The Western world is scrambling to buy face masks and other PPE materials.
And all the conditions are met for highly expensive mistakes. If I could ring the proverbial alarm bell, this article is my way to do that.
Most suppliers are very new to this game.
A reporter of Week in China found that:
According to the business data firm Tianyancha, more than 28,000 companies have added masks, disinfectants and PPE to their product ranges since early February. The number of firms selling forehead thermometers jumped 3,700% in the same period, it said.
This was a quick response to a gigantic need. In a way, that’s great. According to the Financial Times, China was making 12 times more masks at the end of February than at the start of that month (!!). And it got multiplied again in March.
On the other hand, many of those products are of substandard quality.
Two weeks ago, I wrote Advice for Buying Face Masks in China without Losing your Shirt, in which I warned buyers of the very unpleasant market they were entering and the high risks they were running.
Since then, several European countries complained about products they bought that were found non-compliant to EU standards. This comes as no surprise.
And, despite those well-reported incidents, I found that few buyers are even aware of the risks they are running. As a consequence, virtually none of them are applying a quality assurance program that addresses the main risks.
Let’s go through a list of the 9 major risks I see when it comes to face masks.
1. Testing the filtering property takes weeks
Why wear a mask? To filter small particles. The single most important component of a mask is the very fine mesh that performs that function. If that mesh is substandard, the whole mask is substandard and unacceptable by health care professionals.
Unfortunately, I haven’t seen a single buyer do what is very common when importing other high-risk items: picking samples in the factory, sending them to a lab, and waiting for the results to authorize shipment.
Why? Because nobody has time to wait for the results. Everything is done in a hurry.
For example, to test KN95 masks, we asked a number of testing labs for their lead times. The fastest lab promised 8 working days. It is a Chinese lab, and there is no guarantee they will be on time.
Testing a face mask is not simple. It is actually a whole series of tests. It can’t be done quickly.
For example, for respirators that are to be sold in the European Union, I looked into the EN 149 standard. Many characteristics have to be tested, including:
- Total inward leakage, on 10 separate wearers going through 5 exercises
- Compatibility with skin
- Carbon dioxide content of the inhalation air
- Head hardness (adjustable or self-adjusting, sufficiently robust…)
- Field of vision for the wearer
- Breathing resistance under a certain level
Oh, and there is a preparation procedure that takes time, too. It all adds up!
Now, is there a smart way of addressing this? A testing lab can be asked to check only the “total inward leakage”, and to do it only on 3 wearers, to save time. If you define your own standard and it doesn’t require methods different from the common standards, it should be possible to get some results faster.
2. Checking the CE certificate is not always possible
For example, we noticed that many CE certificates sent by Chinese manufacturers are issued by ICR POLSKA (we don’t know why — they might be known as faster and/or laxer, or maybe they are simply better connected). Unfortunately, nobody can go to ICR POLSKA’s website and verify a certificate instantly.
It is still possible to send them an email, of course, but they don’t always respond within 1 or 2 business days. And they might not respond at all.
(This is not an issue with FDA registrations since all registered companies are listed on the FDA website. And it is not an issue with many other notified bodies for the CE mark.)
Oh, and there is another catch. We noticed that, in some cases, the CE certificate is perfectly legitimate but, when we ask for the corresponding report (showing the results of the lab tests), the most important test (filtration) is marked “N/A”. It means the normal process was not followed! Tricky, isn’t it?
UPDATE: Conor Moore pointed out the issue with the ICR POLSKA certificates: “they’re providing certificates that claim the product meets CE standards for a “voluntary assessment”. The problem is, is that the CE does not allow for voluntary assessments for respirators (no self-declaration of compliance for this category). So they’re not actually CE certified…”
3. Monitoring production is not always possible
Professional manufacturers have the production done in a clean room, often with restricted access. (The cleanliness standard is higher than that of PCBA or food factories.) So, inspectors can’t see the situation first-hand.
What could be a good approach to monitor production, in these conditions?
Two or three technicians can be stationed at the factory and follow a plan such as this:
- If possible, know what company will supply the most critical material (the filtering mesh), do some due diligence on them, and approve them.
- Confirm how many lines will be working on the order, with what hourly capacity (taking into account maintenance-related downtime), for how many hours a day
- Get a plan for upcoming deliveries from the materials & accessories suppliers and the upcoming shipments of finished goods
- Based on the storage methods and the lot traceability, set a plan for monitoring the match between inputs, process time, and outputs. (This may need to involve video calls with someone inside the production area at fixed intervals, in case access is restricted.) Also, if possible, verify the most critical material comes from the approved supplier.
- Finished goods should not be left to accumulate in the production area. All materials should flow through manufacturing and packing until they are ready for outgoing inspection. Check the quality of those products throughout the work shifts.
All this is obviously not an option if you buy 50,000 pieces. But it is usually on the table if you buy 20 million pieces and you don’t negotiate pricing too forcefully.
Why is all this monitoring so valuable? To avoid what I cover in my next point…
4, Undisclosed subcontracting is nearly everywhere, every day in China
You find a very legitimate supplier. You have their factory audited (by the way, this is often refused by suppliers these days, unless you come with very large order quantities), you check their background, etc. and all looks good. They accept your order. They ship it to you on time.
But wait… their in-house capacity is 2 million pieces a week of the exact product you are buying, and they are shipping a total of 10 million pieces a week.
Of course, without close monitoring, that’s is hard to know. (You might get lucky during a factory visit and see an inordinate number of boxes in the finished goods warehouse, and you might be able to look at their shipment records, but sometimes it is hard to verify.)
Does this happen? Yes. A lot. And it means you know NOTHING about what you are buying (where they were made, with material coming from where, etc.).
Yes, this is “a situation or event marked by chaos or controversy”…
5. You may be buying from a middleman that knows very little about the PPE industry
We have seen all sorts of middlemen/traders/brokers/resellers jump on this new market opportunity. And only a small fraction of them have a solid understanding of the standards & certifications and of proper quality control.
Which means… they may not even be aware of all the risks I listed above! There are many traps they might fall into.
6. You may send money in advance and be scammed
What happens when buyers get desperate and leave messages on social media such as “we are urgently in need of PPE”? They attract scam artists, of course. Take a look at some real examples of naive PPE buyers and potential scammers in this post I wrote last week on Sofeast’s blog.
If you send money up front to a company (or worse, to an individual) that you don’t already know, and you don’t even have a basic contract with them, you are taking a serious risk. They might not ship anything to you, and of course, they will keep your money. Or they will send the money in good faith to their “source”, which might scam them.
7. Your shipment may be blocked, even though all the paperwork is in order
Steve Dickinson wrote Buying Face Masks and Other PPE from China Just Got a LOT Tougher, in which he described the amount of confusion the new Chinese regulation introduced.
Freight forwarders are aware of the requirements. The company exporting the goods is aware of them.
However, since the details of the implementation have not been clarified, one can fear a shipment gets blocked for relatively arbitrary reasons. For example, a manufacturer might be audited in order to ensure their processes really comply with FDA and CE requirements (remember, it’s not always about the products, and some standards require a certain level of process controls and/or certain manufacturing good practices). That’s not happening, from what we saw, but it would be in line with the new regulations.
UPDATE 13 April 2020: I wrote about this in more depth in Requirements To Import PPE: You Need To Go Beyond Certificates.
Oh, and if your supplier labels the products as non-medical devices in order to avoid those controls, they might also get hammered. (I expect to hear such cases in the coming days, as I guess many companies are doing it.) In the end, you, as their customer, are impacted, since they might be unable to ship your goods.
8. Your order might suddenly be cancelled unilaterally by the supplier
See US hijacking mask shipments in rush for coronavirus protection. An American buyer offered to buy a batch (already sold and paid for) at 3 times the price, and the supplier re-routed the shipment to them. If you are the original buyer, how do you feel?
With the prices of N95 respirators going up every day, your supplier might not be very happy to sell a batch at the price you agreed on 2 weeks ago. If you don’t have a contract with serious teeth, they will be very tempted to find another buyer and make more money.
9. Your order might be seized in transit
Many governments have made it one of their top priorities to put their hands on personal protective equipment. And they are ready to take steps they would usually not dare take. Here are a couple of examples:
- The USA ‘redirected’ a shipment bound for Germany
- France seizes a cargo to be distributed to other EU countries
These days, it’s ‘every man for himself’. I can’t remember a similar situation in the recent past.
Now I hope buyers have a clearer view of the situation. You are in a hurry, of course. But you need to pause and plan ahead, first.
Companies like mine can help develop a quality assurance plan. China lawyers can also help with due diligence and provide advice. Just don’t go it alone if you lack experience buying high-risk products in China.
If you can think of other risks to add to the list or have been affected by some of the issues I’ve outlined here, please share them as a comment. Thanks!
Need help sorting out an issue with your face mask or PPE order and don’t know where to turn? Contact me – perhaps myself and my team can help or give you some advice and we’ll come back to you if we can!
We are not lawyers. What we wrote above is based only on our understanding of the regulatory requirements. QualityInspection.org does not present this information as a basis for you to make decisions, and we do not accept any liability if you do so.
Very good detailed article!!
A very important point is that to import that kind of staff you need a sanitary license issued by the goberment in your own contry. At least in Spain you need it.
Few importers know that and some of them realize after they already bought the goods.
Renaud Anjoran says
You mean, a Spanish importer of medical face masks needs to have such a license?
Don Vong says
Whenever buying from overseas. QA is a must!
Especially for medical products, I better suggest to
buy professional service from the third party of
QC company. Always check any certificate provided
from the exporters & manufacturers.