Viewing the Product Risk File Detail Record

Users with the appropriate rights can view Product Risk File Detail records. The Product Risk File Detail record displays relevant product risk file information.

  1. From the SmartSolve Portal Page, click the Home tab at the top of the window.
  2. In the Setup and Policy section, click Setup.
  3. In the Risk section, click Product Risk File.
    Result: The Product Risk File Detail record is displayed.
Section/Tab Description

Header

The header of the Product Risk File record is always displayed at the top of the window and contains the following information:

  • Product Risk – Displays the level of product risk, such as Low or Medium.
  • Evaluation – Displays the evaluation status, such as Acceptable.
  • Next Periodic Review Date - Displays the date of the next periodic review for the product.
  • Product Status – Displays the current status of the product, such as Inactive or Active.

Product Risk File

The Product Risk File section displays all of the basic information for the product risk file, including:

  • Product - Displays the product. Click the View Product link to view the Part record.
  • Description - Displays a description of the product.
  • Risk Planning
  • Product Use/Misuse
  • Characteristic
  • Risk Analysis
  • Hazard
  • Failure Mode
  • Risk Control
  • Risk Control Measure
  • New Risk

Risk Evaluation

The Risk Evaluation section displays all of the risk evaluation information for the product.

Overall Residual Risk

The Overall Residual Risk section displays the overall residual risk being assigned to the prosuct.

Activity

The Activity section displays all automatically and manually entered activities for the record.

Attachment

The Attachment section displays all of the attachments tied to the Product Risk File record.

Record Cross Reference

The Record Cross Reference section displays any records that have been attached to the Product Risk File as a reference.

Production and Post Production Information

The Production and Post Production Information section displays the production and post-production review information to continually manage and reduce the risk of a product in accordance with regulatory requirements. Records in other modules associated with the part in the product risk file are displayed in this section. The following tabs are displayed:

  • CAPA
  • NC
  • Complaint
  • Deviation
  • OOS
  • Inspection
  • Audit

NOTE: For additional functionality in the Product Risk File record, see Product Risk File Other Actions.

See Also

Product Risk Files

Product Risk File Setup

     

 

 
Wednesday, December 4, 2019
12:03 PM