There is a broad range of labs that provide medical, chemical, forensics, environmental and DNA testing. Within each lab there is a Standard Operating Procedure (SOP) for R&D and Q/A Q/C performed by certified lab technicians and chemists.
The SOP is generally used in labs where hazardous materials or operations are performed in accordance with U.S. EPA and OSHA compliance regulations. The SOP is comprised of methodology and management of lab testing that provides a clear understanding of R&D through Quality Assurance that specimens developed and tested meet EPA and OSHA requirements.
Lab specimens must all be tested and retested by Quality Assurance lab technicians who ensure all components of testing follow the original mass balance sheet provided by R&D and also chain of custody (COC).
The typical COC is issued by the QA lab at the point where results support testing reliability. In some Quality Assurance labs, a Certificate of Analysis is documented that includes test findings not originally detected during R&D.
The Importance of Quality Assurance in the Lab
In labs where drugs are tested for quality, the basic goal is to ensure drug components are safe for use. However, even in R&D labs, the importance of quality assurance is part of using the SOP as a guide to ensure lab equipment produces accurate data as drugs move through each test phase.
Q/A technicians provide secondary verification of drug tests, non-compromised testing equipment and supporting drug documentation. By standardizing procedures used in quality assurance in the lab, pre-analysis, QA analysis and post analytical testing uncover potential problems.
This is similar to the types of procedures used in computer software labs where software application developers pass newly developed software to the QA lab for beta testing before the software is marketed.
However in QA science labs, QA tests results must pass federal approval for use before products can be used. The U.S. Center for Disease Control’s National Center for Environmental Health reports that “more than a billion laboratory tests identify and measure chemicals performed each year in the U.S.”
These lab tests require quality assurance to improve detection of problems and assure the public of safe products.
Quality Assurance Use in the Lab
The standards used for quality assurance in the lab vary according to the type of lab operation. For example, an environmental lab may test only air, water or soil. Other environmental labs may limit testing to chemicals used in drugs.
Forensic labs rely heavily on quality assurance to define biological and chemical evidence found in cadavers where cause of death is required. Forensic labs generally assist in criminal investigations and produce evidence of cause of death for legal purposes. Quality assurance in a forensic lab consists of verifying initial findings of an expert medical examiner.
In environmental labs where water is tested, specific types of quality assurance equipment is needed to detect heavy metals or other properties contained in water samples. Samples are drawn and tested to discover chemicals like lead, arsenic or other contaminants that are hazardous to humans, animals and the environment. These test results of samples follow the SOP to assure quality testing.
GC/MS (Gas Chromatography/Mass Spectroscopy) equipment is used to features of gas-chromatography and mass spectrometry to identify substances in test samples. This equipment must be regularly inspected and maintained to assure quality in testing.
If gaseous properties are found in lab testing, other equipment like flame ionization detectors (FID) may be required to measure concentrations of organic properties and species in gas streams in test samples.
The Basic Premise of Quality Assurance in the Lab
Quality assurance can be incorporated into testing of samples by simply following the SOP. In other labs, however, a separate QA/QC lab is required due to high volume and types of tests performed.
The basic premise of quality assurance in the lab includes:
. Identifying samples to be tested according to origin
. Set up test standards applicable to each sample
. Documentation of test findings
Since testing for quality assurance can also be performed in offsite labs, it’s advisable to rely on OSHA 24 Hour Hazwoper training from a certified OSHA training group. More details are available at http://www.oshacampus.com/hazwoper-training/24-hours/.