Compliant Risk Assessment in pFMEA with Internal AI Agent

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Goal: Compliant Risk Assessment in pFMEA with Internal AI Agent

Pre state

• The pFMEA (Process Failure Modes and Effects Analysis) process is complex and mandatory for a quality process.
• Inconsistent or incomplete pFMEA documentation leads to errors, missed details, and variability across assessments.
• Manual effort to synthesize SOPs, validation data, and historical deviations adds time and increases the risk of inaccuracies.

Business implications

• Increased likelihood of SOP compliance gaps, with higher audit readiness challenges.
• Risk of incomplete or inconsistent pFMEA documentation, leading to inaccurate RPN scores and weaker quality assessments.

Business Process

Quality Management

• SOP compliance
  • Whatfix Guidance Agent guided workflow to ensure compliant pFMEA creation. 
  • Whatfix comprehends the user's context when initiating a new pFMEA on Veeva's "Create Risk Assessment" screen.
• Process intelligence:
  • Whatfix AI identifies and synthesizes pertinent SOPs, validation documents, and best practices.
• Automation
  • Captures data to trigger AI assistance (Copilot / Internal AI agent) for drafting potential failure modes based on historical deviations.

Personas Impacted

Quality Assurance (QA) specialist