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  Post Number #17  
Old 22nd July 2016, 11:58 AM
Ninja's Avatar
Ninja

 
 
Total Posts: 1,086
Re: Following Order of Work Instructions

So...wrapping this all up together:

- You have WI written in step by step order
- You want folks to follow the steps in order
- It is required that the steps be followed in order unless stated otherwise
- It is never stated otherwise

and the finding(s) are that steps were done out of order...

This is not a document issue at all...it is an "employee behavior" problem.

If I clean window A, then unrelated window B, there is no issue.
If I do the same thing when directed to clean window B first...there is an issue.

And you're back at a choice between mandating something unnecessary and following through with it, or stating otherwise on your WI...
Can't see another option for ya...

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  Post Number #18  
Old 22nd July 2016, 12:09 PM
Candi1024

 
 
Total Posts: 128
Re: Following Order of Work Instructions

That is a good analysis, and that is the production managers view as well.

However..... When I did the effectiveness check, what I saw was illogical order of steps in the WI.

I think you just enlightened me. Not sure what conclusion we will come to in the meeting today, but I see now that what I have uncovered is a completely different issue. I still like the idea of doing audits on the various WI. Of course, I think that's a good idea to start with or without this CAPA in mind.

The effectiveness check still failed because I did not see the employees following the order of the WI.
  Post Number #19  
Old 22nd July 2016, 12:44 PM
notemadres

 
 
Total Posts: n/a
Re: Following Order of Work Instructions

work instruction describes how to perform the conversion itself.
  Post Number #20  
Old 22nd July 2016, 02:09 PM
Ninja's Avatar
Ninja

 
 
Total Posts: 1,086
Re: Following Order of Work Instructions

Quote:
In Reply to Parent Post by Candi1024 View Post

The effectiveness check still failed because I did not see the employees following the order of the WI.
Employees didn't follow direction
Direction reviewed and Mgmt likes it as is.
CA to make them follow direction
Employees still not following direction

...agreed, that wasn't effective.

Have a fun meeting!...weekend's comin!
  Post Number #21  
Old 22nd July 2016, 02:14 PM
Candi1024

 
 
Total Posts: 128
Re: Following Order of Work Instructions

Quote:
In Reply to Parent Post by Ninja View Post

Employees didn't follow direction
Direction reviewed and Mgmt likes it as is.
CA to make them follow direction
Employees still not following direction

...agreed, that wasn't effective.

Have a fun meeting!...weekend's comin!
I just found out the department where I found the most grievous errors was shut down all day to rewrite work instructions.

I have to say, I've seen more management support here than any other company I have been at. Sometimes being a large company they go overboard or the message gets misinterpreted, but they certainly try!
  Post Number #22  
Old 22nd July 2016, 08:04 PM
Ronen E

 
 
Total Posts: 3,736
Re: Following Order of Work Instructions

My humble understanding is that effectiveness check should begin with (and sometimes consist solely of) a check of whether the ROOT CAUSE was eliminated. Sometimes the bigger effect (ie fixing of the problem that triggerd the CAPA) can only be judged after a long time, or be quite difficult to rule "fixed", so "ultimate" CAPA effectiveness checking is not always practical in the short term (or at all).

If the root cause wasn't eliminated, obviously the CAPA shouldn't be expected to be effective (other than by mere luck).

If it was, it still doesn't guarantee CAPA effectiveness, because the root cause might have been misidentified.

Have you identified the root cause? Are you confident that it was identified correctly? Have your actions addressed the elimination of that root cause?

(A preliminary step in effectiveness checking is ascertaining that the prescribed actions have been completed as prescribed. In big orgs it sometimes gets lost in the way.)

Last edited by Ronen E; 22nd July 2016 at 08:15 PM. Reason: Rearranged in attempt to better convey the message.
  Post Number #23  
Old 22nd July 2016, 08:09 PM
Ronen E

 
 
Total Posts: 3,736
Re: Following Order of Work Instructions

Quote:
In Reply to Parent Post by Candi1024 View Post

I still like the idea of doing audits on the various WI. Of course, I think that's a good idea to start with or without this CAPA in mind.
This can be an example of a PA - preventing occurrence of a problem that has not yet surfaced.

As with a CA, it is important to clearly frame the (potential) problem and its root cause.
  Post Number #24  
Old 24th July 2016, 04:30 AM
somashekar's Avatar
somashekar

 
 
Total Posts: 5,371
Re: Following Order of Work Instructions

The order in a work instruction is the output of the best thought that goes into making it considering the actual worker inputs as well. Sometimes a step can be done earlier or later, and here again the best judgment is applied. In typical assembly situation, due to shortages, when a step is decided to be performed later, in our case we just capture this in a deviation log for that instance only. We also have products which has two limbs and each limb has a different part going inside., but the process on both limbs are the same. In case of shortages we finish all the one limb of several lots, and when the shortage material arrives, the other limb of all the lots gets completed. We would not write such a work instruction, however this again is managed with the deviation log. We just care to see if such a work flow introduces any risk to the product with all our best process knowledge and common sense, and mention this as well in the deviation log. All deviations are approved by the responsible managers and records maintained and are open to audit.
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