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Prerequisites

Before starting the approval process, confirm:
  • The risk document is in Draft status
  • All risk records or failure modes have been scored (no unanalyzed fields remain)
  • You have the project_approver role assigned in the project, or a user with that role is available to sign
Once a document enters In Review status, edits through risksheet are still possible but will not invalidate pending signatures unless a Rework action is triggered. Complete your analysis before initiating review.

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Step 1: Open the Risk Document

  1. Navigate to the Risks space in Polarion.
  2. Open the risk document you want to approve (for example, HARA-ANALYSIS or FMEA-SYS-001).
  3. Confirm the document status shows Draft in the document header.

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Step 2: Send for Review

  1. Click the workflow action dropdown on the document toolbar.
  2. Select Send for Review.
  3. The system automatically:
    • Transitions the document to In Review status
    • Adds default signers: all users with the project_approver role are assigned as Approvers targeting the Approved status
diagram
The AddDefaultSigners workflow function assigns all project_approver role members as signers. You do not need to manually select reviewers.

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Step 3: Provide Electronic Signature

As an approver:
  1. Open the document in In Review status.
  2. Navigate to the Signatures section of the document properties panel.
  3. Review the risk analysis content — examine risk records, RPN scores, risk controls, and residual risk levels.
  4. Click Sign to provide your electronic signature.
  5. Enter your Polarion credentials when prompted to confirm your identity.
The approval policy requires at least one signature from a project_approver to proceed.

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Step 4: Approve the Document

Once the signature requirement is met:
  1. The Approve action becomes available in the workflow dropdown.
  2. Click Approve to transition the document to Approved status.
  3. The system validates that the atLeastOne signature policy is satisfied.
If auto-signature is enabled for the project_approver role, the approval can occur in a single action — the system simultaneously records the signature and transitions the document.

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Step 5: Publish the Document

After approval:
  1. Click the workflow action dropdown.
  2. Select Publish.
  3. The document transitions to Published status — its final released state.
Published documents form part of the Design History File (DHF) and provide the audit trail for ISO 14971 compliance.
TransitionFromToConditions
Send for ReviewDraftIn ReviewAssigns default signers
ApproveIn ReviewApprovedRequires at least one project_approver signature
PublishApprovedPublishedNo additional conditions

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What Happens to Signatures

Electronic signatures create an audit record:
  • Signer identity and timestamp are recorded
  • Signatures are tied to the document version at the time of signing
  • If the document is sent back to Draft via Rework, all signatures are marked as obsolete and verdicts are reset

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Troubleshooting

ProblemCauseSolution
”Approve” action not visibleNo signatures recorded yetAsk a project_approver to sign the document
No signers assigned after “Send for Review”No users have the project_approver roleAsk the project admin to assign the role
Need to make changes after sending for reviewDocument is in In Review stateUse Rework to return to Draft