Root Cause Analysis as Training

ISO_Man

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#1
There's a finding related to uncontrolled forms that were found in manufacturing during an audit. The real answer to why they were there is that the supervisors on the team let them use the forms. The supervisors had been through document training but no document audit had been performed in that area. A new process is in place now to perform work area audits, but it had not been in place when the documents were created. It's hard to write a good root cause analysis for something that was just "missed." Especially for an external auditor. Any tips?
 
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Sidney Vianna

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#2
How valid is the finding? (assume you are using the term finding synonymously with nonconformity). Is the need for a form real? Is the need for a "controlled form" real?

What is the impact of the "uncontrolled form"? Is any relevant data being missed? Before diving into a rabbit hole of why did this happen, for everyone's sanity sake, let's confirm a problem exist.
 

ISO_Man

Involved In Discussions
#3
That's a good question and leads to another question -- when does a form not need to be controlled? I err on the side of caution, that if any form is used in production it should be controlled. This one measures parts flow through a specific area to identify any areas for concern for identified employees.
 

Tagin

Trusted Information Resource
#5
The real answer to why they were there is that the supervisors on the team let them use the forms.
Are the name and uses of these forms identified in your process documentation? Are the resulting completed forms intended to be used for approvals and/or stored for historical purposes?

I'd be looking at a somewhat larger picture, relating to the possibility of inadequately documented processes, which in turn led to inadequately documented forms.

It's hard to write a good root cause analysis for something that was just "missed."
"Missed" = "Failure to apply 7.5 to process X"
Root cause might be that the audit process is not using the process approach. That is, auditing each process by going through clauses 6-10 for each process. Or, at least, having those clause elements on an audit checklist for each process.
 

optomist1

A Sea of Statistics
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#6
what about LPAs, layered process audits? LPAs executed correctly and as prescribed should flush out this type of anomaly
 
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tony s

Information Seeker
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#7
There's a finding related to uncontrolled forms that were found in manufacturing during an audit. The real answer to why they were there is that the supervisors on the team let them use the forms. The supervisors had been through document training but no document audit had been performed in that area. A new process is in place now to perform work area audits, but it had not been in place when the documents were created. It's hard to write a good root cause analysis for something that was just "missed." Especially for an external auditor. Any tips?
There are various premises here that warrant probing to extract the immediate cause/s of the problem:
  1. "The real answer to why they were there is that the supervisors on the team let them use the forms". WHY did they allow the use of uncontrolled forms?
  2. "The supervisors had been through document training". WHY did they fail to implement what was taught to them?
  3. "... no document audit had been performed in that area". WHY it was not performed?
  4. "A new process is in place now to perform work area audits". WHY it was not performed in the manufacturing supervisors' area? or WHY it failed to check the use of uncontrolled forms?
I've just asked the 1st WHYs. If you need determine the underlying cause/s, probe them further by asking more WHYs.
 

Al Rosen

Holed-up in a Hotel in South Florida
Staff member
Super Moderator
#8
I don't know that not performing an audit in the area is a cause for the use of the uncontrolled forms. If an audit was performed it would only revael the issue sooner, not eliminate it. I don't think that not performing audits is a root cause. Maybe the issue is the training. You only trained the supervisors. Why was the training not effective? You might want to expand the training to a larger population.
 

Jim Wynne

Staff member
Admin
#9
The supervisors had been through document training but no document audit had been performed in that area.
Internal audits should be done on processes, not documents. Part of an internal process audit should be review of forms and documents. I don't know who, in this case, needs to be retrained, but someone does. It looks to me like at least part of the root cause is that internal auditing is misdirected.
 
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