Reviewer Coordinator: Supplier Quality Development / Rev#: 01.00
QA Manual
Documentation
QAM / Where Used: Change Control, Supplier Quality Development / Effective: 09/12/2012
Site: All ABG-US sites (Ada, Buena Park, Lakeview, etc.) / Page 1 of 2
1.0Scope
This 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.
2.0Purpose
The purpose of this document is to clearly state our supplier requirements and expectations, as they relate to CHANGE CONTROL. Failure to follow these, as enumerated within, will result in one or more of the following:
a)Commercial harm to relationship
b)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
c)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.
3.0Requirements
3.1Supplier Change Control Expectations
It is agreed that ABG (Amway/Nutrilite) suppliers shall communicate changes in the supply system, in advance. Suppliers shall inform ABG in writing, prior to initiation, of any intended changes which may affect the quality, marketing authorization or supply assurance of material(s) manufactured for ABG. Suppliers shall implement effective Change Control procedures (extending to their own sub-suppliers) to confirm that product characteristics and material supply will be unaffected by the intended change(s), and shall be supported by appropriate technical documentation.
Example changes subject to these Change Control Requirements include (but are not limited to) the following:
3.2Applicable Change Control Examples
Change Type /Description / Change
Source
Change in corporation name, identity, or legal structure / Man
Change in QMS (Quality Management System) representative and/or ABG Supplier QA contact
Change in QA reporting structure, independence, or Quality Management System authorities
Reduction in QA Final Audit/inspection sampling plans
Changes in Incoming and/or In-Process inspection sampling plans and acceptance criteria.
Change in 3rd Party Quality/Safety Certificates obtained or lost (including those from FDA/Gov’t Authorities)
Changes in manufacturing processes and/or process flow (for Regulated products) / Method
Changes in manufacturing processes and/or process flow (for ABG-owned or specified formulas/designs)
Changes in manufacturing processes and/or process flow (for Supplier-owned formulas/designs)
Changes in HACCP Plans or product/material Control Plans (for Supplier-owned formulas/designs)
Changes or reductions in Critical Control Points (contained in HACCP Plans)
Changes in Key Product and/or Process Characteristics (contained in Control Plans)
Changes in Warehousing location and/or Storage Conditions
Changes in Transportation/Freight method and/or Carrier
3.2 Applicable Change Control Examples (continued)
Change Type /Description / Change
Source
Changes in processing equipment and/or infrastructure (for Regulated products) / Machine
Changes in processing equipment and/or infrastructure (for ABG-owned or specified formulas/designs)
Changes in processing equipment and/or infrastructure (for Supplier-owned formulas/designs)
Tear-down, refurbishment, or removal of processing equipment and/or infrastructure
Changes in process capability (processing equipment performance unable to achieve CpK of 1.33)
Machine, equipment, or infrastructure failures (realized later) - leading to necessary containment actions.
Material, supplier or manufacturer substitutions (for Regulated products) / Materials
Material, supplier or manufacturer substitutions (for ABG-owned or specified formulas/designs)
Material, supplier, or manufacturer substitutions (for Supplier-owned formulas/designs)
Changes to material trade name or specification target/range (for Supplier-owned formulas/designs)
Changes to material trade name or specification target/range (for ABG-owned or specified formulas/designs)
Changes to material trade name or specification target/range (for Regulated products)
Changes in inspection/measurement equipment utilized as Critical Control Points (within HACCP or Control Plans) / Measure-ment Systems
Measurement Systems Evaluation (MSE) failures and/or when MS error is determined to be in excess of 20%
Deterioration or loss of (or changes to) ABG-approved Master and/or Boundary inspection samples
Facility loss, necessitating urgent alternate facility qualification / Mother
Nature
Facility loss or planned shutdowns, leading to significant downtime and impact to supply continuity
Facility capability reduction - where process control robustness and/or product integrity is placed at risk
The temporary or permanent loss raw material/feedstock supply, necessitating urgent resupply & qualification
Temporary or permanent loss of product storage and/or manufacturing environmental controls (temp, humidity, etc)
Facility and/or product pest infestation (as discovered first party, or as reported by a competent 2nd or 3rd party)
"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 management approval."
Approvals
Title / Name / SignatureGroup Leader - SQD / Chris Alder / Reference Documentum.
Sr. Lead Analyst - CC / Nick Kavanaugh / Reference Documentum.
Author / Cara Fritsma / Reference Documentum.
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