02 nd May Quality – reaping the rewards
Director of a leading regulatory affairs consultancy Jonathan Trethowan, shares his thoughts on quality.
There are nine words that when strung together in one particular order, are the perfect excuse to indulge my natural scepticism; ‘…we offer the highest quality service to our customers’. It will be no surprise to you that my expectations have rarely been met with such superior claims of quality. On occasion, I have even struggled to identify any form of quality from the service being delivered to me, let alone experience a service that has ascended to the giddy heights of the highest quality.
In times where, despite the best efforts of technology, we find ourselves the most time poor generation, quality must surely mean getting it right, first time, every time. These days none of us have time to waste on repeated conversations between multiple points of contact within a company, unclear procedures and an inability to obtain answers to questions that; (perish the thought) sit outside the bounds of a company’s website FAQ section. With these somewhat, less than stationary goal posts in the delivery of ‘quality service’, how confident are we when it comes to claims of good quality? A troubling thought for a regulatory affairs professional where there is no scope for error in the work we do.
Dwelling for a moment on the role of a regulatory affairs professional; to assist, question and challenge pharmaceutical companies in demonstrating that they are meeting and exceeding quality, safety and efficacy requirements of medicines. Perhaps it is the very work we do that makes us more critical of quality claims than our sibling sectors; even dooms us to a future of continual disappointment where claims of good quality service are involved.
Although; I’d hazard a guess that there is an opportunity presenting itself to us. The skill set and outlook required for a successful regulatory affairs professional makes us the perfect fit to pick up this quality gauntlet. With our core values, it surely wouldn’t be long before regulatory affairs became renowned as THE sector of quality focussed, trail blazers.
As co-founder of TRAC (The Regulatory Affairs Consultancy), I’ve looked at starting this journey at home with a review of ways in which TRAC could improve and continually improve the quality of our service to the benefit of each of our customers. It led us to quickly identify that achieving the International Standards Organisation certificate for quality, better known as ISO9001:2015 needed to be an ambition. In working towards and recently achieving this best practice system, we can now benchmark, audit and measure our performance, an outcome that gives our team confidence in our own delivery of quality service. Just as importantly, it’s a step in the right direction in reclaiming confidence and assuring a generation of customers that this is a certification that represents an organisations commitment towards continual improvements in the delivery of quality service. In other words, to maintain ISO 9001, TRAC must continually demonstrate how we are meeting and exceeding quality requirements.
Like myself, as a scientist you’ll be asking ‘why’ and how’ can I have confidence in the ISO 9001 quality stamp of approval? Speaking from our experience at TRAC; we’ve been inspired to develop clear, air tight processes and procedures in all areas of our work. Demonstrably more effective and efficient in everything we do, we have the tools to identify that we’re getting it right, first time, every time. There is not one area of our business from finance to HR to customer service to training which, has not been examined and improved on through ISO 9001.
And the result so far? With 85% of our customers returning to us for help from when they want to clear their backlog to when they need an extra pair of hands to support their team; perhaps it’s not just myself that can see the benefits to more quality certification in the world of regulatory affairs.
Below image: The author, Jonathan Trethowan and members of the TRAC team with their Quality ISO9001 certificate