- April 19, 2020
- Posted by: AQI Service
- Category: Quality Control
Table of Contents
- Current market situation of face masks
- Supplier search and Investigation
- Face mask type and import
- Due diligence on face mask suppliers
- Product quality inspection and inspection before shipment
- Mask product inspection checklist
As the COVID 19 pandemic swept the world, more and more people realized the seriousness of this situation, and it seemed that thousands of people began to look for face masks and other personal protection products (PPE).
As a Third-party quality control company, we saw that many people did not understand the market, but after pay the remittance, they received unqualified products or did not receive anything at all. Who should be blamed?
Let us first look at the fierceness of this market and then assess whether this market is suitable for everyone. So we are here to warn you about the risk of importing if you are new in this product. But if you already determined to pursue your project, pay special attention to the knowledge you know, and whether the people who work with you can have sufficient ability to control this risk.
Face Masks: Seller’s Market
Based on our understanding of the current market, we have the following warm tips:
Masks: the current absolute seller’s market
The demand in the world market has far exceeded the supply, and the imbalance situation is getting worse. This is very obvious, and many people who have no experience in sourcing from Asia or who have not been exposed to medical products are frantically contacting potential suppliers. But these people do not know how to reduce the risk of purchasing these products, because this market is changing every day, involving the entire supply chain and national policies, even political factors.
Many new entrants know nothing about the production of medical consumables and only invest in them for short-term benefits. The Chinese have begun to call the face mask production line “money printing machine.”
Over the past few days (since April), we have seen:
- Although the price of masks has been rising before, it has stabilized;
- Production plants reject small orders (their minimum order quantity is 100,000, 1,000,000, or even higher).
- Many manufacturers are very busy and are overloaded every day. They do not want to send samples or accept factory audits.
- If you have appointed an audit company, the auditor may only be allowed to visit the office, and he is not allowed to visit the production plant;
- If your order quantity is small (less than 100,000 or 200,000), contacting a spot dealer is not a bad choice;
- Delivery time is usually 2 weeks to 1 month.
100% prepaid before shipment, high transaction risk
Most Chinese companies tend to act honestly at all times, and these companies have really helped a lot of people in January or even February during the COVID-19 Outbreak. These companies are also professional medical device manufacturing companies.
But when market supply and demand are distorted, the market changes and many distributors or new suppliers continue to pursue short-term benefits. They know that these new production lines must be profitable in a short time.
The temptation to cut corners and even cheat is high. After all, many people say that this industry can payback within 5 days, and in some countries, export face masks are prohibited. The supplier may not tell you if he has this permission? Especially current frontline health professionals are screaming for more protective equipment, while some countries are trying to steal those products from other countries. This is the current chaotic market.
Supplier search and Investigation
It is not difficult to find suppliers with the ability to supply face masks For many people, because their Chinese suppliers are buying masks or introducing manufacturers to overseas importers, and you will also receive a lot of emails about supply information from China. Besides, you can also find these supply information on Alibaba, Global Sources, Made-in-China, Google, and other platforms.
- In our experience, please conduct a preliminary review of these people before wasting time discussing them with the wrong people. Here are some tips:
- Don’t worry about buying goods from middle-men or manufacturers. But make sure that the middleman is a legitimate company, not a scammer who deceives prepayments
- Know what you are looking for. Prepare a list of questions. Don’t seem to know anything, or you will be a tempting target for scammers.
- Keep in touch with your freight forwarder at any time to get the latest information on import customs clearance;
- If you only buy 5,000 or 10,000 PCs, do not want to get a formal RFQ. Because your supplier may purchase directly from the market instead of arranging factory production, according to our experience in auditing the factory, the capacity of a face mask machine can be 3500pcs / hour;
- Confirm whether the supplier can provide some detailed product information, including factory pictures, product photos, certifications, packaging materials, and pictures, etc., to confirm that the supplier is an experienced exporter.
Types of Face Mask and Import
Face Masks that are designed to protect the wearer are often classified as personal protective equipment (PPE), often referred to as respirators. On the other hand, masks for protecting patients are generally classified as medical masks. Please note that this definition may vary by country.
In addition, the European Union, the United States, and China have also classified certain types of masks based on their filtering capabilities.
FFP1, FFP2, FFP3 masks (EU)
The requirements and standards for respiratory protective equipment were established according to the unified EN standard 149 of the Personal Protective Equipment Directive (EU), and they were classified according to the filtration efficiency of masks (i.e., FFP1, FFP2, FFP3).
The filtration efficiency of these three masks is:FFP3 (99%)> FFP2 (94%)> FFP1 (80%).
Their inward leakage is:FFP1 (maximum 22%)> FFP2 (maximum 8%)> FFP3 (maximum 2%).
Please note that usually in manufacturing, unless the supplier provides ready-made products, the higher the protection level, the more complicated the manufacturing process, and the longer the delivery time maybe.
N100, N99, N95 masks (USA)
The filtration efficiency of N95 is slightly higher than that of the FFP2 mask, and the minimum filtration rate of particles larger than 0.3 microns in diameter is 95%.
N95 masks can effectively prevent the inhalation of particles, such as coal, iron ore, flour, metal, wood and pollen, and other non-oil-based liquids.
The filtration efficiency of the three masks is:N100 (99.97%)> N99 (99%)> N95 (95%).
KN100, KN95, KN90 masks (China)
GB2626 is a regulation formulated by the General Administration of Quality Supervision, which stipulates the requirements for the material, structure, appearance, performance, filtration efficiency, and labeling of the respirator.
Similar to the NIOSH respirator standard, there are two systems and three classifications to distinguish the filtering efficiency of the mask, which are KN series and KP series.
In short, the filtration efficiency of these three masks is:
KN100 (99.97%)> KN95 (95%)> KN90 (90%).
Surgical mask (3 layers / 4 layers / 5 layers)
The main purpose of surgical masks is to protect patients from bacteria and viruses, which may be transmitted through droplets and liquids during surgery, medical examinations, etc.
Surgery on a 3-layer mask is a very standard product. It may be the same from one supplier to another. These days, its price is very high.
Due diligence on mask suppliers
If you are not familiar with international trade and have no experience in importing products from China, it is recommended that you do not try to buy directly from Chinese manufacturers.
If someone in the network you trust is willing to be your supplier, it may be a safer way. Of course, please confirm that he has practical experience in international trade and mask export. Otherwise, you and your friends will face huge risks.
The following are some of the questions we suggest you ask potential suppliers to reply to when determining the qualifications of Chinese suppliers:
- • Are you legally authorized by the government to supply this product? How many years of experience do you have in this product? Can you prove this? For example, what was the scope of your business registration certificate or ISO 9001 certification last year?
- • Do you have the test equipment to confirm the filtration efficiency? Or do you trust your nonwovens supplier?
- • Do you have a certificate? Are they in your company name and address?
- • Can you provide your business card?
- • Are you working in a cleanroom? What is the standard of that cleanroom? (For example, it should be higher than in the electronics factory.)
- • Have you passed ISO 13485 certification? What product range does it apply to? (Not required, but always a sign of a security supplier.)
Can’t test products in a short time to obtain certificates and test reports
Recently, the testing laboratories, including SGS‘s medical department, are very busy with the work of certifying products (for new companies in the PPE market). They are relatively slow to process if the application is one-time test requests or new companies.
Suppose you buy masks and want to perform BFE (bacterial filtration efficiency) tests on these masks based on existing standards (for example, EN 149 or ASTM F2010-19). This will take a few weeks!
However, you may need to place an order and send money within a few days. The best you can do is to find the existing tested products and place an order for shipment; then, how do you confirm the certificate and laboratory test report provided by the supplier at this time?
Please make sure that the documents are not forged, and conduct due diligence on the supplier. Please have your supplier provide the relevant materials and visit their site to inspect the factory’s overall quality system, process control, basic hygiene conditions, production capacity, etc. Of course, there are sometimes difficulties in performing these in-depth verifications.
We have already mentioned in the first part of this article. When we contacted the supplier on behalf of the customer to seek confirmation of the audit date, the supplier completely rejected our request. Why?
First, they believed that the order was too small. It’s not worth spending all day to follow-up on the auditor’s needs or inquiries. They just want to sell as many products as possible in the shortest possible time to make a profit.
Second, they are not committed to building a long-term business.
This phenomenon should not be blamed, because this is the reality of the market, so buyers need to be more discerning to ensure the quality of the ordered products and the smooth import.
Here are some key points to verify the certificates:
- Can we verify the legality of this document with the issuing organization?
- Do you have the corresponding laboratory test results?
- Is there anything that looks abnormal in the test results?
- When did the test complete and released.
- Does the organization endorse such testing on such products?
- What’s the certification body? What’s the type of organization?
- What’s the type of test standard used?
- The supplier is the applicant in testing.
Shortage of raw materials
Recently, we learned that the bottleneck of mask production lies in the lack of intermediate filter materials. Many people enter the raw material factory with a bag full of cash to obtain the raw materials that have just been produced faster, and the prices of these raw materials are also Many times higher than regular prices.
No one knows how long this situation will last, Chinese regulations are moving in the right direction, but the terms between international customs are often changing.
If you are working hard to import PPE and other medical supplies from China, please always keep in mind that this is like the commodity trading market … average Speaking of this, small companies or small investors with little experience will be squeezed!
Product Quality Control and Pre-shipment Inspection
Before hiring a third-party quality control company, there are some precautions to understand:
- When the inspector is on-site, and the factory does not have professional testing equipment, the inspection company cannot test the nonwoven fabric and confirm its filtration efficiency;
- It is safer to buy medical supplies from ISO 13485 certified manufacturers.
- These types of products are usually manufactured in relatively high-end clean rooms.
- Be sure to ask your supplier to tell you the final inspection address, these addresses may not be in the same city as your supplier address, or the inspection address may be in a warehouse;
- Before buying a mask, make sure you know the expiration date. Yes, they have a certain lifespan and need to be processed after the expiration date.
- Please confirm that the product packaging contains a qualified card. This qualified card cannot be a temporarily printed sticker;
Learn more about Pre-shipment Inspection
Face Mask Product Inspection Checklist
The inspection flow of conventional mask products is to check the appearance of the product, the conformity of the product quantity, the conformity of the product and layers, the packaging method and the labels, printings markings, and on-site testing, which are several important components. According to different products, it is necessary to match the corresponding inspection and inspection steps.
1) Product Appearance Inspection
Check whether the outer and inner layers of the “mask” are stained, dirty, or damaged by the naked eye and touch. Check the earrings of the mask to see if the interface is secure. Check whether the nose clip of the mask is completely wrapped with nonwoven fabric. Check the tightness of the nose clip. In addition, it is necessary to fully extend the mask to check whether the edges of the mask are hot, and then extend the mask to check the shape of the folds. Check whether the size of the mask, earrings, and nose clip meet the standard.
2) Product Quantity Conformity Check
Check whether the completed product quantity is consistent with the PO quantity of the order.
3) Product Conformity Check
a. Whether the model of the product is the same as that ordered by the customer, whether the product is civilian or medical, if it is medical, whether the packaging requirements meet the standard of medical masks,
b. Whether the tensile test can meet the standard requirements of related face masks. 10S test (for 10 seconds within 10 Newtons) According to the (GB / T32610-2016) standard, medical masks must meet the 50N / 10S test (for 10 seconds within 50 Newtons).
c. Layer the masks and check whether the masks are composed of inner, middle, and outer layers. The composition of the fabric must include nonwoven fabrics and melt-blown materials.
d. Whether the material of the product is consistent with the requirements of the customer. The material, color, and weight are compared with the customer’s requirements or reference samples.
Remark: The typical material used in the manufacture of surgical masks is polypropylene, which is made of 20 gsm weight. 25 gsm is made by melt-blown technology.
4) Functional Check
a. Waterproof Test: Put the mask on a piece of white paper and perform a waterproof test. If the white paper is soaked, it means that the waterproof function of the mask does not meet the standard. If the white paper does not have any water stains, it meets the standard.
b. Use an open flame to ignite the edges of the face mask for flame retardant testing. Masks that meet the standard cannot burn, and vice versa.
c. Odor test and skin allergy test to check the irritating odor to ensure the comfort of the skin.
5) Weighing Inspection
Check the weight of the face masks that have been cut and divided into layers. Since the face masks are special textile fabrics, they must be weighed using a professional gram plate. Use a sampler to cut the layered masks. The lower fabric is weighed in a gravimetric tray to ensure that the weight meets the corresponding standards.
Email us for Face Mask Inspection Sample Report.
Author: AQI Service as a professional quality control service company in China specialized in providing a complete range of quality inspection and testing certification services in China & Asia for global importers, buyers, retailers, and sellers.
What is First Article Inspection? First article Inspection (FAI) is also called ”initial quality control.” It examines and contrasts a requirement (product design) with the final product (production result). The first item made using the new method, or a sample from the first batch of parts is wholly tested as part of the First articleOctober 27, 2022
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