Most manufacturing processes include a quality control check at the end of production before the products are shipped out the door. In some cases, it might be as simple as a visual inspection. But in the case of food and beverage or pharmaceuticals, it can be a rigorous check requiring lots of testing, instrument calibrations, and data management.

A quality control check may be as simple as entering some data into a form with a lot number to tying those records to a batch—replicating the common clipboard approach. A more complex quality control check may involve a system that automatically flags out of spec samples, generates multi-page reports including instrument calibration certificates with user information. There are also plenty of options between these two extremes.

Sample Management

The first problem most Lab Information Management (LIMS) systems solve is sample management. This involves receiving samples in the lab, registering them in the LIMS system, and then setting the samples up for further processing.

Typically samples will be tied to a particular manufacturing batch via a lot number. If applicable, sample data may contain additional information related to a customer order, the facility where it was produced, when it was made, and which tests need to be run.

Sample Management can also include generating barcodes or QR code labels to affix to sample containers or pallets. These labels are usually customizable to give the lab personnel the information they need for the sample, and allow for streamlined chain of custody tracking as the barcode can be scanned at each step along the journey through the lab (updating the current handler and location in the database).

For processes where automatic samples aren’t the norm, or where additional samples need to be collected, a LIMS system can also act as a scheduling system for taking the samples. The lab technicians can request samples through the LIMS system and alert operators on the plant floor assuming the LIMS and SCADA systems are integrated. This is a straightforward process if you are using something like Ignition for your LIMS and SCADA system.

QA/QC

Once the samples are collected and taken to the lab, the next piece of the LIMS puzzle is tracking quality data. Typically this will involve entering data from the various lab processes and equipment into the LIMS system to store a record of that particular batch—and to determine if the sample meets the desired specifications. If batches don’t meet the required specs, additional processes can be integrated with to generate alerts, schedule new samples, or flag the batch for quarantine (until further processing can be done to ensure compliance) or to scrap the batch entirely.

One powerful feature of a LIMS system is the ability to specify different specifications for different end users of your product. You can automatically pull in the correct specs based on customer requirements, flagging the sample if it is in or out of spec—before pulling in a different customer’s specs for the next batch—all while having every check performed automatically as the data is entered. This allows you to be granular in your data, and can provide a additional value for your customers who might have specific tolerances to meet with your products.

Instrument and Sensor Management

If your lab uses any automated equipment, and/or you would like to include instrument certifications in your reports, you can easily integrate your LIMS system with the lab equipment and certification systems to provide more detailed reporting capabilities.

For example if a strain gauge is used to measure a part, you can collect the entirety of the reading to display on a graph with the strain charted over the time of the test. Or, if you are testing chemicals and want to include the output of a mass spectrometer reading, you could configure the machine to save the reading on a computer integrated with your LIMS system and then pull the data into any report you need.

A LIMS system can also track when machines were calibrated, when they are scheduled for maintenance. It can also alert lab technicians if a machine has not been calibrated recently and will therefore not be valid for testing until it is calibrated. Similarly, all of this information can be pulled into reports.

Reporting

The main deliverable from a LIMS system are the reports on various tests performed on samples, as well as any supporting data from equipment, notes from lab technicians, or even the chain of custody log.

Everything that is entered into the LIMS system is available for reporting, and you can also integrate the LIMS system with your other backend business systems to add data to the LIMS reports, or provide the LIMS reports combined with other deliverables.

For example, you could integrate the LIMS system with a Shipping and Receiving system to send a report of the quality results on a handful of batches when the shipping labels are created. These can be printed out and included with the shipping documents, and sent to the customer along with their shipment tracking information. The customer will have a full picture of the goods they are receiving with all of the quality data to back it up.

Audit Logging

A LIMS system can also track who entered what data and when. If changes need to be made to results for any reason, you can keep records of the original entries, what changed, when it changed, and collect operator feedback about why adjustments needed to be made.

This helps you keep your people honest, run your business with integrity, and provide more transparency for your customers.

Wrapping Up

A LIMS system is a powerful tool for any manufacturing company. It gives you the ability to track quality over time, for every batch you produce. It can increase your customer service capabilities by integrating more detailed specifications into your process. It can also give your customers peace of mind with a transparent process using detailed reporting—with an audit log available when data has changed along the way.

LIMS systems can also be fully integrated with your other business systems, as well as your SCADA system to give your entire organization visibility into one of the most critical operations at your company: making sure what you are producing is ready for customer consumption.

Updated - 6/20/2022