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Statistical quality control: a look at process design – the materials involved

Stephen Macdonald returns with the second in a series of articles on internal quality control, specifically looking in this issue at process design and the impact of the materials used.


An appropriately designed statistical quality control (SQC) process should “verify the attainment of the intended quality of results”.1  This means measuring the performance when the process is stable, detect when it is becoming unstable, and reduce the risk of reporting patient results when the process is out of control. This a requirement of ISO 15189:2012. Compliance is reliant on the use of an appropriate control material. Irrespective of the discipline in which we work, or the nature of our assays, the control material, and what we need from it, is common to us all in pathology laboratories.


Control material characteristics
Defined as a “device, solution or lyophilised preparation intended to monitor the reliability of a test system”,2 control material is central to all SQC processes. Unfortunately, no control material can control all our assays. Many different control materials may need to be used on the same technology, and the same assays often require different control materials. 


Control materials for quantitative assays are often validated by manufacturers and provided to us as users with expected values and associated ranges (assayed controls). While helpful to the medical laboratory, quantitative ranges should be verified locally to reflect precision and performance of the system being tested. The initial ranges reflect the performance across a wide range of device and reagent combinations. 

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Upcoming Events

Pathology Horizons 2024

MacDonald Bath Spa Hotel, Bath
18-20 April, 2024

Diagnostics North East Conference 2024

The Catalyst, Newcastle upon Tyne
19 April, 2024

ECCMID 2024 - European Congress of Clinical Microbiology and Infectious Diseases

Fira Gran Via, 08038 Barcelona, Spain
27-30 April 2024

British Society for Microbial Technology Annual Microbiology Conference

UK Health Security Agency, Colindale, London
2 May 2024

EQA Reports: Interpreting Key Information & Troubleshooting Tips

ONLINE - Zoom
Thursday 16th May 2024

Participants’ Meeting: UK NEQAS Immunology, Immunochemistry & Allergy

Sheffield Hallam University, City Campus, Howard Street, Sheffield
24th May 2024

Access the latest issue of Pathology In Practice on your mobile device together with an archive of back issues.

Download the FREE Pathology In Practice app from your device's App store

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