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 and 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 highly interactive two day course on principles of lean documents and lean configuration will present 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 used 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 will:
- 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
- Be able to prepare a Quality Management System (QMS) for a medical device company using lean documents and lean configuration methods
- Be able to prepare and manage a CAPA system using lean documents and lean configuration methods
Who Will Benefit:
This course is designed for people tasked with maintaining and improving 21 CFR 820 Quality Systems for medical device manufacturers. This includes individuals that have ISO 13485 Quality Management System responsibilities for making general improvements in their organization’s performance specifically related to Corrective and Preventive Actions (CAPA) as well as manufacturing operations. Following personnel will benefit from the course:
- Senior quality managers
- Quality professionals
- Regulatory professionals
- Compliance professionals
- Production supervisors
- Manufacturing engineers
- Production engineers
- Design engineers
- Process owners
- Quality engineers
- Quality auditors
- Document control specialists
- Record retention specialists
- Medical affairs
- Legal Professionals
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 present 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.