Design for Compliance

Getting product compliant first time by design

At the big trade show customer after customer picks up your power converter product and says “This looks great but where is your CE mark?” And it has become clear that no matter what the sales people do they just cannot talk their way out of this. In order to sell into Europe the agent is insisting that the product be CE marked and the Chinese agent say the product needs a CCC mark for China. And it needs a UL mark for the USA.

Product compliance can be an expensive part of power electronics design when it is the last thing on the development program. Most likely the product will not meet some requirement and the test lab will send it back without it passing the test. And then it gets redeveloped all the while it is not getting sold. At ELMG our electrical design services take the required compliance into consideration before the problem arises, minimising any delays associated with this.

The CE mark gives access for products to the EU. This diagram shows what the mark looks like and how to get the geometry of the CE mark right. Products in the EU are covered by one or more of a number of Directives and each Directive has a list of harmonised standards that are identified as EN. This stands for EuroNorm.

Market access depends on compliance

To be sold in the EU power converters need a CE mark. Without the CE mark they are not guaranteed free movement over the EU border and possibly may be forfeit in the event that a complaint against the product is upheld. UL gives acceptance of power converters in the US and the Chinese CCC mark gives legitimate access to the billion people in China. There are other compliance systems also. NOM in Mexico and GHOST in Russia are examples. New Zealand and Australia have the common C Tick and the states of Australia have compliance systems also. When you look most products for the world need some type of product compliance. And the rules on product compliance need to be met by designing them in just like any other requirement.

How will this effect how we work?

As a good example design traceability is common in safety critical devices like medical and functional safety equipment. It means that the design requirements and design decisions need to be clearly documented to allow an auditor to check not only the outcome but the process also. This is based on evidence that shows that this is the best way to develop safety critical and medical technology.

In the case of the medical device it is often the case that there are more compliance requirements than there are actual product operational features and functions. Just as an example the main standard for Medical devices is IEC/EN60601 part 1. This standard is harmonized to a Euronorm, EN standard and has about eight hundred pages. Alongside all the requirements of this main are those from the device specific part 2 standard and the risk management and requirements traceability. The development effort in developing a compliant medical device is mainly about getting the device compliant. If this seems over the top then just remember that the medical device may well end up pumping morphine, or some other life threatening chemical, into you when you are in hospital. Each jurisdiction will require a medical device to conform to its own rules also.

The ELMG How to do Compliance Product – Design for compliance

The How to Do Compliance service is a set of six steps that will ensure product compliance by design with minimal cost. The first three of these steps are below but before them comes step zero. Step zero came about when we used the system and found that the first step is to make the product folders.

0. Create a product folder for each product as the one place to put the compliance information.

Create a separate folder for each product. One folder per product. Do not have common folders between products or even variants. And make it a real hardcopy folder. Put these folders on a shelf in the company where the design and development teams have access to them. Make an index page for the contents of the folder. Label the folders with the product name and the words Product Compliance File.

1. Collect the compliance requirements.

The compliance requirements are often defined by the country or jurisdiction where the device will be used. The EU, USA and China are three large jurisdictions with well defined requirements and wealthy customers.

Put this compliance requirements information in the product folder.

North American product compliance systems include the FDA who look after medical device safety and operation. The FCC administer radio frequency compliance, EMC interference and Telecomunication.

The North America Free trade Area NAFTA includes the USA, Canada and Mexico. Compliance systems for general electrical equipment in these countries are UL (Underwriters Laboratories), CSA (Canadian Standards Association) and NOM (Norma Official Mexicana). This NAFTA area contains up to three hundred and eighty million wealthy people who all need compliant products.

Product compliance for the EU is implemented by directives and harmonised standards. Products for the EU use the CE mark and declaration of conformity to demonstrate compliance.

2. Decide which regulation, legislation or rules cover your product

In order to make the product compliant the design team need to know what the regulations or rules for the product are. Finding these is often the hardest step. The key is to search for this information on a jurisdiction basis. Countries, states, free trade areas, political unions all have the ability to make these rules. Find the jurisdiction and find the rules.

Once again put this information in the product folder.

Product compliance for the EU is implemented by directives and harmonised standards. Directives for products include the Toy Safety Directive, The Pressure Vessels Directive, Machinery Safety Directive, EMC Directive and the Low Voltage Directive. These last three are the most common for electrical equipment. Products for the EU use the CE mark and declaration of conformity to demonstrate compliance.

The Chinese compliance system is CCC (Chinese Compulsory Certification). This involves type testing, factory inspection and follow up. CCC uses GB (Guobiao) standards which are similar to ISO and IEC standards.

3. Find which of the standards applies to your product – Look at competitors product compliance if possible

Standards often enact the regulations. Choosing the standard can be approached by looking at what your competitor does. And if your competitor does nothing this does not mean they have got it right. That said competitors’ products are worth a look. Often times it is clear from the competitors’ manuals what they have done to achieve compliance. And yes put this information in the product folder too.

Remember market compliance requirements for your product are well known before the product is designed and developed even if your product is brand new and you have no competitors. Simply find the compliance requirements. It may seem like a hard process. Keep in mind the markets that this can open up.

The Chinese compliance system is CCC (Chinese Compulsory Certification). This serves the compliance needs of products for the one billion Chinese people. The CCC involves type testing, factory inspection and follow up. CCC uses GB (Guobiao) standards which are similar to ISO and IEC standards.

Purpose

When we develop any product we always make it compliant for the market it is going to. Over the years we have seen more than a few great products disappear without a trace because other development teams did not design the compliance in. And we have also realised that lots of people and companies have never learned How to Do Compliance. Getting products compliant by design is how ELMG do compliance. It is cost effective and once your team can work this way compliance will become no problem.

We just thought that what we had would be all right if we made a few changes at the end of the development. And then the product needed redevelopment.

This “doing it at the end thinking” is a real trap. And often a trap that is aided and abetted by test labs.

There are good labs and bad labs. It is not always the case that test labs are like this but generally test labs make more money from products that fail compliance tests than from those that pass. Basically if you have a product, you have developed it, you take it to the test lab and do your compliance testing and fail they charge you for the testing. You go away, you change it, you come back and you get charged again. Now not all test labs have an interest in your failing because that is not actually too good for the overall economy. However there is the fact that test labs make more money if you test more and if your product fails you are going to test again.

So let’s get back to why it is best to design compliant product. Market access depends on compliance. And way back when the product is being thought about, conceptualized and what it is meant to do and how much it is meant to cost is being sorted is the time to sort the compliance. At that time the design for compliance process starts. This is the requirements process and the main reason for designing a compliant product is that it is way less expensive to do product development with all the requirements known. So put all the requirements in.

Testimonial from Brian Willoughby from Plinius Audio www.pliniusaudio.com

What were the obstacles that would have prevented you from  buying the How to Do Compliance service? “Simply lack of understanding of the whole process and probably not understanding what benefits we could get from doing it properly. In other words not understanding the value that we would gain from understanding it.”

What you found as a result of buying the service? “First thing was the discipline that resulted in us following your advice. Each product having its own product folder.Others results are

Following the routines and processes that brings results in fast. Production of new folders for each new product as we bring them on line for development.
A level of confidence from our senior tech about what compliance was actually about and an ability to design better test procedures in house that better test for compliance through the design/prototype process for new products.
Buying laboratory testing for things we can’t measure and are uncertain about instead of buying it for every simple test in the schedule, many of which we can do ourselves with confidence, has meant much lower costs for compliance testing.”

Would you recommend this service and why? “Every time! It demystifies compliance testing. It gets it inside the design process and it changes our relationship with the test labs where we understand exactly what we need done and why so that we can control the process, instead of delaying the expense until the end, when the goods just disappear and come back pass/fail. This all needs to be understood widely in the manufacturing community and become a part of design thinking from the moment the graduates start learning about designing things.”

Take a look at the success that Plinius Audio are having with CCC compliance for China as a result of ELMG Design for Compliance. Please note this link opens a new browser window.

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