Confident Data Collection in the QC Lab:Spectrometer Performance AssuranceFederico Izzia and Mike Bradley, Ph.D., Thermo Fisher Scientific, Madison, WI, USA

Introduction

The central use of spectroscopy in quality control andquality assurance laboratories involves verification of aproduct’s compliance with control specifications – productidentity or purity. Strict standard operating procedures(SOPs) define each step. The workflow is defined, fromsample collection to data analysis and report-out. Often thefirst step in this chain involves confirmation of instrumentperformance and the reliability of the instrument for theSOP task. Internal, regulatory and legal bodies requirethat an independent verification of the instrument beperformed regularly, with signed, archived reports, for the final spectral evidence and report to have force.

In the past, frequent performance testing wasperformed by personnel who started their careers duringthe age of “open cockpit” spectrometer operations.Knowledge of how the spectrometer worked – fromproperly loading chart paper to basic calibration methods– was required to obtain acceptable data. QC laboratorieshave evolved substantially, in terms of personnel,instrumentation and expectations.

This evolution has progressively placed more of theresponsibility for performance verification on the instrumentitself. Spectrometer performance criteria are increasinglystringent, as various oversight agencies require assurancethat spectral data collected in the QC lab is trustworthy.Add-on software and hardware tools have made thisprocess simpler, but the requirement for a set of routinetools fully integrated with the spectrometer (hardware andsoftware) has become clear.

The latest generation of FT-IR spectrometer is theThermo Scientific Nicolet™ iS™10. Unlike previous FT-IRspectrometers, this instrument and its software were designedand built with performance verification as a core metric.All Nicolet iS10 spectrometers ship with traceable standardsmounted on an internal validation wheel, meaning any labrequiring system performance verification can now integratesuitability tests into laboratory procedures withoutadditional purchases. Spectrometer Performance Verification(SPV) software tools provide a new level of operationaland customizable functions for spectrometer validation.Finally, the new QCheck function within the OMNIC™

software, described in detail elsewhere, provides instantquality control activity through spectral comparisons orsemi-quantitative analyses. The combination of these toolsmakes the Nicolet iS10 the best fit for any QC application.

A QC Laboratory Scenario

The primary function of most QC laboratories involvesdetermining if an incoming raw material or outgoing productmeets specifications. If a problem arises downstream,resulting in a customer complaint, the data from the QC lab becomes a critical component in the investigation.Quality issues arising from suppliers can affect product,resulting in a need to take corrective or legal action upstream.Thus, much hinges on the reliability of the information.Customers or suppliers can shift the focus from addressingthe problem to questioning the spectrometer, and time andmoney can be wasted.

This applies to forensics laboratories as well. Ananalysis may tie a suspect to the scene of a crime, butsavvy defense lawyers can raise doubt regarding the databecause there is nothing showing the spectrometer isreliable. The tiny doubt this can raise in a jury’s malleableopinion may be sufficient to undermine the case.

The pharmaceutical industry has been living withscenarios like this for many years, as they are heavilyregulated worldwide – all drug-related data must be backedwith instrument performance verification and validation.The food and beverage industry is increasingly movingtowards the same model, as the regulatory system becomesmore involved. Sharpening instrument performanceverification tools is more important than ever.

Key Words

• QualityAssurance

• Quality Control

• Raw Material

• SOP

• SystemPerformanceVerification (SPV)

• SystemSuitability

• ValPro

Technical Note: 51508

The Thermo Scientific Nicolet iS10: Data collection with confidence