Laboratory Quality Management System Introduction (PDF)

Introduction- Laboratory Quality Management System Learning Objectives At the end of this activity, participants will be able to: Explain the importance of a quality management system List the quality system essential elements Describe the history of development of quality...

Introduction- Laboratory Quality Management System Learning Objectives At the end of this activity, participants will be able to: Explain the importance of a quality management system List the quality system essential elements Describe the history of development of quality principles Discuss relationship of this quality model to ISO and CLSI standards Introduction Laboratory Quality Management System-Modul 2 e1  The Quality Management System Organization Personnel Equipment Purchasing Information Process & Management Control Inventory Documents Occurrence & Management Assessment Records Process Customer Facilities Improvement Service & Safety Introduction Laboratory Quality Management System-Modul 3 e1 What is Quality? Introduction Laboratory Quality Management System-Modul 4 e1  Achieving a 99% level of quality means accepting a 1% 1% error rate Introduction Laboratory Quality Management System-Modul 5 e1 5  In France a 1% error rate would mean everyday 14 minutes without water or electricity 50,000 parcels lost by postal services 22 newborns falling from midwives’ hands 600,000 lunches contaminated by bacteria 3 bad landings at Orly Paris airport Introduction Laboratory Quality Management System-Modul 6 e1  Result: 1% failure Introduction Laboratory Quality Management System-Modul 7 e1 7  Essential to all aspects of health care are laboratory results that are  accurate,  reliable, and  timely Introduction Laboratory Quality Management System-Modul 8 e1 Laboratory errors cost in time personnel effort patient outcomes Introduction Laboratory Quality Management System-Modul 9 e1  Organization Personnel Equipment Purchasing Process Information & Control Management Inventory How do we achieve excellent Documents & Occurrence Management Assessment performance Records in the laboratory? Process Improvement Customer Service Facilities & Safety Introduction Laboratory Quality Management System-Modul 10 e1 Quality Management System Definition Coordinated activities to direct and control an organization with regard to quality (ISO,CLSI). All aspects of the laboratory operation need to be addressed to assure quality; this constitutes a quality management system. Introduction Laboratory Quality Management System-Modul 11 e1 Complexity of a Laboratory System Reporting Patient/Client Prep Sample Collection Personnel Competency Test Evaluations Data & Laboratory Management Safety Customer Service Sample Receipt and Accessioning Record Keeping Sample Transport Quality Control Testing Introduction Laboratory Quality Management System-Modul 12 e1  Path of Workflow THE PATIENT Test selection Sample Collection Preexamination Phase Sample Transport Laboratory Analysis Examination Phase Report Transport Report Creation Result Interpretation Postexamination Phase Introduction Laboratory Quality Management System-Modul 13 e1 WHY is the Path of Workflow essential to consider in health laboratories? The entire process of managing a sample must be considered:  the beginning: sample collection  the end: reporting and saving of results  all processes in between. Introduction Laboratory Quality Management System-Modul 14 e1 Laboratory tests are influenced by  laboratory environment  knowledgeable staff  competent staff  reagents and equipment  quality control  communications  process management  occurrence management  record keeping Introduction Laboratory Quality Management System-Modul 15 e1 Twelve Quality System Essentials Organization Personnel Equipment set of coordinated activities that Purchasing Information Process function as & Inventory Control Management building blocks for Documents Occurrence quality & Records Management Assessment management Process Customer Facilities Improvement Service & Safety Introduction Laboratory Quality Management System-Modul 16 e1  Organization Personnel Equipment Purchasing Process Information & Control Management Inventory Path of Workflow Documents Occurrence & Assessment Management Records Process Customer Facilities Improvement Service & Safety Introduction Laboratory Quality Management System-Modul 17 e1 Organization Responsibilities, Authorities Quality Policy Provision Communication of resources Introduction Laboratory Quality Management System-Modul 18 e1 Personnel  human resources  job qualifications  job descriptions  orientation  training  competency assessment  professional development  continuing education Introduction Laboratory Quality Management System-Modul 19 e1 Equipment  acquisition  installation  validation  maintenance  calibration  troubleshooting  service and repair  records Introduction Laboratory Quality Management System-Modul 20 e1 Purchasing and Inventory vendor qualifications supplies and reagents critical services contract review inventory management Introduction Laboratory Quality Management System-Modul 21 e1 Process Control quality control sample management method validation method verification Introduction Laboratory Quality Management System-Modul 22 e1  Information Management  confidentiality  requisitions  logs and records  reports  computerized laboratory information systems (LIS) Introduction Laboratory Quality Management System-Modul 23 e1  Documents Records creation collection revisions and review review control and distribution storage retention Introduction Laboratory Quality Management System-Modul 24 e1 Occurrence Management complaints mistakes and problems documentation root cause analysis immediate actions corrective actions preventive actions Introduction Laboratory Quality Management System-Modul 25 e1 Laboratory Assessment Internal External Internal Proficiency testing (EQA) Inspections Accreditations Introduction Laboratory Quality Management System-Modul 26 e1 Process Improvement opportunities for improvement (OFIs) stakeholder feedback problem resolution risk assessment preventive actions corrective actions Introduction Laboratory Quality Management System-Modul 27 e1 Customer Service  customer group identification  customer needs  customer feedback Introduction Laboratory Quality Management System-Modul 28 e1 Facilities and Safety  safe working environment  transport management  security  containment  waste management  laboratory safety  ergonomics Introduction Laboratory Quality Management System-Modul 29 e1  Implementing Quality Management does not But it detects guarantee errors that may an occur and ERROR-FREE prevents them Laboratory from recurring Introduction Laboratory Quality Management System-Modul 30 e1 Organizatio Personnel Equipment n Laboratories not Purchasing & Process Control Information Management implementing a Inventory quality management Documents Occurrence Assessmen system guarantees & Manageme t Records nt UNDETECTED ERRORS Process Customer Facilities Improvement Service & Safety Introduction Laboratory Quality Management System-Modul 31 e1 Laboratory Quality Management System Coordinated activities to direct and control an organization with regard to quality. ISO 9000:2000 Introduction Laboratory Quality Management System-Modul 32 e1 Innovators of Quality Walter W. Edwards Shewhart Deming 1891-1967 1900-1993 Joseph Juran Philip Crosby Robert Galvin 1904-2008 (103 years) 1926-2001 b. 1922 Introduction Laboratory Quality Management System-Modul 33 e1  A Brief History of Quality Management Quality Management is not new. Innovator Date Cycle Walter A.Shewhart 1920s Statistical Process Control W. Edwards Deming 1940s Continual Improvement Joseph M. Juran 1950s Quality Toolbox Philip B. Crosby 1970s Quality by Requirement Robert W. Galvin 1980s Micro Scale Error Reduction Introduction Laboratory Quality Management System-Modul 34 e1  Standards Organizations ISO CLSI International Organization Clinical and Laboratory for Standardization Standards Institute (formerly known as NCCLS) Guidance for quality in Standards, guidelines, and manufacturing and service best practices for quality in medical laboratory testing industries Broad applicability; used Detailed; applies by many kinds of specifically to medical organizations laboratories Uses consensus process in Uses consensus process in developing standards developing standards Introduction Laboratory Quality Management System-Modul 35 e1 ISO Documents - Laboratory ISO 9001:2000 Quality Management System Requirements Model for QA in design, development production, installation, and servicing ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories ISO 15189:2007 Quality management in the clinical laboratory Introduction Laboratory Quality Management System-Modul 36 e1  ISO 15189:2007 The foundation of international medical laboratory quality management Medical laboratories–Particular requirements for quality and competence Introduction Laboratory Quality Management System-Modul 37 e1 CLSI Quality Documents HS1-A2 A Quality Management System Model for Health Care describes quality system model, 12 essentials aligns to ISO 15189 and parallels ISO 9000 applies to all health care systems GP26-A3 Application of Quality Management System Model for Laboratory Services describes laboratory application of quality system model relates the path of workflow to the quality system essentials assists laboratory in improving processes relates to HS1-A2 and ISO 15189 Introduction Laboratory Quality Management System-Modul 38 e1 In summary Quality management is not new. Quality management grew from the good works of innovators who defined quality over a span of 80 years. Quality management is as applicable for the medical laboratory as it is for manufacturing and industry. Introduction Laboratory Quality Management System-Modul 39 e1 Key Messages A laboratory is a complex system and all aspects must function properly to achieve quality. Approaches to implementation will vary with local situation. Start with the easiest, implement in stepwise process. Ultimately, all quality management system elements must be addressed. Introduction Laboratory Quality Management System-Modul 40 e1 Organization Personnel Equipment Questions? Purchasing Process Information & Control Management Inventory Comments? Documents Occurrence & Assessment Management Records Process Customer Facilities Improvement Service & Safety Introduction Laboratory Quality Management System-Modul 41 e1