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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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md-010-design-validation-sop-1.0