1. Quality Management
Documents & Templates
Design Validation
Additional potential Hazards or Failure Modes may be discovered during Validation
activities. Some previously identified Hazards or Failure Modes may be observed or
estimated to have a frequency greater than previously anticipated. Risk Analysis
documentation shall be updated as necessary.
All products subject to Validation studies should be properly labelled and all equipment,
tools, and fixtures used in Validation must be documented and traceable to calibration
and maintenance records.
Validation testing should include simulation of expected environmental conditions such
as temperature, humidity, shock, vibration, etc. These environments may be
encountered during use or during shipping and storage.
Validation testing should include product labelling and packaging. These may have
human factors implications and may affect product performance.
7.2 Design Validation Deliverables
The following documents are deliverables for the Design Validation Phase:
• Design Validation Matrix
• Design Validation Equipment Log
• Validation Protocols
• Validation Reports
• Design Review documents
Each of these deliverables shall be approved by the PL /HE and Quality Assurance. The
Validation program (columns 1-6 of the Design Validation Matrix) and the Validation
Design Review documents shall also be approved by the DRC.
These documents constitute a Validation File and shall become part of the DHF.
7.3 Design Validation Matrix (Part 1)
The Design Validation Matrix serves as a plan for the Design Validation effort. The matrix
demonstrates traceability between each User Requirement and the Validation results. It
is a summary of the Validation Phase.
• 1st column: User Requirement# - list the User Requirement number.
• 2nd column: Validation Protocol# - list the number of the Validation Protocol. One
Protocol may apply to more than one User Requirement.
• 3rd column: Responsible Party - list the person or group responsible for the
Validation.
• 4th column: Validation Method, SOPs, Standards - summary of the activity to be
performed to verify the requirement is described. Activity details are entered into
the Protocol (explained below). Reference documents such as SOPs, Standards
are listed.
Document Type Document ID Version Status Page
SOP XX_WWW_ZZZ_YYYY 1.0 Approved 10/26
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