Analytical laboratories know that data quality is of the utmost importance. It’s the essence of what you do and the reason for what we do. Having appropriate quality control measures in place to deal with a range of variables increases your ability to meet regulatory needs and in turn, impact your laboratory's revenue.
Quality control generally applies to four basic functions of the analytical process:
- Method development
- Staff training
- Ongoing performance
- Corrective action
When a new method is being developed by a laboratory, it is important to determine if the method meets defined criteria.
: degree of agreement between independent measurements under controlled conditions
: degree of agreement of a measure valued with the true or expected value
- Linear range
: ability to analyze samples ranging from reporting limit to estimated upper end
: ability to accommodate change in various factors such as sample size, pH adjustment, column type, amount of acid, or composition of sample matrix.
A change in laboratory personnel is a significant variable that needs to be evaluated.Use certified reference materials to ensure newly hired staff is appropriately and sufficiently trained to conduct your routine analyses.Certified Reference Materials (CRMs) or Quality Control standards (QCs) can also be used to regularly document the accuracy and precision of your experienced analysts.QCs can also be used when expanding the analytical responsibilities of staff by giving analysts an opportunity to analyze real world samples under direct supervision.
Once a method is established in your laboratory, there are many variables that can affect its performance.
- Standards and reagents
- Laboratory environment
- Sample matrix
- Random errors
A routine QC program can help to minimize problems that may arise as a result of a change in these and other variables.
CRMs are effective when conducting root cause analysis of laboratory deviations. CRMs can help identify the source of the error – man, machine, materials, or method. Once the root cause is identified and corrective action implemented, analysis of a CRM can prove and document that corrective was effective.
To start a routine QC program, call ERA
and speak with a Customer Service Representative.