Hey Monica!!
I have the EXACT SAME Problem as you... right down to the original Auditor not being able to come and getting a "newbie" who doesn't understand our business!!
Anyway, it looks like, from reading the entire thread, that "Big Jim" sent you a link or something ( ANAB's "Heads Up" 137)?? I don't know what this is but, if you've found your solution, than you've probably found mine as well... Do you mind sharing?? I'm kinda out of ideas on how to make this Auditor happy. She just sent my whole plan back to me and stated "No Root Cause"! Well, whats the root cause for, "I forgot!"
Anyway, anything you could share would be greatly appreciated! Thanks in advance!
Pete
Hi Peter,
Welcome to the Cove.
The ANAB "Heads Up 137" can be found on the ANAB web site. If you don't have it yet, I recommend it.
Let me try to walk through some of what you need to understand.
A proper response to an audit nonconformance (and good form for any corrective action) has three main elements, Correction, Root Cause, and Corrective Action.
Many people tangle Correction and Corrective Action so lets start with definitions. From ISO 9000, the definition of Correction is action taken to overcome a nonconformance. Don't get tangled by the fact that the word action is involved with the definition. ISO 9000 defines Corrective Action as the action taken to overcome the CAUSE of a nonconformance. Did you get that? Correction to overcome the nonconformance, and Corrective Action to overcome the CAUSE of the nonconformance.
Often, the term "containment" is used for Correction. It is the immediate action you take to resolve the nonconformance.
Once containment is out of the way, effort needs to be made to find out why it happened. Specifically, to find the root cause or final cause. There may be many contributing causes along the way, but if you don't dig the root out, it will grow back, just like a dandelion in your lawn. The most common method (usually very effective and reasonably easy to do) is known as "5 why". It is based on the concept that if you ask why enough times you will eventually get the the bottom (root) of the problem. 5 is often the magic number, but depending on the situation, it may take more or less. As long as you can reasonably still ask "why", you probably are not yet at the root.
Only after the root cause is determined, can you formulate a plan to overcome the root cause.
Some simple logic here to obey. The Correction and Corrective Action can never be the same. Correction is what you do to overcome the problem. Corrective Action is what you do to overcome the CAUSE of a problem.
The root cause can never be the same as the original problem statement. That was just the symptom, and not even a contributing cause.
Objective evidence is needed for both the Correction and the Corrective Action.
Let's try an example. This is only an example, and may not fit any particular real world experience.
A customer rejected a part because it was not manufactured to print. One of the dimensions was off.
The Correction may be to build another part, or replace it with one from stock.
Upon investigation, you determine that the part was built to the wrong print. It was made to Rev B and should have been built to Rev E. The machinist says that the drawing was missing from the traveler package, but he still had a drawing in his tool box from when he made what he thought was the same part two years ago. Further, you find that the traveler did not reference the drawing Rev as expected. On further investigation, you find the work instruction on how to create a traveler does not address drawing revision control.
This example may actually have more than one root cause, and that is OK. The most glaring one (to me) is the lack of proper instruction on creating the traveler.
Another trail to follow would be why did the machinist have an old drawing. What happened to document control to have permitted this. Perhaps there is a training issue here.
To summarize:
Correction: Replace the part.
Objective evidence: Show that a replacement part was shipped.
Root Cause 1: Inadequate work instruction on how to create a traveler and traveler package.
Corrective Action 1: Re-write the work instruction for traveler generation.
Objective evidence: The revised work instruction.
Root Cause 2: Machinist had inadequate training on document control.
Corrective Action 2: The machinist was trained.
Objective evidence: Training record showing the machinist received training.
Follow-up: Both Corrective Actions will be re-visited at the next internal audit.
I hope this helps.
