The new perspective of supplier control after Corona
The current Corona (Covid-19) pandemic forced the digital transformation of our work environment much quicker than we anticipated. We had no other option instead of pushing ourselves forward to come out of comfort zone in order to be acquainted with more significant changes within our everyday life.
To some extent, the lockdown condition is currently eased off throughout the whole world. As a result, the world starts moving back to its Pre-Corona state. Simultaneously, a question arises; will we be able to replace our present practice of working with the old one? Or, are we actually intended to switch back to the old working method?
During that Corona phase, a little difference has been noticed in the sphere of medical device industry in terms of maintaining effective control on its process, subcontractors and on suppliers.
Right before that lockdown, we were used to do Supplier Audits. Simultaneously we needed to go through supplier’s QMS. Scrutinizing a site audit is time consuming. Usually it takes one day; sometimes it requires two days to complete an audit. It actually depends on the criticality of suppliers and these audits are conducted at least once a year.
The travel restrictions of present situation, resulting a change in remote work and in the ability of effectively control processes, subcontractors and suppliers with an onsite audit is limited. The capability of such processes and (critical) suppliers has also been compromised.
The fact is that, the solutions to this problem were available in the form of remote audits (Also known as eAudits, on line audits, virtual audits, web-based audits etc.) all the time but not used within the industries so frequently. This method of auditing was around for some time. Finally it was explicitly addressed in 2018 version of ISO 19011 — Guidelines for auditing management systems. (This again is referenced in ISO13485:2016).
The Corona Pandemic has made us realize and use this solution. But what about using this tool for a routine and frequent check on our critical suppliers.
Specially after the supplier has proven a robust QMS with a certificate or our onsite audits. We can go through frequent remote audits sessions to see trends and potential risk in the manufacturing quality to increase the security of the products.
What can be audited during these frequent remote audits sessions?
-Deviations: Is there any trend regarding a certain process or deviations type? Is the likelihood of a near miss getting higher?
-Manufacturing quality: How are the overall KPI such as OEE, waste and yield developing?
-Changes: Are there any changes in the recent period which can affect the security of our products?
Why these topics?
We think that, these topics give a very effective insight and indicate if there is any imminent danger to our products, subsequently to our patient. Furthermore, if these topics are dealt well by the suppliers, it is also a strong indicator for the strong quality focus of the company.
Orginally Content was published avumed.com