Risk Assessment

Details

Risk assessment is the process of organising information, made up of risk identification (what could go wrong), risk analysis (the probability and severity, and where relevant detectability), and risk evaluation (comparison against defined criteria); taking that output and deciding whether to reduce or accept, and then acting, is risk control — assessment produces the material for the judgement and control carries the judgement out. ICH Q9(R1) §4.3 requires the work to begin from a well defined problem statement or risk question and to answer the three questions of what might go wrong, what is the likelihood, and what are the consequences, and notes that the robustness of the data determines the quality of the output, so assumptions and sources of uncertainty should be made explicit. Inspections cite documents with no risk question so that what was assessed cannot be told, FMEAs with no data behind the scores, signs that the conclusion was fixed first and the scores fitted to it, detectability overrated so as to lower the risk, and assessments whose results never became control decisions.

Related sections

Related terms

Real inspection findings

Findings from regulators' inspection documents in which this term appears.

1. However, it is unknown how long the cracked plexiglass existed on the ISO (b)(4) LAFHs, and you did not perform an investigation or risk assessment to mitigate any potential concerns with distributed product.

   FDA · FDA Warning Letter · 2025-11-25

2. Your responses do not indicate whether the cited investigations were conducted if absent or reopened if previously closed, if product impact and/or risk assessments were completed, or if there were resulting corrective and/or preventive actions (CAPAs).

   FDA · FDA Warning Letter · 2023-05-30

3. A detailed risk assessment addressing the potential effects of the observed (b)(4) system failures on the quality of all drug product lots currently in U.S.

   FDA · FDA Warning Letter · 2026-08-18