Equipping Engineers to Navigate Standards and Safety Responsibilities

The world is changing. The unprecedented number of accidents and product recalls in recent years and subsequent low consumer recall compliance raise questions about the role that various factors (i.e., education, regulations, etc.) play in ensuring safer products. The increase in quantity and complexity of products also leads to an increase in potential hazards, which can endanger the safety of people or properties, even when those products are installed, maintained, and used for their intended purpose.

In this article, we present an argument for how effective engineering education can increase the impact of professionals involved in safety compliance. Our reasoning should help guide the academic engineering community and make a compelling case for greater resource allocation in educational programs and initiatives to improve compliance for safer products.

We will also discuss specific aspects of product safety compliance, including the meaning of compliance, the role of product safety standards, policies that can be used to address safety-related incidents, and the responsibilities of product safety compliance professionals.

Product Safety Compliance: The Concept

The concept of compliance is a broad topic, and it is often hard to define as its operational boundaries can vary. The term follows a philosophical tradition involving the belief that people lack the ability to self‑govern and, consequently, the need to establish a robust governing authority.

At its most basic level, product safety compliance means that a product meets all regulatory requirements that apply to it. However, standards and directives vary widely based on the type of product, and they are constantly changing in different areas. So compliance also means investing the necessary time and energy to understand which regulations apply, and to be mindful of new and potential changes to their requirements.

Product compliance also depends on obtaining the necessary evidence to affirm that a product meets the prescribed requirements. This involves testing, labeling, on-product disclosures, or certificates and approvals. Further, compliance requirements applicable to a given product can span a dozen countries, hundreds of suppliers, and global markets. As a result, adhering to them becomes a priority for product manufacturers looking to sell their products globally.

Adhering to laws and regulations is also a way of mitigating societal risk and encouraging ethical behavior. However, the principles that are the foundation of compliance are only now being integrated into organizations’ day-to-day activities, making it necessary to distinguish between regulatory and internal compliance.

Regulatory compliance involves following the rules for a specific industry or field established by an outside authority. Thus, regulatory compliance should not be confused with internal compliance, which refers to the procedure of following internal processes and best practices established by an organization. In what follows, we will refer to the actions that need to be taken to ensure safety compliance of products.

Product Safety Compliance in the Context of Organizational Compliance

In today’s world of rapidly advancing technology and the expanded use of artificial intelligence, there exist intelligent tools that can be used to screen products against numerous up-to-date regulatory lists and requirements. These tools, which feature easy-to-use dashboards, auditable product histories, integrated reporting, and automatic notifications when regulations change, can help make the compliance process more efficient and effective for any manufacturer.

However, arguing that regulatory compliance merely consists of meeting rules and regulations limits the notion to the legislative area, omitting a set of related values, such as commitment and integrity. From this perspective, compliance becomes a defense tool to hold organizations accountable.

But compliance and accountability are interconnected because accountability involves the acceptance and assumption of responsibility for complying with regulations. Viewed from this perspective, compliance with the rules is also an act of accountability. It means establishing enforcement procedures and ensuring that everyone is set to a standard expectation when it comes to regulations.

From an even broader perspective, the compliance concept extends to all participants involved in the regulatory chain, from the regulation originator to the regulated party. More specifically, given the complexity and evolving nature of the regulatory environment, it is critically important to integrate the concept of accountability into every step of the regulatory process.

Establishing and maintaining assurance requires supporting efforts by management and other stakeholders to identify and consider the critical risks arising from technology. In this context, communication plays a crucial role in strengthening the assurance function in compliance. Effective communication enables organizations to identify the causes of potential gaps and to implement control mechanisms.

To support this effort, employees should be trained in compliance policies and procedures. Applicable regulatory requirements and the entity’s related policies, procedures, and processes should be clearly communicated to everyone. Penalties for not adhering to internal policies and regulatory requirements should also be covered. Training should be ongoing and address legal developments and changes to compliance policies and procedures. Finally, a clear and well-defined reporting structure formalizes oversight and accountability.

An organization’s board of directors is ultimately responsible for compliance oversight. A director’s duty of care includes a requirement to make good faith efforts to ensure that the corporation has reporting and information systems that are adequate to detect potential violations of law. Not only must the board confirm that a reasonable compliance program has been adopted, but the board also should approve key elements of the compliance program and oversight framework. In addition, the board should assess the program’s general effectiveness through regular management reports. Significantly, where an effective compliance program is not in place, directors could be liable for losses resulting from failure to comply with applicable legal standards.

Adherence to compliance policies and procedures should be enforced consistently. Employees should be held accountable for compliance failures. Additionally, the organization should take steps to address compliance weaknesses. Such enforcement requirements highlight the importance of defining and educating management on compliance responsibilities. Compliance is, therefore, considered an action required by a supervisory authority that organizations need to put into practice. This concept supports our view that an organization needs to work consistently to align organizational goals and regulatory requirements.

Product-Specific Safety Standards

Safety and performance standards are developed for products and materials, providing methodologies for testing and certification. Different categories of products have specific safety and performance standards that apply to them, with some products falling into more than one product category.

Across industry, safety-compliance roles align along four main standard families:

• Risk management standards (ISO 31000, ISO 12100, IEC 61508, IEC 62061, ISO 13849, ISO 14971),
• Management & governance standards (ISO 9001, ISO 45001, ISO 37301),
• Security & digital resilience standards (IEC 62443, ISO/IEC 27001),
• Product safety standards (developed by IEC, ISO, ASTM, ASME, NEMA, etc.)

These standards also include labeling (marking and user information) requirements, both for on-product and for shipping and transport. These regulations can vary based on geography, as well as product type.

Well-managed organizations explicitly map job roles to these standards to ensure clear accountability, audit readiness, and regulatory defensibility. Organizations can better manage risks in their activity by automating the scanning and indexing of unstructured data safety, such as that captured in Excel spreadsheets, PDFs, and PLMs. The proliferation of AI tools, such as machine learning (ML), helps translate unstructured information and documents into a standard BOM format that makes them easier to understand and work with.

Basic Policy Regarding Accidents

Organizations must be prepared to address situations involving regulation violations and be ready to correct legal breaches to avoid encountering similar situations in the future. Here is a potential framework for specific actions that can be taken in the event of regulatory violations and non-compliance:

1. The manufacturer shall establish and maintain processes to identify, monitor, and comply with applicable international, regional, national, and local legal and regulatory requirements related to product safety and security.
2. The manufacturer shall implement procedures to collect, document, and, where required, proactively disclose information related to product-associated accidents.
3. The manufacturer shall ensure that any product accident is reported without undue delay to the relevant competent authorities in accordance with applicable legal and regulatory obligations.
4. The manufacturer shall promptly inform affected customers and stakeholders when a product recall, corrective action, or repair is required.
5. The manufacturer shall provide appropriate warnings, instructions, and safety information, where necessary, to support the safe use of its products throughout their intended lifecycle.
6. In the event of a product accident, the manufacturer shall conduct a documented root-cause analysis and shall implement corrective and preventive actions to prevent recurrence.
7. The manufacturer shall integrate risk identification and risk assessment activities into the product design and development process to prevent foreseeable harm.
8. The manufacturer shall take appropriate measures to identify and eliminate product vulnerabilities prior to product release and shipment.
9. The manufacturer shall collect, evaluate, and maintain relevant information regarding product vulnerabilities to reduce the likelihood and severity of harm.
10. The manufacturer should cooperate with relevant external organizations and stakeholders to implement, improve, and communicate product safety and security measures.

Product Safety Compliance Professionals (PSCP)

Generally, product safety compliance professionals (PSCPs) work in positions in which they are directly involved in identifying and mitigating the risks of harm associated with products and supply chains during the entire product life-cycle. They need to know which regulations are related to design (included in safety standards), production, logistics, and marketing, etc., and are also responsible for dealing with market surveillance authorities in the case of non-compliance incidents related to accidents, often working in tandem with legal professionals.

PSCPs plan, organize, direct, control, and evaluate the implementation activities of safety requirements included in product standards, and regulations at international, regional, and national levels (for compliance needs). They work either alone or in conjunction with other professionals (i.e., human resources, legal department, design teams, supply chains, goods manufacturing production, testing, inspectors which control risks of harms in the workplace, quality assurance, marketing, insurance, servicing, post-market surveillance, development, and continuous education, etc.) to develop, establish, and approve safety objectives (policies and programs) for the company.

Some examples of PSCP-related role functions in industry are:

• Product safety
• Product compliance
• Regulatory compliance
• Safety compliance
• Risk and compliance
• Technical compliance
• Conformity assessment
• Certification
• Standards & regulations
• Functional safety
• Process safety
• Reliability & safety
• Safety systems
• Hazard analysis
• Risk assessment
• Regulatory affairs
• Market access
• Compliance program
• CE marking
• Product registration
• Product security
• Cybersecurity compliance
• Secure product lifecycle
• Vulnerability management
• Safety & security integration
• Vigilance & post-market surveillance
• Safety & liability
• Product liability
• Compliance strategy

(Note: Do not confuse PSCPs with public and environmental health and safety professionals or with occupational health and safety specialists. Also, keep in mind that there is a difference between quality control/assurance and product safety compliance.)

To effectively perform any of these functions, a PSCP needs to have the relevant skill levels defined by the amount and type of education and training required to enter and perform their duties. Here’s a proposed categorization for recommended skill levels:

1. Skill level A: University degree (bachelor’s, master’s, or doctorate)
2. Skill level B: Three to five years of post-secondary education at college, or institute of technology and more than two years of on-the-job training, or job-specific training courses
3. Skill level C: Completion of secondary school and some short-duration courses or training specific to the job, or some secondary school education, with up to two years of on-the-job training, training courses, or specific work experience
4. Skill level D: Short work demonstration or on-the-job training, or no formal educational requirements

The required skill level depends on the specific type of work to be performed, and is based on a number of factors, including similarity with respect to the educational discipline or field of study required for entry into the job. Additionally, a prerequisite for entry may also include the industry of employment with documented experience in one or more of the previously listed functions.

Sometimes the skill levels are replaced by the degree of training, education, experience, and responsibilities (TEER) required for the job. For functions designated as Manager, Engineer, Specialist, or Technician, the following skill levels should be required:

• For Manager: Level A
• For Engineer: Level A or Level B
• For Specialist: Level A or Level B
• For Technician: Level C

Engineering Education for Product Safety Compliance Professionals

One of the big challenges for product safety is underestimating its impact on society. Nevertheless, after a long series of accidents with critical losses, regulators began developing more regulatory initiatives to adapt to the current landscape. One of the achievements in safety regulations was recognizing that even minor accidents can result in devastating damage, injuries, lost production, and significant fines. Such risks have always become the cornerstone of safety management, and therefore, are an important component of safety compliance.

To further the impact of product safety compliance, we need to step up our efforts to broaden awareness of the importance of product safety and build the relevant skill set to implement effective product safety management efforts. Many organizations simply do not have access to engineering personnel with the requisite knowledge and expertise to address even the most basic product safety requirements, let alone navigate the increasingly complex regulatory compliance landscape.

Everyone involved in an organization’s product safety efforts must be well-informed, versatile, and creative. And PSCPs need to understand the process for determining what, where, when, why, and how product safety risks can be identified and mitigated.

Yet, with all efforts to train good PSCPs, it seems that something is still missing. Finding qualified candidates to fill open PSCP positions is still a challenge. Even with advanced engineering degrees and training, there’s little focus on product safety in educational curricula. That’s because product safety is not a top priority among engineering schools.

Self-education through various texts, articles, and technical literature can help, as well as training by knowledgeable consultants who conduct workshops on a variety of product safety topics. But this approach can be superficial and incomplete, due to the absence of a consistent methodology.

Most professional engineering associations are increasing their efforts to highlight the importance of product safety in conferences and other events. But this too is not enough.

The Potential Benefits of Investing in Product Safety Education

We believe that a comprehensive formal product safety educational program at the university level is the best path forward. A robust and well-designed program would provide participants with a more complete understanding of the essential function of product safety compliance in the design and development of new technologies. It would also provide the knowledge and skills necessary to execute the responsibilities of a PSCP in an organization. 

Institutions in several global regions are already giving increased attention to standards and product safety compliance educational needs. For example, South Korea is giving increased attention to the important role that standards compliance plays in effective marketing efforts. Today, there are 40 universities and 6000 students involved in standards education in that country. It may be the most impressive program in the world.

In addition, educational institutions in China, India, and Japan are beginning to see the strategic value of standards and product safety compliance and have also introduced these subjects into their university engineering curriculums.

Finally, the American National Standards Institute’s United States Standards Strategy (USSS) has established standards education as a national priority in private, public, and academic sectors. These programs focus on the needs of leaders and top executives, as well as those who participate in the development of standards, university and college students, and other interested parties.

Clearly, countries and institutions that invest educational resources to train their engineering students in the field of standardization and product safety compliance will have a clear and distinct competitive advantage in our ever-changing global marketplace.

What Do We Need To Do?

In the years to come, product safety compliance will continue to evolve from an engineering art to an engineering science. Therefore, the need to understand the theoretical and the practical application of product safety principles becomes even more essential. Product safety compliance must become an integral part of the engineering curriculum.

Students need to learn and gain experience via a flexible combination of lectures, laboratory tests, computer simulations, independent research and design tasks, and individual and group projects. They will also gain relevant experience in documenting and presenting their findings to both technical and non-technical audiences.

Each student’s progress and accomplishments can be assessed in a variety of ways, including tests, written and oral examinations, and peer and independent evaluation of projects, reports, and presentations. And outcomes can be evaluated by a committee consisting of representatives from academic staff, industry, governmental organizations, and regulatory bodies.

A typical plan of study of “Product Safety Compliance for Industry” in engineering-related educational programs could include some or all of the following issues:

• New product development – Safety by design
• New product manufacturing – Safety by control
• Accidents – Causes and means of prevention
• Products safety hazards
• Systems safety
• General criteria for compliance
• Products safety standardization
• Basic safety concepts and considerations
• Failure mode analysis
• Functional safety
• Risk management
• Abnormal conditions
• Selection of components
• Sensors, transducers, and actuators
• Construction
• Energy management
• Labeling (markings and Instructions)
• Electromagnetic disturbances
• Safety of products that use radiation
• Safety for products used in hazardous locations
• Programmable electronic systems
• Cybersecurity
• Environmental requirements
• Dependability
• Usability
• Regulatory affairs
• New product evaluation – Safety by testing
• Instrumentation for testing
• Safety cost estimation
• Post-production surveillance
• Global market access

The proposed curriculum takes into consideration the needs of industry and guidelines established by product regulatory bodies by raising the profile of science, technology, and mathematics (STEM) careers, and encouraging more students to consider career opportunities in the product safety compliance field.

Conclusion

The only way in which engineers will be well prepared to fill their product safety compliance roles in providing safer products is through good academic preparation and continuing education.

We invite readers of this article to share their comments and feedback on this proposed plan so that we can work together to bring it to reality!

References

1. S. Loznen, C. Bolintineanu, J. Swart, Electrical Product Compliance and Safety Engineering, Artech House, Norwood, MA, USA, 2017.
2. C. Bolintineanu, S. Loznen,” Product Safety and Third-Party Certification,” in The Electronic Packaging Handbook, Edited by Glenn R. Blackwell, Boca Raton, CRC Press LLC, 2000.
3. S. Loznen, C. Bolintineanu, Electrical Product Compliance and Safety Engineering, vol. 2, Artech House, Norwood, MA, USA, 2021.