Design Documentation
Design Documentation
Corey Beth Monarch
Lindsey Novak
Michael Seikel
Whitney Young
Importance of Design Documentation
• 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
▫ Preliminary design sketches
▫ CAD drawings
▫ Tolerance stack-ups
▫ Testing
Minimum Necessities of Documentation
• Date and time
• Parties present
• Discussion items
• Action items
Good Documentation Practices
• http://www.youtube.com/watch?v=Q7bnVkshW
Rc
• http://ezinearticles.com/?Learning-Good-
Documentation-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
• 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:
▫ 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)
▫ 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
• Communicates and documents changes
• Creates links between revisions
• Traces development of new product
• Approved by appropriate departments during development
Design Verification/Validation
• 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
