Principles of quality management
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This document provides an overview of laboratory quality management principles. It discusses total quality management philosophy and history. The key aspects covered include the quality management system and its essential elements as defined by ISO 15189, including organization, personnel, equipment, inventory management, and more. It also distinguishes between quality assurance and quality control. Accuracy and precision are defined, as well as basic statistics used. The seven tools of quality control are outlined. Finally, it discusses calibration and qualification of laboratory equipment.
Principles of quality management
- 1. Principles of Laboratory Quality Management Gift Ajay Sam Sr. Demonstrator Transfusion Medicine and Immunohaematology CMC, Vellore nimrodarcher2011@gmail.com 1
- 2. Overview • Laboratory Quality Management – Introduction. • TQM philosophy. • History • Quality Management System. • Essential elements of the QMS (ISO 15189). – Quality Assurance & Quality Control • QA vs QC. • True value vs Measured value. • Precision & accuracy. – Calibration. • Instrument vs equipment? • Qualification & calibration? – Conclusion 2
- 3. TQM Principles 1. Customer focus 2. Leadership 3. Involvement of people. 4. Process approach (maximize profit by minimizing waste). 5. System approach to management (managing interrelated processes). 6. Continual improvement. 7. Factual approach to decision making. 8. Mutually beneficial supplier relationship. 3
- 4. History of TQM 1942- 1952 US Military develop requirements for contractors for shell, aircraft, missile suppliers. Till 1968 Quality management by weapon industries. 1979 BSI (British Standard Institute) BS 5750 for civilian (industry) use. 1987 ISO modified BS 5750 to ISO 9000 for Industrial standards. 1987- 2012 ISO 9000 (Industry) ISO 14000 (Environmental management) ISO 17025 (Testing or calibrating laboratories) ISO 15189 (Clinical laboratories). 4
- 5. Quality Management System • What is Quality? – The right thing the first time. – Producing products of consistent characteristics. – Compliance to a standard. 5
- 6. Quality Management System • ISO 9000- “The degree to which inherent characteristics fulfill requirements”. • Management- Plan, organize, staff, lead (direct) & control. • Quality Management- Quality + Management + system. 6
- 7. Quality Management System • Quality management – “An aggregate of organizational activities, plans, policies and processes in formulating and implementing a TQM approach”. 7
- 8. Essential elements of the QMS QMS Process control Information management. Documents & records. Occurrence management. Assessment. Process Improvement. Customer Service. Safety facilities. Organization Personnel Equipments Inventory Control. 8
- 9. Essential elements of the QMS • Organization Quality Policy Responsibility & authority. Communication. Provision of resources 9
- 10. Essential elements of the QMS • Personnel – HR – Qualification & job description. – Orientation & training. – Competency assessment. – Professional development. – Continuing education. 10
- 11. Essential elements of the QMS • Equipment – Acquiring – Installing – Maintaining – Calibrating – Service & repair. – Records. 11
- 12. Essential elements of the QMS • Inventory management – Protocols to select vendors. – Vendor evaluation. – List of vendors & supplies. 12
- 13. Essential elements of the QMS • Process control – QC – Sample management – Method validation & verification. 13
- 14. Essential elements of the QMS • Info management – Confidentiality. – Requests – Logs & records – Reports – LIS 14
- 15. Essential elements of the QMS • Documents & records 15 Documents Records Reference medium approved for use by laboratory. Evidence of activity. Issued: Revised: Amendment. Collected: Reviewed: Retained for a period.
- 16. Essential elements of the QMS • Occurrence management – Complaints & problems. – Documentation – RCA – CAPA. 16
- 17. Essential elements of the QMS • Assessment 17 Internal External QI PT Structured audit programme Inspection Management review. Accreditation
- 18. Essential elements of the QMS • Process improvement – Stakeholder feedback. – Opportunities for improvement. – CAPA. 18
- 19. Essential elements of the QMS • Customer service – Customer group identification. – Customer need identification. – Customer feedback. 19
- 20. Essential elements of the QMS • Safety – Safe working environment. – Safe transport. – Waste management – Ergonomics. 20
- 21. Quality assurance & Quality Control • Quality Assurance – “Overall management plan to guarantee the integrity of data”. – SYSTEM • Quality Control – “A series of analytical measurements used to assess the quality of analytical data”. – Tools used in the system. 21
- 22. True value vs Measured value • True value – “Known accepted value of a quantifiable property”. • Measured Value – “Result of an individuals measurement on a quantifiable property”. 22
- 23. Accuracy vs Precision Accuracy Precision 23
- 24. Accuracy vs Precision Accuracy • How well measurement agrees with an accepted value. • Closeness to estimated value that is considered to be true. Precision • How well measurement agree with each other. • Repeatability of results. 24
- 25. Basic Statistics Descriptive statistics • Describes the data • E.g. Histograms, pie charts, scatter plot, etc Summary statistics • Summarize data. • E.g. Mean, Median, Mode, range, SD, Correlation. 25
- 26. Summary statistics • Mean/ Average (x bar) & Median – Measure of centre. – Mean= sum of values / number of values. – Median= the mid value. i.e. half the values on each side. • Standard deviation (σ) – Measures the distance from average. – Steps • Square the numbers. • Find the mean of the squared numbers. • Find the square root . • Correlation (r) – Measures the strength of linear relationship b/w 2 variables. – R always b/w +1 & -1; No correlation r= 0. – Steps • Convert x & y into standard units (value- mean/ SD). • Take the product of standard units (SU (X)* SU (Y)) • Take the mean of the products that is r. 26
- 27. Quality assurance & Quality Control • 7 tools of QC a. Cause & effect diagram b. Flowcharts c. Checklist d. Control charts e. Scatter diagrams f. Pareto analysis g. Histograms. 27
- 28. 7 tools of QC- Cause & effect diagram 28 1. Ishikawa diagram or fish bone diagram. 2. Kaoru Ishikawa 1968.
- 29. 7 tools of QC- Flow charts 29 1. Describe a process. 2. Arrows- flow of direction.
- 31. 7 tools of QC- Checklist 31
- 32. 7 tools of QC- Control charts 32 1. Shewhart chart, 1920. 2. Mean value in centre. 3. Upper cut off limits & lower cut off limits on either side of mean. 4. 68% of values b/w ± 1SD; 95% of values b/w ±2SD; 99.7% values b/w ±3 SD.
- 33. 7 tools of QC- Scatter diagrams 33 1. Determine the correlation b/w events. 2. Shows if a relationship exists b/w 2 sets of data.
- 34. 7 tools of QC- Pareto analysis 34 1. Joseph M Juran, 1940. 2. Vilfredo Pareto- Italian Economist- 80/20 principle. 3. 20% of work generate 80% benefit.
- 35. Calibration 35 Analytical* Device Instrument A device used to collect the scientific data and measurement of results Equipment Refers to the various supporting tools used for performing analysis in the laboratory Analytical devices classified into 2 http://www.ispe.org/glossary?term=Equipment#sthash.X6v7BNF6.dpuf
- 36. Qualification & Calibration • Qualification (4 Qs) –basically proves that the equipment works correctly and actually leads to accurate and reliable results • Calibration –Ensures that on an on-going basis that the equipment is performing properly 36
- 37. Qualification • Design Qualification (DQ) – functional and operational specifications/ requirements (physical environment in which instrument needs to operate). • Installation Qualification (IQ) – Establishes that the instrument is delivered as designed and specified, that it is properly installed in the selected environment, and that this environment is suitable for the operation and use of the instrument. • Operational Qualification (OQ) – Verify that the main operating parameters—injection volume, flow rate, mobile-phase mixing, column thermostating temperature, and detection wavelength are within their specified limits for accuracy and precision. • Performance Qualification (PQ) – Demonstrate that instrument performs consistently as per specifications defined by the user and is appropriate for the intended use. – Done after AMC. 37
- 38. Calibration Program • System must be in place to ensure that all instruments are calibrated and also to prevent use of an instrument that is not calibrated, unusable due to damage or malfunction, or has exceeded its established calibration interval • Frequency – manufacturer’s recommendations – relevant procedures – sensitive? – instrument performance history 38
- 39. Conclusion • Quality Policy “To provide the best possible, cost effective, appropriate and maximally beneficial service to our customers while making an impact on national practice of laboratory haematology, transfusion medicine and immunogenetics through innovation in practice, education, training and research in alignment with the goals of Christian Medical College, Vellore”. 39