This handbook explains, in detail, each section of the Certified Supplier Quality Professional Body of Knowledge (updated 2023). It is a handy reference for those already working in the field and is an essential text for those working toward a CSQP certification.
Food companies, regardless of their size and scope, understand that it is impossible to establish a single division devoted to "quality", as quality is the responsibility and purpose of every company employee. Applying this theory demands the cooperation of each employee and an understanding of the methodology necessary to establish, implement, and
This book provides guidelines for obtaining research and development (RD) results of a consistent and known quality. The approaches discussed here have been developed for an industrial research center engaged in RD to support operating divisions of the parent corporation.
he present state-of-art book has been written as per the new syllabus of B. Pharmacy, introduced by Pharmacy Council of India (PCI). This book has an inclusive content that covers the wider aspects of pharmaceutical quality assurance required by under- graduates, post graduates, industry personnels, researcher, and students preparing for various competitive exams. The distinguishing feature of this book is that the book is written in lucid, simple and easy to understand language. The book is accompanied with Multiple Choice, Fill in the Blank, True-False, Short Answer and Long Answer type of questions for the self- evluation of learning. The answers of the Multiple Choice, Fill in the Blank and True-False questions have also been given. Web links/further reading are included to help the readers for keeping themselves abreast with th latest developments in the held of pharmaceutical quality assurance. Academicians and instructors in universities/colleges may use the book as primary or additional teaching material for under-graduate and post-graduate pharmacy courses.
Chapter 7: PROJECT CONSTRUCTION -- I. MATERIAL IDENTIFICATION AND CONTROL -- II. CONTROL OF SPECIAL PROCESSES -- III. INSPECTION -- IV. HANDLING, STORAGE, AND SHIPPING -- V. NONCONFORMING MATERIALS, PARTS, OR COMPONENTS -- APPENDIX: AN ANALYSIS OF CORRECTIVE ACTION REPORTS GENERATED DURING A 3-YEAR PERIOD -- REFERENCES -- Chapter 8: CONTROL OFMEASURING AND TEST EQUIPMENT -- I. THE NEED FOR FORMAL CONTROL -- II. TRACEABILITY -- A. Definition of Traceability -- B. Purposes and Uses of Traceability -- C. Measurement Traceability and Standards Traceability -- D. The Question Posed to NBS -- E. NBS Advice on Traceability -- III. PROGRAM DESCRIPTION -- IV. SCOPE -- V. QUALITY LEVELS -- VI. CENTRALIZED CONTROL -- VII. CALIBRATION PROCEDURES -- IX. EVALUATION OF CALIBRATION SUPPLIERS -- REFERENCES -- Chapter 9: TEST CONTROL -- I. TEST PLAN -- II. TEST PROCEDURES -- III . DOCUMENTATION AND REVIEW OF RESULTS -- REFERENCES -- Chapter 10: SOFTWARE -- I. BACKGROUND -- II. THE SOFTWARE QUALITY ASSURANCE PROGRAM -- A. Planning -- B. Software Quality Levels and QA Plans -- C. Software Development Process -- D. Evaluation -- REFERENCES -- Chapter 11: RECORDS AND REPORTING -- I. PROJECT RECORDS -- II. REPORTS -- III. TRACEABILITY -- IV. RETENTION -- REFERENCES -- Chapter 12: AUDITING THE PROGRAM -- I. GENERAL AUDITING CONSIDERATIONS -- II. PROJECTS -- A. Specified QA -- B. Standard Laboratory Practice -- III. SYSTEM AUDITS -- IV. SUPPLIER AUDITS -- REFERENCES -- INDEX
The FDA and ISO 9001 require manufacturers to institute comprehensive and rigorous pre-production quality assurance processes to assure that design defects will be eliminated prior to manufacture and product sale. Pre-Production Quality Assurance for Healthcare Manufacturers addresses the product design and development phases for a medical product life cycle and shows how this effort can be successfully undertaken in accord with current Good Practice and ISO 9001. The authors provide a detailed step-by-step approach to ensuring that effective pre-production quality assurance is established and effectively in place and explore the key concepts of design, product, and process.
Although regularly introducing new products or services is the lifeblood of most industries, bringing them to market can be fraught with peril. Timing, cost, and quality all play important roles in a successful product launch and avoiding expensive- often in more than just dollars- recalls and redesigns. Quality Assurance: Applying Methodologies fo