Defective China PPEWe have written frequently here on some of what you can do to increase your odds of you getting the PPE you pay for from China. For an in-depth look at the various issues buyers of PPE face from China, go here to get the recording of a 90 minute webinar where two lawyers from our PPE legal team and a VP of procurement from a large hospital consortium spoke extensively and go here for How to Buy PPE from China Without Getting Ripped Off.

In the below post, Sajag Agarwal of Movley writes about the importance of having someone you trust perform a QC inspection on the PPE you are buying, before that PPE leaves China. On Sajag’s Linkedin page, Sajag describes Movley as helping “brands manufacturing in China build better products through on-the-ground quality control inspections. We have a native English speaking back-office for communication & translation, cutting-edge tech for transparency and communications, and provide recommendations on all inspections—all at the same price or less compared with other leading firms.” We’ve known Sajag for years and can vouch for all that.

 

 Think your PPE is good because it comes from an FDA-registered vendor? Think again. Here’s what is happening on-the-ground in China right now with PPE and how you can mitigate your risks of bad PPE without compromising on speed. 

Bad Quality PPE is Everywhere in China; Even in FDA Certified Factories. My company, Movley, regularly inspects personal protective equipment, especially masks, set for distribution worldwide and we routinely see QC issues with those products, whether they are standard civilian grade or medical items. For example, we recently inspected Class II FDA (Product Code: MSH) KN95 masks, and found over 7% had holes in them large enough to easily see with the naked eye. Just because a supplier is FDA-registered does not mean their product quality is good. The fact that it is so difficult to buy PPE on anything but a 100% upfront payment basis makes inspections all the more necessary. In Faulty N95 Masks Hamper Hospitals on Coronavirus Front Line, the Wall Street Journal wrote about the risks of getting bad masks from China.

Mitigating Product Quality Risks with Product Inspections. Virtually ever major company regularly uses product inspections when sourcing direct from China and you should be doing the same with PPE. Here are the best practices to use when inspecting: 

  • Large Sample Sizes: Most inspection companies use the ISO 2859-1 specification to determine sample sizes, which separates into three notable sample sizes for each batch size: Level I, Level II, and Level III. The higher the level, the more thorough the inspection. Using a Level III whenever possible may be the best course of action to ensure the highest standards possible with PPE. 

Here’s a table for statistically significant sample sizes that you can use with your inspection company based on ISO 2859-1, starting from 501 units. 

Lot or Batch Size  Level I  Level II  Level III 
500,000+  500  1250  2000 
150,001-500,000  315  800  1250 
35,001-150,000  200  500  800 
10,001-35,000  125  315  500 
3,201-10,000  80  200  315 
1,201-3,200  50  125  200 
501-1,200  32  80  125 

 

  • Visual Check: A simple visual look through the sample size can be highly indicative of issues such as loose threading, or in the case mentioned above, of holes! This includes inspecting the product packaging and each individual unit in the sample size for any apparent issues.  
  • Product Tests: Though lab testing may not be possible and might take too much time for PPE, it DOES NOT mean it is impossible to test the quality of the products at all. A good test list includes simple checks your inspector can do to catch major problems. For example, on a few units per batch of KN95, you can check waterproofing, dye penetration, air flow (by trying to blow a lighter out through the mask, which should be very difficult), and by testing flammability to ensure no subpar materials were used. You must make sure the exact test list and quantities to test are confirmed in advance. My company uses pre-made checklists for PPE. 
  • In-House Lab Tests: If it is not possible to send product to a certified or third-party lab, you may be able to use your supplier’s quality control lab, if one exists. You can specify similar tests to those done in a lab when booking your inspection (along with photos or videos of the test and expected results). Your inspectors can collaborate with your supplier’s engineers to run tests and to use the machinery with random sampling as a quick means of testing quality. 
  • Re-Sterilization & General ConfirmationsAfter the inspection is completed, if your products are sterilized, you will need to ensure the supplier will re-sterilize and repackage the opened units. Though this is a standard practice for most manufacturers in China, it does hurt to confirm the specified with your supplier beforehand.

Pre-Shipment Vs. During Production Inspections. Pre-shipment inspections are the industry standard and typically used typically all orders. These are inspections done right before the product ships, but after production has completed. For ongoing production lines, you may also opt for inspections during production. A during production inspection is done mid-production (such as when 20% of the product has been made) to lower the risk of a bad batch. If defects are found early-on in the production process, your factory will likely be much more willing to resolve them for you, simply because it has to deal with far fewer bad products. Your inspection company should — if at all possible — be documenting the steps in the production line to create benchmarks as between orders and to be able to better cross-check among different suppliers. However, in the current climate for small PPE orders, many Chinese factories are not allowing for these types of inspections and they may end up causing more relationship troubles than it may be worth. 

The big problem with PPE inspections is time. PPE buyers want and in many cases need their PPE fast and inspections can slow things down. But on the flip side, Chinese companies are not above taking advantage of your hurry to slip through 10-20 or even 100 percent bad quality product. Even the most basic of inspections can greatly improve the odds of you getting the PPE you’ve paid for.