Compliance is an essential subset of the tools required for excellence. However, it is only a small subset. Innovation rarely comes from solely following the rules – a notable thought captured in the book, Four Types of Problems by Art Smalley. What caught my eye in the library was not the title, written in bold, but the underlying subtitle, From reactive troubleshooting to creative innovation. It’s that moment when you realise innovation is nothing more than problem-solving level 4.
In pharma manufacturing, we are good at problem-solving; we have procedures for it, we have systems for it. So can we bring it up to level 4?
2020 is still troubleshooting our COVID-19 problem. The world is trying to solve the conundrum of balancing the economy and saving lives. From reactive lockdown to hypothetical herd immunity, you can appreciate all levels of risk assessment and risk control measures more or less successfully.
While some communities follow global guidance, others define them and lead the pack. I don’t think there is one smarter nation, but leaving feelings aside and looking proactively at the problem in a no-blame culture surely helps – and that is the role of engineers and scientists. Politics should help them convey the message that the sometimes shy SMEs fail to express clearly.
There is a striking analogy between the macro scale of the world fighting COVID-19 and what happens in our manufacturing plans. Balancing business and human lives is what you do every day when you work in the industry, and if you don’t see that, you should probably not be working in this industry. The good thing? There are no better times than these for an engineer to work in the pharmaceutical industry. But then again, I have been telling myself that for the last 20 years.
The future will be for the nations, the companies, and the projects that save the most lives at the right cost. The available tools, from digitalisation to knowledge transfer, would only be useful if used to drive process understanding and build our knowledge of what defines quality.
How to Innovate? Where does the idea come from? The idea leading to innovation comes from using the existing tools in new ways, and turning them into new paradigms.
Since I started in the pharmaceutical and healthcare industry in 2001, our ethics haven’t changed. Today, like we did yesterday and will do tomorrow, we aim to make safe and efficient medicine. This is how we do it; the approach towards both the tools and guidance has evolved and will continue to evolve.
Our approach towards process knowledge was challenged – from the black box to the quality by design (ICH Q8), from everything needing to be qualified to the risk-based approach (ICH Q9), from the “You don’t change what works” to the push of innovation (ICH Q10) and its enabler to change (ICH Q12). Our tools evolved from the linear paper process to the paperless database, from grab samples to continuous online monitoring, from stainless steel to single-use, from cleanroom with operators to robotic isolators, and many more. Our product also evolved, from antibiotics to vaccines to monoclonal antibodies to cell and gene therapies.
Today, these may look revolutionary. However, they were the product of the daily integration of new ideas and tools leading to innovations. None of them happened in isolation, and communication towards problem-solving still remains a catalyst. Note that none of those were driven by compliance, but mostly, by a shared vision of addressing new challenges.
If I had to bet on existing tools and ideas that would support pharma industry innovation, these would be my obvious choices:
- Lean Thinking
- Increase effectiveness by identifying the value stream contributing to the safety/quality/delivery/cost of our drugs.
- Increase efficiency by removing waste in our processes.
- Problem-solving skills (which is different from deviation management)
- Understand the difference between troubleshooting, gap to standard, target condition and open-ended problems.
- Data gathering, understanding and analysis to support decision making
- Digitalisation leading to machine learning
- New diseases and a global pandemic
Now, what about you? How do you plan your innovation? Are you waiting for the next regulation to improve your quality system?
At No deviation, we partner with you to help you with troubleshooting or your CAPA, executing your CQV process, or implementing new digital solutions. Our team will come with an open mind and follow the simple steps that are Understand, Observe, Define, and Implement.
Reach out to us to know more about Paperless CQV, Web-based EMS, or simply like-minded resources support. You can also visit our website for more information on our services.
