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
Guidelines for the Establishment of a Chemical Substances Management System
Table of Contents
1. THE AZBIL GROUP’S POSITION ON CHEMICAL SUBSTANCE MANAGEMENT.............. 1
1.1
1.2
PURPOSE OF ESTABLISHING GUIDELINES ......................................................................................1
SCOPE OF THE GUIDELINES ...........................................................................................................1
2.
CMS PARTS CERTIFICATION SCHEME ............................................................................ 2
3.
PROCEDURE FOR ESTABLISHING A CMS ....................................................................... 3
3.1
3.2
3.4
3.5
3.6
3.7
3.8
3.9
3.10
CONCLUSION OF THE MEMORANDUM OF UNDERSTANDING .........................................................4
SELECTION OF CMS CERTIFICATION METHOD ............................................................................4
SUBMISSION OF CMS SUPPLIER SURVEY SHEET .........................................................................5
QC PROCESS CHART ......................................................................................................................5
CERTIFICATE OF NON-USE OF MATERIALS ...................................................................................5
CMS SELF-EVALUATION ...............................................................................................................6
CERTIFICATE OF NON-USE OF ARTICLES TO BE DELIVERED........................................................6
AUDIT BY THE AZBIL GROUP .........................................................................................................6
CMS CERTIFICATION ....................................................................................................................6
CMS OPERATION ............................................................................................................... 6
4.
4.1
4.2
OPERATION OF A CMS ..................................................................................................................6
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
Guidelines for the Establishment of a Chemical Substances Management System
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).
AGS-541A-006 Attachment 2 Rev. 3
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Guidelines for the Establishment of a Chemical Substances Management System
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
CMS certified manufacturing line
Certification
Process to prevent admixture and contamination of
prohibited substances
CMS certified products
Raw materials that do not contain
prohibited substances
Certification
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.
Example of required re-certification
Supplier
Certification
Supplier Factory B
Supplier Factory A
CMS certified manufacturing line
Manufacturing line
Certification
CMS certified
products
Certification
Production transfer
Certification
Change of factory requires CMS
re-certification
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Guidelines for the Establishment of a Chemical Substances Management System
3.
Procedure for establishing a CMS
The procedure for suppliers establishing a chemical substances management system is shown
below.
Notification from azbil Group of
materials subject to CMS
Contact persons for the azbil Group
and supplier are determined
“Memorandum of
understanding on
chemical sbustances in
materials delivered to
the azbil Group”
(Form 3)
Submitted only in case of
initial certification
Start of CMS certification program
Use of azbil CMS certification
Use of another company’s certification
Application for
use of another
company’s
certification
(Form 8)
CMS certification
method selected
Submission of
form
Notification of approval of
other company’s
certification
CMS establishment
and operation
Supplier Survey
Sheet created
Use of other company’s
CMS certification for
probihited substances
Supplier
Survey Sheet
(Form 4)
Receipt of certificate
of non-use for raw
materials, auxiliary
materials, etc., from
their suppliers
Obtaining of certificate of
non-use of substances in
raw materials, auxiliary
materials, parts, etc. from
manufacturers
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.
(See Note 1)
Submission of
form
Identify processes
where admixture and
contamination can occur
CMS self-evaluation
Declaration of non-use
Submission of
form
QC process
chart
CMS audit
checklists
(Forms 5–7)
(Refer to 3.7)
Submission of
form
Submission of
form
Certificate of non-use of chemical
substances in products (Form 9)
Document audit or on-site
audit by azbil Group
Note: In case of use of another company’s
certification, the document audit may often be
conducted.
Approved
CMS
certification
Internal audit (every year)
Submission of
form
CMS self-evaluation
CMS audit checklists
(Forms 5–7)
Re-certification audit (every 2 yeras)
CMS self-evaluation
Document audit or on-site
audit by azbil Group
Submission of
form
Use of other
company’s
certification for
re-certification
CMS audit checklists
(Forms 5–7)
Application for use of
other company’s
certification (Form 8)
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Guidelines for the Establishment of a Chemical Substances Management System
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.
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Guidelines for the Establishment of a Chemical Substances Management System
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
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Guidelines for the Establishment of a Chemical Substances Management System
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
AGS-541A-006 Attachment 2 Rev. 3
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Guidelines for the Establishment of a Chemical Substances Management System
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.
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Guidelines for the Establishment of a Chemical Substances Management System
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.
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Guidelines for the Establishment of a Chemical Substances Management System
(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.
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Guidelines for the Establishment of a Chemical Substances Management System
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
● 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.
2 [2.2]
Definition of scope of
management
● “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.
3 [2.4]
Establishment of
organizational system,
responsibility & authority
● 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.
4 [3.1] Design and development
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Guidelines for the Establishment of a Chemical Substances Management System
[3.1.1]
Design for manufacture
of substances/
preparations
● When manufacturing
(1)
substances/preparations, information
regarding chemical substances in raw (2)
materials shall be verified, and
products and manufacturing processes (3)
shall be designed to satisfy
management criteria. Specify
specifications of purchased products if
necessary.
(4)
(5)
(6)
(7)
(8)
[3.1.2]
● When manufacturing articles from
(1)
Design for manufacture
substances/preparations, information
of articles using
on chemical substances in raw
substances/preparations
materials shall be verified. Any
possible changes in concentration and
type of contained chemical substances (2)
in processes shall be understood.
Furthermore, the product shall be
(3)
verified as conforming to the
management criteria.
[3.1.3]
Design for manufacture
of articles using articles
(4)
● When manufacturing new articles from (1)
existing articles, information regarding
chemical substances in articles (e.g. (2)
parts), and compliance of the product
with the management criteria, shall be
(3)
verified.
(4)
(5)
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.”
Included content (upper limit values) for managed chemical substances are determined
from legislation and industry criteria relating to products subject to management.
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.
Manufacturing conditions include prevention of incorrect use, admixture, and
contamination, as well as appropriate management of reaction processes.
It is important to verify at each stage (e.g. testing, prototype manufacture, and mass
production) in the design and development stage.
The results of design and development are shown in specifications, drawings,
manufacturing specifications, work specifications, and manuals, etc.
When constituent materials are designated by the customer, specifications and
management criteria, etc. are determined in discussions with the customer.
Use of MSDS and MSDSplus, etc. is recommended for verification of information on
chemical substances in substances/preparation.
Surface processes such as plastics molding, plating, painting, and printing, and fusion
processes such as soldering and gluing, are examples of the manufacture of articles from
substances/preparations. In the case of gluing, for example, there is a possibility that
changes may occur in the concentration and type of chemical substances contained, and
care is therefore required.
In many cases, a process is conducted simultaneously with the process of manufacture of
a new article from an existing article, and care is required to ensure that action items
(3.1.3) relating to design and development are not missed.
When manufactured articles are supplementary to substances/preparations, it is important
to verify information regarding chemical substances contained in those
substances/preparations (e.g. coolant, grease, lubricating oil, rust preventive oil).
Refer to 3.1.1 (1)–(8).
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.
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.
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.
Refer to 3.1.1 (1)–(7). Not including responses relating to chemical reactions.
Refer to 3.1.2 (3).
AGS-541A-006 Attachment 2 Rev. 3
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Guidelines for the Establishment of a Chemical Substances Management System
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
substances in purchased products (IN
information) shall be acquired and
verified that it contains the necessary
details, as well as that it is compatible
with the management criteria. For new
products and changed products,
acquisition and verification of
information regarding chemical
substances in products in accordance
with the management criteria shall be
complete prior to commencing mass
production.
● When selecting a new supplier, the
status of management of chemical
substances in the supplier’s products
shall be verified. When continuing with
an existing supplier, reconfirmation
shall be conducted as necessary.
Measures for verification results shall
be fixed. Supplier items to be verified,
criteria, frequency, and method, etc.
may be set in relation to risk level.
(1) Information regarding chemical substances in products covers inclusion or exclusion in
substances subject to management, the contained amount, concentration, and use, etc.
(2) When the purchased product is a substance/preparation, MSDS and MSDSplus, etc. are
available as means of obtaining information regarding the chemical substances
contained.
(3) When the purchased product is an article, AIS and JGP files, or the JAMA/JAPIA
integrated data sheet, are available as means of obtaining information regarding the
chemical substances contained.
(4) Since substances subject to management may vary with use, it is desirable that the other
party be informed of use when making inquiries.
(5) The CAS number, or names, numbers, and symbols, etc. are used in identification of
substances subject to management.
(1) Evaluation of the supplier risk level is based on acquired content information, the
possibility of unintended inclusion (presence or absence of reaction processes, parallel
production, constituent materials, etc.), the status of compatibility with these guidelines,
the presence or absence of an environmental/quality management system, and past
performance, etc.
(2) Verification of the status of management of chemical substances in products is based on
documentation and visits, etc.
(3) Examples of measures to deal with results of verification are acceptance, continuing
transactions, requests for improvement, guidance, and discontinuing transactions.
● When accepting purchased products, (1)
such products shall be verified as
compatible with company management (2)
criteria. Items to be verified, criteria,
method, and frequency, etc. may be
selected in relation to the risk level of
(3)
the purchased products.
It is important that company acceptance procedures are clarified in response to risk in
management of chemical substances in products.
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.
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.
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Guidelines for the Establishment of a Chemical Substances Management System
7 [3.4] Process management
[3.4.1]
● Implementation of measures to prevent (1)
Preventing incorrect use,
incorrect use, admixture and
admixture, and
contamination of chemical substances
contamination
shall be subject to management.
In practice, it is possible to separate processes, and equipment and jigs, etc., into those
requiring priority management and others. Processes requiring priority management are
those in which chemical substances having management criteria are used, and it is
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]
● Management shall ensure that
(1)
Appropriate management residues do not remain, or are not
of reaction processes
created, when management criteria for
chemical substances subject to
(2)
management are exceeded, due to
changes in constitution and
concentration.
[3.4.3]
Management of
manufacturing
sub-contractors
● Management of manufacturing
sub-contractors shall be appropriate.
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.
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.
(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.
AGS-541A-006 Attachment 2 Rev. 3
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Guidelines for the Establishment of a Chemical Substances Management System
8 [3.5]
Shipping verification
● 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.
9 [3.6]
Traceability
● 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.
AGS-541A-006 Attachment 2 Rev. 3
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Guidelines for the Establishment of a Chemical Substances Management System
10 [3.7]
Change control
11 [3.8]
Non-conformity response
12 [4.1]
Training
● Rules for control of changes in
management of chemical substances
in products shall be determined, and
the following details clarified.
(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) 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.
(1) Examples of details to be verified are changes in chemical substances in products, and
compatibility with criteria.
(2) It is necessary to ensure that information regarding changes in suppliers is reliably
obtained.
(3) Verify compatibility with criteria before making changes.
(4) Provide updated information regarding chemical substances in products as soon as
possible following any changes. Provide the customer with product lot information and
identification information as necessary.
(5) It is difficult to provide prior notification when changes occur in chemical substances in
products (products sold via catalog, general market) delivered to the general public, and it
is important to identify products by methods such as handling as separate products.
(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.
● Details of training required for
(1) Examples of details of training are details of business covered, concepts of management
management of chemical substances
of chemical substances in products, related legislation, industry standards, management
in products, and related persons, shall
of chemical substance risk, efforts by industry organization, cases of use and
be identified and implemented.
contamination of managed substances, and methods of analysis.
(2) It is important to verify that none of the necessary items have been missed.
AGS-541A-006 Attachment 2 Rev. 3
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Guidelines for the Establishment of a Chemical Substances Management System
13 [4.2]
Management of
documentation and records
● Rules relating to management of
(1)
chemical substances in products shall
be documented, maintained, and
(2)
managed. Records of results of
operation shall be prepared and stored
appropriately.
(3)
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).
It is important that documentation content is reviewed as required, and that the most
recent version is available for viewing as necessary.
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.
AGS-541A-006 Attachment 2 Rev. 3
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Guidelines for the Establishment of a Chemical Substances Management System
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
Self-evaluation
CMS establishment
Agreement on Chemical Substances
Form 3
Contained in Procured Products
Application form for use of another
company’s certification for azbil Group
Form 8
Chemical Substances Management
System Establishment
○
－
○
○
Form 4
○
－
QC process chart
－
○
－
Evidences of raw materials
(ICP/table of ingredients)*
－
azbil Group CMS Supplier Survey
Sheet
Submission to be separately requested upon
request by the customer.
azbil Group CMS Supplier Audit Report
Form 5
○
azbil Group CMS Audit Checklist
Form 6
○
azbil Group CMS Audit Findings and
Form 7
Corrective Action Report
Certificate of Non-Use of Chemical
Form 9
Substances in Products for azbil Group
azbil Group CMS Supplier Audit Report
Audit
CMS certification method
Use of certification
Azbil CMS certification
that has been already
scheme
obtained from another
company
azbil Group CMS Audit Checklist
○
○
Form 5
○
Form 6
○
azbil Group CMS Audit Findings and
Form 7
Corrective Action Report
○
○
○
○
○
○
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.
AGS-541A-006 Attachment 2 Rev. 3
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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
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Guidelines for the Establishment of a Chemical Substances Management System
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.
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Guidelines for the Establishment of a Chemical Substances Management System
11.
Prohibited chemical substances in manufacturing processes
The chemical substances prohibited and restricted in manufacturing processes are defined in
section 3.2, “Prohibited chemical substances in manufacturing processes,” of “Explanatory
Material for Suppliers on Standards for Chemical Substances (Contained in Products) with
Environmental Impact.” In establishing a CMS, suppliers must check that auxiliary materials and
other materials used in the manufacturing process do not contain any of these prohibited chemical
substances.
12.
Forms
The table shown below lists the forms necessary for certification. Forms 5, 6 and 7 are contained
in one file.
Table 3. List of forms
Form No.
Form Name
Form 3
Agreement on Chemical Substances Contained in Procured Products
Form 4
azbil Group CMS Supplier Survey Sheet
Form 5
azbil Group CMS Supplier Audit Report
Form 6
azbil Group CMS Audit Checklist
Form 7
azbil Group CMS Audit Findings and Corrective Action Report
Form 8
Form 9
Application form for use of another company’s certification for azbil
Group Chemical Substances Management System Establishment
Certificate of Non-Use of Chemical Substances in Products for azbil
Group
AGS-541A-006 Attachment 2 Rev. 3
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Guidelines for the Establishment of a Chemical Substances Management System
Contact: For inquiries, contact Azbil Corporation or an azbil Group procurement department.
©2008-2015 Azbil Corporation
All RIGHTS RESERVED．
AGS-541A-006 Attachment 2 Rev. 3
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Azbil Corporation / The azbil Group
Third Edition: March, 2015
AGS-541A-006 Appendix Document 2 Rev.3