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Customer Requirements Into Ctqs
Customer Requirements Into Ctqs
Customer Requirements Into Ctqs
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Requirements Into CtQs
Practices To Translate Customer
Category B:
How Do You translate Customer
Requirements into CtQs?
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Practices to Translate Customer Requirements into CtQs
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
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Practices To Translate Customer
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Requirements Into CtQs
Model
Quality Function Deployment
Practices to Translate Customer Requirements into CtQs
B
Company: 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
Practices to Translate Customer Requirements into CtQs
F
Company: 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)
Practices to Translate Customer Requirements into CtQs
A
Company: 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)
Practices to Translate Customer Requirements into CtQs
A
Company: Medical Devices
1001-5000 employees
North America
A
Company: Medical Devices
1001-5000 employees
North America
A
Company: Medical Devices
1001-5000 employees
North America
ROOF: CORRELATION
P M Star rating of facilty
R E
event satisfaction score
E A
C
D S # customer complaints
T
I U
Q # cu feet per person
C R
'
T E # entrée options
S
I S
noise level
V
E = taste rating
Direction of
ROOF Improvement
# customer complaints
Synergy Strong 9 Competition Key:
# entrée options
Machine Machine Machine
High Conflict XX Weak 1 1 2 3
taste rating
noise level
Importance
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
A
Company: Medical Devices
1001-5000 employees
North America
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Requirements Into CtQs
Requirements Cascade
Practices to Translate Customer Requirements into CtQs
A
Company: 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))
Practices to Translate Customer Requirements into CtQs
A
Company: 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
A
Company: Medical Devices
1001-5000 employees
North America
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Requirements Into CtQs
Key Tools
Practices to Translate Customer Requirements into CtQs
B
Company: Medical Devices
10,001 + employees
Global
I
Company: Medical Devices
10,001 + employees
Global
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
I
Company:
Medical Devices
10,001 + employees
Global
DF “X”
DF R = Reliability
DF M = Manufacturability
DF S = Serviceability
DF C = Cost
Practices to Translate Customer Requirements into CtQs
I
Company: 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.
Practices to Translate Customer Requirements into CtQs
I
Company:
Medical Devices
10,001 + employees
Global
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Requirements Into CtQs
Risk Management
Practices to Translate Customer Requirements into CtQs
C
Company: 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
C
Company: Medical Devices
10,001 + employees
Global
4 1 1 2 3 3
3 0 1 2 2 3
2 0 0 1 2 2
1 0 0 0 1 2
1 2 3 4 5
Severity of Harm
Practices to Translate Customer Requirements into CtQs
C
Company: Medical Devices
10,001 + employees
Global
IPM
2. Discard and select
5. Follow up and CTQs with proper
update plan rationale
Response Flow
4. Create an 3. Propose and
analyze ideas for
implementation plan
making more robust
for the ideas selected
each selected CTQ
Practices to Translate Customer Requirements into CtQs
C
Company: Medical Devices
10,001 + employees
Global
F
Company: Hospital & Health Care
10,001 + employees
Global
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
F
Company: Hospital & Health Care
10,001 + employees
Global
F
Company: Hospital & Health Care
10,001 + employees
Global
F
Company: Hospital & Health Care
10,001 + employees
Global
– Transfer Functions
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Requirements Into CtQs
D
Company: 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)
Practices to Translate Customer Requirements into CtQs
D
Company: Medical Devices
10,001 + employees
Global
D
Company: Medical Devices
10,001 + employees
Global
D
Company: Medical Devices
10,001 + employees
Global
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Requirements Into CtQs
E
Company: Medical Devices
1001-5000 employees
Global
QFD
CtQ
Practices to Translate Customer Requirements into CtQs
E
Company: Medical Devices
1001-5000 employees
Global
E
Company: Medical Devices
1001-5000 employees
Global
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Requirements Into CtQs
F
Company: Hospital & Health Care
10,001 + employees
Global
CTQ Cascade
User Needs/Requirements
F
Company: Hospital & Health Care
10,001 + employees
Global
CTQ Cascade
Customer Needs and Requirements
Product Requirements
Measureable Performance
Requirements
Architecture: Subcomponents?
F
Company: Hospital & Health Care
10,001 + employees
Global
CTQ Cascade
Customer Needs and Requirements
Product Requirements
Process Requirements
F
Company: Hospital & Health Care
10,001 + employees
Global
CTQ Cascade
Customer Needs and Requirements
Product Requirements
Process Requirements
Risks
Mitigations, Controls
F
Company: Hospital & Health Care
10,001 + employees
Global
CTQ Cascade
Customer Needs and Requirements
Product Requirements
Process Requirements
F
Company: Hospital & Health Care
10,001 + employees
Global
CTQ Cascade
Customer Needs and Requirements
Product Requirements
Process Requirements
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Requirements Into CtQs
G
Company: Medical Devices
5001-10,000 employees
Global
Parts
Dimensions
Capability
Launch
Practices to Translate Customer Requirements into CtQs
G
Company: Medical Devices
5001-10,000 employees
Global
Therapy system shall deliver the prescribed negative pressure to the wound site when
Voice of the Customer powered on
(User needs)
Access Risk level
Technical Requirements Therapy unit shall maintain pressure within ±x mmHg of target pressure from Top Down*
and Usability *
perspective
Part Drawings – (Link to Therapy Unit, Canister, Dressing (e.g. drape), System Interactions (sub-assembly) Link to DFMECA
for Risk
DFMEA for Risk)
Carry over to
Pump Flow rate Drape adhesive properties Canister – Unit interface PFMEA
CTQ Characteristics Pump Diaphragm characteristics
•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. 48
• Usability risk analysis: evaluates the potential hazards related to the use or misuse of the product.
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Practices To Translate Customer
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Requirements Into CtQs
Managing Requirements
Practices to Translate Customer Requirements into CtQs
H
Company: Medical Devices
10,001 + employees
Global
Managing Requirements
Component
Reqs
Design Review
Trace to Design
Outputs
Process
Planning
Matrix
Practices To Translate Customer
Requirements Into CtQs
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Practices to Translate Customer Requirements into CtQs
K
Company: Medical Devices
10,001 + employees
Global
PDP Process
Design
Product UFMEA Material
Qualifications
Specifications DFMEA Specifications
Process Development
& Validations
Risk Identification
Non-
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
K
Company: Medical Devices
10,001 + employees
Global
Design
identifying their
Product
Specifications
UFMEA
DFMEA
Material
Specifications
Qualifications
& Validations Critical Parameters for their
assigned products
Process & Process
Customer
Assembly PFMEA Qualifications
Complaints
Specifications & Validations
Non-
Inspection Scrap Testing
then:
1. Assessed for capability Starting with complaints and
2. Mitigations defined working to the left, critical
3. Improvement plans created safety, performance and
4. Controls & Monitors implemented compliance parameters
identified
Practices to Translate Customer Requirements into CtQs
K
Company: Medical Devices
10,001 + employees
Global
Design
by DA, identifies their Critical
Product
Specifications
UFMEA
DFMEA
Material
Specifications
Qualifications
& Validations Parameters and rigorously
tests them.
Process & Process
Customer
Assembly PFMEA Qualifications
Complaints
Specifications & Validations
K
Company: Medical Devices
10,001 + employees
Global
Design
Product UFMEA Material
Qualifications
Specifications DFMEA Specifications
& Validations
Non-
Inspection Scrap Testing
conformance
Results Reporting Results
Reporting
Practices to Translate Customer Requirements into CtQs
K
Company: Medical Devices
10,001 + employees
Global
• Gap analysis
Where we are now
Improvement plans to achieve desired “State of Control”
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Requirements Into CtQs
J
Company: Medical Devices
10,001 + employees
Global
J
Company: Medical Devices
10,001 + employees
Global
DMR (Design)
1. Product drawings
“Refinement of Design Input” 2. Label text & artwork
(Product performance criteria) 3. Material specs
DIO Document 4. Software code
5. Product test specs
Intended Use/ DI # Design DI Acceptance criteria DI Acceptance DO # Design Outputs
User Need Input criteria Justification (PN/ Feature) Design Spec/tolerance 1-1-1-1
Design Spec/tolerance 1-1-1-2
1 1-1 xxxx Design Input Acceptance xxxx xxxx 1-1-1 Design PN/Feature 1-1-1 Design Spec/tolerance 1-1-1-3
criteria 1-1
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
J
Company: Medical Devices
10,001 + employees
Global
DIO Document
DMR (Design)
1. Product drawings
2. Label text & artwork
3. Material specs
Manufacturing has visibility of all 4. Software code
product design specs in the DMR 5. Product test specs
Design Outputs
Practices to Translate Customer Requirements into CtQs
J
Company: Medical Devices
10,001 + employees
Global
– 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
J
Company: Medical Devices
10,001 + employees
Global
J
Company: Medical Devices
10,001 + employees
Global
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
J
Company: Medical Devices
10,001 + employees
Global
5.30
Length
Design tolerance
5.20 5.40
5.10 5.50
Significant departure from
Design tolerance
(for CQA identification)
J
Company: Medical Devices
10,001 + employees
Global
J
Company: Medical Devices
10,001 + employees
Global