Jane Wood, former Head of R&D Quality at J&J, and Principal of YourEncore’s Quality Center of Excellence, is one of YourEncore’s leading subject matter experts in all things Quality, collaborating with clients to improve and innovate their Quality systems and regulation/change readiness. In this Expert Q&A session, Jane provides valuable insights into the evolution of Quality and the current challenges and demands Quality organizations face.
How have you seen the evolution of Quality over the years?
I’ve seen so much change in the last 40 years: changes that reflect the need for strong quality management systems, the development of thoughtful metrics and tools, the advancement of artificial intelligence and automation, the sharing of industry data and ideas, the development of global regulations, and regulators that share information for the betterment of patients and consumers.
In my opinion, the Quality landscape has primarily gone from a reactive Quality environment to one that’s proactive. We’ve moved away from a police force-type function, where it was much more about Quality Control (QC) of data and documents, to that of a sophisticated organization that supports and facilitates the rest of the functions in a company. Quality also provides an expert viewpoint on the regulations, so I see a major shift in emphasis away from strict QC adherence to one of mutual and beneficial partnerships.
I also see a revolution in the development and use of Quality tools and metrics, – the gathering of data, applying key performance indicators and interpreting data in sophisticated ways – resulting, at the end of the day, in far better patient and consumer outcomes. There have been so many changes, and hopefully more to come as we advance to where Quality truly belongs: owned by everyone.
What is the greatest challenge in Quality organizations?
I think, in some areas, the greatest challenge is still balancing the need for compliance versus proactive partnerships. It’s keeping up to date with the regulations and managing all of this in a cost-constrained environment: one where mergers and acquisitions (and change) are commonplace.
There are increasing Regulatory and company demands: the need for data transparency is significant, we have serious breach reporting (which is a good thing), an increase in Pharmacovigilance regulations, and changes in the medical device world. The challenge is keeping on top of all this change while still keeping the wheels on the road of day-to-day business.
Another area that is a hot topic right now is vendor oversight. Much of the business uses CROs, suppliers, and vendors, so ensuring how the sponsor stays on top of their performance and delivery is paramount and something that is still evolving to some extent.
What advice would you give QA professionals in today’s world?
I used to say this all the time to my colleagues: You should smile and be happy; don’t sweat the small stuff, and treat others as you would like to be treated! We can get so caught up in the challenges and pressures of what we do that we can forget to sit back and enjoy being in Quality. Quality is wonderful; it’s a super function! Let’s face it, who doesn’t want a Quality product or process? We get to touch nearly all parts of a company and learn so much; enjoy it!
Being able to think outside of the regulations is also really important, and this skill often comes as your experience grows in the Quality environment. Consider the importance of the compliance observations in the grand scheme of things. Sometimes it’s better to help and advise for a better outcome, rather than citing a failure. I’ve noticed a tendency that people often feel more comfortable citing failures. Put yourself in the shoes of the recipient: it’s so much more fun and productive helping them succeed!
Wear your business hat at all times. We are part of a business; even though we are independent and the guardians of compliance, we should learn to think and talk in the business’ language. It will serve you well as you navigate the complexities of corporate communication.
Where do you see Quality going in the next 5 years?
I’d like to say that there will be a huge change, but I don’t think it is that simple. Perhaps we will see different ways of establishing Quality organizations; perhaps we will see more Quality colleagues within business functions. Either way, if we retain the independence of audit, then it’s fine; let’s explore different functional options if they can serve us better.
I also think we need to plan how to ensure Quality professionals are ready to audit and support Artificial Intelligence systems. Alongside that, I still think there are areas that are not yet totally buttoned up – pharmacovigilance, vendor oversight, data integrity, etc. – so more of the same training, enhanced communication, and thinking like business professionals will all serve us well.
Quality Management Systems with risk-based thinking are a requirement, but are they well and truly embedded in all companies? I’m not sure. When you dig deeply, sometimes the systems don’t hold up as well as they should, and components like Quality Tolerance Limits are still not deeply understood. I would love to see more sponsors coming together and working on these concepts collectively.
One thing is for certain: Quality will continue to be pressured. Everything in the pharmaceutical, medical device, and consumer world is pressured, and I don’t see that going away. Ultimately, I think Quality must be incredibly adaptable. There will always be Regulatory and organizational changes that will force us to evolve. Let’s embrace those changes, go with the flow, and remember that, at the end of the day, in everything we do, it’s all about the patient.