Beyond Samples, COAs: Establishing a True Partnership With Your Testing LaboratoryBeyond Samples, COAs: Establishing a True Partnership With Your Testing Laboratory
It is essential that the manufacturer and the contract laboratory forge a relationship that consists of more than just the exchange of samples and certificates of analysis (COAs); rather it needs to be a true partnership between the two entities.
September 9, 2016
Food and beverage manufacturers juggle a lot of responsibilities. Maintaining an adequate supply of raw materials, managing employees, installing and repairing equipment, and fulfilling customer requests are just a few examples of the countless responsibilities that food and beverage manufacturers face on a daily basis. They also undergo regulatory scrutiny, have to pass third-party audits, and must maintain strict quality standards for their finished products. Yet, despite having to address all of these challenging tasks, food and beverage manufacturers would likely agree that all of these point toward one ultimate responsibility: producing safe and wholesome foods and beverages for consumers to enjoy.
In order to ensure they are meeting this ultimate responsibility of producing safe and wholesome products, manufacturers often utilize contract laboratories to test for certain microbiological and chemical parameters. By monitoring these parameters over time, the manufacturer is able to determine whether their processes are under control or if corrective actions are needed. Thus, this data is undoubtedly crucial to manufacturing operations. With such great emphasis placed on the quality and timeliness of this data, the contract laboratory consequently has a great responsibility with regard to the success of the manufacturer. Therefore, it is essential that the manufacturer and the contract laboratory forge a relationship involving more than just the exchange of samples and certificates of analysis (COAs); rather, it needs to be a true partnership between the two entities.
In any partnership, there has to be an element of trust. One of the essential standards that laboratories are held to, in order to demonstrate their technical competence (and ability to produce trustworthy data), is accreditation to ISO/IEC 17025. The ISO/IEC 17025 standard, issued by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC), specifies the management and technical requirements for the competence of a laboratory to carry out tests and/or calibrations, including sampling. Thus, just as food and beverage manufacturers have to undergo customer audits and third-party audits to obtain certification to certain global food safety standards, laboratories also have to undergo third-party audits to obtain their accreditation to ISO/IEC 17025.
Obtaining accreditation to ISO/IEC 17025 is a rigorous process that requires laboratories to use objective evidence to demonstrate their compliance to the standard. This involves on-site audits, quality record reviews and direct observations by an accrediting body. These assessments verify that the laboratory’s quality system and scope of testing and/or calibration activities meet the standard’s management and technical requirements. Some examples of the management requirements included in ISO/IEC 17025 are document control, internal audits, corrective actions, preventive actions and record control. Examples of technical requirements include items such as competency and training of personnel, equipment maintenance and calibration, traceability, sampling and result reporting.
Although accreditation to ISO/IEC 17025 is demanding, manufacturers should not view it as an end-all, be-all criterion for the competency of a laboratory. Indeed, the partnership between the manufacturer and the contract laboratory should have enough transparency that the manufacturer is given the opportunity to perform their own desk and on-site audits of the laboratory. Audits, especially unannounced audits, are good tools for manufacturers to use in obtaining full confidence that the contract laboratory is meeting expectations and is producing trustworthy data at all times. If there is a true partnership in place, the contract laboratory should welcome these audits in a positive light, and should treat any deficiencies as opportunities to improve its service to the food or beverage manufacturer. Furthermore, audits are good opportunities for the food or beverage manufacturer to learn more about the methods used to analyze their products and to ensure the methods have been properly validated.
Just as there has to be an element of trust in a partnership, there also has to be an element of understanding. The contract laboratory should understand that often, the manufacturer has a turn-around-time for data that must be met in order for the manufacturer to proceed with releasing product or to act swiftly in response to a process control issue. The contract laboratory should understand there may be times when the manufacturer will provide them with an onslaught of samples that have to be analyzed in response to a critical situation such as a product recall. Consequently, the laboratory should always be prepared to respond accordingly. Likewise, a contract laboratory should make value-added services, such as consultation and technical expertise, available to its food and beverage manufacturing partners. In return, the manufacturer should help the contract laboratory by partnering with them for the long term rather than continually shopping between many laboratories for the most inexpensive data. Overall, a long-term business partnership will help the contract laboratory grow as the manufacturer grows.
Any partnership should have elements of trust and understanding, and this is especially true for relationships that are forged between food and beverage manufacturers and contract laboratories. If these elements are in place, each party should benefit and should be able to help each other be successful. Even more importantly, both parties will be able to work together toward achieving the ultimate responsibility of producing safe and wholesome products, which everyone can agree is most important and is the reason that we are all in business.
Learn more about creating a true partnership with contract laboratories in the Workshop: Evaluating and Partnering with Contract Labs on Wednesday, Oct. 5 at 1:30 p.m. at SupplySide West.
And check out the Healthy INSIDER podcast where Brandt uncovers what an audit of a contract laboratory should entail.
Alex Brandt, Ph.D., serves as the director of technical services for Food Safety Net Services Ltd., where he assists customers with development of challenge studies, validation studies, shelf-life studies and other custom research. He also provides educational outreach and training, and technical and regulatory guidance. Brandt earned his doctorate degree in food microbiology and safety from Texas Tech University and has a master's of science and bachelor’s of science in food science and technology from Texas A&M University.
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