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Food safety Right Data for Real Food

From Ed Ingalls* |

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Food testing laboratories need reliable data management systems in order to comply with the ever increasing regulatory requirements. LIMS platforms play an important role in terms of compliance with HACCP and ISO 17025 as well as in the implementation of comprehensive security mechanisms.

Fig.1: Food testing laboratories have to deal with ever larger amounts of data due to increased regulatory requirements.
Fig.1: Food testing laboratories have to deal with ever larger amounts of data due to increased regulatory requirements.
(Source: ©Andrey Popov -

Assuring food quality and safety is a global issue and food testing laboratories now operate within an increasingly stringent regulatory environment that requires robust testing tech­nologies and effective information management. Today’s approaches to food safety aim to eliminate contamination incidents, and are based on risk assessment and the application of preventative control plans. One of the challenges for food testing laboratories is to manage the high volume of data that these approaches generate. Advanced Laboratory Information Management Systems (LIMS) provide the tools for standardizing and harmonizing food testing operations, managing the data flow and enabling compliance with the ISO 17025 international standard.

The Codex Alimentarius

The HACCP system is based on the principles of the Codex Alimentarius. The Codex coordinates the fair trade in food on an international level and aims to protect the health of consumers with the help of uniform standards. It consists of seven principles:

  • Principle 1: Perform a hazard analysis.
  • Principle 2: Determine the Critical Control Points (CCPs).
  • Principle 3: Define one or more limit values ​​which, if exceeded, measures are initiated.
  • Principle 4: Establish and document a system for monitoring the CCP.
  • Principle 5: Determine the corrective actions to be taken if monitoring indicates that a particular CCP is no longer controlled.
  • Principle 6: Establish the verification procedures (as evidence) that confirm that the HACCP system is working effectively.
  • Principle 7: Introduce and maintain documentation of the hazard analysis and critical control points, which takes into account all processes and records relating to these principles and their application.

The Regulatory Environment is Evolving

Microbial, chemical and physical contamination of food products all pose threats to human health. Containing these within accepted limits requires a rigorous approach to food safety management and testing. Food safety concerns over recent years have led to industry and governmental bodies responding by strengthening regulations and increasing the focus on risk management in food production processes.

ISO 17025 is a quality management standard that enables labo­ratories to demonstrate that they operate competently and generate valid results, and in 2017 was updated to provide a risk-based approach with an increased focus on information technology. The requirements of ISO 17025 build on the critical points for food safety described in the mandatory Hazard Analysis Critical Control Points (HACCP) methodology, which is at the core of food safety management programs.

Meeting ISO 17025 Requirements with LIMS

ISO 10725 guidance is focused on: resource qualification and control; validated sampling and testing methods; accuracy and traceability of results; incidents and deviations; performance evaluation; and improvements. The processes and systems needed to achieve and maintain compliance involve the storage and management of large amounts of data. Effective data management is essential to avoid the risk of erroneous information, compromised product quality and regulatory noncompliance.

Advanced LIMS offer a solution that can be implemented across the entire workflow at food manufacturing and testing facilities to provide a single user interface that enables standardization and eases compliance across multiple testing sites. Modern LIMS are built to comply with ISO 17025, delivering preconfigured processes that support laboratories in integrating analytical and quality workflows to achieve compliance, streamline data management and preserve data integrity.

The seven core principles of HACCP can be addressed using LIMS (see LAB Info) , with workflows mapping directly to laboratory processes. Following hazard analysis, critical control points (CCPs) are determined and can be entered into LIMS, with contamination grades assigned and critical limits set. Monitoring procedures are established by defining sampling schedules and setting other parameters, so that LIMS can identify and report incidents to drive corrective action. The system will also drive verification procedures and preventative measures at the defined CPPs. All data, processes, instrument reports and user details remain secure within the LIMS.

The workflow-based functionality of LIMS enables not only the mapping of laboratory processes, but also the automation of decisions and actions according to defined criteria. Data integrity and records are maintained according to the ALCOA+ principles, created originally for the pharmaceutical industry but equally applicable to the food and beverage environment.

Two sample lifecycles that are important in food safety and quality — environmental monitoring and quality control (QC) samples — are both managed by LIMS and are associated with the final product. LIMS dashboards can be optimized by product and facility to give operators visibility of the entire process. Data visualization in real time makes it easy to monitor critical process points in order to detect and quickly respond to results that are out-of-specification or showing adverse trends. Here, preconfigured rules enable LIMS to notify operators if a process is trending out of control before the product fails, allowing mitigating action to avoid losses and rework.

Equipment calibration and maintenance, traceability, record-keeping, validation and reporting can all be managed in LIMS. This protects against the use of equipment and instrumentation that is due for calibration or maintenance and prevents users without proper training records from conducting tests. Electronic signing ensures a permanent record of all approvals in line with the record-keeping requirements of HACCP.

Collaborative working is made easy with secure access, from any location, to system dashboards and reports. Once testing is complete, autogenerated Certificates of Analy­sis show final results and demonstrate that product specifications have been met. Activities though the entire process are tracked and stored in the audit trail.

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Food testing laboratories require reliable data management systems to better ensure they meet evolving regulatory needs. LIMS platforms that deliver integrated workflows, automated procedures and secure record keeping have an important role in directly supporting HACCP and ISO 17025 compliance, and in integrating wider safety functions in food testing facilities.

* E. Ingalls: Thermo Fisher Scientific, 02454 Waltham/USA