Need 5 why’s help

TacitBlue

Involved In Discussions
#1
We received a finding: 7.5.3 in AS9100. No process to document minor changes to a procedure.

Let me give you background, the auditor first identified a document which showed a minor change on the doc change history on the doc itself. The auditor looked at our uncontrolled minor change log and did not see a recording for the minor change to that document in the log. We failed to record the minor change for that doc. The auditor then asked if we had a procedure for recording minor changes. The auditee was unable to provide our work instruction because they forgot we had a work instruction for minor changes, so it was never provided. The auditor then looked over our main document control procedure and the auditor did not find any procedure for recording minor changes or any reference to our minor changes WI or log because we never included that information in the procedure. Therefore, we got the CAR.

How could I write a professional and solid 5 why’s to show cause and effect for this finding?
 
Last edited:
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Jen Kirley

Quality and Auditing Expert
Leader
Admin
#2
Sigh. Having a previous life as Document Control Queen, my heart is with you.

Let us dissect this.

1) What was this minor change?
2) What does your document control procedure say about managing minor changes? For example: an edited hyperlink, changed business name/icon in the header, paragraph numbering.

It is worthwhile to build into your document control system a means to manage administrative changes. If you don't want to do that permanently but you allow yourself the ability to make a temporary change, this temporary change might be leveraged to suspend (for a short time) typical controls so a minor change (we might call it a "nuisance change" if it is widespread) can help you get the job done without landing yourself in audit trouble.

Do you allow your system to make temporary controlled changes?
 

TacitBlue

Involved In Discussions
#3
Hi Jen,

We failed to record a simple update to a document. I believe it was wording.

at the time of the finding we didn’t have anything referencing process for minor changes in our doc control procedure. However we have since included the requirement for processing minor changes and the logging of those minor changes within our doc control procedure.

we have an internal uncontrolled work instruction and log for minor changes so yes we allow such changes. However minor changes are only recorded for controlled documents.

in fact we had the wi and log prior to the audit. Just wasn’t part of our procedure. Now it is.
 
Last edited:

Jen Kirley

Quality and Auditing Expert
Leader
Admin
#4
Hi Jen,

We failed to record a simple update to a document. I believe it was wording.

at the time of the finding we didn’t have anything referencing process for minor changes in our doc control procedure. However we have since included the requirement for processing minor changes and the logging of those minor changes within our doc control procedure.

we have an internal uncontrolled work instruction and log for minor changes so yes we allow such changes. However minor changes are only recorded for controlled documents.

in fact we had the wi and log prior to the audit. Just wasn’t part of our procedure. Now it is.
It seems as though you have addressed the issue. Planned arrangements for document updates are important. I have seen many document control processes that are very confining: small (administrative) changes are not planned for, and temporary changes are not planned for. It seems okay to describe your systems' previous lack in the response to this nonconformity, especially since you found it was worth actually fixing.
 
#6
This issue doesn’t warrant using such an approach. Correct it and move on. External auditors tend to see everything as an iceburg.
 

TacitBlue

Involved In Discussions
#8
Nonconformance FINDING: Our department made minor change to a document, but did NOT log the minor change in the minor change log.

Why: the personnel responsible did not record the change in the log.

Why: the personnel forgot to log the minor change.

Why: they were not held accountable to record the change.

Why: the manager was unaware of the minor change needing to be recorded.

Why: there is no internal requirement as part of the minor change process to notify the manager of a pending minor change.

Root cause: Our internal document control procedure does not state a manager notification or minor change requirement.

Corrective Action: Internal document control procedure will be revised to include minor change process requirements including manager notification.

Will this be accepted by the technical reviewer??? The only thing that I am question is whether the issue was really because the personnel forgot to do it and how we can prevent them forgetting again in the future? For example, even if we included the minor change requirements as part of our doc control procedure, how would that prevent the personnel from forgetting to log the minor changes? That’s why I am thinking the important part of this is not so much that our minor change requirements be included as part of our doc control procedure, but that we have a trigger to the manager to ensure the logging actually gets completed. Right?
 
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#9
Nonconformance FINDING: Our department made minor change to a document, but did NOT log the minor change in the minor change log.

Why: the personnel responsible did not record the change in the log.

Why: the personnel forgot to log the minor change.

Why: they were not held accountable to record the change.

Why: the manager was unaware of the minor change needing to be recorded.

Why: there is no internal requirement as part of the minor change process to notify the manager of a pending minor change.

Root cause: Our internal document control procedure does not state a manager notification or minor change requirement.

Corrective Action: Internal document control procedure will be revised to include minor change process requirements including manager notification.

Will this be accepted by the technical reviewer??? The only thing that I am question is whether the issue was really because the personnel forgot to do it and how we can prevent them forgetting again in the future? For example, even if we included the minor change requirements as part of our doc control procedure, how would that prevent the personnel from forgetting to log the minor changes? That’s why I am thinking the important part of this is not so much that our minor change requirements be included as part of our doc control procedure, but that we have a trigger to the manager to ensure the logging actually gets completed. Right?
With the greatest respect, you have taken on a monster, which you must now feed. You are attempting to fix something by treating it as a systemic issue, when it should have simply been corrected. The auditor should have audited your system, not created a monster. As a result, you will have to feed the monster, including worrying about the completeness of a 5Why and its acceptance.
 

Bev D

Heretical Statistician
Leader
Super Moderator
#10
Nonconformance FINDING: Our department made minor change to a document, but did NOT log the minor change in the minor change log.


Will this be accepted by the technical reviewer??? The only thing that I am question is whether the issue was really because the personnel forgot to do it and how we can prevent them forgetting again in the future? For example, even if we included the minor change requirements as part of our doc control procedure, how would that prevent the personnel from forgetting to log the minor changes? That’s why I am thinking the important part of this is not so much that our minor change requirements be included as part of our doc control procedure, but that we have a trigger to the manager to ensure the logging actually gets completed. Right?
First: did you talk to the person who ‘forgot’ to log the finding? As a reviewer I would not accept the ‘5why‘ because it reads like it was created in a vacuum.

Second: and more importantly I’m not sure this a finding requiring anything more than simplifying your procedure. Why isn’t noting the minor change in the document history enough? Why do you have to ‘double‘ record it? This path is a more effective approach to truly solving the ‘issue’.

Third: how can you prevent anyone from forgetting? Everyone forgets; it’s built into our nature. The only way to prevent forgetting is to error proof the process. Simplification is one way, electronic barriers and paths in documentation are another. You don’t need a trigger to a mananger - you are making the process more complicated with more opportunities for failure.

I would recommend taking a deep breath and thinking about this in a different way.
 
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