It can be incredibly hard to find technicians with the appropriate lab skills and train them in your procedures, while keeping all other processes running smoothly. Amid the multi-tasking, it’s also important to ensure employee satisfaction and that your staff are developing and growing in their roles.
The list of responsibilities for a quality control microbiologist is long and varied. Some of their duties include being in charge of lab performance and maintenance, quality control, routine microbial testing of raw materials and finished products, preservative efficacy testing and reviewing and compiling all of the test results. When dealing with over-the-counter drug products, the microbiologist has to perform additional testing to meet regulation requirements.
They also must write standard operating procedures and protocols, maintain equipment, and order supplies and manage inventory. The quality control manager oversees planning, budgeting, and cross functional interaction with manufacturing leadership.
On top of all this, managers are responsible for hiring and developing lab staff. That process is time-consuming, and when the lab is short staffed this means more work for the current technicians. With the added pressure, employees can become dissatisfied and quit. It becomes a negative cycle of low morale and inadequate staffing.
For many laboratories, the loss of qualified employees is felt across the company and downstream operations may not realise the consequences, but they will feel it. Any time an employee leaves, the laboratory is impacted, and productivity may be reduced causing a bottleneck in the supply chain. There is a loss of knowledge and an added strain on the other employees to maintain production timelines. It is important to include steps to improve laboratory efficiency as a part of your retention strategy.
Rapid microbial methods may be the answer
Rapid microbial methods may be the best answer to your “Help Wanted” needs. Rapid microbial detection and identification technologies are one way that can improve your laboratory efficiency. Rapid methods replace traditional methods and significantly reduce time to results without reducing quality. They often make microbial testing laboratories more efficient, and can require less time, materials, and expertise to operate.
Rapid microbial detection methods can automatically produce fast and objective results, drastically reducing subjectivity and the risk of human error. This is where the benefit of a rapid microbial detection method is at its highest and most realised by the laboratory. For the small percentage of products that test positive for microorganisms, they can be triaged through the rapid detection initial screen and then selected to undergo further evaluation. By taking this route, exceptions are isolated and managed, allowing you to release the in-specification products days faster than before. A rapid, presence/absence primary screen will indicate which products can be immediately moved to distribution and others that need a deeper look. A more efficient lab allows you to put your trained microbiologists on projects that require their specific skills instead of wasting their time looking at plates all day.
Another example of a rapid method is a rapid microbial identification system called a MALDI-TOF (matrix assisted laser desorption/ionisation time of flight) instrument. Fast and accurate identification is essential when you find positive microbial detection results. Knowing what the microbe is can help you determine whether it is harmful or not and give you the ability to utilise an effective remediation strategy. An accurate and quick identification result helps you make decisions to reduce the potential negative effect on supply chain, while ensuring that you’re getting safe products to market.
A MALDI system works by directly analysing a microbial colony without any elaborate preparation. This method uses a microorganism’s proteins to determine the species identity. When a sample is analysed on a MALDI-TOF, the resulting data is a protein spectral image, similar to a fingerprint. When the “fingerprint” finds a match in the database, a species-level identification can be reported. This analytical instrument produces identification results that are very accurate and reproducible.
By implementing MALDI-TOF, the laboratory can save a significant amount of time and reduce workload. The MALDI-TOF instrument takes minimal preparation, less skill to operate, is easy to train on, and almost literally spits out an identification in minutes. In comparison, the traditional method of DNA sequencing needs highly experienced microbiologists to analyse and perform the tests, which are time consuming.
A MALDI-TOF identification system can easily be outsourced or insourced if you purchase your own instrument to get answers right away. So many labs rely on other systems such as gram staining and quick test strips because they seem easier to use, cheaper, but often take longer than expected to get results. These identification systems can frequently produce unreliable results and may require more preparation and retesting. All in all, MALDI-TOF is a great choice for efficiency and ease of use in your quality control microbiology lab.
Training needs of the microbiology lab
One of the most important responsibilities in the quality control laboratory is training technicians. Training ensures that everyone is performing each task the correct way, and this is what allows for consistency in results. Standard operating procedures should be strictly followed, and training reduces potential errors or misinterpretations. When training is rushed, mistakes are more likely to happen, and the necessary retesting will take even more time away from their current project responsibilities. Many tests have subjective data interpretation, and training is the only way to resolve potential discrepancies. A typical day in the life of a quality control microbiologist is full of reviewing plate after plate and “counting” microbial colonies. Often microbial presence can be an uncommon event and your microbiologists are essentially counting zero colonies. In a typical, controlled manufacturing facility, over 97% of products pass the final microbial limits test. Even though only a small percentage of tests have detectable microbial growth, all finished products and raw materials need to go through this very manual and time-consuming process. When you use a traditional method, nothing is fast tracked, and everything whether it’s a positive or a negative result, takes time.
By implementing a rapid detection and identification method you are able to develop training programs with a consistent workflow that will streamline your process and increase productivity, allowing your staff to focus on other important tasks. As recently as 2023, warning letters from the FDA have cited home and personal care companies for delinquency in adequate training for staff to perform their responsibilities required by the US Code of Federal Regulations, CFR 820.25(a). Manual and subjective processes like microbial detection plating can be difficult to train adequately and document. Automated processes like rapid microbial methods require significantly less training and prior microbiology experience in order to operate. Rapid methods already have documented processes and vendor-supplied protocols. Additionally, finding a vendor that can aid in the training process can prevent these training inconsistencies from happening in your workplace.
Benefits of rapid microbial methods
Companies push themselves to streamline and accelerate process flows while managing expenses, trying to save snippets of time and money wherever possible. But there is often one overlooked opportunity…investing in your microbiology lab. There are new technologies that can replace the traditional method that significantly reduce time to results without reducing quality. Using the traditional methods often leads to delays and can grind your manufacturing process or product release to a halt by holding up and delaying shipping. While there are efficiency gains which help lighten the load in the laboratory, there are also financial and sustainability benefits that help the entire company.
Rapid microbial detection and identification methods are not just a benefit for your microbiological lab, they can have a direct effect on your operational efficiencies. With new technology, product release approvals can be made with confidence, quicker and more effective contamination remediation, and timelines can be shortened, which impacts the company both operationally and financially. This is an opportunity to improve your company’s profitability by effectively streamlining the manufacturing process including your quality control lab. Rapid methods benefit your entire organisation, starting from the bottom up. Your quality control lab is able to deliver quick and accurate answers on whether your products are contaminated or not, enabling your company to make more confident decisions on safety before shipment deadlines. Products are no longer stuck in quarantine, waiting for a go/no go result.
Rapid microbial detection and identification methods offer a lot of benefits. They offer a more automated workflow, help streamline training, and the objective test results generate a clear answer. Laboratory technicians can spend their time on other tasks, trusting in the accuracy provided by the rapid methods. With a lighter workload and more confidence, technicians have greater job satisfaction. This increases employee retention and eliminates the need for more hiring. Overall, a win for both the employee and the business!
