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What are the best ways to audit SOP documentation?

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SOP documentation is essential for any manufacturing process, as it ensures consistency, quality, and compliance. However, SOP documents can become outdated, inaccurate, or irrelevant over time, which can lead to errors, inefficiencies, or risks. That's why it's important to audit your SOP documentation regularly and update it as needed. In this article, we'll share some of the best ways to audit your SOP documentation and keep it in line with your manufacturing goals and standards.

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Rick Prinzen

Senior Executive helping those that help others towards a healthier, more equitable and productive society.
Jeff Rodman

Truss Production Scheduler @ Star Lumber & Supply

1 Define your audit scope and criteria

Before you start auditing your SOP documentation, you need to define what you want to achieve and how you will measure it. For example, you might want to check if your SOP documents are clear, concise, and accurate; if they reflect the current best practices and regulations; if they align with your quality management system and objectives; and if they are accessible and usable by your staff. You should also decide on the frequency, format, and method of your audit, as well as the roles and responsibilities of the auditors and the auditees.

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Rick Prinzen

Senior Executive helping those that help others towards a healthier, more equitable and productive society.
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The best way to audit SOP documentation is not having to audit them in the first place. Inspecting quality into your documentation is no different than inspecting quality into your products / outputs. It's wasteful. Build your documentation to be reflective of your process that ensures product / output quality. Examine the documentation against what is actually happening during the execution of the process. Bring your documentation to the front-lines and observe. are they aligned or is there a mis-match? Your quality and cost metrics will send you a signal if something needs to be examined.

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Jalil ????

Plant Coordinator I Digital Formation I SAP Specialist I Power BI Expert
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1. Review Document Structure and Format: 2. Verify Compliance: 3. Evaluate Content Accuracy: 4. Assess Clarity and Understandability: 5. Check for Consistency: 6. Confirm Accessibility and Availability: 7. Review Revision History: 8. Assess Training Requirements: 9. Perform Operational Checks: 10. Solicit Feedback: 11. Document Audit Findings: 12. Continuous Improvement:

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2 Review your SOP documents

The next step is to review your SOP documents and compare them with your audit criteria. You can use various tools and techniques to do this, such as checklists, flowcharts, gap analysis, or process mapping. You should also consult with the people who use or create the SOP documents, such as operators, supervisors, engineers, or trainers. They can provide valuable feedback and insights on the effectiveness and relevance of the SOP documents. You should document your findings and observations, as well as any issues or discrepancies that you identify.

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Jeff Rodman

Truss Production Scheduler @ Star Lumber & Supply
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It’s incredibly important to involve on the job or on the floor workers who actually use each SOP in the review, to gain their perspective and hear first hand how the process is done and whether the SOP aligns to how the process is done. If there are steps that are missing or are not clear then the SOP will need a revision. The frequency of review will depend on the criticality of the process and the frequency of how often it’s performed.

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3 Analyze your audit results

Once you have reviewed your SOP documents, you need to analyze your audit results and identify the root causes of any problems or gaps. You can use different methods to do this, such as the 5 Whys, fishbone diagrams, or Pareto charts. You should also prioritize the issues based on their impact, urgency, and feasibility. You should then propose solutions or recommendations to address the issues and improve your SOP documentation. You should also quantify the benefits and costs of implementing the solutions or recommendations.

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Carrie Abrath

Senior Quality Assurance Team Leader ISO 17025 compliance Archive Leader
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Reviewing your documents should be an easy task. Write down the critical steps in the process and make sure those are all covered. Then go back and make sure all details are clearly defined.

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4 Implement your audit actions

The next step is to implement your audit actions and update your SOP documentation accordingly. You should follow a systematic and structured approach to do this, such as the PDCA (Plan-Do-Check-Act) cycle or the DMAIC (Define-Measure-Analyze-Improve-Control) methodology. You should also communicate your audit actions and updates to all the relevant stakeholders, such as your staff, managers, customers, or regulators. You should also provide training and support to your staff on how to use the updated SOP documents.

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5 Monitor and evaluate your audit outcomes

The final step is to monitor and evaluate your audit outcomes and verify if they have achieved your desired goals and standards. You should use relevant metrics and indicators to do this, such as quality, productivity, safety, or customer satisfaction. You should also collect feedback and suggestions from your staff and other stakeholders on how to further improve your SOP documentation. You should also document your audit outcomes and lessons learned, as well as plan for future audits and continuous improvement.

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6 Here’s what else to consider

This is a space to share examples, stories, or insights that don’t fit into any of the previous sections. What else would you like to add?

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What are the best ways to audit SOP documentation?

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3

4

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6

1 Define your audit scope and criteria

2 Review your SOP documents

3 Analyze your audit results

4 Implement your audit actions

5 Monitor and evaluate your audit outcomes

6 Here’s what else to consider

Manufacturing

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What are the best ways to audit SOP documentation?

1

2

3

4

5

6

1 Define your audit scope and criteria

2 Review your SOP documents

3 Analyze your audit results

4 Implement your audit actions

5 Monitor and evaluate your audit outcomes

6 Here’s what else to consider

Manufacturing

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