Beyond Compliance Design Of A Quality System

Next Level Results for Your QMS You don't just want a compliant quality management system, you want a robust one a QMS that's easy to implement and maintain. Beyond Compliance Design merges two sets of experiencess that of a quality system designer/auditee and that of an external auditor to help you make that possible. Move beyond a focus on checking all the right boxes to the opportunities for continuous improvement, waste reduction, employee engagement, and customer satisfaction and delight. Author Janet Bautista Smith, with the contributions of external auditor, Robert Alvarez, guides you in this process with her models, case studies, lessons learned, and an array of simple tools and templates you can customize for your organization and begin using immediately, including: Implementing layered metrics to align with the auditor's perspective Employing DMAIC analysis to process customer complaints Discovering hidden factories through a Process Grid Walk Addressing common pitfalls of documentation systems with lean solutions Achieving operational compliance and excellence within processes Determining QMS, customer, and auditor satisfaction Fostering synergy among the QMS, customer, and auditor perspectives Engaging management review for critical support

Next Level Results for Your QMS You don't just want a compliant quality management system, you want a robust one a QMS that's easy to implement and maintain. Beyond Compliance Design merges two sets of experiencess that of a quality system designer/auditee and that of an external auditor to help you make that possible. Move beyond a focus on checking all the right boxes to the opportunities for continuous improvement, waste reduction, employee engagement, and customer satisfaction and delight. Author Janet Bautista Smith, with the contributions of external auditor, Robert Alvarez, guides you in this process with her models, case studies, lessons learned, and an array of simple tools and templates you can customize for your organization and begin using immediately, including: Implementing layered metrics to align with the auditor's perspective Employing DMAIC analysis to process customer complaints Discovering hidden factories through a Process Grid Walk Addressing common pitfalls of documentation systems with lean solutions Achieving operational compliance and excellence within processes Determining QMS, customer, and auditor satisfaction Fostering synergy among the QMS, customer, and auditor perspectives Engaging management review for critical support

This publication introduces a portable audit model to facilitate a simple, flexible, and effective audit of single or multiple quality system standards and achieve both compliance and initiation of improvement initiatives. This model is similar to a universal adaptor plug, allowing easy connection and interchangeability of the multiple standards even under rapid system changes typical of modern day operations. This universal plug will allow focus on compliance verification and improvement at a high level of consistency with minimum process disruption and cost. Emphasis is not only on compliance but also on improvement partnership with operations through the use of strategy models. These strategy models will help accentuate the internal audit role as a dynamic element and catalyst for improvement. Real life-based challenges (masked identity) are used in case studies to demonstrate the application of typical internal audit methodologies combined with an implementation engine such as Lean auditing strategies. This will clarify theories that are commonly viewed as abstract by the novice and, in some cases, misunderstood by experienced professionals. This is the breakthrough from a dormant internal audit program into a proactive tool for added-value improvement. Lean methodology is integrated through simple models that don’t require one to be a Lean or Black Belt guru. The focus is using logical sense to understand and apply the concept.

Many companies limp along from day-to-day treating the quality side of the business as a necessary evil, and doing only what is minimally necessary for compliance to regulations. This kind of approach to compliance almost always results in inefficiencies and sometimes can result in a curious kind of noncompliance. Documentation created with compliance as the sole consideration often ends up confusing the employees who must use the documentation. This book looks beyond what is necessary for compliance alone to address what makes a quality management system (QMS) both effective and efficient. This book also never forgets that real people must make any QMS work; the book provides a blueprint for creating a QMS that real people will find useful. After a review of the challenges that any medical device company faces in the world of today—the multiple sources of QMS requirements—the book poses a question: are we satisfied with the QMS we have now, or could we do better? If we want to do better, this book can help. This book offers: Advice that will lead to an effective and efficient QMS. Detailed guidance on the key decisions to be made regarding the quality system being established. Detailed ideas on how to execute those decisions. Up-to-date information on compliance to current regulations and standards and guidance on staying up to date. Specific examples of procedures. Information regarding requirements for combination products, such as a drug + device combination. Advice on incorporating risk management in the QMS.

CD-ROM includes: Multimedia overview of book, including case studies -- High tech enablers examples -- Sample forms that support the quality management system -- Free workdraw process mapping software -- Web support database.

ISO 9001:2000: A start-to-finish implementation guide to the newly updated ISO standard from two of the world's leading quality practitioners! -- The realist's guide to ISO 9001:2000 -- internal audits, choosing registrars, ensuring customer focus, measuring results, and much more. -- Dell's Asset Recovery Business (ARB): A start-to-finish ISO 9001 case study, from the insiders who made it happen! -- Moving ISO 9001 from "cost center" to "profit center"! To maintain their ISO 9001 certifications, organizations worldwide must upgrade to the brand-new ISO 9001:2000 standard. In this book, two of the world's leading quality practitioners present the most realistic, business-focused guide to ISO 9001:2000 implementation. The book's focus isn't on mere "conformance: " it shows companies how ISO 9001:2000 can support their key strategic initiatives -- and how to move ISO 9001:2000 from "cost center" to "profit center." Tom Taormina and Keith Brewer cover every aspect of ISO 9001:2000, including the new process model; the latest and most effective internal auditing techniques; how to select a registrar; how to reflect the new standard's requirements for customer focus and management involvement; and much more. In a start-to-finish ISO 9001 case study, the authors show how Dell's Asset Recovery Business (ARB) has gone beyond mere "compliance, " leveraging ISO 9001:2000 standards to build a fully integrated business management system that uses continuous improvement models to drive operational excellence and profitability.

"The book describes the design rules required to document, implement, and demonstrate quality management system effectiveness in compliance with the latest version of the ISO 9000 International Standard. This systematic and engineering approach simplifies the many complexities in maintaining compliance with ISO standards. This hands-on guide is packed with tips and insights the author has garnered from personally designing quality management systems that integrate organizational strategy with quality management. Moreover, the book helps professionals create meaningful documentation and a user-friendly, informative quality manual that together form the core of an effective and responsive quality management system."--Jacket.

The author’s lessons learned—during more than 25 years of hands-on quality management experience in environments including manufacturing, medical devices, military, aerospace, automotive, and logistics—are condensed in this book to provide reference material to both beginners and seasoned professionals in the development and sustainability of an effective quality and operational system. Experiences shared in this book include the design from ground zero-to-deployment, risk mitigation, and maintenance of quality standards such as ISO 9001, AS9100, ISO/TS 16949, TL 9000, FDA/GMP and C-TPAT standard, and Lean Six Sigma principles. The main focus of this book is to promote the use of the internal auditing tool as a feedback mechanism not only for compliance verification but also for the measurement and enhancement of the system’s effectiveness. The catalysts for this goal are: Auditing beyond compliance to include identification of improvement opportunities Use of process metrics as feedback mechanism in the discovery of hidden factories and risks Concepts and models discussed in this book are clearly illustrated using anonymous real-life examples encountered in day-to-day operations. These examples include lessons learned associated with compliance, continuous improvement, and techniques in the conversion of performance metrics as process indicators, savings’ generators, and risk mitigation. The examples and models are simple and easy to understand accompanied with templates for quick application on the creation of problem statements, root cause analysis methods, and design of action plans with measurement of success. Workshop modules for ‘training the trainers’ are included in this book with practical hands-on exercises on the different tools associated with problem solving, development of process metrics for risk mitigations and auditing.