Automatic selection of statistical quality control procedures
First Claim
1. A computer implemented method for automating the selection of an analytical statistical quality control (QC) procedure, the method comprising:
- a) providing inputs of a quality requirement and observed performance characteristics of a method of measurement;
b) providing a database of theoretical operating characteristics of statistical QC procedures;
c) providing an analytical quality-planning algorithm which relates the quality requirement, the observed performance characteristics of the method of measurement, and the theoretical operating characteristics of statistical QC procedures;
d) providing QC selection criteria and selection logic;
e) automatically choosing, based on the quality requirement, observed method performance, and operating characteristic of candidate QC procedures, a subset of control rules and numbers of control measurements which satisfy selection criteria and selection logic.
3 Assignments
0 Petitions
Accused Products
Abstract
Disclosed is a computer implemented method for automating the selection of an analytical statistical quality control (QC) procedure. Inputs of a quality requirement and observed performance characteristics of a method of measurement are initially provided, together with a database of theoretical operating characteristics of statistical QC procedures. An appropriate quality-planning algorithm (either analytical or clinical) which relates the quality requirement, the observed performance characteristics of the method of measurement, and the theoretical operating characteristics of statistical QC procedures is also provided. Using predetermined QC selection criteria and selection logic, a computer is programmed to automatically choosing, based on the quality requirement, observed method performance, and operating characteristic of candidate QC procedures, a subset of control rules and numbers of control measurements which satisfy selection criteria and selection logic. Also disclosed is a dynamic QC process for automatically changing the statistical QC procedure when there are changes in performance of a method of measurement. In this embodiment, real-time statistical estimates of the performance characteristics of a method are provided through on-line sampling with an analytical instrument and this data is used to automatically select a QC procedure.
78 Citations
23 Claims
-
1. A computer implemented method for automating the selection of an analytical statistical quality control (QC) procedure, the method comprising:
-
a) providing inputs of a quality requirement and observed performance characteristics of a method of measurement; b) providing a database of theoretical operating characteristics of statistical QC procedures; c) providing an analytical quality-planning algorithm which relates the quality requirement, the observed performance characteristics of the method of measurement, and the theoretical operating characteristics of statistical QC procedures; d) providing QC selection criteria and selection logic; e) automatically choosing, based on the quality requirement, observed method performance, and operating characteristic of candidate QC procedures, a subset of control rules and numbers of control measurements which satisfy selection criteria and selection logic. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11)
-
-
12. A computer implemented method for automating the selection of a clinical statistical quality control (QC) procedure, the method comprising:
-
a) providing inputs of a quality requirement and observed performance characteristics of a method of measurement; b) providing a database of theoretical operating characteristics of statistical QC procedures; c) providing a clinical quality-planning algorithm which relates the quality requirement, the observed performance characteristics of the method of measurement, and the theoretical operating characteristics of statistical QC procedures; d) providing QC selection criteria and selection logic; e) automatically choosing, based on the quality requirement, observed method performance, and operating characteristic of candidate QC procedures, a subset of control rules and numbers of control measurements which satisfy selection criteria and selection logic. - View Dependent Claims (13, 14, 15, 16, 17, 18, 19, 20, 21, 22)
-
-
23. A dynamic QC process for automatically changing the statistical QC procedure when there are changes in performance of the method of measurement, the method comprising:
-
a) providing inputs of a quality requirement and initial observed performance characteristics of a method of measurement; b) providing a database of theoretical operating characteristics of statistical QC procedures; c) providing quality-planning algorithms which relate the quality requirement, the observed performance characteristics of the method of measurement, and the theoretical operating characteristics of statistical QC procedures; d) providing QC selection criteria and selection logic; e) automatically choosing, based on the quality requirement, observed method performance, and operating characteristic of candidate QC procedures, a subset of control rules and numbers of control measurements which satisfy selection criteria and selection logic; f) providing real time statistical estimates of method performance characteristics through on-line sampling with an analytical instrument; g) repeating steps b)-f) above for a sequence of runs thereby automatically selecting a higher number of control measurements or more sensitive control rules when method performance deteriorates and decreasing the number of control measurements or changing to less sensitive control rules when method performance improves; h) implementing the selected statistical QC procedure through calculations and control charts; i) providing an assessment of the state of control and a decision about the acceptance or rejection of individual analytical runs based on the selected statistical QC procedure.
-
Specification