March 21, 2013 by Kevin Keras
Is your instrument A-OK? If not, you may want to fix it PDQ (or you may be SOL) – LOL!
Is there an acronym for excessive use of acronyms? It seems every industry has a long list of abbreviated jargon to capture the essence of what is important to their needs…and the life sciences industry is no exception. Below are a just a few of the many acronyms that we encounter in our daily support of lab instruments and some brief definitions.
OEM – Original Equipment Manufacturer, generally the name of the company who sold the instrument. However…there have been numerous mergers, acquisitions and bankruptcies over the past decade or more so your BioRad thermal cycler might be sitting on the bench with an older model with an MJ Research logo, or your Zymark Twister robot could now say Caliper Life Sciences (which is now Perkin Elmer)…you get the idea.
MVS – Multi-Vendor Services, a generic term that describes a single services provider who works across multiple vendor brands and product lines. Giants include Unity Lab Services (Thermo), PE OneSource, Agilent, Johnson Controls and GE Healthcare.
ISO – Independent Service Organization, anyone other than the OEM. Typically a local provider who works directly with customers or acts as a sub-contractor to MVS’s.
PM – Preventive Maintenance, sometimes called Periodic Maintenance. A pro-active service performed prior to instrument failure designed to catch wear items before they escalate into more costly failures resulting in downtime.
MTBF – Mean Time Between Failure, a spec provided by some OEM’s that statistically predicts instrument reliability. Failures are generally defined as abnormal occurrences that cannot be easily remedied by an operator and render the instrument or system inoperable.
MTTR- Mean Time To Repair, the average time required to repair a failed instrument or system. Total number of failures / total time instrument/system is unavailable for intended operation.
IQ – Installation Qualification, documents that the correct instrument was received and installed properly. IQ can be performed by the user or the vendor (typically both during the site acceptance of a device or system).
OQ – Operational Qualification, tests that the instrument meets specifications in the user environment. OQ can be performed by the user or the vendor. Some instrument include simple diagnostic routines that can be run by users, however a number of such tools are password protected or visible only to service personnel.
PQ – Performance Qualification, tests that the system performs the selected application correctly. PQ must be performed by the user, or in the case of some GxP or CLIA labs, a third party that provides hard data.
CV – Coefficient Of Variation (not your curriculum vitae, or resume), a normalized measure of dispersion of a probability distribution. Insofar as labs are concerned, this is generally a reference to unexpected errors across a microplate. The resulting errors or outliers may often be traced back to liquid handling or pipetting performance.
GLP 0r GMP – Good Laboratory/Manufacturing Practices, a set of standard operating procedures (SOP’s) to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of chemical (including pharmaceuticals) non-clinical safety tests. Insofar as automation of assays is concerned, these SOP’s may contain periodic OQ & PQtesting of individual instruments, using NIST traceable tools and including analytical date (where applicable) . Techs working in such labs may be required to show tool certificates prior to beginning work and produce validation results.
CLIA – Clinical Laboratory Improvement Amendments, any facility which performslaboratory testing on specimens derived from humans for the purpose of providing information for the diagnosis, prevention, or treatment of disease or impairment, and for the assessment of health. As with GxP above, CLIA labs follow stringent SOP’s regarding instrument support or verification, often requiring certified documentation (audit trails).
Did I forget any? Don’t be shy, let me know. TTFN!