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From: Food Quality & Safety magazine, April/May 2008

A Contract Lab Questionnaire

The right questions can ensure that a contract lab is a good fit

by Caroline Vogel

Finding the right outside contract laboratory is one of the most important decisions a food company must make. The laboratory you hire must be able to serve as a strategic partner to help your company navigate the many challenges of supply chain safety in today’s global economy.

As trade barriers came down during the 1990s, foreign investment in agriculture and food processing grew exponentially. This increased globalization within the food industry has forced companies to face a myriad of new issues and demands as part of their responsibility to provide safe products that are of high quality.

A good contract laboratory can help your company augment its staffing needs, and, more importantly, provide you with independent, unbiased technical expertise and a cost-and-time saving advantage both at home and abroad. Whether you are testing for product and ingredient safety and quality, substantiating claims, looking for assistance in defining nutritional attributes, developing testing methodology, or trying to meet product development needs, the right contract laboratory should become an extension of your company. It should share your objectives, understand and meet your requirements, and provide the confidence you need to substantiate the safety and quality of your product.

Selecting the correct partner laboratory will require extensive time and effort. The first steps you must take are to research prospective laboratories and clearly define your company’s requirements. A company that has a well-defined goal or need before starting the search can make a stronger decision and get better information and specifics from the contract lab it is interviewing. If you want to make an informed decision, there are several key questions to ask.

What are the advantages of using this contract laboratory? This is perhaps the best first question you can ask prospective laboratories. Many food companies are increasingly looking for contract laboratories that offer a wide range of services yet can be flexible enough to provide customized programs and protocols. Consultants and outside contract laboratories can offer many advantages such as extending your company’s own technical capabilities and reducing your operational costs by minimizing expensive investments in testing equipment, testing methods, validations, and standards.

Also, if results of in-house testing become routine and the resources to validate and update methods are not available, partnering with a third-party laboratory can remove this burden from the operation and provide stability and fast entry into the marketplace. Having inventory waiting for release is a costly holding pattern. Without current technical abilities and equipment, your product or ingredient might not make it to the marketplace.

An outside contract laboratory can allow your company to concentrate on its own areas of competence, while your contract lab provides concentrated technical assistance and quality assurance outside of your company’s direct capabilities.

Does the contract laboratory have a global testing program? With so many ingredients and products manufactured overseas, confidence in your supply chain is a critical business issue. If you are using apple puree from China in a food product in the United States, how can you know it is safe and complies with Food and Drug Administration (FDA) regulations?

Look for a contract laboratory that provides third-party manufacturing, auditing, and testing services overseas to help expedite, monitor, and ensure the safety of the ingredient or product you are importing. Also, with global target markets, regulatory issues, and product claims changing so quickly, make sure that your laboratory is a resource you can rely on for up-to-date industry regulations and global challenges.

Is the laboratory qualified to conduct the analysis or service that you require? Visit the laboratory, meet the key personnel, and check the facility for regulatory compliance. Knowledge of, and compliance with, good manufacturing practices (GMPs) and good laboratory standards, as well as FDA and International Organization for Standardization certifications and audits, are necessary. Check for accreditation from such organizations as the International Association of Analytical Communities, the American Society for Testing and Materials, and others.

Before hiring a lab, conduct an audit and ask for previous FDA audit reports. Manufacturers and retailers often want their outside contract labs to perform facility audits; you want a laboratory that is experienced in this area. An external audit is more comprehensive than a self inspection and should be done at least once a year.

Audits are needed to verify that the manufacturer is GMP and FDA compliant and that hazard analysis and critical control point (HACCP) measures are in place. Look for auditors certified in HACCP and regulatory affairs, and ask for both their experience and a copy of one of their typical audit reports.

Are laboratory personnel proficient in the testing or consulting that you require? Technical consultants with testing knowledge and experience from a broad range of clients can provide your company with information about technical and regulatory issues for all your product needs. Ask about the kinds of past projects they have done and about the experience of their personnel. Make sure you see training charts and curriculum vitae of involved personnel. If possible, interview the manager of the laboratory about the experience he or she has in the areas you need assistance with.

Does the laboratory have the quality services, facility, equipment, and methodology to meet your requirements? A good laboratory should be able to meet all your quality assurance needs, including raw material testing, in-process quality control, and finished product release. When evaluating a lab for quality assurance/quality control (QA/QC) services, look for a separate QA/QC department that monitors scientists’ training records and develops and maintains standard operating procedures (SOPs), as well as records of calibrations of instrumentation. Analytical methods should be well documented and validated. Ask to review the SOPs to make sure the lab is using the methods of your choice.

Make sure the laboratory has a regulatory group as part of its QA/QC department. Whether you are importing food ingredients or making a label claim, you need a partner that understands regulatory compliance. This is an integral component of your success in the marketplace.

Are there adequate procedures in place for the receipt, handling, and retention of your samples? Are there detailed records for product handling, from receipt to data submission to the client? These are necessary for traceability; you want everything relating to your sample to be traced back through receipt by the lab.

Are there adequate means to address your needs regarding communication and turn-around time? Communication is paramount in maintaining a good relationship with your contract laboratory. Information between partners should flow in an easy and understandable format. A written contract establishes and defines the expectations of your partnership and should resolve any questions of ownership of methods, procedures, and intellectual property.

It is also important to state clearly who will accept responsibility for damages and losses resulting from misconduct or negligence. Be sure to include details such as report formats, expected timelines, budgets, and the process outline of how information will be exchanged. Have the contract laboratory assign a representative or point person who will be available for technical consultation for your company on a day-to-day basis.

Are comprehensive reports provided that document sample identification, data, methods, and interpretation of results? Report formats with clearly identified sample documentation and data should be outlined in your contract or proposal before testing commences. Your representative should be able to give you a clear and concise explanation of the work performed and the results at hand if there is any ambiguity in the format or results. Open dialog with your consultant should always result in answers to all of your questions.

What are the laboratory’s lead-time requirements? If you need to have data in a 48-hour turnaround period and the results come back in five days, thousands of dollars of inventory could be involved, possibly sitting past its expiration date. Make sure that your laboratory has agreed to, and can meet, your company’s time constraints.

Negotiate the time requirements with the contract lab from the start. The laboratory should be responsive to the timelines agreed upon. If your company requires a two-day turnaround time, then ask for it, but understand that the cost may be higher for an expedited testing schedule. A typical turnaround time from submission of product or ingredient to written report will be about two weeks. A lab should be judged on its ability to meet timelines.

Vogel is manager of product development at Shuster Laboratories, an independent provider of quality assurance testing, product development, and supply chain support services. Reach her at caroline.vogel@shusterlabs.com or (781) 821-2200.

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