In Enzyme Quality Owners, Editors and Approvers can create new Design Control cards.

Note: This video was created using V1.24.2. Enzyme is updated weekly so some elements may change.  

Create New Design Control Cards

Access the Design Control module under Process in the Navbar.  

To create a new Design Control Card, click on the + icon in that category. 

Once a new window opens, enter the title and description.  

When you save your changes, you’ll return to your Design Control module and will see your new card under its corresponding category. 

Click on the card to add more information about it. For each card you will see:

  • The identifier for the card
  • The title of the card you added
  • The description you provided
  • The status 

To edit any of these - click on the Edit button and click Save when you are done. The title, description and attachments are controlled data meaning any changes to the data have to be documented and submitted for approval.  

Each design control card has three sections - Overview, Files, and Comments.

Overview
Overview is additional information about the card. Here you can add:

  • Tags: Tags are metadata and uncontrolled so any changes do not have to be submitted for approval. 
  • Tracing Dependencies: Demonstrate tracing between design inputs and outputs. See the article for more details. 
  • Impact Groups: It is useful to have Impact Groups when teams within the company are working independently on parts of the product.  
  • Subsystem: As your product grows in complexity, it can be useful to subdivide design data into subsystems. You can also set approval settings based on subsystems 

Files
Attach any files or controlled documents to the design control card. Files are generally most pertinent to Design Outputs (drawings, specs, code), and Verifications and Validations (test reports).

Comments
Under comments you can add comments or review its approval history.

Link/Unlink to Pull Request

In Enzyme, you can also link a Design Output card to a pull request. 

Once a Design Output card is approved, any linking or unlinking of a pull request will return that card into Draft mode. The card will then once again have to be submitted for approval. This is to ensure traceability and maintain a design history. 

Submit for Approval

Once you have entered all the information pertaining to the design control card, you will have to submit it for approval by submitting a change request.  

Before a design control card is approved, if needed you can Pullback the change request. The card will once again be a draft state. 

If you have any questions, you can reach us through the chat or email us at support@enzyme.com.

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