Being first to market is what enables a company to capture the rewards of an efficient product development program. Among the benefits of such a program is a greater return on investment (ROI), triumph over the competition and increased shareholder’s satisfaction. However, there are pressures such as a slow growth domestic economy, a growing global marketplace and a highly competitive market environment.
Compliance Strategy
In the drive to reduce product development cycle times and cost, one area often left to the eleventh hour is EMC, Product Safety, and Environmental/Health Safety regulatory compliance design considerations. A manufacturer should focus on this area early in the product’s development process by establishing the product’s regulatory compliance requirements for these requirements are of significant importance in developing the product’s configuration. By addressing these requirements with a well thought out process, considering both time-to-market and cost as they affect product’s market release, the manufacturer will achieve a greater ROI.
Compliance Program Plans
It is important to develop EMC, Product Safety, and Environmental/Product Safety Program plans. These plans should contain specific information on the tasks that must be performed in order to meet all of the product’s regulatory compliance requirements. The plans should include a definition of all activities related to achieving the product’s certification, beginning with the initiation of the product’s conceptual design stage and continuing through to the end of life and disposal of the product. It is difficult to know which cost is higher: the cost of the added investment for corrective actions, the cost of delayed revenue, or the cost of the lost of competitive advantage.
Information Required to Meet Compliance Requirements
Design for Compliance as a term denotes both a philosophy and a practice that considers the compliance environment at every stage of a product’s life cycle. When applying this approach the manufacturer should continuously ask the following important questions.
- What are the directives and standards that apply to your products and how do they vary from country to country, in which you intend to market your products?
- What is the status of the directives and standards documents, are they in a change process?
- Are new directives and standards being developed for new technology products?
- Does your product design optimize or limit the ability of your product to meet the compliance requirements of multiple global markets?
- Have you formulated a comprehensive cost effective EMC, Product Safety, and Environment/Health Safety testing program?
- Does your product design include only compliance compatible components? There should be a technical justification for the compatibility of each component added to a certified product’s design. Each added component can effect the product’s certification status, cost, reliability, and its quality status.
- Does your design change procedure include a review of the impact of the change on the product’s compliance status?
Compliance Testing Plans
The collateral documents to the EMC, Product Safety, and Environmental/Health Safety Compliance Program plans are the Compliance Testing plans. These documents should specify all tasks and activities that are associated with the product’s testing requirements. It should contain the following information:
- An identification of all product variants.
- A complete description of the product, including test related technical information.
- The various test configurations and system’s set-ups. Operational modes and test parameters to be monitored.
- Test schedules and facilities where tests are to be performed
- Identification of the units to be tested
- Pass/fail criterion.
- Plan for correcting compliance failures that could occur during testing.
A well formulated EMC, Product Safety, and Environmental/Health Safety Testing plan can result in minimizing the product’s certification development costs.
Product Certification Requirements
With the conclusion of compliance testing and the resolution of all outstanding compliance problems, a testing report along with a Declaration of Conformity document must be included in the certification package. Many countries recognize requirements developed by international technical bodies such as the International Electromechanical Commission (IEC). EMC, Product Safety, and Environmental Health/Safety requirements vary, to some degree, from county to county and from state to state in the United States (for environmental safety factors). The manufacturer must evaluate these variations in defining their compliance requirements.
The manufacturer should have an on going compliance plan to ensure that his product continues to meet its certification requirements throughout its market life. It should include an evaluation of design and component changes, periodic retests, and a continuous review of current regulatory changes. It is recommended that compliance personnel receive the required continuous training to upgrade the product certification skills.
Conclusion
The expanding global market place coupled with the fast pace of technological advances makes it mandatory for the manufacturer to achieve timely regulatory compliance approvals. A Design for Compliance testing and certification program should be employed by a manufacturer as a mechanism for ensuring that his product obtains certification and stays on schedule. Design for Compliance successfully implemented, along with a well-developed compliance management plan, heightens the awareness of the impact of regulatory compliance factors in every phase of the product’s life cycle. Regulatory compliance factors have a significant impact on the manufacturer’s bottom line. 
Anthony A. DiBiase is President of Spec-Hardened Systems a consulting firm. He has authored several articles and presented several seminars on issues related to EMC, Product Safety, and Environmental/Health Safety regulatory compliance. He can be reached at SHSESC @aol.com.
