Balancing regulatory safety, speed during a crisis
This article was taken from malaymail.com . Original Link Here: https://www.malaymail.com/news/what-you-think/2020/04/07/balancing-regulatory-safety-speed-during-crisis-ken-chiew-leong-madani-saha/1854200
As engineers and a public health physician, we write in response to the Covid-19 global crisis. We propose several common-sense ways to balance safety and speed when producing new medical equipment during times of crisis, such as face masks, protective gowns, and gloves.
The world has adopted health and safety regulations for the benefit of citizens and consumers. In a crisis, however, overly complex and numerous regulations can be detrimental. When supplies are low and there is a dire need for them, governments must balance between the safety of “ticking all the boxes for certifications” and the flexibility to “obtain all supplies we possibly can.”
During a crisis, we need new production lines to retool and spring into action in the shortest time possible. This means that regulatory bodies and standards must change to balance safety and speed. As an overarching idea, we may need a Temporary Standards for Malaysia that is monitored by the Standards Department or Sirim.
We propose several specific suggestions. One, regulatory bodies must identify “must-haves” and “nice-to-haves.” Authorities could justify the relaxation of certain criteria to increase supply in the market and/or create different tiers of compliance for different categories.
Some criteria may not be critical for achieving the performance required. For example, some 3-ply masks (even those for the public) may not need to be meet the same blanket requirements as those intended for medical use.
Two, regulatory bodies can play a more active role. Current procedures rely on a Waterfall Model where certain boxes have to be ticked before progressing to the next step. In this model, regulatory bodies play a passive role.
During crises, regulatory bodies could adopt the Agile Model where they play an active role and be involved in the whole process from conception to delivery, making the process transparent to all stakeholders.
Three, regulatory bodies can deliver a pre-approved solution. Instead of approving endless proposals from the private sector, regulatory bodies could offer an open-sourced blueprint that is pre-approved.
As long as the manufacturer adheres to the exact blueprint from start to finish, they are considered pre-approved until proven otherwise.
For example, in the case of face masks, there could be a blueprint “solution in a box” where operational aspects (e.g. modular factory floorplan) and design aspects (e.g. product size, range of material thickness) are fixed. Manufacturers can use the textbook solution for much quicker production.
We write this letter as an example of the unconventional thinking and inter-disciplinary collaboration needed to fight Covid-19. The balance between safety and speed is crucial during a crisis.
We hope that Malaysia is able to look beyond previously set practices and conventions and rethink some of our approaches to overcome this outbreak.
This article is written by Dato' Madani Sahari, CEO of Malaysia Automotive, Robotics & IoT Institute (MARii),
Ken Chiew Leong, an engineer, consultant, and entrepreneur.
and Dr. Khor Swee Kheng, a physician, and a public health specialist.