The What and Why of Trace, Track & Control
By W. Scott Fillebrown, Chief Technology Officer of Libra Industries, Scott.Fillebrown@LibraInd.com
We think of traceability as a process for the medical or military OEMs who were supported by the large EMS companies. It was not long ago that this was actually the case. This was driven by the large investment to internally develop the MES software tools to manage the traceability. That is not the case anymore. There are several ‘off-the-shelf’ MES systems to choose from: Aegis, Cogiscan and Valor to name a few. In this article, any features or capabilities mentioned will be based on the Cogiscan software and hardware. First and foremost it is important to know what it means to have a Trace, Track and Control system in place.In this day of governmental regulation, litigation and cost control, it is surprising how few EMS companies have implemented full traceability in their facilities. On the other hand, if you consider how few OEMs require traceability, and understand its importance, maybe it’s not so surprising. We live in a market-driven economy where demand creates the supply. The fact of the matter is: EMS companies should not wait for traceability to be demanded and customers should be requiring it.
So many people see the traceability portion simply as the ability to know the processes that the circuit assembly went through at their EMS provider. However, true traceability starts at with supply chain and ends at customer delivery. As a basic starting point, on the supply chain side it is imperative to know the date and lot code, for the EMS provider to know the steps and the equipment used, and for mechanical assembly to know the serial numbers of the boards and test/burn in results. For most FDA and aerospace products, you need all of the details of the processes so that it can easily be demonstrated that the same steps are used successfully for each rebuild. On the other hand, for commercial products it is important to have the ability to know what to recall if an issue arises. If you have the ability to trace, then you have the ability to track – the next important part of the system.
Being able to track not only helps with locating product throughout the process, but it also helps in knowing where your materials are on the manufacturing floor. Knowing these two items helps with performance goals in both product flow and continuous improvement. A simple example is tracking where defects occur and where they are caught. In this case, you can gain insight to where your processes may need to be improved, systems calibrated, or people trained. If this is done correctly, product will flow through the facility faster; thus, increasing margins. The key is to have the proper controls in place to improve performance.
As you look at the control side of the system, it is important to consider more than just acceptability standards. While having the proper reports allows you to have acceptance levels for both personnel and equipment, it also will ensure that all required processes have taken place and will be repeated for each run of the product. In the above example, if a defect takes place then the next step required is a rework and a retest. The control element is responsible for ensuring that the defect is recorded, preferably through an automated approach (like a CAMX Adapter IPC-2546), and that there is a forced rework route in the electronic traveler. This is typically called a branch route and would include a retest step. As we have gone briefly through each of the three key components, you may be asking yourself: why would an EMS provider ever want to implement such a system?
Trace, Track and Control is important to an EMS company for several reasons. The first item on the list is the doors it opens for new customers. Properly implemented, the system will support the requirements for ISO-13485, FDA and AS-9100, as well as larger OEMs’ production requirements. However, the system can do so much more for the manufacturer. In one facility, the management noticed that solder defects seemed to be trending higher so they ran a report showing defects by printer. The results were very clear – one of the printers had more than double the solder defect rate than the other printers on the factory floor. By tracking the board flow through the facility, they were able to take control of the process by replacing the printer and reducing the solder defect rates. You could run the same report for type of solder paste, by employee or by customer just to name a few. With EMS margins shrinking, there is more pressure to run lean and spend your capital where you know you need to, not where you think you need to. With the proper systems and reports in place, EMS companies should have the knowledge to make razor sharp decisions on what, why and where to spend their precious resources. For many of the same reasons, the OEM looking for an EMS provider should require a full traceability facility.
The top concerns of most OEMs are quality and assurance of supply at the lowest possible price. As an OEM starts the search for an EMS supplier, they have the challenge of finding a supplier that meets these three qualities. By far, the easiest of the three is price. If price were the only variable that mattered, then you could pick a few supplier, have them quote the work, and boom you are done. Unfortunately, life is not that simple. Free puppies are the most expensive pets you will ever have! The same is typically true if you choose an EMS supplier on price alone – the cheapest vendor could have huge long-term costs. These costs could be hidden manufacturability issues or could be as catastrophic as a recall.
One of the best approaches to choosing your supplier is to understand their MES software and how they utilize it. It is one thing to have an electronic shop floor traveler, but is another to have a system that allows you to understand what is actually happening on the manufacturing floor. The Trace, Track and Control system should allow the EMS provider to give you a competitive product with the feedback for cost reductions and the ability to improve throughput over time. You will have the peace of mind that the steps called out on the traveler were followed, manufacturability improved, and God forbid if a component vendor calls to tell you that you have a bad date code on a component, you have a partner to support you in the recall and repair of your product. Bottom line, certifications indicate that the EMS vendor has the processes in place, while Trace, Track and Control prove it.
In the end, it is in everyone’s best interest to have a Trace, Track and Control system in place. Whether you are an EMS facility wanting to improve and open new markets, or an OEM wanting to know that you are getting the best quality and most reliable product for your money, there is peace of mind knowing that process have been documented and followed in a platform that leads to constant improvement across the board.
W. Scott Fillebrown is the CTO of Libra Industries. He has over 25 years’ experience in the electronics industry. Scott graduated from the University of Texas – Dallas in 1989 with his B.S. in Business Administration with a concentration in Marketing. He is well versed in finance, manufacturing operations and marketing. His out-of-the-box thinking towards manufacturing has led to numerous awards for revenue growth and technology advances.
Libra Industries is a leading provider of integrated Electronic Manufacturing Services (EMS), serving OEMs with complex or technologically sophisticated manufacturing requirements in a broad range of industries including industrial automation, medical, military and aerospace, instrumentation and LED lighting. Five world-class manufacturing facilities allow Libra Industries to provide customers with manufacturing flexibility including complete system build, module and subassembly production, as well as simple to complex PC board assembly. With an ongoing commitment to investment in people, quality systems, and the latest manufacturing equipment and processes, Libra Industries is committed to managing their clients’ products from initial design and prototype to full production; assisting their clients in their efforts to improve time to market, reduce total systems cost, and increase quality.
Originally published by Electronics Production World, see article here.
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