This chart has been updated to show FY2017. It's not that different from 2016.
The chart at left shows the top 10 Part 820 subparts cited in Form 483 device observations. listed by descending frequency along with their percentage of all citation subparts.
Underneath each are example citation descriptions representative of the subpart.
Note these top ten comprise 78% of all citation subparts.
Note that two descriptions list documentation specifically.
A diagnostic framework
The first requirement for compliance is that procedures have been created that would satisfy regulations when followed. Companies starting from scratch might struggle with this.
The second is that these procedures are followed. Newly acquired companies may find this difficult in new environments. Procedures are usually written to be read and interpreted. This is a complex human endeavor subject to all sorts of challenges.
Third is that these procedures produce some sort of documentation when executed. Operational documents are best because they are needed and naturally produced. Otherwise this documentation could easily be omitted to save time and/or effort.
Sadly the FDA treats lack of documentation as lack of execution. So if a required action is not documented then the FDA concludes that it was not performed.
I am researching this crisis to find solution(s). If you work for a medical device OEM you could really help.
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