Interview to Anna Bortoluzzi

"WHAT NUMBERS TELL US"

Interview to Anna Bortoluzzi

Auditor and Business Operator

Lecturer at the University of Milan

1) Dr. Bortoluzzi, what was your career path in labs?

After an experience in the research laboratories of the University of Milan, I directed two internal labs, with the postition of Lab Manager and Quality Manager within the Companies. This dual role thaught me the value of the measures and “numbers” in companies. From the beginning of my career I realized that if knowledge is power, then quantifying through numbers is the best way to support business decisions, even the most critical and strategic.

2) Do you work more often with companies or associations?

I started my own lab 20 years ago and ever since I offered services to companies, as a consultant in the areas of innovation and management. At the beginning of my professional activity I believed it would be wiser to target SMEs, but soon after I had to change my mind. In a few years the interest of medium and large companies for the services I offered grew and completely changed my customers network. Today I develop very challenging projects for very large companies and it’s a great satisfaction. I learned a very important lesson: if you know how to listen to your customers needs, they will show you how to maximize the services you can offer. As far as associations are concerned, I can say that they approached me recently, following the “word of mouth” of large companies or driven by such specific needs that no other professional on the market was able to meet with adequate experience.

3) What are the most common requests of companies? Do they have any knowledge gaps? Which corporate roles do you work with more often?

Requests from companies are very different, but they all relate to innovation and strategy. In fact, those who contact me more often work in the top management. They heard about my work and ask me to develop a specific project for them. Regarding the gaps, a common denominator is the lack of skills in promoting basic technical knowledge: analysis and statistics.

4) Why do we need statistics?

Statistics is often perceived as a more complicated form of “mathematics”. But statistics is part of everyone’s life and has an irreplaceable role. Statistics describes each phenomenon in our life, from car insurances to electoral surveys. In companies, statistics is even more valuable, because it’s often the only tool able to make us understand the factors that influence business results: both technical and economical. Statistics allow companies to broaden horizons and find new solutions. The effect is equivalent to what you get by wearing a pair of glasses, they suddenly make see what you could not even manage to imagine. Those who renounce to the statistical approach, do so only because they do not know its power. As a “cultural mediator of statistics” I assure you that, once companies use statistics, they no longer take decisons without it. This shows “statistics” are not so complex. All it takes is the right guidance at the beginning and a bit of motivation!

5) When can we consider a product as compliant?

Let’s take the example of food contact materials and objects. A sample subjected to analysis can be declared compliant with release limits set by the law only if we know the value of the uncertainty of measurement. International Regulations states that a production batch can be declared compliant only if the value of one of its representative samples falls within the area of “conformity certainty”. This area is determined with a statistical approach, simply by subtracting the value of the uncertainty of measurement from the legal limit. So it is precisely the uncertainty of measurement the (statistical) value we need to determine, in order to be sure that our products are safe and can be put on the market.

6) What do you mean by uncertainty of measurement?

I don’t not mean to be provocative, but the uncertainty of measurement today is a “must have”, like Chanel’s little black dress! The number of laws and regulations that require it is growing and the calculation is simple and often intuitive. All accredited laboratories have the obligation to provide it to the customers who require it, even if few of them know it and even less explicitly ask it when they commission tests on their products. Knowing the uncertainty of measurement is therefore immediate if you hire an accredited laboratory (n Italy by Accredia) and has no additional costs. In fact, the calculation of the uncertainty of measurement is an indispensable prerequisite for obtaining accreditation of the tests by Accredia. Should I have to explain the uncertainty of measurement in a simple way, I would say that the uncertainty of measurement indicates how much flexibility is allowed around a reference value that is generally the average value of the products of a lot. In practice, the uncertainty of measurement tells us how accurate and precise a measurement is. People working in the company are aware of the role of tolerances, applied to a property of a product, because nobody draws up sales documents without identifying an area of ​​tolerance. The uncertainty of measurement has the same important role when it comes to test results and, at times, can also be related to product tolerances. But I want to stress that the uncertainty is always determined through a statistical study, while tolerances rarely have a statistical approach.

7) What is an interlaboratory?

An interlaboratory test, also called Round Robin Test, is a well-known statistical experiment, and since a few years, also widely regulated at international level through ISO Standards. An interlaboratory test involves several laboratories that are compared by examining the same sample. The important goal of these tests is to assess how much the result of a measurement can vary, if the same product is tested by different labs. An interlaboratory test provides a clear answer to the doubt that many companies have: why if I send the same sample to more than one laboratory, I get different and often contrasting results? Actually, those who have this doubt do not take into account the role played by uncertainty of measurement. In these cases, it is right the uncertainty of measurement that resolves every doubt. Lukily, an interlab is one of the most effective means we have to obtain a reliable assessment of the uncertainty of measurement. It is no coincidence that the reference laboratories such as JRC, in case of food contact materials, use interlaboratory tests to guarantee the European Commission and consumers on the effective capacity of labs to carry out the tests.

8) Which are the Standards that regulate an interlab?

The importance of interlabs has always been recognized worldwide, and for this reason two international ISO standards have been developed: UNI ISO 13528: 2016 “Statistical methods used in the evaluation tests through interlaboratory comparisons” (for the implementation of the statistical plan) and UNI CEI EN ISO / IEC 17043: 2010 “Conformity assessment – General requirements for inter-laboratory evaluation tests” (for the organization of the activity and for the reporting of the test). Each interlaboratory test involves the drafting of a very detailed report that must contain all useful information, including the description of the statistical approach used.

9) Who can participate to an interlab? What is the advantage for the labs?

Interlaboratory tests are open to all laboratories: external labs, company labs, accredited or not accredited labs. The advantages are many, but the most significant: each participant can assess his performance compared to the others (expressed in the Z-score parameter) and is able to understand if his analysis are “state of the art”. Participation in interlaboratory circuits, in the case of accredited laboratories, is a mandatory obligation in order to maintain the accreditation. According to international requirements, specific tests can only be accredited if run by labs which participate in an interlaboratory test, for that type of test, at least every three years, and if the results obtained in these tests are adequate (z-score values ​​below 2). Interlaboratory tests qualify labs’ ability to perform tests with certain levels of precision and accuracy. Interlaboratory tests have legal significance when they testify the ability of a laboratory to perform the state of the art, as often referred in laws. For these reasons the laboratories are increasing their participation in interlaboratory circuits, even if this implies increasing costs. The participation to a circuit has the cost of several hundred euros for each sample analyzed and often samples are different, especially if there are several operators to assess on the test of each laboratory.

10) What is the difference between accredited and non accredited laboratories?

It is very easy to remind the significant differences between accredited laboratories and non-accredited laboratories for certain tests (note: accreditation is issued for individual tests and is not extended to all activities of the laboratory). Accredited laboratories have the obligation to calculate, and make available to the customer, the value of the uncertainty of measurement. In addition, accredited laboratories have the periodic obligation to qualify and demonstrate their ability to perform state of the art tests through the participation in the interlaboratory circuits. This participation also allows confirmation, or fine tuning, of the uncertainty of measurement value declared by the laboratory to customers. Customers can ask to include in contracts with labs their right to see the results they scored when taking part to interlab circuits. This is not required for non-accredited laboratories.

11) Do you need to be accredited to participate to an interlab?

No, as I said, it is not necessary to be accredited to participate in an interlaboratory circuit. In fact, the statistical test, which is the base of the circuit, is a such a valid method that always allows to identify laboratories that do not perform regularly and that can’t be considered qualified to run the tests, regardless whether or not they have been accredited.

“…an interlaboratory test provides a clear answer to the doubt that many companies have: why if I send the same sample to more than one laboratory, I get different and often contrasting results?”

“…uncertainty is always determined through a statistical study, while tolerances rarely have a statistical approach”

“… if knowledge is power, then quantifying through numbers is the best way to support business decisions, even the most critical and strategic”

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