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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.
What can we do TODAY to improve the well being of animals? People are passionate about animals, and this is reflected in the diverse opinions surrounding animal issues. Underlying all the spirited discussions is a common desire to make a positive difference in the lives of animals. EXCELLENCE BEYOND COMPLIANCE: Enhancing Animal Welfare Through the Constructive Use of the Animal Welfare Act helps zoological professionals and organizations make such a difference, and in doing so reframes the conversation about animal welfare. Excellence Beyond Compliance presents a voluntary, non-regulatory plan for attaining compliance with the federal Animal Welfare Act-and moving beyond it to embrace excellence in animal welfare. Zoological professionals and organizations engage daily with countless challenges and opportunities. Excellence Beyond Compliance empowers them to channel their passion and dedication into concrete actions to better serve the animals in their care. It is an essential guidebook that will improve-and even transform-those who put its principles into practice. Some of the key items addressed for zoological organizations include: - Creating an outstanding leadership team, including a dedicated Animal Welfare Officer - Preparing for inspections, with tips on creating inspection checklists, conducting entrance briefings and ensuring key staff availability during the inspection - Interacting with inspectors during and after inspections, including advice on how to respectfully address differences of opinion with an inspector - Utilizing self-certified compliance reporting to maintain compliance and document improvements between inspections and accreditation reviews - Designing Animal Welfare Enhancement Plans and Zoo, Aquarium and Park Improvement Plans - Addressing serious incidents and emergencies to ensure the safety of animals and people - Handling investigations, complaints, and other challenges in a manner that promotes exceptional animal welfare and organizational excellence - Developing an organizational culture where everyone shares responsibility for-and can make a difference in-the lives of animals. For twenty-five years, author and attorney James F. Gesualdi has dedicated himself to legal, regulatory and strategic engagement with animal welfare and wildlife conservation issues. Excellence Beyond Compliance distills the experience and wisdom he has gained along the way into an inspiring yet eminently practical guide to bring people together to enhance the lives and welfare of animals. Advance recognition for EXCELLENCE BEYOND COMPLIANCE: Enhancing Animal Welfare Through the Constructive Use of the Animal Welfare Act "Jim Gesualdi is a knowledgeable, tireless, and enthusiastic advocate for improving the welfare of animals in human care. His Excellence Beyond Compliance program is a unique resource, full of advice and useful tools gleaned from decades of experience, to help those of us dedicated to caring for animals do our very best each day. As he frequently says: 'It's all about the animals.' " Wendy Bulger, Esq. General Counsel San Diego Zoo Global "Gesualdi's primer is a 'must have' for anyone or any facility attempting to navigate the Animal Welfare Act. His team approach to welfare challenges every staff member to recognize that their performance, no matter what the task, should translate to improving the welfare of the animals in their care. My favorite quote: 'EXCELLENCE BEYOND COMPLIANCE is an ongoing process rather than a destination.' His challenge of continuous improvement takes us from just meeting requirements to developing a culture dedicated to welfare, health and safety for animals and their caregivers." Yvonne Nadler, DVM, MPH Consultant to the Zoological community on all hazards contingency planning
Many of the best and most successful companies are no longer content to do the minimum required to achieve compliance with environmental regulations. Instead, a new standard of environmental excellence has arisen. A high-quality environmental system is now seen both as a means to regulatory compliance and as a very cost-effective way of increasing the efficiency and effectiveness of operations in general. In this way, the environmental audit often serves as a significant driver for improvement within the overall management system. Auditing for Environmental Quality Leadership details these new techniques and practices in environmental auditing and shows how their place in a Total Quality Environmental Management System can help companies achieve environmental excellence and a competitive advantage. Sponsored by the Environmental Auditing Roundtable, this book covers the major topics in defining, conducting, assessing, and improving an environmental audit. Unique in its breadth and depth of coverage, this book includes: Comprehensive treatment of environmental auditing by recognized leaders in the field Application of Total Quality Environmental Management methods to develop efficient environmental auditing programs that delve into root causes and sort out what adds value from what does not Analysis of the movement toward standardization of environmental auditing principles and practices, including such timely international issues as efforts to produce North American standards, the European Eco-label and Audit scheme, and the International Standard Organization's ISO 9000 and 14000 series Examination of innovative auditing programs developed by leading corporations and trade organizations, including Allied Signal, Union Carbide, Lockheed, and many others Latest methods of information management technology and automated auditing for assembling, auditing, and reviewing environmental data Because of its thorough, authoritative examination of the issues, illuminating case studies, and wealth of practical guidance, environmental professionals and corporate and government managers will find Auditing for Environmental Quality Leadership essential reading on this crucial topic. Auditing for Environmental Quality Leadership Beyond Compliance to Environmental Excellence To meet the challenges of regulatory compliance, international standards, and the need to "work smarter" in today's marketplace, greater emphasis is being placed on environmental auditing—especially among the most forward-looking companies. In this book, you will find a comprehensive presentation of the entire field of environmental auditing by leading experts in the field. It covers the latest practices and shows, through specific case studies, how major corporations are applying them to achieve environmental excellence and competitive advantage. Sponsored by the Environmental Auditing Roundtable, this book covers the major procedures used in defining, conducting, assessing, and improving an environmental auditing program. Such timely and important subjects as Total Quality Environmental Management, the internationalization of standards, and the use of information technology are clearly presented and explored. Auditing for Environmental Quality Leadership will give managers, consultants, and environmental professionals authoritative guidance in this increasingly important field.
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
Companies in highly regulated industries face unique challenges in optimizing business performance and profitability while maintaining strong governance and strict regulatory adherence. In High Performance Operations, leading business performance consultant Hillel Glazer shows how to achieve these goals through the successful integration of lean- and systems thinking. Writing for a broad audience of operations and governance executives, Glazer shows how to systematically incorporate compliance into planning for overall performance, value, and profitability, rather than viewing compliance practices as an end in itself. Glazer helps you discover and implement the pre-conditions for success! uncover the secret sauce that helps you scale their successes, eliminate single points of failure, and get more of what went right! define what value and operational excellence look like in your company, and identify the costs you'll have to pay to achieve them! create solutions, establish proof-of-performance, justify investments, measure performance, and implement continuous improvement! translate solutions into working policies, patterns, processes, and procedures.Using this book's proven techniques, you can build your company into the best place to work, the best value to your customers and the best source of return to your stakeholders. An indispensable resource for all operations managers, compliance teams, process control managers, and other decision-makers in regulated industries such as healthcare, pharmaceuticals, manufacturing, IT, finance, and environmental services.
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.
The global sourcing of ingredients has created complex supply chains, significant management challenges, and additional regulatory compliance requirements. This places tremendous pressure on food manufacturers, many of whom lack the knowledge, concepts, techniques, and procedures to comply with these increased requirements. Providing a roadmap for
Great is no longer good enough. Beyond Great delivers a powerful new playbook of 9 core strategies to thrive in a post-COVID world where all the rules of the game are being re-written. Beyond Great answers to two fundamental questions which face business leaders today in a world shaped by daunting and disruptive technological, economic, and social change. First, what is outstanding performance in this new volatile era? Second, how do we build competitive advantage in a world with new and often uncertain rules? Supported by years of research and hands-on consulting practice, this book presents a comprehensive framework for building a high performing, resilient, adaptive, and socially responsible global company. The book begins by taking an incisive look at these disruptive forces transforming globalization, including economic nationalism; the boom in data flows and digital commerce; the rise of China; heightened public concerns about capitalism and the environment; and the emergence of borderless communities of digitally connected consumers. Distilled from the study of hundreds of companies and interviews with dozens of business leaders, the authors have distilled nine core strategies – the new winning playbook of the 21st century. Beyond Great argues that business leaders today must lead with a new kind of openness, flexibility and light-footedness, constantly layering in new strategies and operational norms atop existing ones to allow for "always-on" transformation. Leaders must master a whole new set of rules about what it takes to be "global," becoming shapeshifters adept at handling contradiction, multiplicity, and nuance. This book will show them how.
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.
Most executives say they care about cybersecurity. If that's true, why do we still see so many breaches? And why do data breaches increase every year? Yes, hackers are getting more creative, but security technology is also getting smarter, better, and faster. So what are we missing? In my over 25-year career in cybersecurity, I have noticed a few patterns: The belief that cybersecurity is mostly about technology An overwhelming number of great technology gadgets and pressure to choose the best one Excellent product marketing that promises to solve all or many of our security problems Limited resources, know-how, time, and budget Lack of consideration/implementation of GRC (Governance, Risk, Compliance) Reliance on the IT and security team or your MSP to make everything secure. The complexity and not knowing where to start Yes, it is a puzzle of technology, people, processes, governance, risk, compliance, standards, industry, and legal requirements—no matter what industry you are in, what country you operate in, or where your clients are located. This book is designed to help you understand: What else may I be missing? Why GRC is so important and how to easily implement it How to minimize my AI risks and leverage the opportunities it offers What questions should I ask my internal team and suppliers to understand the gaps and risks? How do we perform internal security, risk, and compliance checks? As a business owner myself, I understand the desire to protect and grow your business. While you are focusing on growth, service, and product delivery, managing your staff, and ensuring your IT is operational, this book will show you areas that you may not have paid enough attention to. These areas are equally important for your business protection and growth. This book will show you how to leverage security, GRC, and AI to your benefit to grow, increase customer trust and confidence, and set yourself apart from the competition. This is the book that will help you put the puzzle together. Bonus: With this book, you get access to our continuously growing online collection of templates, playbooks, worksheets, and insights to implement all of this.