Free fillable tool

The Risk Assessment Worksheet

A fillable PDF that turns the universal compliance pathway into a tool you can use today: set specifications, run the ICH Q9 risk assessment, remediate worst-first, verify.

What’s inside

  • ·Scope & intended use — define the operation and check the regulators in play (DEA Schedule III, state medical/adult-use, FDA, EU GMP, ISO 17025, customer audit)
  • ·Specification register — translate each requirement into a measurable CQA/CSA, test method, and acceptance criterion at the highest common bar
  • ·ICH Q9 risk register — score Probability × Severity × Detectability into a Risk Priority Number, with a built-in scoring legend and action thresholds
  • ·Risk control & remediation plan — additional controls, residual risk, owner, and due date, each tracing back to a risk and a specification
  • ·Verification & lifecycle sign-off — where the recurring obligations live (DEA biennial inventory, state annual audit, periodic review)

The thinking behind it is in the companion essay, “One Pathway, Every Regulator” — why every cannabis regime reduces to the same two moves.

4-page fillable PDF (AcroForm). By Intrepid Scientific. Free. Not legal advice.

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