Words by Martin Lush, Global Vice President, Pharma Biotech and Medical Devices, NSF International.
To prosper in this era of brutal disruption with new science, new regulations, new governments, and new challenges, we must think differently.
To help you succeed, here are our top five recommendations for the pharmaceutical industry.
1. Simplify to Survive
Simplify documentation systems, particularly SOPs. They have become overly complex and impossible to follow. Instead of improving consistency and being written for the user, they have been written for the auditor or regulator and increase the risk of errors. For guidance on writing good SOPs, look at a recipe book! You’ll see lots of pictures and simple diagrams!
Simplify batch manufacturing records (BMRs). Excessively detailed instructions, poorly designed documents, and excessive check signatures contribute to user overload, stress, and mistakes. BMRs need to provide essential guidance and an accurate and reliable history of events.
2. Make Less More
Tune up your change control system. If it approves everything, it’s dangerous. A good system works on the principles of Pareto and only approves the 20% of changes that provide 80% of the benefit.
Whether your change control system approves or rejects planned changes, risk remains constant. To make the right decisions, you must have excellent risk management skills and competencies.
3. Hire People Who Break the Rules
Employing rule-breakers in an industry that prides itself on compliance seems counterintuitive. But rule-breakers push the boundaries, keep asking why, and never give up.
Rethink your recruiting. If companies recruit the same types of employees, they get the same decisions and outcomes, and maintenance of the status quo. But, in an era of brutal disruption, the status quo is no longer good enough. The pharma industry desperately needs people who think differently.
Don’t just recruit people from traditional sources like the pharma company next door. Try attracting candidates from the automobile and microelectronics sectors. They have been practicing total quality management for over 50 years!
Hire people who know how to think. The upside of falling prices for our medicines and rising manufacturing costs is that we all must think differently.
4. Become Obsessed with Finishing and Following Up
·Become obsessed with disciplined execution, implementation, and follow-up! The pharma industry is populated with very bright people who have lots of very bright ideas… that usually fail. The root cause? Poor (ill-disciplined) implementation. This is compounded by no follow-up to see what has worked and what hasn’t. We just need to apply Deming’s PDCA (plan – do – check [measure and follow up] – adjust) plan.
5. Focus on the Main Thing… Or Perish
When visiting companies, ask people – from the warehouse supervisor to the CEO – about their products and patients. Do they really understand how they work, their key quality attributes, and how they improve patients’ quality of life?
The most important job of leadership is to keep people motivated by giving them a reason to care about what they do beyond the P&L. This means constant reminders that the patient is at the centre of every decision.
Have a question? Contact pharmamail@nsf.org
Visit www.nsfpharmabiotech.org to learn more about our services.