As we are now in the midst of the COVID-19 pandemic, the regular operation of Quality Infrastructure is greatly reduced and partly at standstill. At the same time, we observe how Quality Infrastructure organisations are adapting their services to the reality of lockdown and home office work. Since we also have to stay at home, it is an excellent opportunity to use this time to eventually start the blog #QI4D.
Quality infrastructure organisations are faced with the dilemma of protecting their staff from becoming infected, on the one hand, and maintaining their services, on the other hand. Quality Infrastructure services are of great value when trying to find the right responoses to the pandemic. For example, patients, medical professionals and the society as a whole must be able to rely on the results of COVID-19 tests. This is only possible if laboratories are technically competent and can at best prove this through internationally recognised accreditation.
Faced with the crisis, Quality Infrastructure organisations have shown to be adaptable. One example is the International Standards Organisation (ISO) whose standards committees are now working virtually. As online meetings of standards committees happened before, it was easy to mainstream this practice.
In response to the outbreak of COVID-19, many national standards institutes have made standards, which are relevant for fighting the COVID-19 pandemic, freely available online. This applies to standards for masks, personal protective equipment (PPE), ventilators and other medical devices. In doing so, National Standards Institutes are foregoing essential revenues, but they are supporting the entry of new suppliers into the market, especially Companies which purposing their production lines to join the fight against COVID-19, and ensure access of healthcare professionals and patients to urgently needed equipment.
Quality Infrastructure is equally important for controlling respiratory masks. Particle filtering half masks, better known as FFP masks (FFP = filtering face piece), are recommended for medical personnel. In Europe, the EN 149-2001 standard specifies this, while similar requirements are defined in the N95 (NIOSH-42CFR84) standard of the United States and the KN95 (GB2626-2006) standard of China. Due to the sharp rise in demand, international trade of fake masks are now increasing dramatically. For the protection of medical staff and patients, functioning market surveillance and the existence of accredited testing laboratories is the essential.
Meanwhile, the International Accreditation Forum (IAF) allows alternative procedures for assessing the conformity of products. In Brazil, for example, the inspection authority INMETRO allows an alternative method of compliance with the factory audit that is required for the maintenance or recertification of INMETRO product certification projects. Accredited product certification bodies are expected to perform a risk analysis based on the records of the manufacturer’s last internal audits, management review and handling of customer complaints. INMETRO allows the use of 1st or 3rd party accredited laboratories in Brazil or international laboratories accredited by ILAC members, regardless if the criteria for test reports written in the specific product certification.
All these practices, born out of necessity, can give us essential ideas for innovation in the work of the Quality Infrastructure in times of lockdown and pandemic. The advantages of the digitisation of services, which has received a new push as a result of the crisis, are already apparent. Processes that previously seemed lengthy,have reached the phase of prototyping after a few weeks only. At the same time, new modes of working, such as home office and video conferencing, are attracting increasing attention in the areas of cybersecurity and occupational safety and health. Here too, Quality Infrastructure is required and can offer a range of standards and technical regulations.
To start a discussion on innovation of Quality Infrastructure in times of a global crisis, we request directors and other staff of QI institutions to share novel practices that are probed by their institutions and other opportunities for fundamental innovation in the work they are recognizing. We would also like to discuss methods and procedures that prove being inflexible and obsolete in the face of such a crisis and what the alternatives could be.
Please, share your experiences and ideas, using the comment function in this blog.