Ensuring product compliance is a little like building software: In the early days of the discipline, it was a highly manual, ad hoc endeavor that depended extensively on expert knowledge and experience. Every project was unique, making it challenging to apply a standardized framework or set of processes to all operations.
That has changed. Just as software engineers have learned over the past several decades to embrace standardized, repeatable frameworks and methodologies, similar processes are transforming product compliance.
The result is that product compliance operations at forward-thinking organizations are beginning to look more like a standardized engineering discipline than a process beholden to specialized expertise, a change that’s poised to deliver major benefits both to compliance practitioners and to businesses as a whole.
To understand the nature of this change, you must first understand what product compliance (meaning the process of meeting safety, environmental and other regulations or requirements when bringing products to market) has traditionally entailed.
Historically, businesses that needed to keep products compliant brought in experts who had experience in whichever specialized regulatory niches the organization needed to address. Then, the experts manually assessed the product, identified compliance gaps and advised the business on how to close them.
That approach worked well enough in a world where products evolved relatively slowly and were sold within a limited set of jurisdictions. It increasingly falls short in the present, however, due to factors like the following:
- An ever-growing list of regulations and standards that products must meet, making it more challenging to find experts who understand product compliance requirements in their full complexity.
- The need or desire to sell products across multiple jurisdictions, and meet the varying compliance requirements of each one.
- Growing pressure from regulators and customers to ensure visibility into product compliance and testing processes.
- Goals by businesses to update products on a rapid basis, making periodic, one-off review checks insufficient to ensure continuous compliance.
In this new world, product compliance operations must become highly scalable, efficient and repeatable.
This is where the concept of applying engineering principles comes in. Efficient engineering teams operate based on standardized processes and repeatable methodologies that enable them to work through complex challenges efficiently and at scale. Hence how software engineers are, for example, able to churn out application releases on a daily basis in some cases, or how construction engineers can design and oversee the implementation of massive buildings in a matter of months.
When this playbook is extended to product compliance, the product compliance process becomes grounded in capabilities such as the following:
Repeatability. Using automated tooling and structured product data, the same compliance methodology can be applied across many products and jurisdictions, while still accounting for the specific product attributes and regulatory nuances that determine the actual compliance path.
Traceability .The systematic collection and linkage of evidence generates a record that businesses can use to demonstrate product compliance to stakeholders.
Structured decision-making. Instead of relying on expert knowledge and intuition, businesses can deploy standardized controls and procedures to identify and address compliance risks.
Product-specific applicability. Regulations can be assessed against a structured understanding of the product itself, including factors such as product category, intended use, materials, components, power source, connectivity, packaging, labeling and markets where the product is sold.
Scalability. Automation and standardized processes make it possible to manage compliance obligations for hundreds or thousands of products using a centralized toolchain and methodology.
Of course, product compliance can’t be scaled by treating regulations as generic checklists. A regulatory requirement matters to a business because it applies to a specific product in a specific context. That applicability might depend on what the product is, what it contains, how it’s powered, whether it communicates wirelessly, how it’s packaged or labeled, where it’s sold, who uses it and what role the business plays in placing it on the market.
This is where product compliance begins to look especially engineering-like. To make compliance scalable, businesses need to transform unstructured regulatory text into structured decision systems. Those systems must connect the conditions and obligations embedded in regulations to the attributes of the products the business actually makes, sells or sources.
For example, a regulation may apply only to a certain product category, material, chemical substance, component, energy use profile, radio technology or market placement scenario. Once those applicability conditions are identified, they can be evaluated against structured product information. When the regulation applies, the relevant requirements can then be translated into concrete actions, evidence needs, review workflows and reporting obligations.
This doesn’t eliminate the need for expert judgment. Rather, it gives compliance experts a more systematic way to encode, validate and govern their expertise. Instead of answering the same product applicability questions manually and repeatedly, experts can help define the decision logic, review exceptions, validate outcomes and ensure that the system remains aligned with regulatory change.
Actually enabling the product compliance approach described above requires, for starters, organizational change. Businesses must recognize the importance of automating and scaling product compliance.
From there, they need to embrace compliance automation tooling that enables a scalable, standardized approach to product compliance. This includes artificial intelligence capabilities that can help assess regulatory applicability against structured product information, interpret how requirements apply to unique products, and extract the requirements and actions that follow from those product-specific nuances. It also includes more conventional types of automations, like those that collect compliance evidence, assess whether controls are being met and generate reports.
Thus, while modern AI is part of the product compliance modernization story, it’s not the whole narrative. Rather than shiny AI tools, businesses’ real focus should be on implementing the cultural changes, and migrating to the broader compliance automation tooling, necessary to bringing a disciplined, engineering-like approach to product compliance.
To be clear, automating and scaling product compliance doesn’t mean that human compliance experts no longer have a role to play in the process. There will always be a need for experienced compliance practitioners who can interpret compliance requirements, define the product attributes that matter, configure the necessary controls and automations to meet them, and validate that the resulting decisions are correct. There will also always be complexities and edge cases that require expert judgment.
However, the more mundane aspects of product compliance operations, like data collection and reporting, no longer need to fall to humans working manually. By extension, businesses no longer have to worry about their compliance teams becoming overstretched, or unable to keep up with constantly changing products and constantly evolving multi-jurisdictional compliance requirements.
This is the outcome that businesses can achieve starting now. They just need the right organizational commitment to compliance scalability, coupled with tools that can allow product compliance to follow a streamlined methodology similar to that employed in engineering fields.
