In the same way that technology expands the reach of information on a global scale, it can aggregate information from various divisions within the same enterprise to create a portal for superior organization and business intelligence. Frequently, more than in other industries, the food business is under extreme pressure to ensure the production of quality products while maintaining strict regulatory compliance and a high level of productivity. Without adhering to these rigorous standards, companies run the risk of audits, recalls, erosion of consumer confidence, and loss of brand integrity.
Explore this issueFebruary/March 2018
Food producers and manufacturers need to go through a complex web of processes to bring raw materials through their production lifecycle to packaging and release to the market. With diverse remote sources involved and multiple divisions within each company, all procedures require meticulous monitoring and constant improvement to keep up with the high demands of the world’s growing consumer base. In addition, global regulations require stringent controls, ensuring the food put on tables is safe for consumption. Implementing data management systems to monitor and collect a multitude of testing and quality control data allows these companies to focus on their primary objective—bringing safe and healthy food from farm to fork.
Data management systems have become the foundation of any food safety laboratory to track samples and comply with increasingly complex regulations, but how does implementing an integrated laboratory information management system (LIMS) help to increase productivity and streamline workflow without taking too much time dealing with the system itself? Here are some tips and best practices for working with LIMS, how to leverage the integrated system, and why it is essential for managing today’s complex global food safety requirements.
Identify and Manage Fail Points
From a food safety and quality perspective, there are several potential fail points within a typical food manufacturing process that must be recognized and closely tracked. Monitoring these checks across multiple processes can quickly become overwhelming, causing delays and eventual bottlenecks in overall production. From receiving raw material to competent batch release, laboratories can have a substantial influence on production speed and efficiency.
In order to increase lab efficiency and not tie up man-hours in the tracking of every individual procedure, it is important to itemize all fail points, establish a protocol for these hazards in the LIMS, and manage processes so not even the smallest detail is left to chance. Integrated informatics builds in fail points in order to preserve data integrity across three common areas where prevention is key to success: inventory, standard operating procedures (SOPs), and traceability.
Inventory. Cataloging products can initially seem like a basic management project. Most laboratories run routine tests and regularly need the same stocks replenished. However, because inventory is generally a straightforward process, fail points regarding pre-planned ordering or automated supply level monitoring can easily be overlooked. Using a LIMS to electronically track supplies as they are used and send an alert when items are running low enables labs to maintain their efficiency and eliminate fail points in this area.
SOPs. These are one of the most significant procedural necessities in any lab, outlining what needs to be done and exactly how. Straying from SOPs can cause severely detrimental effects for food safety due to unintended errors that could be avoided. A LIMS can implement electronic SOPs to protect against this risk and statistical quality controls to detect non-conformance, defining stepwise workflows and technical corrective actions to ensure consistency and adherence to protocols.
Traceability. Tracking and logging a product from origin to release provides accountability and accuracy of results needed for quality control and regulatory review. Given that labs typically work with thousands of samples, this process can be laborious and full of potential fail points. Without a documented and unbroken chain between data and sample, results become indefensible. An integrated informatics solution reinforces adherence to encoded guidelines, safeguards data quality, and accelerates the delivery of results so that production can continue uninterrupted.
Maximize Process Improvement
Most quality assurance and quality control systems follow the Hazard Analysis and Critical Control Points (HACCP) methodology. HACCP aids in the development of relevant regulations to ensure proper workflow and prevent food safety hazards. In order to handle the extensive volume of instrument data and records generated from comprehensive HACCP programs, labs can leverage LIMS to collect and manage data over the entire lifecycle of a food product. Analysis of data from this approach aids in the improvement of involved processes by considering the five critical steps outlined below.
Hazard evaluation. Evaluation of potential hazards that can arise from user interaction, raw material handling, or packaging can bring to light process areas that need close monitoring or automated protocols. Allowing LIMS to manage these identified hazard points makes preventing issues simpler and managing the effects of process errors less consequential.
Preventive steps. Prevention is extremely important in eliminating potential hazards before they arise, removing the need to cope with hazard response. Users should define preventive measures and manage them with a LIMS, including automating instrument maintenance reminders, electronically updating user training documentation, or monitoring product quality checks for non-conforming products. Resulting process workflows will prevent potential issues that could severely impact product, site, and user safety.
Monitoring controls. Automatically establishing monitoring controls in a LIMS after inputting hazard points and preventive measures further simplifies monitoring tasks by scheduling measurements, setting alerts, applying control limits, and analyzing data in one integrated system for easy planning. All data generated from workflow monitoring can then be stored in the LIMS database for review.
Record maintenance. Food safety regulations require extensive recordkeeping, which can result in piles of separate data trails. Integrating a LIMS to maintain monitoring records organizes data into clear and comprehensive archives, simplifying recordkeeping and offering easy retrieval for review.
Corrective actions. Specifying corrective actions in advance through a LIMS results in more effective decision-making by providing clearly defined resolution protocols in the event of an incident and decreases error response time. Once an issue has been resolved, the LIMS enables quick assessment of the extent of an issue for informed process improvement.
Automate Compliance Management
Food production is truly a global business and one that is scaling rapidly. Regulators have therefore introduced more standards in order to encompass global progression, and control the broad expansion of the food and beverage industries. Even stricter regulations from the U.S. FDA and the European Union (EU) have been affected and updated to accommodate this growth by focusing on audits that assess industry practices instead of acting after an adverse event. An integrated informatics platform provides access to large amounts of information in a timely manner, allowing food producers to provide proof that activities were performed properly, records collected precisely, and enable access to accurate supporting information.
Automating compliance management helps to guarantee processes and controls meet the strictest requirements. Voluntary standards such as ISO 22000 and mandatory regulations, including the U.S. Food Safety Modernization Act and the EU Regulation No. 178/2002, enforce the quality and safety of food products and provide clear benchmarks for accountability. Building in regulation parameters to a LIMS provides a systematic approach to ensuring compliance with multiple regulatory requirements across all networked facilities and through every step of every process.
Relying on a LIMS for automated compliance promotes higher quality processing and manages workflows to provide accurate data to auditors and reduce contamination risk. Through the management of all aspects of production, LIMS gives users insight into data capture necessary for regulatory reporting and control. This benefits food producers by increasing efficiency, improving product safety, and reducing or minimizing the impact of recalls. As a result, optimal production practices protect the brand by assuring food is safe from contaminants or impurities, thus preventing any instance of recall or harm to the public which could erode trust in the brand from consumers.
Create a Central Repository
A centralized database offers flexibility for users to correlate data and combine results for an overall depiction of the food production process. Collecting data from every workflow and monitoring control into one location with a LIMS ensures robust traceability, confident contamination and recall management, and solid data assimilation to verify regulatory compliance.
An integrated informatics system stores all information in a single platform, automatically recording and retaining system maps within the data records to describe relationships between batches and the connection between instruments, methods, specifications, and results. Managing lab activities in this way delivers more consistent and reliable data since it is being collected in the same way for all users.
Implementing a LIMS to centralize and manage test data facilitates end-to-end traceability of samples, products, and associated laboratory procedures. This increased traceability of products throughout their lifecycle allows companies to analyze process efficiency and adjust production to create improved processes, ultimately producing better products and easing regulatory reviews.
Implementing an enterprise-wide LIMS system offers versatility and improved time management capabilities so that users can efficiently perform tasks in addition to analyzing how procedures can be updated and improved. Integrated informatics solutions give food companies the tools to asses and review manufacturing productivity across the supply chain, while detailing each step in a process to investigate the quality and safety of work being done. By learning from the data provided by the LIMS and adapting processes to improve productivity, use of integrated informatics can translate to enhanced business intelligence while providing more innovation, powerful automation, and in-depth integration to accelerate informed decision-making and provide the opportunity for transformation and growth of the enterprise.
van Cann is a product specialist for chromatography software at Thermo Fisher Scientific. Reach her at firstname.lastname@example.org.