2024 Tutorials

This tutorial teaches how to apply decision rules in order to comply with ISO/IEC 17025:2017 regarding statements of conformity (e.g. pass/fail, in-tolerance or out-of-tolerance).  The tutorial is appropriate for both beginners in this subject and people with high levels of expertise.  Many decision rules are covered along with their level of false accept and false reject risk.  Original reference papers are also provided along with examples and how to use different free software to make the analysis work easier. 

 Attendees are encouraged to bring laptop computers. 

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A discussion of “legal metrology” and what Weights & Measures regulatory officials do to ensure equity and secure confidence in the marketplace.  While metrology laboratories deal in verifications, calibrations, applications of uncertainties and traceability to national and international standards, the resulting field standards are used to reach far beyond grocery store scales and gasoline pumps in assuring “certainty” for both buyers and sellers at all levels of daily commerce.  A look at what we all take for granted…. but shouldn’t. 

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The modern understanding of weighing metrology has had to change!  

The traditional approach of treating weighing in the same way as less nuanced disciplines of metrology has caused a mix of too much testing, inappropriate testing and often use tolerances that are too tight to be realistic for the given location/application. This results in a significant number of methods not actually achieving their metrological goals! 

Authorities have recognized that the roll-off of the measurement uncertainty components of an electronic weighing device is very different than the uncertainty roll-off on mechanical balances and scales.  

National and International Standards are being updated to reflect modern mass metrological science.  

We will break down how measurement uncertainty exhibits itself across the capacity of an electronic balance or scale and cover how to correctly assess and assign a Measurement Uncertainty budget.  

We will discuss modern, robust, risk-based approaches to the assessment and estimation of significant, contributing uncertainty components in order to build a thorough, scientifically-sound, risk-based program for bench or floor weighing instruments. 

Time will be spent covering phenomena that affect the accuracy of weighing, to illustrate how easy it is to create poor weight data!  To contrast this, you will learn how to overcome these potential sources of error, and optimize a balance metrology and service regime. This course focuses on:  

•  User testing  
•  Balance location and set up 
•  Factors influencing Measurement Uncertainty  
•  Common problems, and how to overcome  
•  Factors influencing repeatability  
•  Personal weighing technique 
•  Service needs for balances and scales 
•  Increasing productivity from your weighing equipment 

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This tutorial provides an overview of industry best practice calibration process management solutions that are tailored towards optimizing compliance while reducing costs and providing significant competitive advantage. Several examples of innovative calibration process improvements will be described. The course will provide a thorough review of fundamental calibration concepts and regulatory requirements.  Consideration for optimizing cGMP calibration service provider qualification and approval will be provided as well. 

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Many industrial customers require suppliers to provide objective evidence on the capabilities of their processes to consistently meet their customers’ requirements.  This tutorial will cover how to perform a MSA, SPC, and Process Capability Study.  

The topics and subtopics are based on the ASQ Certified Quality Engineer Body on Knowledge topics associated with the control and improvement of product and service processes.  It is also based on the AIAG APQP (Advanced Product Quality & Planning). 

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To ensure reliable and consistent measurements, it is imperative to understand the metrological characteristics of measuring devices.  

This presentation will provide attendees with a comprehensive understanding of the metrological characteristics of measuring devices and their practical implications, emphasizing on measurement traceability and measurement uncertainty.  

Whether you are a scientist, engineer, technician, or simply interested in the science of measurement, this knowledge will enhance your ability to make informed decisions and ensure the quality of your measurements.  

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This tutorial aims to teach practical internal auditing skills to individuals familiar with the activities of an ISO/IEC 17025 accredited laboratory. We will examine auditing principles and techniques and practice internal auditing skills. While the tutorial is based on internationally recognized approaches to conducting internal audits, we will also draw on attendees’ practical laboratory experience, as well as ensure that the requirements of ISO/IEC 17025:2017 for an internal audit are understood. The course includes easy-to-implement methods for risk-based thinking, continual improvement, and closing out findings through the analysis of root causes aimed at their elimination. 

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ISO/IEC 17025:2017 stands as the global reference for ensuring the competence of testing and calibration laboratories. This presentation intends to analyze, compare, and elucidate the distinct characteristics, methodologies, and compliance intricacies between testing and calibration laboratories within the framework of this standard. 

This presentation examines the fundamental differences and critical aspects of testing and calibration laboratories, as well as commonalities within ISO/IEC 17025:2017. 

Testing involves the evaluation and analysis of materials or systems against specified criteria, while calibration focuses on determining the accuracy of measurement equipment against known standards. 

A side-by-side comparison of testing and calibration laboratories is attempted, highlighting their individual objectives, quality management systems, technical competencies, and proficiency testing protocols as mandated by ISO/IEC 17025:2017, as well as many other controversial aspects such as metrological characteristics, measurement uncertainty, compliance decision, reporting the results, risk management, and more. 

The presentation intends to allow laboratories, quality managers, and professionals in comprehending, implementing, and optimizing the testing and calibration processes within the ISO/IEC 17025:2017 requirements, reinforcing the reliability and trustworthy laboratory practices. 

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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: 

1. 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. 

1. 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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