In this episode…
Renaud Anjoran is joined by Clive Greenwood, an expert in product compliance to discuss the issues with compliance that most importers face and some compliance gaps and ‘loopholes’ to be aware of.
Many people buy products from China (or elsewhere) without checking if they are compliant with their country’s rules and regulations. This means that a lot of products are being
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✅ Clive introduces himself and what he does. Clive brings around 30 years of experience in the manufacturing field to the table, especially with manufacturing compliance, quality, and raising their standards, and is currently CTO at WWMG associates who specialize in standards and compliances to manufacturing industries. His hobby is reading standards! 🤓
✅ Where does the lack of attention to product compliance come from? Is it lack of awareness of the standards, a risk-taking attitude, greed, or all of these cases? It tends to be driven by trying to make the maximum margin while keeping products as cheap as possible. The vast majority of importers do know they need to meet standards but rely on their Chinese or Asian manufacturers who may hold certain certificates which suggest that products will be tested and adhere to standards, but in fact, this is not necessarily what happens at all. E-commerce vendors can especially behave naively and assume that if a supplier’s website shows a CE logo that products are compliant, however, they don’t try and confirm if this is truly the case.
✅ Exploring the example of non-compliant respirator masks and other PPE being imported into the West from China in Spring 2020. The melt-blown fabric was the largest issue here as it is very hard to control the quality of and there wasn’t enough of it. The manufacturers of melt-blown fabrics exploded and checks on if the materials were actually medically effective were skipped in favor of manufacturing masks in massive quantities in a panic. Clive gives some interesting examples of how Western authorities had predicted that a viral pandemic was a likely future risk, but didn’t act on it and were left in a position where they had to procure PPE desperately and so created a fertile environment for non-compliant products to be made due to the massive demand. Lots of manufacturers sprang up that no one could go and check due to lockdowns and there was also a lot of fake documentation going around. It was like the Wild West.
✅ Why the lack of compliance concern is a combination of the factors mentioned before (naivety, overtrust, greed, pressure, etc). Sending someone to China to check a supplier probably costs around £2,000 and this is sometimes seen as something to cut to improve margin ‘IF a supplier says the products are certified.’ The people who do the accreditations are to blame a lot, too. Often the same company that gave the accreditation were doing the inspections which is a conflict of interest. Not surveilling manufacturing and a lack of trained inspectors to do audits is a problem across a wide range of industries, not just consumer and medical products. Buyers often don’t understand a product specification and can’t ascertain if it’s even applicable to their products.
✅ Do the customs in the EU still check the documentation of medical devices such as PPE being imported? The customs have visibility of the declaration of conformity, but that’s it. Border control inspects about 10% of everything. They may check large shipments of medical devices, but they are not experts in medical devices and some fakes are very good. The combination of lack of manpower to check items at the docks and buyers not understanding what they were buying and a lot of fraud meant that non-compliant PPE got through (and probably still does).
✅ Let’s say you set up a company and import consumer products into the EU or USA. Who checks that your products are compliant? In the EU the market surveillance authorities are supposed to check the documents, technical files, etc for any products you have placed on the market and check if everything has been declared properly and check for compliance. However, they usually only become involved after there have been some complaints about a product. The timescale between them investigating a product and removing it from sale can be up to 18 months (unless there is a major disaster)! Border agencies usually do not take a sample of products and check them unless there is something glaringly wrong and they are poor at understanding the documentation and products in any case.
✅ What is the main loophole with compliance these days? Compliance is far more than just a sticker on a product. When products are sent for testing the accredited body’s certification merely states that when they were tested they complied, but this doesn’t mean that your manufacturing is compliant. Generally, the factory should be audited, but inspectors usually only act after there is a report of problems. A common loophole is that accredited bodies provide certificates, but don’t follow up. This means that products can be submitted for testing, found compliant, certified, but then however many million more can be made that are not technically compliant (this might save costs on materials etc) and they are sold as compliant, but in fact, are not.
✅ Who has liability for any products that have a fault that causes danger or damage to people or property? Renaud gives the example of an eBike that is plugged in to charge in the garage overnight and, for some reason, the battery has developed a fault and it causes a fire. Who is responsible for this? The easy answer, says Clive, is whoever imported the product and put it on the market. For products used in a medical setting, such as medical devices and PPE, the importer is liable for manslaughter if your products don’t perform as required and cause people to catch a disease and die, so the stakes are high.
✅ Wrapping up. This episode covered compliance gaps and loopholes. People don’t know what applies or don’t want to pay the money to investigate and assure compliance or pay professionals to do so for them. They often trust their supplier too much. On the enforcement side, border forces, etc, are not as proactive and systematic as one may assume. The manufacturer in China or Asia doesn’t really care as they know that enforcement is unlikely to come to them if products they’ve made cause problems or danger to users.
This episode is going to be followed up soon with another about how compliance standards are evolving. 👌
- What Is Compliance Testing? [Podcast]
- US Compliance Documents When Importing from China: Q&A With an Expert
- Product Compliance 101: What Every Importer Must Know [Q&A]
- We’re Buying Medical Devices From China And Are Worried Our Supplier Isn’t Legit | Disputes With Chinese Suppliers Q&A (Volume 8)
- Do Sofeast’s quality inspectors confirm that the products are fully compliant based on certificates provided by the factory?
- 11 Common Electronic Product Certification And Compliance Requirements
- Why YOU Need a Product Safety Program
- Can Sofeast help us with the certification of our new product?
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