We now turn to looking at the steps you can take to assure the results you create and deliver are reliable and trustworthy. You will notice in the examples cited above they have all entailed an element of dishonesty to manipulate laboratory data so that it conforms to some predetermined expectation.

Ensuring Reliability

So what steps can be taken by a laboratory to provide a high level of confidence in the reliability and trustworthiness of the results, and they have not been manipulated to suit a particular purpose?

High Performance Liquid Chromatography Example

To answer this question let’s take a scenario where one party is challenging the integrity of some results delivered by a laboratory. The analysis of a sample (for example by high performance liquid chromatography) is a process which needs to follow a pre-established set of events as shown here in this flow diagram.

This entails identifying the correct sample supplied by the customer. Generally this will need some kind of preparative stage to convert the sample into a form suitable for analysis by the chosen technique. This would usually entail preparing some kind of solution containing the analyte.

The analytical solution is then analysed, which essentially involves separating the components of the solution and measuring some property of the analyte which is quantitatively related to its amount in the analytical solution, and converting it into an electronic signal.

For chromatographic analysis the output is a series of peaks who’s areas are proportional to the concentration of the substance to which they relate. The peaks of the chromatogram are then integrated to yield the peak area.

Quantitation is then achieved by comparison with a standard solution of known concentration to yield the amount of the analyte in the sample which is then presented in a final report.

Analyse Process Steps

The next step is to identify how each step in the analytical process could be manipulated to compromise the reliability of the final reported result. To do this we need to analyse each step of the analytical process in detail.