Root Cause for "Simple" External Audit Findings

Guys,

From time to time we miss something simple that an external auditor might catch.

For example we changed the scope of our certificate but neglected to update the required exclusions.

What is an acceptable way to root cause something this simple? It's obvious easy to fix and has been done but how do you convince an auditor that you just "missed" it?

Thanks

Re: Root cause for external audit findings

It's all about root cause. Why was it "just missed"? Doesn't the standard say something about control of changes, review of changes, definition of authorities and responsibilities for same?

Is there an existing flowchart you follow when you make those changes? I ask because we do tend to forget something as we go along even though we have a list in tow all the time.

Our team formulated one that we now attach to the review items whenever anything is changed so we can see what's the next step and not just rely on the list that we have. That flowchart we have standardized as a requirement when checking all items.

Just my two cents

Important be honest raise nonconformity establish root cause don't mind even when you fail or forgot its a reason importantly any experienced auditor will want to see what is mechanisms (CA and PA) you will establish to ensure it ll not happen again.

Rgs

Don't over analyse things. As they say "Sh*t happens". Trying to find a root cause for some things just isn't worthwhile.

We may do simple containment for these low risk items but we always do CA and root cause. If the same type of thing is found over and over even though it's not considered major the fact it happens multiple times shows there is more going on. You may not want to process the little things but it may help in the long run because it may help reveal a pattern.

For such things I tend to use 5xWhy for RCA. You start with "Sh*t happens" because sometimes people make mistakes. As people do not like to get blamed when you question them, they tend to come up with excuses. So, if the guy who missed the requirement comes up with such excuses during the next 4 Whys then you easily get some corrective and preventive actions from it. Examples would be "The form is not well organized", "I was not aware that in that space I need to also enter X" , "the checklist/procedure does not explicitly state you need to...", "Nobody ever told me..." etc.
If she/he just says "Well it happened, so what?" then list some of the PA you already have in place, state a single error and call it a day...

rvanelli said:

Guys,

From time to time we miss something simple that an external auditor might catch.

For example we changed the scope of our certificate but neglected to update the required exclusions.

What is an acceptable way to root cause something this simple? It's obvious easy to fix and has been done but how do you convince an auditor that you just "missed" it?

Thanks

Click to expand...

I feel you can visualize the root cause when you see into THIS and THIS thread ....
Good luck

Bjourne said:

Is there an existing flowchart you follow when you make those changes? I ask because we do tend to forget something as we go along even though we have a list in tow all the time.

Our team formulated one that we now attach to the review items whenever anything is changed so we can see what's the next step and not just rely on the list that we have. That flowchart we have standardized as a requirement when checking all items.

Just my two cents

Click to expand...

To add and maybe if this can help, this is a flow-chart spin-off of what we have as "requirement". Sorry I forgot to take it home

1) Root cause can be like " Work procedure doesn't state including exclusion in Quality manual, hence was missed."

And revising the same to incorporate this step in your work procedure would be your corrective action.

2) You may also say that the "format doesn't include recording exclusion , hence was missed" as a root cause
Corrective action would be revising the format to incorporate exclusion as a point.

Since Work instruction, procedures , formats, checklists , etc. are being used as a reference / as a guideline to prevent missing of any activity / things.
And small small things adds value to the system.

This is just my opinion.



Thanks,
Amit