Risk Factors to Consider in Product Quality Assurance

Choosing an analytical testing laboratory or the type of test methods to confirm or identify the condition of a food or beverage product is not an easy task. But with the recent revision of ISO/IEC 17025:2017 and its emphasis on the testing laboratory’s need to consider, define, and implement risk-based thinking, it seems it is also a good time to think about risk factors in other considerations.

For example, the choice of appropriate testing activities, specific methods, and attributes of the testing laboratory should be based on risk management and mitigation principles. Decisions need to be based on the types of testing that are appropriate or necessary; whether to perform the testing oneself or to outsource; and how to ensure one’s confidence in the competence of those performing the activity; and, ultimately, in being able to rely on the results being credible and accurate.

Notwithstanding the legal ramifications of selling an “inherently dangerous product,” a foremost aim of all food and beverage processing plants is ensuring that the products they have produced are safe; not hazardous to the intended consumers — human or animal. Plant management ensures this by assuring that the raw materials coming into or produced in the plant are not contaminated or otherwise adulterated, and that its manufacturing processes do not inadvertently render a product unsafe.

Human nature being what it is, the degree of one’s willingness to accept the risk of an adverse outcome (e.g., for a food plant’s inaccurate test results) is inversely proportional to the degree of rigor expended in managing the risk. It is generally directly proportional to the potential adverse consequences (health and/or economic) of failing to manage the risk appropriately. All other things being equal, judgment in choosing between in-house product-safety testing and outsourcing this activity should be based on the complexity of the task, the confidence in the competence of those doing the analysis, the relative risk of contamination or adulteration of the food product itself and, as mentioned, the willingness to accept the risk of an inaccurate test result.

IN-HOUSE OR OUTSOURCED TESTING. Some major determinants in choosing to do some or all of the testing in-house or outsource this activity lie in the careful evaluation of your organization’s needs and goals. In-house testing requires accounting for both the direct and indirect (overhead) costs of maintaining a laboratory operation (e.g., the human and capital resources), but it also needs to account for the liability of having an inaccurate test outcome. Depending on the product being manufactured, decisions need to be made based on the required complexity of the methods, the availability of staff with appropriate skills, and the anticipated volume of testing.

In addition, decisions on the types of testing and whether or not to perform it internally are also related to the relative risk category of the food product being manufactured. Products with a higher propensity toward microbial contamination or greater possibility of chemical adulteration will have to have more safety and quality testing than those that are lower on that scale or pose less risk of bringing a potential contaminate onto the processing floor. Many manufacturers address the latter by outsourcing any product with an adverse initial finding (e.g., presumptive positive test result) to an independent, third-party laboratory, and address the former by maintaining a small screening testing capability. This risk-based approach demonstrates due diligence as well as keeping the costs as low as feasible.

CHOOSING A THIRD-PARTY LAB. If based on the risks mentioned, the manufacturing plant decides to outsource some or all of its product testing, how does it decide which independent, third-party testing laboratory to choose to perform this work?

Consider the following risk factors:

1. The cost of a test. Cost is certainly a factor in the decision-making process; however, it should never override the other factors.
2. Location and distance from the manufacturing facility. Location and logistics play a large role in deciding on a testing laboratory. While perhaps still appropriate for confirmatory testing, if the testing facility is not sufficiently close, or if it does not have courier service capability or other means of rapid transport, then these factors are likely to render this choice of laboratory inappropriate for routine testing, regardless of the other factors involved.
3. Analytical turnaround time. The rapidity of test results is another significant risk factor in the decision tree, especially in the food industry where many products are highly perishable. It does the food producer no good if the time it takes to obtain the results is not consistent with the allowable product hold time. Thus, this should be a major factor in deciding on a laboratory.
4. The quality and reliability of test results. This risk goes without saying but is probably the hardest to judge because it is the least empirical, and the proper choice is dependent on going through an appropriate risk mitigation strategy. However, there are a number of approaches that can be taken, each of which has its own risks and opportunities:
• Have a prospective laboratory complete a questionnaire (self-audit). This would be useful in obtaining categorical data, such as turnaround time, frequency of repeated or redone work, and success rate in proficiency testing (PT) activities, but it would not give a good sense of qualitative factors, such as competence of the staff or how errors are mitigated. If the questions are not worded properly, it also could be prone to the garbage-in/garbage-out syndrome. However, this could be appropriate for a product considered low-risk.
• Conduct a quality (supplier) audit. This would cover areas deemed important by the producer, and typically would involve the plant staff evaluating the laboratory’s method performance, results verification, records management, and corrective action processes. The producer usually prioritizes these visits based on risk evaluation of the importance and criticality of the supplier and/or product, with those of lower critical risk often assessed, instead, through a self-audit or high-level review. The downside is that this activity requires a significant expenditure of dedicated resources and some degree of specialized training.
• Rely on testing results evidenced through proficiency testing or blind samples. This provides the manufacturing plant with risk mitigation through real-life information on the laboratory’s ability to obtain generally acceptable results. The downside of this is that the available proficiency testing programs may not offer fully relevant matrices or analytes that are reflective of the producer’s product. In addition, an associated risk is that the time and effort to set up blind check samples may be costly and time consuming, and the results may not have sufficient statistical validity.
• Rely on laboratory recognition by conformity assessment bodies. Focusing on recognition of a quality control testing laboratory as assessed against internationally recognized quality system standards by an accreditation or certification body combines the components of all the aforementioned activities into one process. Unlike an accreditation body, a registrar cannot confirm the technical competence of a laboratory, but both systems use a risk mitigation approach to look at the laboratory’s integrated structure of responsibilities, activities, resources, and events so as to ensure the laboratory is capable of meeting the international quality requirements.

With so many options and variables, it is not easy for a food and beverage processing plant to decide the best manner of obtaining quality and safety testing data on its products. There are many risk factors to consider, each of which may fit the manufacturer’s needs to a different degree and may change as circumstances dictate.

Because the testing choice has considerable impact on the safety of the food product and its fitness for human and/or animal consumption, it is critical that all things are considered. The final decisions made on the choice of a particular risk mitigation strategy can have significant ramifications.