Quality Progress - January 2016 - (Page 22)

BACK TO BASICS Best of SEPTEM 2010 BER BY SCOTT STAMM Assessing Failure The effect of faulty measurement on previously produced products A MEASURING instrument, gage or device sometimes in large organizations, measur- the highest range in the counter-clockwise failed recalibration, and you have been ing devices are sent to the metrology area direction but is used only in the lowest asked to determine the influence on previ- for inspection and recalibration with no range in the clockwise direction, there is no ously produced products. Where do you explanation. harm to previously produced products. start, and what do you do? For the third step, carefully review how Another method used to understand any the gage or instrument is used and the char- possible harm is by partial vendor product be a problem. If a gage or instrument is out acteristics it measures. This is especially processing. The vendor may duplicate of calibration that was used to measure a true for functional gages that are specifically the failed measurement or a proxy of the product, all products made since the last designed to measure a single aspect of a measurement. In addition, if your organiza- known successful calibration are suspect product. Intimately understanding how the tion has a receiving inspection function, the and may need to be recalled. measuring instrument, gage or device is fail- actual failed measurement or a proxy of the ing is necessary, as it could lead to insights failed measurement may be performed upon 9001:2008 (clause 7.6) and the U.S. Food about the influence on previously produced receiving the product in-house. and Drug Administration's quality system products. To begin with, understand why this could Additionally, ISO 9001:2000 and ISO When all else fails, another possible requirements, among other standards and For example, point micrometers oc- technique may help determine any harm to regulations, require determining an out-of- casionally fail a calibration check because previously produced products: Examine an calibration gage's or instrument's influence the tips have worn off the points. The failure approved first article layout (FAL) of the on previously produced products. mechanism is that the point micrometers supplied material, such as forging, cast- understate the actual measurement. As ing or pre-finishing component. If the FAL Step by step such, any harm to products measured is to is approved and proven, and nothing has Start investigating the potential harm to pre- the high side of the tolerance. changed since its approval, it may be pos- viously produced products. First, determine If the dimension in question has bilateral sible to substitute the failed measurement if any actual products using this measure- tolerances, then the minimum tolerance side using the FAL as a proxy or determine the ment device have been made since the of the dimension is not in question-only minimums and maximums of a dimension last known successful calibration. In large the maximum tolerance. Look to subsequent in question. organizations with many SKUs, not all prod- dimensional checks, such as an optical ucts are regularly manufactured. Check this comparator or overlay check, that may in- as ammunition to avoid a product recall, before investigating how the measurement spect the maximum dimension. In addition, as a recall is sometimes necessary and device failed and its influence on previously compare the tolerances of the dimension appropriate. Rather, it is intended to help produced products. checked with the gage with the amount the an examiner ensure a full investigation is Next, while reviewing the influence on gage is out of tolerance. It is possible that completed. QP previously produced products, determine even though the gage is out of calibration, how the device was discovered to be out the amount is still within the tolerances. of calibration. Was the out-of-calibration status determined because of a scheduled Taking it a step further recalibration, or was it the result of a Additionally, check to see if the measure- specific event, such as dropping the gage on ment device's failure is in the actual use the floor? range. For example, torque wrenches are If it was the result of a sudden event, it usually calibration-checked at the low, is possible the gage or instrument was not middle and high end of their scale in clock- used after the event and there is no harm wise and counter-clockwise directions. If to products. This may seem obvious, but the torque wrench only failed calibration in 22 QP * www.qualityprogress.com This information should not be construed BIBLIOGRAPHY ASQ, ANSI/ISO/ASQ Q9001-2000, Quality management systems-requirements, 2000. International Organization for Standardization, ISO-9001, Quality management systems-requirements, 2008. U.S. Food and Drug Administration, 21 CFR 820-Quality system requirements, 1996. SCOTT STAMM is a senior quality engineer at Zimmer Inc. in Warsaw, IN. He earned an MBA from the University of St. Francis in Fort Wayne, IN. He is a senior member of ASQ and is a certified calibration technician, quality manager, mechanical inspector, reliability engineer, biomedical quality auditor, Six Sigma Black Belt, quality engineer and quality auditor. http://www.qualityprogress.com

Table of Contents for the Digital Edition of Quality Progress - January 2016

According to Plan
Solid Proof
Use Your Head
Stakeholder Management 101
Customer Delight
All About Data
Eight Simple Steps
Minimizing Chaos
Take Note
Pyramid Scheme
Assessing Failure
Which Six Sigma Metric Should I Use?
Turning ‘Who’ Into ‘How’
In the Beginning
Outputs and Outcomes
That’s So Random—Or Is It?
Understanding Variation
Improving a System
Putting It All on the Table
Know the Drill
It’s Fun To Work With an F-M-E-A
Solve Problems With Open Communication
Tell Me About It
Separate the Vital Few From the Trivial Many
To DMAIC or Not to DMAIC?
Breaking It Down
Smart Charting
1 + 1 = Zero Defects
QFD Explained
Curve Your Enthusiasm
Make a Choice
What Is a Fault Tree Analysis?
Successful Relationship Diagrams
The Benefits of PDCA
Creative Combination
Return on Investment
The Art of Root Cause Analysis
Why Ask Why?
Get to the Root of It
Checks and Balances
Calculated Risk
Sufficient Evidence
Sample Wise
Clearing SPC Hurdles
Supplier Selection and Maintenance
Team Advantage
Building a Quality Team
Plan Experiments to Prevent Problems
Substantiation Test
Training Day

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