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Design documentation. Lina Elsamaloty Marcel Ingels. 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 (cont’d). - PowerPoint PPT Presentation
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Design documentation Lina Elsamaloty
Marcel Ingels
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 (cont’d)
Can include, but not limited to: Operator manuals Instruction sheets Online help systems Maintenance manuals Verification and Validation
Communication should be maintained throughout the documentation process
GDP – Good Document PracticeIf it isn’t documented, it didn’t happen!
Importance of documentation
Creates paper trail tracing design documentation
Maintains proof of design process Meets governing body requirements
What needs to be documented
Everything throughout the process! Technical Reviews: date, length, attendance,
purpose, and outcomes. Drawings: models, computer generated
drawings (CAD, Solidworks, etc.), and tolerance stack-ups
Signatories on documents
What needs to be documented(cont’d)
Testing: Standards Calibration of equipment Materials used Method Scope Study Design (Statistical Relevance) Risk Level
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 Binders
Forms of Documentation (cont’d)
Records Electronic Document system (JDE, Matrix, etc.) Hard Copies (in secure document center)
Forms provided by the FDA or other organizations to regulate products
Types of Documents
Business Proposal Product Specifications Design Specification Software Quality Assurance
Plan (SQAP), where applicable
Software Requirements Specifications (SRS), where applicable
Software Design Description (SDD), where applicable
Design History File (DHF) Design Input Design Output Design Review Verification and
Validation
Device Master Record (DMR)
Device History Record (DHR)
Design Transfer
Design Change
Business ProposalAn Executive Summary introducing what will be provided to
the customer and how they will benefit from it. Product Overview, Objectives, Major Milestones,
Schedule Market need and market potential Product proposal Risk analysis Economic analysis Supporting documentation
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)(cont’d)
Design review meeting information
Design plans Inputs and Outputs
Sketches/Drawings Risk Assessment Photos
Emails Notebooks Performance Testing Reviews Verification and
validations Test procedures
Design Inputs
Functional Requirements All functions the final product must perform
Performance Requirements Strength and durability Product longevity/Shelf Life
Sterilization Packaging/Labeling requirements
Is special packaging needed for this device? Human factors
Immune response to foreign body
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.
Design Review
Formal review of device Conducted by representatives involved in
design effort and any other interested parties (e.g. sales, marketing, manufacturing engineering).
Documented in DHF Date, participants, design version reviewed,
results of review
Design Verification and Validation
Verifies the output conforms to design input. Tests, inspections, analyses.
Validated using initial/low production process. 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
Device History Record (DHR)
Shows all operations, processes, etc. described in the DMR have been accomplished for the finished device and also includes:
Date(s) of manufacturing Quantity manufactured Quantity released for distribution Any device identification and control number(s) Primary identification label Labeling used for each production unit Acceptance records which demonstrate the device is
manufactured in accordance with DMR.
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 Transfer of product from design engineering to
manufacturing. Includes detailed production specifications
Detailed product drawings, workmanship standards, manufacturing instructions, inspection criteria, heat treat conditions, etc.
Some components might be purchased elsewhere, integrates them in the process.
Increases efficiency and quality of production
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
Risk Management
Document that tries to foresee possible risks and provides response plans to avoid the impact of reoccurring errors.
Design Failure Mode Effects Analysis (DFMEA)
Process Failure Mode Effects Analysis (PFMEA)
FDA Required Documents
Medical Device Definition Device Classification 510k
Design and development plans Design reviews Design verification Validation testing and results Product specification
Premarket Approval (PMA) Good Manufacturing Compliance (GMP)
FDA Regulation Guidance
Summary
Assume everything you hear, say, think, write, read, and create is important no matter how insignificant, trivial, irrelevant, or inconsequential you might think it may be.
Record, date, sign, and save everything throughout the devices design.
FDA will come in to audit all information for approval.
Questions?
