Download - Principles of quality management
Principles of Laboratory QualityManagement
Gift Ajay SamSr. Demonstrator
Transfusion Medicine and ImmunohaematologyCMC, Vellore
1
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
TQM Principles1. Customer focus2. Leadership3. 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
History of TQM
1942- 1952US Military develop requirements forcontractors for shell, aircraft, missilesuppliers.
Till 1968 Quality management by weaponindustries.
1979 BSI (British Standard Institute) BS 5750 forcivilian (industry) use.
1987 ISO modified BS 5750 to ISO 9000 forIndustrial standards.
1987- 2012
ISO 9000 (Industry) ISO 14000(Environmental management) ISO17025 (Testing or calibrating laboratories)
ISO 15189 (Clinical laboratories).
4
Quality Management System
• What is Quality?– The right thing the first time.– Producing products of consistent characteristics.– Compliance to a standard.
5
Quality Management System
• ISO 9000- “The degree to which inherentcharacteristics fulfill requirements”.• Management- Plan, organize, staff, lead
(direct) & control.• Quality Management- Quality + Management
+ system.
6
Quality Management System
• Quality management– “An aggregate of organizational activities, plans,
policies and processes in formulating andimplementing a TQM approach”.
7
Essential elements of the QMS
QMS
Processcontrol
Informationmanagement.
Documents &records.
Occurrencemanagement.
Assessment.
ProcessImprovement.
CustomerService.
Safetyfacilities.
Organization
Personnel
Equipments
InventoryControl.
8
Essential elements of the QMS
• Organization
QualityPolicy
Responsibility &authority.
Communication.Provision ofresources
9
Essential elements of the QMS
• Personnel– HR– Qualification & job description.– Orientation & training.– Competency assessment.– Professional development.– Continuing education.
10
Essential elements of the QMS
• Equipment– Acquiring– Installing–Maintaining– Calibrating– Service & repair.– Records.
11
Essential elements of the QMS
• Inventory management– Protocols to select vendors.– Vendor evaluation.– List of vendors & supplies.
12
Essential elements of the QMS
• Process control– QC– Sample management–Method validation & verification.
13
Essential elements of the QMS
• Info management– Confidentiality.– Requests– Logs & records– Reports– LIS
14
Essential elements of the QMS
• Documents & records
15
Documents RecordsReference medium approvedfor use by laboratory.
Evidence of activity.
Issued: Revised: Amendment. Collected: Reviewed: Retainedfor a period.
Essential elements of the QMS
• Occurrence management– Complaints & problems.– Documentation– RCA– CAPA.
16
Essential elements of the QMS
• Assessment
17
Internal ExternalQI PTStructured audit programme InspectionManagement review. Accreditation
Essential elements of the QMS
• Process improvement– Stakeholder feedback.– Opportunities for improvement.– CAPA.
18
Essential elements of the QMS
• Customer service– Customer group identification.– Customer need identification.– Customer feedback.
19
Essential elements of the QMS
• Safety– Safe working environment.– Safe transport.–Waste management– Ergonomics.
20
Quality assurance & Quality Control
• Quality Assurance– “Overall management
plan to guarantee theintegrity of data”.– SYSTEM
• Quality Control– “A series of analytical
measurements used toassess the quality ofanalytical data”.– Tools used in the system.
21
True value vs Measured value
• True value– “Known accepted value
of a quantifiableproperty”.
• Measured Value– “Result of an individuals
measurement on aquantifiable property”.
22
Accuracy vs Precision
Accuracy Precision
23
Accuracy vs Precision
Accuracy• How well measurement
agrees with an acceptedvalue.
• Closeness to estimatedvalue that is considered tobe true.
Precision• How well measurement
agree with each other.• Repeatability of results.
24
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
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
Quality assurance & Quality Control
• 7 tools of QCa. Cause & effect diagramb. Flowchartsc. Checklistd. Control chartse. Scatter diagramsf. Pareto analysisg. Histograms.
27
7 tools of QC- Cause & effect diagram
28
1. Ishikawa diagram or fish bone diagram.2. Kaoru Ishikawa 1968.
7 tools of QC- Flow charts
29
1. Describe a process.2. Arrows- flow of
direction.
Flow chart example
30
7 tools of QC- Checklist
31
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 oneither side of mean.
4. 68% of values b/w ±1SD; 95% of values b/w±2SD; 99.7% valuesb/w ±3 SD.
7 tools of QC- Scatter diagrams
33
1. Determine the correlation b/wevents.
2. Shows if a relationship existsb/w 2 sets of data.
7 tools of QC- Pareto analysis
34
1. Joseph MJuran, 1940.
2. VilfredoPareto- ItalianEconomist-80/20principle.
3. 20% of workgenerate 80%benefit.
Calibration
35
Analytical*Device
Instrument A device used to collect the scientificdata and measurement of results
EquipmentRefers to the various supporting tools
used for performing analysis in thelaboratory
Analytical devices classified into 2
http://www.ispe.org/glossary?term=Equipment#sthash.X6v7BNF6.dpuf
Qualification & Calibration
• Qualification (4 Qs)–basically proves that the equipment works
correctly and actually leads to accurate andreliable results
• Calibration– Ensures that on an on-going basis that the
equipment is performing properly
36
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 issuitable 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 detectionwavelength 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
Calibration Program
• System must be in place to ensure that allinstruments are calibrated and also to preventuse of an instrument that is not calibrated,unusable due to damage or malfunction, or hasexceeded its established calibration interval• Frequency– manufacturer’s recommendations– relevant procedures – sensitive?– instrument performance history
38
Conclusion
• Quality Policy“To provide the best possible, cost effective,
appropriate and maximally beneficial service toour customers while making an impact on nationalpractice of laboratory haematology, transfusionmedicine and immunogenetics through innovationin practice, education, training and research inalignment with the goals of Christian MedicalCollege, Vellore”.
39