Transcript Design Documentation - Bioedesign's Weblog

Design Documentation
Corey Beth Monarch
Lindsey Novak
Michael Seikel
Whitney Young
Importance of Design Documentation
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Creates paper trail tracing design development
Maintains product design knowledge base
Meets governing body requirement
Communicates design planning and
implementation
What needs to be documented?
• General
▫ Meeting minutes
▫ Phone calls
▫ E-mails
• Technical
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Preliminary design sketches
CAD drawings
Tolerance stack-ups
Testing
Minimum Necessities of Documentation
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Date and time
Parties present
Discussion items
Action items
Good Documentation Practices
• http://www.youtube.com/watch?v=Q7bnVkshW
Rc
• http://ezinearticles.com/?Learning-GoodDocumentation-Practices&id=2071847
Documentation Methods and Examples
• Engineering Notebooks
▫ Preliminary sketches
▫ Meeting discussions
▫ Concept developments and ideas
• Microsoft Word and Excel documents
▫ Memorandums
▫ Analyses
• E-mail messages
▫ Design development discussions
Important Design Documents
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Drawings
Design Changes
Design and Process Validations/Verifications
Risk Management Documentation
Process Routers
Inspection Criteria
Design Control Plans
Material Specifications
Sterility and Cleaning Process Verifications
Tolerance Stack-ups
Device Master Record (DMR)
FDA Submissions
Design History File (DHF)
• Compiles records describing the design history of a
finished device
• Complies with FDA requirements for marketing medical
device
• Specific to each company
FDA Requirement:
“Each manufacturer shall establish and maintain a DHF
for each type of device. The Device shall contain or
reference the records necessary to demonstrate that the
design was developed in accordance with the approval
design plan and the requirements of this part.”
Code of Federal Regulations, Title 21 – Food and Drugs, Chapter I – Food and Drug Administration Department of Health and Human Services, Subchapter H – Medical Devices.
Design History File (DHF)
• Items can include:
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Customer Requirements
Design Inputs
Design Outputs
Design review meeting information
Test Procedures
Biocompatibility Reports
Design Planning
• Outlines the activities to be taken during the
design control process
• Sets target dates for finishing each stage of
development, as well as design reviews
▫ Gantt Chart
• Identifies team members from each necessary
department
Customer Requirements
• Defines the use for the product in the market
• Drives the development process
• Typically gathered by marketing team
Design Inputs
• Translate customer’s needs into design
• Reduce miscommunication between engineering
and marketing teams if used effectively
• Improve efficiency of the design process
• Require documentation and approval
• Define performance and function requirements
Design Inputs
• Functional requirements
▫ Lists all functions the final product must perform
▫ Lists compatibilities with mating parts
• Performance requirements
▫ Benchmarks the final product must meet
▫ Include strength, durability, and lifespan
Design Inputs
• Sterilization Method
▫ Defines how product will be cleaned
• Packaging/Labeling requirements
▫ Defines specifications that labeling/packaging
must meet
• Human Factors
▫ Specialized inputs to define how people interact
with a medical device
Design Outputs
• Bring design inputs to life
• Outline what happened in design process
• Items include:
▫ Product specifications, drawings, packaging,
labeling, instructions for use, design rationale
Risk Management
• Evaluates all risks of product and production
process
• Identifies actions to manage unacceptable
design and process risks
Risk Management
• Design Failure Mode Effects Analysis (DFMEA)
• Process Failure Mode Effects Analysis (PFMEA)
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Potential product failures
Effects of product failures
Causes of failures
Corrections of failures
FMEA Example
http://www.qualitydigest.com/aug06/articles/04_article.shtml
Design Review
• Identifies and evaluates design
• Utilizes knowledge base of multi-function team
representatives concerned with the design stage
• Includes reviews conducted at specified stages of
development
• Approved by multiple departments in order to
proceed with development
▫ Packaging, Labeling, Product Development,
Quality, Regulatory, etc.
Design Change
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Communicates and documents changes
Creates links between revisions
Traces development of new product
Approved by appropriate departments during
development
Design Verification/Validation
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Ensures that outputs conform to inputs
Consists of tests, inspections, and analyses
Documents verification activities
Requires documentation of acceptance criteria
and protocols
Device Master Record
• Compilation of records containing the
specifications and procedures for a finished
device
▫ Device specifications including appropriate
drawings, composition, formulation, component
specifications, and software applications
▫ Production process specifications including
appropriate equipment specifications, production
methods, production procedures, and production
environment specifications
Device Master Record
• Items include:
▫ Quality assurance procedures and specifications
including acceptance criteria and the quality
assurance equipment used
▫ Packaging and labeling specifications, including
methods and process used
▫ Installation, maintenance, and service procedures
and methods
Device Master Record
Design Transfer Documentation
• Facilitates transfer of product from design
engineering to manufacturing engineering
• Includes detailed production specifications
• Increases efficiency and quality of production
Summary
• http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirem
ents/QualitySystemsRegulations/MedicalDeviceQualitySystemsManual/ucm122416.htm
Summary
• Assume everything you hear, say, think, write,
read, and create is important no matter how
insignificant, trivial, irrelevant, immaterial, or
inconsequential you might think it may be
• Record, date, sign, and save everything
• Document as though an audit will occur
Questions?