Manufacturing Process Validation: Concepts, Tools, and Industrial Applications

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Arturo Realyvásquez-Vargas Jorge Luis García Alcaraz (Autononous University of Ciudad Juarez, Chihuahua, Mexico)

Manufacturing Process Validation

Concepts, Tools, and Industrial Applications

Arturo Realyvásquez-Vargas, Jorge Luis García Alcaraz (Autononous University of Ciudad Juarez, Chihuahua, Mexico), Suchismita Satapathy , José Roberto Díaz-Reza

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English

CRC Press
05 August 2025

Product design; Quality Assurance (QA) & Total Quality Management (TQM); Operational research; Manufacturing industries; Engineering: general

Unlock the secrets to optimizing manufacturing processes with this essential guide to process validation. Designed for both industry professionals and academics, this book bridges the gap between theory and practice, offering a clear roadmap to enhance quality and productivity. Discover core concepts, step-by-step implementation strategies, and powerful problem-solution tools. Explore the real-world case studies that showcase how process validation transforms production lines, from data collection to actionable improvements. Whether aiming to streamline operations or achieve operational excellence, this book provides the knowledge and practical insights to drive continuous improvement.

Manufacturing Process Validation: Concepts, Tools, and Industrial Applications discusses the importance of manufacturing process validation in addressing quality issues. It explores the primary tools utilized in implementing process validation within industrial settings and features two case studies demonstrating how validation can enhance production processes. Process validation is crucial in guaranteeing a process's quality and efficiency. The book goes on to emphasize the significance of collecting and evaluating data from the design phase through production to establish a process's quality and reproducibility.

Designed for professionals, this resource serves as a crucial link between theoretical concepts and real-world applications. It provides a comprehensive guide for successfully implementing process validation, offering a clear and detailed roadmap for achieving optimal results.

By: Arturo Realyvásquez-Vargas, Jorge Luis García Alcaraz (Autononous University of Ciudad Juarez, Chihuahua, Mexico), Suchismita Satapathy, José Roberto Díaz-Reza
Imprint: CRC Press
Country of Publication: United Kingdom
Dimensions: Height: 216mm, Width: 138mm,
ISBN: 9781041096092
ISBN 10: 1041096097
Pages: 130
Publication Date: 05 August 2025
Audience: Professional and scholarly , Undergraduate
Format: Hardback
Publisher's Status: Forthcoming

1. Process Validation: Concepts and Definitions. 2. Auxiliary Methods and Tools in Process Validation. 3. Case Study 1. Validation of the Seal Ring Annealing Process. 4. Case Study 2. Validation of Ultrasonic Sealer for Laparoscopy Model Production.

Arturo Realyvásquez Vargas is a full-time Department of Industrial Engineering professor at Tecnológico Nacional de Mexico/Instituto Tecnológico de Tijuana in Mexico. He received a Ph.D. in Engineering Sciences from the Autonomous University of Ciudad Juarez in Mexico and a Ph.D. in Innovation in Product Engineering and Industrial Process at the University of La Rioja (Spain). His main research areas are industrial process optimization, lean manufacturing, and ergonomics. Furthermore, Dr. Realyvásquez is an author/coauthor of around 20 papers published in journals indexed in the Journal Citation Reports and has supervised more than 20 bachelor theses and five master theses. Jorge Luis García Alcaraz is a full-time researcher at the Industrial Engineering and Manufacturing Department at the Autonomous University of Ciudad Juarez in Mexico. He received a Ph.D. in Industrial Engineering Sciences from Ciudad Juárez Technological Institute (Mexico), a Ph.D. in Innovation in Product Engineering and Industrial Process from the University of La Rioja (Spain), a Ph.D. in Sciences and Industrial Technologies from the Public University of Navarre (Spain), and a Ph.D. in Mechanical Engineering from the University of Zaragoza (Spain). His main research areas are the multicriteria decision-making process and techniques applied to lean manufacturing, production processes, and supply chain modeling. Dr. García is an author/coauthor of 299 documents indexed in Scopus and has attended more than 150 international conferences. Suchismita Satapathy is an associate professor at the School of Mechanical Sciences, KIIT University, Bhubaneswar, India. She has published over 130 articles in national and international journals and conferences. Her research interests include production operation management, operation research, acoustics, sustainability, and supply chain management. She has more than 15 years of teaching and research experience and has guided many Ph.D. (two completed, four ongoing), MTech (20), and BTech (49) students. Suchismita has published books such as Production Operation Management (Stadium Press) and MCDM Techniques for Waste Management with CRC Press. José Roberto Díaz-Reza has a master's degree in industrial engineering with a specialty in quality, a Ph.D. in innovation in product engineering and industrial processes from the University of La Rioja (Spain), and a Ph.D. in advanced engineering sciences from the Autonomous University of Ciudad Juárez (Mexico). He has published a book and some articles in indexed journals related to lean manufacturing tools. Dr. Diaz-Reza has also participated in international congresses, and his areas of interest are optimizing industrial processes using Lean Manufacturing tools.