Guidelines for the Management of Chemical Substances in Products

Transcription

1 Guidelines for the Management of Chemical Substances in Products September 27, 2005 Revision 1 Japan Green Procurement Survey Standardization Initiative (JGPSSI)

2 Table of Contents 1. Background Definition of Terms The Role of the Guidelines for the Management of Chemical Substances in Products Purpose Applicability to Management System Standards Applicable Industries Anticipated Users Units and Targets of Management Use of the Guidelines Fundamental Approach to the Management of Chemical Substances in Products Principles Structure of the Supply Chain Characteristics of the Manufacturing Processes that Convert Substances/Preparations into Articles (Original Components) The Four Types of Manufacturing Processes Classifications of the Manufacturer Name and Identification of the Manufacturing Processes Importance of Management Focusing on the Unit Process Frameworks Focusing on Manufacturing Processes and Unit Processes The Action Item List & Check Sheet Evaluation Criteria Self-Declaration of Conformance Principles for Use Disclousure of Validated Records Validating Self-Declaration of Conformance Use of These Guidelines Protecting Proprietary Information An Approach to Incorporation into Existing Systems (ISO 9001, ISO 14001)...25 Attachment 1: Information Sheet on the Inclusion of Certain Chemical Substances...26 Attachment 2: JIG Annex A and Annex B...27 Attachment 3: Comparisons between the Action Item List & Check Sheet, ISO 9001, and ISO (Annex 1) Action Item List & Check Sheet...Separate Sheet (Annex 2) Self-Declaration of Conformance (Example), Self-Declaration of Conformance (Data Example), Explanation of Self-Declaration of Conformance (Data Example)...Separate Sheet 1

3 List of Abbreviations EIA EICTA JCIA JGPSSI REACH Electronic Industries Alliance European Information and Communications Technology Industry Association Japan Chemical Industry Association Japan Green Procurement Survey Standardization Initiative Registration, Evaluation and Authorization of Chemicals (currently under discussion) RoHS Directive Directive 2002/95/EC of the European Parliament and of the Council on the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment TSCA Toxic Substances Control Act of

4 1. Background With regard to environmental and human health issues that result from the content of chemical substances in products, there are those caused by exposure to hazardous chemical substances given off by products (for example, Sick House Syndrome), and those soil and ground water pollution issues caused by hazardous chemical substances that leach out of discarded products. Against this backcloth, we have entered an age where it has become necessary to control certain hazardous chemical substances contained in electrical products and machinery. Evidence of this is offered by the Directives of the European Parliament and the European Council regarding the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment (EU Directive, 2002/95/EC: hereinafter abbreviated RoHS ). These directives cover products used in the European Union. To respond to the needs of the times, all firms within a supply chain must implement systems for the appropriate and effective management of chemical substances contained in their products. Work by related groups has produced tools by which to share information on both the applicable chemical substances and on the amount of these substances contained within products. Centering on major information technology equipment manufacturers within Japan, the Japan Green Procurement Survey Standardization Initiative (JGPSSI) was established with the aim of developing a common procurement system. At the same time, JGPSSI cooperated with the Electronic Industries Alliance (EIA) and the European Information and Communications Technology Industry Association (EICTA) to establish common guidelines for investigations from a global perspective, and in May 2005, under the approvals of JGPSSI and EIA, the Joint Industry Guide (JIG) for Material Composition Declaration for Electronic Products was issued. It is in such an environment that, in cooperation with the Ministry of Economy, Trade and Industry (METI), the Survey Report for the Certification of the Control of Information Regarding Chemical Substances Included in Products was published in March 2004 by the Committee for Researching Certification Systems for Controlling Information Regarding Chemical Substances included in Products (which included the participation of electrical and electronic equipment manufacturers, the chemical industry, etc.). The report included a draft proposal on Guidelines for the Management of Chemical Substances in Products. The essence of the draft was that it is imperative that there be standardization of the systems for controlling chemical substances within the products of each company in order to insure information reliability. This standardization was to be obtained through the cooperation of all firms in the supply chain, from raw materials suppliers through to the final product manufacturers. After receiving this draft, in order to further specify action items, the JGPSSI analyzed specific cases to add standards by which to evaluate conformance, arriving at the Guidelines for the Management of Chemical Substances in Products published by the JGPSSI. 3

5 2. Definition of Terms Terms used in these guidelines are defined as follows: (1) Substance (a single chemical substance) A substance is a chemical element or compound that either exists in nature or is obtained via a manufacturing process. A substance includes impurities introduced in manufacturing processes, and additives required for stability maintenance. However, solvents that can be broken down without affecting the stability of the single chemical substance and without changing the composition thereof, are excluded from this definition. (Reference: JIS Z 7250) Examples: Lead oxides, nickel chlorides, benzenes, etc. (2) Preparation (a mixture) A preparation is a mixture comprising two or more individual chemical substances (including solvents). (Reference: JIS Z 7250) Examples: Paints, inks, solders prior to use, adhesives, alloys, etc. * Note that in use, preparations become articles at the point wherein reactions, such as curing, have occurred. (3) Articles (fabricated products) (3-1) TSCA Definition The United States Toxic Substances Control Act (TSCA) refers to an article also as product or goods, and defines an article as an item that: 1) Is formed into a specific shape or design during manufacture, 2) Has end use functions dependent in whole or in part upon its shape or design during end use, 3) Has either no change of chemical composition during its end use, or only those changes of composition which have no commercial purpose separate from that of the article, with the added provision in the United States Occupational Safety and Health Agency Hazard Communication Standard and the Code of Federal Regulations (CFR) Toxic Chemical Release Reporting (40 CFR Part 372) that the item does not release a toxic chemical under normal conditions of processing or use, where 4) Fluids or particles are not considered articles regardless of their shape or design. Examples: Keyboards, main units of computers, and other fabricated objects. The application of the terminology is broader than that of Original Components. (3-2) REACH Definition (not yet approved*) The European Union s chemical policy known as REACH (Registration, Evaluation and Authorization of Chemicals) has the following definition: An article is an object made from a chemical substance or mixture that is given a specific shape, appearance, or design in manufacturing that determines the ultimate function in use more than does the chemical composition thereof. (Reference: Draft Directive for REACH) * As of August 2005, this definition has not been approved, and so should be used for reference purposes only. 4

6 (4) Original Components A component that has been produced through a manufacturing process such as molding, drying, heating, coating, etc., wherein the amounts of chemical substances included are fixed. Example: A single key in a keyboard for a personal computer, a capacitor, solder after use, etc. Note: Original components are subsets of articles. They have been produced through passing through a manufacturing process that fixes the amounts of chemical substances included. (5) JIG Guidelines regarding the disclosure of information related to chemical substances in products, created jointly by the JGPSSI, EIA and EICTA and issued after approvals of the JGPSSI and EIA. Its English official name is the Joint Industry Guide (JIG) for Material Composition Declaration for Electronic Products and the issuer is the EIA. There is a Japanese version of this guide issued by the JGPSSI. The guide is abbreviated as the JIG. (6) JIG Annex A and Annex B These are the lists of groups of common chemical substances to be investigated, as stipulated by the JIG. There are 15 and 9 groups of substances listed in Annex A and Annex B, respectively. Groups of substances in Annex A and Annex B were selected based on the following criteria: Annex A: Chemical substances whose use is prohibited, restricted or required to be reported, subject to domestic or overseas regulations Annex B: a) Substances that are of significant environmental, health, or saefty interest b) Substances that would trigger hazardous waste management requirements c) Substances that could have a negative impact on end-of-life management (7) JGP Files This refers to the JGP file format, established by the JGPSSI, for electronic files used in standardized green procurement survey responses. The JGP files establish the types of response data, the sequence of response data, and the data delimiters (tab characters). The following freeware templates are provided by the JGPSSI: the Survey Response Tool in Excel format for creating the JGP files; and the Data Checking Tool by which to check the contents of the JGP files. In accordance with the introduction of the JIG, the JGPSSI will propose a JGPSSI recommended format that meets the JIG standards and improve the existing JGP files. (8) Content Flag Information An investigation item stipulated in the JGPSSI recommended format that meets the JIG standards. In this recommended format, the investigator is asked to answer in Yes or No whether the relevant group(s) of chemical substances are intentionally added ( intentionally added refers to the case where the substance is added to the product in order to add a certain performance to the product) or are present in excess of the threshold level. 5

7 (9) MSDS This refers to data sheets regarding the safety of chemical substances and is an abbreviation of the Material Safety Data Sheet. In Europe, it is called the Safety Data Sheet (SDS). It is a document created and provided for companies who handle chemical substances, so that the environment and human health may be protected, work safety may be maintained, and necessary measures may be addressed. In Japan, submisssion of the MSDS is required by the Industrial Safety and Health Law, the Law Concerning Reporting, Etc., of Releases to the Environment of Specific Chemical Substances and Promoting s in their Management (the so-called PRTR Law ), and the Poisonous and Deleterious Substances Control Law. The form is stipulated in ISO (corresponding JIS: JIS Z 7250) and the guidelines for the preparation of the MSDS is published by the Japan Chemical Industry Association (JCIA). (10) Information Sheet on the Content of Certain Chemical Substances A format that supplements the MSDS. It is used to provide information regarding the amount of certain hazardous substances contained in products, such as some traces of cadmium. It is used in cojunction with the MSDS and is recommended by the JCIA. Please see the JCIA website and the Information Sheet on the Content of Certain Chemical Substances (Annex 1). It is also referred to as the MSDS Plus. (11) Contain Content refers to the content of a chemical substance, as a constituent of a component, material, or product. The content includes cases wherein a chemical substance that is contained naturally (an impurity) is included, or wherein a substance that is left over from a common industrial refining process (an impurity, a residual solvent, a non-reacted monomer, or other residual substance) is included. (12) Threshold This is a boundary value that evaluates the figures. When managing chemical substances in products, is is used to determine whether the relevant chemical substance is present or absent in the product. <Remarks> Generally in green procurement surveys, it is used as the lower limit of the amount of included chemical substances when it is required to answer the survey. However, in carrying out green procurement surveys, the JGPSSI defines that a threshold is a concentration level that requires notification based on the green procurement survey requirement items stipulated by the JGPSSI. When the amont of chemical substances or materials contained in a homogeneous material of a product or a component exceeds (or equalizes with) this value, notification is required. JIG Definition Threshold level: Concentration level which defines the limit (equal to or) above which the presence of a substance or material in a product or subpart must be declared based on the requirements of this guide. 6

8 (13) Supply Chain The supply chain generally refers to the linked series of operations linking the provider to the consumer, from development through procurement, manufacturing, distribution, and sale. In this document, this extends to the manufacturing of the final product, where the supply chain relates to materials manufacturers, chemical product manufacturers, article manufacturers, parts manufacturers, set manufactures, and so forth. (14) Products A product refers to that which is shipped by a company. This includes not just the final product, but also materials and semi-completed goods requiring further processing or conversion prior to being sent to the greater market. (15) Manufacturing Process Although for products produced by the supply chain, manufacturing processes can be categorized broadly into 1) Substance/preparation manufacturing, 2) Original component manufacturing, 3) Parts manufacturing, and 4) Equipment manufacturing, typically firms perform more than one type of manufacturing mentioned above. The manufacturing process refers to the processes that perform these types of manufacturing. These are also referred to as processes. (16) Unit Process Each of the manufacturing processes described in (15), above, requires the three actions of purchasing, manufacturing, and sales. These three processes are known as the unit process for control. (17) Management Framework The management framework refers to the action items that are controlled in the unit processes for substances, preparations, and articles. These are also referred to as management schemes. (18) High-Risk Materials The word high-risk materials does not have a clear definition. Generally speaking, however, it is used in the following meaning: A raw material or component with a concern of exceeding the threshold in a certain frequency (see 2. Definition of Terms (12)), resulting from unevenness in the amount or concentration of included chemical substances which require management. Reporting of high-risk materials are required mainly in the following cases: chemical substances which require management that are contained in raw materials and components are highly likely to become mixed, difficult to remove, or easily accumulable when recycling and reusing the products. 7

9 3. The Role of the Guidelines for the Management of Chemical Substances in Products - It is important to standardize several requirements that are required for the various companies in the supply chain to cooperate with each other and for the appropriate management of the chemical substances contained in the products to be performed efficiently. These requirements are outlined in Table 1. Of these, Selection of types of substances subject to management and Making of survey reply format for sending information have been prepared thanks to the efforts of the JGPSSI and the JCIA. These guidelines are the requirements for improving the reliability of the information disclosed, and summarize the specific action items and requirement items regarding the management of chemical substances in products. Table 1: Requirements for the Efficient Management of Chemical Substances in Products by Firms in the Supply Chain, Specific Approaches Thereto, Etc. Requirement Purpose Specific Approach, Etc. Selection of types of substances subject to management Making of survey reply format for sending information Determination of the subject of these guidelines: specific action items regarding the management of chemical substances in products - To standardize the focus of surveys - To avoid excessive surveys - To rectify imprecision in surveys - To supplement the information included in the MSDS - To improve reliability of information disclosed through survey reply format described above - To standardize key points in the structure of management systems - Standardized by JIG Annex A and Annex B - Standardized by JGPSSI after introduction of JIG (JGP files) - JCIA Datasheet for Certain Chemical Substances in Products - These guidelines are being drawn up by the JGPSSI with the aim of providing a reference when individual companies structure control systems for the chemical substances in products - There are already a variety of approaches taken to management of chemical substances in the chemical industry, including the responsible care movement. These guidelines compile information that will serve as a reference when structuring management systems in order to make it possible to address the management of chemical substances included in products in firms outside of the chemical industry as well. - It is necessary to create a system in the overall supply chain by which to control chemical substances in products and by which to transmit appropriate information such as the amounts of contained chemical substances. This figure shows how these guidelines standardize the requirements so that there will not be inconsistencies in management from company to company in structuring and running systems for the appropriate management of the chemical substances contained in the products of each individual company. 8

10 Scheme to calculate data of hazardous substances in purchased products and inform data of hazardous substances in its products to its customers Supplier B1 Supplier B2 "management chains" of hazardous substances Supplier A1 hazardous substance-free products Supplier B3 Supplier A2 Supplier A3 Final Product Manufacturer Data of hazardous substances The organization shall inform data of hazardous substances in its products to its customers. The data shall be calculated from data of hazardous substances in purchased products. To enhance the credibility of data of hazardous substances in products, the organization(s) should establish, im plem ent and m aintain the management system of hazardous substances. Material Declaration Assurance System Policy and principles Planning of operational processes Identification of organization structure, roles, responsibilities and authorities Management review Selection of significant issues to be addressed Design and Development Purchasing Production Product release <ex> Rule mentions that prohibition and restriction of the use of certain hazardous substances must be noted on specifications <ex> D ata of certain hazardous substances and its evidence exist for all purchased products <ex> Operation procedures to prevent the mixing of certain hazardous substances are defined <ex> Data of certain hazardous substances in products are traceable Management review Analysing and handling nonconform ities Self-declared claims or Audits It w ill be expected to reduce the loads for both m anufacturers and suppliers by holding the management system of hazardous substances in common Figure 1: Overview Regarding the Use of Tshese Guidelines 9

11 3.1. Purpose The purpose of these guidelines is to define the requirements for firms in the electric and electronics industry supply chain in order to accurately control the chemical substances contained in their own products, and to provide standardized requirements for accurate and efficient management of contained chemical substances. The goal is to have firms in the supply chain establish management of the contained chemical substances in order to increase the reliability of the information on the chemical substances contained in raw materials and components, making it possible to comply with legal regulations such as the RoHS Directive. However, even if the management of chemical substances in products is implemented in accordance with these guidelines, these guidelines do not verify the compliance of individual products with regulations such as the RoHS Directive, regardless of whether the products are sold by companies that have introduced these guidelines Applicability to Management System Standards Because the supply chain may include interactions with foreign companies, the ISO Guide 72, Guidelines for the Justification and Development of Management System Standards, was used as a reference when compiling the action items shown in these guidelines. Specifically, the action items were researched while referencing standard requirements for management systems Applicable Industries These guidelines apply to all industries in the supply chains of the electrical and electronic industries, from materials manufacturers through to set manufacturers Anticipated Users The users anticipated for these guidelines are as follows: (1) Parties Responsible For Structuring the Systems for Managing Chemical Substances in the Products of Their Firms These guidelines are anticipated to be a reference when the systems for managing chemical substances in products are constructed in individual firms. When, during the stage wherein the systems are constructed, the parties with the primary responsibilities for constructing the systems engage in the work after referencing these guidelines, then later, after the systems have been constructed, these guidelines can be used as training tools within the company, making it possible to insure a shared knowledge of the critical points of the system for managing chemical substances in products. Moreover, these guidelines may also be used when the firm s compliance department performs internal audits regarding whether or not the system for managing the chemical substances in products is functioning. 10

12 (2) Individuals Auditing the Systems for Managing Chemical Substances in Products on the Supplier Side These guidelines are anticipated to be used as a reference by external organizations including purchasers, in order to confirm whether a system for managing chemical substances has been constructed on the supply side Units and Targets of Management The units and targets for management in these guidelines are as described below: (1) Units for Performing Management In these guidelines, the unit for managing chemical substances in products is envisioned as the organization, rather than the product. From the standpoint of information reliability, there are those who would point out that the product unit is superior to the organization unit, but it cannot be denied that management by the product unit may be costly in terms of the labor, efficiency, and costs for the companies. Moreover, from the perspective of corporate social responsibility (CSR), it is becoming increasingly important to exhibit compliance as an organization regarding the management of chemical substances in products, and thus in these guidelines it is recommended that the unit of management be the organization unit.s * Here the organization indicates companies, corporations, business departments, and individual contractors, and combinations of the same. Example: Factory, Inc.; Division., Inc.; Product Dept., Group (2) Substances Subject to Management The substances subject to management are not specifically stipulated in these guidelines, and they rather vary depending on the green procurement standards of each firm. However, in consideration of efficiency in management and surveys, it is recommended that the management cover the survey substances listed in the JIG Annex A and Annex B Use of the Guidelines These guidelines may be used by following the flow described below: (1) Structure the Management System The first task to be performed by each firm in the supply chain is to provide/structure a system for controlling the chemical substances included in the products of the firm. Although the optimal form of the control system will vary depending on the type of industry, industrial conditions, and details of the operations within the firm, these guidelines will serve as a reference when structuring management systems. (2) Declare Structure of the Management System There are the following two methods by which to indicate to external organizations, such as purchasers, that a system for managing chemical substances in products has been structured based on these guidelines. 11

13 1) Self-declaration of conformance 2) Be audited and obtain certification from an external organization (either a second party (an external organization with a direct interest) or a third party (an external organization without a direct interest)) Of these, there are many issues requiring research, such as globalization, when it comes to obtaining certification from a third party in particular, where it is anticipated that substantial time will elapse before globalization. Thus the JGPSSI favors the use of self-declaration of conformance to allow firms to begin participation as quickly as possible. The method of self-declaration of conformance uses the definition in the international standard for self-declaration of conformance (ISO/IEC , 2), and a portion thereof is quoted below: - When an individual or organization (supplier) that has the responsibility for fulfilling requirements makes a declaration that the product (or service), process, management system, individual, or organization complies with specific requirements. - The specific requirements include standard documentation such as standards, guides, technical specifications, laws, regulations, etc. This type of declaration of conformance can reference the results of evaluations by a first party (internal organization), a second party (interested external organization), or a third party (not interested external organization), or by more than one of the above. However, the reference cannot be interpreted as reducing the liability of the supplier in any way. Note that these guidelines provide only information to serve as a reference in structuring the system for managing chemical substances in products. The self-declaration of conformance for structuring the system based on these guidelines does not form a guarantee for commercial transactions between the two parties of the supplier and the purchaser. 4. Fundamental Approach to the Management of Chemical Substances in Products In order to use these guidelines, it is necessary to understand the management of chemical substances in products. The management of chemical substances in products will be explained by going through the process for a specific example Principles The management of chemical substances in products can be described as 1) the acquisition of content information for purchased materials (IN information), 2) the manufacture of products using those materials in a manufacturing process, and 3) the provision of content information for the products sold (OUT information). The management of these three processes 1), 2) and 3) must be performed throughout the entire supply chain. 1) Content Information for Products Purchased (IN): Obtain content information (IN information) for each substance/preparation and each article, and confirm the reliability of the content information. 2) Manufacturing Using a Manufacturing Process: Increase the reliability in the daily quality management activities, such as preventing the content of incorrect components and preventing contamination by substances/preparations or 12

14 articles that contain prohibited substances. 3) Content Information for Products Sold (OUT): Improve reliability by providing content information (OUT information) for each substance/preparation or article Structure of the Supply Chain Figure 2 shows the overall flow in the supply chain from the upstream companies (the materials manufacturers) to the downstream company (a set manufacturer) for the specific example provided by personal computers. Substances/ Preparations Raw materials (Chemical substances) Basic designed amounts Manufacturing Process Manufacturing/ Processing Amounts are fixed Articles Fixed included Component amounts Amounts included in components do not change Product Paints Pellets Additives F9 Molding process Printing process (Original component) MSDS Information MSDS Plus plus flow etc. Figure 2: Supply Chain Flow JGP files etc. 1) The further upstream the company, the more likely the products sold are substances or preparations, and the further downstream the company, the more likely the products sold are articles. 2) The further upstream the company, the more likely the products purchased are substances or preparations, and the further downstream the company, the more likely the products purchased are articles. 3) Between 1) and 2) are manufacturing processes that convert substances/preparations into articles. These are the original component manufacturing processes. <Discussion> As discussed in 1) through 3), the management in the upstream companies requires management of substances and preparations, where management in the downstream company requires management of articles in addition to management of substances and preparations. Note that the amounts of chemical substances contained are fixed in the manufacturing processes that convert substances/preparations into articles. 13

15 4.3. Characteristics of the Manufacturing Processes that Convert Substances/Preparations into Articles (Original Components) As explained in Section 4.2, there are manufacturing processes in the supply chain that convert substances and preparations into articles, and these manufacturing processes serve as a boundary between different management methods. The characteristics of the manufacturing processes that convert substances/preparations into articles are described below: 1) Because the articles are made out of substances and preparations, the amounts of contained chemical substances are fixed in these manufacturing processes. Consequently, these manufacturing processes are key points in the management of amounts of chemical substances in products. 2) These manufacturing processes are found even among the processes at the set manufacturers, such as soldering operations (because solder is a preparation). 3) In these manufacturing processes, the substances/preparations are purchased as raw materials, and so it is important to receive from the vendor correct inclusion information for any substances subject to management. Specific examples on how to obtain content information include the MSDS, Information Sheet on the Content of Certain Chemical Substances, JGP files (including Content Flag information), specifications, and the like. 4) The content amounts do not vary in the articles after manufacturing using these manufacturing processes. Consequently, there is an obligation to disclose to subsequent processes accurate inclusion data. (The JGPSSI system works by trusting responses and receiving accurate information.) As specific examples of disclosures of content information there are JGP files (including Content Flag information) and so forth. It is desirable to acquire this content information in order to assure greater accuracy of content information through obtaining both the Information Sheet on the Content of Certain Chemical Substances and the Content Flag information of the JGP files The Four Types of Manufacturing Processes The manufacturing companies involved in the supply chain come from a broad variety of industries, and each has its own manufacturing processes. As explained above, the pivotal point in managing the chemical substances in products is the manufacturing processes that purchase substances and preparations and convert them into articles. From this perspective, the unit of management should be the manufacturing process. For each of the manufacturing process units, there are the following four manufacturing processes, depending on the characteristics of the management. A specific example will be used in the explanation in order to facilitate understanding. * In the sections below, substance will be abbreviated as S, preparation will be abbreviated as P, and article will be abbreviated as A. The numbers following S, P, or A indicate the type of product. 14

16 1) Substance/Preparation Manufacturing Process (hereinafter S/P Manufacturing Process ) Example (1) Product Purchased Manufacturing Process Product Sold S1 S0 Refining * The production of a metal powder from ore through processes such as extraction and refining. This also applies to the production of any single substance from petroleum as a raw material, etc. Example (2) Product Purchased Manufacturing Process Product Sold S1 S0 P1 S2 Reaction S3 Mixing * Substances S1, S2, and S3 are purchased and a chemical product (P1) with a higher added value is produced. P1 is a preparation, such as ink or an adhesive. 2) Original Component Manufacturing Process Example (1) Product Purchased Manufacturing Process Product Sold S1 A1 P1 Hot Molding P2 * S1, P1, and P2 are purchased, and a product that is an original component (an article, A1) is produced through hot molding and curing. This applies to plastic cases, ceramic capacitors, etc. Example (2) Product Purchased a Manufacturing Process Product Sold S1 A00 S2 Molding/Sintering P1 Coating/Drying Product Purchased b A1 Article Assembly A2 * The Product (A00) is produced through purchasing S1, S2, and P1, and subjecting them to processes such as molding, sintering, coating, and drying, and then assembling purchased A1 and A2. This often applies to button capacitors and semiconductors, coated wires, coated metal plating, and components structured from so-called compound materials. Note: The purchased products a are often referred to as main raw materials, and the purchased products b, such as a terminal, are often referred to as secondary materials. (This is different from 3), below.) 15

17 3) Parts Manufacturing Process Product Purchased a Manufacturing Process Product Sold A01 A000 A02 A03 Article Assembly Product Purchased b Surface Painting, Soldering P1 * Articles (such as components) A01, A02, and A03 are purchased and assembled. Adhesive, display ink, etc. (P1) are purchased when assembling. Note: The purchased products a are often referred to as main raw materials, and the purchased products b, such as the display ink, are often referred to as secondary materials. (This is different from Example (2) in 2), above.) 4) Finished Goods Manufacturing Process Product Purchased a Manufacturing Process Product Sold A001 A0000 A002 A003 Equipment Assembly Product Purchased b Surface Painting, Soldering P1 * Fundamentally the same as 3), above. A001, A002, and A003 are parts manufactured in 3), above, and the products purchased b are secondary materials such as solder. Note: It has been explained that there are four manufacturing processes [1) S/P Manufacturing Process, 2) Original Component Manufacturing Process, 3) Parts Manufacturing Process, and 4) Finished Goods Manufacturing Process], however, do not make judgments based only on your in-house ordinary manufacturing processes. (Example: If a set manufacturer has a process in which substances/preparations are converted into articles, not only the Finished Goods Manufacturing Process but also the Original Component Manufacturing Process shall be covered for management. See 4.4 2) for details.) <Supplementary> Products include both substances/preparations and articles. JGPSSI s survey is based on the unit of product, however, it comprises two groups, one being substances/preparations, wherein the contained amounts change during the manufacturing processes, and articles, wherein the contained amounts do not change. For an article, because there are cases wherein the chemical substances cannot be specified, caution is required when handling these two different groups as a single group. 16

18 4.5. Classifications of the Manufacturer Name and Identification of the Manufacturing Processes (1) The respective manufacturing processes of the manufacturing companies in the supply chain shown in Section 4.2 were categorized into four different manufacturing processes : 1) the S/P Manufacturing Process, 2) the Original Component Manufacturing Process, 3) the Parts Manufacturing Process, and 4) the Finished Goods Manufacturing Process. (2) Each manufacturer has at least one of the four different manufacturing processes. (Companies such as trading companies that do not have their own manufacturing processes are categorized by the products they sell.) (3) The relationships described above are summarized in Table 2. However, there are times when, at the discretion of the company, the frameworks can be viewed as encompassing all companies in an industrial group, or may be looked at in terms of an outsourcing vendor or a factory as the unit of analysis, or may be looked at with the Manufacturing Department as the unit of analysis. Moreover, the, and characters in the figure below indicate specific examples, and are provided as a reference with the understanding that there may be differences depending on the product of the firm. 17

19 Table 2: The Manufacturing Process Unit Manufacturer Name Class Manufacturing Process ificati on Materials/chemical product manufacturers Original component manufacturers Parts manufacturers Set manufacturers Examples of the Processes S/P manufacturing process Refining, chemical substance manufacturing, chemical substance mixing S/P manufacturing process Original component manufacturing process S/P manufacturing process Original component manufacturing process Parts manufacturing process S/P manufacturing process Original component manufacturing process Parts manufacturing process Finished goods manufacturing process Chemical substance manufacturing, chemical substance mixing Molding, sintering, coating, drying, soldering, electroplating Chemical substance mixing Molding, painting, soldering Article/component assembly Chemical substance mixing Molding, painting, soldering Article/component assembly Equipment assembly : Requires substance/preparation management : Requires article management : Requires both substance/preparation management (on the purchasing side) and article management (on the sales side) : Critical process for determining the contained amounts <Discussion> If it is possible to check the manufacturing processes possessed by the firm, all of the manufacturing processes that are owned by the firm are subject to management of the chemical substances in products Importance of Management Focusing on the Unit Process The manufacturing processes described in Section 4.4 are those having to do with purchasing, manufacturing, and sales processes, and these are positioned as the unit processes for management. (1) Because the management methods are different for substances/preparations and articles, there are a total of six processes that are termed unit processes : The purchasing, manufacturing, and sales for substances/preparations, and purchasing, manufacturing, and sales for articles. (2) For specific management of chemical substances included in products, it is rational to select management methods based on these six unit processes for each of the four manufacturing processes. 18

20 (3) For the six unit processes for each of the four manufacturing processes, described above, actually check, referencing Figure 3 in page 21, the applicability of the unit processes to the manufacturing processes subject to management within the firm. It is also necessary to control each of the individual chemical substances in firms that have multiple manufacturing processes and unit processes Frameworks Focusing on Manufacturing Processes and Unit Processes Section 4.6 explained that it is rational to establish management methods based on the six unit processes for each of the four manufacturing processes. The items that must be controlled for the management of the included chemical substances, performed for each of the six unit processes, are known as the frameworks. Moreover, those items that are the same for all six frameworks (policies, objectives, etc.) comprise the common management framework. I [Substance/Preparation Purchasing] II [Substance/Preparation Manufacturing] III [Substance/Preparation Sales] IV [Article Purchasing] V [Article Manufacturing] VI [Article Sales] VII [Common Management Framework] The items in the parentheses, above, are unit processes. (1) Considering the above, checks should be performed as to which of the frameworks that should be managed actually apply to the company. The method of checking is that the frameworks in the company are the I through VII beneath the intersections of the four manufacturing processes and the six unit processes in Figure 3, page 21. In organizations wherein there are multiple manufacturing processes and unit processes, it will be necessary to manage multiple frameworks. For example, if in the organization the manufacturing process is article manufacturing and the unit processes are purchasing and manufacturing of substances/preparations, and purchase of articles, then the frameworks will be I, II, VI, and VII. (It is necessary to control multiple frameworks when there are multiple manufacturing processes, just as it is in the unit process example above.) Note that these guidelines also cover companies without manufacturing processes, such as sales companies, importers, and distributors, incorporated with organizations that purchase or sell substances, preparations or articles. Also, for organizations without manufacturing processes that perform designing process only, the management of designing is covered by these guidelines, when such designing involves the six unit processes described above. <Discussion> If management methods are established combining the six unit processes of I [Substance/Preparation Purchasing] through VI [Article Sales], with V [Common Management Framework], then the method of managing chemical substances in products will be defined clearly for the entire supply chain. With regard to sales companies and importers who do not have manufacturing processes, it is desirable that manufacturers of relevant products communicate these guidelines to 19

21 them and instruct them so that they may be able to carry out activities in accordance with these guidelines. Also, sales companies and importers are required to know the management status of the manufacturers who sell products through collecting information from them regarding compliance with these guidelines, etc. Substances/Preparations Articles Purchasing Manufacturing Sales Purchasing Manufacturing Sales S/P Manufacturing Process Materials/Chemical Products Purchasing Materials/Chemical Products Manufacturing Unit Processes Materials/Chemical Products Sales Original Component Manufacturing Process Parts Manufacturing Process Manufacturing Processes Materials/Chemical Products Purchasing Original Component Manufacturing (Conversion of substances/preparations into articles) Original Component Purchasing Parts Assembly Original Component Sales Parts Sales Finished Goods Manufacturing Process Parts Purchasing Parts Assembly Products Sales Frameworks I II III IV V VI Key Points in Management 1) Obtain the MSDS 2) Exchange of specifications 1) Process management 2) Prevention of contamination/ mixing 3) Understanding of change in composition 1) Obtain the MSDS 2) Exchange of specifications 3) Provision of information that there is no inclusion 1) Obtain JGPSSI data and other data 2) Confirm receipt Common Management Framework: VII 1) By-lot management 2) Prevention of inclusion of incorrect components 1) Provision of JGPSSI data and other inclusion data Figure 3: Manufacturing Processes, Unit Processes, and Frameworks <Supplementary> Based on Figure 3, how to determine frameworks of a company is explained below, using a specific example: The company has a manufacturing process in which electronic parts are soldered to printed circuit boards after purchasing printed circuit boards, electronic parts such as capacitors, and solders. Solders: Because electronic parts are soldered to printed circuit boards, there is a process of Materials/Chemical Products Purchasing of the Original Component Manufacturing Process (framework I. Framework omitted hereafter), and Original Component Manufacturing of the Original Component Manufacturing Process (II) is also applied. Electronic parts and printed circuit boards: Original Component Purchasing, Parts Assembly, and Products Sales (includes cases where the parts are handed over to the next process) of the Parts Manufacturing Process (IV, V, VI respectively) are applied. In the example above, frameworks I, II, IV, V, VI, and the Common Management Framework VII must be covered in the management. Also, in addition to soldering, when display inks and adhesives are incorporated into the equipment (articles) after 20

22 hardening them in the manufacturing processes, it is important to correctly acknowledge that these are the Original Component Manufacturing Process (conversion process into articles). 5. The Action Item List & Check Sheet The Action Item List summaraizes what is actually to be performed in the seven frameworks (I through VII) explained in Section 4.7. Also, based on the Action Item List, the Check Sheet evaluates whether the systems for managing chemical substances in products are properly constructed and operated within companies that implement these guidelines. The Action Item List & Check Sheet (Annex 1) incorporates the Action Item List and the Check Sheet. In the Action Item List, the action items picked up from among the action frameworks I through VII have been organized and described using PDCA in order to make the action items easily understood. Note that PDCA refers to the act of ongoing improvement through performing a cycle of planning (P: establishing policies and plans), doing (D: implementing the plans and performing the operations), checking (C: evaluating and improving performance) and taking action (A: Performing a management review). In order to satisfy the Action Details in the Action Item List, creating systems (rules) and actually implementing (operating) them are both required. Each item in the Action Item List is explained below: Action Items : These list the items that are required for managing the chemical substances in products and comprise the five major items of 1. Establishing guidelines for the management of chemical substances in products through 5. Management Review, where these five major items are divided into 18 minor items. Action Details : The Action Details describe, for each Action Item, specifically what the Action Item is to accomplish. Although it is important to have shared terminology throughout the entire supply chain, there may be cases where the words used do not communicate in a specific industry. In such cases, Action Details should be performed according to the line of business of the relevant company based on an understanding of the intent of the Additional Explanations or Required Level, and on an understanding of the degree to which the Action Item is to be performed. However, note that Action Details that do not apply to the firm need not be fulfilled. For example, if there is no design functionality (department) in the firm, then the Action Details in 3-1-1: Design/Development of the Action Item List is deemed not applicable. Required Level : To further clarify the meaning of the Action Details, the Required Level describe the degree to which the Action Items must be performed in a more specific manner, demanding for important common requirements throughout the entire supply chain. There may be cases where some requirements do not apply to your company, or some requirements that are important to your company are not included or are inadequate. In such cases, on reading 21

23 Additional Explanations or examples specified in the relevant Required Level column, change the expressions (terms, words, etc.) into similar expressions used in your company in order that you may be able to carefully determine such descriptions are applicable to your company and ensure that management is not lacking. 6. Evaluation Criteria (1) Determination of Frameworks Applicable to Your Unit Processes Based on the Required Level in the Action Item List, select from management frameworks I through VII that are applicable to your company s unit processes. If none of the frameworks are applicable, clarify the reasons. (2) Evaluation for Each Action Item Regarding whether the systems for managing chemical substances in products are properly constructed and operated, evalution is carried out for each Action Item and Action Details according to the following four levels based on the Required Level. Conforming: When there are both appropriate systems (rules) for fulfilling the Required Level and activities (implementation) based on the systems (rules), then it is deemed Conforming. The results of systems (rules) and activities (implementation) must be verfied objectively either through documentation or records. Requires : When there are appropriate systems (rules) for fulfilling the Required Level but the activities (implementation) are insufficient or partially performed, or when activities (implementation) for fulfilling the Required Level are performed but the systems (rules) are insufficient or partially stipulated, then it is deemed Requires. The results of systems (rules) and activities (implementation) must be verfied objectively either through documentation or records. : It is deemed when one of the following applies: 1) There are systems (rules) for fulfilling the Required Level (including cases where they are partially inappropriate) but activities (implementation) based on the rules are not performed. 2) Activities (implementation) based on Action Details are performed (including cases where they are partially inappropriate) but there are no systems (rules). 3) There are systems (rules) and activities (implementation) are performed but both of them are partially insufficient. : When the Required Level does not apply to management within the company, then it is deemed 22