Read on for a story about control, learning and trust.
Fidget spinners are everywhere in Belgian schools nowadays. Just like in any other country, young children got intrigued by this new toy. They make it spin all the time: in class, on the playground, while waiting for the school bus… Some can even put it on the top of their nose and keep it spinning (yes I am guilty too). Despite all the fun that fidget spinners bring, some schools have it now forbidden. It would distract children and cause fights on the playground.
By exercising control, schools create the illusion that children will now better concentrate and no longer fight. Forbidding is typical for a controlling organization. You don’t need an academic degree to understand that this is nonsense. There will always be something to get distracted or fight about. I rather expect my children’s school that they teach them how to focus and play together.
Around the same time, Dutch reverends warned about a devilish rap song(“Kind van de duivel”, Child of the devil) that children in primary schools were singing. In reality, my children just like the music and have no idea what is meant when they sing “I am a child of the devil”. Interestingly, in both cases there is a call for control of something that can’t be controlled anyway. Controlling organizations thrive on complying with rules. However, by exercising control, an opportunity for learning and building trust is lost. How will children ever learn if they are not allowed to make any deviate from rules?
Compliance & Control
You may wonder what fidget spinners and devilish rap songs have to do with quality & compliance in pharmaceutical business. Essentially, the control mechanism plays a part. Pharma business is highly regulated and to ensure that companies comply with those regulations, they define a collection of mandatory business processes. This way, companies (try to) control their operations and avoid any mistakes, human errors, non-conformances or whatever you may call the deviations from those processes.
In health care, the stakes are always high. They are dealing with human lives, you know. Hence you need a controlling organization that defines metrics, objectives and processes, and that monitors all of these carefully. Whenever there is a deviation, you should look for the root cause and adapt your processes as needed. With human lives at stake, no time should be wasted to prototype or pilot process updates. Instead, make sure that your procedure contains all possible details to guarantee a flawless execution of the process. The more detail, the better. Don’t worry too much about complexity; that’s why there is an e-learning course in the learning management system.
If the process itself is not the problem, it must be the people and their training. If employees have not understood a process well enough, re-train them. For the sake of effectiveness, don’t spend too much time on creating training material: just send them a lengthy PowerPoint deck or even better: ask them to read the standard operating procedure once more and your re-training is done. We all want to be lean, don’t we?
If you have followed the above, all metrics in your dashboard will be green. You are now fully compliant, everyone is trained, there is full central oversight and you are ready to endure any audit or regulatory inspection. Game, set, match, victory!
Compliance & Illusions
Controlling organizations thrive on compliance with regulations. Now when you focus too narrowly on compliance, you are driving with blind spots. In case you have missed the irony in the paragraphs above, I’ll tell you this little story of what could happen in compliance-driven culture:
A woman is informed by the hospital that her husband had a car accident. She rushes to the hospital but is too late: her husband has passed away. A nurse brings the woman to the mortuarium to greet her beloved husband.
When the woman touches his hand, it still feels warm. She bends over and it looks like he is still vaguely breathing. She tells her suspicions to the nurse. The nurse takes the clipboard from the man’s bed and says: “That’s impossible. According to this document, your husband passed away at 2.13pm today.”
The woman can’t believe her ears, runs out of the mortuarium and begs a doctor in the hallway to examine her husband. He is still alive.
This could happen in a compliance culture where people no longer look beyond the document, the metric or the single data point. Exercising control gives us the illusion that we have everything under control. But, no metric can be understood without full understanding of its context. Underneath every dashboard is a whole reality that cannot be captured into simple metrics. If all your metrics are green, your business looks fully compliant but you may still miss the real risks.
Just like the fidget spinner at school, attempts to control everything in pharmaceutical companies are doomed to fail. As brilliantly described by Celine Schillinger in her posts on Deming’s management principles, you can standardize equipment, systems and processes but not employees. When people feel that they need to fit a template, they will disengage, self-censor and avoid risks. Say goodbye to innovation.
Quality & Compliance
In some way, quality can be seen as the complement of compliance. Whereas compliance looks at meeting regulatory requirements while performing a task, quality refers to the degree in which a task achieves its intended purpose.
Let me illustrate with an example .There is a regulatory requirement that you need to understand Good Clinical Practice (GCP) regulations before executing any tasks during the conduct of a clinical trial. If you read the entire GCP regulations and document this in your training file, you are considered compliant. Does that mean that you are qualified to execute those tasks? Not at all!
It requires a deeper understanding why regulations matter in the interest of patients. Those regulations may look black and white on paper but in reality you will rather find 50 shades of grey. You will need coaching, accompanied visits to clinical sites, dialogue with colleagues etc. so you can distinguish all those shades of grey and take the right decisions in the field. That’s the moment where you don’t look at a document to verify if a man is alive or dead.
Quality & Learning
Whereas controlling organization thrive on compliance, quality is driven by learning organizations. These are companies that embed quality pro-actively in their business processes. They consider any deviation from those processes as a learning experience to further improve their commitments in terms of patient safety, data integrity or ethics.
Since the stakes are high when dealing with human lives, you should carefully change your business processes. The design thinking techniques of prototyping and piloting help you to learn and gain feedback before you are making any radical modifications. When implementing those updates, you should not rush but apply adult learning techniques and invest in people’s development to do things differently. Once employees execute those processes, don’t forget to give them access to experts and helpful resources (job aids, “how to” videos, case studies, best practices…) to deepen their knowledge or refresh their memory when needed.
When individuals work in a culture that values learning from mistakes, they will also take more risks with positive impacts on quality and innovation. Diversity then becomes an asset instead of a liability, or as written by Celine Schillinger:
Variation of individuals should be leveraged to continuously co-create and improve quality. When people are involved in findings solutions and are not feeling ‘standardized’ that is when quality will improve.
Quality & Trust
A critical condition for a learning organization and a quality culture is trust. Employees should feel supported by their management to raise new ideas and experiment. Despite its enormous power, trust is not something you can “implement”. So where can you start?
One of the things you can implement are enterprise social networks (also called: social technologies) where people can discuss their work. This is what John Stepper calls “working out loud”. Through conversation with your colleagues, you can discover new insights, react to people’s opinions and develop completely new ideas.
If you want to improve your business processes, this dialogue is critical. In the old days, employees met at the coffee machine and discussed their work-related issues in an informal setting. Nowadays, there are still coffee machines but people work more dispersed (from home, at different sites or even in other countries). Thanks to social technologies, the potential reach of their ideas has increased exponentially. Hence, quality and innovation can flourish.
Conclusion
In my opinion, all these principles seem so logical — almost trivial — and still we forget them because we think we can do it faster, more efficient, leaner, more whatever… It’s like with devilish rap songs and fidget spinners. They become so easily “regulated” that we are also missing the true learning opportunities.
The ultimate aim of a pharmaceutical business is creating high quality products that address the unmet needs of patients. In that sense, quality is a goal, whereas compliance is a means to achieve that goal by ensuring data integrity, product safety or ethics. The key difference between a compliance and a quality culture is in its ability to learn and adapt. Hence, it’s no coincidence that the word “learn” pops-up several times in the context of quality cultures:
As Dr. Paul Janssen used to say: “There is so much more to be done; the patients are waiting.” This was his way to motivate his employees at Janssen. Although we serve patients, their families, doctors and nurses, everything starts with the employees that make it all happen. In a quality culture, human-centered design should be the standard to create, adapt and implement business processes.
