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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
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.
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.
There are many occasions when a project leader will preside over a team meeting that ends up falling short of the desired outcomes. Entering a room full of people who are expecting you to guide them to results can be a source of tremendous pressure, even when you feel fully prepared as a leader. This book offers a deeper understanding of how a workshop needs to be managed, how a team can be guided, and how workshop tools should be deployed to achieve a team's objectives. Notes: Facilitation for Quality offers several updates to traditional quality tools to better suit non-manufacturing environments. If you work in an service, office, non-profit, or professional setting, you will find these tools helpful (and you will use them to achieve real results). This book also offers five new tools invented or refined by the authors for those who practice or promote quality, innovation, and effective workshop management to add to their toolbox. Tracy Owens, CQE, CMQ/OE, is a process improvement consultant in Dublin, Ohio. Tracy holds a masters degree in international business from Seattle University, and he was elected to the 2016 class of ASQ Fellows. He is the author of two previous books from Quality Press: Six Sigma Green Belt, Round 2 (2011) and The Executive Guide to Innovation (2013, co­author), and several articles in Quality Progress magazine. Therese Steiner, ASQ CSSBB, is the Director of Operational Effective­ness and Customer Experience at LexisNexis, where she has worked for 20+ years since completing her Juris Doctorate degree at the University of Dayton School of Law in 1999. Therese is a 2020-2021 ASQ Board Member and Geographic Communities Council Region Director. Therese has been a speaker on Customer Experience and Quality topics at global and regional conferences, including ASQ WCQI and OPEX World Summit, as well as at local meetings for ASQ and other organizations.
10 practical Actions for IT management to improve your business and reach compliance at the same time. How to make sense of SOX, COBIT, CoSo, ISO 20000, BS7799/ISO17799. "Beyond Compliance" provides a structured and yet practical approach to improve IT Governance and implement IT Risk Management to comply with regulatory and auditory requirements and increase the benefits IT delivers to the business. Ralf -T. Grünendahl and Peter H.L.Will argue that you should use the momentum SOX or other external triggers provide to reorganise the way you handle your IT.
An extensively researched study of Chinese participation in international organisations, this book argues that the record of China's international behaviour since the 1970s indicates the long-term effectiveness of the multilateral system.
This book offers refineries a practical guide for implementing environmental management systems (EMS).The author, who has implemented hundreds of successful EMS programs throughout North America, Europe, Russia and the Middle East, provides a detailed explanation of what an EMS is and how it can benefit refinery operations in complying with environmental laws and improving the overall efficiency of their operations. The author's approach has been internationally recognized as an integrated model that captures improved compliance and financial savings by reducing operating costs through dedicated pollution prevention programs.
We are in what many call “The Age of the Customer.” Customers are empowered more than ever before and demand a high level of customer attention and service. Their increasing expectations and demands worldwide have forced organizations to transform themselves and prepare for the customer experience (CX) battlefield. This landmark book addresses: What customer experience really means Why it matters Whether it has any substantial business impact What your organization can do to deliver and sustain your CX efforts, and How we got to this particular point in CX history This book is the result of exhaustive research conducted to incorporate various components that affect customer experience. Based on the research results, the authors make a case for seeing CX and associated transformations as the next natural evolution of the quality management system (QMS) already in place in most companies. Using an existing QMS as the foundation for CX not only creates a more sustainable platform, but it allows for a faster and more cost effective way to enable an organization to attain world-class CX.
Protecting and maintaining water distributions systems is crucial to ensuring high quality drinking water. Distribution systems-consisting of pipes, pumps, valves, storage tanks, reservoirs, meters, fittings, and other hydraulic appurtenances-carry drinking water from a centralized treatment plant or well supplies to consumers' taps. Spanning almost 1 million miles in the United States, distribution systems represent the vast majority of physical infrastructure for water supplies, and thus constitute the primary management challenge from both an operational and public health standpoint. Recent data on waterborne disease outbreaks suggest that distribution systems remain a source of contamination that has yet to be fully addressed. This report evaluates approaches for risk characterization and recent data, and it identifies a variety of strategies that could be considered to reduce the risks posed by water-quality deteriorating events in distribution systems. Particular attention is given to backflow events via cross connections, the potential for contamination of the distribution system during construction and repair activities, maintenance of storage facilities, and the role of premise plumbing in public health risk. The report also identifies advances in detection, monitoring and modeling, analytical methods, and research and development opportunities that will enable the water supply industry to further reduce risks associated with drinking water distribution systems.