Quality In The Laboratory Flashcards
(61 cards)
A management philosophy and approach that focuses on processes and their improvement as the means to satisfy customer needs and requirements.
Total Quality Management (TQM)
It include analytical processes and the general policies, practices, and procedures that define how all aspects of the work are done.
Quality Laboratory Processes (QLP)
Emphasizes statistical control procedures (QC procedures), but also includes nonstatistical check procedures, such as linearity checks, reagent and standard checks, and temperature monitors.
Quality control
Concerned primarily with broader measures and monitors of laboratory performance
Quality Assessment
Provides a structured problem-solving process to help identify the root cause of a problem and a remedy for that problem.
Quality Improvement
“set of key and quality elements that must be in place for an organization’s work operations to function in a manner to meet the organization’s stated quality objectives.”
Quality Management System
A comprehensive program in an institution in which all areas of operation are monitored to ensure quality with the aim of providing the highest quality patient care.
Quality Assurance
Set of instructions for methods used in the laboratory. Also known as procedure manual
Standard Operating Procedures
Training, Calibration and Maintenance are examples of what quality costs:
Prevention cost
Inspection and Quality Control are examples of what quality costs:
Appraisal costs
Scrap, Rework and Repeat runs are examples of what quality costs:
Internal failure costs
Complaints, Service and Repeat Request are examples of what quality costs:
External Failure Costs
Increasingly used to reduce error (Six Sigma) and waste (Lean)
Lean Six Sigma
The major measurement for Lean:
Time
A performance improvement program, the goal of which can be summarized by the mantra “improvement by eliminating process variation”: improved performance, improved quality, improved bottom
line, improved customer satisfaction, and improved employee satisfaction . it is oriented toward process identification and process improvement.
Six Sigma
Process improvement in six sigma
DMAIC
Define
Measure
Analyze
Improve
Control
A system ensuring accuracy and precision. It is used to monitor the analytic variations that can occur with a new instrument or with new lots of control.
Quality control
Measures the smallest concentration
Sensitivity
Ability to measure only the analyte of interest
Specificity
Nearness or closeness of the assayed value to the true value
Accuracy
Ability to give repeated results on the same sample that agree with one another
Precision/Reproducibility
High SD and CV
Poor precision
Low SD and CV
Good precision
Refers to the ability of laboratory testing to maintain accuracy and precision over an extended period of time.
Reliability
