1. Quality Control
Presented by :- Sqn Ldr Amrita
Parmar
Moderator :- Lt Col Mithu Banerjee

2. Quality
• Conformance with the requirements of users
and customers
• Satisfaction of the needs of users and customers
• Users- nurses and physicians
• Customers – patients and parties who pay the
bills.
• CONSTRAINT - cost

3. Quality Costs
Costs Of Conformance
Prevention
Cost
Appraisal
Cost
Training
Inspection
Calibration
Quality
Control
Maintenance
Costs Of Non-Conformance
Internal
Failure Costs
External
Failure Costs
Scrap
Complaints
Rework
Service
Repeat Runs
Repeat
Requests

4. • Quality improvements occurs when problems are
eliminated permanently
• Industrial experience shows that 85% of all
problems are process problems that are solvable
only by managers – as only management has the
power to change work processes
• Remaining 15 % are the problems that require
the action and improvement in performance of
individual workers.

5. CONCEPT OF TOTAL QUALITY
MANAGEMENT (TQM)

6. FIVE ‘Q’ Framework
Quality Planning
Quality
Improvement
Goals
Quality Lab Processes
Objectives
Quality Requirements
Quality
Assessment
Quality Control

7. Quality lab procedures (QLP)
• Includes analytical processes and general
policies, practices, and procedures that define
how work is done.

8. Quality Control (QC)
• Emphasizes statistical control procedures
• Also includes non statistical check
procedures, such as
- linearity checks
- reagent and standard checks
- temperature monitors

9. Quality Assessment (QA)
• Concerned with broader measures and
monitors of laboratory performance, such as
- turnaround time
- specimen identification
- patient identification
- test utility

10. Quality improvement (QI)
• Provides a structured problem solving process
for identifying the root cause of the problem
and then the remedy

11. Quality Planning (QP)
• Necessary to
- standardize the remedy
- establish measures for monitoring
performance
- ensure that the performance achieved
satisfies quality requirements
- document the new QLP

12. PDCA cycle (plan, do, check, act)
Quality Planning
Quality
Improvement
Goals
Quality Lab Processes
Objectives
Quality Requirements
Quality
Assessment
Quality Control

13. BASIC DEFINITIONS

14. Accuracy
• Closeness of agreement between a measured
quantity value and a true quantity value of an
analyte

15. Precision
• Closeness of agreement between measured
quantity values obtained by replicate
measurements on same sample.

16. Systematic error
• Remains constant or varies in a predictable
manner in replicate measurements

17. Measurement bias
• Estimate of a systematic measurement error

18. Random error
• Varies in an unpredictable manner in replicate
measurements

19. Standard Deviation (SD)
• Standard deviation - extent of random
variation
• SD = √
d
n-1
d=difference of individual result from mean
n=number of observations

20. CV
• Co-efficient of variation
relative magnitude of variability while
comparing two procedures
• CV % = (SD x 100)/mean

21. Standard Error
• Measure of dispersion of mean of a set of
observations
• SE = SD/√n
Where n= number of observations

22. OPERATIONAL LINES
No Bias
Constant Bias

23. OPERATIONAL LINES - 2
Proportional Bias
Combined Bias

24. OPERATIONAL LINES - 3
Proportionate Random Error
Constant Random Error

25. Thank you