Hey, it's Pam
This one's about a pattern that quietly costs regulated teams time: good information in the wrong order. I get into why solid deviation reports keep coming back, what the FDA's new guidance signals about clarity, and how one aviation team rebuilt the way it writes.
Is there a writing or review headache you want covered in a future edition? Just hit reply and tell me what's tripping up your team. I read every response, and your questions shape what comes next. In this issue: |
- Why good reports keep getting kicked back
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The FDA wants plain language, and it's the law
- How an aviation team rebuilt its writing
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| Why good reports keep getting kicked back |
Here's a pattern I see a lot in regulated industries. A deviation report comes back for revision, and the writers include unnecessary details, which mislead or confuse the reader.
Most reports get written in the sequence things happened. You start at the beginning, walk through every step, and save the impact for the end. It feels thorough. But your reader needs the impact first: what was affected, how badly, and what you've already done about it. Bury that under a play-by-play and they lose the thread before they reach the part that drives the decision. So flip it: |
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Lead with impact and mitigation
- Keep only the event details that support them
- Cut anything that doesn't connect to the impact
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A report that respects the reader's time is a report that clears on the first pass. |
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The FDA wants plain language, and it's the law |
The FDA isn't just nudging you toward clearer writing; it's also bound by the Plain Writing Act to write that way itself, and pushing the same standard onto pharma and life science companies. Two things to take from it: |
- Plain language is a compliance expectation, not a nicety
- The people that write and suck at it have to adapt
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In future newsletters we'll be showing you examples of how to use plain language. |
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How an aviation team rebuilt its writing |
An international aviation manufacturer brought us in for a team that wrote for mechanics, engineers, and managers all at once and struggled to reach any of them cleanly. After a customized onsite workshop built around their own documents, the change was concrete. Reviewing time was cut by 25% and 80% of documents were approved without revision. 90% of writers felt more confident after our workshop. |
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