Pressure to get product to market is stressful, as well as full of scenarios that most engineers and designers would like to forget about. Yet in the beehive of activity, the regulations that a product must comply with are critical to those design engineers, as well as other teams. So much, in fact, that a slight misstep early on or during the product life cycle can create devastating circumstances. Driven by market or other business issues some may succumb to the “limp factor” (LF): get it to work and ship at all costs for the first country or countries of use and worry about the others at a later time when the pressure is off. So, how can we prevent the LF from occurring?
Despite good intent, business operations may lack the understanding of what engineering and other teams need to determine the correct regulations, as well as how these same teams could be impacted by them in their daily jobs. Biz ops may believe word of mouth or an occasional e-mail is adequate. Information may dribble out from multiple sources, or it may be released in phases. All this non-value added activity is spoon feeding with potential for major issues down the road. Simply, a “Regulatory Roadmap” (RM) is needed. But what is it and what does it mean beyond a name that sounds good?
The RM is a global regulatory perspective for the product. But a slight twist exists; there is more than just the regulations. A robust RM should provide visibility across the organization, beyond that of engineering, and clearly link key product or customer criteria to the applicable regulatory requirement and the business team it touches. Groups such as distribution, quality, technical operations and sales and marketing can use the RM to see how they fit into the aggregate regulatory requirements and the impact on them. The effectiveness of the RM is only as good as the upfront effort placed into it along with the follow-up to maintain its accuracy over time. In preparing and developing the RM several key factors need consideration.
Business Discipline: This is required by all the business teams including sales and marketing, product planning, engineering, manufacturing, quality, distribution and supply chain to make the RM part of the jargon and working plan of the organization. It should be embedded as a deliverable to all organizations and made part of the program management scheme that monitors the product design, shipment and launch cycle. Practically speaking, the RM is active throughout the product lifecycle, from birth to end of life, and continued focus on it is required to maintain accuracy. Key staff, or champions, should be assigned to make this a real, live, breathing task as opposed to being a one time, one shot picture. One has to remove the organizational mindset that “it was complete when we first launched the product so that should be good enough.”
Staff Support: The RM is rarely a static entity. The champions noted above should partner with the right players to collect key information regarding the product and finalize on a method to deploy the RM on a routine basis throughout the product lifecycle. These champions should be multi‑disciplinary, having representatives from all functional teams. These players will determine who and what assignments are needed to complete the entire RM, as well as select a delivery method such as Excel or a database program. Unless one can guarantee they know other champions’ job and role, it is dangerous to “not invite” all the representatives to the RM building process. They must work as a team to prepare and distribute the RM to all parties needing it.
Control and Release: The RM should be under documentation and version control, be integral to the quality system, and be in the teams’ hands well ahead of critical milestones where this information would be needed to make product decisions. One example is the initial conceptual block diagram design of the product, where the product’s architecture is fundamental to meeting many specifications on a broad level.
Detailed Content: The content of the RM should not be underestimated or simplified. This can be a dangerous situation leading to serious implications. The key point is to get all business functions involved in its development so that the contents inside the RM can include each business operations input. It should include the general terminology such as Americas, EMEA, Russia and CIS, or Asia Pacific, but in addition be specific by the product model or type, down to the country, customer, launch date, how it will be identified to the market place, key specification or feature requirement and pertinent information on the market segment such as commercial or consumer, or governmental. The specifics on the product’s distribution plan such as direct import, dealers or distributors need to be identified for purposes of meeting import regulations that could be problematic if not accounted for.
Product Features: It is extremely important to consider product feature additions or upgrades and when and where they occur and in which product. Other factors must also be considered such as indoor/outdoor use, transmitter frequency bands, channels and power limits, interfaces to the network, etc. These can trigger added regulatory requirements and may complicate the filing and certification procedures. Also, certain products may have specific requirements that need to be captured on the RM, including items such as labeling, packaging or manuals with safety instructions that must be included with the product as part of maintaining regulatory approval.
External Help – Labs/Consultants: There are most certainly internal experts within a business that are responsible in one way or another for the regulatory compliance of a product. Some companies design products with a “take it one country at a time” attitude due to their internal capability, only to find out that the next country may have requirements quite different or more strict regulatory wise. Generally companies have individuals with a “basic” handle on the scope of the regulations. However, unless there is an ongoing process to keep up to speed on the latest regulatory requirements, it makes good business sense to identify competent business(es) whose job it is to be 100% current on the latest requirements. During the RM development processes identify competent firm(s) and share the RM under a non-disclosure agreement. They should be able to assist in pointing out the regulation requirements, as well as be the check and balance. In selecting the external firm(s) make sure in the initial discussions that they indeed have the scope to handle the RM. Summarize the RM into major discussion areas first such as RF, packaging, EMI, safety, energy efficiency, product environmental (RoHS, REACH), etc., and then go into detail, as well as provide a global indication of the countries. Surprisingly some firms do not have the internal expertise to know everything and as such they must bring in others to assist. This is not generally a bad business practice, but be aware of it. Probe on their internal processes and how they keep current, what the limitations of their company are and how gaps can be addressed. Do you detect they will be proactive or reactive to your needs?
Sharing Information Best Practices: One meeting rarely completes the RM analysis. Several will be needed before you finalize it. Remember, these firms are in business to help, but if you do not provide a clear discussion and spend the time working with them so they fully understand your product, the results you get may indeed be incomplete. Share with them the aggregate business picture, point out your concerns, communicate the unknowns or other concerns you have and, most importantly, represent equally each of your internal business functions and how they touch the product. Best case, there will be no regulation and some business functions may not be impacted at all. Worst case, a product could be shipped non-compliant, and no one is aware of it. The product may get stuck in customs due to a missing mandatory regulatory Mark; it may be tested by the competition and non-compliance reported to the regulator(s); it may need to be recalled due non-compliant critical components or materials supplied in the marketplace.
Capturing Regulations: Should you need their help, use your external business support described above to help complete the RM. In the context of the previous items, the appropriate regulation(s) need to be entered by name, reference number, version, date and key specification. More than likely one may find that a “lowest common denominator” regulation may indeed cover more than one product requirement. Challenge in all cases any RM item that does not have a regulation associated with it. Understand why or why not, and be cautious if there is an indication that the regulation is vague or non-descript. Vague items quickly spiral into being non-issues, i.e. the “limp factor,” yet in reality the homework was not done to rule it out one way or the other. It may indeed be correct that none exists and if such is the case that item could be removed from the RM for simplicity sake. In addition, recognize that regulations are not static and in most cases will change over time. Your RM needs to take this into consideration and capture these changes and when they occur. When considering any regulation always have a forward looking view of at least 2+ years (can vary based on your product design and release cycle) to prevent surprises. No one wants to release a service or product only to find that a new regulation kicks in one month after initial release! By having a forward looking view, knowing when new regulations will be effective, and how they are going to impact shipping product, you can make design allowances and changes so that when the new regulations become effective your product lineup can be ready.
Cautions: Some may feel that regulations are centric to a specific organization or function, or wrongly assume the other team “has it under control.” Efficiency wise, the RM provides a level playing field to all parties integral to the product. It documents the commitment to do it right the first time, ensures that all functional organizations have their vested interests included, and serves as a foundation upon which future products can be built upon. If done correctly the RM is an asset, but doing it for the first time can appear as overkill. However, the impact on the business for not knowing a regulation is non-forgiving, can easily degrade market share, drive customers toward competition, or potentially lead to the dreaded “r” word – recall.
|Peter S. Merguerian is President and CEO of Go Global Compliance Inc. (www.goglobalcompliance.com) and provides regulatory engineering consulting and global certifications for companies worldwide. He has 30 years global regulatory compliance experience with an emphasis on safety, EMC, wireless and telecoms where he had corporate-wide responsibility in various global test laboratories for Market and Conformity Surveillance, Regulatory and Testing Services, Global Engineering, Accreditation and Global Certifications. Mr. Merguerian holds a Bachelor of Science Degree in Electrical Engineering from the Illinois Institute of Technology, Chicago. He speaks five languages and owns and moderates two popular global regulatory groups, one on Linked In: “Global Regulatory Compliance” and the other his blog at www.goglobalcompliance.com/blog. Mr. Merguerian can be reached at firstname.lastname@example.org.|
|Dennis W. Bartelt is President of Bartelt Consulting Corp. (BCC). He has 30+ years of past experience in telecommunications and consumer products with Motorola Mobility Inc.(formerly the cellular division of Motorola Inc.). His credentials include product design, software quality, service and repair, product safety, regulatory and environmental compliance, customer satisfaction and process enhancement. Under his leadership the teams he managed provided approvals for more than 100,000 unique products. Dennis has a Master’s Degree in Electrical Engineering Technology from Northern Illinois University along with 30 hours pre-doctorate work. He is currently consulting with industry firms and specializes in process enhancement in the product regulatory and safety compliance areas. Dennis can be reached at email@example.com or firstname.lastname@example.org.|