RCA for every nonconformity? (10.2)

Newby here, hello!

I work in a large organization that is transitioning to 2015. We are currently stuck in a mode of assuming that any nonconformance to a documented process must go through thorough root cause analysis and corrective action (which dilutes the attention we can pay to high risk problems). While 10.2.1(b) indicates that we explicitly have the ability to evaluate the need for action based on the root cause, I have seen in this forum (and among my more experienced quality peers) that it is possible to stop and think about whether a nonconformity is a "big deal" or not before descending down the path of a full root cause analysis. I am having trouble aligning this common sense approach with 10.2.1(b)(2) which states that we must "determine the cause" of the nonconformity in order to determine whether corrective action is required. It seems like this requires a full RCA for all nonconformities, but we can decide whether or not to implement corrective actions. This doesn't align with the many threads that say a full RCA may not be needed if the problem is not systemic.

 

You're reading too much into it. You don't necessarily have to do a full RCA to determine the cause. Some causes can be "obvious." Also, when you get to the end of 10.2.1 it says "corrective actions shall be appropriate to the effects of the NC encountered." Every problem isn't a nail and thus every solution isn't a hammer. You analysis should look something like this:

1) Problem or NC
2) One off or systematic
3) If it is a one off, fix it and move on. If it is systematic, then mover towards a full RCA.

The worst thing you can do to your system is require a full RCA and 8D Corrective action process for every issue. It drives people crazy. Focus on the real stuff. Good luck.

 

Here's how my current informal triage tree works for such matters - bear in mind that it's an ever-evolving point of view ....


Is action necessary?


If no action is necessary, then there is no need for either cause analysis nor corrective action


When a root cause has been determined, and if appropriate, correction made, would a corrective action result in a change to the process?


If there is no process change it is unlikely the corrective action would be effective.


Ineffective corrective actions discourage support for the system.


Risk management – if it’s not important enough to change the process, it’s not that serious a risk.


Training may be conducted if appropriate, but if the system remains the same, the potential for recurrence does not significantly change.

 

Nice topic! This may not directly hitting the subject but let me share this interpretation where I subscribe to:

 

Thank you for your help!

 

Nice topic FlightlessWaterfowl.

This also prompted me to ask our esteemed members: DOES A COMPLAINT FROM A CUSTOMER AUTOMATICALLY WARRANT A CORRECTIVE ACTION?

 

I would say nothing is automatic. However depending on the complaint, I would say the lean is toward a CA. In our case product complaints usually do. Other complaints, like "you didn't get back to me soon enough" even though they emailed at 5:00 on a holiday -- we won't.

 

Here's a question related to this:

-ISO tells us we need to review the effectiveness of corrective actions taken. I set goals for myself and inform others that I need to collect objective evidence a few times over a span of a month or 2 in order to "close it out".
...So what is happening is I end up with a collection of open CAR folders that I am sitting on, waiting to follow up and collect evidence on..

My question is, for CAR's where a lot of time has passed and there is no way to collect evidence other than observing that it has not reoccurred, is it okay to make a statement of "there has been no further re-occurrences since this CAR has been issued". Is that enough?

 

Well... "because I am the quality assurance guy and that's my job" See the quotes? lol

 

I see your point though... hmmm

I could be getting the managers/ sups responsible to collect evidence. That could really streamline things.

 

Excellent advice!
Right after this I am marching into their offices! Maybe I'll have a clipboard in my arm with some important looking documents on it so it looks like I mean business!

Or, maybe I need to work on the "approach" first...haha

People here love doing more work, so this should be a breeze!



Thanks!!