Good Manufacturing Practice in Transfusion Medicine

TQM AND TAYLORISM; HOW THEY COMPARE H. Bremer Preface The industrial world today is divided between two camps: a culture based on the principles of Total Quality Management (TQM), developed in the Far East, and one still strongly influenced by the origins of "Scientific Management", intro duced in the West by F.W. Taylor and others at the turn of the century. This divergence will be shown to have arisen in the last forty years, long enough for a new generation of managers and corresponding culture to emerge. The two cul tures are so deeply entrenched that it is difficult for one to change to the other. However, there is strong evidence to support the contention that people-oriented TQM is superior, and those companies clinging to Taylor models now face diffi cult decisions. Actions by Taylor-companies to move to TQM rnight weH be hindered rather than helped by applying present Quality Assurance Standards, developed by Taylor-oriented national and international Standards Institutions.

Klappentext

Transfusion medicine provides an excellent bridge connecting the healthy community donors with the patient's needs at the bedside; the dominant philosophy has been on patient care and science, but it is now realised that blood banks manufacture increasing amounts of blood components to administer to patients -- a role analogous to manufacturing functions. The concept of Good Manufacturing Practice (GMP) is therefore relatively new. While quality has always been important, the impact of GMP, Total Quality Management (TQM) and Quality Assurance (QA) will be profound. As the regulatory agencies, like the FDA in the U.S.A. and the EEC Commission in Europe, increase their enforcement activities, doctors, technical experts and managers will have to face many issues of quality assurance including documentation, validation, audit system, regulatory laws, licensing, teaching and training of staff and their job descriptions, standards, processing facilities, procedure validations, automation, record keeping, internal and external quality control of products and their release. The expansion of this philosophy to include Good Clinical Practice (GCP) is an even greater challenge demanding consensus therapy protocols and quality management of transfusion through auditing by the hospital transfusion committees. Such comprehensive plans will profoundly affect the financial and organisational structure of blood transfusion in the future. br/

Zusammenfassung
Proceedings of the Eighteenth International Symposium on Blood Transfusion, Groningen 1993, organized by the Red Cross Blood Bank Groningen-Drenthe

Inhalt
I. Principles of Good Manufacturing Practice (GMP).- State of The Art and Future Directions. A Brief Overview.- Definitions in Quality Assurance and Quality Management.- The Quality Assurance Concept.- The Good Manufacturing Practice Concept.- Error Policies and Audit Systems in Transfusion Medicine.- Discussion.- II. Legislative and Regulatory Aspects.- European Community Action on Good Manufacturing Practice: Consumer Protection and Product Liability.- Regulatory Systems and Mechanisms.- Good Manufacturing Practice and Blood Derivatives: Requirements and Mechanisms for Product Licensing.- Standards and External Quality Audit Systems.- Blood Transfusion Committees and Other Approaches to Improving Clinical Transfusion Practice.- Discussion.- III. Processing, Manufacturing and Quality Control Aspects.- Teaching and Training of Personnel: Good Manufacturing Practices.- Good Manufacturing Practice in Transfusion Medicine: Job Descriptions and Standard Operating Procedures.- Blood and Plasma Processing: Facilities and Physical Requirements.- Documentation and Record Keeping: The Key to Compliance.- Validation Procedures and Internal Audit Systems.- Quality Control and Release Procedures for Products Derived from Human Blood or Human Plasma. Application to Pasteurized Plasma.- A Plant for the Manufacturing of Virus Inactivated Plasma According to GMP-guidelines.- Bar Coding in Health Care: The Needs of the Blood Banks.- Discussion.- IV. Good Clinical Practice (CGP).- Good Clinical (research) Practice.- Error Policies at the Bedside. Quality Management of Blood Transfusion in Dutch Hospitals.- Consensus Protocols for Supportive Hemotherapy.- Hospital Blood Transfusion Audit Systems.- Discussion.