In 2016 in a blog titled ‘Don’t Reduce your Costs’ I wrote:
“The costs of any organization, setting aside fraud, incompetence and stupidity, are largely a function of its processes (and adherence to them or not). The costs further reflect the supporting technology, the application of people’s skills and behaviours and, critically, the management attitude, i.e. the balance of autonomy and constraint as expressed through control (or management) processes.”
Today, we have heard that a vaccine has been approved for use in the UK and that a programme of vaccination will commence within days.
That should of course be regarded by all as excellent news presenting, as it does, the prospect not only of dramatically reducing the toll of death and illness resulting from the virus but also the potential for the NHS to revert to conventional operations and the greater part of the population to be released from the constraints of tiers and lockdowns with all their consequent personal, social and economic impacts.
Never a nation to take good news without a healthy dose of pessimism, questions are now being asked about whether the vaccine has been fast-tracked without adequate safety checks, whether the approval process has been skimped, the risks down-played and the usual public safeguards bypassed.
Wrong questions. Perhaps it is not that this approval is fast but that the system is, normally, far too slow.
What we should rather be focused on is NOT how come this vaccine gained approval so quickly but how come it takes so long under ‘normal’ circumstances?
I have not examined the particular process for THIS vaccine, I have though over many years worked on and with processes of all sorts including those for pharmaceutical development, agro and petro-chemicals, manufacturing of food, paper, steel, supply of sterile equipment, logistics, energy and integration of data. What can be seen when we examine each of them (and many projects) is that they are made of up two key elements – work and waiting – and, as Taiichi Ohno (Toyota Production System, original ‘Lean’ guru) would put it:
“waiting is waste or muda”
Waste is all the time that is spent waiting, by people, things or data, for the next step in the process to be undertaken – and it often accounts for a substantial portion of cost and the greater part of process time. If we can eliminate the delays, the decision can be reached much more quickly.
I like to think that in the case in point the urgent need to deliver an effective outcome to address a clinical need on a global basis has given new purpose and focus to the necessarily meticulous scientific work of the regulators. This purpose and focus has perhaps enabled them to overcome the conventional (I hesitate to call them bureaucratic) delays inherent in a regulatory system.
A really positive outcome to this process would not just be the approval in record time of this vaccine (and others going through the same process) but the recognition that the regulatory revolution that has enabled this approval should be the basis for all future approvals. If ONE pharmaceutical can be approved in a record process time then the potential exists for ALL to be approved in this time.
Let us permanently eliminate the muda that must have been present in the old process and make today’s exception tomorrow’s norm.