Quality Management from the perspective of a medical laboratory.

1. Principles of Laboratory Quality
Management
Gift Ajay Sam
Sr. Demonstrator
Transfusion Medicine and Immunohaematology
CMC, Vellore
nimrodarcher2011@gmail.com
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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
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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.
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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).
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5. Quality Management System
• What is Quality?
– The right thing the first time.
– Producing products of consistent characteristics.
– Compliance to a standard.
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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.
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7. Quality Management System
• Quality management
– “An aggregate of organizational activities, plans,
policies and processes in formulating and
implementing a TQM approach”.
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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.
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9. Essential elements of the QMS
• Organization
Quality
Policy
Responsibility &
authority.
Communication.
Provision of
resources
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10. Essential elements of the QMS
• Personnel
– HR
– Qualification & job description.
– Orientation & training.
– Competency assessment.
– Professional development.
– Continuing education.
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11. Essential elements of the QMS
• Equipment
– Acquiring
– Installing
– Maintaining
– Calibrating
– Service & repair.
– Records.
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12. Essential elements of the QMS
• Inventory management
– Protocols to select vendors.
– Vendor evaluation.
– List of vendors & supplies.
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13. Essential elements of the QMS
• Process control
– QC
– Sample management
– Method validation & verification.
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14. Essential elements of the QMS
• Info management
– Confidentiality.
– Requests
– Logs & records
– Reports
– LIS
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15. Essential elements of the QMS
• Documents & records
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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.
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17. Essential elements of the QMS
• Assessment
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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.
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19. Essential elements of the QMS
• Customer service
– Customer group identification.
– Customer need identification.
– Customer feedback.
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20. Essential elements of the QMS
• Safety
– Safe working environment.
– Safe transport.
– Waste management
– Ergonomics.
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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.
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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”.
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23. Accuracy vs Precision
Accuracy Precision
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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.
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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.
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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.
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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.
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28. 7 tools of QC- Cause & effect diagram
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1. Ishikawa diagram or fish bone diagram.
2. Kaoru Ishikawa 1968.

29. 7 tools of QC- Flow charts
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1. Describe a process.
2. Arrows- flow of
direction.

30. Flow chart example
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31. 7 tools of QC- Checklist
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32. 7 tools of QC- Control charts
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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
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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
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1. Joseph M
Juran, 1940.
2. Vilfredo
Pareto- Italian
Economist-
80/20
principle.
3. 20% of work
generate 80%
benefit.

35. Calibration
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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
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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.
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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
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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”.
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