Design Controls

OMTEC® 2014
The 10th Annual Orthopaedic Manufacturing & Technology
Exposition and Conference
Martin Browning President, EduQuest, Inc.
EduQuest, Inc.
EDUcation: QUality Engineering, Science and Technology
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Global team of FDA compliance experts based near Washington,
DC, with staff located in U.S. and Europe
Founded by former senior officials from FDA’s Office of
Regulatory Affairs (ORA) Headquarters
Advisors to medical device, pharmaceutical, and biologics
companies worldwide since 1995
Expertise focused on audits and training for Quality Systems,
Supplier Control, Risk Management, Part 11, Validation, and
Inspection Readiness
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EduQuest
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22 years with U.S. FDA as expert investigator and rule-maker
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Special Assistant to Associate Commissioner of
Regulatory Affairs
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Co-Author of 21 CFR Part 11 for Electronic Records & Electronic Signatures
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Former chair of U.S. ISO 9000 committee; served as FDA liaison to the Global
Harmonisation Task Force (GHTF)
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Helped to develop the Quality System Regulation (QSR) for Medical Devices
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Chair of EduQuest’s live training courses (www.EduQuest.net)
EDUcation: QUality Engineering, Science, & Technology
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The Four Core Subsystems 
 Management Controls
 Production and Process Controls (PAPC)
 Corrective and Preventive Actions (CAPA)
 Design Controls
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Management Controls
 Quality Policy
 Adequate Organization
 Authority
 Resources
 Management Representative
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Management Controls
 Management Review
 Quality Planning
 Quality System Procedures
 Quality Audit
In Summary: Management must provide
Oversight and Responsibility
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Production and Process Controls
 Product must meet the device design
 Control must be exercised over
change, environment, personnel,
contamination, buildings, equipment,
manufacturing materials, automated
processes
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Production and Process Controls
 Product must meet the device design
 Inspection, measuring, and test equipment
must be controlled and calibrated
 Process Validation with established
procedures for monitoring and control
over process parameters to ensure
requirements continue to be met
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Corrective and Preventive Actions
 Analysis of all processes, quality data, post
market data, nonconformities
 Verifying or validating corrective and
preventive actions for effectiveness
 Maintaining traceability
 Feeding management review
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Design Controls
 Control to
 Design and build a safe and effective
product
 Meet our customers needs and expectations
 Design quality into our devices
 Design the product we require
 Follow our plans
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Design Controls
 Control to
 Meet users’ needs and intended uses
 Create and follow Requirements and
Specifications
 Comply with regulatory requirements
 Ensure the device can be reproducibly and
reliably manufactured
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Tools are necessary for achieving these
purposes. Tools include:
 Established design control procedures
 Plans for design projects (Including interfaces
between R&D and other units)
 Processes for transferring outputs to production
and for documenting successful transfer
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Tools are necessary for achieving these
purposes. Tools include:
 Procedures for validating and documenting that
devices perform and function as intended and as
users need and expect
 Processes for conducting and documenting
design reviews throughout the process
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Tools are necessary for achieving these
purposes. Tools include:
 Procedures and processes for identifying and
documenting design inputs - requirements and
high level specifications for the device
 Procedures and processes for developing and
documenting design outputs (to final
specifications in the DMR)
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Tools are necessary for achieving these
purposes. Tools include:
 Procedures and processes for verifying and
documenting through measurement, analysis,
test, and inspection that outputs fulfill input
requirements
 Procedures and processes for controlling changes
during design, development and for existing
devices
 Procedures and processes for documenting
design activities in a “living” design history file
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Procedures must ensure that formal
documented reviews of the design results
are planned and conducted at appropriate
stages of the device's design development
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Design Verification and Validation
Design Validation
Software
Requirements
Specifications
System Requirement
Specifications
Design Validation
Hardware
Requirements
Specifications
Software Design
Specifications
Electrical
Schematic
Software
Detailed Design
Specifications
Drawings to
Create “Stuffed
Board”
Source
Code
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Initial Design Input
Requirements
Blue = Design Verification
Red = Design Validation
Green – Software Validation
“Stuffed
” Board
Drawing
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Establish procedures for verifying the
device design
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Verification shall confirm that design
output meets the design input
requirements
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The results of the design verification
shall be documented in the DHF,
including
 Identification of the design
 Verification method(s)
 Date and individual(s) performing verification
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Verification is not a phase, nor is it a one-time effort,
it is an ongoing set of activities
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Tracing is a verification activity (input/output
verification/validation)
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Peer reviews may be used as a verification tool
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Track defects and resolutions throughout as a means
of controlling the design process
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Design verification is part of design validation
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Establishes, proves the appropriateness or
correctness of the specifications
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Designed the correct product in reference to
requirements
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Utilized to finalize the design specifications at
each stage in the design process
 Example: Stack-up Analysis
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Inspection, measurement, test or analysis
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Most verification activities, per FDA’s Design
Control Guidance, is analysis, not testing
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It consists of both objective and subjective results
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Verification activities are those that allow you to
move from your initial design input requirements
to your final design output specifications
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Verification provides theoretical proof of the
appropriateness of the final design relative to the
design input requirements
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Trace Documentation
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Stack-up Analysis
Technical, chemical, physical and other
engineering analyses
Automated test scripts
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Software Reference Drawing
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Peer Reviews, Code Reviews, Code Walk
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Throughs
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Issue tracking and closure
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Verification activities (if testing) must be
conducted using calibrated test equipment
(when equipment is used) and written and
approved protocols or methods of analysis
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Protocols or methods must contain objective
acceptance criteria
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The sample sizes used in any testing must be
documented with a statistical rationale
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Establish and maintain procedures for validating
the device design
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Perform validation under defined operating
conditions on initial production units, or their
equivalents
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Ensure devices conform to defined user needs
and intended uses
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Must include testing of production units under
actual and/or simulated use conditions
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Must include documentation of the use of good
software development practices and risk
analysis, where appropriate
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Results of the design validation, including
identification of the design, method(s), the date
and individual(s) performing the validation shall
be documented in the DHF
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Not just clinical studies or user studies or
usability studies or user preference testing
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Proves the device will meet label claims
(intended uses) as well as needs of user or
patient
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Performance and functionality – device as
designed performs and functions as needed
and expected
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Validation activities must be conducted using
calibrated test equipment and written and approved
protocols
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Protocols must contain objective acceptance criteria
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Observations can be qualitative, quantitative, or
both
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The sample sizes used in testing have to be
documented with a statistical rationale
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 Marketing activities done to either
confirm user needs or intended uses are
Design Validation Activities
 Examples include –
 Customer Preference Testing
 User Survey Testing
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 Marketing Validation Activities must
have –
 Approved Protocol for test
 Statistical rationale for sample size
 Predetermined acceptance criteria
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Ensures product undergoing verification or
validation is the product required
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Ensures supplier or manufacturing is capable of
achieving design intent
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Allows design engineer to better understand
manufacturers ability to meet tolerances
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During design validation, need more components and
subassemblies from manufacturer to test at tolerances –
worse case; random samples may be used but actual
specifications of the tested samples should be well
documented
 Need to know more than during normal manufacturing
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During design verification – only need samples if a test
is required, should test, inspect, measure or analyze at
worst case limits (extremes of use) as well as at
nominal
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Where bench and animal testing may be
inadequate or inappropriate models to address
questions of safety and effectiveness, clinical
study may be necessary
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Clinical Study is an extension of Design V&V
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Clinical study records are a part of the DHF
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Clinical studies regulated by FDA:
http://www.fda.gov/cdrh/devadvice/ide/index.shtml
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Good software design and development – FDA Guidance
for medical device software validation, ISO 62304
 Also need to follow for software developed to test product at
incoming, in-process and finished product
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Includes firmware, off-the-shelf, configurable software
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Configuration management and defect tracking
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Unit, integration, system-level (with hardware, software)
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Documented change management through out
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Cybersecurity for networked devices
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