Selecting a laboratory can be a complicated process. Typically, when clients call to request laboratory services the initial questions are; what the price is, turn-around time, and is sample pick up available. Some clients go so far as to ask about the methodology used for analyzing samples.
However, it is not just enough to call the lab and request the price and the turn around time that the laboratory can provide. As a company doing its best to protect an investment, brand, and most importantly consumers, it is important that you audit the laboratory or laboratories under consideration regardless of where you are in the supply chain process. Auditing the laboratory will help provide transparency and help you understand the process used to generate the data and claims of your product.
Even though there are accreditations, like ISO 17025 – the pinnacle accreditation in third-party lab testing, as well as state certification requirements, there are still large shades of gray between laboratories. As the consumer of the laboratory service, you need to know what you are buying.
You don’t have to be chemist, microbiologist or scientist to audit your lab. It may help, but it’s not necessary. There are basic workflows and procedures that anyone can understand, and an audit provides transparency. More importantly there are several steps a lab should be taking to ensure its providing you with the most accurate results possible. If you want to understand and audit the more technical data, the lab may be willing to explain it to you or you can always hire a consultant. Here are a few things that you can inquire about without needing help from an expert.
- Ask to review the company’s Quality Assurance Manual and give it a read through. Again, some of the content may be technical, but just because its technical doesn’t mean the data will not make sense. The quality assurance manual will document what types of records are kept, as well as, how data and other information is recorded to ensure accuracy in results. You should be able to read the Quality Manual and follow it and its prescribed paper trail, which ensures accurate record keeping of all data that was used to generate any analytical result from the lab. You may not understand all the data, but like reconciling a bank account, everything should be accounted for.
- One place you can drill down is to look for the company’s validation protocol or procedure, this may be a separate operating procedure. Once you have reviewed the validation procedure ask for the documentation to support the validation of that method. While you may need an expert to help you understand the validation itself, the company should not be weary about showing you the components of the validation data that prove the method of the service you are purchasing works and is reliable, and that, more importantly the method has been proven to work successfully on your sample matrix or an equivalent sample matrix.
- When you purchase the test, you are also purchasing the data used to generate your result. If you have already submitted a sample to the laboratory, ask for the lab to walk you through the data used to generate the results from that specific sample. We call the raw data, the data packet. This is a perfect test case for any audit. Any laboratory should be able and willing to do this and can do so without releasing proprietary data or methods. While your test may have been on an analytical run with other client’s samples, your data can be individually separated and turned over to you. If the lab is not willing to share the data with you, be weary and concerned about what they might be trying to hide.
- We also suggest comparing data between a few laboratories to see who can generate the best data and provide you with the most accurate result. This information will allow you to select a laboratory not just based on price and turn around time alone, but also on the lab’s analytical capabilities and proficiency. We caution against requesting data for every sample as data packet preparation for a single sample is cumbersome and may incur an additional fee from your lab, but occasional data requests should not be an issue or concern for your laboratory.
- Visit your laboratory and see how they manage the facility. Is the facility clean? Is it orderly? Labs are notorious for taking up every square inch of space. However, that doesn’t mean the lab should not be organized and cleaned regularly. You will want to look for scenarios that could lead to contamination of your sample or potential confusion of samples during login, if the login process is not properly facilitated. Additionally, you may need to visit the laboratory if you are requesting procedures and manual from the lab. Due to the document’s proprietary nature, the lab may only allow you to assess those documents while on site at the facility.
- When selecting a laboratory, transparency is paramount. An audit provides transparency and can provide the necessary and detailed information required to feel comfortable with the services you are procuring. The best way to conduct the most thorough audit to is to visit and audit your third-party laboratory in person. Simply selecting a lab based on price and turn around time may present unnecessary risks and liabilities.
- When you audit your laboratory, ask to see documentation for everything from the quality assurance manual to the sample login process to the data generated for the results of your product. The lab should be collecting and documenting everything. Be wary of poor documentation or lack of documentation as well as a lack of transparency of data.
At the end of the day, your reputation is based on the quality of your products. If the lab cannot substantiate and back up its analytical data, they could be putting your reputation, your products, and the consumer at risk.