LIMSzine
APPLICATION ARTICLE
The following application article discusses some of the key issues affecting
the food processing industry, most particularly HACCP and the emerging Food
Laboratory Accreditation program, what those regulations mean to LIMS, and
how General Mills, Kraft Foods, and Silliker Labs are addressing the challenge.
LIMS Address New Food Regulations
Two key criteria are driving change in the food industry. The increased
regulatory requirements and the need for a formalized laboratory accreditation
program are coalescing into a need for greater laboratory efficiency. Many
food laboratories are implementing or upgrading a Laboratory Information
Management System (LIMS) to deliver the required results.
Food processors must deal with numerous issues to get their products to
market, and the laboratory is playing an increasingly important role in
the process. Labs must check for pesticides and chemical contaminants in
incoming raw materials. In-process and final quality control (QC) and quality
assurance (QA) checks of product against specifications must be performed
to ensure product safety and integrity. The special chemistries involved
with packaging must be evaluated to ensure the product does not chemically
interact with the packaging material. Product labeling must be accurate
and comprehensive. Reports of all these measures and results must be delivered
not only to the customer when appropriate, but to various government agencies
as well.
Increased Regulatory Requirements
Regulations are beginning to rain down hard and heavy on the food industry.
From the Food Quality Protection Act (FQPA) of 1996 to the new Hazard Analysis
Critical Control Points (HACCP) and Pathogen Reduction Rule that became
effective in 1997. The food processing GMPs are next in line for a revision
by the U.S. Food and Drug Administration (FDA) in the near future.
The new HACCP rule is the latest in a list of regulatory requirements designed
to ensure safe food production. The concept was initially introduced in
1971, and is now required by the FDA for seafood processors and by the U.S.
Department of Agriculture's (USDA) for meat and poultry industries.
HACCP uses scientific principles to ensure food safety through the control
of hazards by identifying and monitoring critical points in the production
process to avoid contamination where it is most likely to occur. These
critical control points are tested for contaminants, such as E. coli and
Salmonella, using microbiological detection techniques.
HACCP is a QC program at heart. Once the critical control points are determined,
the organization then designs safety steps to prevent or detect errors and
deal with problems before product safety is compromised. In process laboratory
testing is used to meet these HACCP requirements. This type of laboratory
testing is usually performed by a QA/QC lab whose job it is to pull samples
from the line and test those samples against specifications. An if/then
scenario ensues whereby if the sample passes, the lot or batch is approved.
If the sample or samples do not pass, then corrective action is taken.
While HACCP will require changes in food processing techniques to ensure
that the test results will be in line with requirements, it has also been
predicted that HACCP will require greater proficiency in data management
than the industry currently possesses. Critical control points require
monitoring, verification and recordkeeping.
LIMS Address HACCP Requirements
A LIMS can assist greatly in performing these tasks. For instance, because
slaughter plants are now required by HACCP to have Sanitation Standard Operating
Procedures (SSOPs) for sampling and testing carcasses for generic E. coli,
the LIMS can automatically capture the sample data, check for out-of-spec
results, and assemble the data into a variety of report formats. The reports
can compare the results with baseline data to verify that pathogen reduction
performance standards are being met.
LIMS can connect the analytical instruments in the lab to one or more workstations
or personal computers (PC). These instruments -- such as gas chromatographs
-- are used to collect data. An instrument interface is used to forward
the data from the instrument to the PC. The LIMS collects the sample data
from the analytical instrument via the instrument interface, and processes
the raw data into meaningful information.
The power of a LIMS is most apparent when its extensive database capabilities
come into play. LIMS are used to log in samples; track samples; provide
sample status; check for out-of-spec results; list tests to be performed;
keep records of when tests were performed; format the information into reports;
and archive the data, results, and reports. The reporting function is one
of the most important features. Laboratory information captured and processed
by a LIMS can be sorted and organized into a wide variety of report formats.
Reports can be generated using the report templates provided with the LIMS,
or downloaded to a third-party program, such as Microsoft Excel, for report
generation. All this can be done automatically.
There are more than four dozen LIMS vendors offering everything from simple
spreadsheet-type programs to sophisticated client/server Oracle-based systems.
It's important to note that most LIMS had their genesis from a single system
written for a specific company. For instance, if the LIMS was originally
written for a pharmaceutical application, the sample log-in fields and report
formats will be geared toward pharmaceutical samples and reports. According
to Leigh Richardson, President of Telecation, "the food industry is
product oriented rather than sample oriented. Therefore, the LIMS must
be capable of handling raw materials as well as intermediate and final products."
Telecation (Lakewood, CO) offers several LIMS solutions.
New Technology Drives Upgrades
Organizations such as General Mills that must track large volumes of product
and sample data have had some kind of LIMS in place for years. Prior to
1994, the company used a proprietary Fortran-based system that ran on an
IBM mainframe. Unfortunately the system only allowed one user at a time
to enter data in any given area, and new reports had to be created by writing
a new Fortran program. The original benefits of the system had fallen behind
the capabilities currently available with newer technology. Thus, in 1994,
General Mills replaced the Fortran-based system with Beckman Instruments'
(Allendale, NJ) LabManager LIMS, client/server Oracle-based system.
According to Michael Shay, Senior Research Chemist at General Mills, the
relational database structure available from Oracle eliminates the limitations
of the Fortran-based system. Now, there are no constraints in the number
of user-defined functions, database field size limitations, or limitations
on the number of fields. In fact, user-defined functions allow many operations
to be handled by analysts in the laboratory rather than by the system manager.
A series of Find functions now enable staff to query the database to obtain
results and sample status. A series of reports were also added that enable
the analysts to locate samples and determine sample disposition. Migrating
to the Oracle-based system allowed General Mills to add many such functions
that make the end-user's jobs easier and the various processes more streamlined
and efficient.
Supplement LIMS with Charting
Kraft Foods, one of the largest packaged goods companies in the world,
also recently migrated from an in-house system to a commercial solution.
Kraft's R&D facility in Glenview, IL, is the main analytical site for
all Kraft products worldwide. "In fact, an on-site pilot plant can
reproduce many plant processes," states Jim Zdunek, Associate Technology
Principal for Kraft Foods. Kraft has two other U.S. labs: one in Madison,
WI, that analyzes Oscar Meyer products, and one in Tarrytown, NY, that analyzes
Jello and Kool-Aid among other products.
The Glenview R&D lab recently implemented a LabWare LIMS. This is
the fourth implementation of a LIMS at Kraft, and the first commercial system
installed by the company. The new LabWare LIMS from LabWare (Wilmington,
DE) has the potential to connect all three sites in the U.S., as well as
several international locations. It uses one large database for North America
that ties in microbiological, chemistry, packaging, and consumer complaint
information.
After the LIMS was installed, Zdunek wrote a program that added charting
capabilities. This charting program allows Kraft to keep an eye on the
QA of various measurements. "Information is kept on the LIMS as QA
samples," he explains. The program provides charts over a period of
time, usually a year, that enable a close look at QA criteria, such as pH
mean values and standard deviations for a specific product. "For instance,
factory-blend cheese sauce is tested for acidity and must fall within certain
pre-defined quality criteria," Zdunek adds.
Supplementing the LIMS with add-on functionality like charting optimizes
the laboratory data available through the LIMS. "I used the familiar
Windows environment," Zdunek reports. "It allows the user to
select the appropriate chart by clicking on an icon. The chart information
is then handled through the LIMS via a report generation scheme with Crystal
Report Writer. The LIMS provides the query functions and the information;
the charting package simply places the results into a desired format."
In addition to analyzing products and samples in their own labs, Kraft
uses contract labs when an independent analysis of certain items is required.
Increased Reporting Capabilities
Food processing plants that do not have, nor wish to operate, an in-house
laboratory for testing and analysis, have the option to use contract laboratories
to perform the required tasks. One of the largest contract food testing
labs in the world, Silliker Laboratories has 15 laboratories throughout
the U.S. and Canada that are capable of processing any type of food sample.
Headquartered in Homewood, IL, Silliker provides microbiological analysis;
analytical chemistry; research; training; and technical consulting. One
of the ways in which they help clients solve QA/QC problems is by addressing
HACCP requirements through training and by developing HACCP programs.
HACCP requirements must be addressed by the contract lab if the food processor
is to provide the appropriate regulatory agency with required sample information.
The in-house LIMS that ran on an IBM AS400 mainframe in each lab was adequate,
however Silliker wanted a single lab-wide solution that could process sample
information more efficiently and deliver the more robust reports to their
clients.
Silliker had been monitoring the LIMS industry for some time, but "previously,
we didn't think there was anything available that created a big enough leap
to warrant the investment," recalls Bob Solomon, Vice President of
Marketing and Business Development at Silliker. "And, most LIMS are
written for a specific industry -- not necessarily this one. It made more
sense to continue customizing the in-house system. The decision to migrate
to a commercial system means that the Information Systems (IS) emphasis
has switched from a hardware and programming perspective to what the customer
needs. The focus now will be on software the labs can utilize more efficiently."
The reasoning behind this switch as Larry Vaerewyck, Silliker's Director
of MIS, explains is that "we asked if we were going to have an in-house
staff to modify applications or if we wanted software vendors to do the
programming and develop code. We determined that our focus must be on our
core competencies, and that our people would work with our labs and customers
to meet their business needs through better use of the LIMS."
To this end, Silliker is installing a LabWare LIMS that will automate approximately
85% of the laboratory functions. "We expect the LIMS to improve productivity,
efficiency, and accuracy," states Vaerewyck. "In the microbiological
lab, the LIMS will capture results at the raw data level and then automatically
calculate the reprintable results. To our knowledge, no other testing lab
does this at this time."
The isolated IBM AS400 mainframes are history. "Now, all data will
be at one site with a Wide Area Network (WAN) to tie it all together,"
Vaerewyck remarks. "This functionality will provide a significant
advantage for the national food companies we serve. For instance, the customer
will be able to log in their own samples and have access to their data,
including sample status and results regardless of which Silliker lab performed
the testing. In addition, more flexible result retrievability and report
formats will be available to the customer."
Laboratory Accreditation
A critical driver pushing the food industry is the need for a formalized
Laboratory Accreditation Program. A Laboratory Accreditation Program would
ensure the integrity of laboratory data via validated processes.
There has not previously been a Laboratory Accreditation Program in the
U.S. -- an issue of major concern for foreign purchasers of exported food
stuffs. However, such a program is finally in the works and should be released
by the end of 1997.
Silliker has already been certified to several lab accreditation programs
overseas in the absence of a formal U.S. program. "Food testing has
been relatively unregulated," Solomon points out. "The USDA has
some programs that confirm if the lab's samples meet USDA criteria, but
that's been about it. Fortunately, a movement is currently underway by
the Food Laboratory Accreditation Working Group to develop accreditation
standards."
"A program is being developed along the guidelines set forth in the
[International Organization for Standardization's] ISO Guide 25, which is
directed at testing and calibration labs. However, the lab accreditation
program will be more specific to food," he adds. "It goes beyond
ISO Guide 25 and ISO 9000 [another quality management system from ISO] to
deal with the validation of results, with specific emphasis on methods and
analytes of importance to the food industry."
Conclusion
The latest government regulations are requiring additional safety precautions
during food processing that in turn require greater depth in data reporting
and management. A formalized Laboratory Accreditation Program will ensure
that all accredited laboratories operate at a comparable level to ensure
sample and sample data integrity. Companies that automated data collection
and analysis years ago are finding that they must upgrade their systems
to current technology to keep pace. LIMS have proved to be a viable solution
that help many organizations meet regulatory requirements by managing lab
data more efficiently.
The above article was written by Helen Gillespie,
Web Master for the LIMSource, and reprinted from Inside Laboratory Management,
October 1997
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