Non-functional Corrective Action - Could Not Find some Documents

John Broomfield

Leader
Super Moderator
XXXXX had # (small #) of corrective actions for the year. Both had shallow RCA performed and did not find true root cause.

itsbiodiversity,

It seems to me that you've agreed with the auditor. You seem to agree that your system failed to determine root causes so they could be eliminated or mitigated.

Not being able to retrieve records of the actions taken to determine root causes is a failure of your filing and archiving process (see 4.2.4).

You may need to invest in Ford Global 8D training so you have a well-defined methodology. You can Google for some excellent forms a free elearning is available in the methodology.

As to root causes avoid blaming any individuals. Your management system seem to lack a process for succession planning and take a look at your processes for bringing the necessary competences into your organization. You may find recruiting and/or training are weak.

While your at it work with your colleagues to develop a plan for revitalizing your process-based management system so it help employees to meet requirements.

Good luck,

John
 

Wes Bucey

Prophet of Profit
itsbiodiversity,

It seems to me that you've agreed with the auditor. You seem to agree that your system failed to determine root causes so they could be eliminated or mitigated.

Not being able to retrieve records of the actions taken to determine root causes is a failure of your filing and archiving process (see 4.2.4).

You may need to invest in Ford Global 8D training so you have a well-defined methodology. You can Google for some excellent forms a free elearning is available in the methodology.

As to root causes avoid blaming any individuals. Your management system seem to lack a process for succession planning and take a look at your processes for bringing the necessary competences into your organization. You may find recruiting and/or training are weak.

While your at it work with your colleagues to develop a plan for revitalizing your process-based management system so it help employees to meet requirements.

Good luck,

John
Ah, John, you've uncovered a "dirty little secret" of top tier consultants: "the dysfunction and a workable change process are almost immediately apparent to the expert from afar. The trick is to make it clear to the guy with the ink in his pen AND avoid humiliating him because HE didn't see it. Further, the expert from afar can't make it too easy or the client balks at paying the big bucks."
 

Mike S.

Happy to be Alive
Trusted Information Resource
XXXXX had # (small #) of corrective actions for the year. Both had shallow RCA performed and did not find true root cause.

Maybe I'm slow, but now I'm confused.

First you said " ...I was hit with an internal audit that requested our CAPAs...well I could not locate them so we got a Corrective Action. ... Now with my External Auditor (registrar) he thinks that's a pretty sorry excuse and wants another Corrective Action on what I suppose is my "newness" to the job at the time..."

I at first thought the auditor's finding was that you could not locate the records. But now it looks like the finding is that "both" the CARs had shallow analysis and lack of finding a root cause.

If you only had 2 or other small number of CARs issued to your company in a year's time, you must be doing really well.

Now, were the CAR responses weak, effective, or what?
 
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