Regulatory Compliance Program for a Manufacturer’s Product Development Program and the Role of the Compliance Specialist

In the ever-changing global economy there is a growing number of product regulatory compliance requirement standards being imposed on manufacturers. Before marketing their products to domestic and international customers a manufacturer must deal with regulatory issues that apply to the development of their products. This results in the manufacturer having to have a regulatory compliance function within his company’s organizational structure that is staffed by competent well-trained personnel. This includes a Compliance Specialist who will need to stay abreast of the steadily changing regulatory compliance requirements, technology advances, and new areas of product regulations. The primary areas where product regulatory compliance requirements are applied are EMC, Product Safety, Environmental Protection, and Energy Conservation. All of these requirements have a direct impact on a product’s development program that includes its quality and reliability attributes.

The Compliance Specialist
The basic requirements needed to be a competent and effective Compliance Specialist are to have a solid engineering background, complemented by extensive practical experience. Continuing education is a mandatory requirement for the Compliance Specialist in order for him to stay current, effective and efficient. There are several sources that can be utilized in obtaining continuing education in the field of compliance engineering. These sources include attending seminars that address regulatory compliance related topics, reading articles on regulatory compliance material published in technical periodicals, taking short courses, and/or enrolling in university level programs. There is a growing number of universities globally that are setting up programs in the field EMC studies and Environment Science research and other related educational studies. This is notably true as it pertains to automotive, medical, and military products/systems compliance design requirements.

The Compliance Specialist’s Required Knowledge Base
A Compliance Specialist must have a comprehensive understanding of the following topics:

  • A basic knowledge of electromagnetic waves theory and its effects on physical products and systems.
  • A knowledge of EMC effects mitigating techniques which include grounding, shielding, filtering, transient suppression, cabling EMC design, and printed circuit layout EMC rules.
  • Staying current on the status of regulatory compliance requirement standards that apply to his company’s products.
  • A solid basic understanding of Product Safety, EMC, and Environmental Protection regulatory compliance testing methods and requirements.
  • Knowledge of Product Safety regulatory compliance design requirements that apply to the markets that his company’s products are to be sold in.
  • A fundamental knowledge of his company’s product’s designs as they relate to environmental/health safety regulatory compliance requirements. These include the product’s component chemical composition, end-of-life disposal requirements, and energy conservation design parameters.
  • A proficiency in formulating the company’s Regulatory Compliance and Testing Program Plans so that they produce a reduction in compliance related costs.

Related Job Functions
The Compliance Specialist must perform the following functions:

  • Participate in product design reviews and contribute to addressing and resolving all regulatory compliance issues as they relate to the product design under review.
  • Evaluate compliance testing data and provide recommendation for resolving all outstanding non-conformance issues.
  • Formulate and publish final compliance testing reports
  • Produce the company’s Regulatory Compliance Program and Testing Plans.
  • Procure and make available to cognizant company personnel the regulatory compliance directives and standards that apply to the company’s products.
  • Act as a consultant to product development personnel on design requirements as they concern compliance related issues.
  • Perform a pre-compliance design review of the company’s products prior to conducting the product’s compliance tests.
  • Interface with third party organizations that are contracted to performing regulatory compliance functions for the company’s products.
  • Produce required documentation to certify that the company’s products have met all its regulatory compliance requirements, and issue the required Document of Compliance document.
  • Maintain a regulatory compliance file that contains all related compliance information related to the company’s regulatory compliance program.

A key element in a company’s ability to meet its regulatory compliance requirements, in a timely and cost effective manner, is strongly dependent on the proficiency of the company’s regulatory compliance organization and its Compliance Specialist. In our highly competitive global environment, with its steadily increasing and changing product regulatory requirements, it is essential that a manufacturer pay close attention to keeping a high degree of efficiency in his compliance organization. favicon

Mr. DiBiase is president of Spec-Hardened Systems, an EMC and Product Safety consulting firm. His firm specializes in providing consulting services to small and medium size companies. Spec-Hardened Systems was founded in 1988 and offers consulting services that include EMC and Product Safety design, training, and global regulatory compliance program management. Prior to founding his consulting firm, Mr. DiBiase was employed by the Eastman Kodak Company where he held in various engineering positions. These positions were in the areas of Radiation and Nuclear Effects, Electronic Systems Design, Reliability, and Quality Assurance Engineering. He is a graduate of the Rochester Institute of Technology where he received his BSEE degree in 1968. His professional affiliations include the IEEE, the Rochester Institute of Technology Alumni Association, and the International Resource Group.