A Contract Lab Questionnaire

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.