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Supplier Requirements- Certificates of Analysis (Send Method & Content Requirements)

QPC007

Reviewer Coordinator: Supplier Quality Development Rev#: 02.00

Where Used: All Areas Effective: 11/08/2012QA ManualDocumentation

QAM Site: All Areas of 9

This document is uncontrolled when printed.For the most current and official copy, check the CMX portal on the Intranet.

1.0 ScopeThis document applies to all ABG-US (Amway-Nutrilite) suppliers, who provide direct materials (raw materials, chemicals, components, finished goods) to any ABG-US location, or globally at the direction of any ABG-US entity.

2.0 PurposeThe purpose of this document is to clearly state our supplier requirements and expectations, as they relate to CERTIFICATES OF ANALYSIS (CofA’s) – Send Method & Content Requirements. Failure to follow these, as enumerated within, will result in one or more of the following:

1. Issuance of an ADR (Arrival Defect Report). Issued ADR’s will result in a zero (0%) RFT (Right First Time quality metric) score for the Purchase Order Line in question.

2. Issuance of an NCM (Non-Conforming Material) report – in more severe cases where material cannot be properly identified, or material quality/safety is in question. Issued NCM’s will result in a zero (0%) RFT (Right First Time quality metric) score for the Purchase Order Line in question

3.0 Requirements3.1 When to Provide a C of A

A non-historical C of A is required for each and every unique lot received at any ABG-US facility

3.2 How to Provide a C of AThe C of A must be provided in 2 ways, for each and every unique lot received at any ABG-US facility

#1 of 2 Physically attach to the subject shipment, sent with the shipping documents (preferably grouped with the Bill of Lading and Packing List)

#2 of 2 Electronically send to one (of the following two) addresses prior to shipment (email send method is preferred):

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Business Line / Material Type / Location First Choice Second Option

Chemicals / Raw Materials (Ada, MI) [email protected] Faxed to: 616-787-8981ATTN: Amway SCQA Lab

Packaging Components (Ada, MI) [email protected] Faxed to: 616-682-4059ATTN: Amway SQPQA Lab

Home Tech Components (Ada, MI) [email protected] Faxed to: 616-682-4072ATTN: Amway SQPQA Lab

Finished Goods / Buy-Outs (Ada, MI) [email protected] Faxed to: 616-682-4073ATTN: Amway SQPQA Lab

Nutrilite Components Raw Materials Finished Goods (Buy-Outs)

(Buena Park, CA Lakeview, CATrout Lake, WA Quincy, WA Ada, MI)

[email protected]

3.3 Emailed CofA’s (Subject Line Nomenclature)

a) For items where the Supplier and Manufacturer are one and the same, the e-mail Subject Line for the C of A should include the following 4 components:

Supplier Name ABG Item# ABG PO# Lot/Batch #

b) For items supplied via a Distributor, the e-mail Subject Line for the C of A should include the following 5 components:

Manufacture Name Distributor Name ABG Item# ABG PO# Lot/Batch #

3.4 Control Limits versus Release Specifications

a) Control Limits are manufacturing control parameters for the production of the material, component or product

b) To control unnecessary scrap or rework, the Control Limits should fall within the Release Specifications, and become increasingly narrow as production processes are optimized.

c) CofA “Control Limits” should fall within the ABG Release Specifications, and not merely match them.

3.5 CofA Header Content (Minimum Information, 11 or 12 fields )ABG Part Number/SKU Manufacturer NameManufacturer’s Trade Name (if applicable) Manufacturer Location & Country of OriginLab Test Date Manufacturer’s Lot/Batch NumberLab Approval/Release Authority (name) Manufacturing DateLab Approval/Release Authority (contact information)

Shelf Life Days (from Mfg Date) or Expiration Date

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a) The complete ABG Part Number/SKU

Must match ABG Purchase Order/PO Line

Must match ABG Specification

Must match Container Label

c) Manufacturer’s Trade Name – Common for raw materials, ingredient or chemical items

Must match ABG Specification (if listed)

Must match Container Label (only applicable if on ABG Spec)

d) Manufacturer Name – (must be the Manufacturer’s name, not the Broker or Distributor)


Must match the Container Label

e) Manufacturer Location - City/State or City/Province are acceptable.



f) Manufacturer Country of Origin – May be included as one line with Manufacturer

Location



g) The unique manufacturer/vendor Lot/Batch Number. Lot traceability is required for each container.


In some rare cases, suppliers will be directed (by ABG Specification or Agreement) to use an 8-digit AMC lot code to replace their lot/batch number (please reference section 4.1 for further guidance).

h) Manufacturing Date - Month/Day/Year (MM/DD/YY) on which material is manufactured. If Julian-based, the manufacturer/vendor Lot/Batch number can be substituted for Manufacturing Date.

3.6 How to Determine Which Tests are Required on CofA

a) The tests required for each product or material are itemized within each ABG Specification.

b) All tests prefixed with ‘COA’ or (C), on the ABG Specification, are required to appear on each CofA.

c) Please refer to the ABG Specification examples (in Section 4.0) for further guidance.

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3.7 CofA Test Information Content (Minimum Information, 6 or 7 fields )

ABG preference is that the following information is presented horizontally:Test

NameTest Unit of

MeasureTest

MethodSpecification

RangeTest

ResultPass /Fail

**

a) For certain Durables Business Line items (engineered components), Ppk, Cpk, or Standard Deviation may be required

b) ** Pass/Fail verification necessary to ensure an independent review of results by manufacturer Release Authority.

3.8 CofA Test Results

ALL line items on the CofA are required to meet their respective specification Release Limits.

4.0 References and Examples

1. For LABEL / CONTAINER INDENTIFICATION requirements, please refer to the SHIPPING section of the ABG Supplier Portal (www.supplier.amway.com)

2. For an ABG SPECIFICATION EXAMPLE, please refer to pages 4 through 7 of this document.

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“This document may contain confidential information and is considered proprietary information. Use of this document is covered by the corporate agreement regarding confidentiality and intellectual property. This document is not to be shared with third parties or with employees outside of normal business conduct without prior approval from the Director of Quality Assurance."

Approvals

Title Name Signature

Group Leader- SQD Chris Alder Reference Documentum.

Group Leader- SCQA Jerry Visscher Reference Documentum.

Group Leader- SCQA Kristina Parkanzky Reference Documentum.

Group Leader- SCQA Gregor Stasik Reference Documentum.

Group Leader- SCPQA Heath Paukette Reference Documentum.

Group Leader- NQA Allison Zolnay Reference Documentum.

Group Leader- NQA Amy Caplette Reference Documentum.

Author Cara Fritsma Reference Documentum

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