Transcript Design Documentation - Bioedesign's Weblog

Design Documentation
Clint Kehres, Brian Krouse, Jenn Shafner
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DHF- design history file1.
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Not all national regulators are equal.
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Diligent records at every step.
Legal Requirements
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Maintain knowledge base of the product
design.
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DHF owner = Company, not individual.
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Required by Governments
– Document everything clearly in case audited.
Manufacturer Benefits from
Design Documentation
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Design History File (DHF)
Device Master Record (DMR)
Design Changes
Technical Files
FDA Submissions
Design and Process Validations/Verifications
Risk Management Documentation
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Process Routers
Drawings
Meeting Minutes
Inspection Criteria
Laboratory Notebooks
Design Control Plans
Material Specifications
Sterility and Cleaning Process Verifications
Tolerance Stack-ups
– Design Failure Mode and Effects Analyses
– Process Failure Mode and Effects Analyses
Design Documents
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Every step requires design documentation.
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Each step has its own specific type of documents.
Logical Path of Design
Development/Control
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Exact requirements depend on specific
company.
-Most are self regulated.
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FDA States, “Each manufacturer shall
establish and maintain a DHF for each type of
device. The DHF shall contain or reference
the records necessary to demonstrate that
the design was developed in accordance with
the approved design plan and the
requirements of this part”.
Design History File…
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Hard Copy DHF’s and Paperwork
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Images and Photos
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Excel and Word Documents
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Company specific document templates and
regulations
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Digital Document Management System
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Specific Document Management Departments
Methods of Documentation
Customer requirements must be translated into
engineering design inputs.
◦ The customer requirements and design inputs are
arguably the most important items in a design.
◦ Because of their importance, they must be
documented very comprehensively and avoid being
vague.
 Requirements are often identified from Marketing
team.
- Good documentation reduces poor assumptions
between the engineering and marketing teams.
- Comprehensive identification/documentation of
design inputs increases the likelihood of having an
efficient development process.
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Design Inputs:
The design input requirements shall be documented and shall be reviewed and
approved by designated individual(s).
The approval, including the date and signature of the individual(s) approving the
requirements, shall be documented.
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Result of detailed designed process
addressing design inputs.
Outputs include risk management, product
specifications, drawings, packaging, etc.
Includes a Design Rationale
◦ Detailed description of product functions or features
◦ Includes general description of various parts of
device, functional purpose of device, compatibility
with other devices, etc.
Design Outputs:
Each manufacturer shall establish and maintain procedures for defining and
documenting design output in terms that allow an adequate evaluation of
conformance to design input requirements.
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Design/Production team need to evaluate all
risks associated with product and production
process.
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Investigation to identify hazards, estimate risk
and identify actions to manage unacceptable
design and process risks.
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Often Document:
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Potential failures of product
Failure’s effect on the consumer and severity
Cause of failure
Actions to reduce failure or risk occurrence
Risk Management:
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Very common
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Communicate the change
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Document control department:
◦ Documents are properly identified
◦ A master list or index of documents is compiled.
◦ Govern entry of documents into the document control system (ECO’s)
◦ A history of document revisions
◦ Procedures for distributing copies
◦ Removal and deletion of obsolete documents.
Design Changes
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Verification ensures that outputs conform to inputs.
◦ Tests, inspections, analyses
◦ Mechanical testing data, tolerance stack-ups, mathematical models
◦ Detailed reports are required to document verification activities.
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Validation ensures that outputs meet ultimate user needs.
-Product should be tested in actual or simulated use environment.
-This would include clinical trials if necessary. ((Cadaver Labs))
-Test protocols and acceptance criteria must be documented.
-For a complex design, the detailed results may be contained in a
variety of separate documents and summarized in a validation
report.
Design Validation/Verification:
The results of the design verification, including identification of the design,
method(s), the date, and the individual(s) performing the verification, shall be
documented in the Design History File.
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Purpose – DMR is a compilation of those records containing the
specifications and procedures for a finished device.
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Device specifications including appropriate drawings, composition,
formulation, component specifications, and software applications.
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Production process specifications including appropriate equipment
specifications, production methods, production procedures, and
production environment specifications.
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Quality assurance procedures and specifications including acceptance
criteria and the quality assurance equipment used.
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Packaging and labeling specifications, including methods and process
used.
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Installation, maintenance, and service procedures and methods.
Device Master Record
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Once a product has been designed, it must be transferred to
the production phase.
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The manufacturing facility needs detailed production
specifications.
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These include: detailed product drawings, workmanship
standards, manufacturing instructions, inspection criteria,
heat treat conditions, etc.
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Comprehensive documentation is required for efficient and
high quality production of the product.
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One must remember that a different supplier in the future may make the
product.
Design Transfer
Documentation
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Each manufacturer shall establish and maintain procedures to
ensure that formal documented reviews of the design results
are planned and conducted at appropriate stages of the
device's design development.
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The procedures shall ensure that participants at each design
review include representatives of all functions concerned with
the design stage being reviewed and an individual(s) who
does not have direct responsibility for the design stage being
reviewed, as well as any specialists needed.
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The results of a design review, including identification of the
design, the date, and the individual(s) performing the review,
shall be documented in the design history file (the DHF).
Design/Project Review
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A design history file will be required for
each groups senior design project.
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This DHF will be submitted in the Spring
semester with the final report
DHF SENIOR DESIGN
REQUIREMENT
ASSUME EVERYTHING YOU HEAR,
SAY, THINK, WRITE, READ, AND
CREATE IS IMPORTANT! NO
MATTER HOW INSIGNIFICANT,
TRIVIAL, IRRELEVANT,
IMMATERIAL, OR
INCONSEQUNETIAL YOU THINK IT
MAY BE. RECORD, DATE, SIGN,
AND SAVE EVERYTHING!
You will be audited!
SUMMARY
• http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/G
uidanceDocuments/ucm070627.htm#_Toc382720792
• http://medicaldesign.com/mag/model_device_development_0908/
• http://books.google.com/books?id=X1a9fQyKSuQC&pg=PA39&lpg=
PA39&dq=design+transfer+documentation&source=bl&ots=coHNb3
RDYz&sig=cUvLb6VDHI3dLXu2B9cb9bfjgFs&hl=en&ei=rQXvSvjRP
M6TlAfn4az_BA&sa=X&oi=book_result&ct=result&resnum=2&ved=0
CA4Q6AEwAQ#v=onepage&q=design%20transfer%20documentatio
n&f=false