Information on SOP writing

About this video

• Video Title: Information on SOP writing
• Channel: ScreamBiscuit
• Speakers: None explicitly named
• Duration: 00:05:21

Overview

This video provides guidance on writing Standard Operating Procedures (SOPs) and differentiates them from work instructions. It covers the purpose of SOPs in managing compliance, the steps involved in writing an SOP, and additional considerations for both authors and managers of procedural documents.

Key takeaways

• Documents for GCP Compliance: Two types of documents manage compliance: Instructions (like SOPs and work instructions) which provide guidance, and Records which provide evidence of adherence.
• SOP vs. Work Instruction: SOPs are detailed, broad written instructions to achieve uniformity in performing a specific function, while work instructions are more detailed process flows that guide how to perform a particular task within an SOP.
• Steps to Write an SOP: Key steps include mapping the process end-to-end, identifying stakeholders and their responsibilities, recognizing gaps and potential non-compliance (risk areas), determining necessary records, and defining the SOP's purpose, scope, tasks, and responsibilities.
• Elements of an SOP: An SOP should clearly outline its purpose and scope, define tasks and responsibilities, and can reference work instructions for detailed task execution. It must also identify a document owner and involve key stakeholders in review and approval.
• Post-Approval Procedures: After approval, SOPs need an effective date, circulation to stakeholders, documented training for users, and maintenance of training records.
• Additional Points for Authors: Procedural documents should be crisp, concise, and unambiguous. Authors should understand the process thoroughly, agree on timelines, use clear titles and terminology, and avoid assigning one responsibility to multiple stakeholders or external parties.
• Additional Points for Managers: Procedural documents need a clear numbering and identification system with version control. Obsolete documents should be maintained for audits, and a lifecycle for documents, including review frequency and conditions for updates or retirement, should be established.