Work Instruction Question

duff999

Involved In Discussions
#1
Hi Folks

I have a work instruction question and looking for a little guidance.
We typically have work instruction developed for certain processes that the users follow. All of that is working well. We have now introduced a new piece of software for the production process that includes work instructions that the user will follow. The work instructions are the same as what we have written out separately, and these have been imported into the new software. Is there a need to keep the original work instruction since the users now follow the same steps by using the software.

Hope I explained this well enough.

Thanks
 
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John C. Abnet

Teacher, sensei, kennari
Staff member
#2
Is there a need to keep the original work instruction since the users now follow the same steps by using the software.
Good day @duff999 ;
The short answer is "no".

Considerations..
1- By "original" do you mean the digital master? If, for example, you can not write into the new software you describe, then you will want to control and retain the digital "original", so you can make any changes and then upload those changes.
2- The version displayed to the operator via your new software will still need to be controlled in regards to revision and history. Be sure not to lose that ability to track the displayed version either at the point of work or back to the "original" as described in "1-"
3- Avoid duplicate "originals" , as that can (will) create a document control nightmare.

Remember, the point of all of this is to...
a) Ensure the intended (current) and only the intended (current) revision is available for use.
b) Ensure that there is traceability from what is being used, to the change history.

Hope this helps.

Be well.
 

duff999

Involved In Discussions
#3
Thank you for your comments. What I was trying to do is reduce redundancy.....I think. With the new software, we can create steps that the user has to follow and complete before moving to the next step, each step is documented. I was trying to avoid creating a new work instruction, and then rewriting it, or importing it into the new software. I was hoping to just create it once in the new software without having to create a new work instruction.

In short, create the workflow in the new production software, the software has an audit trail, once the production run is complete, tie the results back into our test summary report that lives in our eQMS. Am I opening myself up to an audit mess or does the tracking in the new software, then tied back to my final report, have the traceability that I need
 

yodon

Staff member
Super Moderator
#4
There are no requirements to have WIs. If your software provides suitable direction for the users to consistently perform the task correctly, I wouldn't think you'd need a WI. As for the original WI (pre-software), you should indeed obsolete them (do retain them per the retention requirements).

the software has an audit trail, once the production run is complete, tie the results back into our test summary report that lives in our eQMS
This is irrelevant to the WI discussion but does bring up the point that the software should be validated.
 

John C. Abnet

Teacher, sensei, kennari
Staff member
#6
What I was trying to do is reduce redundancy.....I think
Yes, you should indeed avoid redundancy at all means. If the software allows you to create/edit your work instructions in the software, then I can see no reason why you would want a separate "copy"/method (i can see many reasons why you would NOT want a second copy/method). Simply ensure that you can trace your change point control/revision history.

Hope this helps.
Be well.
 
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