7.1 Planning of Hazardous Substance Reduction Processes and Product Realization
The requirements of ISO 9001 shall be used in conjunction with the following requirements:
The organization shall plan and develop processes for the realization of hazardous substance-reduced products.
| | In planning the realization of hazardous substance reduction products, the organization should, where appropriate, determine the following:
a) Quality objectives and requirements for hazardous substance reduction products;
b) The need to establish hazardous substance reduction processes, documentation, and provide resources for hazardous substance reduction products;
c) Validation, validation, monitoring, inspection, and testing activities required for hazardous substance reduction products, as well as product acceptance criteria. Information service providers should be included where appropriate;
d) Procedure documents or work instructions for processes using restricted substances, including preventative measures in the presence of contamination;
e) Evidence needed to demonstrate that the hazardous substance reduction implementation process and the resulting products meet the requirements;
f) The output of the hazardous substance reduction plan should be in a form suitable for the organization's operating methods.
Note 1: Documents used to determine the hazardous substance reduction process (including product realization process) and resources for a product can be called a quality plan.
c. On-site audits;
d. Random spot checks (frequency determined based on risk analysis);
e. Management of samples sent by customers.
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Product realization refers to all processes involved in creating a product. Essentially, it's the process from customer needs to mass production of a product. This differs from product design and development. Product design is the process of translating regulatory, technical, safety, functional, market, or other product requirements into technical specifications. In short, the design process can be seen as the process of creating a product from scratch, while product realization is the process of bringing it to mass production. In the ISO 9000 framework, product realization includes product design. Management system planning is a higher level than product realization planning. a) Define the quality objectives and requirements for Hazardous Substance Reduction (HSF) products: This is essential. It's crucial to clearly define which products need to meet hazardous substance restriction requirements, the types of restricted hazardous substances, and their limits.
b) Establish HSF processes, documentation, and provide resources for HSF products: Producing HSF products requires process replanning, which will change process inputs, outputs, and resource requirements. Documenting these processes is necessary.
c) Define the required verification, validation, monitoring, inspection, and testing activities for HSF products, as well as product acceptance criteria. Information service providers should be included where appropriate. Whether the product's hazardous substance characteristics meet requirements needs to be tested. Many aspects need to be considered for hazardous substance testing; see Chapter 2 of Part 2 of this book.
d) For processes using restricted substances, documented procedures need to be developed for control, and these documents should include provisions for preventing contamination or material mixing.
e) Evidence is needed to demonstrate that the HSF implementation process and the resulting products meet the requirements. This evidence is reflected both in the product's hazardous substance testing results and in the implementation records of various processes.
f) Planning outputs do not necessarily have to take the form of quality plans; in fact, the established hazardous substance process management system is a more macro-level planning output.
7.2 Customer-related requirements
The requirements of ISO 9001 shall be used in conjunction with the following requirements.
| | 7.2.1 Determine Requirements Related to Hazardous Substance Reduction for Products
The organization shall determine:
a) Hazardous substance reduction requirements determined by the customer
b) Requirements not declared by the customer but necessary for the identified or intended use of the product (when known)
c) Legal and regulatory requirements for hazardous substance reduction related to the product
d) Other hazardous substance reduction requirements determined by the organization
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The concept of defining product-related requirements is the same as in ISO 9001, except that it includes additional requirements from customers and regulations regarding hazardous substances in the product.
The following documents may contain customer requirements regarding hazardous substances: purchase contracts, purchase orders, hazardous substance content benchmarks/standards, test reports, sample feedback, penalty notices, return notices, quality assurance agreements, environmental assurance agreements, procurement documents, green procurement standards, on-site inspection reports, etc. Additionally, customers may convey these requirements via telephone, email, fax, etc. Given that RoHS involves legal liability, such requirements generally require written confirmation from the customer.
a) Regarding customer-defined hazardous substance reduction requirements, this includes limits and management requirements for hazardous substances.
Limits for hazardous substances include the types of hazardous substances, their content, and the implementation period for these restrictions. Some companies, when restricting hazardous substances, only consider the restrictions on the six categories of hazardous substances specified in the RoHS directive, without taking into account the restrictions on a range of other hazardous substances raised by customers; regarding concentration limits, they only consider the limits stipulated in the RoHS regulations, without considering the stricter requirements of some customers for certain hazardous substances. These are all insufficient. Companies have a long time to respond to the RoHS directive, and the pressure from customers is also relatively high, so they generally pay more attention to the limits of hazardous substances in their products. However, companies often fail to identify the content of customers' requirements regarding hazardous substance management, such as requirements for product realization process control, change management, and control over suppliers' suppliers, which are all common customer requirements regarding hazardous substance management. b) Requirements that are not declared by the customer but are necessary for the product's defined or intended use (when known). In terms of hazardous substance control, apart from customer and regulatory requirements, such requirements are actually relatively few. For defined or intended use, when hazardous substances are present, products containing hazardous substances often offer better performance assurance than those without. Therefore, companies do not need to consider this requirement too much when implementing it.
c) Legal and regulatory requirements for the reduction of hazardous substances related to products. The RoHS Directive is the most familiar to us, but there are actually many other legal and regulatory requirements that limit hazardous substances in products. See Part One of this book for details. Regarding regulatory requirements, there are not only requirements for limiting hazardous substances, but also other requirements related to meeting the WEEE Directive. Companies need to consider these requirements during the product realization stage, not just after the product is sold in Europe. Once the product is sold in Europe, not only will the cost of compliance increase, but some requirements may even be impossible to meet, such as the requirements for the recycling ratio of product materials. If the materials are not properly selected during the product design stage, the recycling ratio of the materials themselves will not meet the requirements, and the product will not be able to meet the requirements after it is scrapped.
China's RoHS labeling and information disclosure requirements, as well as Japanese and Korean regulations, also have similar requirements.
To effectively address regulatory requirements, or to make full use of the disclaimers in regulations, such as the disclaimers in the UK's RoHS regulations, companies should not only understand the direct requirements of the regulations, but also pay attention to collecting regulations that include implementation requirements, such as the "RoHS Implementation Guidelines." After identifying and reviewing the limits and management requirements for hazardous substances, companies should determine their product development strategy based on their overall development strategy, identifying which products need to be converted to environmentally friendly products and which do not, and establishing a specific timeline. Then, based on customer requirements and regulatory requirements, and according to the company's product development strategy, companies should formulate their own requirements, including limits for hazardous substances, testing requirements, and hazardous substance management requirements. These requirements should then be distributed internally. Within a company, many departments are involved in hazardous substance management, and many departments may receive customer-related information. Therefore, companies should centrally communicate information from different departments to a designated responsible department, which will then manage this information. After forming internal requirements, this department should then communicate them to relevant departments.
| | 7.2.2 Review of Hazardous Substance Reduction Requirements Related to Products
The organization shall review the requirements related to hazardous substance reduction products. The review shall be conducted before the organization commits to supplying hazardous substance reduction products to customers and shall ensure that:
a) Hazardous substance reduction product requirements have been determined;
b) The organization has the capability to meet the determined hazardous substance reduction requirements;
c) Customers have been communicated regarding any use of restricted substances or potential contamination, and any processes or products that may contain restricted substances;
d) Records of the results of the hazardous substance reduction review and the measures determined during the review shall be maintained. |
The concept of review should be consistent with ISO 9001, except that the review content includes the review of requirements related to hazardous substances in products. However, it is crucial not only to consider the review of product hazardous substance restrictions but also to simultaneously consider the review of customer requirements for hazardous substance management to ensure the completeness of inputs when meeting customer requirements. This is an aspect that many companies currently tend to overlook in their hazardous substance management. These management requirements involve the management of different processes and departments within the company. After identifying and reviewing these requirements, the company should communicate them to the relevant departments so that they can incorporate this content when developing management standards. The review of hazardous substance requirements should be a highly specialized task. When determining whether the company can meet these requirements, an opinion should be provided by a department with expertise in hazardous substance management. Clause c) mentions that customers should be informed about processes and products using restricted substances, as well as any potential contamination or contamination from processes or products containing restricted substances. Communicating with customers about processes and products using restricted substances is necessary and easily achievable, including the application of exempted hazardous substances. This allows customers to focus on these aspects at each stage. For products and processes that only pose a potential for contamination, requiring notification to customers for every instance might raise concerns for many companies, as it could impact their business. Customers might refuse to purchase your products simply because you honestly provided this information. Therefore, I have reservations about this requirement. When implementing standard requirements, companies should communicate with customers if they believe there will be no negative impact. Communication with customers involves many aspects of hazardous substance management, such as providing customers with material breakdown tables, declarations of conformity for hazardous substances, hazardous substance testing reports, and hazardous substance management agreements. In daily hazardous substance management, situations may arise where customers believe that a batch of materials submitted by the company exceeds hazardous substance limits, requiring communication for resolution. Some companies may establish an integrated material information platform for the entire supply chain, requiring suppliers to submit relevant information on this platform. How these tasks are carried out can be stipulated in the customer communication procedures of the existing ISO 9000 quality management system, or a separate "Customer and Legal HSF Requirements Identification and Company HSF Requirements Determination Procedure" can be developed, with document examples provided in Chapter 3 of this document.
7.3 Design and Development The requirements of ISO 9001 shall be used in conjunction with the following requirements.
| | **7.3.1 Planning for the Design and Development of Hazardous Substance Reduction Products**
The organization shall plan and control the design and development of hazardous substance reduction products.
During the design planning process, the use of restricted substances shall be identified in documents and plans designed to control and ultimately replace/eliminate these components. |
Generally, when designing HSF products, it is necessary to consider the hazardous substance characteristics of the materials, the material's adaptability to the process, and the possibility of changes in the product's hazardous substance characteristics caused by the process. It is also necessary to consider how to meet the requirements for product disassembly, reuse, recycling, and recovery after product disposal, reduce the potential environmental impact throughout the product's life cycle, correctly label the product, reasonably disclose hazardous substance information, and facilitate product testing.
When designing and planning HSF products, it should be determined at which stages of the design process to consider meeting the above requirements. Readers can refer to Chapter 3 of Part Two of this book.
Here, the standard specifically states that if a new product design involves the use of hazardous substances, a document or plan must be developed specifying how to control and ultimately replace/eliminate these components containing hazardous substances. If the newly designed product does not use hazardous substances, this requirement does not need to be considered.
| | **7.3.2 Hazardous Substance Reduction Design and Development Inputs**
Inputs related to hazardous substance reduction product requirements should be identified and recorded.
The adequacy of hazardous substance reduction inputs should be reviewed. Requirements should be complete, clear, and non-conflicting. |
In terms of hazardous substance management, design inputs include customer and regulatory requirements for hazardous substance limits on products, product compliance with the WEEE Directive, labeling and information disclosure requirements of China RoHS, and other regulatory requirements, such as some requirements of the EuP Directive. This necessitates that the department responsible for identifying, compiling, and determining the hazardous substance requirements for products based on the company's product development strategy communicate these requirements to the product design and process design departments. Designers should accurately understand these requirements and consider their fulfillment in the design process.
| | **7.3.3 Outputs of Hazardous Substance Reduction Design and Development**
The outputs of hazardous substance reduction design and development should be presented in a verifiable manner, ensuring compliance with design and development inputs, and should be approved before release.
When the design requires the use of restricted substances, procedures should be documented to control, identify, monitor, and measure processes/products (including products from subcontracted processes). |
According to ISO 9001 requirements, design and development outputs should provide appropriate information for procurement, production, and service. Regarding hazardous substance management, the information required for procurement includes a Bill of Materials (BOM) and material specifications. Material specifications should include information related to hazardous substances, such as hazardous substance content requirements, product process adaptability requirements (e.g., maximum temperature adaptability requirements for components), and material recyclability requirements. These requirements generally need to be confirmed before they can be clearly defined. Other requirements include how to identify products and how to provide information (e.g., environmentally friendly service life of materials, information on components containing hazardous substances, product disassembly information, and necessary information for consumers). Some design outputs may apply to all products, while others are specific to different products. Regarding hazardous substance management, appropriate information for production and service generally includes the determination of production processes, as different process requirements may lead to variations in the content of hazardous substances in products. Examples include the surface passivation treatment of galvanized steel, storage environment requirements after passivation treatment, and injection molding processes for plastics using decabromodiphenyl ether as a flame retardant. Here, design outputs should be verifiable. Hazardous substance characteristics can generally be verified through testing, and other requirements are generally verifiable as well. When a product being designed uses restricted substances, the design output should include a document that specifies how to identify hazardous substances, how to control, monitor, and measure the product and process, and how to prevent contamination of other HSF products.
| | 7.3.4 Review of Hazardous Substance Reduction Design and Development
At an appropriate stage, the design and development should be systematically reviewed in accordance with the hazardous substance reduction plan.
7.3.5 Validation of Design and Development
The requirements of ISO 9001 shall apply to the following requirements.
7.3.6 Validation of Design and Development
The requirements of ISO 9001 shall apply to the following requirements.
7.3.7 Control of Changes to Hazardous Substance Reduction Design and Development
Changes to hazardous substance reduction design and development should be identified and recorded. Where appropriate, changes should be reviewed, validated, and validated, and should be approved before implementation. |
Regarding the characteristics of hazardous substances, generally speaking, design validation requires testing to prove that the content of hazardous substances in the product does not exceed the limits. Design review primarily verifies that the content of hazardous substances in the product does indeed not exceed the limits by reviewing various test reports. Simultaneously, design review also determines whether the output of the design and development provides suitable information for subsequent procurement, production, and service. This includes reviewing the Bill of Materials (BOM) and product specifications required for material procurement, and the process specifications required for production. Design validation, on the other hand, needs to consider whether the content of hazardous substances can still be guaranteed to remain within limits under the product's intended use or application conditions. For example, based on the characteristics of the restricted hazardous substances, special consideration should be given to the potential changes in decabromodiphenyl ether and trivalent chromium under use and storage conditions, which could lead to exceedances of nonabromodiphenyl ether, octabromodiphenyl ether, and hexavalent chromium. In terms of process design, the suitability of the process can also be demonstrated through product testing. The disassembly and recyclability of the designed product should also be verified. The product's labeling and information provision should be reviewed to ensure that requirements are met. Regarding the control of design changes, special attention should be paid to changes involving materials. Additionally, changes to processes that may affect the hazardous properties of the product should also be monitored. After a change occurs, it must undergo necessary review, verification, and validation.
7.4 Procurement of Hazardous Substance Reduction Products
The requirements of ISO 9001 shall be used in conjunction with the following requirements:
a) The organization shall ensure that the products procured comply with the hazardous substance reduction requirements.
b) The organization shall assess and select suppliers based on their ability to provide products in accordance with the organization's hazardous substance reduction requirements.
| | a) General requirements for procurement. Please note that if the company has outsourced processes that affect the hazardous substance characteristics of its products, these outsourced processes must be managed in accordance with this clause.
b) Requirements for supplier selection. What kind of companies might be considered suppliers? Suppliers capable of providing products according to the company's hazardous substance reduction requirements. This adds new selection and evaluation criteria for suppliers in terms of hazardous substance management. Generally, the following should be examined: whether the hazardous substance characteristics of the products provided by the supplier meet the requirements (check test reports, labeling, or conduct physical testing); whether the supplier's quality assurance capabilities are sufficient (on-site audits should be conducted for high-risk suppliers); and whether the supplier can provide the necessary documentation as required (such as material breakdown sheets, test reports, declarations of conformity, warranty agreements, etc.). Companies can categorize suppliers into high-risk and general-risk suppliers based on their quality assurance capabilities and the inherent risk of the materials supplied. Quality assurance requirements for high-risk suppliers should be more stringent, such as conducting on-site quality assurance capability audits.
c) The organization should ensure that all hazardous substance-reduced components/materials are free from contamination by restricted substances.
This is a requirement for procurement process control. Given the inherent characteristics of hazardous substances, the likelihood of contamination during the general procurement process is not high; the more probable cause is the supplier delivering the wrong goods. However, companies should analyze the specific characteristics of their procured products and processes. d) The procurement of restricted substances should be clearly indicated in procurement documents and upon receipt of materials. Companies should provide suppliers with relevant requirements regarding hazardous substances, including limits, management requirements, testing requirements, and information provision requirements. This can be done through procurement contracts, agreements, orders, and other means. Procurement information should be accurate and complete. If the procured products contain hazardous substances, this should be clearly recorded in the incoming material inspection records and material ledgers. e) Verification of Hazardous Substance Reduction Procurement Products f) To ensure that procured products meet the established hazardous substance reduction procurement requirements, the organization should establish and implement necessary inspections or other activities. Incoming material inspection is necessary. Companies should ideally have their own testing equipment, typically rapid screening equipment. For items that the company cannot inspect itself, it should stipulate that external testing be conducted.
Does the lack of testing equipment mean a company absolutely cannot pass QC080000 Hazardous Substance Process Management System certification? The author believes that the effectiveness of hazardous substance control should be given prominence in hazardous substance process management system certification. Even if a company lacks its own testing equipment, if all materials undergo routine testing at some point in their respective supply chains, and all materials are sent for annual external inspection based on risk, and if the company has effective process control throughout the supply chain, then the lack of its own testing equipment is acceptable. After all, testing equipment is relatively expensive. In this case, many companies typically check the name, serial number, and specifications of incoming materials to ensure their accuracy, check for environmental labels, and verify that the supplier's annual inspection report is within the annual timeframe. These are also necessary tasks. Furthermore, companies without testing equipment must send high-risk materials for annual external inspection. g) The procurement route of purchased items should be fully understood, and any processes that may be contaminated by restricted substances should be fully identified. Procurement activities related to hazardous substance mitigation processes should be documented in the established procedures. The procurement route essentially refers to the path through which goods are purchased. It generally includes two components: the source of the goods and the process from the source to locations under the organization's control. Source control is crucial. Some of an organization's materials may be purchased directly from manufacturers, others from distributors, and still others even from ordinary sales markets, resulting in different routes. So, to what level should the understanding of the procurement route be? Standards do not provide specific requirements. The UK government's RoHS guidelines require companies to manage their suppliers. That is, the regulations require companies to manage Tier 1 suppliers, but suppliers should also manage their own suppliers. When auditing suppliers, their control over their suppliers should be considered. Of course, from a reliability perspective, the clearer the understanding of the procurement route, the better for control. Ideally, it should identify risk-free suppliers or suppliers of homogeneous materials. When the Tier 1 supplier is a distributor, the company should focus its monitoring on the purchased product itself and its manufacturer, rather than the distributor, because the distributor has minimal influence on the hazardous substance characteristics of the product. Fully identifying any process that may be contaminated by restricted substances means identifying potential contamination situations along the procurement route. For example, a supplier may simultaneously produce both environmentally friendly and non-environmentally friendly products; potential contamination during product transportation, receiving, and storage should all be identified. Documented procedures should list procurement activities related to the hazardous substance mitigation process, requiring that suppliers of hazardous substance mitigation products and processes, the items supplied by suppliers, and their specifications be clearly defined and documented. H) Documented procedures should be developed for the inspection and identification of hazardous substances contained in purchased items. Hazardous substances should be identified by type in the inspection data.
The inspection and identification of hazardous substances in incoming materials should be documented as follows. See Chapter 2 of Part II of this book. If a hazardous substance is detected, the type and concentration of the hazardous substance should be specifically noted in the inspection record.
i) A process for handling anomalies/nonconformities should be included.
This can be combined with the nonconforming product control process.
J) If processes are integrated, documented procedures should be established to differentiate between components. The term "interconnected processes" primarily refers to the integration of the procurement processes for HSF products and HS products, creating points of overlap. In such cases, documented procedures are necessary to prevent potential contamination and ambiguity during the procurement process. |
7.5 Production and Service Provision
The requirements of ISO 9001 shall be used in conjunction with the following requirements.
| | **7.5.1 Control of Hazardous Substance Reduction Production and Service Provision Processes**
The requirements of ISO 9001 shall be used in conjunction with the following requirements.
The organization shall plan hazardous substance reduction production and service provision under controlled conditions. Where applicable, controlled conditions shall include:
a) Hazardous substance reduction information describing the characteristics of the product
b) Hazardous substance reduction work instructions, where applicable
c) Use of suitable hazardous substance reduction equipment
d) Having and using hazardous substance reduction monitoring and measuring equipment
e) Implementing hazardous substance reduction monitoring and measuring
f) Implementing control over hazardous substance reduction release, delivery, and post-delivery processes
g) Identifying and documenting processes that may cause contamination
h) Documenting procedures to determine preventive measures to prevent possible contamination. |
If all of a company's products are HSF products, then the requirements for controlling the production process itself are not too complex. The focus of control should be on processes such as design and procurement. Of course, some special processes need attention, such as the passivation process of trivalent chromium on galvanized steel surfaces, changes in lead content in wave soldering furnaces, and the decomposition of decabromodiphenyl ether, which may be used. However, because China's RoHS has not yet truly implemented restrictions on hazardous substances, many companies currently produce both HSF and HS products. Some companies may produce in different factories, some in different workshops, some on different production lines, some on the same production line, and some even using the same equipment and the same batch of tooling and fixtures. In these situations, production control issues arise. The control requirements increase from the first to the last in the list. For example, if an injection molding company uses the same injection molding machine to produce HSF or HS plastic products at different injection times, the control requirements here are quite high. a) Determine whether the product being produced is HSF or HS. If it's HS, identify the hazardous substances present and their potential for contamination or mixing with other products. If it's HSF, identify the most likely hazardous substances present. This information should be included.
b) In cases where work instructions are unavailable to guarantee the consistent HSF characteristics of the product, work instructions should be provided. For example, in situations where the same injection molding machine is used to produce both HSF and HS products, the entire injection pipe and cavity must be cleaned during the switch between the two products. The implementation of this cleaning process should be documented.
c) Ensure the equipment has sufficient capacity to manufacture HSF products. In the industry's transition from HS to HSF products, the most common equipment modifications or upgrades involve welding equipment, including wave soldering, reflow soldering, and manual soldering irons. The process parameters of the equipment should be clearly specified in the work instructions;
d) There are not many monitoring and measuring devices used in the production process to monitor and measure the characteristics of hazardous substances in the product. This is determined by the characteristics of hazardous substance detection;
e) Monitoring and measurement of hazardous substances in the production process are often relatively infrequent. Generally, it involves visual inspection of the correctness of markings, including the markings of incoming materials, intermediate products, and finished products, as well as packaging markings. In some cases, continuous monitoring of process materials may be necessary.
For example, the detection of lead content in wave soldering furnaces can generally be done once a week to ensure accurate understanding of changes in lead content. Monitoring of process parameters of some equipment is also required;
f) The implementation of hazardous substance reduction and release should be approved. Control should be implemented on the delivery and post-delivery processes to ensure that the hazardous substance characteristics of the product do not change;
g) Contamination or mixing may occur during the production process. Enterprises should first identify these processes and then strictly control them. Contamination processes such as the contamination of tin in the solder bath by the pins of electronic components during wave soldering; contamination of subsequent HSF products by injection molding pipes and cavities that are not properly cleaned; and contamination of the board by hexavalent chromium produced during the trivalent chromium passivation process of galvanized sheet due to improper process control, should all be controlled by documented procedures;
h) can be combined with the procedure documents or work instructions required in g).
| | 7.5.2 Validation of Hazardous Substance Reduction Processes in Production and Service Provision
The organization shall validate hazardous substance reduction processes in production and service provision whose outputs cannot be verified by subsequent monitoring and measurement. This includes hazardous substance reduction processes where defects only become apparent after product use or service provision. |
There aren't many HSF (Hazardous Substances) processes that require validation, because such processes only need validation if two conditions are met: first, the product from the process cannot be tested and verified; and second, the process may lead to the degradation of the product's hazardous substance properties. We know that hazardous substances can be tested, but it's a matter of cost, and the ability to test is relative; cases of deterioration in the product's hazardous substance properties are rare. Two examples of processes meeting these two conditions are the trivalent chromium passivation process on galvanized steel sheets and the injection molding process of plastics containing decabromodiphenyl ether. The former requires proof that hexavalent chromium is not introduced during the process, while the latter requires proof that the process will not cause decabromodiphenyl ether decomposition, leading to excessive levels of nonabromodiphenyl ether or octabromodiphenyl ether. Companies need to determine whether a process requires validation based on their specific products and processes. Given the high cost of measuring the HSF characteristics of a product during routine production, process validation is an efficient approach. Many HSF production process validations are often conducted simultaneously with corresponding HSF process validations; however, validation must ensure not only the ability to guarantee other product properties but also the ability to guarantee HSF characteristics.
| | 7.5.3 Hazardous Substance Reduction Labelling and Traceability
a) Where appropriate, the organization shall label hazardous substance-reduced products in a suitable manner throughout the product realization process.
b) Processes containing restricted substances shall be uniquely identified and separated to prevent contamination with hazardous substance-reduced products.
c) The organization shall consider monitoring and measurement requirements to identify the status of hazardous substance-reduced products.
d) When traceability is required, the organization shall control and record the unique identification of the product. |
Labeling plays a crucial role in the management of hazardous substances in products. Due to the difficulty in detecting hazardous substances, labeling is necessary to make this characteristic visible. Furthermore, only effective labeling can guarantee product traceability. a) Labeling can be applied to areas, production lines, equipment, transport vehicles, packaging, and products, and companies should choose the appropriate method based on their specific conditions, products, and locations. b) Labeling distinguishes processes containing hazardous substances. c) For routine management, monitoring and measurement are generally visual, requiring visual labeling. For hazardous substance content testing, labeling is less critical, as hazardous substance testing can be applied to materials in any labeling state. d) Traceability should be maximized to facilitate post-incident analysis and liability determination. c) Organizations should consider monitoring and measurement requirements to identify hazardous substance levels in products. d) When traceability is required, organizations should control and record the unique identifier of each product.
| | 7.5.4 有害物質部件的處理
應有形成文件的程序來處理和貯存有害物質。這個程序應包括接收和運輸的記錄，以及表明有害物質被分隔及分開管理的記錄。
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Effective handling and storage of hazardous substances can prevent contamination or mixing with HSF products. Of course, hazardous substances are present in components, so handling and storage of hazardous substances is essentially handling and storing the components containing hazardous substances. Companies that still have hazardous substances, including those with exemptions, should have documented procedures for handling and storing these hazardous components. To effectively protect products from contamination or mixing with HS products, attention should also be paid to potential product variations. For example, reports indicate that trivalent chromium easily transforms into hexavalent chromium in humid and alkaline environments; therefore, the storage environment should be strictly controlled. Other possible transformations should be determined by the company based on the characteristics of its products and the environments they may encounter. 7.6 Control of Monitoring and Measuring Devices Used in the Hazardous Substance Reduction Process The requirements of ISO 9001 should be used in conjunction with the following requirements.
a) The organization shall determine the required monitoring and measurements, and the necessary monitoring and measurement equipment, to provide evidence that the hazardous substance reduction product meets the defined requirements.
b) The organization shall establish processes to ensure that monitoring and measurements can be performed and in a manner consistent with the hazardous substance reduction monitoring and measurement requirements.
The required monitoring and measurements may be performed primarily in accordance with the requirements of 7.1 or 8.1.1. The main requirement here is the control of the monitoring and measurement equipment. The most common hazardous substance detection equipment purchased by companies is X-ray fluorescence spectrometer (XRF). Some companies may have atomic absorption spectrometry, some may have qualitative detection of hexavalent chromium, and some may have gas chromatography. Very few companies have equipment for precise testing of various hazardous substances. Without precise testing equipment, there is naturally no issue of controlling precise equipment. Therefore, the main focus here should be on the control of the rapid testing devices used by the company.
For the control of rapid testing devices, the first thing to consider is the selection of the measuring device, such as whether its sensitivity, range, and accuracy meet the requirements.
A common question is how to calibrate and measure the XRF. Calibration of hazardous substance measuring devices is typically performed through standard reference material comparison and repeatability/reproducibility analysis. Additionally, attention must be paid to the control of the standard reference materials themselves and whether they meet the measurement range requirements. Maintaining the instrument's stability and ensuring proper operation are paramount. The accuracy of measurement results is easily determined using standard samples; if necessary, comparison with external testing results can also be used. Therefore, companies should establish strict operating procedures for the instruments and contact the equipment supplier frequently when problems arise, as this is crucial for ensuring the accuracy of measurement results. Regarding ensuring monitoring and measurement can be performed, precision testing is certainly possible since disassembly and sample preparation are necessary. For coarse screening, the timing of the measurement is critical. Once the product is assembled into a finished product, testing of many components may become impossible; generally, incoming material inspection is more important. If absolutely necessary, disassembling the product for testing is advisable.
