By The Pro QC Quality Assurance Team With the critical importance of personal protective equipment and a rising number of scams worldwide, Pro QC recently launched a quality assurance and quality control solution specifically for the medical device and PPE segment. This could not be an ordinary service, as the environment in which it was launched has been far from ordinary. Here’s a little about what we’ve learned, and how we’ve tweaked it along the way, to help you better verify suppliers Where does our demand come from? Most of our inquiries so far have come from China, Turkey, and Cambodia – a hint that suppliers are ready to take on the challenge of getting PPE production back on-line, efficiently. Getting around travel restrictions We launched a remote service to help identify high-risk suppliers, as travel restrictions have been a major challenge for much of the auditing process. The remote service has been extremely successful – it gives us the flexibility to schedule audits for the next day, and coupled with the tight regulations on supplier submissions of photo evidence, we have reduced risk of fake photos being sent in by the factories. Our in-office product certificate validations are able to quickly identify potentially fake or invalid certifications. Scams are difficult to spot Many factories selling PPEs are registered FDA (for the United States), or CE (Europe) compliant, as Personal Protective Equipment – however, the fine-print specifies these items are not for medical purposes. The factories will try to sell the product to the client as medical devices, but the packaging will not reference medical use, as they are not intended for that purpose either. Additionally, despite the fact that governments are encouraging medical PPE manufacturers to return to working functionality (and most of these, especially in China, are running smoothly), we do warn clients that many non-experienced factories are purchasing PPE production equipment to set up small face-mask producing operations. These are usually non-compliant, so fall squarely into the scam bracket. Is this service going to go away after COVID-19 is over? We estimate the need for medical PPE equipment will be part of our “new normal” for a long time to come. What we’re here to do is make sure we can help clients identify manufacturers trying to sell them the wrong product – for example, face-masks for industrial (for chemical factories) and medical face-masks are quite different. The standard used for particles allowed to penetrate the mask surface, as well as the production and sterilization needs under specific environmental conditions, are dissimilar for industrial and medical purposes, but certain manufacturers will illegally try to sell it as the same product. Pro QC wants to ensure clients avoid these situations. A Sticky Situation Pro QC recently had a client who came to us with a rush purchase order for 500,000 medical face-masks. A supplier had quoted them US$0.62 per unit for KN95 masks. The current market price for KN95 masks is around $1.90, so the pricing seemed suspiciously low. Our clients needed to get back to their customers with a final quote on the per price masks within 24-hours. We took on the challenge and were able to schedule a remote supplier verification for the next day. The supplier submitted photo evidence as requested, and since the masks were being sent to the U.S. and Germany, they also submitted relevant FDA and CE registrations. On closer inspection, we found that while the supplier’s FDA registration was verified in the FDA Establishment Registration & Device Listing, we found that the masks they were verified for were for industrial – rather chemical lab purposes, and would not have been suitable for use in any medical context. The CE registration was marked in the official registry as “Fake or Invalid”. As the situation was high-risk – it would have been a great loss to our client if they had purchased from this particular supplier, as the masks would have effectively been garbage-on-delivery – our team quickly delivered the report the same day the verification checks were conducted. (Our usual practice is within 24-hours of assignment completion). When the client called Pro QC to personally thank the team for catching a potentially catastrophic decision in its tracks, we were pleased to have been able to help. Pro QC’s teams are located around the world and have significant experience in working with suppliers across the medical PPE Industry. Get in touch if you need us to work with you to prevent supplier-fraud, and have your medical PPE supplies delivered as quickly and hassle-free as possible.
