By The Pro QC Quality Assurance Team

Let’s start with this: what is the e-bike industry? Also known as an electric bicycle, an e-bike is essentially a bicycle with a lithium battery-powered electric motor which can assist in easier, speedier movement. It looks and pedals like a regular bicycle but allows the rides to gather momentum with ease. It’s also worth noting that e-bikes can be powered by lead-acid, nickel-cadmium (NiCd), or nickel-metal hydride (NiMh) batteries as well. For this post, we will focus on lithium batteries as about 90% of electronic bikes are powered in this manner.

The industry is booming. The global e-bike market is projected to be worth $21.7 billion by 2027, according to a Report Linker analysis published in August 2020. In Europe alone, 17% of total bicycle sales in 2019 were e-bikes.

China is the biggest producer of electric bicycles, overtaking Japan, with one figure stating that over 10 million e-bikes were produced by China in the first 5 months of 2018 alone.

So, what do you need to know before you jump into e-bike production in China?

1. Recognize Standard E-bike Production Risks

It is important to know that countries around the world have implemented different regulations for what makes an e-bicycle safe for import into their market. The major risks are related to regulatory and quality issues.

In terms are regulatory requirements, the most important things to ensure are that the product is tested for Phthalates (for CE requirements) and that the battery and e-bikes are marked for the correct destination market (for Europe this would again be per CE requirements). Full documentation must accompany the products for customs.

Quality issues to be aware of include, but are not limited to:

• Supplier provision of batteries from the correct manufacturer
• Poor battery performance (charge/discharge, capacity)
• Poor insulation
• E-bike performance not matching specifications
• Bumps or ripples in the welding; porosity of the welding
• Dents and scratches on the surface
• Frames out of tolerance
• Issues with paint/surface treatment peeling
• Color not matching the Pantone color requested
• Misaligned mudguard/wheels/frames; unstable e-bike due to poor assembly
• Poor packaging can lead to damage during shipping

We have noted that harmful substances used in the paint, decals, and plastic rubber upholstery, are often reasons for the e-bikes to be detained at customs, especially when imported into Western European countries. This is due to the bikes not meeting regulations for harmful substances used in the raw materials for the components.Most risks can be prevented if caught during the assembly process, which is why in-process quality inspection is key.

2. Mitigate E-bike Production Risks

Finding good suppliers who are qualified in terms of basic quality infrastructure and have a quality management system in place is critical. Such suppliers will have a higher likelihood of delivering a quality e-bike that meets relevant regulations and safety requirements.

Ensuring that raw materials used in the supply chain conform to regulations is an important part of a quality supplier. This is why quality inspection and quality control of e-bike components is imperative throughout the manufacturing process.

One of Pro QC’s clients was having issues and asked us to verify samples through an independent at-random-selection process (to ensure the integrity of the testing results) from the factory during production. This enabled confirmation that the production process was clean enough to avoid any external contamination.

A solid tip is to find e-bike suppliers in China who have either worked with automotive components before or who are set up to follow the automotive manufacturing approach. These suppliers will understand and are more likely to comply with regulatory standards.

3. Perform Industry Standard Quality Assurance

As mentioned earlier, regulatory standards cover a broad remit which differs from country to country. Before starting production, a good approach is to implement Advance Product Quality Planning (APQP) to ensure that each critical component related to safety is considered.

A trial and pilot-run are also a good way to stress test the stability of the production line. As part of its quality control services for e-bikes in China, Pro QC often goes into factories to conduct process capability analyses to determine if production processes are stable enough to provide long-term manufacturing quality.

Aside from the general quality control required, it is important to pay special attention to the lithium-ion batteries used in e-bikes. Shipping companies classify lithium batteries as dangerous items, so importers need to be aware of individual import regulations.

Any lithium-ion battery over 100WH is classified as ‘Class 9 – Miscellaneous Dangerous Goods’ under the Dangerous Good Regulations for Transport by Road (ADR) and by Air (IATA & IACO). Importers, therefore, need to ensure that all e-bikes and e-bike packaging are correctly marked for shipping and market presence and that all necessary bills for customs are attached. These include a Declaration of Conformity, Bill of Materials, List of Applicable Standards, e-bike manual, AC adapter datasheet, battery datasheet, a risk assessment, and lab test reports.

Markings differ for individual markets. For example, European import regulations require compliance with these marking rules:
a) The frame must be visibly and permanently marked with a serial number at a readily visible location
b) The frame must be visibly and durably marked, with the name of the manufacturer or the manufacturer’s representative and the number of European Standard, i.e. EN 14764
c) The vehicle must be durably marked with the following words: EPAC according to EN 15194

During any product inspection for electric bicycles, Pro QC usually verifies the end-to-end journey of the product: quality inspections and quality control for e-bike product quality and performance, as well as final product inspection and verification of documents and markings on the e-bike and packaging.

Please get in touch with us for any further information on e-bike production quality or to further understand Pro QC’s quality control services in China.

By The Pro QC Quality Assurance Team

Whether you’ve been in the supply chain game for a while or just getting into it, one of the most important questions is – how do you make sure your goods meet your quality criteria? Checking every item is too costly and time consuming so inspecting random samples from production lots has become the norm. Here’s where AQLs come in. 

1. What is AQL 

   AQL stands for ‘Acceptable Quality Limit’ – defined by ISO 2859-1 as the ‘quality level that is the worst tolerable’, it sets the standard for how many and to what extent defects are considered acceptable based on inspections of random samples of goods taken from the entre production lot.

There are three types of defects: minor, major, and critical.

Minor: a defect that won’t hinder the functionality of the product, or the end consumer’s need to return it. For example, a small scratch on the leg of a chair that can’t be seen.

Major: a cracked tablet face; a label for a pair of linen trousers that indicates they should be washed in hot water rather than cold; a calculator with two of the same button.

Critical: anything that could be a health hazard or life-threatening – either to the consumer or to anyone within the vicinity of the product, and could be a source of legal liability for you the importer or seller. Examples include a piece of furniture that does not stand; wearable garments with sharp pins; a severed thumb in a canned good.

Randomly testing samples from manufactured lots before shipping makes it much easier to pick up on any defects and handle the situation quickly and efficiently.

2. What is the common approach to AQL?

Pro QC uses the ANSI ZI.4-2013 single normal sampling chart as a standard (there is also an option for double sampling, but more on that another time). There are several possible scenarios based on the chart.

First, you need to know your inspection level. The most common is General Inspection Level II (see table below). Considerations for choosing inspection levels are outlined below.

Once you’ve chosen your inspection level, it’s time to plug in some of the numbers. – if production consists of 1000 widgets, how many do we inspect. Following the chart below, you’ll see that the recommendation will be to pull, at random, 80 widgets out of the production for inspection.

Finally, you need to choose your acceptable levels for critical, major, and minor defects –how many defects will still result in the shipment remaining acceptable for shipment?

3. What are the important things to keep in mind with AQL?

There is no set-in-stone approach for your manufacturing lot. Once you’ve started the process, it becomes easier to tweak your strategy. As you develop a relationship with your manufacturer and work with them on inspection feedback, the process normally becomes a lot smoother.

Considerations for determining inspection levels include the lot size for sampling, the amount of time you have to sample, and the cost.

Other factors come into play such as whether the conditions for production for this particular lot were exactly the same – i.e. the same shift, team, and raw materials. If yes, then the need for a larger sample size would be reduced. If it was produced by different lines, with different raw materials, then a greater sample size may be required.

4. What are the risks of reducing the sample size? 

   As pointed out, the biggest question for clients is how to balance risk and cost, and therefore lot size with sample size, and the amount of time that will take – without causing too much delay to getting products where they need to be. 

For those with smaller batches in production, it is always a concern as to how much time, money, and effort they can afford to spend on getting samples randomly inspected for AQL. However, reducing the sample size can also lead to legal repercussions, so it is important to consider the practical and legal perspective before deciding how many pieces you should really be testing.

5. Why following an AQL Sampling Plan is important

The chart below depicts the risk associated with reducing the inspection sample size in certain situations. In our example, our client’s lot size is 12,000 pieces and an AQL of 1.5 is used. At this AQL level, they can accept a 5% defect rate (i.e. combination of major & minor defects equalling 5%).

The recommended sample size is 315 pieces and at this sampling rate, the chances of having a ‘false pass’ is just over 8% (see the blue curve below). A false pass implies that the sample defect rate is less than the acceptable rate (5% in our example) but the defect rate of the lot is, in fact, greater than the acceptable rate.

When sample sizes are reduced, the probability of a false pass increases. Reducing the sample sizes to 200 or further to 125 pushes the ‘false pass’ rate to 21% and 40% respectively. Of course, no sampling plan reduces consumer risk to zero, and relying on 100% inspections is cost-prohibitive. That said, AQL sampling is the tried and tested approach to balancing cost and risk. The sampling plan recommended by Pro QC or another quality company should be adhered to unless special circumstances, such as those mentioned in the previous section, exist.

Note regarding quality control company liability: the above example shows that consumer risk is never zero even when following the prescribed sampling plan. Even though it may be highly unlikely to occur, it is still possible for a buyer to receive a shipment with a higher than expected defect rate when the inspection report found the goods sampled to be within the acceptable limit. An inspection company can only be held liable where they were negligent in their performance of the service. Overall, inspections go a long way to reducing risk but the risk is never eliminated.

So, how do you get started with AQL?

Talk to the experts. Pro QC is a third-party quality assurance provider who can help both in guiding you toward the right level for your production and also with the random sampling inspections. Get in touch with us with any questions.

By The Pro QC Quality Assurance Team

What is the EUVFTA?

Signed into effect by the European Parliament and Vietnam at the end of June 2020, the EU-Vietnam Free Trade Agreement (EUVFTA) is both a trade agreement and an investment protection agreement that offers opportunities for trade, jobs and growth for both signatories.

According to the official European Union documentation, the agreement effectively tackles the following points:

• Eliminates 99% of all tariffs between the EU and Vietnam
• Reduces regulatory barriers and overlapping red tape
• Ensures protection of geographical indications
• Opens up services and public procurement markets
• Ensures the agreed rules are enforceable

The EUVFTA will not only protect labor rights and environmental concerns, but also aims to protect certain traditional European foods and goods from imitation through increased standards, regulations – and indisputable legal enforcement of these.

Key products being exported from the EU for example, include dairy – the 20% tariffs will drop to 0% over a five-year period. Other examples of rates that will fall to 0% over seven years are vehicles with current 78% tariffs, wine with current 50% tariffs, pharmaceuticals with current 8% tariffs, and chocolate with current 30% tariffs.

The opportunity for Vietnam exporters, according to Global Risk Insights, is a gateway into a US$18 trillion market. For EU investors looking at Vietnam, the move signifies an opportunity capitalize further on projects beyond traditional investment into heavy manufacturing and oil and gas. Sectors such as agriculture, pharmaceuticals and automobiles stand to gain in the long run.

So, what’s the Context?

Although the deal offers greater perks for European buyers, the US-China trade war and ongoing tensions between the two countries, have also spurred a deeper interest in Vietnam from US companies as well. Another element that has come into play more recently is the fact that Vietnam was able to control the impact of Covid-19 quite well, and with ardent screening and testing, managed to keep the country’s supply chains up and running efficiently. As a result, Vietnam has been one of the great resources for medical supplies and medical PPE for the rest of the world through this time.

Pro QC has been active in Vietnam for a couple of decades, and we have seen an uptick in business heading that way, with companies increasingly looking for alternatives to China over the past 12-18 months.

But what are the Challenges?

The most obvious challenge is of course, that Vietnam is not China.

While Vietnam does have relatively low costs for manufacturing and increasingly liberalized trade and investment policies, as well as a stable political system, which stand in its favor, unlike China the country depends on foreign inputs for production. It also has a much lower population, and Vietnam’s labor force is only 7% the size of China’s, which limits its ability to attract a larger number of firms looking for competitiveness with Chinese manufacturing. Another key point is that Vietnam has been successful with textiles, footwear and electronics, but it has yet to tackle electronics in the same way that China has done so successfully.

On the plus side, many of Vietnam’s factories are Chinese, Japanese and Korean owned, which means the logistical infrastructures are in-place to meet demand in the same way as it would be in the native countries of the owners. This makes Vietnam an interesting growth story to follow, especially as the EUVFTA really kicks into action.

Pro QC is well established throughout Vietnam, and we are here to answer any questions you might have on manufacturing there.

By The Pro QC Quality Assurance Team

What is ISO 9001:2015?
If you want to indicate that your organization has a functional quality management system, ISO 9001:2015 is the certification you need. The official ISO.org website says the steps a company takes to demonstrate its ability to consistently provide quality products and services that meet customer and applicable regulatory requirements, combined with the company’s aim to enhance customer satisfaction through the effective application of the system, are the core tenets of the certification.

ISO 9001:2015 is applicable to any organization of any size – whether it offers manufactured goods of any kind, or services.

Why do we need an ISO 9001:2015 certification?

The certification tells customers that the goods manufactured, or the services offered by the company they are looking to potentially be a client of, adhere to the best practices laid out by the official ISO 9001 quality management system guidelines.

It is very much a global standard, so anyone will recognize it anywhere in the world.

So how do you prepare for ISO 9001:2015 certification?

Getting an ISO 9001 audit is imperative to working through the journey toward being certified.

There are six key steps to achieving the ISO 9001 certification:

1. Understanding the ISO 9001 – classroom training on the standard and documentation review
2. ISO 9001 audit – conducted by a third-party audit company to complete an on-site gap analysis and suggest an action plan
3. Preparation of documentation – based on the results of the ISO 9001 external audit, the third-party audit company works with the team on necessary documentation and next steps
4. ISO 9001 implementation – committing the entire organization to effective uptake of a quality management system that adheres to the certification standard
5. ISO 9001 audit – as part of the requirements for the ISO 9001:2015, an internal audit review is required annually to demonstrate continued effectiveness of implementation of the quality management system at the company
6. ISO registration – before an organization can apply for an ISO 9001:2015 standard, evidence of consistency within the quality management system is required for up to six months; this is verified through a third-party audit

The process to complete the necessary steps can take up to nine months if starting from scratch. Proving consistency and verifying this through a specific audit is imperative to the process.

What are the challenges to getting ISO 9001 certified?

Preparing for the ISO implementation is often the hardest part of the process – aligning the company and having everyone fully onboard, defining the technical requirements, collating relevant documentation, and communicating the procedures to the entire company are just some of the challenges. Many organizations assign an internal representative or champion and often outsource the audit and facilitation to a third-party auditor who is familiar with the certification process and can provide unbiased advice to drive changes more successfully.

The ISO 9001:2015 quality management system is a core building block of an organization’s foundation. This means that each and every member of the team needs to be on board throughout the process and ensure that nobody flips back into old or bad habits. To ensure quality management system consistency is maintained, a third-party auditor can ensure quality management system gaps and the associated corrective action plan are managed to completion. This approach can help to ensure that ISO 9001 certification is just around the corner for your organization.

If you are looking for help with a customized plan for reaching ISO 9001 certification, Pro QC can help.