Monthly Archives: November 2011

BIOMEDevice Show

December 6-7, 2011, San Jose, CA, 10am-4pm

We will be giving a seminar called “Innovation in Medical Product Design”. Register at: MD&M

Sometimes no matter how well your vibration fixture is designed, you absolutely MUST use two or more control accelerometers to get all the way through your test spectrum. Now I’m NOT talking about using multiple control accelerometers to make a bad fixture work, there’s no excuse for that, I’m talking about a large, complex fixture that is designed optimally, but you can’t get around the laws of physics.

If you decide to control on the average of the accelerometers, fine, but understand what is really happening. When you look at that beautiful post test plot that shows you ran the test right in the middle of the spec, it’s an average of what really happening. Now look at the individual plots of each accelerometer. That’s the truth, and what it will show is that at some frequencies in some locations you have over-tested, and at some frequencies in some locations you have under-tested.

If you are concerned about your test specimen breaking due to the over test, then go ahead and don’t average, but instead control off of the peak values. You won’t over-test, but certainly when you look at the individual control plots you will find that there are places where you under-tested. Conversely, if you are concerned about under-test and not qualifying to the specified environment, then go ahead and control off of minimum values. Now your individual plots will show that you tested to the specified amplitudes everywhere, but will also show where you over-tested.

In summary, the “averaged” post test plot or the plot showing the combined peak or minimum, will look nice, but you REALLY need to look at the individual plots to see what ACTUALLY happened.

Medical Risk-Based Testing
with IEC60601-1 3rd Edition

by Ops A La Carte, part of the Ops monthly webinar series.

Friday December 2nd, 8:30-9:30am PST

The medical industry is moving in a similar direction to many other industries – Risk Based Testing. We will discuss what this means and how to comply. We will highlight each of the clauses in the document and help you decode what each means and how to comply. But more than that, we will show you how to change your approach to testing so that any test you consider, you think of the risks involved before you plan out the test.

It starts with Risk Management (work with Notifying Body / Test House, Regulatory Agencies, Regulatory Affairs Department). FMECAs, FTAs, Fishbone, etc. (Hazards & Risks). Use, Design, Process, and Software FMECAs are typically used as well as System Hazard Analyses. ISO 14971:2009 Application of Risk Management to Medical Devices also plays a big part.

Register at:

Contact Us Info For more info or to register.


Solar Reliability Webinar

on Nov 10

Thursday November 10th, 9-10am PST – FREE WEBINAR on Reliability in the Universe of Solar Products, by Ops A La Carte and Concurrent Design, part of the ASQ Reliability Society webinar series.

The universe of solar products is large and expanding rapidly. Of all of the emerging clean tech industries, the solar industry is one of the most challenging from a reliability engineering perspective because the industry is innovating so rapidly. Customers (and investors) are demanding very high reliability products, commonly requiring a minimum 25-year operating life.

Each aspect of a solar product must be considered for reliability. For example, in a solar power installation, the cells, the panels, the trackers, the inverters, even the installation itself, there are opportunities for failures. Join us for a quick trip through the Solar Universe and the many faces of Reliability Engineering in this rapidly expanding sector. The presentation will include technical information on the benchmarking, reliability, life cycle and end-of-life susceptibility of components in solar products.

Register at:

Contact Us Info For more info or to register.

In order to gain cooperation with the supplier, the key point is to look at your improvement objective in the eyes of the supplier – “Why should I do this”?  “What’s in it for me”?    The intent is to bring value to the supplier as well as the customer – both to win/gain!

GAIN WHAT – reduction in cost!

How do we do this?  There are tools/methods such as:

  • SMED – Single Minute Exchange of Die – How does help?
  • VMI – Vendor Managed Inventory

Who is using such inconcert with your suppliers?  We will explore each on future blogs – please provide your comments both supportive or otherwise!

A client developed a novel FMECA technique that I think has much to recommend it. A key difference lies in the way “Occurrence” is handled. Generally, when we develop a FMECA, we assign a somewhat-arbitrary number (1 – 10) to the occurrence factor. In this approach, the failure rate (in FIT’s) is used for each of the components. The total of the FIT’s for the components in the subsystem considered is then used to normalize the FIT for each component. In this way, the most critical components can be determined. The total can also be rolled up to the next higher level. Another feature of this approach is that the failure mode of the component (for example: open, shorted, parameter change) can be included in the analysis since, in some cases, a particular failure mode can have a more deleterious effect than another.

The main advantage of this approach is that it removes some of the arbitrariness of the standard approach. A challenge however, lies in finding the FIT values (and especially the ratios of the failure modes) for some of the components.