Integrated Laboratory Informatics Deliver the Traceability and Data Management Needed for Comprehensive Food Safety Monitoring
Most of the industry-wide regulations require extensive application of the Hazard Analysis and Critical Control Points (HACCP) methodology, a systematic approach to preventing food safety hazards that has been in use for several decades.
Establishing a “preventive controls plan” (as described in FSMA Section 103 – Hazard Analysis and Risk-Based Preventive Controls) based on the HACCP methodology is the best and simplest way to achieve enterprise-wide compliance. This route is not without its challenges, however: HACCP, when properly practiced, generates a significant amount of instrument data and records.
Managing this information is key to success, which is why many food producers put a Laboratory Information Management System (LIMS) at the core of their regulatory compliance system. A LIMS enables producers to monitor and record the progress of all product batches as they enter into, travel through and are shipped from production facilities. In addition, it also guides producers through the five steps for establishing a preventive controls plan: evaluating the hazards, specifying preventive steps, specifying how the facility will monitor its controls, maintaining monitoring records and specifying corrective actions to correct problems.
LIMS and Preventive Controls Plans
- Evaluating the Hazards
The first and most important step in managing food safety hazards is identifying them: one can’t minimize a hazard without being aware of it. Contamination risks are commonly found where materials are added, product is extracted, vessels are opened, raw materials are introduced, finished products are packaged or, most pernicious of all, where employees are most unlikely to follow operating procedures.
A LIMS can help food safety professionals by generating a software map of these hazard points. In addition to locations within the facility, the LIMS can also store supplier data for all incoming shipments. Using this map, the manufacturer can then use the LIMS to group data by batch, supplier, date or any other relevant parameter, allowing management to easily identify potentially contaminated or out-of-spec materials.
- Specifying Preventive Steps
With food safety, prevention is always better than hazard response. This is why defining preventive measures is one of the most critical parts of a controls plan. Hazards can be introduced to the production process in many ways, including equipment failures, human error, poor environmental or site-specific conditions, as well as the use of nonconforming materials. A LIMS can play a role in preventing all of these hazards.
When a LIMS is integrated with all laboratory instrumentation, it can provide automated maintenance reminders for those instruments to relevant staff members in the lab. In addition to maintenance records, detailed operator competency and training records are stored so that management can verify whether staff have received the appropriate training, and so that untrained personnel are prevented from performing critical tests and procedures. This safeguard will be particularly important if the organization is audited for any reason, or has to deliver reports proving full traceability of processes and materials to a regulatory agency.
Finally, a LIMS can be used to monitor the quality of raw and process materials as they pass through quality checks during processing, helping manufacturers detect non-conforming materials as early as possible, ideally before they leave the facility.
- Monitoring Controls
The hazard points identified in the first two steps require regular monitoring – as a result, they generate significant amounts of data. Using a LIMS, food safety professionals can schedule measurements, apply control limits, set alerts and analyze data for each control point in the facility.
Sampling plans for control points can be managed as a group, which means that producers can use a consistent protocol for each type of product moving through the facility. This capability allows management to compare data from one batch to those from another. All data generated by process monitoring is stored in a relational database and can be presented in the way that’s most useful to each user, including graphs, real-time alert messages and process map overlays.
- Maintaining Records
Food safety regulations require extensive record-keeping for use in regular compliance audits. A LIMS greatly simplifies the process of record-keeping and retrieval by enabling entirely paperless data collection and reporting. All records stored within the LIMS are searchable, secure and authenticated by electronic signatures and audit trails, making audits much easier by capturing and organizing all data necessary to demonstrate compliance and producing it in report formats either required or easily recognized by auditors or regulatory authorities.
- Specifying Corrective Actions
When a food safety incident occurs, clearly defined corrective actions – developed in advance – must be known by all relevant staff. The records housed within a LIMS play an important role here: by analyzing the data pertaining to the affected batch, food producers can know in real time the extent of the problem and what corrective actions are required. Detailed incident reports are then stored within the system for critical review, driving continuous process improvement and streamlining any regulatory review.
What all food regulation has in common is data – producers must collect, store and present massive amounts of it. This is why LIMS are now so prevalent in the food industry: proven data collection, analysis and recording capabilities can help producers monitor product quality at every step of the process, enabling them to account for full traceability of all processes and materials. From low-tech loading docks to high-tech packaging cleanrooms, a LIMS can continuously monitor an entire food production process and make demonstrating regulatory compliance much easier. More important, a LIMS can help ensure that the trust customers place in their food is supported by the most advanced technologies available today.