Böcker av Janet Bautista Smith

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.

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 opportunitiesUse of process metrics as feedback mechanism in the discovery of hidden factories and risksConcepts 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.

Next Level Results for Your QMSYou 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