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Handy Contract Labs: Not Just For Testing Anymore
by Virginia Deibel, PhD, and Joseph D. Meyer
The story about contract lab services used to read: “Once upon a time, contract laboratories were places where tests were run and results were generated. The end.”
Today, the story is quite different. While a food manufacturer’s goal is to provide quality products that meet the needs and expectations of consumers, the stakes are at an all-time high to ensure quality and safety. To aid in this goal, contract labs can play an integral part.
The specific roles for laboratories have changed and contract labs are now considered as collaborators in the manufacturer’s food safety system. Contract labs play a multitude of roles in the collaboration of quality and safe food production by serving as a multi-faceted verification tools and technical resources.
The scope of how integrated the lab becomes in the manufacturing process will vary from manufacturer to manufacturer, but the following are some areas to explore as tangible benefits that can be provided.
Multi-Faceted Verification Tool
Quality and safety testing is a primary function when considering contract lab services that assist in food manufacture. Ongoing testing of finished products, equipment, plant infrastructure, and raw materials all embody a robust monitoring process to verify that a Hazard Analysis and Critical Control Points (HACCP) plan, Good Manufacturing Practices (GMPs), and prerequisite programs are functioning as designed. Tasks can include:
- Testing incoming materials against a purchase specification,
- Periodic testing of materials against baseline or historical values,
- In-process tests to ensure the process is operating within specification,
- Finished product tests against internal or external product specifications,
- Environmental testing to verify sanitation, traffic control, and GMPs are working as intended,
- Supplier/co-manufacturer qualification testing,
- New product verification,
- Process start-up,
- Change-over practices, and
- New equipment validation.
For many manufacturers, it is not practical or feasible to do all verification testing in-house. A contract lab can provide the manufacturer increased testing capability and capacity to verify that the quality and safety programs are on track. Additionally, the contract lab has the capacity to handle the larger than normal testing volumes required by these activities. Also of importance, a contract lab provides the additional benefit of providing test results viewed as being “unbiased.”
A contract lab can help ensure food quality and safety by providing additional technical resources to food manufacturers. These resources may come in the form of additional methods, specialized equipment, or technical knowledge. Many manufacturers either do not have an internal lab or their internal labs have limitations on their testing capabilities. For example, only one method is available to test for a specific organism or no methods are available to test for a complex group of organisms that affect quality, as may be the case with lactic acid bacteria.
Utilizing the best tools helps drive ongoing quality and safety improvements. A contract lab can provide access to methods unavailable in an internal lab due to equipment costs, lack of scientific expertise, time constraints, or high reagent costs because of decreased volume purchasing power. Access to specialized equipment increases access to additional method options. As test methods become more specialized and sensitive, entering into new test methodology can become cost prohibitive, and upkeep costs further add to the barrier to new technology. However, the advantages are that new methods may provide increased sensitivity or specificity, which may be critical in lot disposition determinations.
Contract labs may also conduct testing that provides further information such as when routine tests results are inconclusive, presumptive, out of spec, or point to other potential concerns. This additional level of information can provide insight and direction into the root cause investigation of potential issues. Similarly, these methods may aid in verifying the effectiveness of corrective/preventative actions, when taken. Consider a Salmonella assay: To aid with trending or investigations, serological information is an important tool that enables a producer to know if a harborage site is present, if contamination was removed during sanitation, or if cross-contamination is occurring from one area of the plant to another.
Having a choice of methods also allows for an opportunity to readily compare methods, identify, and then choose the one that best suits the product, process, time restraints, information, and cost needs.
The area perhaps the least explored, but potentially the most valuable, is the technical knowledge that is available to the food manufacturer through the contract lab staff. Contract labs have the educational background and experience within their personnel who can assist in understanding method limitations, identifying the best method for a specific product matrix, or identifying the best method based on testing objectives. They are also a source of information on newly available methods.
The technical knowledge available in the contract lab often goes beyond methodology and may include areas such as product specific knowledge (i.e. quality defects, causes, troubleshooting, and solutions), process experience, and food safety and quality programs. Contract labs may also have access to additional knowledge networks through their external relationships. Their staff are typically exposed to a wide range of products and matrices which adds to their ability to solve analytical challenges.
A Partner in the Quality and Food Safety Management System
As a manufacturer’s relationship with a contract lab matures, it can go beyond transactional and become more consultative. The contract lab can play a more active role in the manufacturer’s food safety system and become an extension of the management system. In this regard, the contract lab is a collaborator. Potential types of management systems include the following.
Test result management. One example of test result management is the contract lab’s direct management of test results and historical data. Online visibility, data trending, and tracking are examples of data management. This could include data compiled from multiple manufacturing locations or from multiple suppliers. The typical contract lab has an advanced data management system that can provide direct communication of results and also communication of results requiring action. For those results requiring further action, the lab may be able to provide resources to assist with those actions.
Supplier management. Contract lab integration may work directly with the food manufacturer’s raw material suppliers to schedule testing and provide direct communication of results prior to release of materials for shipping. As stated above, when combined with the finished product testing, the compiled data can be used to quickly flag potential issues.
Product and process development. Contract labs can support product and process development by providing consulting or onsite resources to design a test regime, collect and test samples, perform a data review, and assist with further actions based on the results.
The contract labs of today offer a wide variety of collaborative options to help ensure the safety and quality of the foods manufacturers produce. They should be viewed as an extension of the manufacturer’s own capabilities. Developing a good working relationship with shared expectations is the key. Knowing all of the capabilities that the contract lab has to offer will help maximize the benefit that a contract lab can bring to a quality and safety management system. The benefit should go well beyond “a place where tests were run and results were generated.”
Dr. Deibel is the director of microbiology, nutritional chemistry and food safety, for Covance Inc. She can be reached at firstname.lastname@example.org. Meyer is the director, microbiology, at Covance. He can be reached at email@example.com.