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Integrated Quality System: Building a Bridge with Contract Laboratories
4/23/2018 11:07 AM
by Edgar Grigorian, Vice President of Techincal Affairs at Genysis Labs
The process of choosing the right contract laboratory continues to evolve and change with the regulatory and business requirements of the current landscape. The companies that are at the forefront of the supplement and food industries understand that the analytical labs they choose to work with have to become a direct extension of their quality management system. This level of partnership and synergy is critical for companies and analytical laboratories in achieving the current rigorous quality control requirements while exploring the next cutting edge breakthrough that will set the new standard for innovation and excellence.
There are a lot of great guidelines on how to go about qualifying laboratories by looking at company test needs, laboratory expertise, accreditation status and scope, and audit programs. In order to get to a level of quality management system integration with the contract laboratory partners, additional work has to be done to provide a complete picture of the company requirements and expectations. A thorough review of a company’s current state laboratory needs, shortcomings and constraints is a good starting point. If contract laboratories are routinely used, it is imperative to include the historical performance highs and lows, data trends and challenges. This information can provide valuable insight into areas that need improvement, as well as areas of service that have been exceptional.
One important aspect that is sometimes missed in this preparation stage is the analysis of the future strategic direction of the organization and its need for innovative analytical solutions to complement the research and development pipeline. It is not uncommon for organizations to have departments that are isolated and out of sync with each other which, in turn, can distort the review of critical issues and needs. A major cornerstone of any successful company is its highly engaged employees and teams. The contract laboratory vetting process should place significant emphasis on the engagement level of the laboratory group through discussions related to quality, process, expectations and transparency. The ability to freely discuss the challenges and critical issues identified in the companywide review will reveal how the laboratory group solves complex problems and offers customized solutions.
Over the years, a significant amount of time and effort has been put into educational information related to ISO 17025 accreditation and its significance for testing laboratories. A vast majority of companies are aware that this accreditation is specific to the methods of analysis listed on the certificate scope. One area that is commonly overlooked has to do with the complexity of the matrices that vary from one product to another. Understanding the types of samples the laboratory analyzes on a routine basis is very important even if the method of analysis is on the ISO 17025 scope. Sampling, compositing and preparation steps for products in powder, tablet, capsule, soft gel, bar, and ready-todrink delivery systems may be significantly different based on the laboratory’s expertise and familiarity with these matrices which could be the difference between a conforming and a non-conforming analysis result. Complicating this matter further is the continuously evolving composition of products; botanical extracts, enzyme blends, probiotics, chelated and encapsulated ingredients add a layer of complexity to the analytical process.
Evaluating a contract laboratory’s involvement in testing innovation and quality improvements in the analytical communities is another aspect that needs a closer look. This is especially valuable for strategic partnership evaluations where novel, cutting edge sciencebased technology is highly desired. Analytical research and development emphasis and track record will gauge how much effort and value is invested by the laboratory for future advancement. This will help in determining whether the laboratory is forward-thinking and a leader in its category, or if they are merely following the lead of others.
In the age of automation and data-transfer, the ability to get personalized service is becoming more difficult. Understanding the businesses needs and aligning the operational efficiencies between multiple units in the quality management system requires that clear lines of communication are established and maintained. The communication channels extend far beyond the typical customer services communications. The ability to access the highly valuable technical experts within an organization in a timely manner is essential for real time, data-driven decision making. The smooth transition of effective communication into actions and solutions will be the differentiator in this business where high quality is expected, and completion timelines of analysis are constantly compressed.
About the author: Edgar Grigorian has 12 years of
experience in the dietary supplement industry and
holds a BS degree in chemistry (biological emphasis)
from University of Utah.