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    Supplier Quality

    Requirements Manua

    Amway North America Operations 2011 Edi

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    Table of Content

    1.0 Welcome To Amway ...........................................................1

    2.0 Scope .................................................................................2

    3.0 Communication ...................................................................2

    3.1 Supplier Portal ..................................................................................2

    3.2 Supplier Contact Information ............................................................. 2

    3.3 Supplier Analytics .............................................................................2

    4.0 General Supplier Quality Requirements/Expectations ......2

    4.1 Quality System Requirements ............................................................2

    4.2 Product Requirements .......................................................................3

    4.3 Specification Requirements ...............................................................3

    4.4 Document Requirements ....................................................................3

    4.5 Regulatory Requirements ...................................................................4

    4.6 Packaging & Package Security Requirements ....................................7

    4.7 Labeling & Lot Traceability Requirements ...........................................7

    4.8 Shelf Life and Inventory Control Requirements ....................................7

    4.9 Change Control/Request Requirements .............................................7

    4.10 Shipping Requirements ....................................................................8

    4.11 Communication Requirements ..........................................................8

    4.12 Metrics Requirements .....................................................................8

    5.0 Becoming an Amway Supplier ............................................8

    6.0 Non-Conforming Product ....................................................96.1 Defective Material Disposition Order .................................................. 9

    6.2 Corrective Action/Preventive Action ................................................ 10

    7.0 Performance Measures/Metrics ......................................11

    7.1 Measures .......................................................................................11

    7.2 Metrics ..........................................................................................11

    8.0 Glossary ...........................................................................13

    9.0 Appendix & References ...................................................15

    9.1 Amways Quality Assurance Key Elements & Descriptions ................15

    Page

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    1.0 Welcome to Amway

    Amway is one of the worlds largest direct

    selling companies. Founded in 1959, and

    headquartered in Ada, Michigan, USA, Amway

    offers consumer products and business

    opportunities in more than 80 countries and

    territories worldwide. The company also provides

    product development, manufacturing andlogistics services through its Amway Operations

    and Alticor Corporate Enterprises divisions.

    Amway and its family of companies have more than 14,000 employees globally, and help more than

    3 million people own and operate their own independent businesses in more than 80 countries and

    territories around the world. Some 450 unique, high-quality products carry the Amway name in the

    areas of nutrition, wellness, beauty and home care. Nutrilite supplements and Artistry skin care

    and cosmetics are the companys flagship brands. In 2010, Amways parent company, Alticor Inc.,

    reported global sales of $9.2 billion.

    With facilities in Michigan, California, Washington, Brazil, Mexico, Vietnam,

    Europe and China, Amway Operations serves the business-to-business market

    with sourcing, quality assurance, product development, manufacturing, and

    logistics services through a diverse portfolio of leading wellness, body &

    beauty, and home care products. Amway Operations also operates farms in

    Lakeview, California and Trout Lake, Washington, as well as international

    farms in Mexico and Brazil.

    As an existing or potential new supplier to Amway, you play a critical

    role in our quality processes. This manual contains information to

    assist your company in establishing a successful partnership with us by

    identifying our quality requirements and expectations. We value each of

    our suppliers as part of our team. Thank you for your support in providing

    safe, high-quality products to our customers and consumers.

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    2.0 Scope

    The requirements and expectations contained herein are applicable for those distributors and

    manufacturers supplying into Amway NA (North America) Operations.

    3.0 Communication

    We encourage and expect open and active communication with our suppliers. By working together

    and establishing open lines of communication, we can achieve our mutual goals.

    3.1 Supplier Portal

    The supplier portal, located at http://supplier.amway.com, is a dedicated supplier website designed

    to provide up-to-date requirements, guidelines and business intelligence reporting for Amway NA

    Operations. Throughout this manual, you will see references to the portal, directing you to forms

    and links which will provide you with more specific information regarding our requirements. If at any

    time you have questions, please contact your Amway Procurement Representative or Supplier Quality

    Development (SQD) Representative. An SQD organizational chart is located on the supplier portal

    under Business Requirements > Quality > Contacts.

    3.2 Supplier Contacts

    In order to maintain current contact information for our suppliers, we request you submit to your

    Amway SQD Representative and Technical Regulatory Analyst a name, phone number, and email

    address for the Primary Quality contact and Technical/Regulatory contact for each applicablemanufacturing site supplying products or materials to Amway NA Operations. Supplier Order/

    Sales/Customer Service contact information should be submitted to your Amway Procurement

    Representative. If you are unsure of who to contact, please reference the Item Buyer and SQD

    contacts in Supplier Analytics, our business intelligence system (under the Item Information tab).

    3.3 Supplier Analytics

    Supplier performance information is available through Supplier Analytics. Suppliers are expected to

    monitor their own performance information and discuss performance data with their Amway Procurement

    Representative. Contact your Amway Procurement Representative for access to this system.

    4.0 General Supplier Quality Requirements/Expectations

    Amway desires to partner with you to provide world class quality products to our consumers. Weexpect all suppliers to actively and continuously drive quality improvements that will support the

    prevention of non-conforming material. In order for us to assist suppliers in meeting these goals,

    we expect you to engage in the process and meet certain requirements and expectations, as

    outlined in the pages that follow.

    4.1 Quality System Management Requirements

    referenced under Supplier Quality Assurance Capability Assessments in the Performance Measures/Metrics section of this manual.

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    4.2 Product Requirements

    and which meet product and shipping specifications for Amway NA

    at http://supplier.amway.com, including specific shipping, quality,

    technical regulatory, accounts payable, engineering, specification,

    4.3 Specification Requirements

    departments. Every Purchase Order (PO) contains reference to the proper specification to be

    specifications in your possession, or you cannot locate them on the PO, contact your Amway

    Amway Procurement Representative if not in alignment (or if additional information is needed to

    4.4 Document Requirements

    As a global company, we require our suppliers to provide us with certain documents. Specific

    document requirements can be found on the supplier portal under Business Requirements >

    Technical Regulatory Affairs and Business Requirements > Quality, as well as within Amway

    specifications. When providing documentation for raw materials, please include your Trade Name/

    Chemical Name as well as the Amway Raw Material number if available.

    4.4a Document Types

    1. Provide necessary certificates/documents including, but not limited to, the following:

    4.4b Documentation Compliance

    1. In order to remain in compliance with our requirements, certificate updates should be sent

    to the appropriate Technical/Regulatory Analyst when certification status changes occur

    (reference Business Requirements > Technical Regulatory Affairs > Contacts). Documents are

    required to be updated every three years, in accordance with Amways record-keeping practices,for quality assurance.

    2. All suppliers shall provide a copy of their most recent third party audit report, including any findings,

    from an accredited 3rd party Registrar or certification body (ISO/RAB, GMA-SAFE, SGS, Silliker, NSF,

    TGA, FDA) to [email protected] and to their Amway SQD Representative.

    3

    most current specs).

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    3. When indicated as a requirement on the Amway specification, hardcopy C of As, C of Cs and

    C of Ms are required to accompany every lot shipped to Amway, and should be attached to the

    shipping documents. These certificates are also required to be faxed or emailed to the appropriate

    Quality Assurance (QA) department prior to shipment. Reference Business Requirements > Quality

    > Certificate of Analysis and Business Requirements > Quality > Certificate of Conformance/

    Manufacturing for fax numbers, email addresses, and proper formatting.

    4. Complete a Supplier Self Assessment Form (located on the Supplier Portal under Business

    4.5 Regulatory Requirements

    As a global company with products in over 80 countries and territories, we must adhere to the

    rules and regulations for each market. Please refer to Amway product and material specifications

    for details regarding additional requirements including, but not limited to, the following:

    4.5a Nutrition Raw Material and Regulatory Requirements

    All products and materials supplied into Amway

    NA Operations must meet the regulations and

    requirements of the FDA Food Safety Modernization

    Act. Suppliers are expected to develop and follow their

    All products and materials supplied into Amway NA

    Operations must meet current regulations/requirements for restricted and disallowed ingredients

    per Amway specifications. Contact your Amway Procurement Representative if you have

    Distributors and Raw Material Manufacturers who provide raw materials to our Nutrilite division

    must comply with Food cGMPs; however, Dietary Supplement cGMP compliance is strongly

    recommended. Additional dietary supplement guidance may be found on the Standardized

    Information on Dietary Ingredients (SIDI) website: http://www.crnusa.info/SIDI/index.html. As

    part of Amways Risk Minimization Program, an Amway Procurement Representative or SQD

    Representative may request Technical Regulatory records to support your compliance level.

    Amway desires to use functional botanicals from organically farmed and socially sustainable

    sources. For those sources purchased from suppliers (and not our own certified farms), we have

    developed the NutriCert Auditing program. The NutriCert program ensures our global agricultural

    suppliers meet Nutrilites triple-bottom-line standards. Nutrilites founder, Carl Rehnborg, set

    the bar high for quality farming with his Nutrilite Sustainable Farming System (NSFS) practices.

    It was precisely those quality farming practices that led to the development of quality nutrients

    and supplements. NutriCert has been founded as the vehicle to ensure Carls legacy. The

    guiding principles of our NutriCert standards are based on common NSFS elements familiar to

    all sustainable and certified organic farms: Encourage Diversity, Build Soil, Dont Contaminate,

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    most current specs).

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    Suppliers of botanical ingredients may be subject to the NutriCert auditing program at the farm

    (source) location. Discussions regarding the complete botanical supply chain and the NutriCert

    policy, standards and auditing procedures - are the first steps of cooperation with our program.

    Farms are scored based upon compliance to NutriCert standards, and are certified accordingly.

    NutriCert certification status is integral to Amway Global Procurement sourcing strategies and

    considerations. Now, more than ever, trusted botanical suppliers who demonstrate a willingness

    to provide organically grown raw materials are of great value.

    Raw materials or products that have been irradiated or treated with ethylene oxide are prohibited.

    The following statement is required on CoAs or on signed company letterhead and must

    accompany incoming shipments:

    This raw material (including all sub components such as additives or excipients, and the origin

    feed stock) has not been subjected to irradiation or ethylene oxide treatment.

    Botanical/material that Amway Nutrilite purchases (from origin feed stock to finished material).

    not limited to: preparation, actual extraction, and clean-up of the material produced).

    describing all process steps from Feed Stock through Finished Product.

    Stripping, and/or special Clean-Up processes utilized.

    must clearly define the full Chain of Custody.

    All ingredients for Amway branded products will be non-GMO or Identity Preserved (IP) with a

    recombinant DNA threshold of 0.9% with the exception of flavors, and subcomponents with no

    function or presence in the final formula.

    Suppliers of ingredients where GMO crops exist will be required to provide chain of custody to

    substantiate GMO status.

    Definitions and requirements for GMO Free, Identity Preserved (IP), PCR Negative, and GMO

    Suspect materials can be found on the supplier portal under Business Requirements > Technical

    & Regulatory Affairs > Nutrilite Global GMO Policy.

    Materials or products destined for the Japanese market will need to abide by these regulations, and

    may be subject to Japan Import Testing (JIT). If prohibited materials are naturally occurring, please

    provide documentation. Contact your Amway Procurement Representative or SQD Representative for

    specific information, and refer to Amway product specifications for requirement status.

    Materials or products destined for the Chinese market may be subject to CIQ (China Import and

    Quarantine). Regulations may include, but are not limited to, the following:

    1. Raw materials must meet National Standard requirements or receive pre-approval prior to import.

    2. Full disclosure of the manufacturing process, including process flow diagrams, is required.

    3. Specific requirements related to resin extraction technology must be met.

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    Materials, products or components for use in electrical/

    energy using appliances must meet the current

    or components must be in accordance with Annex XVII

    Materials, products or components must be compliant with

    California Proposition 65 requirements and limits.

    Where applicable, products and/or components must meet and/or be certified and/or recognized

    in accordance with electrical safety standards. This includes the appropriate IEC and/or UL

    standards. Appropriate documentation in the form of test reports or certificates from authorized

    test houses or certifiers is an expectation.

    Products and/or components must meet the appropriate EMC limits in accordance with current

    FCC, IEC, EN, VCCI standards, where applicable. Appropriate documentation in the form of test

    reports or certificates from authorized test houses or certifiers is an expectation.

    Where applicable, materials, products or components intended for use in drinking water treatment

    applications must meet current NSF/ANSI requirements for material safety. Suppliers should

    be prepared to disclose material formulation information directly to NSF International Toxicology

    with foods and the EU requirements for materials in contact with foods. Materials, products or

    components must be compliant with California Proposition 65 requirements and limits.

    The supplier shall provide documentation, where applicable, such as listing of their material on

    List (Canada), and Inventory of Existing Chemical Substances (China).

    4.5d Cosmetic/Beauty/Personal Care Regulatory Requirements

    The supplier shall provide documentation, where applicable, citing compliance with the US Code of

    Domestic Substances List (Canada), and Inventory of Existing Chemical Substances (China).

    Amway routinely ships products and raw materials into the European Union. In 2013, certain

    specified materials which are imported into the European Union (above a designated volume) will

    be considered reportable under this chemical inventory regulation. The Amway Regulatory Affairs

    Department may contact you for more information in regards to the status of your materials and

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    4.6 Packaging & Package Security Requirements

    To ensure product integrity and guard against the possibility of adulteration, Amway

    requires TAMPER-EVIDENT seals and features on all raw material, chemical, and

    component packaging forms.

    Examples of Compliance

    zip-tied. Seal integrity (for paper sacks) is self-evident by its very nature.

    bung covers, zip-ties, etc. Pails are fitted with lids having tamper-evident tear tabs (and/or zip-

    ties). Tankers and Rail Cars have C-TPAT-compliant safety seals at each opening.

    This Amway requirement has been traditionally enforced for all APIs (active pharmaceutical

    ingredients), excipients, and NMIs (non-medicinal ingredients), as well as tankers and rail cars

    subject to the US Governments C-TPAT program.

    the compliance date for enforcement will be

    September 1st, 2011. Non-conforming shipments will be subject to rejection (DMDO) and/or ADR

    (Arrival Defect Report) issuance.

    4.7 Labeling & Lot Traceability Requirements

    Provide properly labeled materials and products per Amway specifications and shipping

    4.8 Shelf Life and Inventory Control Requirements

    Amway seeks to provide our consumers products of the highest possible quality. As such, product

    age and freshness is an important part of that commitment.

    remaining Shelf Life is less than 50%. In cases where suppliers cannot meet this guideline to

    fulfill open orders, we expect suppliers to gain the Prior Approval of their Item Planner and/or Item Buyer, and document this agreement on the Suppliers Certificate of Analysis (to avoid

    rejection at Incoming Inspection).

    With the exception of market-specific item specifications, our suppliers cannot possibly know the

    final destination of their materials (besides the US). In these cases, Amway Item Planners will

    communicate to suppliers, at (or prior to) order placement, these higher Shelf Life needs.

    4.9 Change Control/Request Requirements

    validation, control, and lot traceability including, but not limited to, the following categories:

    1. Changes in sub-suppliers2. Design/Formulation: Any change in materials used or composition of raw material(s)

    3. Processes: Any change to the manufacturing processes or equipment

    4. Facilities: Moving to a different facility, or adding lines to or changing lines within a current facility

    5. Trade Name or INCI (International Nomenclature of Cosmetic Ingredients) name changes

    6. Test Method changes7

    most current specs).

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    allow for any necessary analytical/reliability/market registration/stability/panel testing to be

    performed. Please be sensitive that some changes may take up to 2 years to implement.

    Please reference Business Requirements > Quality > Notification of Process Change on the supplier

    portal for additional information.

    4.10 Shipping Requirements

    obtained from your SQD representative to ship from an unapproved manufacturing location. A copy of

    the authorization must accompany the Certificate of Analysis for each lot shipped from the unapproved

    manufacturing location.

    4.11 Communication Requirements

    4.12 Metrics Requirements

    the Performance Metric section of this manual. If the RFT Quality Rating Average is below 99%,

    suppliers may be asked to provide short and long-term improvement plans to improve their

    performance.

    5.0 Becoming an Amway Supplier

    Becoming an Amway Supplier is a three step process as illustrated below:

    Risk Screening

    ProspectiveSupplier/

    TechnologyIdentified

    SourcingDecision

    BeginPOs

    Financial Risk& Operational

    CapabilityAssessment

    Trials

    Training

    System Set

    Audits

    CapabilityData Review Probationary

    Trial Period

    FormalSegmentation

    SupplierQualification

    Initiated

    TechnologyAssessment/

    Sampling

    Assessment

    Evaluation

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    New suppliers may become qualified and approved for use in our supply chain through the following

    3 elements:

    If Amway expresses interest in qualifying you as an approved source, you may be asked to:

    Business Requirements > Quality > Forms)

    will evaluate your facility, technology, and quality systems (see sQAC in section 7.2.4)

    6.0 Non-Conforming Products and Materials

    Our Incoming Quality Assurance labs perform product and material inspections per ANSI/ASQ Z1.4.Your control plan directed sampling (for Incoming, In-Process, and Finished Good inspections)

    should fully align with all significant characteristics listed on the Amway specification, per the

    following Acceptable Quality Levels (AQL):

    Should your product or material fail to pass incoming inspection, we will issue a Defective Material

    Disposition Order (DMDO). DMDOs are typically communicated via email from either the Incoming

    Quality Assurance group or your Supplier Quality Development (SQD) Representative.

    Amway defines non-conforming product as any Amway purchased product or raw material that fails

    to meet specifications and agreed upon standards. All non-conforming products or materials are

    identified by a DMDO (Defective Material Disposition Order). The DMDO allows for:

    There are four types of DMDOs that can be issued against a supplier:

    our warehouse.

    after they have passed incoming inspection. Amway reserves the right to reject and return any

    defective material discovered at any point during or after the manufacturing process, including

    entire lots/batches, a percentage of a lot/batch, and/or line fall out.

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    Supplier Shipping, Transportation, Quality, and Packaging Requirements.

    received damaged or the actual quantity received does not match the suppliers (and/or carriers)

    shipping documents or master shipper/case label quantities.

    The following table illustrates the supplier actions required based on DMDO type and disposition.

    Please refer to the supplier portal for a guide on reading DMDOs (Business Requirements >

    Quality > Nonconforming Products & Materials).

    Disposition Request Forms are available on the supplier portal (Business Requirements >

    Quality > Forms).

    A Corrective Action/Preventive Action (CAPA) is a supplier created action plan focused on preventing

    a non-conformance from recurring. The CAPA is created in response to a DMDO (Defective Material

    Disposition Order) issued to communicate non-conforming material or an ADR (Arrival Defect Report)issued to communicate shipping, packaging, identification, or paperwork errors that lead to a delay in

    material or product receipt. CAPAs are required for all DMDOs, and must include the following steps:

    The supplier is expected to acknowledge receipt

    of DMDO/ADR communication and CAPA request within 48 hours.

    DMDOType

    Disposition Description Supplier Action

    External

    Incoming

    or External

    In-Process

    Release Under

    Deviation (RUD)

    Disposition notice issued for products,

    raw materials, or components that

    do not meet specifications but are

    accepted by Amway as-is because

    they have minimum impact.

    Complete CAPA

    External

    Incoming

    or External

    In-Process

    Return to

    Vendor (RTV)

    Disposition notice issued for rejected

    products, raw materials or components

    that will be returned to the supplier.

    Complete Disposition

    Request Form;

    Complete CAPA

    External

    Incoming

    or External

    In-Process

    Scrap Vendor

    Expense (SVE)

    Disposition notice issued for

    rejected products, raw materials, or

    components that will be scrapped

    at Amway and charged back to the

    supplier for payment.

    Complete Disposition

    Request Form;

    Complete CAPA

    External

    Incoming

    or External

    In-Process

    Rework Vendor

    Expense (RVE)

    Disposition notice issued for

    rejected products, raw materials, or

    components that will be reworked

    at Amway, but the charges will

    be forwarded to the supplier for

    payment.

    Complete Disposition

    Request Form;

    Complete CAPA

    ADR

    N/A - No

    Financial

    Impact

    Ex. Transportation: Supplier called

    our core carrier directly Ex. Receiving

    Warehouse: Wrong info. on packing

    slip Ex. QA: Missing C of A

    Complete CAPA

    OS&DFreight or

    Supplier Claim

    Ex. Stock damaged during transit

    Ex. PO Quantity does not match the

    sum of the case label quantities.

    Ex. PO Quantity and case labelquantities do not match actual count

    of product within case.

    Claim Authorization

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    Describe the containment actions taken. Containment is required prior to

    any subsequent shipments and must occur within 48 hours.

    Designate what type of fundamental deficiency occurred (manpower,

    materials, methods, machine, environment) to cause the material/component defect. Also, identify

    the Quality System Escape Point(s) and determine root cause of the Quality System failure.

    Describe the action(s) taken to correct the defective material, reduce

    the rate of failure, and reduce the rate of escape. The supplier is expected to provide verification

    that corrective actions performed are effective in eliminating the non-conformity.

    Describe the action(s) taken to eliminate the cause(s) of failure and/

    or escape. The supplier is expected to provide verification that preventive actions performed are

    effective in preventing recurrence.

    Both the Supplier and Amway will provide names and titles of the

    individuals involved in correcting and preventing DMDO/ADR issue(s).

    required prior to any subsequent shipments. Root Cause determination and a Corrective Action

    CAPA request.

    A CAPA guide is available on the supplier portal at: Business Requirements>Quality>Forms

    7.0 Performance Measures/MetricsAmway has a team of Supplier Quality Development (SQD) Representatives focused on partnering

    with key suppliers to drive mutually beneficial improvements in quality, consistency, and service.

    This is accomplished through:

    7.1 MeasuresOur SQD program measures supplier quality performance and continuous improvement as follows:

    7.2 Metrics

    7.2.1 Supplier Scorecard

    The Supplier Scorecard measures supplier performance using key supply chain metrics, and is

    used to determine whether a long or short term relationship will be sought with the supplier.

    Scorecards are available on the supplier portal in the Supplier Analytics section. Contact your

    Procurement Representative to set up access, as this section is password protected. For more

    detailed information on the elements of the Supplier Scorecard, please review the Supplier

    Evaluation. Additional questions should be directed to your Amway Procurement Representative.

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    7.2.2 RFT (Right First Time)

    The RFT metric measures a suppliers ability to meet agreed-upon specifications and requirements.

    Each incoming Purchase Order Line is assigned a score of 100% or 0%. Any Purchase Order Line

    assigned a Supplier-related DMDO or ADR will be assigned a score of 0%. Suppliers are expected

    to maintain or exceed an overall RFT score of 99%. In addition to CAPA requests for individual

    failures, SQD Representatives will require a Supplier Quality Improvement Plan from suppliers with

    RFT scores < 99%.

    Total PO lines with at least one Supplier Related DMDO or ADR

    Total PO lines received

    RFT

    Score ( )= 1-

    7.2.3 sQAC (Supplier Quality Assurance Capability Assessment)

    Amway utilizes Supplier Quality Assurance Capability Assessments to

    Amway reviews 20 key elements when performing audits and Supplier Quality Assurance Capability

    Assessments. These 20 key elements and their descriptions are included in the Appendix of this

    manual. Please reference the Supplier Quality Assurance Capability Assessment tool located under

    Business Requirements > Quality.

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    8.0 Glossary

    ADR

    Arrival Defect Report; issued for inbound shipments not in compliance with Amway supplier

    shipping, transportation, quality, and packaging requirements.

    AQL

    Acceptable Quality Levels

    cGMP

    Current Good Manufacturing Practices

    CAPA

    Corrective Action Preventive Action

    CDA

    Confidentiality Disclosure Agreement

    CERCLA

    Comprehensive Environmental Response, Compensation, and Reliability Act

    CIQ

    China Import and Quarantine

    C of A

    Certificate of Analysis; summarizes testing performed on referenced product/material

    demonstrating its acceptance against the specifications.

    C of C

    Certificate of Compliance; a declaration from a non-consumable item supplier stating the

    referenced product/material meets all requirements, standards, and/or specifications.

    C of M

    Certificate of Manufacture; a declaration from a finished good supplier indicating whether any

    deviations were made to the process or formula laid out in the specifications.

    Corrective Action

    Supplier created action plan focused on containing non-conforming material and determining root

    cause and immediate resolution of issue.

    DMDO

    Defective Material Disposition Order; used to identify and communicate non-conforming products or

    materials which fail to meet specifications and agreed upon standards.

    External Incoming DMDO

    Issued for products found out of specification at time of receipt.

    External In-Process DMDO

    Issued for products found defective or out of specification after passing incoming inspection; may be

    discovered at any point during or after the manufacturing process.

    GMO

    Genetically Modified Organisms

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    INCI

    International Nomenclature of Cosmetic Ingredients

    JIT

    Japanese Import Testing

    OS&D

    Over, Short, and Damage; issued by receiving personnel for shipment received damaged or for

    quantity discrepancies between the actual quantity received and what is documented on the

    shipping papers or master shipper/case labels.

    PO

    Purchase Order

    Preventive Action

    Supplier created action plan focused on preventing a non-conformance from reccurring.

    QAKE

    REACH

    Regulation on Registration, Evaluation, Authorization and Restriction of Chemicals

    RFT

    Right First Time

    RUD

    Release Under Deviation; products/materials that do not meet Amway specifications but are

    accepted as-is due to minimum impact.

    RTV

    Return to Vendor; disposition notice issued for rejected products/materials that will be returned to

    the supplier.

    RVE

    Rework Vendor Expense; disposition notice issued for rejected products/materials that will be

    reworked at Amway but charges will be forwarded to the supplier.

    Root Cause

    Fundamental deficiency that caused the non-conformance to occur

    SARA

    Superfund Amendments and Reauthorization Act

    SIDI

    Standardized Information on Dietary Ingredients

    SQD

    Supplier Quality Development

    SVE

    Scrap Vendor Expense; disposition notice issued for products/materials that will be scrapped atAmway and charged back to the supplier for payment.

    TSCA

    Toxic Substances Control Act

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    9.0 Appendix & References

    1. Leadership

    Senior site management must give personal leadership and define the requirements to encourage

    a quality culture. Individuals and teams should be judged and rewarded for delivering quality

    product on time as well as preventing issues.

    2. Training

    All facilities are staffed with a sufficient number of trained and qualified personnel to ensure thatquality materials are produced and distributed. The training is job specific and includes the relevant

    details of Quality Assurance and Company Policies.

    All buildings and equipment are designed to encourage compliance with good quality procedures. Layouts

    provide sufficient space and direct product flow to help prevent mix-ups. Design and construction facilitate

    easy cleaning, sanitization, preventive maintenance, accurate process measurement capability, and other

    protection from weather, pests, and other sources of contamination.

    4. Technical Standards

    Specifications and standards form the foundation of any Quality System. Operating limits are set

    to ensure compliance with specifications and Regulatory requirements. Once proper limits are set,

    they are rigorously followed. Systems are in place to ensure that only up-to-date specifications and

    standards are in use.

    5. Written Procedures

    In order to achieve consistency of product quality, work processes must be reproducible. The key

    to achieving this reproducibility is well written and consistently followed procedures. Procedural

    change control is managed according to defined and documented procedures.

    6. Validation/Verification

    Products, methods, processes, software, production systems, procedures, and test methods are

    validated where appropriate to ensure they are capable of consistently achieving their desired

    results. Where validation is required, there should be a written procedure specifying which process

    and procedures required validation and the nature and scale of validation.

    All potential sources of contamination, whether biological, chemical, or physical, are identified and

    controlled. The front line of defense is always good, basic housekeeping and maintenance. Where

    products are susceptible to microbial contamination, regular microbiological monitoring is carried out.

    8. Material Control

    The quality of raw materials, packing materials, and components is important to the final quality

    and integrity of products. Starting materials are purchased from approved suppliers according to

    approved specifications. In R&D, starting materials are those materials used in laboratory and pilot

    plant facilities. Starting materials must be controlled upon receipt, during storage, and in use.

    9. Manufacturing Operations

    The quality of the making operation largely determines the quality of the final product. Making

    operations consistently produce high quality product when they convert approved starting materials

    into finished product using properly specified procedures.

    10. Packaging Operations

    Effective package design and packing line performance establishes adequate product protection

    (e.g. damage, identity, contamination, etc.) Lot coding and expiration dating are critical for product

    traceability and, in some cases, for meeting legal requirements. Packing operations consistently

    produce high quality packages when they convert approved starting materials into finished

    packages using properly specified procedures and equipment.

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    Effective handling and distribution operations help ensure high quality product by preventing product

    damage due to the environment, improper handling, or excessively long storage periods.

    12. Laboratory Control

    Professional laboratory operations are critical to the successful control of production. Laboratories

    must have adequate facilities, instrumentation, analytical methods, procedures, record keeping,

    and qualified personnel to ensure that product quality decisions are based upon sound data.

    13. Process Control

    Effective Process Design and Control will consistently deliver high quality product at the lowest

    achieve consistent quality.

    To ensure that only quality products are delivered to customers, good control is established over

    the release of product, shipping practices, inventory control, and returned goods. Robust systems

    ensure that products released for shipment meet all finished product specifications. There is a

    system for handling deviations. There also is a system for retrieving product in case a serious

    problem is identified after a product has been shipped.

    15. Records

    Thorough documentation is good science, makes good business sense, and for some businesses,is a legal requirement. Records enable us to investigate complaints, spot trends, make product

    improvements, establish a paper trail for research, and maintain the ability to retrieve product should

    that ever be necessary. Accuracy and timeliness are critical parameters for a useful records system.

    16. Internal Audits

    An Internal Audit Program is an effective tool used to ensure the quality of our products and

    compliance with corporate and government regulations. A well functioning internal audit program

    identifies and corrects in a timely manner any deficiencies present in the sites quality system and

    causes permanent systemic solutions to be implemented.

    17. Customer Learning & Response

    Customer and consumer complaints are a significant source of information concerning the design

    and perceived performance of products. It is essential that all information received in the complaint

    system is recorded accurately and acted upon promptly. When reported, problems must be

    investigated to determine if products not complying with specifications or presenting a risk to

    the consumer have been distributed. Complaints can also be an important source of product

    improvement ideas.

    18. Quality Metrics Tracking & Improvement

    Measurement, tracking and improvement of results are a key Total Quality principle. We know how

    systems are performing so that priorities and improvement efforts can be established and tracked. Each

    operation in R&D and product supply establishes results tracking systems for their key Quality Assurance

    systems to paint an accurate picture of the current state and identify needs for improvement.

    19. Accountability for SuppliersEach Amway supplier retains primary responsibility for the quality for any sub-supplier they use. This

    whom they are responsible.

    20. Safety & Security

    Facility management is expected to communicate requirements for workplace health and safety to its

    employees. Adequate and compliant safety training is supplied and documented. Controlled access

    to facilities and to sensitive areas is restricted to qualified individuals. Systems need to be in place

    to adequately protect materials and prevent product diversion. Processes are necessary to protect

    proprietary information and protect the security and reputation of the Amway business.

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