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No two laboratories are alike. Each laboratory is unique based on the analysts and management staff, the types of clients that they serve, and the types of analyses that are performed. At Analytical Products Group, Inc., our goal is to improve the overall quality of laboratory data worldwide, regardless of the type of testing that is performed in your facility. In order to assist laboratories with this task, the answer isn’t always one that can be pointed to in a catalog as a simple fix to a quality assurance and quality control program. As a means of providing a solution, APG is proud to introduce our Total Quality Program.
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The foundation of a quality assurance program is based on the three-tiered approach of calibration standards, quality control standards, and routine third party verification of performance, also known as proficiency testing. With each tier, comes the opportunity for error when these functions are handled internally. APG can work with your laboratory to develop sound standards that will result in greater accuracy of the data that you report to your customers or regulatory agency.
Calibration Standards
The traditional approach in preparing calibration standards is to develop a three to five point calibration curve in order to define the instrument’s response at these true values. The calibration curve should cover the linear range that the majority of your laboratory’s analyses are performed. When preparing these calibration standards, normally stock solutions of 100 or 1000 units of weight per unit of volume, typically mg/L, are purchased. These solutions are then diluted down in order to cover the linear range described above.
If a three point calibration curve is desired, three stocks are produced allowing for three potential errors in preparation. If additional points or multiple analytes are desired, the opportunity for error increases significantly. Once the three to five point calibration standards are prepared, little verification of their concentration is performed by a laboratory. At APG, we will work with your laboratory to develop calibration standards that meet your analytical needs, containing the analytes you need at a concentration range that covers the samples you analyze. In addition, each standard will be verified and will be accompanied by a Certificate of Analysis that indicates the prepared value as well as the analytically proven concentrations.
Quality Control Standards
Each laboratory defines their calibration frequency based on their own internal needs as well as the integrity of the instruments used. Once the standardization of the instrument is complete, the instrument should be ready for data generation. Through the use of quality control standards, an instrument’s response and the validity of a calibration curve can be verified well after an instrument is standardized. By using reliable quality control standards, you can define control limits that will assist you in developing calibration frequencies.
Even in today’s world of technology, no instrument is perfect and the potential for drift exists. The ability of an instrument to provide an accurate response can vary over time. Depending on the amount of time that passes from calibration to data analysis, an instrument can drift providing results with either a high or low bias. By using APG’s quality control standards, you can determine if an instrument needs recalibrated before generating data, saving time and allowing you to provide quicker service to your customers. The quality control standards can also be used to bracket your internal samples and can then provide additional confirmation that your instrument remained in calibration from the beginning of the run all the way to the time that the last sample is analyzed.
Independent Third Party Verification
The evaluation of a laboratory by an external source is an invaluable tool in improving overall laboratory performance. The most common program for this is participating in PT (proficiency testing) studies on a predetermined basis. PT studies are required by most accrediting agencies and the data is used to support a laboratory’s license to do business as long as they are within the acceptable ranges as defined by the US EPA. PT studies also have the ability to be used as a tool to monitor laboratory performance over time as well through the use of trending.
An additional type of third party verification is the use of double blind samples. Single blind samples, including APG’s routine PT studies are provided in a labeled vial and each laboratory is aware that this is a sample that is used for evaluation. Upon receipt, the sample is treated as an evaluation sample and additional care is used to ensure that the testing regimen is complete and accurate. A more accurate evaluation can be achieved through the use of double blind samples, which are similar to PT samples, but are disguised as real world samples. These samples are then analyzed under normal testing conditions and are an evaluation of a laboratory’s routine performance. APG can help develop custom double blind samples for your facility to be used for both performance evaluation and training.
We invite you to take advantage of APGs Total Quality Program and allow us to provide a customized assessment of your calibration and verification programs. After receiving a request for an assessment, a qualified representative from APG will contact your laboratory to begin the work towards developing a program. Contact Jon Brownfield (j.brownfield@apgqa.com) or Dale King (d.king@apgqa.com) at 1-800-272-4442 to initiate or continue your Partnership in Quality with APG. |
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