Compliance: an obstacle or an opportunity?

Insights from a Let's Talk Risk! conversation with Raimund Laqua

Note: this article highlights key insights gained from a conversation with Raimund Laqua as part of the Let’s Talk Risk! with Dr. Naveen Agarwal series on LinkedIn. Listen to the full recording of the discussion below.

Key takeaways

Compliance creates the opportunity for innovation: the general view of compliance is that it is a “necessary evil” and a “tax on production”. You have to be compliant otherwise regulatory authorities will shut you down. However, another way to look at these requirements is to treat them as performance standards generally expected by our stakeholders including customers and regulators. In this way, these requirements provide benchmarks of performance we must achieve, or even exceed, to be competitive in the marketplace. Compliance can be seen as just doing the minimum required and check the box, but it also offers an opportunity to compare our current level of performance with what we need to achieve market leadership. We can strive to achieve significantly better quality, better safety, better security and better sustainability. In this way, compliance can be a driver of innovation and continuous improvement.

Treating regulatory requirements as part of product requirements facilitates a problem-solving mindset: it is best to treat regulatory requirements as part of the overall product requirements, not as an add-on to technical requirements. This will encourage us to apply design thinking and a problem-solving mindset to achieve the overall objectives, including compliance. A best practice is to involve your regulatory compliance professionals early in the design and development process before you finalize the product requirements.

Lean compliance helps us focus on reducing waste related to uncertainty: when we apply lean methods, we improve efficiency of our processes by reducing waste. This helps us to increase our capacity to be proactive, to be able to spend effort on improving safety and quality of our products. Waste in the context of lean compliance is the additional effort we spend when we are not in alignment with our goals, including regulatory compliance. When we consider regulatory requirements as part of the total product requirements, we can focus on reducing potential waste related to the effect(s) of uncertainty in meeting regulatory requirements. Lean compliance helps us to take a broader view of the overall business, not just focus on technical retirements. As an example, we can look at our obligations at four levels - regulatory, management, program and governance, to build a lean operational model for the total system.

Lean thinking helps gain leadership buy-in for compliance: engaging leadership to be a part of a lean-based approach to compliance is important. When compliance is presented as an enabler of innovation and market leadership, not as an obstacle, we are able to persuade the leadership to see compliance as an opportunity. Compliance is an outcome of our business processes, which makes the lean approach a means to an end. Compliance should not be treated as an isolated goal; rather as we have noted above, a part of the overall business objective. We should also recognize that regulatory requirements, or standards, do not prescribe a certain way to achieve compliance. They provide the “what”, not the “how”. It is up to us to consider the least-burdensome approach to achieving compliance as part of our overall strategy.

Compliance is a tough-sell; but remember that “c” in compliance means to care: the general perception of compliance continues to be a “necessary evil”. But it is important to take a step back and look at compliance from the viewpoint of our stakeholders, including customers and regulators. There is a reason to have a basic level of expectation about safety and effectiveness of our products. We are not trying to comply with requirements just to check the box, but because we care about our customers, our patients and doctors.

Where there is care, you will find quality; where there is care you will find safety; where there is care, you will find security.

Compliance is about caring!

About Raimund Laqua

Raimund Laqua is the founder of Lean Compliance, where he focuses on helping companies in highly-regulated, high-risk environment to transform their approach to compliance using lean thinking. As a professional engineer trained in electrical and computer engineering, he started his career building test systems for integrated circuits. Over the next 30 years, he consulted with many companies across different industries to help them achieve business results through lean management, systems thinking, risk management, accountability and responsibility frameworks, and continuous improvement. He founded Lean Compliance Consulting in 2017 where he currently serves as the Chief Compliance Engineer

About Let’s Talk Risk! with Dr. Naveen Agarwal

Let’s Talk Risk! with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.

Disclaimer

Information and insights presented in this article are for educational purposes only. Views expressed by all speakers are their own and do not reflect those of their respective organizations.