From Good Laboratory Practice to Total Quality Management 课件.ppt

Organization and Personnel Quality management system On Accountability -Responsibilities -Authorities Training - Competency based 精品文档 Facilities Appropriate infrastructure Safety measures Hygiene measures 精品文档 Equipment Validated - Does it do what you want it to do ? Maintained Calibrated 精品文档 Reagents / Test Kits Evaluated Methodology validated Test run validated - Kit / reagent controls - Internal control 精品文档 Documentation (1) Testing strategies / protocols - Specimen identification - Confidentiality SOPs - Sample processing - Test performance and result interpretation - Inspection of incoming goods - Validation - Equipment maintenance and calibration - Safety 精品文档 Documentation (2) Records - Test results - Equipment maintenance - Equipment calibration - Control charts - Validation - Training 精品文档 Inter-laboratory comparison External Quality Assurance Scheme ( Proficiency Test , P.T. ) 精品文档 By Other Quality Management System International Standards e.g. ISO 9000 series, ISO/IEC 17025:1999 ( General Requirements for the Competence of Testing and Calibration Laboratories ) 精品文档 ISO1/IEC 17025, ISO15189  Development History 精品文档 In 1985 JCAHO published its 10-step QA monitoring process. Assign responsibility for QA plan. Define scope of patient care. Identify important aspects of care. Construct indicators. Define thresholds for evaluation. Collect and organize data. Evaluate data. Develop corrective action plan. Assess action; document improvement. Communicate relevant information. 精品文档 JCAHO has also established nine dimensions of performance that must be included and measured in the design of the organization’s quality assessment and performance improvement plan: 精品文档 Nine Dimension Efficacy Appropriateness Availability Timeliness Effectiveness Continuity Safety Efficiency Care and Respect 精品文档 National Accreditation Scheme CAP Laborat