Preface

Quality management (QM) ensures the reliability and consistency of products or services in a sustainable organization. Consistent quality of products or services is the target of any manufacturer to satisfy the interested parties. "Quality" is defined by ISO 9000:2015 as the "degree to which a set of inherent characteristics of an object fulfills requirements." Typically, QM is composed of four main components: quality planning, quality assurance, quality control (QC), and quality improvement. ISO interprets QC as "a part of quality management focused on fulfilling quality requirements," and it is a process by which entities review the quality of all factors involved in production. Therefore, QM effectiveness is dependent on QC strategy.

QM practices are the basis for the successful implementation and maintenance of any QM system. They should assure the compliance of the seven ISO 9000:2015 principles: customer focus, leadership, engagement of people, process approach, improvement, evidence-based decision-making, and relationship management. In addition, total quality management (TQM) is a strategy that requires not only a QM cycle but also the satisfaction of other basics such as technical requirements. "Total" is understood as the full involvement of all parts of the organization in the continuous satisfaction of interested parties. Compared to a QM strategy based merely on the plan-do-check-act cycle, as referred to in ISO 9001:2015, TQM requires a more detailed QC policy. ISO/IEC 17025:2017 is an example of a global standard based on a TQM policy for the standardization and accreditation of the competence of testing and calibration laboratories. The application of management practices or TQM represents a challenge principally in emerging and developing economies.

QC strategy and practices vary according to the type of organization. At the debut stage, the essential parameters for QC are defined. They vary according to the manufacturing or analytical process. Sampling and traceability types are part of these. Sample traceability is critical to assuring that the reported results are consistent with the sample. A corrective-action/preventive-action (CAPA) viewpoint shows that most of the adverse events reported in laboratories are in the pre-examination phase. This phase is closely related to the source of nonconforming sample traceability. Therefore, a control policy is critical to the reliability of the reports. At the validation stage, the use of experimental lab data distinguishes analytical method validation from the previous selection and verification steps. It is the primary stage using mainly intra-laboratory data. Method validation using appropriate statistical tools should verify the uncertainty of the results in conditions that cannot be entirely controlled by an internal QC design. Obviously, QC cannot be debated just in a testing and calibration laboratory perspective. Control during the manufacturing stage is generally associated with a statistical process control methodology based on the observation of the entire production or on sampling.

This book is focused on new trends and developments in QM and QC in several types of industries from a worldwide perspective. Its content has been organized into two sections and seven chapters written by well-recognized researchers worldwide. The QM section includes a viewpoint of TQM in Nigeria and a discussion of

QM practices in Indian small and medium enterprises. On the other hand, the QC section debates the importance of sample traceability in toxicology and the role of analytical method validation as a first step in drug QC, and presents a case study of quality in testing in a Spanish fuel laboratory. The significance of determination of essential parameters for QC in the production of piezoelectric micropumps is also presented, such as a debate on a class of exponential regression-type estimators of the population mean in two-phase sampling. The determination of impurities in pharmaceuticals is also introduced.

Last but not least, we have to thank the valuable contributions of the researchers. Without them, the publication of this book would not have been possible. In addition, thanks go to our families for all the time taken on the edition of this book.

#### **Paulo Pereira, PhD**

Department of Research and Development, Portuguese Institute of Blood and Transplantation, Lisbon, Portugal

#### **Sandra Xavier, PhD**

**1**

Section 1

Quality Management

School of Health, Polytechnic Institute of Beja, Integrated Researcher in NURSE'IN—Nursing Research Unit for South and Islands, Portugal Section 1
