Industries across the board are coping with relentless
pressure to reduce costs while simultaneously improving product
quality. The hydrocarbon processing industry (HPI) has
an additional challenge in achieving higher product quality as
a result of the heavier raw materials available for processing.
Heavier crude feedstock from sources such as the
Canadian tar sands have high sulfur content, thus making them
more complex and expensive to refine. This heavier feedstock is in direct contrast to
requirements for low-sulfur products dictated by
ever-more-stringent regulatory requirements. In this environment, a well-designed quality
management system (QMS), which includes a robust laboratory
information management system (LIMS) that facilitates
ISO 17025:2005 accreditation is critical to
ensuring product quality and customer satisfaction.
LIMS is vital to quality management.
Inspection systems that perform product sampling and
chemical analyses are expensive; yet, they can be easily
justified. Reprocessing or scrapping product wastes time, money
and resources. Furthermore, off-spec product can lead to
unhappy customers or worse, product recalls that can damage the
manufacturers corporate image. Conversely, product
quality over and above that required by contractual obligations
incurs additional costs for which manufacturers are not
compensated, and this impacts margins and profitability.
A comprehensive QMS with an integrated LIMS can help reduce
product variability and improve operational performance. In the
HPI, lower-grade feedstock may dictate higher
in-process sampling and analysis rates to prevent defects
during the manufacturing process. When integrated with
manufacturing execution system (MES) and enterprise resource
planning (ERP) systems, production and other departments can
access quality-related information generated by the LIMS to
help ensure that products meet defined specifications and
demonstrate compliance with regulatory, product and safety
An LIMS, such as Sample Manager 10 from Thermo Fisher
Scientific, adds value to quality assurance (QA)/quality
control (QC) systems with full traceability functionality and
it serves as a repository for documents and reports as evidence
of compliance. An LIMS can provide vital information at the
front end of the manufacturing cycle. Identifying off-spec raw
materials upon inspection can provide the needed heads-up to
tune the production process to yield acceptable final
product(s). It can demonstrate that a sample was handled
appropriately and that the analysis was done by a properly
trained, qualified technician. It can act as a repository for
laboratory equipment and maintenance histories or analytical
method validation, as well as the corporate quality manual.
LIMS data can also be useful in determining the appropriate
corrective action for off-spec product and to evaluate the
performance of the quality system. Upon final QA quality and
contamination checks, it can quickly release shipments.
If a non-compliant lot was inadvertently shipped, fast
efficient flow of information will ensure that a recall can be
quickly implemented. Without traceability records from an LIMS,
it would be nearly impossible to accomplish product recalls in
a timely and controlled manner.
Integrated LIMS enhances QC.
In the manufacturing environment, analytical measurements
define the who, what, when, where and how of a
manufacturing process. As the backbone of the laboratory, an
LIMS provides quantitative and qualitative information about
chemical processes for enhanced QC. The wealth of analytical
measurements provided places increased importance on
integrating this information into higher-level enterprise
application platforms. To improve response to operational
issues, managers look to technology to connect plant floor
and business systems, like ERP, product information management
system (PIMS) and MES, making it critical that analytical
information are presented to the viewer in the context of their
role, responsibility and authority. For real-time quality
management, information visibility is the driver behind the
demand for better integration of laboratory-generated
information throughout the enterprise. Laboratory ISO
17025 compliance demonstrates commitment to quality.
Due to fluctuations in raw materials, HPI laboratories are
becoming almost like third-party service laboratories. As such,
these labs must assure compliance of product(s) to
specifica-tions, making laboratory accreditation with standards
such ISO 17025:2005 no longer just nice to have, but a
necessity to ensure conformance and customer satisfaction.
Compliance with as ISO 17025 demonstrates a commitment
to quality, and provides customers the assurance that the
laboratorys management and technical requirements adhere
to globally accepted best practices.
ISO 17025 requires a complete history of each piece
of equipment including checks and calibrations performed prior
to being placed in service as well as detailed records of all
calibrations, repairs, maintenance and performance checks
over the serviced life of the device. A clear advantage for
final product manufacturers is that utilizing certified ISO
17025 laboratories as subcontractors fulfills all the
requirements as applicable to calibration and testing
activities of an ISO 9001 quality management system.
This enables the manufacturer to recognize the sub-contractor
as ISO 9001 certified for any work done within the
ISO 17025 scope. Quality audits of an accredited
subcontractor are not required. HPI manufacturers can use the
statements of work provided by an LIMS to ensure that customer
requests match the delivery of samples to the lab, along with
and the delivery of results back to the customer.
has nearly 30 years experience
in the areas of sales and product marketing in
industrial field instruments that utilize a vast
array of technologies including magnetic, Coriolis,
radar, electrochemistry, capacitance and