Revision Control of WI (Work Instructions)

[PeterWang]

We have a 15 pages WI.Now there is a small process change ,so we need update the contents of one page in WI.Our QA guy do not want to updated the version of WI, he thinks we only need replace the determinate page and add a record in beginning page,is this acceptable?

[somashekar]

Originally Posted by PeterWang

We have a 15 pages WI.Now there is a small process change ,so we need update the contents of one page in WI.Our QA guy do not want to updated the version of WI, he thinks we only need replace the determinate page and add a record in beginning page,is this acceptable?

Perfectly acceptable ... also look if you have described how partial document revisions will be addressed in your documented procedure for control of documents.

[harry]

Agree with Soma (above) but first, check your procedure to see what it says. If it is different, you need to change if you want to adopt this method.

[jkuil]

How do you handle the training requirement?

[Stijloor]

Originally Posted by jkuil

How do you handle the training requirement?

Jan is correct. The impact of the change needs to be determined and then you need to decide if the employees affected by this change need to be (re)trained and their competency verified.

Stijloor.

[Jim Wynne]

Originally Posted by jkuil

How do you handle the training requirement?

Originally Posted by Stijloor

Jan is correct. The impact of the change needs to be determined and then you need to decide if the employees affected by this change need to be (re)trained and their competency verified.

Stijloor.

Can someone point me to where this "training requirement" is documented?

[jkuil]

I did not raise thus issue to start the duscussion on the training requirement again. I remember we recently had this in the forum and it was concluded it depended on what the company defined as the training needed to justify that the employee is qualified for his/her job.

In this case, if the company has determined that the employee needs to be aware of this even minor change of the WI to execute its task according to the specification, it needs a training record that provides evidence that this information was transferred (one way or the other). Therefore you like to refer to the amendment. For that purpose the amendment has to be identified by other means than a version number. Compare of how ISO identifies amendments to standards by adding a1, a2 etc for each subsequent amendment.

Alternatively, if you publish your WI with tracked changes you do not need to bother with amendments but just raise the version. The change can easily be identified and trained.
Second alternative: prevent long WIs. WIs should be limited to what one person can do, at one location, a one point in time. WIs ofter contain information not required to execute the task. That should be presented in documents like policies and procedures. Also the product or process specification (limits, instrument settings) needed for the task can be defined in seperate documents where practical. If your WI are as short as max 5 pages you probably would not have started this discussion as the maintainability of your QMS does not initiate alternative approaches.

[Jim Wynne]

Originally Posted by jkuil

I did not raise thus issue to start the duscussion on the training requirement again. I remember we recently had this in the forum and it was concluded it depended on what the company defined as the training needed to justify that the employee is qualified for his/her job.

In this case, if the company has determined that the employee needs to be aware of this even minor change of the WI to execute its task according to the specification, it needs a training record that provides evidence that this information was transferred (one way or the other).
<snip>

I understand. Perhaps it would have been better to ask how the OP is handling the training requirement if there is one. I just didn't want the impression left that there's an ISO 9001 requirement for training (or retraining) when work instructions are revised, which is different from whether it's advisable or not.