In Enzyme’s Risk Management module, companies can track and manage their PHA and FMEA for risk models.

In order to do so in Enzyme

  1. The Jira integration between the project in Jira and product in Enzyme must be set up. This should include setting up the Fields for PHA and FMEA integration.
  2. The FMEA/PHA feature must be enabled by the Quality owner in the Risk Management tab in Company Settings.

Once these are complete, in the product menu select the product for which you set up the Jira integration.

Now you will see the PHA/FMEA tabs and issues in the Risk Management module.

New PHA/FMEA issues

When you create a new PHA/FMEA issue in Jira it will automatically be added as a draft in Enzyme. To make it effective, in Enzyme you will have to create a new change request and add the PHA/FMEA items to it.

On the CR, you can add PHA/FMEA items across several products. Once the items are approved, you’ll see them as approved in the product.

Edit an approved PHA/FMEA item

To edit an approved item, it must be edited in Jira since that is the ‘source of truth’. Once the edits are made in Jira, the approved card will return to draft mode in Enzyme. It must then once again be added to a change request and routed for approval.

Obsolete a PHA/FMEA Item

To obsolete an item, in Jira add the obsolete tag to the item.

Once the tag is added in Jira, that item in Enzyme will have the Deletion requested tag.

This item can then be added to a change request and routed for approval. Once the change request is approved, this item will be removed from the PHA module in Enzyme.

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

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