Category: COVID-19

Making Sure Your Personal Protective Equipment Suppliers Are Verified

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

Medical PPE

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 US 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.

Manufacturing Medical Devices During COVID-19? Know This…

By The Pro QC Quality Assurance Team

COVID-19 has turned up a number of challenges for the entire world, the global marketplace notwithstanding. However, one of the most pressing demands on the supply chain at present is a need for medical devices to help hospitals cope with enormous numbers of coronavirus patients. But how do parties ensure they are getting a quality product?

Inevitably, the coronavirus has posed several quality challenges for medical devices as well as medical products – due largely to the rising number of scams as people try to take advantage of the urgent need for quick production. At Pro QC, our auditors and inspectors have found several cases where the marketed product is not what it claims (e.g. industrial masks proclaiming to meet medical standards) or, in a worst case, not being produced at all.

Medical Device

Under normal circumstances, top producers for medical devices were China, Hong Kong, Taiwan, South Korea, India, and Vietnam. The main exporters in USD value terms were the United States, Germany, Netherlands, Mexico, China, Belgium, Ireland, Japan, Switzerland, and France.

However, with coronavirus lockdowns and major supply chain disruption ongoing around the world, exporting medical devices from countries such as Italy, France, Spain, the UK, and Belgium is almost impossible. While China has typically been first in terms of number of medical device shipments, it has only been fifth in terms of value for that particular market – this is an important note as despite the fact that China is opening up in terms of production, the likelihood of scams in the market is higher there as producers have not typically been as well versed in medical equipment production.

So, alternatives include looking at countries including Vietnam, Taiwan, South Korea, Germany, Hong Kong, Japan, Thailand, Singapore, Mexico, Brazil, Malaysia, and Sri Lanka.

However, medical devices and medical supplies are one of the most stringently regulated products on the market. Not only is it imperative to ensure the supplier is legally registered and has a declaration of conformity for its medical device product, but also that the product complies with market regulations (i.e. The FDA, CE, etc.).

Whether you’re new to medical device procurement, or an old hand, given the unusual COVID-19 circumstances, Pro QC recommends starting at the very beginning to get started: check in with your local customs agents regarding the medical device import process, and make sure you are fully informed before taking next steps.

Make sure any supplier you engage with provides you with relevant certificates for the market you intend to supply to. For the EU and UK market this is the ISO 13485 certificate, business license and CE certificate for the product you intend to purchase, and for the US market, you will need an ISO 13845 or GMP for Medical Devices certificate, FDA factory registration certificate, FDA product registration certificate, and business license for the product.

We know that in this critical period of COVID-19 sometimes the speed of the purchase has a life and death criticality and speed of procurement is of utmost importance. If this is the case, we suggest to conduct a COVID-19 Supplier Verification. If we identify the supplier as low risk, you can then proceed onto next steps in the procurement process; however, we do not recommend you continue to engage with a high-risk supplier. In certain instances, Pro QC might even be able to conduct a remote audit to speed up the decision making.

Ensure the supplier confirms that they are able to export to your market, and make sure everything is confirmed in writing through contract and email. In this time of coronavirus it may not be possible to meet the supplier in person, so we suggest you conduct a face-call over a zoom chat or face-time in order to make sure you are dealing with a knowledgeable manufacturer, and not a scam-artist. Again, Pro QC can help with remote audits or verifications if necessary.

After making a purchase, we highly recommend conducting a product inspection of your medical device. This can either be a first-article, in-process or pre-shipment inspection and Pro QC is specialized in each worldwide. This will minimize risk and raise any red flags as to the product quality and whether the medical products have the relevant certificates from their supplier.

Above all, make sure you keep yourself well informed and up to date on constantly changing rules and regulations regarding shipments for medical supplies.

Pro QC is experienced in COVID-19 Supplier Verifications and Audits. Get in touch with us to see how we can work with you to get urgent medical device shipments well on their way to market.

 

To Avoid Fake Suppliers, Keep This Checklist Handy

By The Pro QC Quality Assurance Team

Last week we discussed avoiding fake suppliers and scammers when sourcing medical personal protective equipment (check out that article here: Avoid Fake Suppliers of PPE & Scams).

This week we’re taking you through the checklist you should have on hand when investigating a supplier for sourcing any product. Any of these points should raise red flags as to the authenticity of a supplier.

Fake or Real

  • The website design looks unfinished, there are many spelling errors
  • The ‘About Us’ and ‘Contact Us’ sections of the website do not contain the full company details: registered company name, address, phone number, and email)
  • The website indicates that the manufacturer is selling several categories of branded products, all listed on a single page
  • The website domain name contains the words ‘genuine’, ‘replica’, ‘original’
  • The website domain name is linked to anything stating an offer or discount
  • There are no return policy, terms & conditions, or privacy policy stated on the website
  • The price of the products offered by the supplier are too low compared to average market prices
  • The manufacturer does not appear on a Google Map search, or it does appear but has been added very recently
  • There is no official registration for the company name in the country it is in

If you are in any sort of doubt, and need help to spot a scam, Pro QC can help. Get in touch with us today to find out more.

 

How Do You Avoid Fake Suppliers & Scams When Sourcing Medical Personal Protective Equipment?

By The Pro QC Quality Assurance Team

So, you’re looking to source Medical Personal Protective Equipment (PPE) while things are in short supply in the current coronavirus environment. However, there’s an abundance of suppliers online, all claiming to offer exactly what you need, and fast. Who do you trust? Here’s our guide to help you spot a scam and avoid fake suppliers during COVID-19 and more generally.

There are a couple of key flags that usually indicate things aren’t quite in order:

  • If the product portfolio is not consistent with what the supplier usually sells – for example, an apparel manufacturer is suddenly selling surgical face masks.
  • A factory that was set up very recently, clearly to capitalize on current opportunities – and with no track record of prior manufacturing.

Scam Alert

However, the scam is often not picked up on until the factory audit process begins. Scam suppliers tend to avoid third party requests to visit their production facilities and will direct auditors to a warehouse or somewhere that doesn’t have the capability to produce the product in question.

There are also other indications that you are dealing with a fake supplier: below market pricing, and accents that don’t match the local country or foreign bank accounts. Also, the vendor insisting on being paid a deposit without allowing any visits.

For common medical PPE, such as surgical masks and simple hazmat suits, the manufacturing equipment and space required is not big. It is easy for opportunistic suppliers to purchase a machine that produces the medical PPE and rent a space to start up their production line – often with no prior experience. These types of suppliers are not invested in safe production environments, which are required by ISO Standards such as ISO 13485 or the Good Manufacturing Practice (GMP) for medical devices, and the products they manufacture will usually not pass quality inspections at customs borders.

More recently Pro QC has encountered cases where several clients are sourcing personal protective items from China; the supplier, despite accepting a client’s deposit, may have several clients engaged in a bidding war without their knowledge, and will only ship the order to the customer who is willing to order a larger quantity and pay a higher price.

Detecting a fake manufacturer isn’t always easy, however. A recent real-life case, not linked in any way to Pro QC, involved a sourcing agent who accepted 5 million yuan to produce 5 million face masks. He found a factory to manufacture the products for 4.5 million yuan and pocketed the remainder of the money as his fee. The facemasks were produced and shipped out a week later, in good time. However, the masks did not clear customs due to quality issues, the CE certificate was fake. The buyer was angry and wanted his money back – and the factory also refused to return the money as they had produced and shipped the masks but had made no promises about quality.

Face Mask

Pro QC has personally experienced scams involving medical masks in Thailand. Clients have contacted us with factory details, so we can go in and conduct the factory audit. However, when we reach out to schedule an inspection, we have experienced several red flags including factory contact phone numbers that cannot be called through local numbers, only by international ones. After sending WhatsApp messages requesting company registration information, we are blocked. Addresses that indicate the factory is based in the city, which is usually unlikely as most manufacturers are not city-based. We’ve even received certificates of registration that appear to be photoshopped – a major tell-tale sign that the factory is a scam operation.

We are able to go back to clients and tell them that we are likely dealing with a fake manufacturer, but there isn’t much more we can do when it reaches that stage. However, we can work with your business to ensure that you’re embarking on a genuine sourcing process from the start. In response to a surge in demand during the COVID-19 crisis, Pro QC has recently launched a new menu of Supplier Verification services to help our clients from being caught in supply scams and reducing costs as a result. We can help with:

  • Performing factory audits; verifying certifications and qualifications of the suppliers
  • Purchasing PPE from authorized suppliers
  • Performing quality inspections to ensure the medical PPE is not defective/contaminated/dysfunctional
  • Assisting with customs clearance through provision of requisite product certificates

You can learn more about this new service at https://proqc.com/industries/COVID-19 PPE/

Other case studies which we have assisted our clients with include genuine suppliers, but issues which occur after the goods leave the factory. With Medical PPE in demand, there’s a lot of in-transit theft occurring. We have worked with our clients to ensure they protect the quality and full arrival of their products, while also verifying quality to ensure authenticity of the product on arrival.

Although the market for medical grade goods is moving very quickly, it is advisable to conduct pre-supply audits with the factories you are intending to engage with. Audits provide informative indications as to the quality management system of the factory, manufacturing capabilities, and the extent of controls they have in their production.

Get in touch with Pro QC today to find out more about how we can help you avoid a fake supplier and source your medical PPE quickly, efficiently, and cost-effectively.

Getting Your Business Back On Track Post COVID-19? Here’s Your Checklist.

By The Pro QC Quality Assurance Team

We’ve been living in unprecedented times, there’s no doubt – but things must get back on track sooner or later, and the supply chain is the first that will be called upon to function well. So how does your business handle it? We’ve put together a handy checklist for you.

As we speak, China is beginning to get back on track, but the impact of COVID-19 remains tangible. The labor force isn’t quite fully back in action, and the other end of the supply chain is missing raw materials. While sub-suppliers get warmed up and factories push all their buttons to get started, quality standards may slip until things are fully back online again.

Covid-19 heat Map

Image Source:Moody’s

Our advice is to treat this as a warm-up; every purchasing company needs to look at this as their first order from a new factory. Pro QC’s checklist ensures you, as a buy-side company, have everything you need to verify your supplier can stick to production deadlines and targets without compromising on quality.

  1. Identify and prioritize critical parts/components/products in your list of purchasing demands
  2. Categorize these into different categories with a pre-determined action plan
  3. Ensure you have a supplier verification audit conducted to ensure the production readiness of your critical suppliers. Treat this as if it is the first time you are working with a factory; focus on prevention and pre-emptive Quality Assurance measures including:
    • Enlist a third-party objective verification of the factory’s production readiness, workforce situation, production capacity, ethical requirement and sanitary compliance
    • Check on the readiness of your supplier’s raw material and the associated quality
    • Monitor quality of existing materials and production during this warm-up phase
    • Implement in-process Quality Control

All of this should be conducted on-site, in order to provide verification that your production is headed in the right direction as things start to return to normal. While you should expect a few problems in this phase, our evaluation serves as a great way to ensure you are able to make better-informed decisions about the next steps for your supply chain.

Pro QC is already using the above framework for many clients to perform on-site factory audits in China and the many other markets in which we work. Get in touch with us to find out how we can help you get your business back on track.