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Category B: How Do You translate Customer Requirements into CtQs? main next home Practic es To
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Requirements into CtQs?
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Practic es To Translate Customer
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Practices to Translate Customer Requirements into CtQs

Practices to Translate Customer Requirements into CtQs main back next <a href=home Table of Contents Practices to Translate Customer Requirements into CtQs 1. Quality Functional Deployment model, QFD 2. Requirements Cascade 3. Key Tools 4. Risk Management 5. Quality Tree model 6. Design and Process CTQs 7. CTQ Cascade model 8. CTQ Flow-down model 9. Managing Requirements 10. Critical Parameter Management Process Model 11. Critical Quality Attributes (CQA) Model " id="pdf-obj-2-4" src="pdf-obj-2-4.jpg">
Practices to Translate Customer Requirements into CtQs main back next <a href=home Table of Contents Practices to Translate Customer Requirements into CtQs 1. Quality Functional Deployment model, QFD 2. Requirements Cascade 3. Key Tools 4. Risk Management 5. Quality Tree model 6. Design and Process CTQs 7. CTQ Cascade model 8. CTQ Flow-down model 9. Managing Requirements 10. Critical Parameter Management Process Model 11. Critical Quality Attributes (CQA) Model " id="pdf-obj-2-6" src="pdf-obj-2-6.jpg">

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Table of Contents

Practices to Translate Customer Requirements into CtQs

1. Quality Functional Deployment model, QFD
  • 1. Quality Functional Deployment model, QFD

2. Requirements Cascade
  • 2. Requirements Cascade

3. Key Tools
  • 3. Key Tools

4. Risk Management
  • 4. Risk Management

5. Quality Tree model
  • 5. Quality Tree model

6. Design and Process CTQs
  • 6. Design and Process CTQs

7. CTQ Cascade model
  • 7. CTQ Cascade model

8. CTQ Flow-down model
  • 8. CTQ Flow-down model

9. Managing Requirements
  • 9. Managing Requirements

10. Critical Parameter Management Process Model

10. Critical Parameter Management Process Model

11. Critical Quality Attributes (CQA) Model

11. Critical Quality Attributes (CQA) Model

Practices to Translate Customer Requirements into CtQs main back next <a href=home Table of Contents Practices to Translate Customer Requirements into CtQs 1. Quality Functional Deployment model, QFD 2. Requirements Cascade 3. Key Tools 4. Risk Management 5. Quality Tree model 6. Design and Process CTQs 7. CTQ Cascade model 8. CTQ Flow-down model 9. Managing Requirements 10. Critical Parameter Management Process Model 11. Critical Quality Attributes (CQA) Model " id="pdf-obj-2-89" src="pdf-obj-2-89.jpg">
Quality Function Deployment Model toc main back next home Pr actices To Translate Customer Requirements Into
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Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: B Medical Devices 10,001 + employees Global 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 " id="pdf-obj-4-6" src="pdf-obj-4-6.jpg">

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Company: B Medical Devices 10,001 + employees Global
Company:
B
Medical Devices
10,001 + employees
Global
Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: B Medical Devices 10,001 + employees Global 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 " id="pdf-obj-4-20" src="pdf-obj-4-20.jpg">

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

Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: B Medical Devices 10,001 + employees Global 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 " id="pdf-obj-4-62" src="pdf-obj-4-62.jpg">

Practices to Translate Customer Requirements into CtQs

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Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: F Hospital & Health Care 10,001 + employees Global 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 what value means from the customer's perspective Relevant FDA Regulations: Applicable throughout design controls (21 C.F.R. § 820.30) " id="pdf-obj-5-6" src="pdf-obj-5-6.jpg">

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Company: F Hospital & Health Care 10,001 + employees Global
Company:
F
Hospital & Health Care
10,001 + employees
Global
Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: F Hospital & Health Care 10,001 + employees Global 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 what value means from the customer's perspective Relevant FDA Regulations: Applicable throughout design controls (21 C.F.R. § 820.30) " id="pdf-obj-5-20" src="pdf-obj-5-20.jpg">

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 what value 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 toc main back next <a href=home Company: F Hospital & Health Care 10,001 + employees Global 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 what value means from the customer's perspective Relevant FDA Regulations: Applicable throughout design controls (21 C.F.R. § 820.30) " id="pdf-obj-5-85" src="pdf-obj-5-85.jpg">

Practices to Translate Customer Requirements into CtQs

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Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: A Medical Devices 1001-5000 employees North America 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 on customer satisfaction Glossary of terms: House of Quality : Also called QFD [Quality Function Deployment] is tool used to systematically translate customer requirements into quantitative parameters that can be used to develop a concept and select a product solution. Typical Uses: QFD is used translate needs statements into measureable requirements Relevant FDA Regulations: Applicable to (21 C.F.R. § 820.30) " id="pdf-obj-6-6" src="pdf-obj-6-6.jpg">

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Company: A Medical Devices 1001-5000 employees North America
Company:
A
Medical Devices
1001-5000 employees
North America
Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: A Medical Devices 1001-5000 employees North America 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 on customer satisfaction Glossary of terms: House of Quality : Also called QFD [Quality Function Deployment] is tool used to systematically translate customer requirements into quantitative parameters that can be used to develop a concept and select a product solution. Typical Uses: QFD is used translate needs statements into measureable requirements Relevant FDA Regulations: Applicable to (21 C.F.R. § 820.30) " id="pdf-obj-6-20" src="pdf-obj-6-20.jpg">

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 on customer satisfaction

Glossary of terms:

House of Quality: Also called QFD [Quality Function Deployment] is tool used to systematically translate customer requirements into quantitative parameters that can be used to develop a concept and select a product solution.

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 toc main back next <a href=home Company: A Medical Devices 1001-5000 employees North America 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 on customer satisfaction Glossary of terms: House of Quality : Also called QFD [Quality Function Deployment] is tool used to systematically translate customer requirements into quantitative parameters that can be used to develop a concept and select a product solution. Typical Uses: QFD is used translate needs statements into measureable requirements Relevant FDA Regulations: Applicable to (21 C.F.R. § 820.30) " id="pdf-obj-6-57" src="pdf-obj-6-57.jpg">

Practices to Translate Customer Requirements into CtQs

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Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: A Medical Devices 1001-5000 employees North America " id="pdf-obj-7-6" src="pdf-obj-7-6.jpg">

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Company: A Medical Devices 1001-5000 employees North America
Company:
A
Medical Devices
1001-5000 employees
North America
Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: A Medical Devices 1001-5000 employees North America " id="pdf-obj-7-21" src="pdf-obj-7-21.jpg">
Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: A Medical Devices 1001-5000 employees North America " id="pdf-obj-7-23" src="pdf-obj-7-23.jpg">

Practices to Translate Customer Requirements into CtQs

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Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: A Medical Devices 1001-5000 employees North America Core Process Using Quality Function Deployment 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 " id="pdf-obj-8-6" src="pdf-obj-8-6.jpg">

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Company: A Medical Devices 1001-5000 employees North America
Company:
A
Medical Devices
1001-5000 employees
North America

Core Process Using Quality Function Deployment

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 toc main back next <a href=home Company: A Medical Devices 1001-5000 employees North America Core Process Using Quality Function Deployment 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 " id="pdf-obj-8-48" src="pdf-obj-8-48.jpg">

Practices to Translate Customer Requirements into CtQs

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Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: A Medical Devices 1001-5000 employees North America QFD Tool example QFD HOUSE 1 ROOF: CORRELATION P M R E Star rating of facilty event satisfaction score E A C D S # custom er com plaints T I U Q C R ' T E # cu feet per person # entrée options S I S V E = noise level taste rating Direction of ROOF Improvement CORRELATION ROOM 4 PREDICTIVE MEASURES =CTQ'S RELATIONSHIP KEY Strong Synergy ++ Synergy + 9 Strong Competition Key: Weak Conflict X Medium 3 Machine Machine Machine Weak 1 High Conflict XX 1 2 3 Customers' Desired Outcomes CUSTOMER PERCEPTION: SATISFACTION LEVEL Primary Want Secondary Want 1 2 3 4 5 Excellent Compan y Party good food 9 9 3 9 9 5.0 good music 3 3 3 9 9 3.0 able to converse without screaming easy to mingle around 1 9 3 9 1.0 9 3 9 1.0 CTQ Priority 55 18 45 9 30 90 72 0 0 0 0 0 0 0 0 0 0 319 HOW IMPORTANT % Importance 17 6 14 3 9 28 23 taste rating noise level # entrée options # cu feet per person # customer complaints event satisfaction scor e Star rating of facilty Importance " id="pdf-obj-9-6" src="pdf-obj-9-6.jpg">

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Company: A Medical Devices 1001-5000 employees North America
Company:
A
Medical Devices
1001-5000 employees
North America

QFD Tool example

QFD HOUSE 1

ROOF: CORRELATION P M R E Star rating of facilty event satisfaction score E A C
ROOF: CORRELATION
P
M
R
E
Star rating of facilty
event satisfaction score
E
A
C
D
S
# custom er com plaints
T
I
U
Q
C
R
'
T
E
# cu feet per person
# entrée options
S
I
S
V
E
=
noise level
taste rating
Direction of
ROOF
Improvement
CORRELATION
ROOM 4
PREDICTIVE MEASURES =CTQ'S
RELATIONSHIP KEY
Strong Synergy
++
Synergy
+
9
Strong
Competition Key:
Weak Conflict
X
Medium
3
Machine
Machine
Machine
Weak
1
High Conflict
XX
1
2
3
Customers' Desired Outcomes
CUSTOMER PERCEPTION:
SATISFACTION LEVEL
Primary Want
Secondary Want
1
2
3
4
5
Excellent
Compan
y Party
good food
9
9 3
9
9
5.0
good music
3
3
3
9
9
3.0
able to converse without
screaming
easy to mingle around
1
9
3
9
1.0
9
3
9
1.0
CTQ Priority
55
18 45
9 30
90
72
0
0 0
0
0 0
0
0 0
0 319
HOW IMPORTANT
% Importance
17
6 14
3
9 28
23
taste rating
noise level
# entrée options
# cu feet per person
# customer complaints
event satisfaction scor e
Star rating of facilty
Importance
Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: A Medical Devices 1001-5000 employees North America QFD Tool example QFD HOUSE 1 ROOF: CORRELATION P M R E Star rating of facilty event satisfaction score E A C D S # custom er com plaints T I U Q C R ' T E # cu feet per person # entrée options S I S V E = noise level taste rating Direction of ROOF Improvement CORRELATION ROOM 4 PREDICTIVE MEASURES =CTQ'S RELATIONSHIP KEY Strong Synergy ++ Synergy + 9 Strong Competition Key: Weak Conflict X Medium 3 Machine Machine Machine Weak 1 High Conflict XX 1 2 3 Customers' Desired Outcomes CUSTOMER PERCEPTION: SATISFACTION LEVEL Primary Want Secondary Want 1 2 3 4 5 Excellent Compan y Party good food 9 9 3 9 9 5.0 good music 3 3 3 9 9 3.0 able to converse without screaming easy to mingle around 1 9 3 9 1.0 9 3 9 1.0 CTQ Priority 55 18 45 9 30 90 72 0 0 0 0 0 0 0 0 0 0 319 HOW IMPORTANT % Importance 17 6 14 3 9 28 23 taste rating noise level # entrée options # cu feet per person # customer complaints event satisfaction scor e Star rating of facilty Importance " id="pdf-obj-9-28" src="pdf-obj-9-28.jpg">

Practices to Translate Customer Requirements into CtQs

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Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: A Medical Devices 1001-5000 employees North America The 5 Core Principles 1. Product design is simply the successive refinement of requirements All specifications are simply means to communicate requirements to the next level of hierarchy through an unbroken cascade. 2. Nothing is more important to success than managing requirements Requirements must be complete, concise, unambiguous, measurable and wholly transparent to all participants. They are the basis for schedules, reviews, testing, metrics, regulatory submissions, customer satisfaction, and continuous improvement. 3. Mitigations and residual risks are requirements that must be managed All failure modes, including use error & foreseeable misuse, must be traced to hazardous situations & all hazardous situations must be traced to potential harms. 4. Evidence of conformance must identify the design configuration Prototypes are cost, not progress. Learning is progress. Configurations used for verification must include assessments showing the configuration tested is equivalent to the design being r eleased. 5. Program Management relies on standard work and objective metrics # + requirements, # + protocols w/GR&R, # + protocols run, % + req verified, % + processes w/capability estimated, % + processes w/capability verified. Chronological hours since last formal customer feedback, fever chart $$ vs plan. You are currently viewin g a featured section of AdvaMed's Case for Quality Library. To view AdvaMed's Case for Quality website, clic k H E R E . To view the full slide deck of AdvaMed's Design Control recommendations, clic k HERE . " id="pdf-obj-10-6" src="pdf-obj-10-6.jpg">

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Company: A Medical Devices 1001-5000 employees North America
Company:
A
Medical Devices
1001-5000 employees
North America

The 5 Core Principles

  • 1. Product design is simply the successive refinement of requirements All specifications are simply means to communicate requirements to the next level of hierarchy through an unbroken cascade.

  • 2. Nothing is more important to success than managing requirements Requirements must be complete, concise, unambiguous, measurable and wholly transparent to all participants. They are the basis for schedules, reviews, testing, metrics, regulatory submissions, customer satisfaction, and continuous improvement.

  • 3. Mitigations and residual risks are requirements that must be managed All failure modes, including use error & foreseeable misuse, must be traced to hazardous situations & all hazardous situations must be traced to potential harms.

  • 4. Evidence of conformance must identify the design configuration Prototypes are cost, not progress. Learning is progress. Configurations used for verification must include assessments showing the configuration tested is equivalent to the design being released.

  • 5. Program Management relies on standard work and objective metrics # + requirements, # + protocols w/GR&R, # + protocols run, % + req verified, % + processes w/capability estimated, % + processes w/capability verified. Chronological hours since last formal customer feedback, fever chart $$ vs plan.

Requirements Cascade toc main back next home Pr actices To Translate Customer Requirements Into CtQs
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Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: A Medical Devices 1001-5000 employees North America Tool/Method/Example Summary Tool/Example Name : Requirements Cascade DHF/DMR General Description: A graphical representation of a requirements cascade where parent requirements are translated to child requirements via a transfer function. Glossary of terms: Transfer Function is a mathematical representation of the relationship between a set of design factors and output variables. Typical Uses: Translates the sensitivities of the top-level requirement to lower-level requirements through a relationship equation Relevant FDA Regulations: Applicable throughout the design control (21 C.F.R. § 820.30) and linkages to DHF (21 C.F.R. § 820.30(j)) " id="pdf-obj-12-6" src="pdf-obj-12-6.jpg">

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Company: A Medical Devices 1001-5000 employees North America
Company:
A
Medical Devices
1001-5000 employees
North America
Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: A Medical Devices 1001-5000 employees North America Tool/Method/Example Summary Tool/Example Name : Requirements Cascade DHF/DMR General Description: A graphical representation of a requirements cascade where parent requirements are translated to child requirements via a transfer function. Glossary of terms: Transfer Function is a mathematical representation of the relationship between a set of design factors and output variables. Typical Uses: Translates the sensitivities of the top-level requirement to lower-level requirements through a relationship equation Relevant FDA Regulations: Applicable throughout the design control (21 C.F.R. § 820.30) and linkages to DHF (21 C.F.R. § 820.30(j)) " id="pdf-obj-12-20" src="pdf-obj-12-20.jpg">

Tool/Method/Example Summary

Tool/Example Name: Requirements Cascade DHF/DMR

General Description:

A graphical representation of a requirements cascade where parent requirements are translated to child requirements via a transfer function.

Glossary of terms:

Transfer Function is a mathematical representation of the relationship between a set of design factors and output variables.

Typical Uses:

Translates the sensitivities of the top-level requirement to lower-level requirements through a relationship equation

Relevant FDA Regulations:

Applicable throughout the design control (21 C.F.R. § 820.30) and linkages to DHF (21 C.F.R. § 820.30(j))

Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: A Medical Devices 1001-5000 employees North America Tool/Method/Example Summary Tool/Example Name : Requirements Cascade DHF/DMR General Description: A graphical representation of a requirements cascade where parent requirements are translated to child requirements via a transfer function. Glossary of terms: Transfer Function is a mathematical representation of the relationship between a set of design factors and output variables. Typical Uses: Translates the sensitivities of the top-level requirement to lower-level requirements through a relationship equation Relevant FDA Regulations: Applicable throughout the design control (21 C.F.R. § 820.30) and linkages to DHF (21 C.F.R. § 820.30(j)) " id="pdf-obj-12-59" src="pdf-obj-12-59.jpg">

Practices to Translate Customer Requirements into CtQs

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Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: A Medical Devices 1001-5000 employees North America Requirements Cascade y Requirement f( ) x REQ 1 REQ 2 REQ 3 REQ 1-1 REQ 1-2 REQ 1-3 REQ 1-4 REQ 1-1 REQ 1-2 3 elements of a cascade REQ 1-1 REQ 1-2 REQ 1-3 Parent requirement [y] Child requirement [x] Y Requirements guide concept Transfer function [f()] development and selection Concepts dictate transfer functions From The METHOD, multiple copyrights Design worksheets determine Xs 2006-2013 " id="pdf-obj-13-6" src="pdf-obj-13-6.jpg">

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Company: A Medical Devices 1001-5000 employees North America
Company:
A
Medical Devices
1001-5000 employees
North America

Requirements Cascade

y Requirement f( ) x REQ 1 REQ 2 REQ 3
y
Requirement
f( )
x
REQ 1
REQ 2
REQ 3
REQ 1-1 REQ 1-2 REQ 1-3 REQ 1-4
REQ 1-1
REQ 1-2
REQ 1-3
REQ 1-4
REQ 1-1 REQ 1-2
REQ 1-1
REQ 1-2

3 elements of a cascade

REQ 1-1

REQ 1-2

REQ 1-3

Parent requirement [y]

 

Child requirement [x]

 

Y Requirements guide concept

Transfer function [f()]

development and selection

 

Concepts dictate transfer functions

From The METHOD, multiple copyrights

 

Design worksheets determine Xs

 

2006-2013

Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: A Medical Devices 1001-5000 employees North America Requirements Cascade y Requirement f( ) x REQ 1 REQ 2 REQ 3 REQ 1-1 REQ 1-2 REQ 1-3 REQ 1-4 REQ 1-1 REQ 1-2 3 elements of a cascade REQ 1-1 REQ 1-2 REQ 1-3 Parent requirement [y] Child requirement [x] Y Requirements guide concept Transfer function [f()] development and selection Concepts dictate transfer functions From The METHOD, multiple copyrights Design worksheets determine Xs 2006-2013 " id="pdf-obj-13-94" src="pdf-obj-13-94.jpg">

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Company: A Medical Devices 1001-5000 employees North America
Company:
A
Medical Devices
1001-5000 employees
North America
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Key Tools toc main back next home Pr actices To Translate Customer Requirements Into CtQs
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Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: B Medical Devices 10,001 + employees Global Key tools used By Phase Concept Definition VOC Monte Carlo g athering M odels KJ VOC Analysis QFD / HoQ Concep t E val & Selection - Pugh Matrix Development Qualification Critical Parameter M anagement Critical Parameter M anagement Design / Application FMEA Design Capability Assessme nt Measurement Systems Analysis (M SA) M fg Capability Assessment Screening / Advanced DOE s T ransfer Functions : Defined, Ranked & Prioritized Monte Carlo simulations " id="pdf-obj-16-6" src="pdf-obj-16-6.jpg">

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Company: B Medical Devices 10,001 + employees Global
Company:
B
Medical Devices
10,001 + employees
Global

Key tools used By Phase

Concept

Definition

VOC

Monte Carlo

gathering

Models

 

KJ VOC

Analysis QFD / HoQ

Concept Eval & Selection - Pugh Matrix

Development

Qualification

Critical Parameter Management

Critical Parameter Management

Design / Application FMEA

Design Capability Assessment

Measurement Systems Analysis (MSA)

Mfg Capability Assessment

Screening /

Advanced

DOE s

Transfer Functions : Defined, Ranked & Prioritized

 

Monte Carlo

simulations

Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: B Medical Devices 10,001 + employees Global Key tools used By Phase Concept Definition VOC Monte Carlo g athering M odels KJ VOC Analysis QFD / HoQ Concep t E val & Selection - Pugh Matrix Development Qualification Critical Parameter M anagement Critical Parameter M anagement Design / Application FMEA Design Capability Assessme nt Measurement Systems Analysis (M SA) M fg Capability Assessment Screening / Advanced DOE s T ransfer Functions : Defined, Ranked & Prioritized Monte Carlo simulations " id="pdf-obj-16-150" src="pdf-obj-16-150.jpg">

Practices to Translate Customer Requirements into CtQs

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Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: I Medical Devices 10,001 + employees Global Tool/Method/Example Summary Focus Groups, Feature Ranking, Online Survey, Feature Value- Cost Analysis, Spider Maps, Conjoint Analysis General Description: Tools to establish customer requirements and to rank them based on value points, cost etc. Glossary of terms: Importance scaling, sorting and scaling, forced ranking, feature trade-off Scatter Plot, Must Haves , Jewels , Peanuts , Black Hole Typical Uses: Tools to determine and analyze customer requirements ( VOC ) Relevant FDA Regulations: N/A Relevant FDA Regulations: These tie the VOC and marketing requirements to design inputs, including part risk classification determination of CtQ in the design controls process. " id="pdf-obj-17-6" src="pdf-obj-17-6.jpg">

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Company: I Medical Devices 10,001 + employees Global
Company:
I
Medical Devices
10,001 + employees
Global
Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: I Medical Devices 10,001 + employees Global Tool/Method/Example Summary Focus Groups, Feature Ranking, Online Survey, Feature Value- Cost Analysis, Spider Maps, Conjoint Analysis General Description: Tools to establish customer requirements and to rank them based on value points, cost etc. Glossary of terms: Importance scaling, sorting and scaling, forced ranking, feature trade-off Scatter Plot, Must Haves , Jewels , Peanuts , Black Hole Typical Uses: Tools to determine and analyze customer requirements ( VOC ) Relevant FDA Regulations: N/A Relevant FDA Regulations: These tie the VOC and marketing requirements to design inputs, including part risk classification determination of CtQ in the design controls process. " id="pdf-obj-17-20" src="pdf-obj-17-20.jpg">

Tool/Method/Example Summary

Tool/Example Name: Focus Groups, Feature Ranking, Online Survey, Feature Value- Cost Analysis, Spider Maps, Conjoint Analysis

General Description:

Tools to establish customer requirements and to rank them based on value points, cost etc.

Glossary of terms:

Importance scaling, sorting and scaling, forced ranking, feature trade-off Scatter Plot, Must Haves , Jewels , Peanuts , Black Hole

Typical Uses:

Tools to determine and analyze customer requirements ( VOC )

Relevant FDA Regulations:

N/A

Relevant FDA Regulations:

These tie the VOC and marketing requirements to design inputs, including part risk classification determination of CtQ in the design controls process.

Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: I Medical Devices 10,001 + employees Global Tool/Method/Example Summary Focus Groups, Feature Ranking, Online Survey, Feature Value- Cost Analysis, Spider Maps, Conjoint Analysis General Description: Tools to establish customer requirements and to rank them based on value points, cost etc. Glossary of terms: Importance scaling, sorting and scaling, forced ranking, feature trade-off Scatter Plot, Must Haves , Jewels , Peanuts , Black Hole Typical Uses: Tools to determine and analyze customer requirements ( VOC ) Relevant FDA Regulations: N/A Relevant FDA Regulations: These tie the VOC and marketing requirements to design inputs, including part risk classification determination of CtQ in the design controls process. " id="pdf-obj-17-79" src="pdf-obj-17-79.jpg">

Practices to Translate Customer Requirements into CtQs

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Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: I Medical Devices 10,001 + employees Global How Do You Translate Customer Requirements into CtQs? Through The Use of State of the Art Tools for Each DfX Pillar & A Phased Discipline approach to Design and Product Realization DDFF XX DF CE = Customer Experience DF R = Reliability DF M = Manufacturability DF S = Serviceability DF C = Cost " id="pdf-obj-18-6" src="pdf-obj-18-6.jpg">

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Company: I Medical Devices 10,001 + employees Global
Company:
I
Medical Devices
10,001 + employees
Global

How Do You Translate Customer Requirements into CtQs?

Through The Use of State of the Art Tools for Each DfX Pillar & A Phased Discipline approach to Design and Product Realization

DDFF XX DF CE = Customer Experience DF R = Reliability DF M = Manufacturability DF
DDFF XX
DF CE = Customer Experience
DF R
= Reliability
DF M
= Manufacturability
DF S
= Serviceability
DF C
= Cost
Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: I Medical Devices 10,001 + employees Global How Do You Translate Customer Requirements into CtQs? Through The Use of State of the Art Tools for Each DfX Pillar & A Phased Discipline approach to Design and Product Realization DDFF XX DF CE = Customer Experience DF R = Reliability DF M = Manufacturability DF S = Serviceability DF C = Cost " id="pdf-obj-18-27" src="pdf-obj-18-27.jpg">

Practices to Translate Customer Requirements into CtQs

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Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: I Medical Devices 10,001 + employees Global Tool/Method/Example Summary Tool/Example Name : Part Risk Classification , DFMEA, PFMEA, Pareto Analysis, Cause-and-Effect Diagram, 2x5xWhy General Description: Tools to classify parts as part of design outputs, identify critical to quality characteristics (CtQs), flow down of CtQs for part and process to manufacturing and suppliers via design transfer. Glossary of terms: Product attributes critical to quality (parts, modules, features), Common failure modes, Top risks of product failure Typical Uses: To identify critical to quality features or process characteristics that are critical determinants of quality, failure modes, risk management and risk mitigation Relevant FDA Regulations: 21 C.F.R. §§ 820.30, 820.50, 820.70 Relevant FDA Regulations: These tie to design for customer experience, manufacturability, reliability, serviceability, and value engineering. They also tie to process and product quality assurance, design innovation and software quality assurance. " id="pdf-obj-19-6" src="pdf-obj-19-6.jpg">

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Company: I Medical Devices 10,001 + employees Global
Company:
I
Medical Devices
10,001 + employees
Global
Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: I Medical Devices 10,001 + employees Global Tool/Method/Example Summary Tool/Example Name : Part Risk Classification , DFMEA, PFMEA, Pareto Analysis, Cause-and-Effect Diagram, 2x5xWhy General Description: Tools to classify parts as part of design outputs, identify critical to quality characteristics (CtQs), flow down of CtQs for part and process to manufacturing and suppliers via design transfer. Glossary of terms: Product attributes critical to quality (parts, modules, features), Common failure modes, Top risks of product failure Typical Uses: To identify critical to quality features or process characteristics that are critical determinants of quality, failure modes, risk management and risk mitigation Relevant FDA Regulations: 21 C.F.R. §§ 820.30, 820.50, 820.70 Relevant FDA Regulations: These tie to design for customer experience, manufacturability, reliability, serviceability, and value engineering. They also tie to process and product quality assurance, design innovation and software quality assurance. " id="pdf-obj-19-20" src="pdf-obj-19-20.jpg">

Tool/Method/Example Summary

Tool/Example Name: Part Risk Classification, DFMEA, PFMEA, Pareto Analysis, Cause-and-Effect Diagram, 2x5xWhy

General Description:

Tools to classify parts as part of design outputs, identify critical to quality characteristics (CtQs), flow down of CtQs for part and process to manufacturing and suppliers via design transfer.

Glossary of terms:

Product attributes critical to quality (parts, modules, features), Common failure modes, Top risks of product failure

Typical Uses:

To identify critical to quality features or process characteristics that are critical determinants of quality, failure modes, risk management and risk mitigation

Relevant FDA Regulations:

21 C.F.R. §§ 820.30, 820.50, 820.70

Relevant FDA Regulations:

These tie to design for customer experience, manufacturability, reliability, serviceability, and value engineering. They also tie to process and product quality assurance, design innovation and software quality assurance.

Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: I Medical Devices 10,001 + employees Global Tool/Method/Example Summary Tool/Example Name : Part Risk Classification , DFMEA, PFMEA, Pareto Analysis, Cause-and-Effect Diagram, 2x5xWhy General Description: Tools to classify parts as part of design outputs, identify critical to quality characteristics (CtQs), flow down of CtQs for part and process to manufacturing and suppliers via design transfer. Glossary of terms: Product attributes critical to quality (parts, modules, features), Common failure modes, Top risks of product failure Typical Uses: To identify critical to quality features or process characteristics that are critical determinants of quality, failure modes, risk management and risk mitigation Relevant FDA Regulations: 21 C.F.R. §§ 820.30, 820.50, 820.70 Relevant FDA Regulations: These tie to design for customer experience, manufacturability, reliability, serviceability, and value engineering. They also tie to process and product quality assurance, design innovation and software quality assurance. " id="pdf-obj-19-78" src="pdf-obj-19-78.jpg">

Practices to Translate Customer Requirements into CtQs

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Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: I Medical Devices 10,001 + employees Global A Five Pillar QA Program Supports Good Design and DfX Practices Supplier assurance how to work with suppliers & flow down of CtQ s Process assurance how to do process control and process validation of automated test systems Product assurance how to conduct post market surveillance and enhance the customer experience Design cycle and innovation assurance how to control design processes (e.g., CMMI) Software validation & assurance how to ensure product SW is robust and bug-free " id="pdf-obj-20-6" src="pdf-obj-20-6.jpg">

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Company: I Medical Devices 10,001 + employees Global
Company:
I
Medical Devices
10,001 + employees
Global

A Five Pillar QA Program Supports Good Design and DfX Practices

  • Supplier assurance how to work with suppliers & flow down of CtQ s

  • Process assurance how to do process control and process validation of automated test systems

  • Product assurance how to conduct post market surveillance and enhance the customer experience

  • Design cycle and innovation assurance how to control design processes (e.g., CMMI)

  • Software validation & assurance how to ensure product SW is robust and bug-free

Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: I Medical Devices 10,001 + employees Global A Five Pillar QA Program Supports Good Design and DfX Practices Supplier assurance how to work with suppliers & flow down of CtQ s Process assurance how to do process control and process validation of automated test systems Product assurance how to conduct post market surveillance and enhance the customer experience Design cycle and innovation assurance how to control design processes (e.g., CMMI) Software validation & assurance how to ensure product SW is robust and bug-free " id="pdf-obj-20-55" src="pdf-obj-20-55.jpg">
Risk Management toc main back next home Pr actices To Translate Customer Requirements Into CtQs
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Pr actices To Translate Customer
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Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: C Medical Devices 10,001 + employees Global Tool/Method/Example Summary Tool/Example Name: Risk Management, CTQ monitoring program General Description: CTQ monitor program to predict and prevent unfavorable behavior Glossary of terms: Risk Management, Fault Tree Analysis, Design FMEA, Use FMEA, Critical To Quality, In Process Monitoring, Response Flow Typical Uses: Patient Safety, Process Control, predict and prevent unfavorable behavior Relevant FDA Regulations: 21 C.F.R. §§ 820.30 & 820.70 " id="pdf-obj-22-6" src="pdf-obj-22-6.jpg">

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Company: C Medical Devices 10,001 + employees Global
Company:
C
Medical Devices
10,001 + employees
Global
Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: C Medical Devices 10,001 + employees Global Tool/Method/Example Summary Tool/Example Name: Risk Management, CTQ monitoring program General Description: CTQ monitor program to predict and prevent unfavorable behavior Glossary of terms: Risk Management, Fault Tree Analysis, Design FMEA, Use FMEA, Critical To Quality, In Process Monitoring, Response Flow Typical Uses: Patient Safety, Process Control, predict and prevent unfavorable behavior Relevant FDA Regulations: 21 C.F.R. §§ 820.30 & 820.70 " id="pdf-obj-22-21" src="pdf-obj-22-21.jpg">

Tool/Method/Example Summary

Tool/Example Name: Risk Management, CTQ monitoring program

General Description:

CTQ monitor program to predict and prevent unfavorable behavior

Glossary of terms:

Risk Management, Fault Tree Analysis, Design FMEA, Use FMEA, Critical To Quality, In Process Monitoring, Response Flow

Typical Uses:

Patient Safety, Process Control, predict and prevent unfavorable behavior

Relevant FDA Regulations:

21 C.F.R. §§ 820.30 & 820.70

Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: C Medical Devices 10,001 + employees Global Tool/Method/Example Summary Tool/Example Name: Risk Management, CTQ monitoring program General Description: CTQ monitor program to predict and prevent unfavorable behavior Glossary of terms: Risk Management, Fault Tree Analysis, Design FMEA, Use FMEA, Critical To Quality, In Process Monitoring, Response Flow Typical Uses: Patient Safety, Process Control, predict and prevent unfavorable behavior Relevant FDA Regulations: 21 C.F.R. §§ 820.30 & 820.70 " id="pdf-obj-22-53" src="pdf-obj-22-53.jpg">

Practices to Translate Customer Requirements into CtQs

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Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: C Medical Devices 10,001 + employees Global Risk Management is integrated into design and development process as part of the PLCP. Product Hazard Analysis uses: F ault Tree Analysis Design FMEA Use FMEA Level 3 represents unacceptable harm and level 0,1, & 2 drive verification & validation confidence statements which must be met. Product Risk Index Matrix 5 1 2 3 2 3 Occurrence of Harm 4 1 1 3 2 3 3 0 1 2 2 3 2 0 0 2 1 2 1 0 0 1 0 2 1 2 4 3 5 Severity of Harm " id="pdf-obj-23-6" src="pdf-obj-23-6.jpg">

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Company: C Medical Devices 10,001 + employees Global
Company:
C
Medical Devices
10,001 + employees
Global

Risk Management is integrated into design and development process as part of the PLCP.

Product Hazard Analysis uses:

Fault Tree Analysis

Design FMEA

Use FMEA

Level 3 represents unacceptable harm and level 0,1, & 2 drive verification & validation confidence statements which must be met.

Product Risk Index Matrix

             

5

1

 
  • 2 3

2

 

3

Occurrence of Harm

         
           

4

1

 
  • 1 3

2

 

3

         
           

3

0

 
  • 1 2

2

 

3

         
           

2

0

 
  • 0 2

1

 

2

         
           
 

1

0

 
  • 0 1

0

 

2

         
 

1

 
  • 2 4

3

 

5

 

Severity of Harm

 
Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: C Medical Devices 10,001 + employees Global Risk Management is integrated into design and development process as part of the PLCP. Product Hazard Analysis uses: F ault Tree Analysis Design FMEA Use FMEA Level 3 represents unacceptable harm and level 0,1, & 2 drive verification & validation confidence statements which must be met. Product Risk Index Matrix 5 1 2 3 2 3 Occurrence of Harm 4 1 1 3 2 3 3 0 1 2 2 3 2 0 0 2 1 2 1 0 0 1 0 2 1 2 4 3 5 Severity of Harm " id="pdf-obj-23-207" src="pdf-obj-23-207.jpg">
Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: C Medical Devices 10,001 + employees Global Risk Management is integrated into design and development process as part of the PLCP. Product Hazard Analysis uses: F ault Tree Analysis Design FMEA Use FMEA Level 3 represents unacceptable harm and level 0,1, & 2 drive verification & validation confidence statements which must be met. Product Risk Index Matrix 5 1 2 3 2 3 Occurrence of Harm 4 1 1 3 2 3 3 0 1 2 2 3 2 0 0 2 1 2 1 0 0 1 0 2 1 2 4 3 5 Severity of Harm " id="pdf-obj-23-209" src="pdf-obj-23-209.jpg">

Practices to Translate Customer Requirements into CtQs

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Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: C Medical Devices 10,001 + employees Global Why? CTQ monitor program is recommended to predict and prevent unfavorable behavior What? CTQ is a potentially vulnerable failure mode or process that is key to assure patient safety Options 2. Discard and select CTQs with proper rationale Perform a failure mode screening according to the CTQ decis ion flow and create a preliminary list IPM Response Flow Fo llow up and up date plan Pro pose a nd analyze ideas for making more robust each selected CTQ 4. Creat e an implementation plan for the ideas selected CTQ Screening: - Failure Mode with high severity and RI (RI: 2 / Severity: 4/5) link to Risk Management processes. - Vulnerable process - High Scrap, NCEPs and /or Complaints - Potentially affects patient safety " id="pdf-obj-24-6" src="pdf-obj-24-6.jpg">

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Company: C Medical Devices 10,001 + employees Global
Company:
C
Medical Devices
10,001 + employees
Global
Why?
Why?

CTQ monitor program is recommended to predict and prevent unfavorable behavior

What?
What?

CTQ is a potentially vulnerable failure mode or process that is key to assure patient safety

Options 2. Discard and select CTQs with proper rationale
Options
2. Discard and select
CTQs with proper
rationale

1. Perform a failure mode screening according to the CTQ decision flow and

create a preliminary

list

Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: C Medical Devices 10,001 + employees Global Why? CTQ monitor program is recommended to predict and prevent unfavorable behavior What? CTQ is a potentially vulnerable failure mode or process that is key to assure patient safety Options 2. Discard and select CTQs with proper rationale Perform a failure mode screening according to the CTQ decis ion flow and create a preliminary list IPM Response Flow Fo llow up and up date plan Pro pose a nd analyze ideas for making more robust each selected CTQ 4. Creat e an implementation plan for the ideas selected CTQ Screening: - Failure Mode with high severity and RI (RI: 2 / Severity: 4/5) link to Risk Management processes. - Vulnerable process - High Scrap, NCEPs and /or Complaints - Potentially affects patient safety " id="pdf-obj-24-39" src="pdf-obj-24-39.jpg">

IPM

Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: C Medical Devices 10,001 + employees Global Why? CTQ monitor program is recommended to predict and prevent unfavorable behavior What? CTQ is a potentially vulnerable failure mode or process that is key to assure patient safety Options 2. Discard and select CTQs with proper rationale Perform a failure mode screening according to the CTQ decis ion flow and create a preliminary list IPM Response Flow Fo llow up and up date plan Pro pose a nd analyze ideas for making more robust each selected CTQ 4. Creat e an implementation plan for the ideas selected CTQ Screening: - Failure Mode with high severity and RI (RI: 2 / Severity: 4/5) link to Risk Management processes. - Vulnerable process - High Scrap, NCEPs and /or Complaints - Potentially affects patient safety " id="pdf-obj-24-44" src="pdf-obj-24-44.jpg">

Response Flow

Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: C Medical Devices 10,001 + employees Global Why? CTQ monitor program is recommended to predict and prevent unfavorable behavior What? CTQ is a potentially vulnerable failure mode or process that is key to assure patient safety Options 2. Discard and select CTQs with proper rationale Perform a failure mode screening according to the CTQ decis ion flow and create a preliminary list IPM Response Flow Fo llow up and up date plan Pro pose a nd analyze ideas for making more robust each selected CTQ 4. Creat e an implementation plan for the ideas selected CTQ Screening: - Failure Mode with high severity and RI (RI: 2 / Severity: 4/5) link to Risk Management processes. - Vulnerable process - High Scrap, NCEPs and /or Complaints - Potentially affects patient safety " id="pdf-obj-24-49" src="pdf-obj-24-49.jpg">

5. Follow up and update plan

Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: C Medical Devices 10,001 + employees Global Why? CTQ monitor program is recommended to predict and prevent unfavorable behavior What? CTQ is a potentially vulnerable failure mode or process that is key to assure patient safety Options 2. Discard and select CTQs with proper rationale Perform a failure mode screening according to the CTQ decis ion flow and create a preliminary list IPM Response Flow Fo llow up and up date plan Pro pose a nd analyze ideas for making more robust each selected CTQ 4. Creat e an implementation plan for the ideas selected CTQ Screening: - Failure Mode with high severity and RI (RI: 2 / Severity: 4/5) link to Risk Management processes. - Vulnerable process - High Scrap, NCEPs and /or Complaints - Potentially affects patient safety " id="pdf-obj-24-61" src="pdf-obj-24-61.jpg">

3. Propose and analyze ideas for making more robust each selected CTQ

4. Create an implementation plan for the ideas selected

Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: C Medical Devices 10,001 + employees Global Why? CTQ monitor program is recommended to predict and prevent unfavorable behavior What? CTQ is a potentially vulnerable failure mode or process that is key to assure patient safety Options 2. Discard and select CTQs with proper rationale Perform a failure mode screening according to the CTQ decis ion flow and create a preliminary list IPM Response Flow Fo llow up and up date plan Pro pose a nd analyze ideas for making more robust each selected CTQ 4. Creat e an implementation plan for the ideas selected CTQ Screening: - Failure Mode with high severity and RI (RI: 2 / Severity: 4/5) link to Risk Management processes. - Vulnerable process - High Scrap, NCEPs and /or Complaints - Potentially affects patient safety " id="pdf-obj-24-75" src="pdf-obj-24-75.jpg">

CTQ Screening:

  • - Failure Mode with high severity and RI (RI: 2 / Severity: 4/5) link to Risk Management processes.

  • - Vulnerable process - High Scrap, NCEPs and

/or Complaints

  • - Potentially affects patient safety

Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: C Medical Devices 10,001 + employees Global Why? CTQ monitor program is recommended to predict and prevent unfavorable behavior What? CTQ is a potentially vulnerable failure mode or process that is key to assure patient safety Options 2. Discard and select CTQs with proper rationale Perform a failure mode screening according to the CTQ decis ion flow and create a preliminary list IPM Response Flow Fo llow up and up date plan Pro pose a nd analyze ideas for making more robust each selected CTQ 4. Creat e an implementation plan for the ideas selected CTQ Screening: - Failure Mode with high severity and RI (RI: 2 / Severity: 4/5) link to Risk Management processes. - Vulnerable process - High Scrap, NCEPs and /or Complaints - Potentially affects patient safety " id="pdf-obj-24-89" src="pdf-obj-24-89.jpg">

Practices to Translate Customer Requirements into CtQs

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Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: C Medical Devices 10,001 + employees Global Translating User Needs into Design Inputs Translates User Needs into Design Inputs o Assess Risks o Initiate Market Specification o Develop product specifications Develop prototypes o Identify possible design concepts, Test methods, design prototypes, evaluate prototypes Develop equipment & process o Assess process technology, develop and execute equipment strategy Define Supply Chain o Define supplier plan, define concept builds, establish supply chain strategy You are currently viewin g a featured section of AdvaMed's Case for Quality Library. To view AdvaMed's Case for Quality website, clic k H E R E . To view the full slide deck of AdvaMed's Design Control recommendations, clic k HERE . " id="pdf-obj-25-6" src="pdf-obj-25-6.jpg">

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Company: C Medical Devices 10,001 + employees Global
Company:
C
Medical Devices
10,001 + employees
Global

Translating User Needs into Design Inputs

Translates User Needs into Design Inputs o Assess Risks o Initiate Market Specification o Develop product specifications Develop prototypes o Identify possible design concepts, Test methods, design prototypes, evaluate prototypes Develop equipment & process o Assess process technology, develop and execute equipment strategy Define Supply Chain o Define supplier plan, define concept builds, establish supply chain strategy

Practices to Translate Customer Requirements into CtQs

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Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: F Hospital & Health Care 10,001 + employees Global Tool/Method/Example Summary Active Requirements Management (RM) Tool General Description: This tool is utilized to ensure that the various (inputs) requirements are translated into predictive, measureable performance values. These outputs can be tracked on the CTQ Scorecard The Risk Flow Down model is utilized to ensure that risks . associated with a specific requirement have the appropriate mitigations. Glossary of terms (specific to this tool/example): None unique Typical Uses: These tools can be utilized during the design process to ensure requirements are adequately translated to quantify performance values. Relevant FDA Regulations: 21 C.F.R. §§ 820.30 design controls & FDA Preamble comment 72. " id="pdf-obj-26-6" src="pdf-obj-26-6.jpg">

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Company: F Hospital & Health Care 10,001 + employees Global
Company: F
Hospital & Health Care
10,001 + employees
Global
Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: F Hospital & Health Care 10,001 + employees Global Tool/Method/Example Summary Active Requirements Management (RM) Tool General Description: This tool is utilized to ensure that the various (inputs) requirements are translated into predictive, measureable performance values. These outputs can be tracked on the CTQ Scorecard The Risk Flow Down model is utilized to ensure that risks . associated with a specific requirement have the appropriate mitigations. Glossary of terms (specific to this tool/example): None unique Typical Uses: These tools can be utilized during the design process to ensure requirements are adequately translated to quantify performance values. Relevant FDA Regulations: 21 C.F.R. §§ 820.30 design controls & FDA Preamble comment 72. " id="pdf-obj-26-21" src="pdf-obj-26-21.jpg">

Tool/Method/Example Summary

Tool/Example Name: Active Requirements Management (RM) Tool

General Description:

This tool is utilized to ensure that the various (inputs) requirements are translated into predictive, measureable performance values. These outputs can be tracked on

the CTQ Scorecard

The Risk Flow Down model is utilized to ensure that risks

. associated with a specific requirement have the appropriate mitigations.

Glossary of terms (specific to this tool/example):

None unique

Typical Uses:

These tools can be utilized during the design process to ensure requirements are adequately translated to quantify performance values.

Relevant FDA Regulations:

21 C.F.R. §§ 820.30 design controls & FDA Preamble comment 72.

Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: F Hospital & Health Care 10,001 + employees Global Tool/Method/Example Summary Active Requirements Management (RM) Tool General Description: This tool is utilized to ensure that the various (inputs) requirements are translated into predictive, measureable performance values. These outputs can be tracked on the CTQ Scorecard The Risk Flow Down model is utilized to ensure that risks . associated with a specific requirement have the appropriate mitigations. Glossary of terms (specific to this tool/example): None unique Typical Uses: These tools can be utilized during the design process to ensure requirements are adequately translated to quantify performance values. Relevant FDA Regulations: 21 C.F.R. §§ 820.30 design controls & FDA Preamble comment 72. " id="pdf-obj-26-62" src="pdf-obj-26-62.jpg">

Practices to Translate Customer Requirements into CtQs

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Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: F Hospital & Health Care 10,001 + employees Global Requirements Management (RM) Tools to Support PDP Active RM allows flowing up process capability and predicted performance to customer requirements Process Req. Componen t R eq. Mark et R eq. Product Req. Assembl y R eq. CTQ Flow down/up: Mark et R eq. Product Req. + Why + Performance Assembly Req. + Performance Componen t R eq. + P erformance Process Req + Why + Capability CTQ Flow down/up: What What, Why, How, Cost? " id="pdf-obj-27-6" src="pdf-obj-27-6.jpg">

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Company: F Hospital & Health Care 10,001 + employees Global
Company: F
Hospital & Health Care
10,001 + employees
Global

Requirements Management (RM) Tools to Support PDP

Active RM allows flowing up process capability and predicted performance to customer requirements

Process Req.
Process Req.

Component Req.

Market Req.

Product Req.

Assembly Req.

CTQ Flow down/up:

Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: F Hospital & Health Care 10,001 + employees Global Requirements Management (RM) Tools to Support PDP Active RM allows flowing up process capability and predicted performance to customer requirements Process Req. Componen t R eq. Mark et R eq. Product Req. Assembl y R eq. CTQ Flow down/up: Mark et R eq. Product Req. + Why + Performance Assembly Req. + Performance Componen t R eq. + P erformance Process Req + Why + Capability CTQ Flow down/up: What What, Why, How, Cost? " id="pdf-obj-27-50" src="pdf-obj-27-50.jpg">

Market Req.

Product Req. + Why + Performance

Assembly Req. + Performance

Component Req. +Performance

Process Req + Why + Capability

CTQ Flow down/up:

What

What, Why, How, Cost?

Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: F Hospital & Health Care 10,001 + employees Global Requirements Management (RM) Tools to Support PDP Active RM allows flowing up process capability and predicted performance to customer requirements Process Req. Componen t R eq. Mark et R eq. Product Req. Assembl y R eq. CTQ Flow down/up: Mark et R eq. Product Req. + Why + Performance Assembly Req. + Performance Componen t R eq. + P erformance Process Req + Why + Capability CTQ Flow down/up: What What, Why, How, Cost? " id="pdf-obj-27-92" src="pdf-obj-27-92.jpg">

Practices to Translate Customer Requirements into CtQs

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Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: F Hospital & Health Care 10,001 + employees Global " id="pdf-obj-28-6" src="pdf-obj-28-6.jpg">

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Company: F Hospital & Health Care 10,001 + employees Global
Company: F
Hospital & Health Care
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Global
Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: F Hospital & Health Care 10,001 + employees Global " id="pdf-obj-28-21" src="pdf-obj-28-21.jpg">
Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: F Hospital & Health Care 10,001 + employees Global " id="pdf-obj-28-23" src="pdf-obj-28-23.jpg">

Practices to Translate Customer Requirements into CtQs

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Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: F Hospital & Health Care 10,001 + employees Global Risk Flow Down FMEA table generated Requirement at each level of the flow down can have a failure d mode. Causes and Effects linked Transfer Functions Risks are connected to requirements and to each other " id="pdf-obj-29-6" src="pdf-obj-29-6.jpg">

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Company: F Hospital & Health Care 10,001 + employees Global
Company: F
Hospital & Health Care
10,001 + employees
Global

Risk Flow Down

FMEA table generated

Requirement at each level of the flow down can have a failure

d

mode.

Causes and Effects linked Transfer Functions

Risks are connected to requirements and to each other

Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: F Hospital & Health Care 10,001 + employees Global Risk Flow Down FMEA table generated Requirement at each level of the flow down can have a failure d mode. Causes and Effects linked Transfer Functions Risks are connected to requirements and to each other " id="pdf-obj-29-52" src="pdf-obj-29-52.jpg">
Quality Tree Model toc main back next home Pr actices To Translate Customer Requirements Into CtQs
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Practices to Translate Customer Requirements into CtQs

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Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: D Medical Devices 10,001 + employees Global Tool/Method/Example Summary Tool/Example Name: Quality Tree General Description: Shows the flow down of customer requirements into Functional requirements, Design, and Process requirements in a hierarchical graphic format to help identify CTQs. Glossary Of Terms: Functional Requirements description or metrics that the device s needs to perform (functional output needs). Design Requirements description or metrics that the device s design to meet the functional requirements. Process Requirements -description or metrics relative to how the device s is manufactured to meet the design and functional requirements. Typical Uses: To help identify the flow down of requirements into critical design or process outputs needed. CTQ s and important aspects of the product are typically shown on this chart. Relevant FDA Regulations : 21 C.F.R. §§ 820.30 (b), (c), (d), (e), and (f) " id="pdf-obj-31-6" src="pdf-obj-31-6.jpg">

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Company: D Medical Devices 10,001 + employees Global
Company:
D Medical Devices
10,001 + employees
Global
Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: D Medical Devices 10,001 + employees Global Tool/Method/Example Summary Tool/Example Name: Quality Tree General Description: Shows the flow down of customer requirements into Functional requirements, Design, and Process requirements in a hierarchical graphic format to help identify CTQs. Glossary Of Terms: Functional Requirements description or metrics that the device s needs to perform (functional output needs). Design Requirements description or metrics that the device s design to meet the functional requirements. Process Requirements -description or metrics relative to how the device s is manufactured to meet the design and functional requirements. Typical Uses: To help identify the flow down of requirements into critical design or process outputs needed. CTQ s and important aspects of the product are typically shown on this chart. Relevant FDA Regulations : 21 C.F.R. §§ 820.30 (b), (c), (d), (e), and (f) " id="pdf-obj-31-20" src="pdf-obj-31-20.jpg">

Tool/Method/Example Summary

Tool/Example Name: Quality Tree General Description:

Shows the flow down of customer requirements into Functional requirements, Design, and Process requirements in a hierarchical graphic format to help identify CTQs.

Glossary Of Terms:

Functional Requirements description or metrics that the device s needs to perform (functional output needs).

Design Requirements description or metrics that the device s design to meet the functional requirements.

Process Requirements -description or metrics relative to how the device s is manufactured to meet the design and functional requirements.

Typical Uses:

To help identify the flow down of requirements into critical design or process outputs needed. CTQ s and important aspects of the product are typically shown on this chart.

Relevant FDA Regulations :

21 C.F.R. §§ 820.30 (b), (c), (d), (e), and (f)

Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: D Medical Devices 10,001 + employees Global Tool/Method/Example Summary Tool/Example Name: Quality Tree General Description: Shows the flow down of customer requirements into Functional requirements, Design, and Process requirements in a hierarchical graphic format to help identify CTQs. Glossary Of Terms: Functional Requirements description or metrics that the device s needs to perform (functional output needs). Design Requirements description or metrics that the device s design to meet the functional requirements. Process Requirements -description or metrics relative to how the device s is manufactured to meet the design and functional requirements. Typical Uses: To help identify the flow down of requirements into critical design or process outputs needed. CTQ s and important aspects of the product are typically shown on this chart. Relevant FDA Regulations : 21 C.F.R. §§ 820.30 (b), (c), (d), (e), and (f) " id="pdf-obj-31-73" src="pdf-obj-31-73.jpg">

Practices to Translate Customer Requirements into CtQs

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Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: D Medical Devices 10,001 + employees Global Developing the Quality Tree Quality Tree should be developed by the team The project customer requirements, Engineering documentation and knowledge of the team are key inputs In sequence the following activities should occur Cr itical Customer Requirements are identified by the end of the Feasibility Functional Requirements are identified by the end of the Feasibility De sign Requirements are identified in the Development Stage or earlier P rocess Requirements are identified in the Development Stage or earlier " id="pdf-obj-32-6" src="pdf-obj-32-6.jpg">

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Company: D Medical Devices 10,001 + employees Global
Company:
D Medical Devices
10,001 + employees
Global

Developing the Quality Tree

Quality Tree should be developed by the team

The project customer requirements, Engineering documentation and knowledge of the team are key inputs

In sequence the following activities should occur

Critical Customer Requirements are identified by the end of the Feasibility Functional Requirements are identified by the end of the Feasibility Design Requirements are identified in the Development Stage or earlier Process Requirements are identified in the Development Stage or earlier

Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: D Medical Devices 10,001 + employees Global Developing the Quality Tree Quality Tree should be developed by the team The project customer requirements, Engineering documentation and knowledge of the team are key inputs In sequence the following activities should occur Cr itical Customer Requirements are identified by the end of the Feasibility Functional Requirements are identified by the end of the Feasibility De sign Requirements are identified in the Development Stage or earlier P rocess Requirements are identified in the Development Stage or earlier " id="pdf-obj-32-53" src="pdf-obj-32-53.jpg">

Practices to Translate Customer Requirements into CtQs

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Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: D Medical Devices 10,001 + employees Global Quality Tree Format " id="pdf-obj-33-6" src="pdf-obj-33-6.jpg">

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Company: D Medical Devices 10,001 + employees Global
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D Medical Devices
10,001 + employees
Global

Quality Tree Format

Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: D Medical Devices 10,001 + employees Global Quality Tree Format " id="pdf-obj-33-23" src="pdf-obj-33-23.jpg">
Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: D Medical Devices 10,001 + employees Global Quality Tree Format " id="pdf-obj-33-25" src="pdf-obj-33-25.jpg">

Practices to Translate Customer Requirements into CtQs

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Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: D Medical Devices 10,001 + employees Global Selecting Your CTQs Once the full Quality Tree has been completed, the team needs to make intelligent choices on which Characteristics should be labeled CTQ's. The Bottom line is assurance of quality as it relates to Critical Customer Requirement(s) American Society for Quality (ASQ) defines assurance of quality as the planned and systematic activities implemented in a quality system so that quality requirements for a product or service will be fulfilled. " id="pdf-obj-34-6" src="pdf-obj-34-6.jpg">

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Company: D Medical Devices 10,001 + employees Global
Company:
D Medical Devices
10,001 + employees
Global

Selecting Your CTQs

Once the full Quality Tree has been completed, the team needs to make intelligent choices on which Characteristics should be labeled CTQ's.

The Bottom line is assurance of quality as it relates to Critical Customer Requirement(s)

American Society for Quality (ASQ) defines assurance of quality as the planned and systematic activities implemented in a quality system so that quality requirements for a product or service will be fulfilled.

Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: D Medical Devices 10,001 + employees Global Selecting Your CTQs Once the full Quality Tree has been completed, the team needs to make intelligent choices on which Characteristics should be labeled CTQ's. The Bottom line is assurance of quality as it relates to Critical Customer Requirement(s) American Society for Quality (ASQ) defines assurance of quality as the planned and systematic activities implemented in a quality system so that quality requirements for a product or service will be fulfilled. " id="pdf-obj-34-36" src="pdf-obj-34-36.jpg">
Design and Process CTQs toc main back next home Pr actices To Translate Customer Requirements Into
Design and Process CTQs
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Key Activities

Practices to Translate Customer Requirements into CtQs

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Key Activities Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: E Medical Devices 1001-5000 employees Global Design and Process CTQs Process Critical to Customer Critical to Critical to Customer Drivers Requirements Design (CtD) Process (CtP) (CtC) VOC KOL Product Desi g n Specification Process Development Requirements Market Review Assessment Procedures/ Product Use Design Risk Process Risk Cases Assessment Assessment QFD Prototype Design Process Verification Validation product QFD CtQ " id="pdf-obj-36-8" src="pdf-obj-36-8.jpg">

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Company: E Medical Devices 1001-5000 employees Global
Company:
E
Medical Devices
1001-5000 employees
Global

Design and Process CTQs

Process

Critical to Customer Critical to Critical to Customer Drivers Requirements Design (CtD) Process (CtP) (CtC) VOC
Critical to
Customer
Critical to
Critical to
Customer
Drivers
Requirements
Design (CtD)
Process (CtP)
(CtC)
VOC
KOL
Product
Desi g n
Specification
Process
Development
Requirements
Market
Review
Assessment
Procedures/
Product Use
Design Risk
Process Risk
Cases
Assessment
Assessment
QFD
Prototype
Design
Process
Verification
Validation
product
QFD
CtQ
Key Activities Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: E Medical Devices 1001-5000 employees Global Design and Process CTQs Process Critical to Customer Critical to Critical to Customer Drivers Requirements Design (CtD) Process (CtP) (CtC) VOC KOL Product Desi g n Specification Process Development Requirements Market Review Assessment Procedures/ Product Use Design Risk Process Risk Cases Assessment Assessment QFD Prototype Design Process Verification Validation product QFD CtQ " id="pdf-obj-36-29" src="pdf-obj-36-29.jpg">

Practices to Translate Customer Requirements into CtQs

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Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: E Medical Devices 1001-5000 employees Global Translating Customer Requirements to CtQs : The many customer requirements are distilled down to the Critical to Customer (CtC) VoC, KOL, Market Assessments, product review The CtC are translated down to Key Drivers by the use of DFQ and ranking Drivers are translated into Product Requirements Product Requirements are translated into Product Specifications (Critical to Design CtD). CtD are approved by the Project Approval Board and reviewed at Gates 2 through 4 and During Design Reviews CtD will drive the process development and the Critical to Process (CtP) parameters to assure product design " id="pdf-obj-37-6" src="pdf-obj-37-6.jpg">

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Company: E Medical Devices 1001-5000 employees Global
Company:
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Medical Devices
1001-5000 employees
Global

Translating Customer Requirements to CtQs:

The many customer requirements are distilled down to

the Critical to Customer (CtC) VoC, KOL, Market

Assessments, product review

The CtC are translated down to Key Drivers by the use of

DFQ and ranking

Drivers are translated into Product Requirements

Product Requirements are translated into Product

Specifications (Critical to Design CtD).

CtD are approved by the Project Approval Board and

reviewed at Gates 2 through 4 and During Design Reviews

CtD will drive the process development and the Critical to

Process (CtP) parameters to assure product design

Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: E Medical Devices 1001-5000 employees Global Translating Customer Requirements to CtQs : The many customer requirements are distilled down to the Critical to Customer (CtC) VoC, KOL, Market Assessments, product review The CtC are translated down to Key Drivers by the use of DFQ and ranking Drivers are translated into Product Requirements Product Requirements are translated into Product Specifications (Critical to Design CtD). CtD are approved by the Project Approval Board and reviewed at Gates 2 through 4 and During Design Reviews CtD will drive the process development and the Critical to Process (CtP) parameters to assure product design " id="pdf-obj-37-81" src="pdf-obj-37-81.jpg">

Practices to Translate Customer Requirements into CtQs

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Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: E Medical Devices 1001-5000 employees Global CtQ in Product Development " id="pdf-obj-38-6" src="pdf-obj-38-6.jpg">

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Company: E Medical Devices 1001-5000 employees Global
Company:
E
Medical Devices
1001-5000 employees
Global

CtQ in Product Development

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Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: E Medical Devices 1001-5000 employees Global CtQ in Product Development " id="pdf-obj-38-25" src="pdf-obj-38-25.jpg">
CTQ Cascade Model toc main back next home Pr actices To Translate Customer Requirements Into CtQs
CTQ Cascade Model
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Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: F Hospital & Health Care 10,001 + employees Global CTQ Cascade Customer Needs and Requirements User Issues User Needs/Requirements Functions to Meet User Needs Concepts to Meet the Functions " id="pdf-obj-40-6" src="pdf-obj-40-6.jpg">

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Company: F Hospital & Health Care 10,001 + employees Global
Company:
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Global

CTQ Cascade

Customer Needs and Requirements

Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: F Hospital & Health Care 10,001 + employees Global CTQ Cascade Customer Needs and Requirements User Issues User Needs/Requirements Functions to Meet User Needs Concepts to Meet the Functions " id="pdf-obj-40-26" src="pdf-obj-40-26.jpg">
Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: F Hospital & Health Care 10,001 + employees Global CTQ Cascade Customer Needs and Requirements User Issues User Needs/Requirements Functions to Meet User Needs Concepts to Meet the Functions " id="pdf-obj-40-28" src="pdf-obj-40-28.jpg">

User Issues

User Needs/Requirements

Functions to Meet User Needs

Concepts to Meet the Functions

Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: F Hospital & Health Care 10,001 + employees Global CTQ Cascade Customer Needs and Requirements User Issues User Needs/Requirements Functions to Meet User Needs Concepts to Meet the Functions " id="pdf-obj-40-42" src="pdf-obj-40-42.jpg">

Practices to Translate Customer Requirements into CtQs

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Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: F Hospital & Health Care 10,001 + employees Global CTQ Cascade Customer Needs and Requirements Product Requirements Measureable Performance Requirements Architecture: Subcomponents? Attributes/ Properties/ Specifications " id="pdf-obj-41-6" src="pdf-obj-41-6.jpg">

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CTQ Cascade

Customer Needs and Requirements

Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: F Hospital & Health Care 10,001 + employees Global CTQ Cascade Customer Needs and Requirements Product Requirements Measureable Performance Requirements Architecture: Subcomponents? Attributes/ Properties/ Specifications " id="pdf-obj-41-26" src="pdf-obj-41-26.jpg">

Product Requirements

Measureable Performance

Requirements

Architecture: Subcomponents?

Attributes/ Properties/ Specifications

Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: F Hospital & Health Care 10,001 + employees Global CTQ Cascade Customer Needs and Requirements Product Requirements Measureable Performance Requirements Architecture: Subcomponents? Attributes/ Properties/ Specifications " id="pdf-obj-41-42" src="pdf-obj-41-42.jpg">

Practices to Translate Customer Requirements into CtQs

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Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: F Hospital & Health Care 10,001 + employees Global CTQ Cascade Customer Needs and Requirements Product Requirements Process Requirements Raw Material Properties, Specifications , Sources of Variation Critical Process Variables, Requirements Equipment Requirements, Sources of Variation " id="pdf-obj-42-6" src="pdf-obj-42-6.jpg">

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Company: F Hospital & Health Care 10,001 + employees Global
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CTQ Cascade

Customer Needs and Requirements

Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: F Hospital & Health Care 10,001 + employees Global CTQ Cascade Customer Needs and Requirements Product Requirements Process Requirements Raw Material Properties, Specifications , Sources of Variation Critical Process Variables, Requirements Equipment Requirements, Sources of Variation " id="pdf-obj-42-26" src="pdf-obj-42-26.jpg">

Product Requirements

Process Requirements

Raw Material Properties,

Specifications , Sources of Variation

Critical Process Variables,

Requirements

Equipment Requirements,

Sources of Variation

Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: F Hospital & Health Care 10,001 + employees Global CTQ Cascade Customer Needs and Requirements Product Requirements Process Requirements Raw Material Properties, Specifications , Sources of Variation Critical Process Variables, Requirements Equipment Requirements, Sources of Variation " id="pdf-obj-42-49" src="pdf-obj-42-49.jpg">

Practices to Translate Customer Requirements into CtQs

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Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: F Hospital & Health Care 10,001 + employees Global CTQ Cascade Customer Needs and Requirements Product Requirements Process Requirements Risk Mitigation Strategies and Controls Risks Mitigations, Controls Improve Chances of Success Proactively " id="pdf-obj-43-6" src="pdf-obj-43-6.jpg">

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CTQ Cascade

Customer Needs and Requirements

Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: F Hospital & Health Care 10,001 + employees Global CTQ Cascade Customer Needs and Requirements Product Requirements Process Requirements Risk Mitigation Strategies and Controls Risks Mitigations, Controls Improve Chances of Success Proactively " id="pdf-obj-43-26" src="pdf-obj-43-26.jpg">

Product Requirements

Process Requirements

Risk Mitigation Strategies and Controls

Risks
Risks

Mitigations, Controls

Improve Chances of Success Proactively

Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: F Hospital & Health Care 10,001 + employees Global CTQ Cascade Customer Needs and Requirements Product Requirements Process Requirements Risk Mitigation Strategies and Controls Risks Mitigations, Controls Improve Chances of Success Proactively " id="pdf-obj-43-44" src="pdf-obj-43-44.jpg">

Practices to Translate Customer Requirements into CtQs

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Company: F Hospital & Health Care 10,001 + employees Global
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Global

CTQ Cascade

Customer Needs and Requirements

Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: F Hospital & Health Care 10,001 + employees Global CTQ Cascade Customer Needs and Requirements Product Requirements Process Requirements Risk Mitigation Strategies and Controls Verification and Validation Specifications, Critical Testing " id="pdf-obj-44-26" src="pdf-obj-44-26.jpg">

Product Requirements

Process Requirements

Risk Mitigation Strategies and Controls

Verification and Validation

Specifications, Critical Testing

Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: F Hospital & Health Care 10,001 + employees Global CTQ Cascade Customer Needs and Requirements Product Requirements Process Requirements Risk Mitigation Strategies and Controls Verification and Validation Specifications, Critical Testing " id="pdf-obj-44-43" src="pdf-obj-44-43.jpg">

Practices to Translate Customer Requirements into CtQs

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Company: F Hospital & Health Care 10,001 + employees Global
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CTQ Cascade

Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: F Hospital & Health Care 10,001 + employees Global CTQ Cascade Customer Needs and Requirements Product Requirements Process Requirements Risk Mitigation Strategies and Controls Verification and Validation " id="pdf-obj-45-23" src="pdf-obj-45-23.jpg">

Customer Needs and Requirements

Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: F Hospital & Health Care 10,001 + employees Global CTQ Cascade Customer Needs and Requirements Product Requirements Process Requirements Risk Mitigation Strategies and Controls Verification and Validation " id="pdf-obj-45-28" src="pdf-obj-45-28.jpg">

Product Requirements

Process Requirements

Risk Mitigation Strategies and Controls

Verification and Validation

Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: F Hospital & Health Care 10,001 + employees Global CTQ Cascade Customer Needs and Requirements Product Requirements Process Requirements Risk Mitigation Strategies and Controls Verification and Validation " id="pdf-obj-45-42" src="pdf-obj-45-42.jpg">
CTQ Flowdown Model toc main back next home Pr actices To Translate Customer Requirements Into CtQs
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Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: G Medical Devices 5001-10,000 employees Global Critical to Quality (CTQ) Flow down Voice of Customer Function P Parts Dimensions Capability Match Capability Vs. Goal Launch " id="pdf-obj-47-6" src="pdf-obj-47-6.jpg">

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Company: G Medical Devices 5001-10,000 employees Global
Company:
G
Medical Devices
5001-10,000 employees
Global

Critical to Quality (CTQ) Flow down

Voice of Customer Function P Parts
Voice of
Customer
Function
P
Parts
Dimensions
Dimensions

Capability

Match Capability Vs. Goal

Launch

Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: G Medical Devices 5001-10,000 employees Global Critical to Quality (CTQ) Flow down Voice of Customer Function P Parts Dimensions Capability Match Capability Vs. Goal Launch " id="pdf-obj-47-33" src="pdf-obj-47-33.jpg">

Practices to Translate Customer Requirements into CtQs

Practices to Translate Customer Requirements into CtQs main back next <a href=home Company: G Medical Devices 5001-10,000 employees Global CTQ Flow Down Post Market Surveillance Clinical Marketing Focus Groups Repairs Complaints Regulatory Therapy system shall deliver the prescribed negative pressure to the wound site when powered on Therapy unit shall maintain pressure within ±x mmHg of target pressure Therapy Unit, Canister, Dressing (e.g. drape), System Interactions (sub-assembly) Pump Flow rate Pump Diaphragm characteristics Drape adhesive properties Canister Unit interface Voice of the Customer (User needs) h l Tec nica Requirements i i Access Risk level from Top Down* and Usability * perspective Link to DFMECA for Risk Carry over to PFMEA Part Drawings (Link to DFMEA for Risk) CTQ Characteristics Link CTQs identified to Risk Top Down : evaluates the potential risks from the system level perspective, before finalizing the design. Mitigations from Top down should be used as an input to the design. Usability risk analysis: evaluates the potential hazards related to the use or misuse of the product. 48 " id="pdf-obj-48-4" src="pdf-obj-48-4.jpg">
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Practices to Translate Customer Requirements into CtQs main back next <a href=home Company: G Medical Devices 5001-10,000 employees Global CTQ Flow Down Post Market Surveillance Clinical Marketing Focus Groups Repairs Complaints Regulatory Therapy system shall deliver the prescribed negative pressure to the wound site when powered on Therapy unit shall maintain pressure within ±x mmHg of target pressure Therapy Unit, Canister, Dressing (e.g. drape), System Interactions (sub-assembly) Pump Flow rate Pump Diaphragm characteristics Drape adhesive properties Canister Unit interface Voice of the Customer (User needs) h l Tec nica Requirements i i Access Risk level from Top Down* and Usability * perspective Link to DFMECA for Risk Carry over to PFMEA Part Drawings (Link to DFMEA for Risk) CTQ Characteristics Link CTQs identified to Risk Top Down : evaluates the potential risks from the system level perspective, before finalizing the design. Mitigations from Top down should be used as an input to the design. Usability risk analysis: evaluates the potential hazards related to the use or misuse of the product. 48 " id="pdf-obj-48-9" src="pdf-obj-48-9.jpg">
Practices to Translate Customer Requirements into CtQs main back next <a href=home Company: G Medical Devices 5001-10,000 employees Global CTQ Flow Down Post Market Surveillance Clinical Marketing Focus Groups Repairs Complaints Regulatory Therapy system shall deliver the prescribed negative pressure to the wound site when powered on Therapy unit shall maintain pressure within ±x mmHg of target pressure Therapy Unit, Canister, Dressing (e.g. drape), System Interactions (sub-assembly) Pump Flow rate Pump Diaphragm characteristics Drape adhesive properties Canister Unit interface Voice of the Customer (User needs) h l Tec nica Requirements i i Access Risk level from Top Down* and Usability * perspective Link to DFMECA for Risk Carry over to PFMEA Part Drawings (Link to DFMEA for Risk) CTQ Characteristics Link CTQs identified to Risk Top Down : evaluates the potential risks from the system level perspective, before finalizing the design. Mitigations from Top down should be used as an input to the design. Usability risk analysis: evaluates the potential hazards related to the use or misuse of the product. 48 " id="pdf-obj-48-11" src="pdf-obj-48-11.jpg">

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Company: G Medical Devices 5001-10,000 employees Global
Company:
G
Medical Devices
5001-10,000 employees
Global

CTQ Flow Down

Post Market Surveillance
Post Market
Surveillance
Clinical
Clinical
Marketing
Marketing
Focus Groups
Focus Groups
Repairs
Repairs
Complaints
Complaints
Regulatory
Regulatory
Practices to Translate Customer Requirements into CtQs main back next <a href=home Company: G Medical Devices 5001-10,000 employees Global CTQ Flow Down Post Market Surveillance Clinical Marketing Focus Groups Repairs Complaints Regulatory Therapy system shall deliver the prescribed negative pressure to the wound site when powered on Therapy unit shall maintain pressure within ±x mmHg of target pressure Therapy Unit, Canister, Dressing (e.g. drape), System Interactions (sub-assembly) Pump Flow rate Pump Diaphragm characteristics Drape adhesive properties Canister Unit interface Voice of the Customer (User needs) h l Tec nica Requirements i i Access Risk level from Top Down* and Usability * perspective Link to DFMECA for Risk Carry over to PFMEA Part Drawings (Link to DFMEA for Risk) CTQ Characteristics Link CTQs identified to Risk Top Down : evaluates the potential risks from the system level perspective, before finalizing the design. Mitigations from Top down should be used as an input to the design. Usability risk analysis: evaluates the potential hazards related to the use or misuse of the product. 48 " id="pdf-obj-48-40" src="pdf-obj-48-40.jpg">

Therapy system shall deliver the prescribed negative pressure to the wound site when powered on

 
Therapy unit shall maintain pressure within ±x mmHg of target pressure Therapy Unit, Canister, Dressing (e.g.

Therapy unit shall maintain pressure within ±x mmHg of target pressure

 
Therapy unit shall maintain pressure within ±x mmHg of target pressure Therapy Unit, Canister, Dressing (e.g.

Therapy Unit, Canister, Dressing (e.g. drape), System Interactions (sub-assembly)

 
Therapy unit shall maintain pressure within ±x mmHg of target pressure Therapy Unit, Canister, Dressing (e.g.
Therapy unit shall maintain pressure within ±x mmHg of target pressure Therapy Unit, Canister, Dressing (e.g.
Therapy unit shall maintain pressure within ±x mmHg of target pressure Therapy Unit, Canister, Dressing (e.g.

Pump Flow rate Pump Diaphragm characteristics

Drape adhesive properties

Canister Unit interface

Voice of the Customer

(User needs)

h

l

Tec nica Requirements

i

i

Practices to Translate Customer Requirements into CtQs main back next <a href=home Company: G Medical Devices 5001-10,000 employees Global CTQ Flow Down Post Market Surveillance Clinical Marketing Focus Groups Repairs Complaints Regulatory Therapy system shall deliver the prescribed negative pressure to the wound site when powered on Therapy unit shall maintain pressure within ±x mmHg of target pressure Therapy Unit, Canister, Dressing (e.g. drape), System Interactions (sub-assembly) Pump Flow rate Pump Diaphragm characteristics Drape adhesive properties Canister Unit interface Voice of the Customer (User needs) h l Tec nica Requirements i i Access Risk level from Top Down* and Usability * perspective Link to DFMECA for Risk Carry over to PFMEA Part Drawings (Link to DFMEA for Risk) CTQ Characteristics Link CTQs identified to Risk Top Down : evaluates the potential risks from the system level perspective, before finalizing the design. Mitigations from Top down should be used as an input to the design. Usability risk analysis: evaluates the potential hazards related to the use or misuse of the product. 48 " id="pdf-obj-48-94" src="pdf-obj-48-94.jpg">

Access Risk level from Top Down* and Usability * perspective

Link to DFMECA for Risk

Carry over to PFMEA

Practices to Translate Customer Requirements into CtQs main back next <a href=home Company: G Medical Devices 5001-10,000 employees Global CTQ Flow Down Post Market Surveillance Clinical Marketing Focus Groups Repairs Complaints Regulatory Therapy system shall deliver the prescribed negative pressure to the wound site when powered on Therapy unit shall maintain pressure within ±x mmHg of target pressure Therapy Unit, Canister, Dressing (e.g. drape), System Interactions (sub-assembly) Pump Flow rate Pump Diaphragm characteristics Drape adhesive properties Canister Unit interface Voice of the Customer (User needs) h l Tec nica Requirements i i Access Risk level from Top Down* and Usability * perspective Link to DFMECA for Risk Carry over to PFMEA Part Drawings (Link to DFMEA for Risk) CTQ Characteristics Link CTQs identified to Risk Top Down : evaluates the potential risks from the system level perspective, before finalizing the design. Mitigations from Top down should be used as an input to the design. Usability risk analysis: evaluates the potential hazards related to the use or misuse of the product. 48 " id="pdf-obj-48-105" src="pdf-obj-48-105.jpg">

Part Drawings (Link to

DFMEA for Risk)

CTQ Characteristics

Practices to Translate Customer Requirements into CtQs main back next <a href=home Company: G Medical Devices 5001-10,000 employees Global CTQ Flow Down Post Market Surveillance Clinical Marketing Focus Groups Repairs Complaints Regulatory Therapy system shall deliver the prescribed negative pressure to the wound site when powered on Therapy unit shall maintain pressure within ±x mmHg of target pressure Therapy Unit, Canister, Dressing (e.g. drape), System Interactions (sub-assembly) Pump Flow rate Pump Diaphragm characteristics Drape adhesive properties Canister Unit interface Voice of the Customer (User needs) h l Tec nica Requirements i i Access Risk level from Top Down* and Usability * perspective Link to DFMECA for Risk Carry over to PFMEA Part Drawings (Link to DFMEA for Risk) CTQ Characteristics Link CTQs identified to Risk Top Down : evaluates the potential risks from the system level perspective, before finalizing the design. Mitigations from Top down should be used as an input to the design. Usability risk analysis: evaluates the potential hazards related to the use or misuse of the product. 48 " id="pdf-obj-48-115" src="pdf-obj-48-115.jpg">

Link CTQs identified to Risk

Top Down: evaluates the potential risks from the system level perspective, before finalizing the design. Mitigations from Top down should be used as an input to

the design. Usability risk analysis: evaluates the potential hazards related to the use or misuse of the product.

48

Practices to Translate Customer Requirements into CtQs main back next <a href=home Company: G Medical Devices 5001-10,000 employees Global CTQ Flow Down Post Market Surveillance Clinical Marketing Focus Groups Repairs Complaints Regulatory Therapy system shall deliver the prescribed negative pressure to the wound site when powered on Therapy unit shall maintain pressure within ±x mmHg of target pressure Therapy Unit, Canister, Dressing (e.g. drape), System Interactions (sub-assembly) Pump Flow rate Pump Diaphragm characteristics Drape adhesive properties Canister Unit interface Voice of the Customer (User needs) h l Tec nica Requirements i i Access Risk level from Top Down* and Usability * perspective Link to DFMECA for Risk Carry over to PFMEA Part Drawings (Link to DFMEA for Risk) CTQ Characteristics Link CTQs identified to Risk Top Down : evaluates the potential risks from the system level perspective, before finalizing the design. Mitigations from Top down should be used as an input to the design. Usability risk analysis: evaluates the potential hazards related to the use or misuse of the product. 48 " id="pdf-obj-48-130" src="pdf-obj-48-130.jpg">
Managing Requirements toc main back next home Pr actices To Translate Customer Requirements Into CtQs
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Practices to Translate Customer Requirements into CtQs

Company: H Medical Devices 10,001 + employees Global toc main back next home Managing Requirements Component
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H Medical Devices
10,001 + employees
Global
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Managing Requirements
Component
Reqs
Design Review
Trace to Design
Outputs
Process
Planning

Matrix

Practices to Translate Customer Requirements into CtQs Company: H Medical Devices 10,001 + employees Global toc
Critical Parameter Management Process Model toc main back next home Pr actices To Translate Customer Requirements
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Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: K Medical Devices 10,001 + employees Global CPM Process Model Value Stream Input Feedback Customer Input Loops PDP Process Product UFMEA Material Specifications DFMEA Specifications Design Qualifications & Validations Process Development Process & Process Customer Assembly PFMEA Qualifications Complaints Specifications & Validations Non- Risk Identification Inspection Scrap Testing conformance Results Reporting Results Reporting & Mitigation Control & Monitoring Critical Parameters are identified in Design and translated throughout the QMS and ultimately is used to focus control & monitoring and prioritized feedback loops. " id="pdf-obj-52-6" src="pdf-obj-52-6.jpg">

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Company: K Medical Devices 10,001 + employees Global
Company:
K Medical Devices
10,001 + employees
Global

CPM Process Model Value Stream

Input

Feedback Customer Input Loops PDP Process Product UFMEA Material Specifications DFMEA Specifications
Feedback
Customer
Input
Loops
PDP Process
Product
UFMEA
Material
Specifications
DFMEA
Specifications
Design Qualifications & Validations Process Development Process & Process Customer Assembly PFMEA Qualifications Complaints Specifications &
Design
Qualifications
& Validations
Process Development
Process &
Process
Customer
Assembly
PFMEA
Qualifications
Complaints
Specifications
& Validations
Non-
Risk Identification
Inspection
Scrap
Testing
conformance
Results
Reporting
Results
Reporting

& Mitigation

Control & Monitoring

Critical Parameters are identified in Design and translated

throughout the QMS and ultimately is used to focus control &

monitoring and prioritized feedback loops.

Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: K Medical Devices 10,001 + employees Global CPM Process Model Value Stream Input Feedback Customer Input Loops PDP Process Product UFMEA Material Specifications DFMEA Specifications Design Qualifications & Validations Process Development Process & Process Customer Assembly PFMEA Qualifications Complaints Specifications & Validations Non- Risk Identification Inspection Scrap Testing conformance Results Reporting Results Reporting & Mitigation Control & Monitoring Critical Parameters are identified in Design and translated throughout the QMS and ultimately is used to focus control & monitoring and prioritized feedback loops. " id="pdf-obj-52-41" src="pdf-obj-52-41.jpg">

Practices to Translate Customer Requirements into CtQs

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Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: K Medical Devices 10,001 + employees Global CPM Process Model Identification Targets - QE Each Quality Engineer has Customer Input been retrospectively identifying their Design Product UFMEA Material Qualifications Critical Parameters for their Specifications DFMEA Specifications & Validations assigned products Process & Process Customer Assembly PFMEA Qualifications Complaints Specifications & Validations Non- Inspection Scrap Testing conformance The identified Critical Parameters are Results Reporting Results Reporting then: 1. Assessed for capability 2. Mitigations defined 3. Improvement plans created 4. Controls & Monitors implemented Starting with complaints and working to the left, critical safety, performance and compliance parameters identified " id="pdf-obj-53-6" src="pdf-obj-53-6.jpg">

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Company: K Medical Devices 10,001 + employees Global
Company:
K Medical Devices
10,001 + employees
Global

CPM Process Model Identification Targets - QE

Each Quality Engineer has Customer Input been retrospectively identifying their Design Product UFMEA Material Qualifications Critical
Each Quality Engineer has
Customer
Input
been retrospectively
identifying their
Design
Product
UFMEA
Material
Qualifications
Critical Parameters for their
Specifications
DFMEA
Specifications
& Validations
assigned products
Process &
Process
Customer
Assembly
PFMEA
Qualifications
Complaints
Specifications
& Validations
Non-
Inspection
Scrap
Testing
conformance
The identified Critical Parameters are
Results
Reporting
Results
Reporting

then:

  • 1. Assessed for capability

  • 2. Mitigations defined

  • 3. Improvement plans created

  • 4. Controls & Monitors implemented

Starting with complaints and

working to the left, critical

safety, performance and

compliance parameters

identified

Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: K Medical Devices 10,001 + employees Global CPM Process Model Identification Targets - QE Each Quality Engineer has Customer Input been retrospectively identifying their Design Product UFMEA Material Qualifications Critical Parameters for their Specifications DFMEA Specifications & Validations assigned products Process & Process Customer Assembly PFMEA Qualifications Complaints Specifications & Validations Non- Inspection Scrap Testing conformance The identified Critical Parameters are Results Reporting Results Reporting then: 1. Assessed for capability 2. Mitigations defined 3. Improvement plans created 4. Controls & Monitors implemented Starting with complaints and working to the left, critical safety, performance and compliance parameters identified " id="pdf-obj-53-47" src="pdf-obj-53-47.jpg">

Practices to Translate Customer Requirements into CtQs

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Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: K Medical Devices 10,001 + employees Global CPM Process Model Identification Targets - DA In a Prospective manner Customer Input the development team, led by DA, identifies their Critical Design Product UFMEA Material Qualifications Parameters and rigorously Specifications DFMEA Specifications & Validations tests them. Process & Process Customer Assembly PFMEA Qualifications Complaints Specifications & Validations Starting with Customer Input Non- and working to the right, Inspection Scrap Testing conformance Results Reporting Results Reporting critical safety, performance and compliance parameters identified The identified Critical Parameters are then: 1. Assessed for capability 2. Risk assessed & Mitigations defined 3. Specifications created Transfer Function output input 4. Designs made robust 5. Tested and optimized 6. Deployed to commercialization " id="pdf-obj-54-6" src="pdf-obj-54-6.jpg">

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Company: K Medical Devices 10,001 + employees Global
Company:
K Medical Devices
10,001 + employees
Global

CPM Process Model Identification Targets - DA

In a Prospective manner Customer Input the development team, led by DA, identifies their Critical Design
In a Prospective manner
Customer
Input
the development team, led
by DA, identifies their Critical
Design
Product
UFMEA
Material
Qualifications
Parameters and rigorously
Specifications
DFMEA
Specifications
& Validations
tests them.
Process &
Process
Customer
Assembly
PFMEA
Qualifications
Complaints
Specifications
& Validations
Starting with Customer Input
Non-
and working to the right,
Inspection
Scrap
Testing
conformance
Results
Reporting
Results
Reporting

critical safety, performance

and compliance parameters

identified

The identified Critical Parameters are then:

  • 1. Assessed for capability

  • 2. Risk assessed & Mitigations defined

  • 3. Specifications created

Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: K Medical Devices 10,001 + employees Global CPM Process Model Identification Targets - DA In a Prospective manner Customer Input the development team, led by DA, identifies their Critical Design Product UFMEA Material Qualifications Parameters and rigorously Specifications DFMEA Specifications & Validations tests them. Process & Process Customer Assembly PFMEA Qualifications Complaints Specifications & Validations Starting with Customer Input Non- and working to the right, Inspection Scrap Testing conformance Results Reporting Results Reporting critical safety, performance and compliance parameters identified The identified Critical Parameters are then: 1. Assessed for capability 2. Risk assessed & Mitigations defined 3. Specifications created Transfer Function output input 4. Designs made robust 5. Tested and optimized 6. Deployed to commercialization " id="pdf-obj-54-41" src="pdf-obj-54-41.jpg">

Transfer Function

CPy output = f(x input )

  • 4. Designs made robust

  • 5. Tested and optimized

  • 6. Deployed to commercialization

Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: K Medical Devices 10,001 + employees Global CPM Process Model Identification Targets - DA In a Prospective manner Customer Input the development team, led by DA, identifies their Critical Design Product UFMEA Material Qualifications Parameters and rigorously Specifications DFMEA Specifications & Validations tests them. Process & Process Customer Assembly PFMEA Qualifications Complaints Specifications & Validations Starting with Customer Input Non- and working to the right, Inspection Scrap Testing conformance Results Reporting Results Reporting critical safety, performance and compliance parameters identified The identified Critical Parameters are then: 1. Assessed for capability 2. Risk assessed & Mitigations defined 3. Specifications created Transfer Function output input 4. Designs made robust 5. Tested and optimized 6. Deployed to commercialization " id="pdf-obj-54-62" src="pdf-obj-54-62.jpg">

Practices to Translate Customer Requirements into CtQs

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Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: K Medical Devices 10,001 + employees Global CTQ s (How Determined) Review of field complaints for high severity items impacting the patient. Consulted with Product Surveillance for assistance with interpreting complaints. Cross-functional review of what constitutes high severity complaints. Customer Input Design Product UFMEA Material Qualifications Specifications DFMEA Specifications & Validations Process & Process Customer Assembly PFMEA Qualifications Complaints Specifications & Validations Non- Inspection Scrap Testing conformance Results Reporting Results Reporting " id="pdf-obj-55-6" src="pdf-obj-55-6.jpg">

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Company: K Medical Devices 10,001 + employees Global
Company:
K Medical Devices
10,001 + employees
Global

CTQ s (How Determined)

Review of field complaints for high severity items

impacting the patient.

Consulted with Product Surveillance for assistance with

interpreting complaints.

Cross-functional review of what constitutes high severity

complaints.

Customer Input Design Product UFMEA Material Qualifications Specifications DFMEA Specifications & Validations Process & Process Customer
Customer
Input
Design
Product
UFMEA
Material
Qualifications
Specifications
DFMEA
Specifications
& Validations
Process &
Process
Customer
Assembly
PFMEA
Qualifications
Complaints
Specifications
& Validations
Non-
Inspection
Scrap
Testing
conformance
Results
Reporting
Results
Reporting
Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: K Medical Devices 10,001 + employees Global CTQ s (How Determined) Review of field complaints for high severity items impacting the patient. Consulted with Product Surveillance for assistance with interpreting complaints. Cross-functional review of what constitutes high severity complaints. Customer Input Design Product UFMEA Material Qualifications Specifications DFMEA Specifications & Validations Process & Process Customer Assembly PFMEA Qualifications Complaints Specifications & Validations Non- Inspection Scrap Testing conformance Results Reporting Results Reporting " id="pdf-obj-55-53" src="pdf-obj-55-53.jpg">

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Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: K Medical Devices 10,001 + employees Global Example Product Deployment of CPM Critical Product and Process Parameters Capability and state of control Gap analysis Where we are now Improvement plans to achieve desired State of Control CPM will involve a reoccurring review of the critical parameter and controls with adjustments made as necessary. " id="pdf-obj-56-6" src="pdf-obj-56-6.jpg">

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Company: K Medical Devices 10,001 + employees Global
Company:
K Medical Devices
10,001 + employees
Global

Example Product Deployment of CPM

Critical Product and Process Parameters

Capability and state of control

Gap analysis

Where we are now

Improvement plans to achieve desired State of Control

CPM will involve a reoccurring review of the critical parameter and controls with adjustments made as necessary.

Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: K Medical Devices 10,001 + employees Global Example Product Deployment of CPM Critical Product and Process Parameters Capability and state of control Gap analysis Where we are now Improvement plans to achieve desired State of Control CPM will involve a reoccurring review of the critical parameter and controls with adjustments made as necessary. " id="pdf-obj-56-44" src="pdf-obj-56-44.jpg">
Critical Quality Attributes Model toc main back next home Pr actices To Translate Customer Requirements Into
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Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: J Medical Devices 10,001 + employees Global Identification of Critical Quality Attributes 1. Design Controls process (per QSR): Ensures that Design Inputs (including DI acceptance criteria) are developed that comprehensively meet the r equirements of the Intended Use and User Needs. 2. Risk Management process (per ISO 14971): Reviews De sign Inputs to ensure that sufficient De sign Inputs ha ve been identified to a ddress iden tified Hazards. 3. Design Controls process (per QSR): Ensures that Design Outputs (including quality attributes) are de veloped that comprehensively meet the r equirements of the Design Inputs. Medical Device Hazards Figure 2: Risk Management focus " id="pdf-obj-58-6" src="pdf-obj-58-6.jpg">

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Company: J Medical Devices 10,001 + employees Global
Company:
J Medical Devices
10,001 + employees
Global

Identification of Critical Quality Attributes

  • 1. Design Controls process (per QSR): Ensures that Design Inputs (including DI acceptance criteria) are developed that comprehensively meet the requirements of the Intended Use and User Needs.

  • 2. Risk Management process (per ISO 14971): Reviews Design Inputs to ensure that sufficient Design Inputs have been identified to address identified Hazards.

  • 3. Design Controls process (per QSR): Ensures that Design Outputs (including quality attributes) are developed that comprehensively meet the requirements of the Design Inputs.

Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: J Medical Devices 10,001 + employees Global Identification of Critical Quality Attributes 1. Design Controls process (per QSR): Ensures that Design Inputs (including DI acceptance criteria) are developed that comprehensively meet the r equirements of the Intended Use and User Needs. 2. Risk Management process (per ISO 14971): Reviews De sign Inputs to ensure that sufficient De sign Inputs ha ve been identified to a ddress iden tified Hazards. 3. Design Controls process (per QSR): Ensures that Design Outputs (including quality attributes) are de veloped that comprehensively meet the r equirements of the Design Inputs. Medical Device Hazards Figure 2: Risk Management focus " id="pdf-obj-58-47" src="pdf-obj-58-47.jpg">
Medical Device Hazards Figure 2: Risk Management focus
Medical
Device
Hazards
Figure 2: Risk Management focus
Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: J Medical Devices 10,001 + employees Global Identification of Critical Quality Attributes 1. Design Controls process (per QSR): Ensures that Design Inputs (including DI acceptance criteria) are developed that comprehensively meet the r equirements of the Intended Use and User Needs. 2. Risk Management process (per ISO 14971): Reviews De sign Inputs to ensure that sufficient De sign Inputs ha ve been identified to a ddress iden tified Hazards. 3. Design Controls process (per QSR): Ensures that Design Outputs (including quality attributes) are de veloped that comprehensively meet the r equirements of the Design Inputs. Medical Device Hazards Figure 2: Risk Management focus " id="pdf-obj-58-51" src="pdf-obj-58-51.jpg">

Practices to Translate Customer Requirements into CtQs

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Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: J Medical Devices 10,001 + employees Global Critical Quality Attributes Critical Quality Attributes are product design specifications and are documented in the DHF as: 1. Design input acceptance criteria (in the Design I/O document) and/or 2. Design output specifications/tolerances (in the DMR) DMR (Design) 1. Product drawings Refinement of Design Input (Product performance criteria) 2. Label text & artwork 3. Material specs 4. Software code DIO Document 5. Product test specs Intended Use/ DI # Design DI Acceptance criteria DI Acceptance DO # Design Outputs User Need Input criteria Justification (PN/ Feature) 1 1-1 xxxx Design Input Acceptance criteria 1-1 xxxx xxxx 1-1-1 Design PN/Feature 1-1-1 Design Spec/tolerance 1-1-1-1 Design Spec/tolerance 1-1-1-2 Design Spec/tolerance 1-1-1-3 1-1-2 Design PN/Feature 1-1-2 Design Spec/tolerance 1-1-2-1 Design Spec/tolerance 1-1-2-2 Design Spec/tolerance 1-1-2-3 Design Outputs " id="pdf-obj-59-6" src="pdf-obj-59-6.jpg">

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Company: J Medical Devices 10,001 + employees Global
Company:
J Medical Devices
10,001 + employees
Global

Critical Quality Attributes

Critical Quality Attributes are product design specifications and are documented in the DHF as:

  • 1. Design input acceptance criteria (in the Design I/O document) and/or

  • 2. Design output specifications/tolerances (in the DMR)

DMR (Design) 1. Product drawings Refinement of Design Input (Product performance criteria) 2. Label text &
DMR (Design)
1.
Product drawings
Refinement of Design Input
(Product performance criteria)
2.
Label text & artwork
3.
Material specs
4.
Software code
DIO Document
5.
Product test specs
Intended Use/
DI #
Design
DI Acceptance criteria
DI Acceptance
DO #
Design Outputs
User Need
Input
criteria Justification
(PN/ Feature)
1
1-1
xxxx
Design Input Acceptance
criteria 1-1
xxxx xxxx
1-1-1
Design PN/Feature 1-1-1
Design Spec/tolerance 1-1-1-1
Design Spec/tolerance 1-1-1-2
Design Spec/tolerance 1-1-1-3
1-1-2
Design PN/Feature 1-1-2
Design Spec/tolerance 1-1-2-1
Design Spec/tolerance 1-1-2-2
Design Spec/tolerance 1-1-2-3

Design Outputs

Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: J Medical Devices 10,001 + employees Global Critical Quality Attributes Critical Quality Attributes are product design specifications and are documented in the DHF as: 1. Design input acceptance criteria (in the Design I/O document) and/or 2. Design output specifications/tolerances (in the DMR) DMR (Design) 1. Product drawings Refinement of Design Input (Product performance criteria) 2. Label text & artwork 3. Material specs 4. Software code DIO Document 5. Product test specs Intended Use/ DI # Design DI Acceptance criteria DI Acceptance DO # Design Outputs User Need Input criteria Justification (PN/ Feature) 1 1-1 xxxx Design Input Acceptance criteria 1-1 xxxx xxxx 1-1-1 Design PN/Feature 1-1-1 Design Spec/tolerance 1-1-1-1 Design Spec/tolerance 1-1-1-2 Design Spec/tolerance 1-1-1-3 1-1-2 Design PN/Feature 1-1-2 Design Spec/tolerance 1-1-2-1 Design Spec/tolerance 1-1-2-2 Design Spec/tolerance 1-1-2-3 Design Outputs " id="pdf-obj-59-39" src="pdf-obj-59-39.jpg">

Practices to Translate Customer Requirements into CtQs

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Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: J Medical Devices 10,001 + employees Global Example Critical Quality Attributes Design Output Specs/Tolerances Design Input Acceptance Criteria 1. Implant fixation force 1. Implant thickness, Device color Implant tip radius, Internal component position Implant actuation sound Drill heat (temperature) Drill metal debris rate 2. Product identification text on device 2. Warning text on device and IFU 3. Implant material 3. Internal component material 4. Software platform/revision 4. 5. Drill torque, Voltage output, Sterility Assurance Level, Device weight, Video resolution Software code for voltage calibration 5. Internal power supply test voltage, Software checksum, Implant hardness DIO Document DMR (Design) 1. Product drawings 2. Label text & artwork 3. Material specs Manufacturing has visibility of all product design specs in the DMR 4. Software code 5. Product test specs Design Outputs " id="pdf-obj-60-6" src="pdf-obj-60-6.jpg">

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Company: J Medical Devices 10,001 + employees Global
Company:
J Medical Devices
10,001 + employees
Global

Example Critical Quality Attributes

Design Output Specs/Tolerances Design Input Acceptance Criteria 1. Implant fixation force 1. Implant thickness, Device color
Design Output Specs/Tolerances
Design Input Acceptance Criteria
1.
Implant fixation force 1. Implant thickness, Device color
Implant tip radius, Internal
component position
Implant actuation
sound
Drill heat
(temperature)
Drill metal debris rate
2.
Product identification text on device
2.
Warning text on device and IFU
3.
Implant material
3.
Internal component material
4.
Software platform/revision
4.
5.
Drill torque, Voltage output, Sterility
Assurance Level, Device weight,
Video resolution
Software code for voltage
calibration
5.
Internal power supply test
voltage, Software checksum,
Implant hardness
DIO Document
DMR (Design)
1.
Product drawings
2.
Label text & artwork
3.
Material specs
Manufacturing has visibility of all
product design specs in the DMR
4.
Software code
5.
Product test specs
Design Outputs
Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: J Medical Devices 10,001 + employees Global Example Critical Quality Attributes Design Output Specs/Tolerances Design Input Acceptance Criteria 1. Implant fixation force 1. Implant thickness, Device color Implant tip radius, Internal component position Implant actuation sound Drill heat (temperature) Drill metal debris rate 2. Product identification text on device 2. Warning text on device and IFU 3. Implant material 3. Internal component material 4. Software platform/revision 4. 5. Drill torque, Voltage output, Sterility Assurance Level, Device weight, Video resolution Software code for voltage calibration 5. Internal power supply test voltage, Software checksum, Implant hardness DIO Document DMR (Design) 1. Product drawings 2. Label text & artwork 3. Material specs Manufacturing has visibility of all product design specs in the DMR 4. Software code 5. Product test specs Design Outputs " id="pdf-obj-60-25" src="pdf-obj-60-25.jpg">

Practices to Translate Customer Requirements into CtQs

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Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: J Medical Devices 10,001 + employees Global Critical Quality Attributes Critical CQA s are critical product design specifications Critical CQA s are product design specifications where being in-spec is considered critical for product quality Note: Expectation is that manufactured product will meet all product design specifications (quality attributes) in the DMR, whether designated as critical or not In accordance with QSR Subpart G, Production and Process Controls The designation of a product design specification as critical merely conveys that the consequences of being out of spec are severe, so additional focus is prudent during manufacturing, verification, etc. Critical Quality Quality Attributes Attributes Verify (Inspect) or Validate Verify (Inspect) or Validate with more rigor " id="pdf-obj-61-6" src="pdf-obj-61-6.jpg">

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Company: J Medical Devices 10,001 + employees Global
Company:
J Medical Devices
10,001 + employees
Global

Critical Quality Attributes

Critical CQA s are critical product design specifications

Critical CQA s are product design specifications where being in-spec is considered critical

 

for product quality

Note: Expectation is that manufactured product will meet all product design specifications (quality attributes) in the DMR, whether designated as critical or not

In accordance with QSR Subpart G, Production and Process Controls

The designation of a product design specification as critical merely conveys that the consequences of being out of spec are severe, so additional focus is prudent during manufacturing, verification, etc.

Critical Quality Quality Attributes Attributes Verify (Inspect) or Validate Verify (Inspect) or Validate with more rigor
Critical
Quality
Quality
Attributes
Attributes
Verify (Inspect) or Validate
Verify (Inspect) or Validate
with more rigor
Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: J Medical Devices 10,001 + employees Global Critical Quality Attributes Critical CQA s are critical product design specifications Critical CQA s are product design specifications where being in-spec is considered critical for product quality Note: Expectation is that manufactured product will meet all product design specifications (quality attributes) in the DMR, whether designated as critical or not In accordance with QSR Subpart G, Production and Process Controls The designation of a product design specification as critical merely conveys that the consequences of being out of spec are severe, so additional focus is prudent during manufacturing, verification, etc. Critical Quality Quality Attributes Attributes Verify (Inspect) or Validate Verify (Inspect) or Validate with more rigor " id="pdf-obj-61-78" src="pdf-obj-61-78.jpg">

Practices to Translate Customer Requirements into CtQs

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Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: J Medical Devices 10,001 + employees Global Identification and Classification of Critical CQA s " id="pdf-obj-62-6" src="pdf-obj-62-6.jpg">

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Company: J Medical Devices 10,001 + employees Global
Company:
J Medical Devices
10,001 + employees
Global

Identification and Classification of Critical CQA s

Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: J Medical Devices 10,001 + employees Global Identification and Classification of Critical CQA s " id="pdf-obj-62-25" src="pdf-obj-62-25.jpg">
Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: J Medical Devices 10,001 + employees Global Identification and Classification of Critical CQA s " id="pdf-obj-62-27" src="pdf-obj-62-27.jpg">

Practices to Translate Customer Requirements into CtQs

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Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: J Medical Devices 10,001 + employees Global Identify Critical CQAs For a given quality attribute, if a significant departure from design tolerance is predicted to result in unacceptable product quality (i.e., major customer dissatisfaction and/or unacceptable risk), that quality attribute is identified as a CQA. Note: For most quality attributes, a large, unlimited departure from design tolerance inevitably results in unacceptable product quality , but this does not imply that most quality attributes are CQA s. The main purpose of CQA identification is to highlight those quality attributes for which a slight departure from design tolerance has unacceptable consequences. " id="pdf-obj-63-6" src="pdf-obj-63-6.jpg">

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Company: J Medical Devices 10,001 + employees Global
Company:
J Medical Devices
10,001 + employees
Global

Identify Critical CQAs

For a given quality attribute, if a significant departure from design tolerance is predicted to result in unacceptable product quality (i.e., major customer dissatisfaction and/or unacceptable risk), that quality attribute is identified as a CQA.

Note: For most quality attributes, a large, unlimited departure from design tolerance inevitably results in unacceptable product quality , but this does not imply that most quality attributes are CQA s. The main purpose of CQA identification is to highlight those quality attributes for which a slight departure from design tolerance has unacceptable consequences.

Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: J Medical Devices 10,001 + employees Global Identify Critical CQAs For a given quality attribute, if a significant departure from design tolerance is predicted to result in unacceptable product quality (i.e., major customer dissatisfaction and/or unacceptable risk), that quality attribute is identified as a CQA. Note: For most quality attributes, a large, unlimited departure from design tolerance inevitably results in unacceptable product quality , but this does not imply that most quality attributes are CQA s. The main purpose of CQA identification is to highlight those quality attributes for which a slight departure from design tolerance has unacceptable consequences. " id="pdf-obj-63-29" src="pdf-obj-63-29.jpg">

Practices to Translate Customer Requirements into CtQs

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Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: J Medical Devices 10,001 + employees Global Identify Critical CQAs For CQA identification purposes, the concept of a significant departure from design tolerance is interpreted as follows: For continuous quality attributes with linear design tolerance, a significant departure from design tolerance should be defined as departure up to a factor of 2 from design tolerance (i.e., up to a 100% f departure from design tolerance). Reference: Juran, J.M. and Godfrey, A. B. (Eds.), Juran s Quality Handbook , 5 edition, New York: McGraw-Hill (1999), Section 22.6-22.7 5.30 Length Design tolerance 5.20 5.40 5.10 5.50 Significant departure from Design tolerance (for CQA identification) Figure: Significant departure from a linear design tolerance " id="pdf-obj-64-6" src="pdf-obj-64-6.jpg">

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Company: J Medical Devices 10,001 + employees Global
Company:
J Medical Devices
10,001 + employees
Global

Identify Critical CQAs

For CQA identification purposes, the concept of a significant departure

from design tolerance is interpreted as follows:

For continuous quality attributes with linear design tolerance, a

significant departure from design tolerance should be defined as

departure up to a factor of 2 from design tolerance (i.e., up to a 100%

f

departure from design tolerance).

Reference: Juran, J.M. and Godfrey, A. B. (Eds.), Juran s Quality Handbook, 5 th edition,

New York: McGraw-Hill (1999), Section 22.6-22.7

5.30 Length Design tolerance 5.20 5.40 5.10 5.50 Significant departure from Design tolerance (for CQA identification)
5.30
Length
Design tolerance
5.20
5.40
5.10
5.50
Significant departure from
Design tolerance
(for CQA identification)
Figure: Significant departure from a linear design tolerance
Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: J Medical Devices 10,001 + employees Global Identify Critical CQAs For CQA identification purposes, the concept of a significant departure from design tolerance is interpreted as follows: For continuous quality attributes with linear design tolerance, a significant departure from design tolerance should be defined as departure up to a factor of 2 from design tolerance (i.e., up to a 100% f departure from design tolerance). Reference: Juran, J.M. and Godfrey, A. B. (Eds.), Juran s Quality Handbook , 5 edition, New York: McGraw-Hill (1999), Section 22.6-22.7 5.30 Length Design tolerance 5.20 5.40 5.10 5.50 Significant departure from Design tolerance (for CQA identification) Figure: Significant departure from a linear design tolerance " id="pdf-obj-64-54" src="pdf-obj-64-54.jpg">

Practices to Translate Customer Requirements into CtQs

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Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: J Medical Devices 10,001 + employees Global Identify Critical CQAs For discrete quality attributes, any departure from design tolerance may be considered a significant departure, but project team personnel should subjectively decide what constitutes a significant departure. Example: For an implant, the color specification green might be considered a CQA if manufacturing that implant as any color other than green (e.g., blue or red ) is predicted to result in unacceptable product quality. " id="pdf-obj-65-6" src="pdf-obj-65-6.jpg">

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Company: J Medical Devices 10,001 + employees Global
Company:
J Medical Devices
10,001 + employees
Global

Identify Critical CQAs

For discrete quality attributes, any departure from design tolerance may

be considered a significant departure, but project team personnel should

subjectively decide what constitutes a significant departure.

Example: For an implant, the color specification green might be

considered a CQA if manufacturing that implant as any color other than

green (e.g., blue or red ) is predicted to result in unacceptable product

quality.

Practices to Translate Customer Requirements into CtQs toc main back next <a href=home Company: J Medical Devices 10,001 + employees Global Identify Critical CQAs For discrete quality attributes, any departure from design tolerance may be considered a significant departure, but project team personnel should subjectively decide what constitutes a significant departure. Example: For an implant, the color specification green might be considered a CQA if manufacturing that implant as any color other than green (e.g., blue or red ) is predicted to result in unacceptable product quality. " id="pdf-obj-65-51" src="pdf-obj-65-51.jpg">

Practices to Translate Customer Requirements into CtQs

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Practices to Translate Customer Requirements into CtQs toc main back <a href=home Company: J Medical Devices 10,001 + employees Global Identify Critical CQAs For CQA identification purposes, the consequence of a significant departure from design tolerance (i.e., the failure effect) is determined using any of the following methods or combination of methods: 1. Judgment of engineering, quality assurance, clinical affairs, and/or marketing l personne on th e projec t t eam 2. Inspection of Risk Management File info 3. Inspection and analysis of field data, test data, theoretical models, NC/CAPA information, standards, regulations, and/or literature for similar products " id="pdf-obj-66-6" src="pdf-obj-66-6.jpg">

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Company: J Medical Devices 10,001 + employees Global
Company:
J Medical Devices
10,001 + employees
Global

Identify Critical CQAs

For CQA identification purposes, the consequence of a significant departure from

design tolerance (i.e., the failure effect) is determined using any of the following

methods or combination of methods:

  • 1. Judgment of engineering, quality assurance, clinical affairs, and/or marketing

l

personne on

th

e projec

t t

eam

  • 2. Inspection of Risk Management File info

  • 3. Inspection and analysis of field data, test data, theoretical models, NC/CAPA information, standards, regulations, and/or literature for similar products

Practices to Translate Customer Requirements into CtQs toc main back <a href=home Company: J Medical Devices 10,001 + employees Global Identify Critical CQAs For CQA identification purposes, the consequence of a significant departure from design tolerance (i.e., the failure effect) is determined using any of the following methods or combination of methods: 1. Judgment of engineering, quality assurance, clinical affairs, and/or marketing l personne on th e projec t t eam 2. Inspection of Risk Management File info 3. Inspection and analysis of field data, test data, theoretical models, NC/CAPA information, standards, regulations, and/or literature for similar products " id="pdf-obj-66-45" src="pdf-obj-66-45.jpg">