Testing the In-House Testing Lab

By Lisa Lupo

The results of the food safety and quality tests that are run in your in-house laboratory will have a significant impact on decisions that are made across your operation, either assuring safety and quality are up to spec or inciting recalls or formulation changes. In either case, it is critical that current, relevant methods and technologies are regularly used to assure the accuracy of the results while also maintaining an efficient, cost-effective rate of testing.

“The best way to assure efficiencies and effectiveness is to design, implement, and train all personnel to Standard Operating Procedures (SOPs),” said Elba Laboratories Micro Bio Microbiology Lab Manager Jennifer Rowe. “Following SOPs will allow for consistent Good Lab Practices and therefore create effective and efficient work flow.”

Additionally, she said, “Performing an internal audit will bring to light any quality and reliability issues as well as inefficiencies. Another way to quickly address these issues is to meet with the lab team each day or at least one time per week.” Continual review of SOPs and personnel training, as well as improvements to the lab processes, also will address inefficiencies, lab proficiencies, and the efficacy of both, she said.

To stay updated on new methods and technologies, a lab can be a part of forums, groups, and publications that assist with keeping lab personnel “in the know” about the food industry. There are also seminars, webinars, expos, and classes for which companies can register to keep the lab operations and personnel up to date in the new methodologies and technologies.

Beyond the basics, said 3M Global Food Safety Specialist Rolando Gonzalez, in-house laboratories should develop a combination of internal and external proficiency testing programs. Through the internal programs, the lab can conduct proficiency testing on a more frequent basis, while the external program can enable an additional level of confirmation and assurance.

It also can be advantageous to have a different lab person conduct the proficiency testing than the one who regularly works with the floor samples. To take it to an even higher level, Gonzalez said, “When you are really comfortable with your program, use blind samples.” Mix these up with internal samples and see what comes out.

While testing is critical for maintaining the quality and safety of your food products, over-testing can be inefficient and costly. And while FDA does require environmental sampling, particularly in ready-to-eat production facilities, the agency does not say how many samples a facility needs to take.

UNDER/OVER SAMPLING. So how do you know how much to test? “One way to determine this is to use science-based references from organizations such as ICMS,” Gonzalez said. The Institute for Complex Molecular Systems Laboratory (ICMS) is a research lab that facilitates the development and characterization of innovative materials from a molecular perspective. Such science- and risk-based references can help an in-house lab establish a baseline for number and frequency of sampling for a particular pathogen, allergen, etc.

When consulting such references, however, he added, you have to realize that they are only providing directional advice. They can’t account for specific variations in your facility (e.g., number of lines, speed of lines, etc.).

The very bottom line of testing is ensuring you are in compliance with all regulation. Going a step above the regulation means determining: “What is the minimum that I am comfortable with? What allows me to sleep at night for my product and my environment?” Then going a step above that is: “Where does my company want to be — at the bottom line or leading the game?” Gonzalez said. “Labs don’t have unlimited resources, but I have seen that companies are going beyond the regulatory requirements to mitigate risk to their brand,” he said.

To determine how to ensure you are testing enough while still staying within your budget, Gonzalez said to consider risk. For example, if you see Zone 2 as your highest risk, test more samples (internally and/or externally) from this zone. You may be able to reduce or eliminate outsourcing of tests for Zone 4 if this is not seen as a risk area, enabling you to increase testing in Zones 2 and 3.

Taking a risk-based approach also means learning from history. A common argument, Gonzalez said, is that “we’ve been testing that way for 30 years.” But if you take a look at industry incidents — such as Jensen Brothers or PCA (which simply resent samples to different labs when it got positive results), you will realize that doing things the way they’ve always been done doesn’t always work in today’s world. Instead, take a tip from “those who’ve done good — the GMs and Cargills of the world,” he said.

A key is to remain flexible, stay updated on, and be open to changes in science and technology. Implementing approaches, such as whole genome sequencing, can bring new information, such as determining if you have a resident strain of a pathogen or it is simply a transient strain.

LAB CULTURE. Integrating a food safety culture into your lab also will lead to continuous improvement. To apply this in the lab, the best foot forward is to define what “food safety culture” is and how it relates to the lab, Rowe said. One way to do this is to establish a core value system within the company in which everyone values food safety over profit, including the CEO, and understands that testing takes time and patience.

“There are several measures to be taken that can define ‘food safety culture’ within the lab setting,” she said. “It is similar to the culture set forth in the food manufacturing facility itself. Start by outlining expectations which each individual should meet (cleanliness, training, etc.). Offer continual education courses (food safety courses) for each level of the company including the CEO.” Then, Rowe said, “once this is established, measure how these are making positive impacts."

“It’s a journey; it’s an evolution; it doesn’t happen overnight,” Gonzalez said. Integrating food safety culture is a matter of moving away from lack of awareness and reacting to a positive sample to developing a risk-informed internalized management that exceeds regulatory compliance, which includes training and robust documentation. It is a culture in which, he said, “food safety data collected by the lab is used proactively, strategically, and for long-term decision making.”

“Labs should do much more than test and collect data; they should act as consultants,” he said. Lab personnel can explain the implications of the results and what is needed for proper corrective action and future improvement. For example, he said, they can ensure that the decision makers understand the difference between indicator organisms and pathogens; the benefits and limitations of ATP testing compared to, or in addition to, microbiological tests; and what variation is okay or not okay, e.g., indicating the presence of biofilm.

If lab data is tracked and reviewed for trends, it will provide the facility with data-driven decision making in food safety and quality and enable proactive improvements.

“The bottom line of a company can be directly impacted by lab results,” Gonzalez said. But by utilizing testing results for continuous improvement, the lab can become a proactive part of the company and help protect the brand.

The author is Editor of QA and can be reached at llupo@gie.net.