azbil Group Guidelines for the Establishment of a Chemical Substances Management System For Suppliers Third Edition: March, 2015 AGS-541A-006 Appendix Document 2 Rev. 3
Table of Contents 1. THE AZBIL GROUP S POSITION ON CHEMICAL SUBSTANCE MANAGEMENT... 1 1.1 PURPOSE OF ESTABLISHING GUIDELINES... 1 1.2 SCOPE OF THE GUIDELINES... 1 2. CMS PARTS CERTIFICATION SCHEME... 2 3. PROCEDURE FOR ESTABLISHING A CMS... 3 3.1 CONCLUSION OF THE MEMORANDUM OF UNDERSTANDING... 4 3.2 SELECTION OF CMS CERTIFICATION METHOD... 4 3.4 SUBMISSION OF CMS SUPPLIER SURVEY SHEET... 5 3.5 QC PROCESS CHART... 5 3.6 CERTIFICATE OF NON-USE OF MATERIALS... 5 3.7 CMS SELF-EVALUATION... 6 3.8 CERTIFICATE OF NON-USE OF ARTICLES TO BE DELIVERED... 6 3.9 AUDIT BY THE AZBIL GROUP... 6 3.10 CMS CERTIFICATION... 6 4. CMS OPERATION... 6 4.1 OPERATION OF A CMS... 6 4.2 RE-CERTIFICATION AUDIT... 7 5. ACTION ITEMS FOR ESTABLISHMENT AND OPERATION OF A CMS... 8 6. DETAILED ACTION ITEMS FOR ESTABLISHMENT AND OPERATION OF A CMS... 10 7. DOCUMENTS NECESSARY FOR CERTIFICATION... 17 8. SUBMISSION OF CERTIFICATE OF NON-USE OF SUBSTANCES IN ITEMS DELIVERED 18 9. CHEMICAL SUBSTANCES DESIGNATED BY THE AZBIL GROUP AND REGULATORY REQUIREMENTS... 19 10. CHANGES IN CHEMICAL SUBSTANCES DURING MANUFACTURING DUE TO CHEMICAL REACTIONS, ETC.... 19 11. PROHIBITED CHEMICAL SUBSTANCES IN MANUFACTURING PROCESSES... 20 12. FORMS... 20 AGS-541A-006 Attachment 2 Rev.3
1. The azbil Group s position on chemical substance management 1.1 Purpose of establishing guidelines The purpose of establishing these guidelines is to define the basic policy and specific activities to be implemented by our business partners to provide assurance regarding the chemical substances contained in our products, to ensure compliance with the laws and regulations of Japan and other countries and to prevent noncompliance caused by inclusion of prohibited substances. Like many other companies, the azbil Group has established a method of certification based on its own chemical substances management system (CMS), and grants certification under this system. In addition, all suppliers are required to read the azbil Group Green Procurement Standard (AGS-541A-006, Attachment 1), which describes the azbil Group s procurement criteria and related terms and definitions, before reading the present document. 1.2 Scope of the guidelines These guidelines apply to the materials (products, parts, subsidiary materials, auxiliary materials, and raw materials) subject to CMS management. An azbil Group procurement department will notify suppliers of the materials that are subject to CMS management. The guidelines do not apply to materials that are not subject to CMS management. With regard to products subject to CMS management within the azbil Group in the future, the Group will shift to procure CMS-compliant materials provided by suppliers who have obtained azbil Group CMS certification or another company s certification that has been approved by the azbil Group, in order to deliver products conforming to market demand that do not include harmful chemical substances. Handling of subsidiary materials, auxiliary materials and raw materials: For subsidiary materials, auxiliary materials and raw materials, which are generally available, suppliers are required only to sign a Agreement on Chemical Substances Contained in Procured Products (Form 3) and submit the Certificate of Non-Use of Chemical Substances in Products for azbil Group (Form 9). For the definition of subsidiary material and auxiliary material, refer to section 2, Terms and Definitions, in azbil Group Green Procurement Standard (AGS-541A-006, Attachment 1). 1
2. CMS parts certification system The azbil Group provides CMS certification for each material (product, part, raw material) to be delivered to the Group. However, please note that the process and system pertaining to the companies, factories and processes for manufacturing the materials that are covered should be included in the certification conditions. The suppliers are required to give notification of any change not only to the materials to be produced but also to the processes related to material production, and to be recertified. Concept of CMS certification Supplier Environmental activities / CMS operation system Certification Supplier s factory Management to prevent admixture of prohibited chemical substances Certification CMS certified manufacturing line Process to prevent admixture and contamination of prohibited substances CMS certified products Certification Raw materials that do not contain prohibited substances Certification Example of required re-certification Auditing of the production line for a product can be omitted if the line is already CMS-certified because it produces another CMS material. Supplier Certification Supplier Factory A Supplier Factory B Certification CMS certified manufacturing line CMS certified products Manufacturing line Certification Certification Production transfer Change of factory requires CMS re-certification 2
3. Procedure for establishing a CMS The procedure for suppliers establishing a chemical substances management system is shown below. Use of another company s certification Notification from azbil Group of materials subject to CMS Contact persons for the azbil Group and supplier are determined Start of CMS certification program Use of azbil CMS certification Submitted only in case of initial certification Memorandum of understanding on chemical sbustances in materials delivered to the azbil Group (Form 3) Application for use of another company s certification (Form 8) Submission of form Notification of approval of other company s certification Use of other company s CMS certification for probihited substances Obtaining of certificate of non-use of substances in raw materials, auxiliary materials, parts, etc. from manufacturers CMS certification method selected CMS establishment and operation Supplier Survey Sheet created Receipt of certificate of non-use for raw materials, auxiliary materials, etc., from their suppliers Identify processes where admixture and contamination can occur Submission of form Submission of form (See Note 1) Supplier Survey Sheet (Form 4) QC process chart Note 1: If the azbil guidelines are used for the establishment of the CMS, the supplier creates and maintains the documents required to assure non-use of prohibited chemical substances in parts (the Supplier Survey Sheet, Certificate of non-use of prohibited chemical substances in materials, QC process chart, etc.) These documents are subject to review during the azbil Group s audit. Approved CMS self-evaluation Declaration of non-use Document audit or on-site audit by azbil Group CMS certification Submission of form Submission of form CMS audit checklists (Forms 5 7) (Refer to 3.7) Certificate of non-use of chemical substances in products (Form 9) Note: In case of use of another company s certification, the document audit may often be conducted. CMS self-evaluation Submission of form CMS audit checklists (Forms 5 7) Internal audit (every year) CMS self-evaluation Submission of form Re-certification audit (every 2 yeras) CMS audit checklists (Forms 5 7) Document audit or on-site audit by azbil Group Use of other company s certification for re-certification Application for use of other company s certification (Form 8) 3
The following section explains the procedure for establishing a CMS and steps for CMS certification. Suppliers implement the procedure below after receiving notification of the items subject to CMS management. 3.1 Conclusion of the memorandum of understanding First, the supplier must submit the Agreement on Chemical Substances Contained in Procured Products (Form 3) in order to obtain CMS certification based on the azbil Group s guidelines. This memorandum is to be signed on a business-to-business basis, and therefore, even if a company has several sites (factories and/or business facilities) and delivers parts subject to CMS management during different periods, only one memorandum is necessary. Also, suppliers whose process for manufacturing the materials subject to CMS management has already been certified by another company may be given our Group s CMS certification based on their current certification status. Please contact an azbil Group procurement department. 3.2 Selection of CMS certification method The supplier shall choose either of the following CMS certification methods. Use of prior certification by another company Use of azbil CMS certification (1) Use of prior certification by another company If the supplier has already obtained chemical substances management certification from another company and if the azbil Group recognizes that certification, the azbil Group can grant the CMS certification without implementing some parts of the procedure, since it considers the supplier s CMS to already be in place. However, even when the supplier s system has been certified by another company, if the certified production line is not the line for the CMS materials delivered to the azbil Group, the certification cannot be recognized as valid for azbil Group CMS certification. The supplier will need CMS certification for the additional location. For details, contact an azbil Group procurement department. To use another company s certification in place of azbil Group CMS certification, the supplier fills in all of the necessary items on the Application form for use of another company s certification for azbil Group Chemical Substances Management System Establishment (Form 8; hereinafter referred to as the other company s certification application form) and submits the application. The materials to be delivered from each site must be specified on the form. To obtain CMS certification using another company s certification for another part that in addition to those subject to CMS management, the supplier submits the completed form for the other company s certification for the added part. (2) Use of azbil CMS certification scheme The supplier establishes the CMS in accordance with these guidelines. 4
3.3 Establishment of a CMS Under the CMS, the supplier manages (controls) the restricted chemical substances on production lines for parts that are subject to CMS. The establishment and operation of this CMS is in compliance with Guidelines for the Management of Chemical Substances in Products, Ver. 2, by the Japan Green Procurement Survey Standardization Initiative (JGPSSI). The present document is viewed as a subset of the JGPSSI guidelines, and suppliers are required to implement item 3, Operation & Management, in section 5 of those guidelines. For specifics, refer to section 5 and section 6 below. The purpose of the CMS is to manage the distribution of all the materials necessary for manufacturing products (raw materials, subsidiary materials, parts, etc.), confirm that the identified materials satisfy the control limits of the CMS chemical substances, and ensure the use of compliant materials rather than noncompliant materials. This management of chemical substances enables us to observe the regulations for restricted chemical substances. In addition, confirmation and management are required for any change of chemical substances (for example, a change in concentration caused by solder dissolution or solidification). Therefore, we can also say that the establishment of CMS provides a system for managing and maintaining the CMS. For changes in chemical substances, refer to section10, Changes in chemical substances during manufacturing due to chemical reactions, etc. 3.4 Submission of CMS Supplier Survey Sheet The azbil Group CMS Suppliers Survey Sheet (Form 4) is the basis of CMS certification. This supplier survey sheet is a document required for identification of the distribution of materials delivered from the supplier to the azbil Group and raw materials, subsidiary materials, and parts, etc., for manufacturing those materials. The commercial distribution needs to be identified for the purpose of preventing logistical errors in the procurement process, and it is also required in order to understand the relevant processes (soldering, plating, plastic molding, etc.) and take appropriate actions where there could be admixture of a regulated chemical substance. Therefore, this survey is highly important as the basis for CMS establishment and CMS management. 3.5 QC process chart The QC process chart is a diagram outlining what is manufactured and how it is managed for the purpose of management of the process. When drawn in accordance with JIS Z 8206, the flow chart can be used for general purposes. In addition, under ISO 9001: 2000 (JIS Q 9001: 2000), creation of QC process charts (or tables) is required in section 7.1, Planning of product realization, 7.5.1, Control of production and service provision, and 8.2.3, Monitoring and measurement of processes. Any format for the QC process chart required by the CMS is acceptable as long as it complies with the above JIS or ISO standard (ISO 9001: 2000 (JIS Q 9001: 2000). Regardless of format, it is necessary to specify the manufacturers product IDs for the raw materials specified on the azbil Group CMS Supplier Survey Sheet (Form 4) on the flow chart so that the supplier can use only the specified raw materials, not materials that have yet to be surveyed (for which the certificate of non-use of materials is yet to be obtained). 3.6 Certificate of non-use of materials The supplier must obtain evidence that the CMS materials procured by the supplier satisfy the required criteria for CMS chemical substances from the material manufacturers named on the Supplier Survey Sheet, as specified in the Certificate of Non-Use of Chemical Substances in Products for azbil Group (Form 9). Any format of evidence from the material manufacturers is acceptable as long as it is at least equivalent to the Certificate of Non-Use of Chemical Substances in Products for azbil Group (Form 9). A supplier that cannot obtain such evidence should contact the 5
procurement department. 3.7 CMS self-evaluation The CMS self-evaluation is the basis for establishing, operating, and maintaining a CMS. CMS certification aims for the establishment and operation of a product chemical substances assurance system in suppliers factories to prevent noncompliance (inclusion of prohibited chemical substances in materials delivered to the azbil Group), as defined in the statement of the purpose of these guidelines. Like ISO 9001, ISO 14001, etc., the CMS self-evaluation checks that the PDCA cycle of activities to assure the status of chemical substances in products is running on a regular basis with the aim of making improvements. The CMS self-evaluation can also function as an internal audit in ISO 9001, etc. The azbil Group in principle conducts the initial audit for the supplier s CMS certification, visiting the supplier s manufacturing site, and after the initial audit, the supplier is to conduct a CMS self-evaluation to check its PDCA cycle periodically. Therefore, suppliers must understand that the CMS self-evaluation is important as the main method of checking the status assurance activities for chemical substances and also as a key part of running the PDCA cycle. The forms used for the self-evaluation are the azbil Group CMS Supplier Audit Report (Form 5), azbil Group CMS Audit Checklist (Form 6), and if the supplier has any corrective action, azbil Group CMS Audit Findings and Corrective Action Report (Form 7). 3.8 Certificate of non-use of articles to be delivered Once all the CMS documents required for 3.1 through 3.7 are prepared for submission, the supplier submits the Certificate of Non-Use of Chemical Substances in Products for azbil Group (Form 9). For the conditions of submission and the purpose of this document, refer to section 8, Submission of Certificate of non-use of substances in items delivered. There are some cases where the supplier cannot complete all the corrective actions for the self-evaluation because time is required to establish the procedures and prepare the necessary documents. In such cases, the supplier should define an action plan and planned date of completion so that it can receive a CMS audit as the next step. For details, contact the azbil Group. 3.9 Audit by the azbil Group As explained in the section on CMS self-evaluation, the azbil Group conducts the CMS audit, which is equivalent to external certification audits such as for ISO 9001, in order to check all of the supplier s manufacturing processes in each target site subject to CMS management (factories and business facilities). In so doing our intent is to identify items that have been overlooked in the self-evaluation by conducting a review from the viewpoint of an outsider, in order to help the supplier to improve the quality of its processes for chemical substances. Therefore, the Group considers this audit as the basis of CMS certification, as it benefits both parties. 3.10 CMS certification Once the necessary documents for the CMS certification are prepared and approved by the certification committee, notification of CMS certification is given to the supplier. Certification is granted on a site basis, and a list of CMS certified items is sent at the same time. The materials (mainly parts and products) described in this list of CMS-certified articles are subject to CMS management. When any material is added to the certified materials list, the list is revised. 4. CMS operation This section explains the items required for operating and maintaining an established CMS. 4.1 Operation of a CMS The requirements are the same as given in section 3.3, Establishment of a CMS. For details, refer 6
to sections 5 and 6. Special instructions regarding operation are as follows. (1) Change management The basis of CMS certification is the CMS Supplier Survey Sheet that is submitted by the supplier at the time of application. Therefore, if a raw material or part that is used must be changed, the supplier must make an application for the change in advance. This requirement applies to any change in the supplier s production line or factory that requires auditing by the azbil Group. (2) Handling of noncompliance If any case of noncompliance occurs in a CMS-certified item delivered contrary to the control criteria for CMS chemical substances, the supplier is required to specify the lot number for the item, prevent its shipment, prevent reoccurrence of the noncompliance, and promptly report the matter to the procurement department. 4.2 Re-certification audit CMS re-certification is conducted once every 2 years. Re-certification is conducted in the form of a document audit if the supplier submits a self-evaluation every year. For the self-evaluation, refer to section 3.7, CMS self-evaluation. If any noncompliance arises in the acceptance inspection at the time of receiving the items delivered, the azbil Group may impose supplementary conditions and/or audits. [1] Submission of CMS self-evaluation (every year) [2] Re-certification audit for CMS certification by the azbil Group (once every 2 years) In order to maintain CMS certification, the supplier must receive the re-certification audit (once every 2 years) before the certification expires. 7
5. Action items for establishment and operation of a CMS When establishing the CMS, the processes required for manufacturing the target products and the sections that design and develop products should be included in its scope. The action items described below are those defined in Guidelines for the Management of Chemical Substances in Products by JGPSSI. Refer to section 6 below, Detailed action items for establishment and operation of a CMS. The numbers in [ ] below are the numbers of the action items in Guidelines for the Management of Chemical Substances in Products by JGPSSI. For the definition of terms, please refer to that document. 5.1 Definition of management criteria [2.1] Management criteria to be followed shall be clarified based on legislation and industry criteria related to management of chemical substances in products, and conveyed to the relevant corporate units. 5.2 Definition of management criteria [2.2] Organizations, business, chemical substances, accompanying materials, processes, products, etc., must be clarified as the scope of application of management criteria for chemical substances in products. 5.3 Establishment of organizational system, responsibility & authority [2.4] Responsibilities and authorities for management of chemical substances in products must be specified. 5.4 Design and development [3.1] (Note: If the product to be delivered is designed by the supplier, the design and development section must also be included in the scope.) Design for manufacturing of substances/preparations Design for manufacture of articles using substances/preparations Design for manufacture of articles using articles The conditions in each manufacturing process must be understood and product compliance with the management criteria must be confirmed. 5.5 Purchasing management [3.2] (1) Information regarding chemical substances in purchased products must be acquired. Verification that the necessary details are present and that they are compatible with the management criteria is also necessary. For new products and changed products, acquisition and verification of information regarding chemical substances in products in accordance with the management criteria must be complete prior to commencing mass production. (2) When a new supplier is selected, the status of management of chemical substances in the supplier s products must be verified. When continuing with an existing supplier, reconfirmation is conducted as necessary. Measures for results of the verification shall be fixed. Supplied items requiring verification, as well as criteria, frequency, methods, etc., may be set in relation to risk level. 5.6 Acceptance verification [3.3] When purchased products are received, they must be verified as compatible with the supplier s management system criteria. Items requiring verification, criteria, methods, frequency, etc., may be set in relation to the risk level of the purchased products. 5.7 Process management [3.4] (1) Measures to prevent incorrect use, admixture and contamination of chemical substances subject to management must be implemented. (2) Management must ensure that residues do not remain, or are not created, when the management criteria for chemical substances subject to management are exceeded, due to changes in constitution and concentration. 8
(3) Any sub-contracted manufacturer is required to manage the processes necessary for sub-contracted manufacturing. Also, the status of management of the sub-contracted manufacturers must be verified on a regular basis. 5.8 Shipping verification Products cannot be shipped until after verification that all specified items have been checked, including checks done during acceptance and during a process. 5.9 Traceability [3.6] Product traceability must be reliable. 5.10 Action items for change control [3.7] Rules for control of changes in management of chemical substances in products must be determined, and the following details made clear. (1) Elemental changes having possible effects on chemical substances in products. Changes and additions in suppliers, changes in purchased items, and changes in processes and so on (including changes not only in the company such as manufacturing conditions, production facilities, molds, and jigs, but also changes in suppliers, sub-contractors, etc.). (2) Company internal and external procedures. Details to be verified, means of verification, approval processes, etc. (3) Records, notification, identification information, etc., about changes in methods of transmitting information inside and outside the company. 5.11 Action items for dealing with noncompliance [3.8] Rules for measures to deal with noncompliant products (emergency measures, determination of causes, prevention of reoccurrence, sharing of information, etc.) shall be determined. 5.12 Training [4.1] Details of the training required for the management of chemical substances in products, and the personnel to be trained, must be identified and training implemented. 5.13 Management of documentation and records [4.2] Rules relating to the management of chemical substances in products must be documented, maintained, and managed. Also, records of the results of operation must be kept and stored appropriately. The above are the basic requirements. Some stricter requirements may apply to particular suppliers using prohibited chemical substances, depending on the product. In addition, the requirements for the azbil Group chemical substances management system are the minimum necessary for the chemical substances management system, and it is recommended that each supplier establish the most appropriate chemical substances management system for itself, in accordance with the characteristics of its products, by satisfying all the points defined in Guidelines for the Management of Chemical Substances in Products by JGPSSI. 9
6. Detailed action items for establishment and operation of a CMS Details regarding action items are given below. To implement these action items, the supplier must have a good understanding of the detailed explanations and action items applicable to the supplier s business type. The numbers in [ ] shown below are the numbers of the action items defined in JGPSSI s Guidelines for the Management of Chemical Substances in Products. Table 1. Detailed action items Action items Action details Additional explanations/notes 1 [2.1] Definition of management criteria 2 [2.2] Definition of scope of management 3 [2.4] Establishment of organizational system, responsibility & authority 4 [3.1] Design and development Management criteria to be followed shall be clarified based on legislation and industry criteria relating to management of chemical substances in products, and conveyed to related corporate units. Organizations, business, chemical substances, constituent materials, processes and products, etc. shall be clarified as the scope of application of management criteria for chemical substances in products. Responsibilities and authorities for management of chemical substances in products shall be clarified. (1) Legislation means legislation that must be followed by the customer. (2) Industry criteria are voluntary criteria determined by the industry. (3) Maintenance and management of information relating to the most recent legislation and industry criteria is important. (4) It is important to verify that information transmitted to related corporate units is understood and is translated into the necessary action. (5) With sub-contracted manufacture, too, it is important to understand the legislation to be followed and to clarify company management criteria. (1) Constituent materials refer to raw materials, parts, and subsidiary materials comprising the product. (2) In some cases, management of information on chemical substances in products (OUT information) is concentrated upstream in the supply chain, and measures suited to the nature of the manufacturing process are necessary. (3) Processes also include sub-contractors and original equipment manufacturers. (4) The scope of application may differ depending on the legislation. For example, products may be exported, or they may be limited to the domestic market. (1) A number of methods are available for classification, e.g., rules for chemical substances in products and organization charts. (2) It is important to clarify the scope of responsibilities and authorities for sub-contractors and original equipment manufacturers as well. (3) After the scope of management is clarified and target organizations are determined, it is important to identify the information necessary for management of chemical substances in products, and to convey and share that information in the organizations. 10
[3.1.1] Design for manufacture of substances/ preparations [3.1.2] Design for manufacture of articles using substances/preparations [3.1.3] Design for manufacture of articles using articles When manufacturing substances/preparations, information regarding chemical substances in raw materials shall be verified, and products and manufacturing processes shall be designed to satisfy management criteria. Specify specifications of purchased products if necessary. (1) When constituent materials are selected not only by the design section, but also by the company, a design function is implied, and this action item is Applicable. (2) Included content (upper limit values) for managed chemical substances are determined from legislation and industry criteria relating to products subject to management. (3) Purchasing and procurement conditions, manufacturing processes, manufacturing conditions, inspection and shipping conditions, etc., are determined so as to satisfy management criteria for the product, and in consideration of chemical substances in raw materials and subsidiary materials, as well as chemical substances added, created, and removed in processes. (4) Manufacturing conditions include prevention of incorrect use, admixture, and contamination, as well as appropriate management of reaction processes. (5) It is important to verify at each stage (e.g. testing, prototype manufacture, and mass production) in the design and development stage. (6) The results of design and development are shown in specifications, drawings, manufacturing specifications, work specifications, and manuals, etc. (7) When constituent materials are designated by the customer, specifications and management criteria, etc. are determined in discussions with the customer. (8) Use of MSDS and MSDSplus, etc. is recommended for verification of information on chemical substances in substances/preparation. When manufacturing articles from (1) Surface processes such as plastics molding, plating, painting, and printing, and fusion substances/preparations, information processes such as soldering and gluing, are examples of the manufacture of articles from on chemical substances in raw substances/preparations. In the case of gluing, for example, there is a possibility that materials shall be verified. Any changes may occur in the concentration and type of chemical substances contained, and possible changes in concentration and care is therefore required. type of contained chemical substances (2) In many cases, a process is conducted simultaneously with the process of manufacture of in processes shall be understood. a new article from an existing article, and care is required to ensure that action items Furthermore, the product shall be (3.1.3) relating to design and development are not missed. verified as conforming to the (3) When manufactured articles are supplementary to substances/preparations, it is important management criteria. to verify information regarding chemical substances contained in those substances/preparations (e.g. coolant, grease, lubricating oil, rust preventive oil). (4) Refer to 3.1.1 (1) (8). When manufacturing new articles from existing articles, information regarding chemical substances in articles (e.g. parts), and compliance of the product with the management criteria, shall be verified. (1) Processes such as assembly of parts, and machining of plastic and metal original components, are examples of the manufacture of new articles from existing articles. (2) When gluing and soldering, etc., articles are manufactured simultaneously using substances/preparations, and care is required to ensure that action items (3.1.2) relating to design and development for the same process are not missed. (3) The use of methods for transmission of information such as the AIS and JGP files, or the JAMA/JAPIA integrated data sheet, is recommended for verification of information regarding chemical substances in articles. (4) Refer to 3.1.1 (1) (7). Not including responses relating to chemical reactions. (5) Refer to 3.1.2 (3). 11
5 [3.2] Purchase management [3.2.1] Verification and acquisition of chemical substances in products information [3.2.2] Verification of supplier management status 6 [3.3] Acceptance verification Information regarding the chemical (1) Information regarding chemical substances in products covers inclusion or exclusion in substances in purchased products (IN substances subject to management, the contained amount, concentration, and use, etc. information) shall be acquired and (2) When the purchased product is a substance/preparation, MSDS and MSDSplus, etc. are verified that it contains the necessary available as means of obtaining information regarding the chemical substances details, as well as that it is compatible contained. with the management criteria. For new (3) When the purchased product is an article, AIS and JGP files, or the JAMA/JAPIA products and changed products, integrated data sheet, are available as means of obtaining information regarding the acquisition and verification of chemical substances contained. information regarding chemical (4) Since substances subject to management may vary with use, it is desirable that the other substances in products in accordance party be informed of use when making inquiries. with the management criteria shall be (5) The CAS number, or names, numbers, and symbols, etc. are used in identification of complete prior to commencing mass substances subject to management. production. When selecting a new supplier, the (1) Evaluation of the supplier risk level is based on acquired content information, the status of management of chemical possibility of unintended inclusion (presence or absence of reaction processes, parallel substances in the supplier s products production, constituent materials, etc.), the status of compatibility with these guidelines, shall be verified. When continuing with the presence or absence of an environmental/quality management system, and past an existing supplier, reconfirmation performance, etc. shall be conducted as necessary. (2) Verification of the status of management of chemical substances in products is based on Measures for verification results shall documentation and visits, etc. be fixed. Supplier items to be verified, (3) Examples of measures to deal with results of verification are acceptance, continuing criteria, frequency, and method, etc. transactions, requests for improvement, guidance, and discontinuing transactions. may be set in relation to risk level. When accepting purchased products, such products shall be verified as compatible with company management criteria. Items to be verified, criteria, method, and frequency, etc. may be selected in relation to the risk level of the purchased products. (1) It is important that company acceptance procedures are clarified in response to risk in management of chemical substances in products. (2) Risk level for purchased products must be evaluated in terms of such factors as the degree of possibility of inclusion in chemical substances subject to management, supplier management level, past performance, and whether or not the purchased product is made from recycled materials. (3) Examples of items that can be clarified with acceptance procedures: a) Method of evaluation (comparison of actual items and information, measurement by company as necessary, etc.) b) Method of recording evaluation results c) Method of managing identification (4) When purchasing from multiple companies (multi-sourcing), it is necessary to implement methods of verification considering the risk of each supplier. 12
7 [3.4] Process management [3.4.1] Preventing incorrect use, admixture, and contamination Implementation of measures to prevent (1) In practice, it is possible to separate processes, and equipment and jigs, etc., into those incorrect use, admixture and requiring priority management and others. Processes requiring priority management are contamination of chemical substances those in which chemical substances having management criteria are used, and it is shall be subject to management. important to manage these separately from other general processes. If processes requiring priority management are not separated, thorough identification and appropriate procedures for changeover are required. (2) In processes requiring priority management, it is important that this be extended to storage of materials, semi-finished products, and finished products, and to warehouses. (3) A minimal response may be sufficient when processes requiring priority management are not within the scope of management, but verification is necessary. (4) When using recycled materials, it is important to understand the degree of risk and determine the management method, and proceed on this basis. [3.4.2] Appropriate management of reaction processes Management shall ensure that residues do not remain, or are not created, when management criteria for chemical substances subject to management are exceeded, due to changes in constitution and concentration. (1) Identify processes for possible changes in the constitution of chemical substances, such as oxidation, reduction, and reaction, and changes in concentration of chemical substances due to evaporation and vaporization, and implement the appropriate management. (2) The process of changing from a substance/preparation to an article may not be associated with any changes in chemical composition, and care is therefore required. For example, in the process of firing paint, the low molecular weight component of the paint film vaporizes, and in the process of the resin hardening, a monomer, hardener, and hardening initiator contribute to the hardening reaction, bonding with, and being incorporated in, the hardened resin, and forming a high-polymer compound with associated changed in chemical composition. (3) If an organization manufacturing articles from substance/preparations is unable to understand the change in chemical composition, it will be necessary to ask the raw materials supplier. [3.4.3] Management of manufacturing sub-contractors Management of manufacturing sub-contractors shall be appropriate. (1) Sub-contracted manufacture should be managed through the structure for management of chemical substances in products within the sub-contractor s organization. The sub-contractor must be informed of the necessary details of process management, and the management system periodically verified. (2) When the sub-contractor is supplied with the necessary raw materials for manufacture, or when the sub-contractor procures the materials, it is necessary to have management that is appropriate to the format of sub-contracted manufacture as well as the risk. 13
8 [3.5] Shipping verification 9 [3.6] Traceability Products shall be shipped after (1) Examples of verifiable items: verification that all specified items have a) accepted raw materials and parts used in manufacture, been checked, including cases of b) manufacture with set manufacturing conditions, equipment, and work methods, implementation during acceptance, or c) appropriate measures implemented when non-compliance occurs, during a process. d) storage of history when changes occur, and e) verification by sampling as necessary. (2) Examples of means of verification: a) identification tags to provide an understanding of the status of management within processes, and b) a production management system to provide an understanding of management data within processes. (3) Measurement is necessary for product warehouses and external distribution warehouses to prevent incorrect shipment and contamination. Product traceability shall be reliable. (1) Traceability (history management) provides an understanding of constituent materials, timing and location of manufacture, chemical substances contained in constituent materials, and information regarding chemical substances contained in manufactured products, in terms of risk to permit identification of the scope of any noncompliance occurring, and provision of information when a change occurs, and provides a structure for the rapid and smooth use, disclosure, and transmission of that information. (2) In processes, it is important to control management information, information regarding abnormalities, and information regarding changes in casual factors, etc. (3) It is important to implement identification and isolation in response to risks. 14
10 [3.7] Change control 11 [3.8] Non-conformity response 12 [4.1] Training Rules for control of changes in (1) Examples of details to be verified are changes in chemical substances in products, and management of chemical substances compatibility with criteria. in products shall be determined, and (2) It is necessary to ensure that information regarding changes in suppliers is reliably the following details clarified. obtained. (1) Elemental changes having possible (3) Verify compatibility with criteria before making changes. effects on chemical substances in (4) Provide updated information regarding chemical substances in products as soon as products. possible following any changes. Provide the customer with product lot information and Changes and additions in suppliers, identification information as necessary. changes in purchased items, and (5) It is difficult to provide prior notification when changes occur in chemical substances in changes in processes and so on products (products sold via catalog, general market) delivered to the general public, and it (including changes not only in the is important to identify products by methods such as handling as separate products. company such as manufacturing conditions, production facilities, molds, and jigs, but also changes in suppliers, sub-contractors, etc.). (2) Company internal and external procedures. Details to be verified, means of verification, approval processes, etc. (3) Methods of transmitting information inside and outside the company. Recording changes, notification, identification information, etc. Rules for measures to deal with noncompliant products (emergency measures, determination of causes, preventing reoccurrence, horizontal deployment, etc.) shall be determined. Details of training required for management of chemical substances in products, and related persons, shall be identified and implemented. (1) Examples of emergency measures are identification of the scope of influence (identification of the affected lot, equipment involved, etc.), containment (halting shipping, halting production), communication within the company, communication to customers, communication to persons responsible for management of chemical substances in products, and managers, as necessary (escalation). (2) Following emergency measures, it is necessary to identify the cause, and determine and implement appropriate measures in order to prevent reoccurrence. (3) Horizontal deployment is deployment not only within one s own section but also to related sections (within the group, related companies) as necessary. (4) It is desirable that preventative measures be developed to prevent problems before they occur. For example, periodic measurements of the concentration of the lead in solder tanks as part of process management. (1) Examples of details of training are details of business covered, concepts of management of chemical substances in products, related legislation, industry standards, management of chemical substance risk, efforts by industry organization, cases of use and contamination of managed substances, and methods of analysis. (2) It is important to verify that none of the necessary items have been missed. 15
13 [4.2] Management of documentation and records Rules relating to management of chemical substances in products shall be documented, maintained, and managed. Records of results of operation shall be prepared and stored appropriately. (1) It is important for the company to prepare a system for management of chemical substances in products, and a system of related documentation (document structure diagram). (2) It is important that documentation content is reviewed as required, and that the most recent version is available for viewing as necessary. (3) Examples of documents are policy documentation, manuals for management of chemical substances in products, related procedure documentation for management of chemical substances in products, rules, standards, criteria, norms, procedure documentation, and document structure diagrams. (4) Examples of records are information regarding the chemical substances contained, acceptance verification data, shipping verification data, internal audit results, survey data, and analysis data. 16
7. Documents necessary for certification Table 3 shown below lists the documents required for the certification to be submitted by the supplier based on the certification methods. Table 3. Necessary documents for each certification method Form CMS certification method Azbil CMS certification scheme Use of certification that has been already obtained from another company Agreement on Chemical Substances Contained in Procured Products Form 3 CMS establishment Self-evaluation Audit Application form for use of another company s certification for azbil Group Chemical Substances Management System Establishment azbil Group CMS Supplier Survey Sheet QC process chart Evidences of raw materials (ICP/table of ingredients)* Form 8 Form 4 azbil Group CMS Supplier Audit Report Form 5 azbil Group CMS Audit Checklist Form 6 azbil Group CMS Audit Findings and Corrective Action Report Certificate of Non-Use of Chemical Substances in Products for azbil Group - - Form 7 Form 9 azbil Group CMS Supplier Audit Report Form 5 azbil Group CMS Audit Checklist Form 6 azbil Group CMS Audit Findings and Corrective Action Report Form 7 - - - Submission to be separately requested upon request by the customer. To be audited on a documentation basis. Remarks: Codes used in Table 3 : Document submission required. -: Document submission not required Even with items for which document submission is not compulsory, in the audit conducted by the azbil Group, appropriate management will be checked by means of documents similar to the said items. * When required by an azbil Group customer, submission of data from the survey on chemical substances in products may be requested. Also, as requested by the customer, the format of the evidence to be submitted may be changed. 17
8. Submission of certificate of non-use of substances in items delivered The following two conditions are prerequisites for submitting the Certificate of non-use of chemical substances in products for the azbil Group (Form 9). Condition 1. The management system for chemical substances subject to regulation has been established or under establishment in accordance with 3.3, Establishment of a CMS and 4.1, Operation of a CMS. When the system is first being established, it is audited by the azbil Group for final confirmation. In such cases, it is desirable for the system to be fully established prior to CMS certification; but if not, it must be completed before delivery of the first lot of CMS-certified materials. Condition 2. The supplier must obtain from raw material suppliers certificates of non-use for raw materials and parts necessary for manufacturing the item as described in section 3.4, Submission of CMS Supplier Survey Sheet. The certificates of non-use from all the raw materials suppliers specified in the azbil Group CMS Supplier Survey Sheet (Form 4) must be ready for submission. For details of the Chemical Substances Designated by the azbil Group and Regulatory Requirements and the concept of obtaining certificates of non-use of chemical substances in materials and products, refer to section 9. Notes: To submit a certificate of non-use, specify the necessary information on Form 9 in electronic format, print it out, add authorization seals or signature, and submit the original to the procurement department. If there are questions, please do not hesitate to contact us (see the last page for contact details). AGS-541A-006 Appendix Document 2 Rev.3 18
9. Chemical substances designated by the azbil Group and regulatory requirements For chemical substances subject to regulation, refer to Explanatory Material for Suppliers on Standards for Chemical Substances (Contained in Products) with Environmental Impact. Among the restricted chemical substances, some heavy metals (cadmium, lead, mercury, and hexavalent chromium) relate to the functions and characteristics of parts and raw materials, and cadmium and other similar substances may also be present as impurities. Therefore, understanding the concentrations, confirmation that they do not exceed the limits, and appropriate management of these substances must be implemented. Regarding other chemical substances that are prohibited in Japan and EU countries, please ask manufacturers of raw materials to provide non-use/non-inclusion certificates for the substances. In the case of difficulty in obtaining these certificates, contact the procurement department. 10. Changes in chemical substances during manufacturing due to chemical reactions, etc. This section concerns cases of changes in chemical substances that occur during manufacturing as a result of chemical reactions, etc., or fluctuations in the concentration of the substances, as described in item 7, Process management, in the table in section 6. Concentration may change in the following cases. (1) Change of a solid to a liquid, powder, or gas due to chemical action, physical action, etc., and then change back to a solid. (2) Attachment of a liquid, powder, gas, etc., to a solid surface, forming a solid layer as a result of adhesion, evaporation, etc. Typical examples of (1) above are soldering, solder plating and metal, plastic and rubber molding, etc. Typical examples of (2) above are plating, etc. Because these substances change their form, they are highly likely to remain as residue, so care is required. The supplier must take pollution prevention measures such as checking that these CMS chemical substances are within limits, using only certified substances, and not using those that have not yet been checked. With regards to plating processes, the sharing of a washing tank may cause contamination even if the trivalent chromate treatment tank and the hexavalent chromate treatment tank are separate. It is important to check for any admixture of pollutants throughout the manufacturing process with the QC process chart, etc. Admixture is possible in those processes that involve prohibited chemical substances, such as: surface treatments, rubber mixing, compounding, changing of colors or reuse of runners in injection molding, etc. 19