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  • Case for Quality Library - Appendix B - Site navigation and instructions

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    Category B:How Do You translate Customer

    Requirements into CtQs?

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    Category B:How Do You translate Customer

    Requirements into CtQs?

    http://advamed.org/res.download/759

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    Table of ContentsPractices to Translate Customer Requirements into CtQs

    1. Quality Functional Deployment model, QFD2. Requirements Cascade3. Key Tools4. Risk Management5. Quality Tree model6. Design and Process CTQs7. CTQ Cascade model8. CTQ Flow-down model9. Managing Requirements10. Critical Parameter Management Process Model11. Critical Quality Attributes (CQA) Model

    1. Quality Functional Deployment model, QFD2. Requirements Cascade3. Key Tools4. Risk Management5. Quality Tree model6. Design and Process CTQs7. CTQ Cascade model8. CTQ Flow-down model9. Managing Requirements10. Critical Parameter Management Process Model11. Critical Quality Attributes (CQA) Model

    Practices to Translate Customer Requirements into CtQs

    http://advamed.org/res.download/759

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    Quality Function DeploymentModel

    http://advamed.org/res.download/759

  • BCompany:nextbackmain hometoc

    Tool/Method/Example Summary Tool/Example Name: Quality Function Deployment (QFD)

    General Description:Process to translate Qualitative Customer requirements into Weighted &Prioritized Quantitative Design, Engineering and Manufacturing requirements

    Glossary of terms: House of Quality Common QFD matrix used to translate Qualitative

    Customer Requirements into Quantitative Design requirements VOC Voice of Customer

    Typical Uses: New Product Development

    Relevant FDA Regulations: 21 C.F.R. 820.30(c) Design Input, (d) Design Output

    Medical Devices 10,001 + employees Global

    Tool/Example Name: Quality Function Deployment (QFD)

    General Description:Process to translate Qualitative Customer requirements into Weighted &Prioritized Quantitative Design, Engineering and Manufacturing requirements

    Glossary of terms: House of Quality Common QFD matrix used to translate Qualitative

    Customer Requirements into Quantitative Design requirements VOC Voice of Customer

    Typical Uses: New Product Development

    Relevant FDA Regulations: 21 C.F.R. 820.30(c) Design Input, (d) Design Output

    Practices to Translate Customer Requirements into CtQs

    http://advamed.org/res.download/759

  • FCompany:nextbackmain hometoc

    Tool/Method/Example Summary Tool/Example Name: House of Quality (HofQ)

    General Description:HofQ is a template used to Cascade requirements when utilizing QFD, including: Customer requirements vs. Design requirements Design requirements vs. Engineering design Engineering design vs. Product Characteristics Product characteristics vs. Manufacturing operations requirements Manufacturing operations requirements vs. Production/ controls

    Glossary of terms: QFD, Quality Function Deployment, links the needs of the customer with product design,

    manufacturing and service functions. Typical Uses:

    HofQ is utilized during the design process to better understand 'true' customer needs and whatvalue means from the customer's perspective

    Relevant FDA Regulations: Applicable throughout design controls (21 C.F.R. 820.30)

    Hospital & Health Care 10,001 + employees Global

    Tool/Example Name: House of Quality (HofQ)

    General Description:HofQ is a template used to Cascade requirements when utilizing QFD, including: Customer requirements vs. Design requirements Design requirements vs. Engineering design Engineering design vs. Product Characteristics Product characteristics vs. Manufacturing operations requirements Manufacturing operations requirements vs. Production/ controls

    Glossary of terms: QFD, Quality Function Deployment, links the needs of the customer with product design,

    manufacturing and service functions. Typical Uses:

    HofQ is utilized during the design process to better understand 'true' customer needs and whatvalue means from the customer's perspective

    Relevant FDA Regulations: Applicable throughout design controls (21 C.F.R. 820.30)

    Practices to Translate Customer Requirements into CtQs

    http://advamed.org/res.download/759

  • ACompany: Medical Devices 1001-5000 employees North Americanextbackmain hometoc

    Tool/Method/Example Summary Tool/Example Name: QFD

    General Description:QFD is used to translate customer needs (whats) into system parameters (hows)and to identify those system parameters which have the biggest impact oncustomer satisfaction

    Glossary of terms: House of Quality: Also called QFD [Quality Function Deployment] is tool used

    to systematically translate customer requirements into quantitativeparameters that can be used to develop a concept and select a productsolution.

    Typical Uses: QFD is used translate needs statements into measureable requirements

    Relevant FDA Regulations: Applicable to (21 C.F.R. 820.30)

    Tool/Example Name: QFD

    General Description:QFD is used to translate customer needs (whats) into system parameters (hows)and to identify those system parameters which have the biggest impact oncustomer satisfaction

    Glossary of terms: House of Quality: Also called QFD [Quality Function Deployment] is tool used

    to systematically translate customer requirements into quantitativeparameters that can be used to develop a concept and select a productsolution.

    Typical Uses: QFD is used translate needs statements into measureable requirements

    Relevant FDA Regulations: Applicable to (21 C.F.R. 820.30)

    Practices to Translate Customer Requirements into CtQs

    http://advamed.org/res.download/759

  • ACompany: Medical Devices 1001-5000 employees North Americanextbackmain hometoc

    Practices to Translate Customer Requirements into CtQs

    http://advamed.org/res.download/759

  • ACompany: Medical Devices 1001-5000 employees North Americanextbackmain hometoc

    Core Process Using Quality FunctionDeployment

    House of Quality used to Cascade requirements Customer requirements vs. Design requirements Design requirements vs. Engineering design Engineering design vs. Product Characteristics Product characteristics vs. Manufacturing

    operations requirements Manufacturing operations requirements vs.

    Production/ controls Consider the Other Voices Business & Process

    House of Quality used to Cascade requirements Customer requirements vs. Design requirements Design requirements vs. Engineering design Engineering design vs. Product Characteristics Product characteristics vs. Manufacturing

    operations requirements Manufacturing operations requirements vs.

    Production/ controls Consider the Other Voices Business & Process

    Practices to Translate Customer Requirements into CtQs

    http://advamed.org/res.download/759

  • ACompany: Medical Devices 1001-5000 employees North Americanextbackmain hometoc

    ROOF

    Strong Synergy ++Synergy + Strong 9 Competition Key:

    Weak Conflict X Medium 3

    High Conflict XX Weak 1Machine

    1Machine

    2Machine

    3

    Customers' Desired Outcomes

    Primary Want 1 2 3 4 5ExcellentCompany Party 9 9 3 9 9 5.0

    3 3 3 9 9 3.0

    1 9 3 9 1.09 3 9 1.0

    CTQ Priority 55 18 45 9 30 90 72 0 0 0 0 0 0 0 0 0 0 319% Importance 17 6 14 3 9 28 23

    PREDICTIVE

    MEASURES

    =

    CTQ'S

    HOW IMPORTANT

    Direction ofImprovement

    CORRELATION ROOM 4

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