Lean six sigma lecture part 1
Introduction
Discussion on timely submission of work and personal scheduling responsibilities in chemistry.
Quality Control in Chemistry
Initiation of topic on quality control (QC).
Lean Six Sigma as the primary focus for the session, with elaboration planned for the next.
Interactive elements incorporated; students encouraged to use calculators.
Purpose of Quality Control in the Lab
Patient Safety:
Importance of accurate reporting in QC to avoid risking patient safety.
Emphasis on trusting lab results and implications of inaccurate diagnostics.
Reliability:
Analytical results must be both accurate and precise.
Error Detection:
Immediate error identification based on the analyzer.
Systematic or random errors require proactive solutions rather than repeated testing.
Stability Monitoring:
Verify the functioning of the analytical system including reagents and controls.
Regulatory Compliance:
Adherence to standards set by organizations like IQMH and Accreditation Canada.
Strategies for Performing Quality Control
Understanding that QC is a constant aspect throughout a professional career.
Focus on spotting shifts and trends in QC data, with a requirement to flag concerns for experts to examine.
Importance of using appropriate materials for running controls to reflect patient serum characteristics.
Coverage of both normal and abnormal ranges in QC tests.
Specific QC practices tailored to certain assays like TSH and PSA; number of QC levels varies.
Mean and Standard Deviation:
Instructions on when to begin new lot correlations; suggested timing of one to two months before depletion of current lot.
Importance of conducting QC at intervals and based on SOP (standard operating procedures).
Westgard Rules Implementation:
Statistical regulations for assessing if QC run is in control; variations based on department practices.
Corrective Action Protocols
Immediate corrective actions required if QC is outside acceptable ranges (3 SD or 2 SD).
Examples of practical fixes, such as replacing aging QC carts, addressing volume issues, or using dedicated software for documentation.
Lean Six Sigma Basics
Lean Philosophy
Lean focuses on waste elimination and efficient lab workflow.
Missteps include unnecessary movements and access challenges within departments.
Eight Types of Downtime:
Defects, overproduction, waiting, non-utilized talent, transportation, inventory, motion, extra processing.
Example scenarios provided that illustrate how to minimize inefficiencies and enhance workflow.
Six Sigma Approach
Six Sigma targets reduction of variation to ensure high reliability in lab results.
DMAIC Process:
Define, Measure, Analyze, Improve, Control.
Target for Six Sigma is a performance level that minimizes defects to approximately 3.4 errors per million opportunities.
Metrics and Quality Assessment
Importance of tracking sigma metrics for analytes to ensure consistent quality in results.
Practical calculation methods discussed for establishing sigma metrics, including allowable limits and CV.
Examples of expected vs. observed performance in tests, revealing implications on patient treatment.
Continuous Improvement and Patient Safety
Trust and safety established through consistent quality control measures.
Relationships reinforced through transparency and by demonstrating the impact of QC on health outcomes.
Proactive identification of QC issues to improve processes and patient care.
Conclusion
Key aspects of maintaining a workflow that ensures timely and effective patient testing.
Discussion on practical adjustments and improvements within the lab setting to achieve better efficiency and accuracy without excessive costs or equipment changes.
Real-world Application Scenarios
Case studies illustrating practical implications of QC on patient outcomes and departmental efficiency.
Challenges faced in rapid testing situations, and the necessity of process re-evaluation for continual operation improvements.