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Appendix 1
Laboratory Quality Assurance and Control

  • Issued: July 2013
  • Content last reviewed: April 2013

The principal objectives in the operation of an analytical laboratory are the production of high-quality data. Through the use of analytical measurements that are accurate, reliable, and specific for their intended purpose. A thoroughly planned and documented Quality System can accomplish this intent. This section provides an oveview of those elements which make up the Quality System that are critical to ensuring the quality of the RPMS data.

The RPMS is accredited by the Canadian Association for Laboratory Accreditation (CALA) as meeting the requirements of ISO/IEC 17025 – "General Requirements for the Competence of Testing and Calibration Laboratories". This accreditation provides formal recognition by an independent science based organization that this laboratory is competent in performing the assessment of radioactivity in various sample media.

In 2011 the RPMS underwent its fourth bi-annual site assessment by CALA. The satisfactory completion of this assessment plus satisfactory participation in proficiency testing is key elements in the accreditation process where conformance to ISO/IEC 17025:2005 is assessed. The 2011 site assessment was successfully completed by the RPMS with a limited number of corrective actions to be carried out.

In addition to being important in the accreditation process participation in inter-laboratory proficiency testing helps demonstrate the proficiency of the RPMS against external unbiased standards and shows that the accuracy of its measurements meets and exceeds required standards. The RPMS took part in two proficiency studies in 2011. The first was the US Department of Energy's (DOE) Mixed Analyte Performance Evaluation Program (MAPEP) Study 24 and the second was the US DOE MAPEP Study 25. Air filters, water, soil, and vegetation samples were provided for analysis and the results submitted by the RPMS for both of these studies were within the acceptable limits of the studies.

The Quality System encompasses all activities relating to the ORSP with an aim of producing work that is accurate and of a very high-quality. The following terms are used in association with the Quality System – Quality Management (QM), Quality Control (QC) and Quality Assurance (QA). Quality Control (QC) consists of procedures used to verify that prescribed standards of performance in the sampling and analysis activities are met. Quality Assurance (QA) is a system of activities and processes put in place to ensure that the quality control activities are being properly implemented.

Specific QC processes have been put in place to estimate the accuracy and precision of analytical results, and to investigate any sources of error introduced by laboratory practices. Statistical QC employs statistical methods for assessing conformance and controlling the measurement process.

Method QC is integrated into each analytical run to monitor sample preparation, the purity of reagents and solvents, the stability, accuracy and precision of equipment and instrumentation, and the overall performance of the analytical system. Control samples are chosen to address sources of variation and bias particular to an individual method.

Standard reference materials obtained from national and international organizations such as the National Research Council (NRC), National Institute for Science and Technology (NIST) and International Atomic Energy Agency (IAEA) are utilized. These materials are certified as to their content, having been rigorously prepared and subjected to thorough analysis. Control samples are used as Method QC Standards, Background and Control Standards for instrument performance, and, Method Blank Standards and Spiked Standards for method performance.

A major component of laboratory QA is the requirement that all laboratory staff rigorously follow a set of documented activities. The use of written Methods and Standard Operating Procedures (SOP's) will ensure the data produced conform to pre-defined criteria and verify that QC procedures have been correctly carried out. Another component ofQA is that analytical results be traceable both to the analyst who carried out the test and to the method employed. Written SOP's for sample reception, sample storage and distribution, maintenance of equipment logs, method calibration and standard preparation highlight some of the activities that are part of QA.

The RPMS is licensed by the Ontario Ministry of the Environment to provide radioanalytical testing services to Ontario Drinking Water Systems. This licence is granted under the Safe Drinking Water Act 2002 (SDWA) and the Drinking Water Testing Services Regulation (O.Reg 248/03) making the RPMS the only Provincial government laboratory legally authorized to analyze Ontario drinking water for radionuclides. In 2011 the RPMS successfully completed two audits (Cycle 15 and 16) by the Ministry of Environment to maintain this drinking Water Testing License.

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ISSN 1929-2899