“I believe strongly in this product and give out demo copies to every client I meet,” says Diane Lawver, President of QAS. “The product is well-designed and focused on the issues around assuring the integrity of organics data used for decision-making.”
QAS uses Mint Miner to conduct quality system audits and evaluate data integrity issues in environmental testing samples. The reports generated by Mint Miner allow QAS to look closer at areas requiring additional scrutiny, which improves the company’s auditing effectiveness.
Changing the Nature of Business
Prior to employing Mint Miner, QAS’s data review process was mostly manual. To check for inappropriate manual integrations, QAS employees would randomly select quality control files and analytes that were suspected to have a high probability of inappropriate practices. The subset of data was small, due to the time it took to manually review electronic data, and the results were not as complete and thorough as QAS wanted. Also, the ‘audit trail’ features included in standard instrument software were inadequate.
When QAS began using Mint Miner it became clear that the old auditing process was incomplete and inaccurate in many ways.
New Levels of Quality Assurance
Mint Miner has also changed the quality assurance practices of QAS’s clients. One laboratory in particular had a practice of separating quality control results from client results during the data review process. To this lab, data review meant that the correct number was in the computer and that the results made sense.
Unfortunately, an analyst had been taking advantage of this data management flaw. The analyst manipulated curves to allow measurements to pass, analyzed samples and quality control with the altered calibration factors, printed out the sample results, and did not save the alterations to the calibration curves. The QC data went into the files and the sample data went on for review.
When the lab used Mint Miner to evaluate the analyst’s practices it became clear what was going on. Now, the lab uses Mint Miner on every instrument to generate routine reports that prevent this sort of problem from recurring.
Future in Regulated Labs?
QAS believes the regulated laboratory community is progressing with regard to ethics & data audits, and that Mint Miner could be a part of that progress. Increasingly, laboratories are embracing NELAP standards for quality systems. QAS feels that if the Office of Water embraces NELAP and enforces its standards, it will open the door to Mint Miner being used to assure data and employee integrity when generating compliance-grade data. There are currently 14,000 environmental testing laboratories generating compliance-grade data, but only about 1,500 are certified by NELAP. QAS anticipates that such a transition would expand the use of Mint Miner significantly.