Lesson 6: How do you build quality into a laboratory testing process? In Mapping the road to analytical quality with charts of operating specifications, Dr. Westgard outlines an 8 step quality planning process that starts with the definition of the quality required for a test, accounts for the observed imprecision and inaccuracy of the method, then leads to the selection of appropriate QC procedures and an appropriate Total Quality Control strategy. This planning process is based on quality-planning models or "error budgets" that can be graphically displayed in the form of charts of operating specifications (or OPSpecs charts). These OPSpecs charts provide "maps" that can be used to locate the performance of your method and determine what QC is needed. Once you know the statistical QC procedure and its capability for detecting errors, you can select an overall or Total QC strategy to provide the appropriate mix of statistical and non-statistical components in your QC system, as described in Total Quality Control Strategies.

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Objectives: Learn the process for selecting appropriate control rules and numbers of  control measurements based on the quality required for a test and the precision and accuracy observed for the method in your laboratory.  Identify the critical information needed to utilize OPSpecs charts to select specific QC procedures for tests in your laboratory.  Understand the relationship between the statistical QC procedure and the Total QC strategy to be used with a test.  Review a detailed example for cholesterol to see how the theory can be easily applied with the aid of an atlas of OPSpecs charts.  Web materials: Essay: Mapping the road to analytical quality with charts of operating specifications  Lesson: Total QC Strategies  QC planning application: Cholesterol with analytical quality requirement  Optional hardcopy materials: JO Westgard. OPSpecs Manual - Expanded Edition. Ogunquit ME, Westgard Quality Corporation, 1996  Things to do: Study the materials.  Find out how your laboratory does QC planning.  Assessment: View the Answers What are the 8 steps involved in the QC planning process?  Who does the QC planning in your laboratory?  What type of quality requirements can be used in this QC planning process?  Who determines what the quality requirement is for a test in your laboratory?  What method performance information is critical for QC planning?  How do you get that performance information in your laboratory?  For which methods does the quality depend most heavily on personnel skills, training, and experience?  Which methods can be most widely rotated among your staff?  Return to the top  See the Participant Q & A

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