In-House or Contract Laboratory Testing – What’s Best for Your Food Business?

Reliable data is not just about protecting reputations, it is integral to many regulatory food standards. For example, in 2011, the USA introduced the Food Safety Modernization Act (FSMA) that granted the Food & Drug Administration (FDA) new authority to demand a ‘farm-to-fork’ approach to food safety. As products and ingredients pass along a supply chain, each operative must be able to trust the data they are being given to ensure regulatory compliance in the target market.

Testing for safety and quality are central to the creation of reliable data but which system generates the best results for your business – in-house laboratory, contract laboratory, or a combination of the two? Data you cannot trust holds no value when making business decisions and could leave you exposed to additional risks.

Common Concerns

Quality must be the first consideration when deciding which laboratory strategy will best suit your business. Accreditation is a measure of a laboratory’s quality.

Currently, one aspect of the FSMA that has not been implemented is the laboratory requirement that allows the FDA to “establish a publicly available registry of accreditation bodies recognized.” A draft document has recently been released, which gives stakeholders some idea of the requirements the FDA will demand of laboratories conducting recognized testing. It is widely assumed accreditation will be central to this plan.

The most commonly used global standard is ISO/IEC 17025:2017 - General requirements for the competence of testing and calibration laboratories. This drives commonality in the standards achieved by laboratories, meaning, wherever you are in the world, you can trust the same systems and practices will be in place to allow ‘apple-to-apples’ comparisons. This accreditation is held by many testing laboratories, including contract, in-house and governmental.

Laboratories with ISO/IEC 17025 accreditation must maintain systems for, among others, corrective actions, internal auditing, traceability of measurements, equipment maintenance and calibration, employee training, and method validation. The laboratory must also evaluate risks and implement corrective actions – including the risk to data integrity. These requirements apply regardless of who owns the laboratory.

ISO/IEC 17025 covers all common types of food testing – microbiology, chemistry, or physical – as well as other laboratory sectors. To make it more specifically food-based, some organizations have developed programs that use the ISO/IEC 17025 structure but add food-specific requirements. For example, AOAC International’s “Guidelines for Laboratories Performing Microbiological and Chemical Analyses of Food, Dietary Supplements, and Pharmaceuticals.” The recent draft released by the FDA will require ISO/IEC 17025 accreditation, but it does not require these additional programs. Since the draft is in the public comment stage, it is not known what the final version will require.

In-House Laboratories

A principle concern with in-house laboratories, especially in smaller companies, is the fact employees may have split duties and may not be fully trained. In-house laboratories therefore often have an abbreviated testing scope.

In some instances, in-house testing can make sense. For example, when performing simple tests, such as Refractive Index or pH testing, at critical control points when immediate decisions need to be made. It might also be the case that passing on to a contract laboratory the necessary deep knowledge required to perform adequate testing can be difficult and time-consuming.

Speed is often the deciding factor for positive release systems but when testing microbiological pathogens, the issue becomes more complex. Cross-contamination and employee safety all need to be considered if technicians are not sufficiently experienced in handling specimens and segregating samples.

Objectivity also needs to be considered. Many buyers prefer independent, third-party data that removes vested interest. In general, in-house testing results are more likely to be accepted for in-process testing and less likely for finished product testing. This is because the product is to be sent externally after the test, to a customer.

Costs can also be significant for in-house laboratories as they can require experienced personnel to staff the laboratory 365 days a year. The equipment used by these laboratories is also expensive to purchase, maintain and calibrate. In addition, the laboratory will need to develop as requirements expand, meaning new methodologies need to be learnt and new accreditations procured. This can be prohibitively expensive for an individual company.

Contract Laboratories

By contrast, because contract laboratories work with multiple clients and across sectors, the cost in terms of training, development and procurement can be spread across customers. The purchasing of specialized equipment makes sense because it allows multiple batch sampling.

Contract laboratories often have access to personnel that can cover a wider range of tests and/or matrices. This will be important as testing needs become more complex and systems more complicated, requiring more equipment, training, and expertise.

Expertise matters. The ability to communicate with the client effectively and with a common understanding speeds up testing. Having a good working relationship between laboratory and client will mean tests are performed correctly the first time. Good communication is vital for a successful relationship.

The final thing to consider when looking at contract laboratories is whether the accreditation is correct for your needs. For example, an accreditation for protein testing is no use if you need testing for mold. All reputable laboratories will share their accreditations with you while addressing any conflicts of interest and/or confidentiality.

Data

When choosing the right laboratory strategy for your business it is important to consider the role data has for your business. Email to deliver test results and information stored on the internet and in ‘the cloud’ provide convenience but they can also represent risk. Email is a significant source of malware, the internet holds false information, and criminals can hold businesses to ransom by withholding data. This matters when laboratory equipment manufacturers, for example, hold test signal database comparisons, calculations, and interpretation algorithms, as well as addition data management information, ‘in the cloud.’

The test results that prove food safety and quality must be held securely to protect your business. In terms of the food industry, the numerous interconnected computer systems that make up many businesses can provide multiple access points for criminals and their ransomware. If the laboratory’s Laboratory Information Management System (LIMS) is then affected, this will cause delays and be extremely costly to rectify. The primary defense is a diligent in-house IT department that monitors and protects the systems, but this can be prohibitively expensive for many businesses to maintain alongside the laboratory.

Questions to Ask

When selecting a contract laboratory consider:

• Can the laboratory handle your volume of work routinely and at peak times?
• Has communication been good during bidding process? Are they responsive to questions and concerns? This may indicate future levels of communication
• Does the laboratory understand your unique requirements? e.g. special reports, handling requirements, specific pick up times, etc.
• Can the laboratory perform all required tests, or do they need to subcontract?
• Does the scope of accreditation cover your testing requirements?
• Will your data be safe? Is there a robust IT policy in place to protect your test result data, brand and confidential product information?
• Can results be provided on-time and safely?
• Will the test results be applicable to your target market?
• Can the contract laboratory answer technical questions, explain results, and suggest possible actions?
• Can they help you prove HACCP plans are appropriate and functional?
• Do they offer support to protect you against fraud and therefore support maintenance of your brand image?

Deciding whether to use a contract laboratory or in-house facility can be hard. While cost can be important, with the cost of sending samples to a third-party being a major consideration, setting up an adequate in-house laboratory is expensive and can leave your business open to addition risks. In addition, independent test results will often have better acceptance in the marketplace, enabling you to grow your market share.