7.1 Planning of Hazardous Substance Reduction Process and Product Realization
The requirements of ISO9001 should be used together with the following requirements.
The organization shall plan and develop processes for the realization of hazardous substances reduction products.
| | In planning the implementation of hazardous substances reduction products, the organization shall determine the following aspects, where appropriate:
a) Quality objectives and requirements for hazardous substance reduction products
b) Determine the need to establish hazardous substance reduction processes, documents and provide resources for hazardous substance reduction products
c) Verification, validation, monitoring, inspection and testing activities required for hazardous substance reduction products and product acceptance criteria. Where appropriate, information service providers should be included.
d) Procedure documents or work instructions for processes using restricted substances to include prevention when contamination exists.
e) Evidence is required to prove that the process of achieving hazardous substance reduction and the products obtained meet the requirements.
f) The form of hazardous substance reduction planning output should be suitable for the organization's operating methods.
Note 1: The document 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 audit;
d. Irregular spot inspections (the spot inspection plan is determined based on the frequency determined by risk analysis);
e. Management of samples sent by customers.
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Product realization process refers to all processes used to form a product. In fact, it is the process from customer demand to product mass production. Different from the product design and development process, the product design process is the process of converting regulatory, technical, safety, functional, market or other requirements that the product needs to meet into the technical specifications of the product. In short, the design process can be regarded as the process of creating a product from scratch, while the product realization process is the process of starting from scratch to mass production. In the concept of ISO9000, the product realization process includes the product design process. Management system planning is one level higher than product realization planning.
a) Determine the quality objectives and requirements for hazardous substance reduction products: This is work that must be carried out. Which products need to meet the hazardous substance restriction requirements, what types of hazardous substances are restricted, and what the limit values are, must have precise regulations;
b) Determine the need to establish hazardous substance reduction processes, documents and provide resources for hazardous substance reduction products: To make HSF products, the process needs to be re-planned. The input, output and resource requirements of the process will change. If necessary, the process document;
c) Verification, validation, monitoring, inspection and testing activities required for hazardous substance reduction products and product acceptance criteria. Where appropriate, information service providers should be included. Whether the hazardous substance characteristics of the product meet the requirements needs to be tested. For the detection of hazardous substances, there are many aspects that need to be paid attention to. Please refer to Chapter 2 of Part 2 of this book.
d) For processes that use restricted substances, documented procedures need to be developed to implement controls, and the documentation should include content to prevent contamination or mixing of materials.
e) Evidence is required to prove that the process of achieving hazardous substance reduction and the products obtained meet the requirements. This evidence is reflected not only in the test results of hazardous substances in products, but also in the implementation records of various processes.
f) Planning output does not necessarily have to be in the form of a quality plan. In fact, the established hazardous substances process management system is the planning output at a more macro level.
7.2 Customer-related requirements
The requirements of ISO9001 should be used together with the following requirements.
| | 7.2.1 Determine requirements related to hazardous substances reduced products
The organization should determine
a) Hazardous substance reduction requirements determined by the customer
b) Requirements not declared by the customer but necessary for the product’s intended or intended use (when known)
c) Legal and regulatory requirements for hazardous substance reduction and exemption related to products
d) Other hazardous substance reduction requirements determined by the organization
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The concept of determining product-related requirements is the same as ISO9001, except that the identification content increases the content of customer and regulatory requirements for product hazardous substances.
The following documents may contain customer requirements for hazardous substances: purchase contracts, purchase orders, hazardous substance content benchmarks/standards, test reports, sample submission feedback, penalty notices, return notices, quality assurance agreements, environmental assurance agreements, purchasing materials , green procurement standards, on-site inspection reports, etc. In addition, customers may also transmit these requirements via phone, email, fax, etc. Since RoHS involves legal liability after all, such requirements generally require written confirmation from customers.
a) In terms of hazardous substance reduction requirements determined by customers, including limit requirements and management requirements for hazardous substances.
The limit requirements for hazardous substances include the types of hazardous substances, the content of hazardous substances, and the implementation time of restricting hazardous substances. When restricting hazardous substances, some companies only consider the restrictions on the six categories of hazardous substances specified in the RoHS Directive, and do not consider a series of restrictions on other hazardous substances proposed by customers; in terms of concentration limits, they only follow the limits of RoHS regulations. Consider, but not consider, some customers' more stringent requirements for certain hazardous substances. These are insufficient.
It takes a long time for companies to respond to the RoHS directive, and the pressure exerted by customers is relatively high, so they generally pay more attention to the limit requirements for hazardous substances in products. However, companies often do not identify the content of customers’ hazardous substances management requirements, such as customer requirements for product realization process control, change management requirements, and supplier control requirements for suppliers. These are all customer requirements. Common requirements in hazardous materials management.
b) Requirements not declared by the customer but necessary for the intended or intended use of the product (when known). In terms of hazardous substances control, apart from customer and regulatory requirements, there are actually relatively few such requirements. For certain or expected uses, when hazardous substances are present, the performance of products that contain hazardous substances is often more secure than those that do not contain hazardous substances. Therefore, companies do not need to think too much when implementing this requirement.
c) Legal and regulatory requirements for hazardous substance reduction and exemption related to products. The one we are most familiar with is the RoHS directive. In fact, there are many laws and regulations that restrict hazardous substances in products. For details, please refer to the first chapter of this book. In terms of regulatory requirements, in fact, there are not only requirements for the restriction of hazardous substances, but also some other requirements for meeting the WEEE directive. To meet these requirements, companies need to consider them at the product realization stage, not when the products are sold to Europe. After the product is sold to Europe, not only will the cost of complying with regulations increase, but some requirements may not even be met, such as the requirements for the recycling ratio of product materials. If the materials are improperly selected during the product design stage, the recycling ratio of the material itself will not meet the requirements. If the product meets the requirements, then the product will not be able to meet this requirement anyway after it is scrapped.
The labeling of China RoHS, namely information disclosure requirements, Japanese regulations and Korean regulations also have similar requirements.
In order to effectively respond to regulatory requirements, or make full use of some exemption clauses in regulations, such as the British RoHS regulations, there are exemption clauses; in addition to understanding some direct requirements of regulations, companies should also pay attention to collecting regulations that contain implementation requirements. Such as "RoHS Implementation Guidelines Document".
After identifying and reviewing the hazardous substance limit requirements and management requirements, the company should determine the company's product development strategy based on the company's development strategy, determine which products need to be converted into environmentally friendly products and which do not need to be converted, and determine a specific time schedule.
Then, the company should formulate the company's own requirements based on customer requirements and regulatory requirements and according to the company's exhibit development strategy, including limit requirements for hazardous substances, testing requirements, and hazardous substance management requirements. After it is formulated, it will be distributed within the company.
Within an enterprise, there are many departments involved in the management of hazardous substances, and there may be more departments in the enterprise that may receive customer-related information. This requires the enterprise to uniformly report the information obtained by different departments to a certain responsible department, and then the department shall Manage this information. After the internal requirements of the company are formed, the department will notify the relevant departments.
| | 7.2.2 Review of product-related hazardous substance reduction requirements
The organization shall review the requirements related to products that are exempt from hazardous substances. The review should be conducted before the organization commits to supplying products with reduced hazardous substances to customers and should ensure that:
a) Hazardous substance reduction product requirements have been determined
b) The organization has the ability to meet the identified hazardous substance reduction requirements
c) Communicate to customers about any use of restricted substances or possible contamination, admixture of any processes or products that may contain restricted substances
d) It is necessary to keep and maintain records of the review results of hazardous substance reduction and measures and the measures determined by the review.
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The concept of review should be consistent with that of ISO9001, except that the content of the review adds the review of requirements related to hazardous substances in products. However, you must not only consider the review of product hazardous substance restrictions, but must also consider the review of customer hazardous substance management requirements to ensure the integrity of the input when meeting customer requirements. This is an aspect that many companies currently tend to overlook in terms of hazardous substance management. These management requirements involve the management of different processes and departments within the enterprise. After the company determines and reviews these requirements, it should pass these requirements to the relevant departments so that these departments can add this aspect when formulating management specifications.
The review of hazardous material requirements should be a relatively professional one. When determining whether a company can meet these requirements, the opinion should be issued by a department with professional capabilities in hazardous material management.
Clause c) mentions that processes and products using restricted substances should be communicated to customers, as well as possible contamination or admixture of any processes or products containing restricted substances. It is necessary and easy to communicate to customers the processes and products that use restricted substances. Customers should be notified of applications including exempted hazardous substances, so that customers can focus on each link. For products and processes that only have the possibility of contamination, if they are required to notify customers, many companies may have concerns, because this may affect the company's business, and customers may be because you honestly provide this information. information without purchasing your product. Therefore, I have reservations about this requirement. When implementing standard requirements, if the company believes that there will be no negative impact, it should communicate to customers.
Information communication with customers has a lot of content in hazardous materials management, such as communicating product material breakdown tables, hazardous material compliance statements, hazardous material testing reports, hazardous material management agreements, etc. to customers. In daily hazardous material management, , it may happen that customers think that the harmful substances in a certain batch of materials submitted by the company exceed the standard and need to communicate and solve the problem. Some companies may establish an integrated material information providing platform for the entire supply chain. As a supplier, you need to submit corresponding information on this platform. information. How to carry out these tasks can be stipulated in the customer communication procedures of the original ISO9000 quality management system, or the company can separately formulate the "Customer and Legal and Regulatory HSF Requirements Identification and Company HSF Requirements Determination Procedures", which are documented in Chapter 3 of this article. Example.
7.3 Design and development
The requirements of ISO9001 should be used together with the following requirements.
| | 7.3.1 Planning of Hazardous Substance Reduction Design and Development
The organization shall plan and control the design and development of hazardous substances reduction products.
During design planning, the use of restricted substances should be identified in documentation and a plan for the control and eventual replacement/elimination of these components.
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Generally speaking, when designing HSF products, it is necessary to consider the hazardous substance characteristics of materials, the material's adaptability to the process, and the possibility that the process will cause changes in the hazardous substance characteristics of the product. You should also consider how to meet the requirements for easy disassembly of the product, reuse, recycling and recovery after the product is scrapped, consider reducing the possible environmental impact caused by the product throughout its life cycle, consider correctly labeling the product, and reasonably disclose the product's Hazardous substance information is taken into account to facilitate product testing, etc.
When designing and planning HSF products, it should be determined at which stages of design the satisfaction of the above requirements will be considered. Readers may refer to the content of Part 2, Chapter 3 of this book.
Here, the standard specifically states that if hazardous substances are used when designing a new product, a document or plan must be formulated that stipulates how to control and ultimately replace/eliminate parts 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 Substances Mitigation Design and Development Input
Inputs related to hazardous substances reduction product requirements should be identified and records maintained.
The adequacy of import exemptions for hazardous substances should be reviewed. Requirements should be complete, clear, and non-conflicting.
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In terms of hazardous substances management, design inputs include customer and regulatory requirements for hazardous substance restrictions on products, requirements for products to meet the WEEE directive, labeling and information disclosure requirements for China RoHS, and requirements stipulated by other regulations, such as some requirements of the EuP directive wait. This requires the department that identifies, summarizes, and determines product hazardous substance requirements based on the company's product development strategy to pass relevant requirements to the product design and process design departments. Designers should accurately understand these requirements and consider meeting these requirements in the design.
| | 7.3.3 Outputs from Hazardous Substances Mitigation Design and Development
Hazardous substance reduction outputs from design and development should be presented in a manner that ensures they are verifiable against design development inputs and should be approved prior to release.
When the design requires the use of restricted substances, documented procedures should be developed to control, identify, monitor and measure the process/product (including products of subcontracted processes).
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In accordance with the requirements of ISO9001, design and development output should provide appropriate information for procurement, production and service. In terms of hazardous substance management, the information required for procurement includes a bill of materials (BOM list) and material specifications. The material specifications should include information related to hazardous substances, such as hazardous substance content requirements and product process adaptability requirements (such as the maximum temperature of components). Adaptability requirements) and material recyclability requirements. Of course, these requirements generally need to be confirmed before they are clear; as well as how to label products and how to provide information (such as the environmental protection use period of materials, information on parts containing hazardous substances, product dismantling information, necessary information provided to consumers), etc. Some design outputs may apply to all products, while others may be specific to different products.
In terms of hazardous substance management, the appropriate information provided for production and services generally includes the determination of the production process, because different process requirements may lead to changes in the content of hazardous substances in the product, such as surface passivation treatment of galvanized steel, passivation treatment The final storage environment requirements, injection molding process of plastics containing decabromodiphenyl ether as flame retardant, etc.
It is required here that the design output should be verifiable, the characteristics of hazardous substances can generally be verified through testing, and other requirements can generally be verified.
When restricted substances are also used in a product being designed, the design output should consider formulating a document that stipulates how to identify hazardous substances, how to control, monitor and measure products and processes, and how to avoid contamination of other HSF products. .
| | 7.3.4 Review of Hazardous Materials Mitigation Design and Development
At appropriate stages, design and development should be systematically reviewed in accordance with the Hazardous Substances Reduction Plan.
7.3.5 Verification of design and development
The requirements of ISO9001 shall apply with the following requirements.
7.3.6 Confirmation of design and development
The requirements of ISO9001 shall apply with the following requirements.
7.3.7 Control of Hazardous Substance Reduction Design and Development Changes
Changes to hazardous materials mitigation design and development should be identified and records maintained. Where appropriate, changes should be reviewed, verified, validated, and approved before implementation.
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In terms of hazardous substance characteristics, generally speaking, design verification requires testing to prove that the hazardous substance content of the product does not exceed the limit value.
The design review mainly proves that the harmful substance content of the product does not exceed the limit value by checking various test reports. At the same time, whether the design and development output results provide appropriate information for subsequent procurement, production and services must also be determined through design review. Such as the review of BOM sheets and product specifications required for purchasing materials, and process specifications required for production.
Design confirmation requires consideration of whether the content of harmful substances can be guaranteed not to exceed the standard under the intended future use or application conditions of the product. For example, according to the characteristics of these restricted hazardous substances, special consideration should be given to possible changes in decabromodiphenyl ether and trivalent chromium under usage conditions and storage conditions, resulting in nonabromodiphenyl ether and octabromodiphenyl ether. The possibility of exceeding the standard for ether and hexavalent chromium.
In terms of process design, product testing can also be used to prove the suitability of the process.
The disassembly and recyclability of the designed products should also be verified.
Product identification and information provision should be reviewed to ensure that requirements are met.
In terms of control of design changes, special attention should be paid to situations involving material changes. In addition, attention should also be paid to some process changes that may affect changes in the characteristics of hazardous substances in products. After changes occur, they must also undergo necessary review, verification and confirmation.
7.4 Procurement of Hazardous Substance Reduction Products
The requirements of ISO9001 should be used together with the following requirements.
a) The organization shall ensure that purchased products comply with hazardous substance reduction requirements
b) The organization shall evaluate and select suppliers based on their ability to provide products in compliance with the organization's hazardous substances reduction requirements.
| | a) is the general requirement for procurement. Please note that if the enterprise has an outsourcing process that affects the hazardous substance characteristics of the product, the outsourcing process needs to be managed in accordance with this clause.
b) is the requirement for supplier selection. What kind of companies might serve as suppliers to the company? Suppliers that have the ability to provide products in accordance with the enterprise's hazardous substance reduction requirements, that is, in terms of hazardous substance management, have newly added selection and evaluation criteria for suppliers. Generally speaking, you should examine whether the hazardous substance characteristics of the products provided by the supplier meet the requirements (check test reports, labels, or conduct physical testing), whether the supplier's quality assurance capabilities are sufficient (on-site inspections should be conducted on high-risk suppliers), Can the supplier provide necessary documentation (such as material breakdown table, test report, compliance statement, warranty agreement, etc.) as required? Enterprises can classify suppliers into high-risk suppliers and general-risk suppliers based on their quality assurance capabilities and the risks of the materials they supply. Quality assurance requirements for high-risk suppliers should be more stringent, such as conducting on-site quality assurance capability reviews. c) The organization shall ensure that all hazardous substance exempt parts/materials are free from contamination by restricted substances
This is a requirement for procurement process control. In view of the characteristics of hazardous substances themselves, the possibility of contamination during the general procurement process is not high. It is more likely that the supplier sends the wrong goods. However, enterprises should conduct analysis based on the characteristics of the products they purchase and the procurement process. d) Procurement of restricted substances should be clearly indicated in procurement documents and upon receipt of materials.
Enterprises should issue requirements related to hazardous substances to suppliers, including hazardous substance limit requirements, management requirements, testing requirements, information provision requirements, etc. It can be issued through various methods such as purchase contracts, agreements, orders, etc. Procurement information should be accurate and sufficient. If the purchased products contain hazardous substances, they should be clearly recorded in the incoming material inspection records and material account books.
e) Verification of purchased products with hazardous substance exemptions
f) To ensure that purchased products meet the determined procurement requirements for hazardous substance reduction and exemption, the organization shall establish and implement necessary inspections or other activities.
Inspection of incoming materials is necessary. It is best for enterprises to have their own inspection equipment, which of course is generally rapid inspection equipment for coarse screening inspection.
For items that the company is unable to inspect itself, the company should provide for outsourcing testing.
Some companies do not have testing equipment, so are they absolutely unable to pass the QC080000 Hazardous Substances Process Management System Certification? The author believes that in the certification of hazardous substances process management system, the control effect of hazardous substances should be placed in a prominent position. Although the company does not have its own testing equipment, if all materials have been tested on a daily basis at a certain point in their respective supply chains, all materials have been sent out for annual inspection based on risks; moreover, the company has strict control over the entire supply chain. Process control is in place. In this case, it should be acceptable if the company does not have its own testing equipment. After all, testing equipment is still relatively expensive. In this case, many companies generally check the name, number, specification model, etc. of the incoming materials to ensure the correctness of the incoming materials during inspection, check whether there are environmental protection labels, and check whether the supplier's annual inspection report is in Within the annual scope, etc., these are also necessary tasks. In addition, companies without testing equipment must send out annual inspections for high-risk materials. 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 the hazardous materials reduction process should be identified in documented procedures.
The procurement route actually refers to the path of item procurement, which generally includes two components, one is the source of goods, and the other is the process from the source of goods to the place under the control of the organization. Supply control is the key. Some of the organization's materials may be purchased directly from manufacturing enterprises, some may be purchased from dealers, and some may even be purchased in some general sales markets. There are different paths. So what level should we know about the purchasing path of items? The standard does not have exact requirements for this. In the guidance notes of the British government RoHS regulations, companies are required to manage their suppliers. That is to say, in the regulations, the level to which companies are required to manage is first-tier suppliers, but Suppliers should be required to manage their suppliers and their control of their suppliers should be considered when reviewing suppliers. Of course, from a reliability perspective, the clearer the procurement route is, the more conducive it is to control, and it is best to be able to identify risk-free suppliers or homogeneous material supplier levels. For cases where the first-tier 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's impact on the hazardous material properties of the product is very small. Adequate identification of any process that may be contaminated by a restricted substance means that there are situations in the procurement route where possible contamination is to be identified. For example, if a supplier may produce both environmentally friendly and non-environmentally friendly products, possible contamination during product transportation, product reception, and storage should be identified. Procurement activities related to the hazardous substance reduction process are listed in the documented procedures. It is required that suppliers related to hazardous substance reduction products and processes, the items supplied by the suppliers, and their specifications and models should be clear and must be It is clearly stated in the document. H) Develop procedural documents for the inspection and identification of hazardous substances contained in purchased items. Hazardous substances should be identified by type in inspection data.
The inspection and identification of hazardous substances in incoming materials should be documented and stipulated on how to carry out the inspection and identification. See Chapter 2 of Part 2 of this book. If hazardous substances are detected, the type of hazardous substance and its content should be specifically noted in the inspection record.
i) A procedure for handling exceptions/non-conformities should be included.
Can be combined with the nonconforming product control process.
J) If processes are combined with each other, documented procedures should be established to distinguish the various components.
The so-called integration of processes mainly refers to the integration of the processes of purchasing HSF products and purchasing HS products, and there are intersections. If this is the case, documented procedures need to be in place to avoid possible contamination and commingling during the procurement process.
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7.5 Production and service provision
The requirements of ISO9001 should be used together with the following requirements.
| | 7.5.1 Control of hazardous substance reduction production and service provision processes
The requirements of ISO9001 should be used together 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 that describes product characteristics
b) If necessary, there are instructions for reducing harmful substances
c) Use appropriate hazardous substance reduction equipment
d) Possess and use hazardous substance reduction monitoring and measuring equipment
e) Implement hazardous substance reduction monitoring and measurement
f) Implement control of hazardous material release, delivery and post-delivery processes
g) Identify and document potentially contaminating processes
h) Document operating procedures and identify preventive measures to prevent possible contamination.
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If all products of an enterprise are already HSF products, then the requirements for controlling the production process itself are not too complicated. The focus of its control should be on processes such as design and procurement. Of course, there are some special processes that should be paid attention to, such as the passivation process of trivalent chromium on the surface of galvanized steel, changes in lead content in wave soldering furnaces, and the decomposition of decabromodiphenyl ether that may be used.
However, since China RoHS has not yet implemented the restrictions on hazardous substances, many companies currently produce both HSF products and HS products. Some companies may produce in different factories, some may be in different workshops, some may be on different production lines, some may use the same production line, and some may even use the same equipment and the same batch of fixtures. In these cases, there are production control problems. In the situations listed above, from front to back, the control requirements are getting higher and higher. If some injection molding companies use the same injection molding machine to produce HSF or HS plastic products at different injection molding periods, the control requirements here are relatively high.
a) Determine whether it is an HSF product or an HS product. If it is an HS product, what kind of harmful substances are there? How likely is it to contaminate other products or be mixed with other products? If it is an HSF product, what is its greatest possible risk of being harmful? Whatever the substance is, it should be required information;
b) If there is no work instruction and the HSF characteristics of the product cannot be guaranteed to meet the requirements stably, there should be a work instruction. As mentioned above, when the same injection molding machine is used to produce HSF and HS products, when the two products are switched, the entire injection pipe and cavity must be cleaned. How to implement this cleaning process should be stipulated in the document;
c) The adequacy of equipment capabilities should be ensured and the ability to manufacture HSF products should be ensured. In the process of converting from HS products to HSF products in the industry, the most commonly involved equipment modifications or updates are soldering equipment, including electric soldering irons for wave soldering, reflow soldering, and manual soldering. The process parameters of the equipment should be clearly specified in the work instructions;
d) There are not many monitoring and measuring equipment used in the production process for the characteristics of hazardous substances in products. This is determined by the characteristics of hazardous substance detection;
e) Monitoring and measurement of hazardous substances during the production process are often relatively small. Generally, visual inspection is done to determine whether the labels are correct, including the labels of incoming materials, intermediate products, finished products, and packaging labels. In some cases continuous monitoring of process materials may be required
For example, the detection of lead content in wave soldering furnaces can generally be done once a week to ensure an accurate understanding of the changes in lead content. There are also some equipment process parameters that need to be monitored;
f) The implementation of hazardous substance reduction and release should be approved, and the delivery and post-delivery process should be controlled to ensure that the hazardous substance characteristics of the product do not change;
g) There may be contamination or mixing of materials during the production process. Enterprises must first identify these processes and then strictly control these processes. Contamination processes such as the contamination of tin in the tin furnace by the pins of electronic components during wave soldering; contamination of subsequent HSF products by cleaning the injection molding pipes and cavities; improper production process control of the trivalent chromium passivation process of galvanized sheets Contamination of plates by hexavalent chromium, etc., such processes should be controlled by documented procedures;
h) can be combined with the procedure documents or work instructions required by g).
| | 7.5.2 Confirmation of hazardous substance reduction processes in production and service provision
The organization shall identify processes for hazardous substance reduction in production and service provision whose outputs cannot be verified by subsequent monitoring and measurement. This includes hazardous substances abatement processes where defects become apparent only after the product has been used or the service has been provided.
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There are not many HSF processes that need to be confirmed, because such processes only need to be confirmed when they meet two conditions. One is that the process products cannot be tested and verified, and the other is that the process may cause the deterioration of the hazardous substance characteristics of the product. We know that all harmful substances can be detected, but it is just a matter of cost. It can also be said that being able to detect is relative; there are not many cases where the characteristics of harmful substances in products deteriorate. There are two examples of processes that meet these two conditions. One is the passivation process of trivalent chromium on the surface of galvanized sheets, and the other is the injection molding process of plastics containing decabromodiphenyl ether. The former needs to prove that no hexavalent chromium is introduced during the process, and the latter needs to prove that the process will not cause decomposition of decabromodiphenyl ether, resulting in nonabromine or octabromine exceeding the standard. Enterprises need to judge whether there is a process that needs to be confirmed based on their own products and processes.
Given the high cost to an organization of measuring the HSF properties of products during routine production, process qualification is an efficient approach. Many HSF production process validations are often carried out at the same time as the corresponding HSF process validations. However, during the validation, attention should be paid not only to the ability to ensure the other characteristics of the product, but also to the ability to ensure the HSF characteristics.
| | 7.5.3 Hazardous substance reduction labeling and traceability
a) When appropriate, the organization shall label hazardous substance-reduced products in an appropriate manner throughout the product realization process.
b) Processes containing restricted substances should be uniquely identified and separated to prevent incorporation into hazardous substance reduction products.
c) The organization shall consider monitoring and measurement requirements to identify hazardous substances reduced product status.
d) When traceability is required, the organization shall control and record the unique identification of the product.
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Labeling plays a very important role in the management of hazardous substances in products. Since the characteristics of harmful substances in products are difficult to detect, in order to make these characteristics of the product visible, the product needs to be labeled. In addition, only good labeling can ensure product traceability.
a) Markings include regional markings, production line markings, equipment markings, transportation markings, packaging markings, product markings, all of which can be used in the management of hazardous substances in products, etc. Enterprises adopt them according to their own conditions, products, places and other characteristics;
b) The process of labeling and distinguishing hazardous substances;
c) If it is daily management, monitoring and measurement are generally visual monitoring, and visual identification applications are required; if it is the detection of hazardous substance content, it does not matter what the label is, because hazardous substance detection can always be applied to materials with any labeled status;
d) It should be traceable as much as possible, which will facilitate analysis and determination of responsibilities after problems occur.
c) The organization shall consider monitoring and measurement requirements to identify hazardous substances reduced product status.
d) When traceability is required, the organization shall control and record the unique identification of the product.
| | 7.5.4 Handling of hazardous material components
There should be documented procedures for handling and storage of hazardous materials. This procedure should include records of receipt and shipment, as well as records showing that hazardous materials are segregated and managed separately.
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Effective handling and storage of hazardous substances can prevent hazardous substances from contaminating HSF products or mixing with them. Of course, hazardous substances are present in components, so the processing and storage of hazardous substances is actually the processing and storage of components containing hazardous substances. Companies that still contain hazardous materials, including those with exemptions, should have documented procedures for handling and storing hazardous materials components.
In order to effectively protect products from being contaminated by harmful substances or mixed with HS products, attention should also be paid to possible mutations in the product itself. For example, it is reported that trivalent chromium is easily converted into hexavalent chromium in humid and alkaline environments. Chromium, then the storage environment should be strictly controlled. Other possible transformations should be determined by the company based on its product characteristics and the environment the product may encounter.
7.6 Control of monitoring and measuring devices used in the hazardous substances reduction process
The requirements of ISO9001 should be used together with the following requirements.
a) The organization shall determine the monitoring and measurements required and the monitoring and measuring equipment required to provide evidence that hazardous substances reduction products meet the identified requirements.
b) The organization shall establish processes to ensure that monitoring and measurement can be performed and are performed in a manner consistent with the monitoring and measurement requirements for hazardous substances reduction.
The required monitoring and measurements may be carried out mainly in accordance with the requirements of 7.1 or 8.1.1. The main requirement here again is the control of monitoring and measuring equipment. The most common hazardous substance detection equipment purchased by general enterprises is X-ray fluorescence spectrometer (XRF). Some companies may have atomic absorption spectrometers, some may have qualitative detection of hexavalent chromium, and some may have gas chromatographs. Few companies are equipped with equipment for precise testing of various hazardous substances. Without precise testing equipment, there is certainly no problem of precise equipment control. So the main concern here is the control of the rapid measurement devices used by the company.
For the control of rapid measurement devices, we should first pay attention to the selection of the measurement device, such as whether the sensitivity, range, accuracy, etc. can meet the requirements.
What everyone has more questions about is how to measure and calibrate XRF. Calibration of hazardous substance measuring devices is usually carried out through comparison with reference materials, repeatability/reproducibility analysis, etc. In addition, attention should be paid to the control of the standard material itself and whether the standard material meets the measurement range requirements. It is more important to pay attention to the correct operation of the instrument and maintain the stability of the instrument. The accuracy of the measurement results can be easily judged by standard samples. If this is not possible, it can also be determined by comparing with the results sent out for testing. Therefore, enterprises should formulate strict specifications for the correct operation of instruments. If you have any questions, please contact the supplier of the equipment. This will be more meaningful for the accuracy of the measurement results.
In terms of ensuring that monitoring and measurement can be carried out, if it is a precise test, it can definitely be carried out, because it has to be disassembled and sampled anyway. If it is a rough screening test, you should pay attention to the timing of the measurement. When the finished product is assembled, the inspection of many components may be out of reach. Generally, more attention is paid to the inspection of incoming materials. When necessary, it is appropriate to disassemble the product for testing.
