Deviation Reports: Writing for Maximum Impact

Posted June 25, 2024

Deviation reports instances where processes or products deviate from established standards or protocols. For example, consultancy firm The FDA Group cites several types of deviations that might necessitate documentation and reporting:

• Equipment failures or malfunctions
• Human errors
• Deviations in ambient environmental conditions
• Unexpected delays in manufacturing, testing, or other processes
• Quality control issues with raw materials or the supply chain

Reports for deviations like these will detail the nature of the issue, its impact, and the corrective actions taken. They are essential for maintaining quality control, ensuring compliance, and improving operational efficiency.

Before Writing the Deviation Report, Ask What Your Readers Need and Expect

Foundationally, understanding your reader is crucial for crafting effective deviation and investigative reports. Primary reads for these reports typically include:

• Management: Need concise, actionable insights to make strategic decisions.
• Quality Assurance Teams: Require detailed information to ensure compliance and improve processes.
• Regulatory Bodies: Expect thorough documentation to verify adherence to standards.
• Operational Staff: Need clear guidance on corrective actions and preventive measures.

If the primary authors don’t know everything that should go into the report for each of these readers, input should be solicited from a wide range of stakeholders, which is the only way to get a complete view of the deviation or incident and what readers need to know about it. The FDA Group recommends that deviation report authors “encourage the participation of cross-functional teams in both root cause analysis and the [Corrective and Preventive Actions] CAPA process to glean a breadth of insights.”

When Writing the Deviation Report, Ensure Readers Can Find the Information They Need

“By understanding your reader’s needs and structuring your reports effectively, you can maximize their impact and contribute to ongoing improvements in your organization,” writes the FDA. To that end, ensure the report incorporates the key information the reader needs and is organized that makes it easy to find exactly what they need to know.

The FDA offers a flowchart that describes the CAPA decision-making process. The ideal deviation report contains the necessary information and is organized to facilitate decision-making at each step in this workflow. For example, the second element in the flowchart asks, “Were quality data sources identified? Have data from these sources been analyzed to identify existing product and quality problems that require corrective action?” Any deviation report should immediately answer these questions so that decision-makers can use the report to work through the CAPA process quickly and effectively.

Consider an organizational structure like the following:

• Executive Summary: A brief overview of the key findings and recommendations.
• Introduction: Contextual information and objectives of the report.
• Description of the Deviation: Detailed accounting of what occurred, including when, where, and how.
• Impact Assessment: Analysis of the deviation’s or incident’s effects on operations, safety, and compliance.
• Root Cause Analysis: Examination of the underlying reasons—not just symptoms—to prevent recurrence.
• Corrective and Preventive Actions (CAPA): Steps already implemented and/or recommended to address the issue and prevent future deviations or incidents.
• Conclusion: Summary of findings and next steps.
• Appendices: Additional data, charts, and supporting documents.

How Do You Write a Document That Management Can Use to Fix the Issues?

The ideal deviation report isn’t just an informational document; it’s a tool that can be used to help solve current and/or future problems. To be maximally effective in this way, make sure to present evidence that supports the analysis and recommendations, including data, expert testimonies, and case studies. Also provide adequate contextual information about the deviation, e.g., detailing the consequences of inaction or wrong action to emphasize the urgency of addressing the issue. Anticipate objections by addressing potential counterarguments or concerns proactively. Finally, conclude with a call to action, encouraging management and stakeholders to implement the proposed solutions.

Additionally:

• Use Clear and Direct Language: Avoid jargon and complex sentences. Aim for simplicity and precision.
• Be Concise: Stick to the essential information and avoid unnecessary details.
• Highlight Key Points: Use headings, bullet points, and bold text to emphasize important sections.
• Make Recommendations Actionable: Ensure proposed solutions are specific, feasible, and clearly defined.
• Include a Timeline: Suggest realistic timelines for implementing corrective and preventive measures.
• Follow-up: Include a plan for monitoring the implementation of recommendations and evaluating their effectiveness.

By following these steps, you can build a strong, persuasive argument that underscores the importance of taking corrective and preventive measures.

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