The document discusses measurement risk and its potential impact on manufacturing processes. It defines measurement risk as the probability that measurements incorrectly influence acceptance decisions about products. Measurement risk can lead to accepting defective products or rejecting good products. The document outlines various factors that contribute to measurement risk, such as instrument reliability and calibration processes. It provides examples of measurement reliability calculations and highlights how ensuring instrument suitability and proper application can reduce measurement risk.
The document discusses measurement risk and its potential impact on manufacturing processes. It defines measurement risk as the probability that measurements incorrectly influence acceptance decisions about products. Measurement risk can lead to accepting defective products or rejecting good products. The document outlines various factors that contribute to measurement risk, such as instrument reliability and calibration processes. It provides examples of measurement reliability calculations and highlights how ensuring instrument suitability and proper application can reduce measurement risk.
The document discusses measurement risk and its potential impact on manufacturing processes. It defines measurement risk as the probability that measurements incorrectly influence acceptance decisions about products. Measurement risk can lead to accepting defective products or rejecting good products. The document outlines various factors that contribute to measurement risk, such as instrument reliability and calibration processes. It provides examples of measurement reliability calculations and highlights how ensuring instrument suitability and proper application can reduce measurement risk.
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Agenda
What is Measurement Risk?
Where does Risk Creep into Your Process? Where does Risk Creep into the Calibration Process? Calibration Results: Impact on Your Process Question and Answer Session
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What is Measurement Risk? Measurement Risk is the probability that measurements are incorrectly influencing the acceptance decision on your product. • This can impact your company in many ways: – Acceptance of bad product, which can lead to negative results ranging from consumer dissatisfaction to fatalities and lawsuits. – Rejection of good product, which can lead to negative results ranging from unnecessarily scrapped or reworked product to wasted resources performing superfluous impact analyses. It is possible that some of your rework, scrap, recall or any problems with released product are the result of unbridled measurement risk. How can you determine if measurement risk is a problem in your manufacturing process? Let’s refer to this in the positive term of Measurement Assurance.
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Where does Risk Creep into Your Process?
Measurement Assurance encompasses a number of assumptions in your
manufacturing process: 1. Product Acceptance You made the right decision about the acceptance or rejection of your product (or a component of your product) during the manufacturing and quality acceptance process. 2. Basis of Decision The decision was based (partially or completely) on quantitative information provided by one or more measuring instruments. 3. Suitability for You made the right choice in selecting instrument(s) Intended Purpose that are appropriate for the measurements in your process. 4. Instrument The instrument(s) were used correctly in the Application manufacturing process.
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Where does Risk Creep into Your Process?
Measurement Assurance encompasses a number of assumptions (con’t):
5. Beginning of The calibration of the instrument prior to your decision about Period Reliability the product indicated it met its performance expectations. 6. End of Period The subsequent calibration of the instrument following your Reliability decision about the product indicates that it continues to meet its performance expectations. 7. Calibration Process Both calibrations were executed correctly. 8. Non-Conformance If a calibration indicates that the instrument failed to meet its Review performance expectations, your quality system reviewed any impact to the decision(s) made about your product(s) that were based on the quantitative values presented by the instrument. 9. NCR Accuracy This impact study was thorough and did not miss the mark on determining any detrimental affect on product. 10. Risk mitigation Any negative result from the impact study was properly mitigated to remove or reduce product risk.
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Where does Risk Creep into Your Process?
Measurement Assurance Reliability • If a value from 0.00 to 1.00 is
(Summary) assigned to each of these Product Acceptance 1.00 factors, then a total reliability figure can be calculated to Basis of Decision 1.00 indicate the health status of Suitability for Intended Purpose 1.00 your Measurement Assurance program. Instrument Application 1.00 • This is accomplished by Beginning of Period Reliability 1.00 multiplying the assigned End of Period Reliability 1.00 values. Calibration Process 1.00 • If all factors have a reliability of 1.00, then overall Non-Conformance Review 1.00 Measurement Assurance has NCR Accuracy 1.00 a reliability of 100%, indicating that no Risk Mitigation 1.00 Measurement Risk is present.
Better by Your Every Measure • 800.828.1470 • www.transcat.com
Better by Your Every Measure • 800.828.1470 • www.transcat.com
Where does Risk Creep into Your Process?
Suitability for Intended Purpose (3) – This means that the
instrument selected: • Measures the right parameter(s) (e.g., voltage, pressure, temperature, length, et.al). • Provides valid measurement results, meaning that the instrument is accurate and stable enough to provide useful information. • Can sustain the environmental conditions to which it must be exposed while in use and still provide valid information to the user. • Is user-friendly at a level commensurate with the education/experience of the operator so that errors are not introduced through improper use/application.
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Where does Risk Creep into Your Process? Instrument Application (4) – This means that the instrument is being used as designed by the OEM. • Incorrect use introduces errors into the measurement process, which will change the decision of the outcome for the part/product. SPRT Entering the wrong coefficients into the display, causing temperature w/Indicator readings to be off (sometimes significantly). Calipers Dropping the calipers, causing a nick or burr on the jaws to interfere with the measurement. Torque Wrench Operator error can introduce upwards of 10% error! Dry Block Using the wrong size insert for the temperature probe; Not Calibrator compensating for axial or radial uniformity errors; overloading the dry block – all of these introduce errors into the perceived temperature being generated by the dry block. Oscilloscope Lack of understanding bandwidth constraints; using the instrument above the frequency cutoff for bandwidth will provide low amplitude readings, causing errors in your decisions about the product/test quality.
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Where does Risk Creep into Your Process?
Beginning of Period Reliability (5) – Some food for thought:
• Did you order the instrument and put it right into production without having it calibrated first? • If you relied on the “production cert”, this is not always a guarantee that the instrument performs within the OEM’s stated performance specifications; often this is simply a statement that the instrument went through an operation check or production test that only guarantees it is functional. • Was the initial OEM cal ISO 17025 accredited? Often this is not the case. • For recalibration of the instrument, was the instrument returned to you in a condition that is ‘close’ to being OOT? How long will it maintain this condition during the current usage period?
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Where does Risk Creep into Your Process?
End of Period Reliability (6) – This is the most critical
information that must be evaluated in order to close the loop on your measurement assurance program: • Was the instrument found to be OOT? • Was the instrument found to be In Tolerance but close to being OOT? • What impact does the lab’s uncertainty have on this condition? • How do you apply this information to the use of the instrument during its last usage period?
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Where does Risk Creep into the Calibration Process?
What are the measurement parameters, or functions, on
the instrument you are submitting for calibration? Are there multiple ranges/values on the instrument? What is the accuracy of these ranges/values? Is the lab capable of performing calibrations for these parameters/functions/ranges/values? How does their measurement uncertainty compare to the tolerances of the instrument? Will they be able to provide a valid result that is meaningful?
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Where does Risk Creep into the Calibration Process?
What test points will they check on your instrument?
What tolerances do they apply? Are they the same as the ones stated by the OEM? If you have decided to use tolerances that are different than those stated by the OEM, does your calibration provider know this and apply them to your calibration? Is the calibration technician competent to perform the calibration? How would you know? Is the calibration report easy or difficult to understand?
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Calibration Results: Impact on Your Process
NCR Review: Whether or not your quality system mandates
it, this step can save you money, can prevent safety problems from occurring, and can prevent negative marketing resulting from bad product being released. • Again, this evaluation is often under-executed resulting in the false perception that there is no impact to the product. • Transcat offers consulting in this area to help your engineers and quality personnel to understand how to get the most out of an impact evaluation. • How many OOT-NCR evaluations have you had in the past 5 years?
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Calibration Results: Impact on Your Process
NCR Review (continued):
• How many of these had a negative impact on your product? • Answer one simple question: If the answer is zero or nearly zero, then is this because you have such a well designed measurement assurance program that it always prevents an impact to the product? • If it seems too good to be true, then you might consider the quality of the evaluations being performed. • Also, an external auditor might not believe you’ve designed a system that is so good that you’ve never experienced a problem with your measurements that affected product.
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Risk Mitigation in Your Process
If you have discovered an OOT condition that may have
negatively influenced your decision about the acceptance/rejection of product, consider this: • If the OOT condition caused you to reject good product, then it is in your best interest to determine how much this cost your company in: – scrapped product – rework costs – OOT-NCR evaluation costs
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Risk Mitigation in Your Process
If you have discovered an OOT condition that may have
negatively influenced your decision about the acceptance/rejection of product, consider this: • If the OOT condition caused you to accept bad product, then it is in your best interest to determine how much this cost your company in: – consumer perception of a troublesome or faulty product – liability suits for safety issues resulting in property damage, medical costs, or fatalities • Determine root cause to reduce or prevent these costs from recurring.
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Measurement Assurance / Measurement Risk In the end, running your business is not only about international, federal, customer, or internal requirements, policies, or procedures – it’s about making a safe, reliable, superior product that fills a need/desire in the market place and is profitable for your company. Measurement Assurance should be designed to help you minimize risks in your decision making process about your product’s safety and quality. Too often it is not fully implemented (all 10 categories), causing the reliability of your Measurement Assurance Program to lose value and become ineffective. If you’re going to put the effort and money into only some parts of this program, it will likely cost you more elsewhere through rework, recall, or consumer perceptions. Make your Measurement Assurance Program robust so that it works for you to keep the cost and safety dogs at bay!
Better by Your Every Measure • 800.828.1470 • www.transcat.com