outputs traceability matrix utilizing the principles of lean documents and...

8/11/2019 Design Inputs - Design Outputs Traceability Matrix Utilizing the Principles of Lean Documents and Lean Configuration

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Speaker :Jose Mora

Jose Mora, is a Principal Consultant specializing in Manufacturing Engineering and QualitySystems. For over 30 years he has worked in the medical device and life sciences industryspecializing in manufacturing, process development, tooling, and quality systems. Prior toworking full time as a consulting partner for Atzari Consulting, Jose served as Director of

Manufacturing Engineering at Boston Scientific and as Quality Systems Manager at Strykermore...

Design Inputs - Design Outputs Traceability Matrix utilizing

the principles of Lean Documents and Lean Configuration

Course Description:

Design controls involve thetranslation of user requirements (aka Voice of the Customer) intospecific technical requirements as design inputs. These design inputs then form the basis ofthe design specification, which becomes the design output. Since design controls requirestracing backwards and forwards in order to link the requirements to their satisfaction, aproblem faced by many companies is in having to maintain duplicate information across manycontrolled documents. This repetition is a major source of inconsistencies and errors.

In this webinar, we apply the Theory of Lean documents and its corollary Theory of LeanConfiguration to present a fresh approach to these linked and cascading documents

Course Objective:

If you are constantly struggling to create, manage, and maintain all of the information found inDesign Inputs, Design Outputs, and traceability matrices, all of which are often redundant,repetitive, and clustered together in an awkward manner, this webinar is something that willgive you a different perspective and a very different approach that you can use.

If your design and manufacturing resources are spending too much time on documentation andnot enough time on actual design and manufacturing you as a manager need to be looking forways to simplify their work.

Topic ID : 497 Duration : 90 Mins

Attend LiveWebinar12-Sep-2014 : 10:00 AM PST

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This webinar presents a new approach yet is based on solid principles and proven practices.

Course Outline:

Brief introduction to Lean Documents and Lean ConfigurationQuality System Regulation, 21 CFR Part 820, and ISO 13485 as these apply to designcontrol documents

Traceability MatrixApplying lean document and lean configuration principles to the aboveBringing it all together

Target Audience:

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

R&DManufacturing EngineeringDesign AssuranceQuality AssuranceOperationsDocument Control

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