Which substep of Step 2 in writing an SOP involves analyzing the process to achieve the SOP objective?

The substep of Step 2 that involves analyzing the process to achieve the SOP objective is writing operational procedures. This step is crucial as it requires a thorough understanding of the processes involved to effectively document them. When operational procedures are being crafted, they should clearly outline each step in the process, allowing anyone using the SOP to follow it accurately to meet the desired objectives. This phase of writing ensures that the procedures are practical, relevant, and geared towards fulfilling the SOP’s goals without ambiguity.

While conducting a risk assessment, reviewing past SOPs, and gathering stakeholder input are all important components of the overall SOP development process, they serve different purposes. Conducting a risk assessment focuses on identifying potential risks and determining appropriate mitigation strategies. Reviewing past SOPs aims to leverage existing knowledge and improve on previous iterations but is more about learning rather than direct process analysis. Gathering stakeholder input involves collecting perspectives and insights from those who will be impacted by the SOP, which is crucial for inclusivity and practicality but not directly about analyzing the specific process itself.