The real reason you’re struggling to stay compliant

Posted: 18 December 2019 | | No comments yet

For companies in highly regulated industries, compliance is second only to survival as a business. Yet why do so many companies struggle with compliance? Dr Rebecca Godfrey explores this issue and provides practical steps that companies can take to ensure best practice.

WE ARE DRIVEN by innovation and the desire to progress scientifically and technologically to bring much needed, often life changing, treatments to patients. At the same time, we need to maintain strict compliance with often complex and ever-changing regulations, not only to maintain our right to operate but also to keep patients safe.

At times, balancing these two aspects, which to some might appear paradoxical, can be difficult. We often put these difficulties down to a lack of resources – be that human resources (not enough staff, or not the right staff), financial resources or simply time. We feel that we are forced into a permanent reactive state, constantly trying to catch up with the latest regulation change and consequently unable to adequately prepare for the next change. We find our processes increasingly complex and thus increasingly difficult to follow and manage, as well as time consuming to update when regulations change. Does this, or at least part of this, sound accurate?

I have worked with some of the world’s most well-known pharmaceutical companies, both as an employee and as a service provider, and regardless of the portfolio, size or geographical reach of the company, these same challenges remain. So what can we do? Must we just accept remaining in this highly reactive state? Will we continue to find this balance a struggle, or is there something we can do differently?

I can assure that there is. First, we must assess whether we are making best use of our resources and, if not, address how we can release some of the pressure and make space for innovation without the need for additional resources. Addressing the following questions will help to alleviate the challenges:

1. Culture – do we have a compliance culture?

Compliance issues rarely just spontaneously occur, often there are issues within processes, structures and training that, if identified early, can avoid compliance issues long before they start impacting regulatory commitments”

Most of my leadership roles have revolved around the world of compliance. In these roles, I advocated that the compliance team should work to ensure correct processes, checks and balances were in place so that when the scientists were reviewing and analysing their data they could be assured it was complete, accurate and robust. I shouted this from the roof tops at times, keen to assert that compliance was not the police, but a partner to the business. Our role was providing support and counsel to colleagues so that they could operate, innovate and progress in the knowledge that they remained in compliance with the multitude of regulations to which they were subject. In order to future-proof our teams in a world where the need to adapt is more important than ever, we must not discourage innovation; instead we must partner across the business to bring the best of minds together in the pursuit of compliance and progress.

2. Scope – do we have clarity on the scope and boundaries of our role and that of our team?

So many teams I meet, on the surface, look aligned and clear of their purpose and scope. However, when we start to scratch below the surface we often find ‘grey areas’. In such scenarios, employees will often flounder near the boundaries of their responsibilities, feeling stuck and unsure whether it is their job or the interfacing team’s job. In an effort not to step on anybody else’s toes, they often slow down, which starts to cause inefficiency, or even worse they start to retract. When employees are unsure if a task or activity is their responsibility, they often step back, leaving a gaping chasm between them and the interfacing team, thus risking significant non-compliance. For this reason, it is vital that the leader is clear on the scope of their team; that they discuss and negotiate the boundaries of their team’s responsibilities with their interfacing teams; and that they clarify the scope of the team and each role within it with every team member.

3. Structure – do we have the right structure in place to support compliance?

This question should be considered, not only in terms of an organisation chart, but in terms of mindset, where control is distributed and colleagues are empowered as subject matter experts at all levels within the organisation.

Sadly, it is still the case in the minds of many leaders that “knowledge is power” and as a result, knowledge remains with the leader who directs and develops the processes. In an environment with complex and everchanging regulations, this approach is risky, for the following reasons:

i. Without distribution of control, a team is not resilient. Instead, the leader becomes the linchpin through which all information, developments and improvements flow. When the leader is unavailable, too busy, away from the office or simply overwhelmed with the many changes and responsibilities they face, the system fails.

ii. Where the leader is solely responsible for developing and maintaining processes, you see only one perspective. The leader may have significant experience and knowledge in their area of expertise, however when looking to innovate, newer and fresher perspectives are needed from which to view problems, rather than relying on old tried and tested methods.

iii. Without ownership, you cannot possibly expect commitment. When control is distributed and the whole team is involved in the development and ownership of processes, we see a significant increase in commitment to their success and to the success of the whole team.

iv. We do not make best use of the knowledge, talent and resources available. Having distributed control and ownership of processes allows companies to share the load in terms of keeping up with the many changes in regulations and reacting to them. It also allows businesses to make best use of their resources and serves as a development opportunity for team members.

4. Staff development – does our staff development focus on building confidence as well as developing skills?

In order to truly develop teams, businesses must focus on developing both skills and confidence. By distributing control and viewing team members more as ‘subject matter experts’; by allowing them space to try and fail in a no-blame culture, they grow, develop and achieve more on a personal level, which not only increases employee motivation but also further frees up the leader’s time. Having a team of people with high skill and high confidence allows the leader to step back, giving team members the opportunity to take the lead, and enabling the leader to move on from ‘doing’ to an oversight role.

In order to future-proof our teams in a world where the need to adapt is more important than ever, we must not discourage innovation”

Compliance issues rarely just spontaneously occur, often there are issues within processes, structures and training that, if identified early, can avoid compliance issues long before they start impacting regulatory commitments. Having better proactive oversight allows risks to be identified early and mitigated proactively, leading to further improvements – something that in a reactive ‘fire-fighting’ state rarely happens.

So, if we do all of this does that mean we are sorted, we are compliant and have the space and time to be more innovative? Well, it is certainly a start. Be mindful of excuses and reasoning for non-compliance. When non-compliance occurs, we so often focus on the process or the resources, yet it is rarely these aspects that created the issue. A challenge within a process is often the symptom but not the cause of the problem. For the true root cause, one must look across culture, scope, structure and staff development; because when just one of these aspects is lacking, we see disengagement, inefficiency and the potential for non-compliance. 

About the author

Dr Rebecca Godfrey completed a PhD in Immunology at the University of Cambridge. Since leaving academic research, Rebecca’s career has given her the opportunity to build and develop a drug safety consultancy business, work with and lead colleagues from more than 90 countries, live and work abroad and lead organisations and groups in roles ranging from Company Director of a small consultancy to Global Head and Global Director roles in two of the world’s top 10 pharma companies. Rebecca is the founder of Etheo, a team and leadership transformation consultancy with a focus on the highly regulated technical industries.