Companies working within the environmental and water
and wastewater sectors face a number of significant challenges
with regard to delivering accurate, consistent, and
traceable results. Since ensuring public safety and delivering quality water are the chief goals of any water company, samples
must be regularly tested and quality monitored between the water
source to the final destination—the consumer’s tap. Effective monitoring
of this process requires that water companies implement
more consistent sampling, testing, and reporting processes that can
help them reliably deliver a safe product while continuing to meet
increasing regulatory requirements. Water companies today, whether
they are large state or municipal organizations, privately run, or small
rural providers, all face the same pressures—to maintain quality of
supply while implementing the most sustainable and efficient processes,
reducing labor-intensive procedures and waste, and increasing
automation. The bottom line is that water companies must ensure
that the business makes the best use of all of its resources.
Changing business requirements are driving some of the latest
developments in informatics solutions in the water quality sector.
Meeting stringent requirements for water and environmental
samples has often resulted in labor-intensive procedures to ensure
compliance, such as paper recordkeeping, demonstration of capability
(DOC), document control, reagent and standard traceability,
proof of training, and reporting. Water and environmental laboratories need solutions that automate and significantly reduce those
manual activities, and hence increase data quality and traceability,
while also meeting compliance requirements for ISO 17025 and
the standards adopted by the National Environmental Laboratory
Accreditation Conference (NELAC).
Advanced informatics solutions such as purpose-built LIMS, which
are designed for the work flow of water and environmental laboratories,
can address many of the industry’s fundamental issues. An
informatics solution designed to manage traceability and promote
efficiency can also be instrumental in facilitating the exchange
of information by connecting the laboratory with the rest of the
organization and thereby helping management at all levels of the
organization make faster and more informed decisions.
Legislative requirements
In 2003, NELAC adopted standards that are used for the accreditation
of environmental laboratories. Among other requirements, the
standards also cover quality management and technical requirements
for laboratories performing environmental analysis.1 Within this
framework, laboratories are required to ensure electronic data security,
software documentation and verification, software and hardware
audits, backups, and records of any changes to automated data
entries. In addition, laboratories must utilize a permanent chronological
record such as a logbook or electronic database to document
custody of all sample containers received in the laboratory.
The current version of the NELAC standard has been fully integrated
with ISO 17025.2 All NELAC-accredited laboratories will
be required to meet adopted ISO 17025 requirements, which specify
general requirements for the competence of testing and calibration
laboratories to carry out tests and/or calibrations, including the
sampling process. These regulations cover testing and calibrations
performed using standard methods, nonstandard methods, and
laboratory-developed methods. The regulations are applicable to
all ISO 17025-certified organizations performing tests and/or calibrations.
This includes first-, second-, and third-party laboratories
as well as laboratories in which testing and/or calibration forms are
part of the inspection and quality process.
Benefits of integrated informatics solutions for water quality analysis
Laboratory managers need to optimize the utilization of their staff
and equipment to improve efficiency and productivity. Minimizing
time-consuming and potentially error-prone manual processes is
a key weapon in the laboratory manager’s armory. LIMS allow for
considerable reductions of administrative overhead in the laboratory.
Laboratory operating costs are especially diminished by
applications featuring built-in functionality specific for water and
environmental laboratory work flows. Predefined test methods,
batch sequences, measurement traceability, and regulatory reports
enable the laboratory to process data faster than ever, while delivering
consistently accurate analytical data. By automating time-consuming
activities, water and environmental laboratories realize
improved efficiency and significant productivity gains while ensuring
traceability and maintaining records for compliance reporting.
Preconfigured solutions enabling compliance with
water and environmental regulations
State-of-the-art LIMS for water and environmental laboratories
have been developed in conjunction with environmental experts for ISO 17025 and NELAC requirements, ensuring the solution
has specific functionality to support the work flows found in water
and environmental laboratories. These new solutions are built with
comprehensive dashboard functionality that can help address the
regulatory and operational needs of three distinct and interrelated
parts of the laboratory’s business—personnel, quality assurance,
and the customer.
Key features of a purpose-built water and environmental LIMS
solution include:
-
Statement of Work (SOW) and project management capabilities
to ensure proper documentation of customer interactions
and contract review
- Customized pricing, quoting, and invoicing management, which
will reduce the need for external software applications and associated
costs (Figure 1)
Figure 1 - Pricing, quoting, and invoicing can be managed from within
SampleManager LIMS (Thermo Fisher Scientific, Philadelphia, PA), reducing
the need for other software applications within a business solution. This also
reduces implementation and integration costs.
Figure 2 - Subsampling allows users to easily manage sample allocation to
various containers upon receipt to the laboratory, ensuring traceability of the
sample from arrival to disposal.
- Extensive sample and subsample scheduling functionality,
including the use of handhelds/personal digital assistants
(PDAs), ensuring proper traceability and management of field
sampling information (Figure 2)
- Built-in predefined test methods and calculations for higher-quality
results and more efficient operations, while also eliminating
the need for external spreadsheets and manual calculations
- Preparation and analytical batches, and their associated methods
and matrices, linked to ensure traceability throughout the
sample testing process
- Project, job, and sample templates that can capture customer
and sample information, guaranteeing chain of custody
- The ability to add document attachments to samples or projects and
generate reports specific to the water industry, facilitating compliance
with NELAC and U.S. EPA regulatory requirements (Figure 3)
Figure 3 - Predefined report templates enable customers to automatically
generate regulatory-required reports in a fraction of the time.
Figure 4 - Dashboards provide graphical representations of information to
permit laboratory management and analysts to visualize critical information in
various forms.
Figure 5 - Data visualization allows users outside of the laboratory to monitor
field collection sites quickly and easily within LIMS.
- Automatic scheduling and maintaining demonstration of capability
(DOC), limits of detection (LOD), and limits of quantitation
(LOQ) studies, which eliminate the need for manual data
gathering and report generation
- Data visualization tools and an intuitive user interface that can allow
users to easily manage and track sample information (Figures
4 and 5).
Optimized operations for laboratory personnel and
management
Today’s water and environmental LIMS solutions provide comprehensive
sample handling, financial control from pricing to invoicing, project and customer management, instrument integration,
and automated reporting capabilities—giving managers
tighter control and saving time on routine tasks. Dashboards are
configured to display sample and project metrics, labor costs,
and monitor hold times at a glance so that users can view the
health of their laboratory and make more rapid decisions about
their operations. Furthermore, by automating and centralizing
the way samples are monitored and tracked, throughput, quality,
and laboratory productivity are also improved, permitting laboratory
managers and analysts to focus on value-added activities.
Meeting ISO 17025 and NELAC requirements for quality
assurance
Testing for water and environmental samples encompasses
a stringent set of requirements that has also introduced a new set of labor-intensive
procedures into the laboratory to
ensure compliance, recordkeeping, DOC, document control,
reagent and standard traceability, proof of training, and
reporting. Using an informatics solution specific to the work
flow found in water and environmental laboratories, Quality
Assurance can rely on fully integrated work processes that
ensure compliance with applicable regulations. With such a
system, records are maintained electronically in a validated
and secure environment, and therefore can be easily retrieved
during audits.
Data validation and traceability for the customer
Each customer relies on the laboratory to provide accurate
and valid data. Whether the laboratory is in-house or a
commercial facility, customer management is a key part of
contract review and sample handling within the regulatory
environment. A built-for-purpose water and environmental
LIMS solution facilitates compliance by documenting customer
processes within a secured environment and maintaining
the information for easy retrieval. The Statement
of Work allows the project manager to associate multiple
customer contacts and comply with reporting, pricing, and
testing requirements in one system. Customer communication
can be saved within the project to document any
changes to the contract, which is an important part of contract
review. By connecting these processes, all versions
of quotes, invoices, and reports are saved electronically to
ensure data traceability and version control.
The latest preconfigured LIMS solutions have been specifically designed
to help environmental and water and wastewater laboratories improve
efficiency, maintain records and traceability, and meet compliance
requirements for ISO 17025 and NELAC. Best practices and key learnings
in the field of laboratory informatics demonstrate that a built-for-purpose
informatics solution can help water and environmental companies
redefine their laboratory processes for improved efficiencies, cost
savings, and regulatory compliance. Companies that have installed these
advanced LIMS solutions have been able to improve both the efficiency
and integrity of their sample management and testing processes.
References
-
The NELAC Institute, Environmental Laboratory Sector, Vol. 1,
Management and Technical Requirements for Laboratories Performing
Environmental Analysis, TNI Standard; www.nelac-institute.org/docs/standards/2009/EL_Volume1_2011.pdf.
- International Organization for Standardization, ISO/IEC 17025/2005
General Requirements for the Competence of Testing and Calibration
Laboratories; www.iso.org/iso/catalogue_detail.htm?csnumber=39883.
Ms. Mensingh is President, EM2 Management Solutions, Houston, TX,
U.S.A. Mr. Thurston is Director of Product Strategy, Process Industries,
Thermo Fisher Scientific, 1601 Cherry St., Ste. 1200, Philadelphia, PA
19102, U.S.A.; tel.: 215-964-6020; fax: 215-964-6021; e-mail: [email protected].