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Related Concept Videos

Quality Control01:05

Quality Control

Quality control is one of the three cyclical quality assurance activities that help keep a system under statistical control. Typical quality control activities include creating quality control charts, conducting proficiency testing, and documenting and archiving results.
Quality control helps track data, visualize trends, and identify variations, making it easier to detect deviations that may affect the accuracy of an analysis. One way to do this is by generating a quality control chart, which...
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast, controlled...
Quality Assurance01:19

Quality Assurance

Quality assurance is the overarching term used to describe the activities employed to ensure the proper performance of a system. These activities can be classified into three categories: quality control, quality assessment, and internal corrective measures. Typically, these activities work cyclically: quality control is performed before and during the analysis, while quality assessment occurs during and after the investigation. Internal corrective measures are implemented based on the findings...
Hazard Analysis and Critical Control Points (HACCP)01:30

Hazard Analysis and Critical Control Points (HACCP)

Hazard Analysis and Critical Control Points (HACCP) is a science-based, preventive system used globally to ensure food safety by identifying, evaluating, and controlling biological, chemical, and physical hazards throughout food production. Originally developed by NASA and the Pillsbury Company for astronaut food, HACCP is now a core component of the Codex Alimentarius.HACCP operates on prerequisite programs—such as Good Manufacturing Practices (GMPs), sanitation procedures, and supplier...
Good Manufacturing Practices01:26

Good Manufacturing Practices

Good Manufacturing Practices (GMP) constitute a foundational set of guidelines that ensure the production of safe, consistent, and high-quality products, particularly in industries such as pharmaceuticals, biotechnology, and food processing. These protocols encompass all aspects of production, from the sourcing of raw materials to the final distribution of the finished product.A core pillar of GMP is stringent hygiene and sanitation across all production environments. This includes routine...
Introduction to Statistical Process Control01:15

Introduction to Statistical Process Control

Statistical Process Control (SPC) is a method used to monitor and control quality within processes, particularly in manufacturing and service delivery, by employing statistical methods. SPC aims to distinguish between natural (common cause) variation and variation due to specific changes or events (special cause), allowing for timely improvements and sustained quality. The control chart, a pivotal tool in SPC, visually displays data over time alongside a central line of upper and lower control...

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Related Experiment Video

Updated: Jun 1, 2026

Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies
09:30

Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies

Published on: March 17, 2023

Laboratory quality control based on risk management.

James H Nichols1

  • 1Tufts University School of Medicine, Springfield, MA 01199, USA. james.nichols@baystaehealth.org

Annals of Saudi Medicine
|May 31, 2011
PubMed
Summary

Clinical laboratories can improve test result quality by applying risk management to identify and control potential errors. This involves mapping processes and implementing controls in the preanalytic, analytic, and postanalytic phases.

Area of Science:

  • Clinical Laboratory Science
  • Quality Management Systems
  • Healthcare Risk Assessment

Background:

  • Clinical laboratories perform risk management activities like test verification and troubleshooting.
  • Quality control plans are essential for laboratory testing accuracy.
  • Identifying weak points in preanalytic, analytic, and postanalytic phases is crucial for error reduction.

Purpose of the Study:

  • To review risk management principles in clinical laboratories.
  • To discuss the adoption of a new guideline for laboratory quality control plans.
  • To enhance the overall quality of laboratory test results through systematic risk management.

Main Methods:

  • Systematic application of management policies, procedures, and practices for risk analysis, evaluation, control, and monitoring.

Related Experiment Videos

Last Updated: Jun 1, 2026

Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies
09:30

Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies

Published on: March 17, 2023

  • Process mapping of laboratory testing to identify potential error points.
  • Development and implementation of control processes to prevent or detect errors.

    • Main Results:

    • Risk management provides a framework for improving laboratory testing quality.
    • Quality control plans based on risk management can enhance the reliability of test results.
    • Weak steps in the testing process are identifiable through process mapping.

    Conclusions:

    • Implementing risk management principles systematically enhances clinical laboratory quality.
    • A new guideline for developing laboratory quality control plans based on risk management is progressing.
    • Proactive error control in all testing phases is vital for accurate patient results.