Internal Auditing of Area with Active Change Control

M

Michele B

#1
Good morning,

I will be conducting an internal process audit in our Distribution Center. Management has an active "approved" change request for a function within this area. The change request has not been closed as document revisions and training are not complete. If I observe the proposed changes in place, is this a nonconformance? I'm not sure if having a change control in place protects the department from a nonconformance. Any guidance is greatly appreciated.

Regards,

Michele
 
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Jen Kirley

Quality and Auditing Expert
Leader
Admin
#2
Re: Auditing area with active change control

Michele B, welcome to the Cove! :bigwave:

Unless the change involves regulatory requirements or requires customer approval to implement, I would generally not assign a nonconformance because the process document has not yet been approved - unless I found written evidence or was was given a verbal description of the changes having been made quite a lot before the process document had been updated - by "quite a lot" I mean months.

Please understand though, that receiving more detail about just what was being done might have prompted my giving a different answer.
 

Jim Wynne

Leader
Admin
#3
Re: Auditing area with active change control

Good morning,

I will be conducting an internal process audit in our Distribution Center. Management has an active "approved" change request for a function within this area. The change request has not been closed as document revisions and training are not complete. If I observe the proposed changes in place, is this a nonconformance? I'm not sure if having a change control in place protects the department from a nonconformance. Any guidance is greatly appreciated.

Regards,

Michele
Is this not covered by your company's documented requirements? If it is, you have your answer--if the requirement isn't met, it's a nonconformity. On the other hand, if the situation you describe isn't addressed, you will be performing a useful function by documenting the disconnection. You shouldn't necessarily be thinking in terms of black and white--conformity or nonconformity. Internal auditors should always be on the lookout for things that need to be improved.
 
M

Michele B

#4
Re: Auditing area with active change control

Hi Jennifer,

Thank you for your quick response. The change control was approved on 10/17/11. The change is minor and impacts 3 different distribution centers. The distribution centers are still editing the written work instructions as they have not come to a final agreement. I have received word that employees are already following the "new" procedure. My concern is how can a new procedure roll out without a finalized document for employees to train on?
 
K

Ka Pilo

#6
Re: Auditing area with active change control

Hi Jennifer,

Thank you for your quick response. The change control was approved on 10/17/11. The change is minor and impacts 3 different distribution centers. The distribution centers are still editing the written work instructions as they have not come to a final agreement. I have received word that employees are already following the "new" procedure. My concern is how can a new procedure roll out without a finalized document for employees to train on?
Actual practice should reflect current/approved document and they should be accurate. The fact that it does not, the document should be approved/updated and employees should be retrained.
 

Randy

Super Moderator
#7
Re: Auditing area with active change control

There are 2 basic questions

1) What is supposed to be happening?

2) Is it happening as planned?

From the answers to those questions you'll make your decision.

Don't try to make it any more difficult than that
 
#8
Re: Auditing area with active change control

Hi Jennifer,

Thank you for your quick response. The change control was approved on 10/17/11. The change is minor and impacts 3 different distribution centers. The distribution centers are still editing the written work instructions as they have not come to a final agreement. I have received word that employees are already following the "new" procedure. My concern is how can a new procedure roll out without a finalized document for employees to train on?
Because training isn't always necessary! You have to look at the nature of the change, which from what you've said doesn't appear too significant. Not all changes need 'training'.

For example, when I arrived in the USA I could drive (on the other side of the road) and we had to change 'procedure' (to drive in the USA, things are often different) but, it's not a requirement to go to training - just take a test (only in some states, as well). If you or your QMS says you need training for documentary changes, this should be reviewed for need...
 
M

Michele B

#9
Re: Auditing area with active change control

Hi Randy,

Thank you. It is not happening as documented/planned. It would be a nonconformance. I was over thinking this one :)

Regards,

Michele
 
#10
Re: Auditing area with active change control

Hi Randy,

Thank you. It is not happening as documented/planned. It would be a nonconformance. I was over thinking this one :)

Regards,

Michele
Another thing you should think about, perhaps, is whether it's prudent to forestall a process improvement while waiting for the documentation to catch up. If your system forces things like this, you might be correct in citing a nonconformity, but maybe the root cause is a system that's not flexible enough to allow for improvement to take precedence over the document review process.
 
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