1. Raechel Huebner Ruthanne Sherer
Design Documentation
Raechel Huebner
Ruthanne Sherer

2. Documentation “Documentation” is what’s written on paper
Provides written details, events, and information about a particular process.
Using documentary evidence to confirm that a fact or statement is true.

3. Documentation Can include, but not limited to:
Operator manuals
Instruction sheets
Online help systems
Maintenance manuals
Communication should be maintained throughout the documentation process
Clear writing, complete information, and good organization are, of course, key to the success of any design document.
If it isn’t documented, it didn’t happen!
Creates paper trail tracing design documentation
Maintains proof of design process
Meets governing body requirements
Collaboration:
Date & Time – self explanatory
Parties present – A list of the people who attended the meeting, and a list of absentees who were supposed to attend
Discussion items – A list of everything discussed pertaining to the project
Action items – A list of activities discussed that need to be completed for the project to proceed

4. Forms of Documentation
Notebooks
Preliminary sketches
Meeting discussions
Concept development and ideas
Messages
Discussion on design development, with all parties involved (i.e. professors, physicians, engineers, team members, etc.)
File Folders
Physical and/or electronic
Binders
Good Documentation Practices

5. Technical 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

6. Product Specification
Statement of what a not-yet-designed product is intended to do. To ensure that the subsequent design and development of a product meets the needs of the user.
Type of product
Market it addresses
Function of the product
Accuracy requirements
Safety issues
Reliability goal

7. Design Specification
Provides explicit information on the requirements for a product and how the product is put together.
Manufacturing strategy
Safety
Cost budgets
Size and packaging
Standards requirements
Environmental constraints

8. 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.”

9. 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 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

10. Design Inputs Sterilization Method 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
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

11. Design Outputs Results of design and engineering.
Specifications of the final device- Manufacturing process, measurement or test methods
How are they documented?
Models, drawings, engineering analysis and other documents
Output must be traceable to input requirement.

12. Risk Management Evaluates all risks of product and production process
Identifies actions to manage unacceptable design and process risks
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

13. FMEA Example: Toothbrush

14. Design Review
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.

15. Design Change
Communicates and documents changes throughout design process
Shows date and time when revisions occur
Traces development of new product
Approved and signed off on by appropriate departments during development

16. Design Verification/Validation
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
Making sure the device works using normal production process rather than using prototype processes
Can the workers of the manufacturing company produce multiple functional prototypes?
Documented in DHF
Verification date, participants, design version reviewed, and review results.
Ensures that outputs conform to inputs
Consists of tests, inspections, and analyses
Requires documentation of acceptance criteria and protocols

17. Device Master Record (DMR)
Routine documentation required to manufacture devices that meet the company requirements.
Contents
Device Specification
Drawings, composition, formulation, component specifications, and software applications
Product Process Specifications
Equipment specifications, production methods and procedures, and production environment specifications
Quality Assurance Procedures and Specifications
Quality Assurance- determining whether or not a product/ service meets the customers expectations.
Design, development, production and service of product are considered
Packing and Labeling Specifications
Installation, Maintenance, and Service Procedures and Methods

18. DMR vs. DHF vs. DHR
Device History File- how you developed the recipe for making your device
Device Master Record- the recipe for making the device
Specifications, work instructions, inspection procedures.
Device History Record-The “batch” or lot of devices was made according to the recipe.

19. Design Transfer Documentation
Facilitates transfer of product from design engineering to manufacturing engineering
Includes detailed production specifications
Increases efficiency and quality of production
Detailed product drawings, workmanship standards, manufacturing instructions, inspection criteria, heat treat conditions, etc.
Some components might be purchased elsewhere, integrates them in the process.

20. 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
Include timestamps and revision numbers on all documents

21. Questions?