FULL DAY COURSE:
Wednesday, March 27th: 10:45am – 5:00pm
Instructor: Yvette Volschenk, ISO/IEC 17025 Consultant; ANAB Contract Lead Assessor; American Standard Calibration Laboratory – South Africa
ABSTRACT:
How do I plan for PT/ILC? How do I perform a risk evaluation on my PT/ILC Plan? What is important about the ILC/Protocol and will the laboratory benefit from participating in the PT/ILC that is specified in the Protocol? How do I interpret the PT/ILC results and how does the outcome of the PT/ILC results add value to the laboratory? How do I perform Corrective actions on my PT/ILC results?
If we read the requirements of ISO/IEC 17025: 2017 section 7.7.2 I quote “The laboratory shall monitor its performance by comparison with results of other laboratories, where available and appropriate. This monitoring shall be planned and reviewed and shall include, but not be limited to, either or both of the following:
- a) participation in proficiency testing;
NOTE ISO/IEC 17043 contains additional information on proficiency tests and proficiency testing providers. Proficiency testing providers that meet the requirements of ISO/IEC 17043 are considered to be competent.
- b) participation in interlaboratory comparisons other than proficiency.”
When we participate in a PT/ILC, it is not just to comply with the requirements of ISO/IEC 17025:2017. It is to get value added from the PT/ILC results to ensure the laboratory performs the calibrations or tests correctly and that the calibration or test results can be repeated under the same circumstances by any laboratory calibrating the same artifact or test specimen.
When a PT/ILC is planned, the predetermined criteria are very important. The predetermined criteria must be fit for what the laboratory is calibrating or testing. This includes the range and measurement uncertainty (where relevant), etc. The planned PT/ILC must be in line with the PT/ILC plan. It is not beneficial to the laboratory if the same type of PT/ILC is planned every year. The planned PT/ILC must take into consideration that the accredited scope is covered in the PT/ILC cycle and it can confirm the working range and CMC (where relevant) of the laboratory.
When the outcome of the PT/ILC results is received back, are the laboratory’s results within the specified criteria? If not what now? Corrective action must be registered, and action must be taken immediately, otherwise, the laboratory risks reporting incorrect results to the customer.
How do I interpret the PT/ILC results? How do I use the PT/ILC results to improve the activities in the laboratory? Just to determine if the En value is within 1 or the Z-score is within 2-sigma does not benefit the laboratory. The results must be analyzed and understood to be able to benefit the laboratory or to be used to improve the performance of the laboratory. By analyzing the results correctly, one can determine where there might be a risk in the system and process, or if the system and process is still fit for use.
When evaluating the PT Plan, the risk associated must be determined. Which areas are high-risk, medium-risk, or low-risk areas? Which calibration or testing activities are performed daily or once a year? How do I determine the criteria for the high-risk, medium-risk, or low-risk areas?
PT/ILC participation ensures the validity of the results reported to the customer and reduces the risk of reporting incorrect results to a customer.
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