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Root cause analysis:

Root cause analysis is a well thought out investigation to find out cause of the nonconformity. It does not
focus on individual mistakes or personnel shortcomings.

You can carry out this investigation by asking questions for example:
What happened?
What failed in the process that led to this nonconformity?, that is you need to first identify the process(es)
that was responsible for the root cause and what part of that process(es) that failed
Why did it happen?
How did we miss it?
What could have been in place that would have prevented the non-conformance from happening?

The above questions are guides; they are by no means exhaustive; you will need to come up with your
own additional questions in order to identify the root cause.

Root cause analysis also includes conducting interviews and reviewing your documents.

Common errors of root cause analysis to be avoided:


Blaming the employee for example the management representative did not…….
Omission
Negligence
It was a mistake
Failure to adhere to procedure
Incompetence
Oversight
Error of Omission
Poor control of record-this is not a complete sentence explaining what went wrong
I am not aware of the requirement of the procedure….(DO NOT PERSONALIZE)

Please note that root cause may be more than one reason therefore may be more than one sentence.

The root cause analysis must be sentence(s) not a phrase(s), you need to answer the question: does
this statement address the nonconformity that is it should be in sync with the nonconformity.

Correction:
When you carry out correction, this is what must be done:

What actions have been taken to correct it? Evidence that the correction has been implemented, is
attached for example updated form or checklist, pictures

Corrective action:
When you carry out corrective action, this is what must be done:

What actions have been taken to prevent this type of finding from happening again and preventing it
from occurring elsewhere (where applicable, for it to occur elsewhere). This action must be based
on the root cause statement (that is, it must match the root cause).
Evidence that corrective action has been taken, is attached for example, revised procedure
Please note that corrective action results in changes to the management system that is corrective
action is a new line of action not a repetition what you have done before this nonconformity was
given. DO NOT USE FUTURE TENSES IN YOUR CORRECTION AND CORRECTIVE ACTION STATEMENTS.

Common errors when providing evidence:

Revision status, issue date and revision date of documents not changed after the document was revised
Changes were made, evidence of communication of new/revised procedure was not provided

Evidences not provided to back actions taken.

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