Managing Data in Food
A LIMS tracks real-time information about the cleanroom and offers the ability
The importance of data management
Scientific C leanrooms play an important role in the prevention of contamination during the production of food and food supplements. They are most often built around food packaging processes, where there is a high potential
for exposure of the finished food product to the atmosphere or
people. Ensuring that the environment within the room remains
uncontaminated requires continuous monitoring of several
variables including air filter condition, product throughput, staff
presence, air pressure, and air purity. This multi-variable moni-
toring creates significant amounts of data, and managing it well is
central to maximizing the effectiveness of the entire system.
The quality of the output of a food production cleanroom hinges on quality of the data generated. If the data collected during
the process are inaccurate or poorly managed, it becomes difficult to spot problems quickly and reliably. This limits the value
of the entire monitoring process and risks the production of
inferior or contaminated products. Ensuring that the products
of a food production cleanroom are safe requires quality process
monitoring equipment as well as great data management.
The most common and relied upon tool for ensuring effective data management in a food production cleanroom is a
laboratory information management system (LIMS). A LIMS
manages highly complex and integrated laboratory operations
(such as SOPs, methods, and workflow) as well as integration
of all instruments for sample management, data collection,
reporting, and archiving. The LIMS also connects the laboratory to other enterprise systems, giving management real-time
information about the health of the lab and giving the organization the flexibility to demonstrate compliance with any
regulatory requirements as needed.
Cost-effective compliance with common standards, such as
Hazard Analysis and Critical Control Points (HACCP), is
critical to food industry producers. While HACCP has been
around for decades, the Food Safety Modernization Act
(FSMA), which became law in 2011, made adopting this more
rigorous methodology mandatory for a much broader group
of food production facilities. Specifically, FSMA section 103,
entitled “Hazard Analysis and Risk-Based Preventive Controls,”
requires that all affected food producers establish HACCP-based written Preventive Controls Plans. Adherence to these
HACCP requirements can be extraordinarily labor-intensive
without a highly integrated, paperless system to manage data.
Because HACCP addresses the analysis and control of
1. Conducting a hazard analysis
biological, chemical, and physical hazards from raw material
production, procurement, and handling to manufacturing,
distribution, and consumption of the finished product, imple-
menting a preventative control plan is onerous. It requires dis-
cipline and strict adherence to policies and procedures.
HACCP is based on seven principles that outline a risk mit-
igation and hazard prevention process. A LIMS is critical to the
success all of these efforts.
The identification of potential hazards should begin before raw
materials even enter the facility. Food producers should create
a database of all materials suppliers within the LIMS, so that all
materials that pass through the facility can be traced from their
point of entry. Next, the manufacturer must identify hazards,
which are often found where materials are added, product is
extracted, vessels are opened, or final products are packaged.
These locations can all be mapped in the LIMS. Together
with supplier data, this digital process map allows clean-room professionals to identify and track all materials coming
through the process from entry to exit. Sample data can be
grouped and reviewed by batch, supplier, date, or other categories to identify trends in the cleanroom’s throughput.
2. Identifying critical control points
The next step is to identify the process critical control points
(CCPs). In general, a CCP is any part of a food production process where checking the quality of a material can prevent a food
safety hazard in the end product.
By storing all CCPs within the LIMS, cleanroom professionals ensure that all food safety data is managed effectively
and is easily accessible. Storing control points in the LIMS also
greatly increases a cleanroom’s flexibility and scalability; adding a new point or modifying an old one is simple when the
facility’s data management system is fully digital.
3. Establishing critical limits
Every control point in the process should also have a clearly
defined critical limit—a point, level, or condition that, when
not met, can do serious damage the end product. These typically take the form of numeric limits, such as an acceptable parts-per-million or temperature range, but they can also be Boolean
conditions for pass/fail limits.
Quickly and accurately identifying products that fall outside
a critical limit—preferably before they reach the market—is
essential. By collecting critical limit data on all products passing through the cleanroom, a LIMS enables food producers to