Certified Quality Control Expert

Introduction

Quality Control is a comprehensive course in QC terminology, practices, statistics, and troubleshooting for the clinical laboratory. Designed for those who have little or no experience with quality control but need a firm grounding, this course will help all students quickly and easily identify and correct errors in quality control procedures. Concepts covered include: running assayed and unassayed controls, specificity, sensitivity, Westgard rules, Levey-Jennings charts, Youden plots, and CUSUM calculations. MediaLab also offers an "Introduction to Quality Control" course to complement the more detailed and thorough presentation in this course.

Objectives

By the end of this course, delegates will be able to:

• Introduce quality control terminology.
• Explain quality control graphical tools, including Gaussian curves, Levey-Jennings charts, CUSUM calculations, and Youden plots.
• Detail Westgard rules used to identify QC problems.
• Provide practical examples of QC in laboratory environments.
• Give suggestions for troubleshooting quality control errors.
• Describe TQM's place in the development of quality methodologies
• Describe the 5 key principles of TQM and their impact on business performance
• Draw up plans to achieve management commitment to quality improvement
• Describe how to empower staff to adopt best practice quality approaches
• Use fact based decision making techniques to solve quality problems
• Use continuous improvement techniques
• Identify the changes needed in their organization to achieve real customer focus
• Describe the basic components of 6 Sigma
  • Describe and use the contents of a "Lean Toolbox"
  • Use business process design techniques
  • Produce an outline approach to implementing TQM in their own organization

Training Methodology

Together with your fellow participants, you bring a wide variety of experience and resources to the program. The course facilitator’s role is to help you learn for yourself and to assist you as you make sense of new ideas and techniques that you can use at work. We learn things as we try them out, stepping out of the zones that we find comfortable. Joining in role-plays and having a go may feel awkward but is often the best way to find out how we are doing with our learning. You will have plenty of opportunities during the workshop to experiment and try out new skills and understanding. The course facilitator will give you some input and then help you to make sense of the models through some discussion and then practice. You’ll then decide actions to apply the learning to your workplace

Who Should Attend?

Quality professionals in production and service industries including managers, supervisors, engineers, chemists, lab analysts and all other titles involved in quality control and assurance.

Course Outline

Definition of Quality Control

What is Quality Control?

Important Concepts in Quality Control

Controls

• What is a Control?
• Safety and Handling of Controls
• Appearance of Controls
• Why Run Controls?
• Assayed and Unassayed Controls
• Controls should be run every day that testing will take place.
• What is an unassayed control? 
• Precision and Accuracy
• Aiming for the Target
• Closer, but not Quite
• Bull's-eye!
• A lab tech is running an assayed glucose control. The manufacturer has determined the control to have a value of 95. The lab tech runs the g...

Specificity

• Calculating Specificity
• Specificity Example
• Specificity Example: Test Results
• Specificity Example: Calculations (1)
• Specificity Example: Calculations (2)
• Specificity Example: Comparison
• Based on the data for the experimental and tried-and-true procedures, which test would produce fewer false negatives?
• Using the data and formula to the right, we can calculate specificity of the West Nile Virus test to be:

Sensitivity

• Calculating Sensitivity
• Sensitivity Example: Calculations (1)
• Sensitivity Example: Calculations (2)
• Sensitivity Example: Comparison
• Specificity vs. Sensitivity
• Based on the data for the experimental and tried-and-true procedures, which test would produce fewer
• Using the data and formula to the right, we can calculate sensitivity of the West Nile Virus test to

Standards and Calibrators

• What are Standards and Calibrators?
• Calibration Curve
• Linearity
• Linearity Example
• Non-linear Calibration Curves
• Which of the following meets the strict definition of linearity given by Plaut?

Random and Systematic Error

• Types of Error
• Random Error
• Systematic Error
• Causes of Error
• Indicate which of the problems in the list below are more likely to be random errors or systematic

Internal and External Quality Control

• Internal Quality Control
• External Quality Control (1)
• External Quality Control (2)
• External Quality Control (3)
• Comparing Types of Quality Control
• Match the type of quality control to the benefits it provides.

Reference Ranges

• Reference Ranges

Quality Control Procedures, Documentation and Interpretation

Basic Terms

• Overview of Statistics
• Mean
• Histograms
• Standard Deviation
• Acceptable Standard Deviation
• In a normal distribution, what percent of data would be more than +/- 3 standard deviations from the

Levey-Jennings Chart

• The Levey-Jennings Chart's Inventors
• What is a Levey-Jennings Chart?
• On which days did the control data fall at least one standard deviation from the mean?

 Westgard Rules

• Using Westgard Rules
• Westgard Rule 13S
• Westgard Rule 22S
• Westgard Rule 41s (1)
• Does the Levey-Jennings chart to the right show acceptable quality control results?
• Does the Levey-Jennings chart to the right show acceptable quality control results?
• Trends
• Shifts

Cumulative Summation Limit

• What is a Cumulative Summation Limit?
• CUSUM Example: Plotting Control Data
• CUSUM Example: Calculating CUSUM
• CUSUM Example: Exceeding the CUSUM Limit
• CUSUM and Westgard Rules

Youden Plot

• What is a Youden Plot?
• Using a Youden Plot
• In the accompanying Youden plot, what conclusions can be drawn about the data?

Systematic Troubleshooting

• Troubleshooting
• Possible Corrective Action (1)
• Possible Corrective Action (2)
• Possible Corrective Action (3)
• Possible Corrective Action (4)
• Possible Corrective Action (5)
• Put the troubleshooting steps below in the order in which they should be tried.

Establishment of Verification of Method Performance Specifications

• Verification of Performance Specifications for Nonwaived Testing
• Verification for Nonwaived Testing