NDLI: Six Sigma® can be dangerous to your health

Content Provider	Springer Nature Link
Author	Krouwer, Jan S.
Copyright Year	2008
Abstract	Six Sigma® is a popular quality program that has been applied to clinical laboratory assays. Sigma is calculated as (TEa − bias)/CV and these sigma numbers are often claimed as a sole measure of quality based on medical requirements. But these sigma calculations do not account for all results. An additional set of wider limits must be added, such that all data are accounted for. This gives a minimum of three zones: zone A, where 95% of the data should be; zone C, where there should be no data; and zone B, where 5% of the data is allowed. An additional problem is that sigma calculations are often based on valid analytical data, meaning that pre-analytical and post-analytical errors are excluded. Also, samples that are flagged by the system and produce no results are, of course, excluded, but delayed results can cause patient harm. A better measure of assay quality can be provided by a failure mode effects analysis (FMEA), which attempts to assess the probability of failure and its severity for every possible failure mode. In this paper, an example of what is entailed is described for two failure modes and the overall process is outlined. The amount of effort required for a full FMEA is beyond virtually any clinical laboratory. Some compromises are suggested. Calculating sigma values, which have little meaning about patient harm, is not recommended.
Starting Page	49
Ending Page	52
Page Count	4
File Format	PDF
ISSN	09491775
Journal	Accreditation and Quality Assurance
Volume Number	14
Issue Number	1
e-ISSN	14320517
Language	English
Publisher	Springer-Verlag
Publisher Date	2008-08-29
Publisher Place	Berlin, Heidelberg
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Six Sigma FMEA Error grid Total error Clinical laboratory assay Marketing Ecotoxicology Biochemistry Analytical Chemistry Commercial Law Food Science
Content Type	Text
Resource Type	Article
Subject	Chemistry Instrumentation Chemical Engineering Safety, Risk, Reliability and Quality

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1	Ministry of Education (GoI), Department of Higher Education	Sanctioning Authority	https://www.education.gov.in/ict-initiatives
2	Indian Institute of Technology Kharagpur	Host Institute of the Project: The host institute of the project is responsible for providing infrastructure support and hosting the project	https://www.iitkgp.ac.in
3	National Digital Library of India Office, Indian Institute of Technology Kharagpur	The administrative and infrastructural headquarters of the project	Dr. B. Sutradhar bsutra@ndl.gov.in
4	Project PI / Joint PI	Principal Investigator and Joint Principal Investigators of the project	Dr. B. Sutradhar bsutra@ndl.gov.in Prof. Saswat Chakrabarti will be added soon
5	Website/Portal (Helpdesk)	Queries regarding NDLI and its services	support@ndl.gov.in
6	Contents and Copyright Issues	Queries related to content curation and copyright issues	content@ndl.gov.in
7	National Digital Library of India Club (NDLI Club)	Queries related to NDLI Club formation, support, user awareness program, seminar/symposium, collaboration, social media, promotion, and outreach	clubsupport@ndl.gov.in
8	Digital Preservation Centre (DPC)	Assistance with digitizing and archiving copyright-free printed books	dpc@ndl.gov.in
9	IDR Setup or Support	Queries related to establishment and support of Institutional Digital Repository (IDR) and IDR workshops	idr@ndl.gov.in

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