Following Order of Work Instructions

Candi1024

Quite Involved in Discussions
#21
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.:nope:

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!
 
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Ronen E

Problem Solver
Staff member
Moderator
#22
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:

Ronen E

Problem Solver
Staff member
Moderator
#23
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.
 

somashekar

Staff member
Super Moderator
#24
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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