The concept of process monitoring and improvement applies to any type of industry: automotive, textiles, food, pharmaceuticals, biologics, medical devices, electronics, aerospace, banking, educational institutions, service providers, and so on. The focus of this book is to identify and apply different process monitoring and improvement tools in any organization. This book is aimed at engineers, scientists, analysts, technicians, managers, supervisors, and all other professionals responsible to measure and improve the quality of their processes. Many times, these professionals do not have a formal education on the use of these tools but learn about them throughout the different improvement projects in which they are involved in their work environment. This book is intended to fill the gap between the lack of formal education in the tools and the need to implement those tools in an improvement project. The book can also be used as a refresher course for those professionals who did learn about these tools as part of their educational background.

The concept of process monitoring and improvement applies to any type of industry: automotive, textiles, food, pharmaceuticals, biologics, medical devices, electronics, aerospace, banking, educational institutions, service providers, and so on. The focus of this book is to identify and apply different process monitoring and improvement tools in any organization. This book is aimed at engineers, scientists, analysts, technicians, managers, supervisors, and all other professionals responsible to measure and improve the quality of their processes. Many times, these professionals do not have a formal education on the use of these tools but learn about them throughout the different improvement projects in which they are involved in their work environment. This book is intended to fill the gap between the lack of formal education in the tools and the need to implement those tools in an improvement project. The book can also be used as a refresher course for those professionals who did learn about these tools as part of their educational background.

The Definitive Guide to Process Improvement & Operational Excellence. This complete body of knowledge for process improvement professionals provides an easy-to-understand foundation for process maturity capability in any company. Gold Medal Winner of the 2015 Axiom Book Award for best business theory book! The Process Improvement Handbook: A Blueprint for Managing Change and Increasing Organizational Performance introduces an all-encompassing body of knowledge for anyone looking to improve their operating environment. It presents a practical way to build and improve processes, and can assist professionals whether they are learning the basics of Process Improvement, planning their first improvement project, or evangelizing process oriented thinking throughout their organization. All of the concepts explained in this book encapsulate everything needed to enable process excellence from start to finish, saving time, conserving resources, and accomplishing more in a competitive timeframe. These practical insights will make you more effective in any Process Improvement role: from contributor, stakeholder, executive, team member, department, business division, supplier, and customer. Highlights include: A comprehensive framework that outlines the methods, tools, and competencies used to create sustainable Process Improvement efforts An industry-leading architecture approach for building organizational processes - Process-Oriented Architecture (POA) Demonstrating the importance of end-to-end process improvement, and the pitfalls of individual and isolated improvement methods Capitalizing on practical agility principles to deliver faster results Sample learning materials such as instructions for getting started, practical guides, real-world case studies, and templates available in the book and on an affiliated website A self-sufficient reference guide that all employees can easily use or self-train with A common vocabulary within the Process Improvement profession for discussing, writing, and applying Process Improvement concepts A robust tool for educating or training organizations and professionals Includes a Foreword from Dr. H. James Harrington, prolific author of over 35 Process Improvement books and winner of numerous quality awards including ASQ's Distinguished Service Medal.

An effective state is essential to achieving socio-economic and sustainable development. With the advent of globalization, there are growing pressures on governments and organizations around the world to be more responsive to the demands of internal and external stakeholders for good governance, accountability and transparency, greater development effectiveness, and delivery of tangible results. Governments, parliaments, citizens, the private sector, NGOs, civil society, international organizations and donors are among the stakeholders interested in better performance. As demands for greater accountability and real results have increased, there is an attendant need for enhanced results-based monitoring and evaluation of policies, programs, and projects. This Handbook provides a comprehensive ten-step model that will help guide development practitioners through the process of designing and building a results-based monitoring and evaluation system. These steps begin with a OC Readiness AssessmentOCO and take the practitioner through the design, management, and importantly, the sustainability of such systems. The Handbook describes each step in detail, the tasks needed to complete each one, and the tools available to help along the way."

Worldwide regulatory agencies perform many inspections annually, and all too often investigation and CAPA system violations are at the top of the list of infractions. Life-sciences regulated companies (not only FDA-regulated ones) must ensure their investigation and CAPA systems look beyond the ‘usual suspects' to identify other quality issues in order to minimize risks (including safe ones) and reduce costs. Enhancements to this third edition include: A new section linking the investigation and CAPA programs with the overall quality culture of the company Fully updated, current versions of regulations including U.S. FDA, EU, ISO 9001, and ISO 13485 Updated inspectional observations from the U.S. FDA and U.K. MHRA A revised investigation and CAPA processes chapter, which has an improved barrier analysis section, including detailed flowcharts describing the barrier analysis process New charts and information related to the investigation of human errors; the human factor section includes information about training and competence A new chapter devoted to analytical laboratory investigations, including a section covering the invalidation of testing results Updated forms and examples of the different elements of the investigation and CAPA plan, including new case studies; a revised diagnostic tool used for investigating human error Jose(Pepe) Rodrguez-Perez, PhD, is president of Business Excellence Consulting, Inc., (BEC), a Puerto Rico-based, consulting, training, and remediation firm that focuses on the areas of regulatory compliance, FDA-regulatory training, and risk management. He is a biologist with a doctoral degree in biology from the University of Granada (Spain). Over his career, he has served as an educator, a technical services manager, and as a science advisor to the FDA.

Do you have a nagging feeling that your monitoring needs improvement, but you just aren’t sure where to start or how to do it? Are you plagued by constant, meaningless alerts? Does your monitoring system routinely miss real problems? This is the book for you. Mike Julian lays out a practical approach to designing and implementing effective monitoring—from your enterprise application down to the hardware in a datacenter, and everything between. Practical Monitoring provides you with straightforward strategies and tactics for designing and implementing a strong monitoring foundation for your company. This book takes a unique vendor-neutral approach to monitoring. Rather than discuss how to implement specific tools, Mike teaches the principles and underlying mechanics behind monitoring so you can implement the lessons in any tool. Practical Monitoring covers essential topics including: Monitoring antipatterns Principles of monitoring design How to build an effective on-call rotation Getting metrics and logs out of your application

Here is a survival strategy for suppliers to the automotive industry. With QS-9000 serving as the new harmonized quality systems requirement of internal and external suppliers for Chrysler, Ford, General Motors, as well as other automobile and truck manufacturers and assemblers, the QS-9000 Handbook is your practical guide for achieving registration. Any company that wishes to achieve registration, must provide evidence of quality production to third-party audits of the registrar. The QS-9000 Handbook will do just that as well as show you how to document your quality systems, train personnel in quality, and improve the effectiveness of any independent quality assurance functions inside your operation.