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As with this first step in product development, compliance issues affect each subsequent step of the product development and deployment process—enabling or otherwise impacting the development, delivery, or sustainability of products in the market. As the wireless market continues to evolve, the industry can expect to see the emergence of new compliance requirements and technologies. This calls for continuous due diligence in the monitoring of the regulatory environment. Implementation of a design for compliance strategy must be a significant objective of the overall product development goal of the manufacturer. Success requires commitment on the part of management to allocate resources in the beginning of a project, so that targeted benefits can be realized. In start-up environments or in companies with downsized staffs, this may require contracting with compliance management consultants. Investment in this area protects the company's product development investments in the longer term.
Compliance Management Plan Success with a design
for compliance program requires performance to an effective compliance
management plan. The following section outlines basic rules and
guidelines for a program aimed at realization of the design for
compliance benefits detailed in Table I.
Regulatory Environment Research of the regulatory environment for new products takes time, but the rewards can be significant. Researchers first need to ask where and to whom the product will be marketed. The answers to these questions will help determine whether existing standards meet the needs of the product being developed (see the sidebar "Regulatory Environment: Key Considerations" below). Compliance Testing It is important to view compliance testing as a natural progression along the road to generating revenue for the company. In this light, compliance testing is a validation of internal processes. It should not be seen, as it is by many, as the "final hurdle" of obligation before a product can ship out the door. Selection of the appropriate test laboratory is critical. This selection can impact the core of a company's promise of quality to its customers, and it plays a crucial part in a company's future success. As a compliance partner, a compliance testing laboratory should be capable of bringing more than just testing to the table. A true partner should bring a background in all aspects of regulatory standards, compliance management, testing and reporting, and certification. Creation of a suitable test strategy, which can be difficult and extremely confusing, is one area in which the compliance partner should be able to assist. Identification of test cases is crucial to the success of a product. There are a number of relevant points to consider before undertaking a full complement of compliance testing:
Product Variants Identification of product
variants may initially seem straightforward; however, if multiple
vendors manufacture critical components, the process becomes more
complicated. This is especially true if multiple locations are used
for the manufacturing of the same product. It is critical to identify the number of different vendors supplying critical subsystems or components (e.g., transceivers). Product manufacturing locations (if more than one) must also be identified. In addition, the number of variants (technical differences) and test candidates must be specified. Note: not all variants require complete compliance testing; partial testing can be accepted provided that a solid rationale is well documented. Documentation Package Prior to the start of testing, it is important to compile a complete documentation package. This information (or a subset thereof) will be requested by many interested parties (e.g., test laboratories, certification authorities, clients, and OEMs). Compilation at this stage saves time, and it can help to ascertain cases in which information is not readily available. Documentation will consist of, but not be limited to, the following items:
Test Configurations and System Setups Creating a list of all tests, and identifying test setups and the variants selected, is the next step. Following this, it is important to determine all ancillary equipment required for each test. If products operate with an integral antenna, for example, it is possible to consider providing a connector (suitable RF type) for conducted measurements and an integral antenna for radiated measurements (mandatory). It is important to note that European standards demand measurement of receiver parameters (performance and interference criteria). A suitable test setup is required for this type of measurement. Receiver testing can be extremely difficult, if not impossible, when testing products using an integral antenna. Complete Compliance Testing An entire test program consists of several elements: precompliance testing, customized software, environmental conditions, performance degradation criteria, and compliance failures. Precompliance
Testing. In an ideal world, all variants would be fully
tested prior to the complete compliance program; however, in practice,
this may not be the case. Risk assessment helps minimize the degree
of pretesting. If pretesting is conducted in-house, it is important
to ensure calibration integrity of all test equipment. Many engineers
have experienced occasions when out-of-calibration test equipment
has been used for pretesting, only to propagate subsequent problems.
It is important to log all results and test configurations, because
these will be used to validate full compliance measurements. Environmental Conditions. The environmental test conditions must be fully defined. These include temperature range (nominal, minimum, and maximum), humidity range, and voltage range (ac or dc)—nominal, minimum, and maximum (+ve or –ve polarity). For battery-operated systems, it is also necessary to ensure that the methodology is available to vary the voltage level. Performance Degradation Criteria. European immunity testing demands that manufacturers declare performance degradation criteria. Keep in mind that simply declaring, "Maintains the link," does not define system degradation. With the proliferation of multiple wireless products, system degradation is becoming an increasingly important parameter. Compliance Failures. Knowing how compliance failures will be handled during pretesting or complete compliance is essential. A strategy specifying the company's process for handling failures needs to be considered. For example, will the component or subassembly be replaced, or will this problem be fed back into the company quality management system for failure investigation and corrective action at the source? Product Compliance Certification With the conclusion of the complete compliance testing and resolution of outstanding compliance issues, the test reports, together with a signed Declaration of Conformity (DoC), become integral components of the documentation package. These items are used in the application for product compliance certification. Ongoing Compliance With compliance testing complete and certification procurement under way, the danger is in thinking that product compliance issues can now be put on the back burner or forgotten about altogether. This is not the case. Passing of formal testing by selected samples does not imply that all manufactured products will exhibit similar characteristics. Remember also that in certain countries, the manufacturer must sign a DoC indicating that all products—not just those that were tested on a one-off basis—will comply with the essential requirements. Characteristics can and do change in the manufacturing process, and these changes need to be managed on an ongoing basis. (Remember Company B.) Ongoing compliance is without doubt the least controlled and most misunderstood area in most manufacturing companies; nonetheless, it is the most important aspect of managing life cycle compliance. Risk Assessment Difficult decisions must be made when addressing ongoing product compliance issues. Clearly, risk assessment is an integral part of the process. Consider the following two common situations:
Because of situations such as those described above, it is important to consider including a regulatory compliance section in the ECO documentation trail. The following should be addressed as a minimum: potential effects on regulatory compliance, parameters at risk, risk analysis, degree of retesting (proposed test suite), retest results, and anticipated and actual cost of testing.
The situation described in the case study of Company B could have developed into something much worse. It also could have been avoided altogether if attention had been given to ongoing compliance in the ECO process. Control and implementation of a strategy addressing ongoing compliance further minimize the risk of being caught by market surveillance authorities. Such a strategy significantly reduces company liability. Conclusion The worldwide market is placing ever-growing demands on mandatory compliance. With shorter product life cycles, an increasingly complex and evolving wireless regulatory environment, and company financial constraints, today's compliance personnel are facing considerable challenges. However, the adoption of a design for compliance program, implemented through use of an effective compliance management plan, is one area in which excellent opportunities exist to increase product revenues, improve corporate image and reputation, and decrease company liability. The time spent up front
in defining and planning a product compliance strategy will be the
most important event in the product life cycle. This early investment
will reap benefits in reducing time-to-market and accelerating time-to-revenue
with new product introductions. A design for compliance philosophy for wireless product development and product-life management has many elements: consideration of the regulatory environment, compliance testing, product compliance certification, and ongoing compliance. These elements, and the way in which they are planned, scheduled, and supported throughout the product life cycle, dictate the level of success of the product and, to a greater extent, the success of the company. An early investment in the compliance cycle will reap rewards in profitability, competitive advantage, and market share growth. A significant part of any successful compliance management program is the selection of an accredited wireless compliance test facility. The selection process can at best be difficult; however, once a suitable compliance partner has been appointed, the partner should bring more than just test expertise to the table. The right partner should be qualified not only through experience in compliance testing, but also through a thorough familiarity with the regulatory environment and with certification and ongoing compliance requirements. With this background, the compliance partner can provide valuable input to the overall success of a design for compliance program. Gordon Hurst, BSc,
CEng, MIEE, is the founder, president, and CEO of MiCOM Labs, an
accredited wireless compliance laboratory headquartered in Pleasanton,
CA. He has more than 15 years in wireless product development and
global regulatory compliance management, having been general manager
of StatestLabs and director of regulatory compliance for Stratex
Networks Inc . He has served on the ETSI technical bodies in developing
wireless standards and on the U.S. Fixed Wireless Communications
Coalition (FWCC). He can be reached at gordon_hurst@micomlabs.com.
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