DESIGN DOCUMENTATION

RAECHEL HUEBNER

RUTHANNE SHERER

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.

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!

FORMS OF DOCUMENTATION• Notebooks

• Preliminary sketches

• Meeting discussions

• Concept development and ideas

• Email Messages• Discussion on design development, with all parties involved (i.e. professors, physicians, engineers, team

members, etc.)

• File Folders

• Physical and/or electronic

• Binders

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

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

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

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.”

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 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

• 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

• 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.

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

FMEA EXAMPLE: TOOTHBRUSH

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.

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

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.

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

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.

DESIGN TRANSFER DOCUMENTATION

• Facilitates transfer of product from design engineering to manufacturing engineering

• Includes detailed production specifications• Increases efficiency and quality of production

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

QUESTIONS?