Writing Deviation Reports – Five Common Errors

Writing Deviation Reports – Five Common Errors

By John Lafferty, Life Sciences Programme Director
Read time: 2 minutes

Based on his many years assisting Medical Device and Pharmaceutical companies with their Quality Management Systems, John identifies the following top five deviation report errors and their solutions.

1. No clear statement of what happened.
   – Clearly state what happened, do not try to tell a story, instead, deliver a message
2. No statement of what should have happened.
   – Refer to the relevant procedures.
   – Contrast what happened with the requirements of those procedures
3. Too much information.
   – Think critically about information before you include it.
   – Ask yourself, why have I included this information? What is its relevance to compliance with regulations, or its significance in relation to root cause investigation.
   e.g. “The incident occurred just before tea break.”  That may be true, but what is the relevance of this information
4. Batch numbers not stated.
   – Include the batch numbers of all affected batches.
   – Identify any unaffected batches, where necessary.
   – Document the rationale as to why the affected batches were deemed affected and the rationale as to why the unaffected batches were not affected.
5. Terminology does not comply with the procedure.
   – Check that the terminology in your deviation report is consistent with your procedure, otherwise it will be very confusing for the reader.
   – It is not a good idea to confuse approvers or auditors.

Learn more about our Technical Writing Skills for Deviations and Investigations training course https://www.sqt-training.com/programme/technical-writing-skills-for-deviations-and-investigations/

This training course will equip you with the knowledge, understanding, skills and tools to help you eliminate errors from your deviation reports and help to get those deviation reports approved at the first time of asking.

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About John Lafferty