Under the [[QSIT]] handbook, investigators will regard [[Design Controls]] as one of the four major quality systems for each form. The following steps are performed:
# Select a single design project
# For the design project selected, verify that design control procedures that address the requirements of Section 820.30 of the regulation have been defined and documented
# Review the design plan for the selected project to understand the layout of the design and development activities including assigned responsibilities and interfaces.
## Note: Evaluate the firm's conduct of risk analysis while proceeding through the assessment of the firm's Design Control system
# Confirm that [[Design Inputs]] were established
# Verify that the [[Design Outputs]] that are essential for the proper functioning of the device were identified.
# Confirm that acceptance criteria were established prior to the performance of verification and validation activities.
# Determine if design verification confirmed that design outputs met the design input requirements. 
# Confirm that design validation data show that the approved design met the predetermined user needs and intended uses.
# Confirm that the completed design validation did not leave any unresolved discrepancies.
# If the device contains software, confirm that the software was validated.
# Confirm that risk analysis was performed.
# Determine if design validation was accomplished using initial production devices or their equivalents.
# Confirm that changes were controlled including validated or where appropriate verified
# Determine if design reviews were conducted
# Determine if the design was correctly transferred
<<image /static/files/FDA/DesignControlsDecisionFlowChart.jpg width:600>>
!Design Planning
Expectations are as follows:
* Complexity should be reflected in elaborate documentation
* Derivation of input requirements
* Robust Risk Analysis
* Inspectors may provide an [[Establishment Inspection Report]] with findings related to each of the issues found.
!Design Input
The following may be subject to review:
* Intended use
* User/Patient/Clinical issues (interviews, usability studies)
* Performance characteristics
* Safety
* Limits and tolerances
* Risk Analysis (methods and inputs)
* Toxity and biocompatibility
* Electromagnetic compatibility
* Compatibility with environment of intended use
* Human factors
* Reliability
* Physical / Chemics characteristics
* Statutory and regularatory requirements
* Volontary standards
* Sterility
* MDRs / Complaints / Failures
* Device History Files
!Design Output
* The design system identifies and defines design outputs
* Outputs are expressed and compared to inputs
* The acceptance criteria are determinded for design output
* The deisgn output has been reviewed and approved prior to release.
!Design review
* Did the manufacturer identify appropriate stages for formal design review?
* Documentation should exist that these reviews happened
* Mechanisms should ensure comprehensive and systematic review
* Appropriat organisational functions should particpate in the review
* The deisgn review system should ensure thaht the identified design inputs are addressed by the design outputs
!Design changes
Investigators want to see:
# Manufacturers producedures that defined and control design changes
# An individual who is authorized to review and approved design changes
# Indication of how the approval is documented
* The stage of the design process the firm identifies when changes to the approved design inputs begin to control
* The criteria in the design change system that are used to accept changes to approved design inputs
* The manner in which the design change system implements a change to the design inputs
* The procedures that are followed to evaluate when verification or validation of design changes are necessary.
* Investigators are thought that all design changes must be //''verified''//
* Unless only verification can be justified and documented that all design changes must be //''validated''//
!Design verification
Investigators will want to see:
# Procedures that control design verification
# Review of the design history
# General and low level detailed documents used
They also want to see:
# Examples of significant points during verification
# Conirm the number of times that a specific input requirement has been fullfilled by the design output
# Identify whether the activities are quantitatiev of qualitative
Finally they want to see:
# The verifiation methods that have been employed to confirm that input requirements are met (e.g. usability testing)
# The verification data that show that output meets input
!Design validation
Investigators may ask the following questions:
* What evaluations where performed to assist in validating that the device deisgn meets user needs and intended uses
* What labels and labelling, packaging and so on are t be used
* What clinical data were generated from studies with approved FDA compliant protocols
* Was [[510(k)]] historical database search performed?
* Did clinical evaluatations include home use?
* Were there literature searches
* Was there any historical product knowlegde?
* Under what actual or simulated conditions was the finished device tested?
* How did the firm resolve discrepancies encountered during validation activities?
* Did discrepancy resolution necessitate a new risk analysis? If not, why not?
* Does the product contain software? How was it validated?
* How have risks been identified and analyzed (e.g. [[FTA]] [[FMECA]])
* Does the [[Design History File]] identify the dates and methods of validation?
!Design transfer
Investigators want to see:
* Procedures that control design transfer
* Typically the investigator will select one or more features and track the process to see if design transfer procedures were followed
!Design History File
Investigators will want to see how the design history file is maintained and retains the acual design history.
* The will make a list of key elemenst of the DHF
* When more devices share a common history, the FDA investigors will want to understand how commonalities are tracked
Sun, 22 Jul 2012 15:42:16 GMT
Sun, 22 Jul 2012 15:42:16 GMT
CFR 21-820.30
Design Controls
Quality System Requirements