Quality Management
Tools - Best Practices for Laboratory Quality Systems
Many environmental decisions are supported
by laboratory data. If data are not of the quality needed for the decision,
then the decision may be incorrect, resulting in unacceptable risk to human
health or the environment or the expenditure of funds for unnecessary activities.
Environmental laboratories that do not follow proper procedures can cause
incorrect data to be used in decision making. Below are links to references,
training, examples and other on-line resources for best practices for laboratory
quality systems. If you can recommend sources of best practices for laboratory
quality systems for use in updating this page, please contact us by phone
at (202) 564-6830, FAX at (202) 565-2441, or E-mail at
quality@epa.gov.
References
Training
- Detecting Improper Laboratory Practices
- This one and one half day course presents tools and techniques for
identifying improper practices in environmental laboratories during
routine laboratory assessments. The course identifies "red flags"
in each step of the assessment process which can indicate improper practices
in the laboratory. The material can also be used by laboratory management
or quality assurance staff to evaluate the laboratory's internal systems
and processes to reduce the likelihood of the improper practices.
- Data Verification and Validation - This one day course
presents tools and techniques for data verification and validation
and includes training on data integrity. (This training is available
at selected Quality System Training Events)
Examples and Other On-line Resources
- U.S. EPA Region 9 Quality Assurance Web page includes information
on analytical methods, data validation, laboratory quality assurance,
and links to quality assurance guidance from other EPA organizations.
www.epa.gov/region09/qa/
- U.S. EPA Region 10 Quality Assurance Home includes information and
links on analytical methods, data review guidelines, quality assurance
reference documents, and other quality assurance links.
yosemite.epa.gov/r10/oea.nsf/Quality+Assurance/Main
- U.S. EPA Office of Solid Waste Methods Team provides expertise in
analytical chemistry and characteristic testing methodologies, environmental
sampling and monitoring, and Quality Assurance. Their web site has a
link to the EPA publication SW-846, Test Methods for Evaluating Solid
Waste, Physical/Chemical Methods. Chapter 1 of SW-846 deals with Quality
Control. The web site also contains related links that connect to a
variety of sites of interest to the laboratory community.
www.epa.gov/epaoswer/hazwaste/test/index.htm
- U.S. EPA's Environmental Test Methods and Guidelines. www.epa.gov/osa/fem/methcollectns.htm
- U.S. Department of Defense - Defense Environmental Network and Information
Exchange serves as a central platform for the dissemination of environment,
safety and occupational health news, policy, and guidance within Department
of Defense activities worldwide and contains a link to the Department
of Defense's Quality Systems Manual for Environmental Laboratories.
http://www.navylabs.navy.mil/ManualsDocs.htm
- The American Chemical Society has guidelines for the teaching of professional
ethics.
www.chemistry.org/portal/a/c/s/1/acsdisplay.html?DOC=education%5Ccpt%5Cts_ethics.html
- The American Council of Independent Laboratories Environmental Sciences
Publications includes documents on a code of ethics, manual analytical
data adjustment, corporate values and expectations, and ethics and data
integrity. There are also standard operating procedures on data integrity
and ethical practices, proper raw data handing, and manual integration.
www.acil.org/displaycommon.cfm?an=1&subarticlenbr=65
- The Datachem Laboratories Inc. Ethics and Data Integrity site includes
information on a waste, fraud and abuse policy, confidential reporting
of improper practices, manual integration, laboratory policies and procedures
for ethical behavior and data integrity through training for all employees,
examples of improper practices, information about fraudulent activities,
standard operating procedures on laboratory ethics and data integrity,
and other related activities.
www.datachem.com/DataIntegrity/index.htm
- The NELAC Institute (TNI) is a 501(c)(3) non-profit organization
whose mission is to foster the generation of environmental data of
known and documented quality through an open, inclusive, and transparent
process that is responsive to the needs of the community.
www.nelac-institute.org
- National Environmental Methods Index has methods information, a Methods
Selections Advisor, and links to other pages.
www.nemi.gov
- The University of Georgia's Quality Assurance Unit has information
and links to FDA documents, EPA documents, the Society of Quality Assurance,
good clinical practices, good manufacturing practices and links to other
quality-related pages. The page contains information on EPA's Good Laboratory
Practice standards.
www.ovpr.uga.edu/compliance/qau/
- The National Institutes of Health bioethics site contains information
and links related to responsible conduct of research. http://www.nih.gov/sigs/bioethics/researchethics.html
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