When a firm receives an FDA 483 finding of “does not follow Standard Operating Procedures (SOPs) for performing X GMP activity,” the immediate response is often to revise or update that specific SOP with more detailed instructions.  While this might seem like the right thing to do for a quick fix, it is crucial to consider whether this revised procedure aligns with other related SOPs within the firm.  Does it integrate smoothly, and does the process remain streamlined across all departments?

  1. Mapping the Process: The Key to SOP Alignment

The first step in revising an SOP effectively is to map the process using a swim-lane flowchart.  This diagram provides a clear, visual representation of each step in the process, while also identifying the personnel or departments responsible for executing each specific task.  A swim-lane flowchart helps create full visibility of the entire procedure, making it easier to spot inefficiencies or areas where steps might be misaligned.

The flowchart enables you to pinpoint any gaps or redundancies.  Additionally, it ensures that all necessary actions are accounted for and assigned to the right departments or team members.

  1. Detailing Your Written SOP: From Map to Execution

Once the process has been mapped out, the next step is to update the written SOP itself.  The instructions should be concise, with short, clear sentences that describe each step in the process, following the structure outlined in the flowchart.  The written procedure should provide enough detail to eliminate ambiguity, so that the person performing the task knows exactly what to do and when to do it.

To make the SOP both effective and practical, avoid jargon or overly technical language that could create confusion.  Instead, focus on simplicity and clarity, ensuring that anyone following the procedure can easily understand and execute the required tasks.

  1. Testing the SOP: A Trial Run for Success

A crucial test for the success of an updated SOP is to involve the Subject Matter Experts (SMEs) who will actually perform the tasks outlined in the SOP.  Conducting a trial run is one of the most effective ways to identify areas where additional details may be needed or where multiple interpretations of a step could lead to errors.

By engaging SMEs in this testing phase, you can receive valuable feedback to further refine the SOP, ensuring that it is both executable and compliant.  This hands-on approach provides insights into practical challenges that may not have been obvious during the initial drafting of the SOP.

  1. Troubleshooting Compliance Challenges: Lachman Can Help

Developing compliant, executable SOPs can be a complex and time-consuming process, especially when the goal is to ensure alignment across multiple procedures.  By following these steps and utilizing effective tools like swim-lane flowcharts, your SOP revisions can lead to smoother, more aligned processes, reducing the risk of compliance issues and ensuring operational success.

If your firm is encountering challenges in creating or updating your SOPs, Lachman Consultants is here to assist!  We specialize in helping organizations streamline their SOPs for better efficiency, compliance, and overall performance.  Reach out to us today at LCS@LachmanConsultants.com to learn how we can help improve your SOPs and ensure that your processes are both compliant and effective!