The nature of documents that govern the design and manufacturing of medical devices are often redundant, repetitive, and cumbersome, and do not work well as a business process to properly support and realize the gains made in lean manufacturing.
Design History Files (DHFs), Device Master Records (DMRs), and Device History Record (DHRs) are examples of three documents and files that are very closely related, yet create many problems and inconsistencies in their management, preparation, use, storage, and retrieval.
The information found in Design Input Design Output traceability matrices often must be repeated in other documents in a way that creates the risk of errors or inconsistencies. These lead either to excessive non-value-added waste, or even worse, deficient products and processes.
Medical device manufacturing plants have the additional responsibility to ensure that each and every step of the manufacturing process is controlled by work instructions, SOPs, set-up instructions, equipment maintenance, and support functions, and that evidence of this work is maintained in controlled records.
This seminar presents a new approach that is based upon solid principles and proven practices. During this seminar, the Theory of Lean Documents and its corollary applied to lean configuration will be applied in order to construct, write, and configure the types of documents and records necessary for medical device design and manufacturing.
Upon completing this course participants should:
Understand the fundamental Principles of Lean Documents and Lean Configuration
Understand how to construct Design History Files (DHFs), Device Master Records (DMRs), and Design History Files (DHFs) using lean document and lean configuration methods
Understand how to construct a Design Input Design Output traceability matrix using lean documents and lean configuration methodologies
Prepare a Quality Management System (QMS) for a medical device company using lean documents and lean configuration methods
Preparing and managing a CAPA system using lean documents and lean configuration methods
The Theory of Lean Documents is the product of applying lean principles to the creation, design, process, and management of controlled documents typically found in regulated industries. Just as lean principles challenge traditional process concepts and "push" systems, many traditional document practices are artifacts of a flawed approach. Lean documents presents a fresh departure from these practices, while building upon proven principles. Lean configuration comes from the same principles, utilizing the unique power of software solutions to take over functions that had previously burdened controlled "paper" documents.
DAY 01(8:30 AM - 4:30 PM)
Registration Process: 8:30 AM – 9:00 AM
Session Start Time: 9:00 AM
Introduction and overview of the principles of lean documents and lean configuration
Overview of 21 CFR Part 820 and where the elements of lean documents and lean configuration may be applied
Detailed description and examples of elements for lean documents and lean configuration
Construction of a Design History File (DHF) using lean documents and lean configuration
Construction of a Device Master Record (DMR) using lean documents and lean configuration
Construction of a typical Device History Record (DHR) template using lean documents and lean configuration
Bringing the above together
Configuration of the above in an electronic system as an alternative to paper documents
DAY 02(8:30 AM - 4:30 PM)
Recap of lean documents and lean configuration elements
Construction of a Design Input Design Output traceability matrix using the principles and methods of lean documents and lean configuration
Typical documents used in manufacturing medical devices using lean documents and lean configuration methods
Examples of CAPA using lean documents and lean configuration methods
Creation of Quality Management System (QMS) Master Record and typical QMS documents using lean documents and lean configuration methods