Overview of Hazardous Substances (HS) Control Methods in the Electronic Components Industry
Keywords: Hazardous substances (HS), Hazardless substances (HSF), HS list, supplier and material risks
Foreword
On July 1, 2006, the EU's RoHS Directive officially came into effect. This directive has had a wide-ranging and profound impact on electronic and electrical equipment manufacturers, suppliers, and traders worldwide that export products to the EU market. The EU is a major exit point for electronic and electrical products from China, and the RoHS Directive has a significant impact on China's electronic and electrical industry; some data indicate that this impact could reach hundreds of billions of US dollars.
As more and more countries and regions around the world enact regulations limiting hazardous substances (HS), such as the EU's Packaging Directive and the End-of-Life Vehicle Directive (ELV), and as countries like South Korea and China have also introduced regulations related to hazardous substance limits, new requirements have been placed on the control of hazardous substances. Violations of hazardous substance requirements may involve illegal activities and legal charges.
Electronic components (such as ICs, transistors, diodes, crystal oscillators, inductors, capacitors, resistors, and transformers) are the foundation of electronic and electrical products due to their wide range of applications. Even if manufacturers do not directly sell their products to EU countries, it is difficult to guarantee that their products will eventually be withdrawn from the EU market. Therefore, any electronic component company of a certain scale, whether it is a design, manufacturing, or trading company, needs to consider the requirements for hazardous substances, including the EU RoHS Directive, and addressing these requirements should be a top priority.
Currently, some domestic electronic component manufacturers are not unfamiliar with the requirements for hazardous substances, and some have even implemented control methods several years ago. However, these measures mainly remain at the level of hazardous substance testing for raw materials and products. For example, annual testing of materials or products. However, simple testing faces many problems, such as the wide variety of electronic component products, the vastly different probabilities of each material containing a particular hazardous substance, the vague requirements for hazardous substance control in the upstream and downstream supply chains, and the uncertainty of whether suppliers can guarantee the quality of each delivery. Therefore, it is impossible to grasp the overall risks of hazardous substance control. How to more effectively manage and control hazardous substances and reduce the risks of hazardous substance management is an essential lesson.
In early 2005, the International Electrotechnical Commission (IEC), based on EIA/ECCB 954 (a systematic certification standard for "Hazardous Substance Free" (HSF) proposed by the Electronic Components Certification Board (ECCB) and the Electronic Industries Alliance (EIA), and following the principles and framework of ISO 9001:2000, developed the IECQ HSPM QC080000:2005 Hazardous Substance Process Management System standard. This standard aims to control hazardous substances and reduce the risk of exceeding limits in products through process and system-based approaches.
The IECQ QC080000 standard was officially released in October 2005. Since its introduction, the corresponding certification process has developed rapidly. Three certificates were issued in 2005, 134 in 2006, 665 in 2007, and more have already been issued in 2008. Currently, more than 900 IECQ QC080000 certification certificates have been issued globally, demonstrating that its role and effectiveness as an international standard for hazardous substance management are increasingly recognized by the industry.
Based on my experience in the electronic components industry and my understanding and insights into the QC080000 standard (hereinafter referred to as the standard), this article discusses how to reduce the overall risk of hazardous substances (HS) and meet the requirements of Hazardous Substance Free (HSF) products (commonly referred to by companies as GP products, green products, RoHS products, etc.) from the perspectives of process and system. For the sake of clarity, this article will use as little technical standard language and clauses as possible.
I. Identification of Hazardous Substances (HS)
1. First, we need to identify the sources of all controlled hazardous substances. These sources should be considered primarily from the following aspects:
2. The country or region where the product will ultimately be used;
3. Relevant HS regulations (such as RoHS) in these regions and countries;
4. Customer requirements regarding Hazardous Substances (HS);
The company's own requirements for hazardous substances (HS);
Once all these HS sources are identified, companies can develop a hazardous substance inventory as the overall input to the entire HS management process and system. In other words, all subsequent processes and activities are planned, managed, and controlled based on this inventory; therefore, the appropriateness and suitability of this inventory are crucial to the effectiveness of the entire HS management.
Hazardous substance lists come in many forms; some companies compile HS manuals, while others simply list an HS control form. In fact, a suitable hazardous substance list can be created by fully and clearly identifying the types of controlled hazardous substances, their limits, sources of control, exempted components, time limits, and different customer requirements.
If some of the HS substances are unlikely to be produced in the products manufactured by a company, exemption from management and control is acceptable. For example, if a customer has a limit on methanol, and general electronic components are composed of materials such as metals, semiconductors, plastics, ceramics, and glass, the probability of methanol being present in these materials is almost negligible. Therefore, the risk of exempting methanol from management and control is very low. Thus, although it must be identified in the HS list, it is acceptable not to control it and not to have an HS test report. Conversely, stricter methods are needed for control.
II. Transfer of Hazardous Substance Free (HSF) Requirements and Control over Suppliers
As we all know, the source of Hazardous Substance (HS) control lies in materials and suppliers. Especially after companies have implemented HSF requirements, the control of materials and suppliers has become a key focus.
According to the HS list requirements, we also require suppliers to provide HS testing reports, which is the most typical practice in the industry. However, this alone is insufficient. This is because, as mentioned earlier, the probability of different hazardous substances (HS) appearing varies depending on the characteristics of the material itself; furthermore, different suppliers have different methods and levels of HSF control. Clearly, risk management methods can be introduced to effectively control HSF based on the risks associated with the materials and suppliers.
For example, if an IC chip manufacturing company uses silicon wafers (where it is almost impossible or very unlikely that the six HS substances specified by RoHS will be produced in the silicon wafers) and the supplier is a well-known company in the industry (i.e., its HSF management level is also relatively high), then we will evaluate the materials it provides and its HSF management capabilities.
The risk assessment criteria for materials can be determined based on the likelihood of the presence of various hazardous substances (such as Pb, Cd, Hg, Cr+6, PBB, PBDE, etc.) in different materials (metals, plastics, glass, ceramics, etc.). The evaluation criteria for supplier management capabilities can be determined based on their overall level of control over hazardous substance-free materials (HSF). Specific control methods will not be described here due to space limitations.
Based on the above comprehensive results, suppliers with lower scores have lower HSF risk, and their control methods can be simpler and less stringent; suppliers with higher scores have higher HSF risk, and their control methods should be more complex and stringent.
The HS requirements in the HSF commitment letter cannot be lower than those in the HS list, including regulatory, customer, and company-specific requirements; this is the transfer of HS requirements. There are many methods for daily monitoring of HSF suppliers (such as telephone inquiries, on-site visits, peer feedback, and media reports). Monitoring can be comprehensive and continuous. This includes monitoring the supplier's internal operations, personnel turnover, HSF management standards, changes in assets or shareholdings, and negative media coverage. The purpose of monitoring is to ensure that all these changes do not negatively impact HSF requirements. When necessary, the materials provided should be evaluated, such as through testing or increased sampling, to ensure compliance with HSF requirements. All this information can be reflected in the AVL (Qualified Supplier List) or other management documents. In short, the key is to ensure that these methods are effectively applied and controlled.
III. Management and Control of the Process
In the production process, we take mixed-line production as an example, that is: both HS products and HSF products are produced.
1. First, clear documentation is needed to manage the two types of products and materials. For example, a production line needs to be changed from producing HS products to producing HSF products.
For welding lines, the following requirements need to be considered:
2. Machine Marking
The marking is to inform relevant personnel, including others, to draw attention to prevent contamination of HS materials and products.
3. Changeover Method
When changing from an HS production line to an HSF production line, it is necessary to clean the machines and production area to ensure that no HS parts are present. Generally speaking, these tasks are carried out by the production department.
4. Line Change Confirmation
Relevant personnel shall check and confirm the compliance of the line change to ensure that there are no HS components. Generally speaking, this work shall be carried out by the Quality Department.
5. Control of HS Components
After receiving HS components and shipping them from production, a complete record must be kept showing their origin and destination, including any repaired products during the production process.
Identification and Isolation of HS Components
The degree of identification for HS components depends on the potential for contamination. If the component is visually indistinguishable from HSF components, then it should be strictly controlled; for example, strictly isolated areas and methods, and requisitioning must be done by designated personnel. Some HS components are proprietary components, and even if mistakenly taken, they cannot be installed on HSF products, or are clearly distinguishable from HSF components (significantly different from HSF components, such as color, shape, etc.). In such cases, the control methods can be simpler and less stringent.
IV. Incoming Material Inspection
When inspecting materials provided by suppliers (the standard refers to the verification of purchased products; for simplicity, we define it as incoming material inspection), the following methods are generally used:
1. HS Testing
Most companies are capable of using X-ray to test for HS in materials to prove compliance with HS content requirements. However, this method only provides qualitative analysis of the presence of HS substances in the materials. This is something companies need to be aware of; if the HS test results show a high level but do not exceed the requirements in the HS list, caution should be exercised. Furthermore, if a company purchases a large quantity of materials, it may not be possible to achieve 100% inspection due to time and efficiency constraints. In this case, the risk assessment level mentioned earlier should be considered. High-risk materials require full inspection, while others can be sampled, which can also ensure overall testing risk control.
2. Material Information Verification
The specifications, markings, and models of the purchased materials, as well as whether they are provided by qualified suppliers, and the validity of the HSF (Hardware Service Validation) evidence provided by the suppliers, must also be confirmed. This can basically meet the HSF requirements.
V. Summary
Some other requirements in the QC080000 standard, such as personnel training, contract review, and product design, are similar to those in the ISO9001 standard and will not be discussed here. In conclusion, controlling HS requirements is not limited to testing HS content. To reduce the risk of HS exceeding limits, electronic component manufacturers need to consider both process and system perspectives to ensure overall HSF effectiveness and meet regulatory and customer requirements.
