to demonstrate compliance.
pinpoint all samples that fall outside the acceptable range and
ensure that they are removed from any outgoing shipments.
4. Establishing monitoring procedures
After identifying critical limits at each point in the system, a
food production cleanroom must establish monitoring processes for each CCP. A LIMS makes these monitoring procedures much more efficient by fully automating data collection
and transmission throughout the organization.
The LIMS not only enables manufacturers to see historical
data and generate reports for compliance; it is also used to proactively alert staff when critical limits are exceeded. Because a
LIMS is a paperless system, it can support an automated monitoring and response capability that is especially important for
cleanrooms that are part of a continuous processing workflow.
5. Establishing corrective actions
When a critical limit is exceeded within a cleanroom, staff must
follow a clearly defined process for correcting the issue. A LIMS
can help ensure that corrective actions are properly carried out
by providing standard operating procedures (SOPs) that walk
staff members through the appropriate response to each error.
Assume, for example, that a piece of monitoring equipment
connected to the LIMS detected that the condition of a clean-room air filter had deteriorated to an unacceptable level. The
LIMS could then alert the cleanroom staff and provide them with
an automated SOP for replacing or cleaning the filter, saving time
and ensuring that the job is done correctly. Additionally, the LIMS
makes audits by senior staff and regulators easier by recording
which staff member performed the corrective action.
6. Defining verification procedures
Out-of-calibration cleanroom monitoring instruments deliver
diminished performance that can make accurately determining product quality impossible. To prevent this, HACCP
methodology mandates that instrument performance be regularly verified. Just as a LIMS can ensure that corrective actions
performed by the staff are done properly, it can also verify that
cleanroom instruments are regularly maintained and calibrated. The LIMS can be used to store instrument maintenance
schedules and can alert cleanroom managers of the need for
maintenance, reducing interruption due to unplanned instrument downtime or malfunction.
7. Establishing recordkeeping procedures
Because a LIMS is entirely paperless, recordkeeping procedures
are much more efficient. All data going in and out of the LIMS are
automatically recorded digitally, making both internal and external
audits for FSMA requirements related to HACCP or other regu-
latory reviews accurate and reliable. Transitioning from a manual,
paper-based system to one that automates nearly all data collection
from the cleanroom enables food producers to easily ensure consis-
tent quality, product safety, and industry compliance.
Accurate digital recordkeeping also makes tracing the origin
of an error much easier. Determining the source of contamination—whether caused by an out-of-specification process or
a questionable raw material—is critical to helping producers
mitigate impact during an incident and ensure that it’s not a
systemic issue. Once the error is isolated, batches produced
between the negative event and the latest acceptable results from
the monitoring program can be quickly isolated, limiting the
extent of damage and reducing product loss to only the batches
that have actually been compromised. The LIMS also generates
incident reports for all product quality issues, which can be provided to management or regulatory bodies upon request.
Traceability outside the cleanroom
In an ideal world all food safety issues would be detected before
any products left the cleanroom. Unfortunately, experience has
proven that this is unlikely to ever be the case. In the event that a
contaminated food product does leave the production facility, a
LIMS provides critical traceability that can help reduce the potential harm and financial impacts caused by the error.
By systematically monitoring batches of raw materials, processed materials, and packaged goods as they pass through the
cleanroom, a LIMS provides manufacturers with the data they
need to rapidly identify contaminated batches. This allows them to
see exactly where contamination occurred, automatically suspend
release of a product during investigation, and identify shipped
products that may need to be recalled. While no manufacturer
wants to have to recall products, the ability to parse data stored
by the LIMS and accurately identify contaminated shipments can
drastically reduce the scope and cost of a recall operation.
A LIMS also adds security to the process, logging important
data such as location, operator, and manifests so that the entire
journey of a batch—and its viability the entire time—is a matter of
record. Information ranges from safety test results, including foreign body, pesticide, and microbiological analysis, to raw ingredient
identification analysis. Information on hazards or substandard processing, such as poor storage somewhere in the supply chain, exists
within the LIMS for reference when and how it’s needed.
Colin Thurston is a Project Director with Thermo Fisher
Scientific of Waltham, Mass. www.thermofisher.com
21 September 2014 • www.cemag.us
A LIMS adds security
to the process, logging
important data such as
location, operator, and
manifests so that the
entire journey of a batch
is a matter of record.