Revision of procedure - Can't update the procedure before the actual process change

L

little__cee

#1
We have a procedure named "Receiving Inspection".

We are in the process of implementing a new system where personnel will be able to receive material electronically with a wireless terminal. This is an exciting development and everyone is eager to get it up and running.

My question: is it okay that for a while the old procedure will be wrong - I cannot update the revision level and put it into place before the bugs are worked out with the new system. So there will be some period of time where the procedure will be old but the method will be new - I don't know what to do about this.

Surely someone must have experienced this before so I am turning to the Cove for help. Help!
 
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D

ddunn

#2
Is your document control system able to indicate a procedure is in revision?
If not, it may be a good idea to add this feature. Then do a draft of the new revision and red-line it when a bug gets resolved. This way none of your process fixes fall through the crack.

An auditor should recognize that a process is in revision and in the test phase. This method will provide good document control during CI.
 

Mike S.

Happy to be Alive
Trusted Information Resource
#3
How will people know what to do regarding the new process? You might want to do a new revision incorporating the changes that you know right now, realizing that you will probably need to tweek it as the bugs get worked out.

Or, start a new revision but don't issue it yet. As bugs get worked out in the new process continue finishing the revision. If an auditor questions things, you can show him the new procedure in the works and explain that you're in the middle of a change. This should be okay so long as you can show that in the interim you aren't having NC's from customers because of a lack of a current procedure and training.
 
K

Kevin H

#4
re: Wrong Old Procedure

We approach this issue with temporary procedures/work instructions and spell out how we control them, who can issue them, etc. in our quality system. They are in effect for a limited time or amount of material produced and while in effect supersede the normal procedures/work instructions.

If you can't step ouside the sytem in a limited, controlled way, how will you ever be able to continuously improve it?

Hope this helps,
Kevin
 
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Wes Bucey

Quite Involved in Discussions
#5
I tend to go along with the concept of "red lining" the existing procedure to incorporate the modifications due to the wireless feature of transmitting data. Once you have finished all the red lines and have a stable process, then you can formally adopt the red lined version as the next revision level.

The concept of red lining is tried and true and is used on procedures, blueprints, and plans throughout scores of industries.

ddunn suggests your document management system should have a method to indicate a document (process, plan, work, instruction, etc.) is in the process of revision/validation. As part of that you want to have an audit trail to keep the subject topic/process "on the table" and moving toward formal revision. (audit trail describes who is responsible, who has input and red line authority, who makes the decision the process is stable enough to proceed toward formal revision.) ddunn is absolutely correct that you don't want this to fall through the cracks.
 
G

Greg B

#6
Kevin H said:
We approach this issue with temporary procedures/work instructions and spell out how we control them, who can issue them, etc. in our quality system. They are in effect for a limited time or amount of material produced and while in effect supercede the normal procedures/work instructions.

If you can't step ouside the sytem in a limited, controlled way, how will you ever be able to continuously improve it?

Hope this helps,
Kevin
Well said Kevin,

We do much the same. We have a Temporary Change Notice (TCN) and this allows us to change procedures or put in place Temporary procedures etc for a given period. It is a single page form that must show the change and it is approved by each level of the management chain: Supervisor, Manager and even Higher (depending on the authority of the document). For instance, any change to specificatiosn must be agreed to and signed off by both the Operations and Marketing Managers. Usually they show the reason for chnage and then have a copy of the new procedure attcahed at the back. This is usually just the current procedure with marked up changes.

Here si a copy of my Procedure and Form. I hope they help. (Please remember where you got it from) :)
 

Attachments

S

SteelWoman

#7
We've successfully used the technique cited by Mike S - we work on a procedure revision while the kinks are being worked out, and once in place we put the new procedure out. When it comes up in an audit I just go to my "pending changes" file and show the auditor what's in the works. These kinds of changes don't come with an ON/OFF button, they don't get turned on and everything just falls into place. It's also helpful if you have/gather some doumentation along the way (in most cases it's already out there - you're not creating it for no reason) that shows the on-going development.

We have a similar situation right now - we're implementing, corporation-wide, an updated software program that will eventually replace an outdated mainframe system. It's being implemented in pieces, with kinks being worked out along the way. I'm keeping abreast of it, but waiting for the kinks to be MOSTLY worked through before integrating the changes into any relevant procedures.
 
#8
I'm not really sure how big this issue is. First, this is not a required documented procedure. Secondly, the reason for documentation is to ensure effective planning, operation and control of your processes (4.2.1 d)). If you are implementing a change to your process (which you are), then you undoubtedly are very much involved in the process. You are "tweaking" the process.

Temporary procedures will probably not be able to keep up with the changes. Work instructions will probably be verbal and will change with each new “tweak”.

My recommendation is to “suspend” all documented procedures and work instructions until you can have something stable to go on. Then, adapt new procedures and work instructions. You will also want to increase your monitoring and measuring of the process to ensure it is effective. You might also have to make a couple of revisions to your documentation, based on your longer-term process evaluations.
 
M

M Greenaway

#9
I would not worry about it at all.

Like you say, you are continuously improving your process, the fact that your documented procedures lag this change process is a fact of life.

The only person in the world who might get a hang up on this is a rookie auditor, however you choose to play that game is up to you !

I perhaps would ask him to point to what he feels is the overall objective of ISO9001 :tg:
 

CarolX

Super Moderator
Super Moderator
#10
I have to agree with Dave B and Martin on this one. I have had several procedures go through radical changes because of technological changes. I wasn't going to change my procedure until we had the bugs worked out.

Remember----do what works for you!
 
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