How to keep old versions of work instructions from being used at point of use?

Renea Koski QAM

Involved In Discussions
I work in a system where all production cells work from paper documents. While it should fall to the Production Manager and Supervisors to ensure their people use the correct documents, it does not. Long before I came here, the Quality Manager (two before me) assumed that responsibility, as he was the one both writing and revising the Work Instructions, as well as controlling all drawings. So, part of that revision process is to print the newest revision, and replace the old revision, which is then destroyed (unless it's so old that there is no electronic copy, in which case it's scanned and then destroyed).

Checking the revision levels of documentation is also a part of our regular WIP Quality inspections.
Thank you!
 

ED76

Starting to get Involved
I agree with issuing the new paper copy and physically removing the previous copy from the workstation but it does depend on how large your operation is and how accessible the copies are this may need to be delegated and tracked by you. As part of my controlled document master list I store the location of any hard copies so that I know which ones require a physical copy to be issued upon revision.
 

Sinus Tarsi

Involved In Discussions
I agree with issuing the new paper copy and physically removing the previous copy from the workstation but it does depend on how large your operation is and how accessible the copies are this may need to be delegated and tracked by you. As part of my controlled document master list I store the location of any hard copies so that I know which ones require a physical copy to be issued upon revision.
@Renea Koski QSM We stamp them with "Copy" and Refer to the Master Doc. List for current revision level. The MDL will list the 'locations' of each document so hopefully there aren't that many you would need to switch out when there is a revision.
 

John Predmore

Trusted Information Resource
I worked in one plant years ago where the company culture had the operator keep the electronic work instruction open on the screen while the work was being performed There were no paper copies in the factory (also because the work was done in a clean room). So the operator always worked to the latest revision (the online master document). The culture was also that the operator had to scroll through the electronic document on the screen, so if they were performing step #23, then step #23 had to visible on the screen. If they were caught not scrolling up the work instruction, they could be written up for that workplace violation. This extra discipline addressed (to a large extent) the other problem with document revisions, that workers will sometimes continue to follow old habits and do the work sequence the way they remember, even after the quality department runs around and replaces all paper copies with new revisions, even after people are "trained" to the new revision.

I personally thought (at the time) the 'extra discipline' was overkill. But I admit the 'extra discipline' does serve to reinforce there is one standard way of performing work and every worker must adhere to that one standard way. I think the 'extra discipline' also cut down on lapses (as defined by Rasmussen and Reason) where Human Error results from a worker forgetting where there are in the sequence, due to interruptions or distractions. Lapses result in steps being skipped, performed twice, or performed out of sequence. Today, I admit there are some products and circumstances where this 'extra discipline' approach would work well to achieve superlative levels of quality. I share this 'extra discipline' approach as one more possible solution to the age-old problem where employees do not faithfully follow the latest work instructions.
 

Hi_Its_Matt

Involved In Discussions
As others have mentioned, you need to get the obsolete versions of the documents off the production floor, to prevent their use.
This aspect change control and removing obsolete documents is really just one aspect of the broader idea of controlling document distribution.
(After all, getting obsolete copies removed from the production floor is pretty useless if a user could easily go print a fresh copy of the obsolete version).

At a tactical level, one thing that can make simply finding and identifying work instructions a bit easier is putting any printed copies in a special colored binder or having a colored cover page/end page type thing attached to the WI's. This serves two purposes. First, now instead of looking for any paper documents in a given area, you know you're looking specifically for ones in a pink/blue/yellow binder. Second, it serves a simple visual reminder to the user that the document is revision controlled, and they may need to verify the version that is being used.

Of course this means you now have to make such supporting material available when WI's are printed, and you have to make sure whoever prints them is aware of such guidance/requirement. It's up to you to determine if "the juice is worth the squeeze."
 

LUFAN

Quite Involved in Discussions
I don't allow self-printed controlled documents on the floor. I instead have a set of controlled binders which I print the necessary SOPs and WIs on blue paper. Upon revisions to documents I swap out documents in the binder. This way I can visually ensure that if someone is using a controlled document on the floor, it's from the controlled binder that I myself placed there and it's current. If someone is using white paper, you've got a problem.
 

Renea Koski QAM

Involved In Discussions
I don't allow self-printed controlled documents on the floor. I instead have a set of controlled binders which I print the necessary SOPs and WIs on blue paper. Upon revisions to documents I swap out documents in the binder. This way I can visually ensure that if someone is using a controlled document on the floor, it's from the controlled binder that I myself placed there and it's current. If someone is using white paper, you've got a problem.
Thank is a great idea! Thanks.
 

FRA 2 FDA

Involved In Discussions
I also do not allow printing or copying of any revision controlled documents. My master document list tells me what location each document is stored at and as part of the closing/releasing process, I remove the old revisions and destroy them.

Before electronic documents were as common place, I worked at a large biotech company as a tech. The document control department would issue new documents to each relevant department. We were expected to place them in our document storage locations and send the obsolete revision back. I'm not sure how they handled tracking on their end, but it is possible to control physical copies of documents even in large facilities.
 
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