How is risk assessed during SOP development?

• A. Only financial risk is considered.
• B. Identify hazards, assess likelihood and impact, assign risk ratings, and implement controls; document in a risk assessment.
• C. Risk is ignored.
• D. Risk assessment is optional.

Answer: (B)

Risk in SOP development is treated as a structured, proactive process. You start by identifying potential hazards or failure points that could affect the procedure. Then you evaluate how likely each hazard is to occur and how severe the consequences would be if it did. Based on that, you assign a risk rating to prioritize what needs attention. Next, you implement controls to remove or reduce the risk, which can include changing the procedure, adding safeguards, providing training, or adding administrative measures. All of this is documented in a risk assessment so the team can review, monitor, and demonstrate compliance over time. This approach ensures safety, reliability, and quality, rather than concentrating only on financial aspects or treating risk as optional or something to ignore.