To this end, many laboratories, including those of FlowMetric Life Sciences have adopted principals defined within GLP and GcLP guidelines, with which a validation strategy may be applied to demonstrate that the assay is Fit for purpose (FFP) within the Context of Use (COU). However, no definitive guidelines have been published, leaving scientists to rely on good practices to develop, qualify and validated robust clinical tests. These included the AAPS Flow Cytometry Action Program Committee, International Council for Standardization in Haematology and the International Clinical Cytometry Society. In order to help ensure quality of flow cytometry assay performance across pre-clinical and clinical applications, several organizations have published recommendations for the standardization of flow cytometry instrumentation and method validation for clinical applications. This confusion stems from several aspects including the fact that although the terms are not interchangeable, they can mean different things within different applications. See How to Change Control Chart Rules in QI Macros.When it comes to assay development for pre-clinical and clinical applications, there may be confusion about the need to either qualify or validate an assay’s performance. However, you can easily switch to the Westgard Rules using the QI Macros menu. QI Macros use Montgomery's Rules as the default. Westgard rules and many other rule sets are Included in QI Macros add-in for Excel Westgard rule #9 is unique and is not included in other control chart rule sets. Four points above/below 1 sigma (4 1s) or two points in a row with one above and one below 2 sigma ( R4s).A trend of seven points in a row increasing or decreasing (7 t).Eight points in a row above/below the center line (8 x), note: this rule will catch 9-12 x.One point above UCL or below LCL (1 3s).Westgard rules include Western Electric rules 1, 2, and 4 and Nelson's Rule 5. They use a combination of traditional rules and some unique rules not used in other rule sets. Westgard Rules are used with Levey Jennings Charts in laboratories. Free Agile Lean Six Sigma Trainer TrainingĬontrol Charts » Control Chart Rules » Westgard Rules Westgard Rules for Levey Jennings Charts Labs running control charts use Westgard rules.Animated Lean Six Sigma Video Tutorials.
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