Planned Deviation Vs Unplanned Deviation

2 Replies

Planned Deviation Vs Unplanned Deviation

Posted by Lokman Hossain on Feb 20, 2019 8:23 pm

Can any one help me to understand - how to handle planned deviation Vs unplanned deviation?

Re: Planned Deviation Vs Unplanned Deviation

Posted by Kaiwen Cheng on Feb 25, 2019 11:57 am

Lokman,
We probably need more information to understand exactly what you want to know.

During my corporate career, a deviation typically meant something unexpected happened that we have to accept in order to continue business.  Therefore it is always "unplanned".  We tried very hard to push everything to follow the change management process and not accepting deviation.  In general, regardless what triggered the deviation, you should restrict/ identify the population, the short action plan to use that population, and the criteria to end the deviation.

Our design engineers used to push for "forever deviation" to avoid going the change process.  That may be the "planned deviation" in your case.  We killed that as much as we could, because that became a traceability nightmare. 

Regards,
Kaiwen Cheng
Owner, KC Business Consulting, LLC
Denver, NC 28037
Phone: +1(980) 429-0292
kaiwen.cheng@outlook.com | https://www.kcbcweb.com
  

Re: Planned Deviation Vs Unplanned Deviation

Posted by Jeremiah Genest on Mar 7, 2019 7:20 am

A deviation is a departure from requirements. A non-conformance.

A planned deviation is a temporary change. You intend to deviate.

I strongly recommend not using planned deviations. Also process through a temporary change. This might seem like semantics but there are key differences that I discuss here: https://investigationsquality.com/2018/10/08/fda-signals-no-such-thing-as-a-planned-deviation/

As that blog post indicates if you are in an FDA regulated industry the terminology makes a difference.