Quality Basics
The acronym is used to describe the principle of Good Clinical Laboratory Practice.
What is "GCLP"?
This tool uses "Why" five times to find the root cause.
What is the "5 Whys" method?
This group is responsible for ensuring that all the reagents prepared, labelled and stored correctly.
What is the "Reagent Support Team"?
This quality tool shares the name with a popular fish and is used to identify the root cause of problem.
What is a fishbone diagram?
This acronym refers to issues observed during an inspection or audit that require correction.
This Document outlines the standard operating procedures in labs.
What is a SOP?
This type of diagram maps out the sequence of events that lead to a problem, helping identify the root cause.
What is a cause-and-effect diagram?
This group has an internal sample management team called "HSMT"
What is an "automation group or "Hamilton Team"?
A Japanese term meaning "continuous improvement", this concept has become a cornerstone of quality management.
What is "Kaizen"?
The primary purpose of this meeting is to discuss quality events, Root cause analysis, how to improve quality, and ensure compliance.
What is a Quality Committee meeting?
A measure of how well a product or service meets customer needs and expectations.
What is "Quality"?
What is the most common root cause of contamination?
What is failure to "handle the aseptic technique"?
This team analyzes the Raw data generated by assays to ensure it meets predefined acceptance criteria
What is the "Data Review Team"?
These team's mission is to prevent "too many cooks in the kitchen" by assigning the task to analyst based on expertise and availability
Who are the schedulers?
This acronym stands for a system that focuses on addressing issues and preventing their recurrence.
What is CAPA? (Corrective and Preventive Action)
An unexpected event in the lab that must be documented and investigated is called this
What is a "Deviation"?
COC discrepancies occur frequently; what could be the root cause that could lead to recurring COC issues?
What is "insufficient oversight"?
This team is responsible for conducting audits to ensure compliance with Good Laboratory Practices (GCLP) and regulatory requirement.
What is "Quality Assurance Team"?
A regent was left out overnight: what is the scientific explanation for why a reagent feels lonely when left out of its proper storage?
What is "it degrades due to improper environment conditions"?
This is often the primary cause of human errors in laboratory settings.
What is a lack of proper training or unclear procedures?
This framework for quality management is built around planning, control, assurance, and improved activities.
what is the "Quality Management System"?
Plates were dropped or knocked off a workstation during a procedure. What is the root cause of dropped and knocked plates?
What is "poor workstation organization or inadequate handling practices"?
This group is responsible for performing, the test measures of biological or chemical activity, ensuring the accuracy and consistency of results in laboratory studies.
What is the "assay group"?
This paradox says you can spend so much time improving quality that you forget to finish the product.
What is "analysis paralysis"?
This is a method used to identify the underlying cause of a problem or defect.
What is Root cause Analysis?