Regulatory Compliance Challenges within Product Delivery

In today's global marketplace, regulatory compliance is a critical aspect of product development and delivery. Whether dealing with financial services, healthcare, technology, or consumer goods, businesses must adhere to a myriad of laws, regulations, and standards that vary by region and industry; the bad news is that it changes much more frequently than in the past.

We have to acknowledge that compliance ensures product safety, protects consumer rights, and upholds data security, but it also presents a complex array of challenges for product managers. I have some real world experience that might help us with these challenges by offering practical strategies for effectively managing regulatory compliance issues within our teams and market.

Understanding the Challenges

One of the first steps to mitigating some of the challenges is acknowledging them. I know it sounds easy, but I once worked with a Product Manager who was managing an activity registration platform for a sport and wanted to support all markets across the globe. Our platform already had internationalization built-in so supporting other countries with payments and languages was already available. However, they didn't count on the countless email and spam regulations that many international countries were starting to impose.

I recall one particular episode with the Canadian Anti-Spam Law (we called it CASL).It was February of 2014, the Product Manager came into my office (I was the Director of Product Operations at the time) and indicated they had an urgent need to change the planned roadmap to account for a Canadian law that was going into effect soon. At first, I dismissed the urgency. My experience was that most legislation took years to actually take full effect, so I let them know the process we would take to help make sure the stakeholders and engineering were aware of the upcoming pivot.

We worked on analyzing the gaps in our current email delivery engines and came up with a plan to fold-in the CASL requirements. The engineering team gave their estimates on the work and it came out to be eleven months of work based on the all the other roadmap items that needed to be delivered. The Product Manager was very nervous and indicated that the law goes into effect in July 2014. I assumed that was not possible given that we just now were given the CASL requirements.

It turns out, the legislation had been in the works for a year or so and it actually was going into effect in 2014. You can imagine the fire-drill that ensued. The moral of the story is that the Product Manager did not do a great job understanding this portion of product delivery. If they had, we would have had plenty of time to fold in the requirements to be ready for mid 2014 launch of CASL. Half the battle is being aware and planning for legislation in your product. It will happen and most of the time it isn't a law passed that requires immediate compliance.

To help our Product Mangers be more aware of these issues, we created some bullet points to help them be aware or enlist the help of other parts of the organization to be aware. Remember that a Product Manager does not have to do everything alone. The most successful ones practice the 4D's and delegate much of this work to other qualified people. However, I think going a bit further with some other insights might help you as well.

Complexity and Variability of Regulations

Regulations can be complex, subject to frequent changes, and vary significantly between different regions and markets. Keeping up with these changes and ensuring compliance at every stage of product development can be daunting. Failure to comply can lead to legal issues, hefty fines, and damage to the company's reputation.

Integration into Product Lifecycle

Integrating compliance requirements into the product development roadmap lifecycle without hindering creativity or extending time to market is a must. Misalignment between product development processes and compliance requirements can result in product delays, redesigns, failures to launch and worse, large fines (see the word fine again?) that put the whole organization at risk.

Cost of Compliance

Ensuring compliance can be expensive due to the need for specialized knowledge, training, certifications, and sometimes alterations in supply chains or production processes. Increased costs can impact the financial viability of projects, especially for startups and smaller enterprises. Make sure these are accounted for and naturally the larger the organization the more at scale they can assist. Be aware though that compliance people and auditors have one job; mitigate risk. Their cloudy view of these initiatives can jeopardize the market opportunities. Just be careful to weigh the risks of not doing the compliance work immediately against market opportunity. Don't ignore the compliance; just be aware that the pressure these people put on you to comply is one-sided at best.

Strategies to Mitigate Compliance Challenges

Leverage Compliance Management Software

Invest in robust compliance management tools that help track regulatory changes, manage documentation, and ensure that all aspects of the product and its marketing adhere to relevant laws and standards. Reduces the risk of non-compliance and automates parts of the compliance process, thus saving time and reducing human error. See below for a current list of these tools that some of my clients use to date:

• NAVEX Global’s RiskRate
  RiskRate provides enterprise risk management solutions that help organizations manage their third-party risk, including compliance with regulations like anti-bribery laws and the Foreign Corrupt Practices Act.
  Features: Risk assessment, due diligence, continuous monitoring, and integrated reporting capabilities.
• Thomson Reuters Compliance Learning
  This platform offers a range of customizable e-learning courses designed to help businesses train their staff on essential regulatory and compliance matters, particularly in the financial and corporate sectors.
  Features: Tailored learning pathways, extensive library of courses covering various regulations, tracking and reporting on employee progress.
• LogicManager
  LogicManager is a widely recognized GRC (governance, risk management, and compliance) software that helps organizations manage audits, compliance, risk assessments, and other governance processes.
  Features: Risk assessment tools, incident management, workflow automation, and comprehensive dashboards for reporting.
• ComplianceQuest
  ComplianceQuest is built on the Salesforce platform and provides a comprehensive suite for managing quality, health and safety, and compliance across industries.
  Features: Real-time visibility into compliance processes, seamless integration with other business applications, and robust analytics.
• MasterControl
  MasterControl offers quality and compliance software specifically designed for regulated companies in industries like pharmaceuticals, medical devices, and biotechnology.
  Features: Document and change control, training management, audit management, CAPA (Corrective and Preventative Actions), and risk assessment functionalities.
• Intelex
  Intelex provides environment, health, safety, and quality (EHSQ) management software solutions that support compliance with various regulatory requirements.
  Features: Mobile incident reporting, real-time performance tracking, compliance reporting, and risk management tools.
• VComply
  VComply organizes, categorizes, and follows up on responsibilities required for compliance in multiple industries. It offers an easy-to-use dashboard that brings visibility into compliance status and risks.
  Features: Compliance scheduling, reminders, document management, and audit trails.
  

Early and Continuous Compliance Integration

Integrate compliance requirements early in the product development process and maintain this integration throughout. This involves regular compliance reviews at each stage of the product lifecycle. Prevents costly redesigns and delays by ensuring that the product aligns with regulatory requirements from the start.

Cross-functional Compliance Teams

Establish dedicated compliance teams that work cross-functionally with product development, legal, and marketing departments. Ensures a holistic approach to compliance, where regulatory requirements are embedded in every aspect of product strategy and execution. Just as in agile teams, we practice cross-functional development teams, we need these people represented as well. Just remember their main goal is compliance and audit, so don't let them dictate your roadmap, be a partner with them and remain well ahead of compliance initiatives.

Training and Awareness Programs

If your product operates in a heavily regulated space, conduct regular training and awareness programs for all employees involved in product development and delivery. This should cover the importance of compliance and the specific regulations applicable to the product. Empowers teams with the knowledge to identify potential compliance issues early and incorporate regulatory requirements seamlessly.

Engage with Regulators and Industry Bodies

Maintain open lines of communication with regulatory bodies and participate in industry groups. Helps stay ahead of regulatory changes and may provide insights into the interpretation and application of complex regulations. Engaging directly with regulators can also aid in negotiating terms and understanding compliance nuances.

Third-Party Audits and Certifications

Utilize third-party organizations to conduct audits and certify compliance with international standards. Provides an external validation of compliance efforts, enhancing credibility and trust with consumers and stakeholders. Some commonly used ones with their sectors and focus are:

• Underwriters Laboratories (UL)
  Sector: Consumer electronics, manufacturing, energy, and more.
  Brief: UL is one of the most recognized names in safety science and compliance testing. It provides safety-related certification, validation, testing, inspection, auditing, advising, and training services to a wide range of clients in various industries.
• Intertek
  Sector: Electrical, toys, textiles, apparel, building products, and more.
  Brief: Intertek offers Assurance Testing, Inspection, and Certification services. They help ensure that products meet quality, health, environmental, safety, and social accountability standards for virtually any market around the world.
• SGS
  Sector: Agriculture, construction, life sciences, consumer goods, and more.
  Brief: SGS is known for providing inspection, verification, testing, and certification services. They are recognized as the global benchmark for quality and integrity, with more than 2,600 offices and laboratories around the world.
• Bureau Veritas
  Sector: Construction, automotive, aerospace, consumer products, and more.
  Brief: Bureau Veritas provides a wide range of quality assurance and compliance services including certification, production monitoring, and risk management audits to help businesses manage quality and compliance in their supply chains.
• TÜV SÜD
  Sector: Automotive, electronics, consumer products, healthcare, and more.
  Brief: TÜV SÜD is a trusted partner of choice for safety, security, and sustainability solutions. They specialize in testing, certification, auditing, and advisory services.
• The British Standards Institution (BSI)
  Sector: Healthcare, food, manufacturing, and more.
  Brief: BSI offers a range of standards-related services, from the development of private standards to training and certification. They help organizations ensure that their products meet the highest levels of quality and safety.
• Perry Johnson Registrars (PJR)
  Sector: Aerospace, automotive, environmental management, and more.
  Brief: PJR is a certification body that provides ISO/other standards auditing and certification services. They help companies achieve compliance with international standards, improving product quality and enhancing customer satisfaction.
• NSF International
  Sector: Food, water, consumer products, and health sciences.
  Brief: NSF International provides various testing and certification services for products and systems to protect and improve global human health. They are well-known for their work in certifying food safety and water quality.

Next Steps

Navigating the waters of regulatory compliance requires a proactive, informed, and integrated approach. By leveraging technology, fostering a culture of compliance within the organization, and engaging with external experts and regulators, product managers can turn compliance from a daunting challenge into a competitive advantage. Our goal is not only to mitigate risks but also enhance product credibility and customer trust, which are invaluable in a competitive market.