February 3rd, 2020 in Pond's Pondering

Why worry about traceability?

  1. Engineers aren't always the smartest, so they may come back 5 months to 1 year later and ask for a review of data. You should be able to reconstruct the data to justify the results. The engineer who wants results yesterday may not look at the data as a whole package for 6 months to 5 years later. This is not a joke.
  2. If there's a legal question about data, how are you going to answer it? Each sample should have a set of papers, or digital "papers", that shows how the sample was processed in your lab, and how you know they showed acceptable criteria.
    • Perform QA/QC with the sample
    • Sample storage
    • Any standards used to quantify unknown in the sample
    • Any reagents and solvents (i.e. purity)
    • Any measurement devices used (from scale to mass spectrometer)

So, you should be able to show the calibration of the instrument, daily controls and records of when an instrument was used to process the sample (i.e. date weighed, time run). Anything that would have an effect on the analyte should be shown to be in control: either by the analyte's certificate of analysis or by calibration. So, when we say we measure 10 mL, we measure 10 mL and not 12 mL.

This applies to syringes as it applies to high resolution mass spectrometers and is a major part of an ISO 17025 accredited method.

~Filtered by Dave Hope~