joel gerber zachary reaver kurt schilling. provides physical proof of development maintains...
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Design Documentation
Joel GerberZachary Reaver
Kurt Schilling
Provides physical proof of development Maintains product design knowledge base Meets government and corporate
requirements Communicates design planning and
implementation Enables smooth project transitions
Why?
Collaboration◦ Meeting minutes◦ Phone calls◦ E-mails
Technical◦ Preliminary design sketches◦ Calculations◦ Tolerance stack-ups◦ Testing records
What needs to be documented?
Date and time Parties present Discussion summary Action items
Collaboration Documentation
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
Technical Documents
Engineering Notebooks◦ Preliminary sketches◦ Meeting notes◦ Concept ideas and development
Microsoft Word and Excel documents◦ Engineering Analysis◦ Summaries
E-mail messages◦ Design discussions
Documentation Methods and Examples
Good Documentation Practices
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:◦ User Needs◦ Design Inputs◦ Design Outputs◦ Design review meeting information◦ Design Verification◦ Design Validation◦ Design Transfer◦ Design Changes
Design History File (DHF)
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
Design Planning
Customer Requirements Defines the use for the product in the
market Drives the development process Typically gathered by marketing team
User Needs
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 Inputs
Bring design inputs to life Outline what happened in design process Items include:
◦ Product specifications, drawings, packaging, labeling, instructions for use, design rationale
Design Outputs
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
Risk Management
Other Examples:•Predicate Device•Testing Standards•Clinical History•Engineering Analysis•Surgical Technique•Intra-op feedback•Design Controls
FMEA Example: Toothbrush
Identifies and evaluates design at several stages of the development process (Design Review I, II, III, etc.)
Each review has a series of checklists and criteria that must be met
Utilizes knowledge base of multi-function team representatives concerned with the design stage
Approved by multiple departments in order to proceed with development◦ Packaging, Labeling, Product Development, Quality,
Regulatory, etc.
Design Review
Communicates and documents changes Creates links between revisions Traces development of new product Approved by appropriate departments
during development
Design Change
Validation – “Are you building the right thing?”◦ Make sure product meets user needs
Verification – “Are you building it right?”◦ Ensure that final product meets initial design
specifications Ensures that outputs conform to inputs Consists of tests, inspections, and analyses Requires documentation of acceptance
criteria and protocols
Design Verification/Validation
Compilation of records containing the specifications and procedures for a finished device
The DMR for each device should include or refer to the location of:◦ 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 (DMR)
Other 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
Device Master Record
Facilitates transfer of product from design engineering to manufacturing engineering
Includes detailed production specifications Increases efficiency and quality of
production
Design Transfer Documentation
Summary
• http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/QualitySystemsRegulations/MedicalDeviceQualitySystemsManual/ucm122416.htm
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 Include timestamps and revision numbers
on all documents
Summary
QUESTIONS?