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Investigating out-of-specification test results of chemical composition based on metrological concepts

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Abstract

A metrological background for investigating out-of-specification (OOS) test results of chemical composition is discussed. When an OOS test result is identified, it is important to determine its root causes and to avoid reoccurrence of such results. An investigation of the root causes based on metrological concepts would be beneficial. It includes (1) assessment of validation data of the measurement process, (2) evaluation of the measurement uncertainty contributions, and (3) assessment of metrological traceability chains critical for measurement parameters and environmental conditions influencing the test results. The questions, how can the validation data be applied for this investigation, and how can measurement uncertainty contributions and/or metrological traceability chains change a probability of OOS test results, are analyzed.

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Authors and Affiliations

  1. The National Physical Laboratory of Israel (INPL), Givat Ram, 91904, Jerusalem, Israel

    Ilya Kuselman

  2. Istituto Nazionale di Ricerca Metrologica (INRIM), 73 Strada delle Cacce, 10135, Turin, Italy

    Francesca Pennecchi

  3. Food and Drug Administration (FDA), 6th Ave and Kipling St, DFC-Bldg 20, Denver, CO, 80225, USA

    Cathy Burns

  4. International Atomic Energy Agency (IAEA), Wagramer Strasse 5, P.O. Box 100, 1400, Vienna, Austria

    Aleš Fajgelj

  5. Istituto Superiore per la Protezione e la Ricerca Ambientale (ISPRA), Via Castel Romano, 100, 00128, Rome, Italy

    Paolo de Zorzi

Authors
  1. Ilya Kuselman
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  2. Francesca Pennecchi
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  3. Cathy Burns
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  4. Aleš Fajgelj
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  5. Paolo de Zorzi
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Correspondence to Ilya Kuselman.

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Kuselman, I., Pennecchi, F., Burns, C. et al. Investigating out-of-specification test results of chemical composition based on metrological concepts. Accred Qual Assur 15, 283–288 (2010). https://doi.org/10.1007/s00769-009-0618-4

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  • DOI: https://doi.org/10.1007/s00769-009-0618-4

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