https://www.avient.com/sites/default/files/2024-03/Global Supplier Quality Manual_2024.pdf
Table of Contents
1.0 Organizational Context ..............................................................................................................................................3
1.1 Purpose ..................................................................................................................................................................3
1.2 Scope ......................................................................................................................................................................3
2.0 Avient Global Quality Policy ......................................................................................................................................4
3.0 Supplier Management ...............................................................................................................................................5
3.1 Supplier Quality Management System..................................................................................................................5
3.2 Performance Evaluation ........................................................................................................................................5
3.3 Supplier On-Site Audit ...........................................................................................................................................5
3.4 Product and Process Changes ................................................................................................................................6
4.0 Supplier Quality Expectations ...................................................................................................................................6
4.1 Raw Material(s), Packaging and Shipping .............................................................................................................6
4.2 Nonconforming Material, Containment, and Supplier Corrective Action ............................................................6
4.3 Contingency / Disaster Recovery Plan...................................................................................................................7
4.4 Sub-Tier Supplier Controls .....................................................................................................................................7
5.0 Avient Business Expectations ....................................................................................................................................8
Additional functional area documentation ........................................................................................................................8
6.0 References..................................................................................................................................................................9
7.0 Definitions and Acronyms .........................................................................................................................................9
Approved
Corporate : Manual
Document #: DOC-02627 Revision: 6
Document
Owners:
Kyle Johnson Effective Date: Mar 20, 2024
Title: Global Supplier Quality Manual
Page 3 of 10
Only the electronic version of this document in ETQ is the controlled version of the document.
Approved
Corporate : Manual
Document #: DOC-02627 Revision: 6
Document
Owners:
Kyle Johnson Effective Date: Mar 20, 2024
Title: Global Supplier Quality Manual
Page 4 of 10
Only the electronic version of this document in ETQ is the controlled version of the document.
https://www.avient.com/resources/safety-data-sheets?page=6995
XGT 43637-0002A-01-1
X 43640-0001A-01-2
X 43640-0001A-01-3
https://www.avient.com/resources/safety-data-sheets?page=3411
NATURAL CAPSTOCK X
AMBER UV PP 3
ORANGE TPU ETHER #3
https://www.avient.com/resources/safety-data-sheets?page=126
DP 9049-3-1000
DP 9050-3-1000
X ET-4844-002-2 Natural
https://www.avient.com/sites/default/files/2021-02/avient-canada-ulc-qst-number-2.4.2021.pdf
As of
suppliers outside QuébecJanuary 1, 2019, certain must register for the QST and collect the tax on certain
taxable supplies they make in Québec.
Registration number 1019288451 TQ 0004
Status Valid
Effective date of status 2017-08-01
Date viewed 2021-02-04
Business's name AVIENT CANADA ULC
Business name SPARTECH PLASTIQUES
Registration number to validate
1019288451TQ0004
Page 1 of 1Validate a QST Registration Number - Revenu Québec
2/4/2021https://entreprises.revenuquebec.ca/EntNa/SX/SX00/SX00.SXCLT20A.ValiderInscription/...
https://www.avient.com/sites/default/files/2022-07/MEVOPUR Chemical Foaming Agents Application Bulletin_CN.pdf
主要特性
根据ISO 13485规定的程序生产
变更控制记录的级别高于CAS编号级别,降低
变更风险
可用于常规注塑机和挤出设备—由技术支持团
队提供设置支持
可用于聚烯烃、苯乙烯和共聚物
可与着色剂联用
•
•
•
•
•
注册药品管理档案(III类)和/或医疗器械主
文件
食品接触声明符合美国FDA和EU规范
法规支持
原材料根据以下法规测试:
- ISO 10993-1
- USP第、章(包含VI级)
- 欧洲药典,各论3.1.3/3.1.5章节(聚烯烃包
装材料)
- 美国药典(聚乙烯)
- 杂质元素符合ICH Q3D要求
•
•
•
轻量化
1.844.4AVIENT
www.avient.com
版权所有© 2022埃万特公司。
在不限制本声明的一般性的情况下,不得将埃万特的产品用于旨在用于以下目的的任何医疗器械应用:
(1) 接触人体组织或体液长达30天或更长时间;
(2)“整形”(整容或重建)手术;
(3) 生殖植入物或任何节育器械;或者
(4) 用于支持或维持人类生命的永久性(超过30天)植入式医疗器械中的任何关键组件。
https://www.avient.com/sites/default/files/2022-07/REMAFIN EP White Masterbatches for Pharma Application Bulletin_CN.pdf
主要特性
生产符合高于CAS编号级别的变更控制原则
(与MEVOPUR母粒类似),降低变更风险
不含动物源性物质和邻苯二甲酸盐
适用于吹膜、注塑、吹塑和挤出
•
•
•
注册药品主文件(III型)
食品接触符合FDA/EU*要求
法规支持
原材料根据以下法规测试:
- ISO 10993-1
- USP第、章,包括VI级别,符合眼
科和鼻腔用药物要求
- 欧洲药典3.1.3/3.1.5(聚烯烃)
- 美国药典(聚乙烯)
- ICH Q3D 杂质元素
- USP和USP,透光率
•
•
•
载体材料 耐光性 热稳定性 产品代码颜料含量/类型
HDPE 50% TiO2 8 300°C PH00075525
LLDPE 60% TiO2 8 300°C PL00075542
LLDPE 70% TiO2 8 300°C PL00075545
PP 50% TiO2 8 300°C PP00075717
适用医疗保健使用限制—见下文。
在不限制本声明的一般性的情况下,不得将埃万特的产品用于旨在用于以下目的的任何医疗器械应用:
(1) 接触人体组织或体液长达30天或更长时间;
(2)“整形”(整容或重建)手术;
(3) 生殖植入物或任何节育器械;或者
(4) 用于支持或维持人类生命的永久性(超过30天)植入式医疗器械中的任何关键组件。
https://www.avient.com/sites/default/files/2024-10/Avient CDP Climate Change %26 Water Submission 20241001.pdf
Scope 3 category 4: Upstream transportation and distribution
(7.5.3) Methodological details
Emissions associated with transport of raw materials to Avient are included in the emission factors chosen in category 1.
Business division Scope 1 emissions (metric ton CO2e)
Row 1 Avient Corporate 4275.031
193
Business division Scope 1 emissions (metric ton CO2e)
Row 2 Global Color, Additives and Inks 3326.306
Row 3 Global Specialty Engineered Materials 20944.881
Row 4 Masterbatch 4568.055
[Add row]
(7.20.1) Break down your total gross global Scope 2 emissions by business division.
Further information & sign off
(13.1) Indicate if any environmental information included in your CDP response (not already reported in 7.9.1/2/3, 8.9.1/2/3/4,
and 9.3.2) is verified and/or assured by a third party?
https://www.avient.com/resources/safety-data-sheets?page=2608
PURPLE 1 CL30
PURPLE 3 CL2250
X SF-153530101
https://www.avient.com/resources/safety-data-sheets?page=3922
X ST-TPE-4967-1A
GRAY #3 T006-GR1262
X ST-PEI-8016-1A