Seven steps towards regulatory excellence - Step 1 - Requirements Identification

By: Simone Bernardi, Anders Ekman, Celeris AB

Simple things work

If you work in a highly regulated environment, I guess you would intrinsically smile by reading the following words:

"The best things in life are simple. Simple things work. They don't foul up. It's the complicated things that get twisted around on you." (Lois Duncan Steinmetz, 1878).

You would smile as you would wish the compliance’s management of your area would be a simple thing. Unfortunately, it is not. Over the last decades, regulatory frameworks expanded and evolved under various driving forces and events. The result: a diverse, heterogeneous, and sometimes even conflicting set of complex regulations, difficult to navigate, within and across themselves. As the cost of noncompliance is high, and in light of the inspiring words of Ms. L. Duncan, the question which comes to our mind is: how can we transform something complex into something simple?

A simple approach to a complex problem

We here propose a step-by-step, simple, and well-structured method labelled “7 steps towards regulatory excellence”, to help professionals in the regulatory management and compliance engineering area to tackle complex regulatory frameworks. Following Agile principles, we take a complex problem and break it down in smaller consecutive steps, which can be tackled one by one. The first steps of the method can be even approached by means of easily accessible and available software like MS Office. By executing on it, you will gain insight into the regulatory frameworks which need to be considered and filter out the noise by focusing on the true key aspects/paragraphs of the regulation. That means, you need to get your requirements from the beginning.

Step 1 – Requirements Identification

The foundation and first step of the approach is the requirements’ identification. In the field of requirements engineering this step is also denoted by “Requirements Elicitation”, “Requirements Development”, or “Requirements Discovery” (see Bahill and Dean (1999) for an example of system requirements discovery process). To identify the complete set of (regulatory) requirements is key to any compliance related product development project. Failure to do so makes compliance to complex regulatory projects even more difficult than what it already is.

It also exposes institutions to error and defect prone products, with non-compliant features, which generate an outflow of maintenance and remediation costs over the product lifecycle. Identification of requirements (properly identified, organized, and centrally stored) also eases collaboration and transparency within a product’s development process. A consistent repository of requirements (always up to date) and available on the shelf to a large set of stakeholders and project’s participants, boosts collaboration and avoids a series of duplication of work and related sunk costs due to information asymmetry on the status of a requirement and their compliance. Once (regulatory) requirements are identified, and properly stored in a central repository, one could say you are already half the way to success, as you started with the right foot. But, there is much more work to do to achieve regulatory excellence and you will find out more in our next newsletter!

References: Bahill, A. T. and Dean, F. F. (1999), "Discovering system requirements", Chapter 4 in Handbook of Systems Engineering and Management, A. P. Sage and W. B. Rouse (Eds.), John Wiley & Sons, pp. 175-220.Source: Seven steps toward regulatory excellence – Step 1 – Requirements Identification | LinkedIn