Top 10 Things to Look For in a Testing Lab
By: Craig Weiss
Posted: August 7, 2007, from the August 2007 issue of GCI Magazine.
page 2 of 36. Openness and Honesty
When visiting or auditing (highly recommended) your laboratory, you should be allowed complete access to your study. This includes the ability to view the biophase of your study to be sure that it is being conducted in compliance with the protocol. It should make little or no difference to your lab if you decide to audit your study unannounced—i.e., without making an appointment. In addition, you are entitled to see all of your study documentation, including raw data, although certain demographic data must be withheld according to law. You should also be able to get copies of the raw data, but be aware you may be charged for duplicating.
Beyond the testing procedure, this means compliance to all appropriate regulations and standard operating procedures. Given that any study may become part of litigation, even in less regulated product categories, it is extremely important that the laboratory has been audited by you and/or a regulatory agency and has been found in substantial compliance. Additionally, in this global economy the laboratory should be conversant with worldwide regulations and methods.
Once again, this should be a given. However, quality is more than the signature of a quality assurance officer on a report. Quality refers to the organization of the laboratory. Does the laboratory have enough personnel to conduct the number of studies it normally conducts? Does the laboratory have an independent quality assurance department that answers to the president or chief executive of the laboratory, not to an operational department?
3. Reliable Advice
The laboratory you choose should know the industries it serves and should be able to advise you as to what is the industry or regulatory standard for the testing you require. Keep in mind that every lab has its limitations and should be able to tell you what those are up front. Additionally, a lab should know and tell you when something is impossible.
Without the ability to communicate with your laboratory when you need to, many of the points above are rendered moot. You should be able to call and discuss your projects, either ongoing or future, without feeling like you are imposing. You should not feel as if you have just sent product into a black hole for testing. Equally important, if something is going wrong with your test halfway through the study, the testing lab should tell you about it immediately, not after the study has finished.