Working on a Root Cause

GunLake

Involved In Discussions
#1
Hello,

I am working on a CAPA and Need 3 Root causes, Occurrence, Non detection, and Systemic. I have Root Causes for Systemic and Non Detection, It was just not simply in our checks/ Control plans, Etc. It was an error before i started working here that i should have caught during project launch, We had 0 checks in place for this, Which is why it wasn't detected. But Occurrence, Essentially we had a Supplier making the parts who didn't follow the standards because they claim it wasn't called out on the print when in fact it was.

I know this all should have been caught during part buy off, etc. But this was all before me, So couldn't say for sure why it wasn't and i over looked it during the launch. Is it acceptable to point out This issue of why it was made, Was the supplier not following standards, Or should i word it different to not directly point the blame onto them?

Thanks,
 
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Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#3
It reminds me of a philosophical idea: Just because you can formulate a question does not imply the Universe is required to provide an answer. 3 Root Causes makes me question which is the real root cause.
 

GunLake

Involved In Discussions
#4
Can you ask others who have been there longer than you?

I am curious, though...why do you NEED 3 root causes?
Small company and only 1 Quality person (Me). So before me it was another guy, So no one really knows why it was never checked and he was on his way out during the beginning of this project, So i just think he didn't care anymore and there are no records or any info on him checking the part. That is just what my customer has requested, a Root Cause for Occurrence, Non Detection & Systemic.
 

Miner

Forum Moderator
Staff member
Admin
#5
Ford requires this for their 8Ds. Suppliers have to perform a 5 Why for the cause of the problem, for the reason why the problem escaped to the customer, and for the systemic reason(s) that allowed the 1st two to happen. Since the 8D process has spread across other industries, this has followed.
 

Tagin

Trusted Information Resource
#6
I have Root Causes for Systemic and Non Detection, It was just not simply in our checks/ Control plans, Etc. It was an error before i started working here that i should have caught during project launch, We had 0 checks in place for this, Which is why it wasn't detected. But Occurrence, Essentially we had a Supplier making the parts who didn't follow the standards because they claim it wasn't called out on the print when in fact it was.
I think Occurrence would be something like 'supplier failed to adhere to stated product requirements'. (Although, there is a further question of the disagreement between you and the supplier as to whether the attributes in question were called out on the print or not, which may rest on a disagreement/confusion of how something must be phrased/identified/stated/etc. in order to be considered 'called out' by both you and the supplier.)

I don't think Systemic would be 'no checks/control plans...'. Instead, Systemic would be answering something like: 'why were there allowed to be no checks/control plans...?' or 'what about the QMS and/or management made it possible for there to be no checks/control plans...?'
 

qualprod

Trusted Information Resource
#7
Small company and only 1 Quality person (Me). So before me it was another guy, So no one really knows why it was never checked and he was on his way out during the beginning of this project, So i just think he didn't care anymore and there are no records or any info on him checking the part. That is just what my customer has requested, a Root Cause for Occurrence, Non Detection & Systemic.
Gunlake.
Could You explain what is root
Cause for Occurrence, Non Detection & Systemic?
I ve developed root cause anlysis by using ishikawa, using 6m, as main bon es, looking for possible causes, sometimes I find several causes, other times , I find one cause.
Based on one or some causes found, I apply action plans to eliminate such causes.
But never heard what you mentioned. please explain.
Thanks
 

optomist1

A Sea of Statistics
Trusted Information Resource
#8
For those not familiar with the Ford requirement/vernacular, a definition of the three classifications would be welcome:

Occurrence, Non detection, and Systemic
 

Tagin

Trusted Information Resource
#9
For those not familiar with the Ford requirement/vernacular, a definition of the three classifications would be welcome:

Occurrence, Non detection, and Systemic
This is not specific to only Ford. It is more generally known as "Three Legged 5 Whys" root cause analysis.

From: Three-Legged Five Whys – A Step Forward? | Business Processes Inc.
The new procedure creates three lines of inquiry. The “Why, Why, Why … ” process is applied independently to each of the following lines (legs):

I. Specific Leg
Why did this specific situation happen? This is the normal non-conformance being analyzed using the Five Why Procedure.

II. Detection Leg
Why was this situation overlooked? This asks why didn’t our in-place detection procedures catch this.

III. Systemic Leg
Why did the possibility exist for this situation to occur? This asks you to look at what about the larger organization, systems, or procedures creates an environment in which this non-conformance occurred?
 
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