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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 editio...

The quality technician is a person responsible for understanding and utilizing quality concepts and tools, statistical techniques, metrology and calibration procedures and protocols, inspection and test techniques, quality auditing, and preventive and corrective action in the context of product/process/service improvement or in correcting problems. Quality technicians frequently work in the quality function of organizations in the various meas...

The 2015 edition of ISO 9001 has been modernized to update terminology and content to meet current and anticipated user needs. The major emphasis of ISO 9001:2015 is still consistent provision of products and services that meet customer and applicable statutory and regulatory requirements. This book explains the meaning and intent of the requirements of ISO 9001:2015 and discusses the requirements as they relate to each of the product categor...

The quality inspector is the person perhaps most closely involved with day-to-day activities intended to ensure that products and services meet customer expectations. The quality inspector is required to understand and apply a variety of tools and techniques as codified in the American Society for Quality (ASQ) Certified Quality Inspector (CQI) Body of Knowledge (BoK). The tools and techniques identified in the ASQ CQI BoK include technical ma...

The handbook is structured to guide organizations new to ISO 9001 through the process necessary to connect their current practices to the requirements of ISO 9001:2015. For organizations already certified to ISO 9001, it advises how to use your upgrade to ISO 9001:2015 as an opportunity to rebuild your QMS into a helpful asset in managing your business.

This book was written to provide guidance for those who need to apply statistical methods for practical use. While the book provides detailed guidance on the use of Minitab for calculation, simply entering data into a software program is not sufficient to reliably gain knowledge from data. The software will provide an answer, but the answer may be wrong if the sample was not taken properly, the data was unsuitable for the statistical test that...

In order for organizations to have high confidence in the reliability of their medical devices, they must ensure that each and every component or service meets requirements, including quality requirements. In that light, supplier management is not only a regulatory requirement but also a business aspect. The intent of this book is to show readers a process of effectively selecting, evaluating, and implementing applicable controls based on the...

The focus of this book is to demystify the requirements delineated within ISO/IEC 17025:2017, while providing a road map for organizations wishing to receive accreditation for their laboratories. AS9100, ISO 9001:2015, and ISO 13485:2016 are standards that have been created to support the development and implementation of effective approaches to quality management, and are recognized blueprints for the establishment of a quality management sy...

The purpose of this handbook is to assist individuals for the Certified Pharmaceutical Good Manufacturing Practices Professional (CPGP) examination and provide a reference for the practitioner. The second edition reflects the Body of Knowledge which was updated in 2015. This edition has also incorporated additional information including updated references. The updates reflect the current trends and expectations of the evolving pharmaceutical i...

This book is written for the leader or management team of any complex organization attempting to lead an organization-wide change. Successfully leading change has never been easy. Many realities of life in the 21st century have combined to intensify the challenge. This book captures the lessons learned during more than 43 years of experience working in complex, large-scale organizations, 14 years between West Point and the United States Army a...

Good data is a source of myriad opportunities, while bad data is a tremendous burden. Companies that manage their data effectively are able to achieve a competitive advantage in the marketplace, while bad data, like cancer, can weaken and kill an organization. In this comprehensive book, Rupa Mahanti provides guidance on the different aspects of data quality with the aim to be able to improve data quality. Specifically, the book addresses: ...

A crucial element of quality control is inspection, but attempting to inspect every product can be impractical. This book covers both the statistical and practical approaches for selecting a particular sampling plan from the c=0 table. Using the plans found in this book can help ensure that you meet your zero defects objectives while saving your company time and money. Zero Acceptance Number Sampling Plans was originally developed to provide...

The purpose of this expanded field guide is to assist organizations, step-by-step, in implementing a quality management system (QMS) in conformance with ISO 13485:2016, whether "from scratch" or by transitioning from variations of the ISO 13485 family. In keeping with ISO 9000:2015's definition of quality as the "degree to which a set of inherent characteristics fulfills requirements, " Myhrberg, Raciti, and Myhrberg have identified the requir...

This ground-breaking book addresses the critical, growing need among health care administrators and practitioners to measure the effectiveness of quality improvement efforts. Written by respected healthcare quality professionals, Measuring Quality Improvement in Healthcare covers practical applications of the tools and techniques of statistical process control (SPC), including control charts, in healthcare settings. The authors' straightforwar...

This book was written to aid quality technicians and engineers. It is a result of 30 years of quality-related work experience. To that end, the intent of this book is to provide the quality professional working in virtually any industry a quick, convenient, and comprehensive guide to properly conducting design of experiments (DOE) for the purpose of process optimization. This is a practical introduction to the basics of DOE, intended for peop...

ISO 9001:2015 includes many changes that not only affect the companies aiming to achieve certification to it, but also auditors. This book is the resource auditors need to fully understand ISO 9001:2015 and help them perform audits to it. This book integrates two different types of audit strategies, conformance audits and performance audits, into one process approach audit. Conformance audits confirm that the organization is meeting the requi...

Synchrony is the ability of a healthcare process to control the pace of the physician process and the pace of the patient process such that the physician and patient are ready for each other at the same time, without waste or delay. When a process achieves synchrony, the patient does not wait for the doctor, nor does the doctor wait for the patient. Dr. Dennis Han is an ophthalmologist specializing in diseases of the retina at the Medical Col...

This book - a result of 30 years of quality-related work experience - was written to aid quality technicians and engineers. It provides the quality professional working in virtually any industry a quick, convenient, and comprehensive guide to properly conducting measurement systems analysis (MSA). The intent of this book is to provide background and examples on the application of gage R&R, methodology (test method validation) for variable and...

Probability is tough - even those fairly well versed in statistical analysis balk at the prospect of tackling it. Many probability concepts seem counterintuitive at first, and the successful student must in effect train him or herself to think in a totally new way. Mastery of probability takes a lot of time, and only comes from solving many, many problems. The aim of this text and its companion, The Probability Workbook (coming soon), is to p...

This handbook was developed to help small and medium-sized organizations better understand ISO 9001:2015. It is intended to facilitate implementation and improvement. The establishment, implementation, and maintenance of an ISO 9001-compliant quality management system (QMS) should allow the organization to experience multiple benefits beyond the achievement of certification. Organizations should also see improvements in the quality of products...