QUALITY SYSTEMS

MANAGEMENT
• Key management goal :
•To ensure that quality laboratory service are
provided
• To accomplish the goal the laboratory should:
a. Obtain modern equipment
b. Hire well-trained staff
c. Ensure well designed and safe
environment
d. Create a good management team
TOTAL QUALITY
MANAGEMENT (TQM)
• Is a system approach that focuses on :
 Teams
 Processes
 Statistics
 Delivery of services /products that meet or
exceed customer expectations
CONTINUOUS QUALITY
IMPROVEMENT
• Is an element of TQM that strives to continually
improve practices not just meet established
quality standards.
TRADITIONAL THINKING TQM THINKING
Acceptable quality Error free quality
Department Focused Organization focused
Quality as expense Quality as means to lower cost
Defects by workers Defects by system
Management controlled Empowered worker
worker
Status quo Continuous Quality
Improvement
TRADITIONAL THINKING TQM THINKING
Manage by intuition Manage by fact
Intangible quality Quality defined
We versus they Us Relationship
relationship
End process focus System Process
Reactive Systems Proactive Systems
• TQM Thinking strives to continually look for
ways to reduce errors (“defect prevention”) by
empowering employees to assist in solving
problems and getting them to understand their
integral role within the greater system
(“universal responsibility”)
TOOLS USED TO IMPROVE
QUALITY
1. Six Sigma
2. Lean

• The key ideas and techniques are often combined

in the methodology of Lean Six Sigma
SIX SIGMA
•Performance improvement program
•Structured process based upon statistics and
quantitative measurements through which
process defects or errors are analyzed, potential
causes are identified and improvements are
implemented.
SIX SIGMA
•Defect
• Anything that does not meet customer
requirements
• Example:
• Laboratory result error
• Delay in reporting
• Quality control problem
SIX SIGMA
•Goal: Improvement by eliminating process
variation
•Improved performance
•Improved quality
•Improved customer satisfaction
•Improve employee satisfaction
 Six Sigma Steps Example
DEFINE project goal Target: Emergency department
that is critical to results in less than 30 min from
quality order
MEASURE baseline Baseline performance:
performance and • 50% of time results are within 30
related variables min
• 70% within 1 hour
• 80 % within 2 hours
Variables:
• Staffing on each shift
• Order to lab receipt time
• Receipt to result time
 Six Sigma Steps Example
ANALYZE data using Order to receipt time is highly
statistics and graphs to variable because samples are not
identify and quantify place in sample transport system
root cause immediately and samples delivered
to laboratory are not clearly flagged
as emergency.
 Six Sigma Steps Example
IMPROVE performance Samples from emergency
by developing and department are uniquely colored to
implementing a make them easier to spot among
solution routine samples
CONTROL factors New performance:
related to the • Results available 90% of time
improvement , verify within 30 minutes
impact, validate
benefits, monitor over
time
 LEAN
•System for reducing waste (“nonvalued
activities”) in production or manufacturing
processes.
 LEAN
•Lean utilize the following techniques:
a. 5S
• Sort
• Set in order
• Shine
• Standardize
• Sustain
 LEAN
•Lean utilize the following techniques:
b. PDCA
• Plan
• Do
• Check
• Act
 LEAN
•Lean follow techniques like 5s and PDCA to
reduce costs by identifying daily work activities
that do not directly add to the delivery of service
in the most efficient or cost effective ways
LEAN
• Characteristic of a lean Laboratory:
a. Utilize fewer resources
b. Reduce costs
c. Enhances Productivity
d. Promotes staff morale
e. Improve quality of patient care
LEAN
• Directly addresses the age-old concept “ That’s why we
always did it” and look for ways to improve process
• Lean can be very broad or unique to a single
laboratory work area by focusing on work flow actions
in performing specific tasks , procedures, or other
activities accomplished by critically reviewing each
step in the process to determine where inefficiencies
can be eliminated.
LEAN
• Some changes require minimal resources and
can be accomplished relatively quickly.
• Example:
• Relocating analytic equipment to an area that would
require fewer steps, thus improving turnaround time
• Consolidating test menus to fewer instruments
eliminating the expense of maintaining multiple
instruments and supplies
LEAN
• Example
• Placing pipettes, culture plates, and so on in east to
access areas and relocating staff to maximize use and
minimize wasteful downtime
• While some Lean and Six sigma projects can
rapidly improve performance , sustained gains
generally require:
 Changes in organizational culture
 Future Monitoring
 Efforts to reinforce systemic changes
 INTERNATIONAL
ORGANIZATION FOR
STANDARDIZATION (ISO)
•Established guidelines that reflect the highest
level of quality
•The ISO 15189:2007
• adopted by CAP
• Laboratory that meets and exceeds these
guidelines can be CAP certified , indicating high
level of confidence in the quality of services
provided by that laboratory
•CLSI has created 12 Quality System Essentials
based on ISO standards
• Each of these 12 areas serves as a starting point
in establishing quality system that covers pre
testing , testing and post testing operations
 QUALITY SYSTEM
ESSENTIALS
1. Organization
2. Personnel
3. Documents and records
4. Facilities and safety
5. Equipment
6. Purchasing and inventory
 QUALITY SYSTEM
ESSENTIALS
7. Information management
8. Occurrence management
9. Assessments (Internal , External)
10. Process improvement
11. Customer service
12. Process Control
QUALITY CONTROL
QUALITY CONTROL
•Component of Quality Management system
•Also called as “internal quality control or “statistical
process control”
• Is a process to periodically examine a measurement
procedure to verify that it is performing according to
pre established specifications.
• Use QC samples
QUALITY CONTROL
•QC samples
• Measured periodically in the same manner as
clinical samples, and their results are examined to
determine that the measurement procedure meets
performance requirements appropriate for patient
care.
• Use Levey-Jennings also called Shewhart plot,
which is the most common presentation for
evaluating QC results
QUALITY CONTROL
•Levey- Jennings
•Also called Shewhart plot
•The most common presentation for evaluating
QC results
• Shows each QC result sequentially over time
and allows a quick visual assessment of
method performance
PROFICIENCY TESTING
• Also known as External Quality Assessment
• Is a program to evaluate method performance
by comparison of results versus those other
laboratories for the same set of samples
 Quality system management
ultimately dispels the concept of
“good enough” and promotes “It
can always be done better”
END OF PRESENTATION