DESIGN DOCUMENTATION

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=Q7bnVkshWRc
 http://ezinearticles.com/?Learning-Good-Documentation
-Practices&id=2071847
DOCUMENTATION METHODS AND
EXAMPLES
 Engineering Notebooks
 Preliminarysketches
 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
 Specializedinputs 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:
 Qualityassurance 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/PostmarketRequirements/Quali
tySystemsRegulations/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