November 29, 2011
There have been a few (including those here, here and here) Class I product recalls of medical devices in the past month or so, particularly in regards to infusion devices having a higher flow rate than specified.
The financial repercussions are relatively obvious, but what’s less obvious are the root causes for these device failures, especially since they come from several different manufacturers. What kind of evaluation processes would a quality engineer have to run through in order to determine the reason for failure? How would his or her team have to prove the strength of their design, particularly since 2010 the FDA has been focused on preventing problems with infusion pumps due to a perceived deficiency in design and engineering? What kinds of test data would they have to show to the FDA to validate the quality of their product, and more importantly, ensure patient health and safety?
July 28, 2011
IntraStage is going to have a booth at NI Week in Austin next week,.
If you’re going to be at NI Week, come by and visit us at booth 526-if you haven’t used our software before, take the opportunity to test out our fully functional demo software. If you’re an existing customer, come by and get some of our giveaways. And we’ll be announcing a new addition to the IntraStage software catalog, so check that out and the accompanying iPod contest.
July 18, 2011
It’s a daunting challenge for a Contract Manufacturer (CM) to aggregate and report data to a customer. Typically, they have to use manual labor to take the appropriate data, parse it into their system, and manually crunch the data (using Excel sheets or similar tools) to generate the report. The man-hours necessary from technicians, management and analysts can quickly add up and the labor costs can eat into the profitability of the contract.
In the next few years, the ability to provide on-demand test data for review and analysis will provide contract manufacturers with a more compelling partnership proposal, especially in comparison to other CMs which don’t offer their customers with visible, clear test data. Those that do offer data and teamwork to the customers will have the upper hand in proving the quality and efficiency of their labor, equipment and processes to prospective and current partners. To all our CM managers: how much nonproductive time do you spend aggregating data for your OEMs?
July 6, 2011
Although there has been much talk about (and some hype perhaps) on the recent affect of the Japan earthquake on the electronic supply chain, it hit home for me when I was visiting an OEM Electronic Manufacturer this past June. They talked about how some of their components like oscillators and capacitors etc which were normally sourced from Japan manufacturers were now needing to be sourced from secondary and tertiary suppliers. Although of the same general specification, these parts turned out to be of inferior quality, causing failures when cycled over temperature or under corner conditions of testing. This has forced this customer to focus on more extensive testing and qualification of supplier components.
Maybe if the OEM customer received the quality data on those incoming parts, they could do their own analysis of where things are breaking down between incoming quality and what they are actually testing. An interesting article on the effect of supply chain components from the Japan Earthquake is here: http://www.ebnonline.com/author.asp?section_id=1096&doc_id=207372&itc=ebnonline_gnews
June 28, 2011
As Original Equipment Manufacturers (OEMs) seek closer ties with their Contract Manufacturers (CMs) in order to more fully control their supply chain during this uncertain economic climate, expectations on those contract manufacturers are evolving. OEMs are purchasing or implementing solutions that will allow greater visibility of their manufacturing and test results, combining the data from in-house and outsourced manufacturing.
Many large CMs already offer these types of tools to their OEMs; however, integration of software often requires significant time and expense, and few CMs can afford the cost. When these tools are in place, the transparency can lead to yield improvements and faster detection of issues and root causes.
We discuss this issue over at a LinkedIn discussion group here. We encourage anyone who reads our blog to join that group and contribute to that (and other) test data management discussions.
June 13, 2011
The last couple of weeks we’ve been blogging about the issues and challenges OEMs face when dealing with contract manufacturing. One particular problem we hear again and again from OEMs is how difficult and time-consuming it is to obtain a true record of test data from contract manufacturers (and forget trying to get real-time data). Conversely, we’ve heard from CMs that they want a better way to manage and report their manufacturing data, especially if they’re producing components for multiple OEMs. Particularly if the CM’s contract dictates that they eat rework and scrap costs, they’ve been interested in refining their processes as efficiently as possible, but this is especially difficult without real-time, accurate manufacturing data.
With upcoming software releases from IntraStage we will be implementing additional Supply Chain module features which will help to solve what we observe to be critical problems facing both OEMs and CMs. But the best way to solve these problems is to get feedback from our customers who are people deeply involved in this area. So please, let us know about your experiences good or bad. We would love to hear them.
May 31, 2011
OEMs which work with contract manufacturers have to follow the old adage: trust but verify. We all carefully vet and work with prospective partners so we can know that we’re working with entities whom we can trust to perform to our expectations. In the case of the OEM and CM relationship a major piece of this trust is visibility and transparency on manufactured product quality.
However, it’s difficult for some OEMs to gain comprehensive insight into the manufacturing processes of their partners and dig into critical details such as SPC, Yield Failures, etc. Even the contract manufacturer might not have the capability to fully calculate the impact of quality on their own operations.
One method to handle this is through “Supplier Chargebacks”. This is a punitive process, which are monetary penalties charged by OEM Manufacturers back to Contract Manufacturers for non-conforming material or products. The charges can include not only the costs for the low-quality product, but also for:
- Eventual disassembly of the part
- Quality department handling
- Handling by the planner to get a new part
- Communications with the supplier – what shall be done with the part?
- Attention from engineers
Standard best practices from OEM’s now incorporate these metrics into a “scorecard” format which are given to the Contract Manufacturers as part of their Continuous Improvement initiatives in the supply chain.
A critical overriding metric in these scorecards are concepts such as “PPM (Parts Per Million) or “DPU (Defects Per Unit)”. This is a threshold number which the OEM sets on incoming defective units into their facilities. For example a score of 50PPM would mean that the CM would have to provide less than 50 units which have failed out of 1 million.
A more proactive versus punitive method of handling such PPM or scorecard processes, would be to have the CM understand the quality of their product before shipping even begins. Such methodologies as SPC or RealTime SPC would give the CM that edge to win on the metric. A collaborative process such as this could well save both the OEM AND CM money, time and resources.
May 24, 2011
I was at the May 2011 Del Mar Electronics (http://www.vts.com/delmar/) tradeshow a couple of weeks ago and attended a seminar called “Counterfeit Electronic Components Workshop”. I had a conversation with a couple of attendees and speaking guests on the impact of counterfeit electronic components (capacitors, resistors, integrated circuits etc). The definition of a counterfeit electronic part is one which has had its deliberately misrepresented by the supplier. ‘Identity’ includes such things as manufacturer, cage code, part number, date and lot code, reliability level, testing, inspection etc.
One surprising statistic that was thrown around is that up to 40% of electronic components going into manufacturing OEMs like Apple can be counterfeit. Depending upon how the components are screened, this can lead to defective, out-of-specification or completely not working end products (ie…an Ipod). The impact of this can be large, not only from the loss of money from purchasing the counterfeit parts but also downstream from the manufacturing cost, to the testing cost to the eventual rework and discovery of the issue.
Bill Cardoso (Creative Electron Inc) who spoke at the Seminar talked about how some 3rd party companies help OEMs catch such counterfeits through techniques such as x-ray, visual inspection, Encapsulation and Electronic Testing. Unfortunately in some cases, the counterfeit can be subtle in that resistor/capacitor/inductor values or even older generation (but functionally the same) IC parts have been misrepresented in order to get them out of someone’s inventory and sold to an OEM. In this case, the functionality of the end product may still be there but the performance may have been degraded due to these subtle value differences.
In the case of aerospace, space or medical applications which need very tight performances on critical parameters, another methodology to catch possible counterfeit components is to monitor measurement trends. The chart below shows a measurement trend (y axis=RF power, X axis=date range of serials tested). As you can see on 8/09 something happened with the measurement which shows that perhaps some component value had changed. Was this a counterfeit component that caused this variation or was it normal? By looking at trend charts like this, at least the investigation can start.
May 16, 2011
There’s an interesting article (link courtesy of CNN) the other week about the rash of consumer electronics that are being shipped to end customers with minor (and at times major) deficiencies in functionality. An important quote from the article reads “Often, companies launching complex hardware-and-software packages are forced to make compromises in order to meet deadlines,’ said Harry Wang, a mobile analyst for market research firm Parks Associates.”
It’s crucial for test data engineers to keep this development in context: if businesses find a quantifiable value in rushing production schedules before a product is fully polished, then it’s important to maintain a steady grasp on your component quality trends before they ship for final assembly. If you aren’t paying attention to your SPC and quality data as the components are being manufactured, there won’t be any second chances or cushion time before the product is in the hands of the consumer-and, unfortunately, test data engineers will inevitably have to shoulder much of the difficult and time-consuming recall and warranty return processes triggered by such an inflexible timetable.
May 9, 2011
I just sat in a product roadmap meeting for IntraStage versions 4.4 and 5.0, and it looks like we have some exciting changes coming.
The development team has been busy soliciting design changes from our customers, and they’ve been working on some significant modifications and improvements to the IntraStage solution.
Stay tuned: we can’t say too much more yet, but we’ll give some details closer to the V4.4 and V5.0 release dates scheduled for later this year.
