Design DocumentationCorey Beth MonarchLindsey NovakMichael SeikelWhitney Young

Importance of Design Documentation•Creates paper trail tracing design

development•Maintains product design knowledge base•Meets governing body requirement•Communicates design planning and

implementation

What needs to be documented?•General

▫Meeting minutes▫Phone calls▫E-mails

•Technical▫Preliminary design sketches▫CAD drawings▫Tolerance stack-ups▫Testing

Minimum Necessities of Documentation•Date and time•Parties present•Discussion items•Action items

Good Documentation Practices•http://

www.youtube.com/watch?v=Q7bnVkshWRc

•http://ezinearticles.com/?Learning-Good-Documentation-Practices&id=2071847

Documentation Methods and Examples•Engineering Notebooks

▫Preliminary sketches▫Meeting discussions▫Concept developments and ideas

•Microsoft Word and Excel documents▫Memorandums▫Analyses

•E-mail messages▫Design development discussions

Important Design 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

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.”

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:

▫Customer Requirements▫Design Inputs▫Design Outputs▫Design review meeting information▫Test Procedures▫Biocompatibility Reports

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

Customer Requirements•Defines the use for the product in the

market•Drives the development process•Typically gathered by marketing team

Design Inputs•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 Outputs•Bring design inputs to life•Outline what happened in design process•Items include:

▫Product specifications, drawings, packaging, labeling, instructions for use, design rationale

Risk Management•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

FMEA Example

http://www.qualitydigest.com/aug06/articles/04_article.shtml

Design Review•Identifies and evaluates design•Utilizes knowledge base of multi-function

team representatives concerned with the design stage

•Includes reviews conducted at specified stages of development

•Approved by multiple departments in order to proceed with development▫Packaging, Labeling, Product Development,

Quality, Regulatory, etc.

Design Change•Communicates and documents changes•Creates links between revisions•Traces development of new product•Approved by appropriate departments

during development

Design Verification/Validation•Ensures that outputs conform to inputs•Consists of tests, inspections, and

analyses•Documents verification activities•Requires documentation of acceptance

criteria and protocols

Device Master Record•Compilation of records containing the

specifications and procedures for a finished device▫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•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

Design Transfer Documentation•Facilitates transfer of product from design

engineering to manufacturing engineering

•Includes detailed production specifications

•Increases efficiency and quality of production

Summary

• http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/QualitySystemsRegulations/MedicalDeviceQualitySystemsManual/ucm122416.htm

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

Questions?