Maintenance of Product Technical Documentation

[Craig Brittain]

I was recently cited for not having a document describing the maintenance of product technical documentation. My initial reaction would just to include this in the ECO process but I think they're looking for more than this. I'm fairly new to the EC requirements and was looking for maybe a draft document addressing this. Any help would be appreciated.

 

[Al Rosen]

Review it periodically and update it like any other document.

 

[yodon]

To add to what @Al Rosen mentioned, there's plenty of postmarket information that you should continually consider for impact on your product and documentation. For example, as failures are reported, this would drive a review of your Risk File (are the likelihood scores accurate, are there new failures that weren't previously considered, etc.). Use issues could be an indication that your instructions for use are not adequate (or worse, that your UI is not supporting safe and effective use). As standards evolve (and are adopted), you need to determine impact which may possibly lead to updates in your V&V documentation.

 

[Ronen E]

I was recently cited for not having a document describing the maintenance of product technical documentation.

If you stated what ("EC") requirement you were cited against it could help us help you. If they can't clearly state such a requirement ("shall"), the "citing" is meaningless.