How to choose between an in-house or contract laboratory

To say that the pressure is on the food industry to be beyond reproach is an understatement. Consumer dissatisfaction can be shared online almost immediately and have a devastating effect on any company that finds itself in the line of fire.

Since the United States’ Federal Food Drug and Cosmetic Act (FD&C Act) of 1938, the US Government has tried to create a system of rules and regulations to ensure the safety of food. By 2011, the FD&C had become outdated and a new Act was required. Enter the Food Safety Modernization Act (FSMA), signed into law in 2011 by then-President Barack Obama. It granted the US Food & Drug Administration (FDA) new authorities in a more ‘farm-to-fork’ approach.

An important part of food safety and quality is testing, but what is the best approach for this important activity? Some believe an in-house laboratory, others consider subcontract to contract providers the best way forwards, and a few use a combination. Whatever approach, it is critical that certain factors are considered.

Common concerns

Whether an in-house laboratory or a contract laboratory, the most basic concern to address is accreditation.

The International Standards Organization (ISO) provides a standard list of requirements for testing laboratories, ISO 17025:2017. This standard approach, adopted globally by testing laboratories, provides a common approach and a minimum set of accepted requirements for systems and practices to allow an ‘apples-to-apples’ comparison between laboratories anywhere in the world.

ISO standards are developed and approved by a global group, the most recent laboratory standard being ISO 17025 in 2017. Many Government, contract and in-house laboratories hold accreditation for their testing laboratories.

While much of FSMA has been implemented, certain parts have not, including the laboratory requirement for the FDA to “establish a publicly available registry of accreditation bodies recognised” (FSMA, sec. 202). This is important as it will establish the requirements demanded of laboratories to conduct recognised testing.

The ISO 17025 standard is the same, no matter the type of testing carried out. While food testing is commonly viewed as either microbiology, chemistry, or physical, the ISO 17025 standard also applies to laboratories in other sectors. Several organisations have developed additional programmes with requirements added to the ISO 17025 standard to make them more specific to food, for example, AOAC International’s Guidelines for Laboratories Performing Microbiological and Chemical Analyses of Food, Dietary Supplements, and Pharmaceuticals.

The ISO standard provides the structure for accreditation, while the additional programme requirements provide the specific details for the food testing industry. It is widely assumed that the FDA will require ISO 17025 accreditation. Whether or not they will necessitate additional programme requirements, like the AOACs, is still to be determined.

The ISO standard requires a laboratory to maintain systems for corrective actions, internal auditing, traceability of measurements, equipment maintenance and calibration, employee training and method validation, to name just a few. These are needed regardless of laboratory ownership – in-house or contracted.

In-house laboratories

There are many challenges for in-house laboratories, some, especially those in smaller companies, tend to be staffed with employees who often have split duties and may or may not have laboratory experience. This restriction can mean that they also have abbreviated scopes of testing.

For some companies, it can make sense that simple tests for critical control points – such as water activity or pH testing – are conducted in-house. However, if microbiological pathogens are required, the issue becomes more complex, and more importantly, might lead to cross-contamination in a plant if not properly segregated and managed. Additionally, the risk to employee safety must be considered, especially if they are not experienced at handling such organisms.

Data integrity plays a key role. Some organisations prefer data from a third-party rather than data generated internally, believing that the third-party has no vested interest. It is therefore important to determine if in-house data will be accepted. Generally, there is a greater likelihood of acceptance for in-process testing, rather than acceptance testing when product is sold from one company to another.

Costs are another concern for in-house laboratories. Depending on the expertise required, staffing costs may be significant, especially when the need for some degree of redundancy to allow for vacations and sick leave is taken into account. Equipment also is costly; once purchased, the maintenance and calibration of equipment adds regular, ongoing expense to a laboratory.
Finally, to prepare for new demands, food manufacturers need to learn and understand new requirements as they are developed, including methodology and accreditation needs. Without appropriate expertise, this may be problematic for companies.

Contract laboratories

Working across multiple clients and possibly sectors, contract laboratories will often have a broader scope of work than an in‑house laboratory. As a result, although their systems may be more complex, they often have more expertise in these tasks.

As testing needs become more complicated, systems get more complicated too, requiring more equipment, training and expertise. While this know-how helps, laboratories will still need certain information to better fulfill requests. Method selection is sometimes based upon certain characteristics of the matrix tested. For example, raw food versus fully-cooked can require different steps to be followed in the method. Communication between a laboratory and its customer is critical to a successful relationship. If you are having trouble with the service and communication, it should be a red flag.

Accreditation should not be the sole qualifier for a contract laboratory, the accreditation should be meaningful for the testing you need. If you require testing for mold, an accreditation for protein is not meaningful. Any laboratory should be willing to share its scope of accreditation with customers and answer questions about it if necessary. As part of their accreditation, laboratories must address any conflicts of interest and/or confidentiality.

When selecting a contract laboratory, here are just some questions to ask:

• Is the laboratory capable of handling the volume of work I require on a routine basis and at peak times?
• How is the laboratory’s communication through the bidding process? Are they responsive to questions and concerns
• Is the laboratory understanding of your unique requirements? For example, if you require special reports, special pick up times, or rush sample, are they able to handle them?
• Can the laboratory perform the testing I require, or will they need to subcontract to another lab?
• Is the testing I require included on their scope of accreditation?
• As legislation is different in countries of manufacture and countries of export and consumption, does the laboratory have the connections to ensure that the tests used are acceptable in receiving countries so that my products can be legally sold?
• Will I have access to answers to technical questions, help to explain what the results mean, and implications and suggestions to potential actions?
• Can they help me prove that any HACCP plans are appropriate and functional?
• Do they offer support to protect me against fraud and therefore support maintenance of my brand image?

The decision to outsource testing, or keep it in-house, can be a difficult one. Some will look at the costs associated with sending samples out and the initial reaction may be that starting an in-house laboratory may be beneficial. However, with the hidden costs associated with staffing, equipment, and accreditation for an in-house laboratory, the hoped-for savings rarely materialise. Add to that the wider acceptance of third-party data over self-generated data and the decision becomes clearer.