QUESTIONS OF THE INTERNAL CONTROL QUALITY ASSURANCE OF TEST'S RESULTS IN THE TESTING LABORATORY
https://doi.org/10.26896/1028-6861-2019-85-4-64-76
Abstract
The problems regarding arrangement and implementation of the intralaboratory quality control (ILC) of test results in testing laboratories (TL) are reviewed and summarized. The main goals of ILC directly aimed at minimization of the risks of getting unsatisfactory test results are considered along with the choice of the methods and types of control. The process and system approaches to organization and performance of the ILC are proposed with allowance for the risk assessment at the stages of planning, implementation, and monitoring of the ILC, which provide a control of all measurement techniques (MT) used in the laboratory, thus making the control procedure transparent to all the parties concerned. An effective way to describe the ILC starting with the stage of planning is recommended. The proposed "ILC Program" ensures the efficiency and effectiveness of the process to match the goals set for ILC: ensuring of the required accuracy (uncertainty) of current test results for the entire nomenclature of measurement techniques, maintaining the testing processes in a statistically controlled state, and, consequently, ensuring of the confidence of internal and external customers and supervisory organizations to the results of testing and activities of the TL as a whole thus proving the technical competence of the laboratory. We present the results of analysis of all ILC stages using the Shewhart-Deming — PDCA principle with a list of possible risks of obtaining unreliable results. Recommendations on the effective implementation of each stage of the process are given. Listed typical mistakes of ILC implementation can help the readers not only to avoid them, but also consider them as possible risks.
About the Authors
Svetlana N. GusarovaRussian Federation
Yuliya M. Erokhina
Russian Federation
Elena I. Hunuzidi
Russian Federation
References
1. ISO 9001:2015 (Е). Quality management systems. — Requirements. — Geneva, ISO Copyright Office, 2015. — 29 p.
2. ISO/IEC 17025:2017. General requirements for the competence of testing and calibration laboratories, http://www.iso.org/ru (accessed February 25,2 019).
3. Dvorkin V I. Metrology and quality assurance of quantitative chemical analysis. — Moscow: MITHT, 2014. — 416 p. [in Russian].
4. Dvorkin V I. Intralaboratory Quality Control. Organization of Stability Control and Assessment of the Performance Measurement Process / Zavod. Lab. Diagn. Mater. 2011. Vol. 77. N 6. P 6 0 - 6 8 [in Russian].
5. Dvorkin V I. Intralaboratory Quality control. Basic approaches / Zavod. Lab. Diagn. Mater. 2011. Vol. 77. N 4. P 65 - 67 [in Russian].
6. Internal quality control. Manual for analytical laboratories / I. V Boldyrev (ed.). — St. Petersburg: TsOP «Professiya», 2015 [Russian translation].
7. ISO 5725-6:1994. Accuracy (trueness and precision) of measurement methods and results. Part 6: Use in practice of accuracy values, http://www.iso.org/standard/11837.html (accessed February 25, 2019).
8. RMG 76-2014. State system for ensuring the uniformity of measurements. Internal control of quantitative chemical analysis result's accuracy. — Moscow: Standartinform, 2015. — 110 p. [in Russian].
9. ISO 7870-2:2013. Control charts. Part 2: Shewhart control charts, http://www.iso.org/standard/40174.html (accessed February 25, 2019).
10. State Standard GOST 53701-2009. Guidance on the application of GOST R ISO/IEC 17025 for sensory testing laboratories. — Moscow: Standartinform, 2011. — 10 p. [in Russian].
11. Methodical Instructions 2.1.4.1057-01. Organization of interlaboratory quality control of sanitary and microbiological water research. — Moscow: Minzdrav Rossii, 2001. — 91 p. [in Russian] .
12. ISO 21748:2010. Guidance for the use of repeatability, reproducibility and trueness estimates in measurement uncertainty estimation. http://www.iso.org/ru/standard/46373.html (accessed February 25, 2019).
13. ISO/IEC-17025:2005. General requirements for the competence of testing and calibration laboratories, http://www.iso.org/statndard/39833.html (accessed February 25, 2019).
14. Adler Yu. P., Shper V. L. Statistical processes control: textbook. — Moscow: NITU "MISiS", 2015. — 235 p. [in Russian].
15. Gusarova S. N., Shper V L. Statistical management of processes and methods of analytical control / Sovr. Lab. Praktika. 2008. N 2. P 20 - 25 [in Russian].
16. Adler Yu. P., Khunuzidi E. I., Shper V L. Quantitative assessments of the role of statistical and systemic thinking in decision-making / Met. Menedzh. Kach. 2007. N 1. P 33 - 37 [in Russian].
Review
For citations:
Gusarova S.N., Erokhina Yu.M., Hunuzidi E.I. QUESTIONS OF THE INTERNAL CONTROL QUALITY ASSURANCE OF TEST'S RESULTS IN THE TESTING LABORATORY. Industrial laboratory. Diagnostics of materials. 2019;85(4):64-76. (In Russ.) https://doi.org/10.26896/1028-6861-2019-85-4-64-76