How to Manage Cleanroom Data for FSMA Compliance Part 2

Food production cleanrooms have to comply with the Food Safety Modernization Act. This entails establishing HACCP-based written Preventive Control Plans. Without a paperless system, this is a truly labor-intensive project.


Having a laboratory information management system (LIMS) can be a huge help in managing your cleanroom data and complying with HACCP. Hazard Analysis and Critical Control Points uses seven principles to outline its risk mitigation and hazard prevention process. Last week we covered the first three principles and how a LIMS can assist with each. Today we will focus on the remaining four:


  1. Monitoring procedures. The third principle was establishing critical limits; once these are set, you need to establish monitoring processes for each. Your LIMS can fully automate data collection and transmission throughout your organization. You can generate reports based on historical data and the LIMS will alert staff when critical limits are exceeded.


  1. Corrective actions. In the case a critical limit is exceeded, you have to have a clearly defined process of correcting the issue. Your LIMS can provide your standard operating procedures and walk staff members through the designated response to each error. Colin Thurston’s “Managing Data in Food Safety Cleanroom” article in cemag,us explains:


“Assume, for example, that a piece of monitoring equipment connected to the LIMS detected that the condition of a cleanroom 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.”


  1. Verification procedures. Cleanroom monitoring instruments can fall out of calibration. Using this equipment will give you an inaccurate reading on product quality. Therefore, you need to regularly verify instrument performance. Your LIMS can store instrument maintenance schedules and alert managers when it’s time for maintenance.


  1. Recordkeeping procedures. With a LIMS, recordkeeping is simple and efficient. All data going in and out of the system is automatically recorded. Internal and external audits are therefore accurate and reliable. With digital recordkeeping, you can also easily trace the origin of error. This saves a lot of time, energy, and money when resolving an issue.


Overall, LIMS helps food manufacturers in a number of significant ways. It helps store and retrieve vital information for HACCP compliance, adds security to your system, and can reduce the scope and cost of a recall operation. It provides the simplest way to establish your Preventive Control Plan. For questions about cleanrooms, validation, or certification, contact Gerbig Engineering Company at 888-628-0056 or

The health and safety of our employees, customers and communities is our top priority.Read about our response to COVID-19.