Following Order of Work Instructions

Project Man

Involved In Discussions
#11
I've been trying to push that. It's not my project, I'm just doing one small part of it. However after my check I'll be making some recommendations based on what I saw, and that will be included.

The argument is that in some cases, (some say more than the majority of steps) it really does matter.
Order does matter. It sounds like you have a mature crew using the instructions. Because the risk of an N/C seems to be low, I would do a "fix em' as you find em'" by empowering the people that use the work instructions to review and inform the proper personnel when they come across a work instruction that needs to be revised for this issue (or any other issues while your at it).
 
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RoxaneB

Super Moderator
Super Moderator
#12
Rather than blitz through the 1,000 work instructions within the immediate future and ascertain if any documented activities must be done in a particular order, would it be possible to make it part of the document review process? This would spread the workload out over time.

Depending on the software used to create the work instructions, would it be possible to use some form of picture/image/symbol as a way to visually convey "This step must be done here/now with no deviation"?
 

Mikishots

Trusted Information Resource
#13
We are currently dealing with an issue involving the order that steps in a Work Instruction are completed. Obviously there are some steps that must be completed in the exact order (remove part from cast THEN clean cast) But others that could be of any order (Clean part / Clean empty cast). It has been written in the procedures governing the WI that they must be done in order unless written otherwise. However I still haven't found a work instruction that uses that exemption.

This has created an issue. How do you handle yours? How exact do we need to be? Can't logic rule?

Note: This is for medical devices
We have Nadcap certification for many processes we have in-house, and the one thing we've learned is that giving operators a choice in how to perform a job is inherently risky and causes difficulties during any root-cause investigations when something goes wrong. IMO, the recommended solution is to have the procedure state that operations are to be performed as defined in the WI, and then provide a WI with clearly identified steps. Even though your issue deals with medical devices, I think the principle is the same.

Reliance on logic is a futile endeavor - there is no way you can reason with it or predict a choice an operator will make. The key is elimination of variability.

To reduce the amount of possible errors or omissions, have the operators participate in the creation of the WI - they are the users and are in a very good position to help you.
 
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Candi1024

Quite Involved in Discussions
#14
I'm still working on this issue :)

This is a CAPA, and it was stated in the initial investigation that employees must carry out the AIs in exact order as stated. So stating the AIs don't necessarily dictate order won't work unless we have a strong reason to change this.

Would starting a regular auditing system where we systematically go through the AIs to verify accuracy be a sufficient preventative action?

Actually I'm not sure what the current preventative action is, because just fixing all of them sounds like a corrective action to me. I'll find out more this afternoon.

Then comes into question the effectiveness check. Currently the effectiveness check is an audit (sample) which includes observing an employee to see if they follow the exact order of the procedure. Perhaps the effectiveness check could instead be a review of the audit program?
 

Ninja

Looking for Reality
Staff member
Super Moderator
#15
Would starting a regular auditing system where we systematically go through the AIs to verify accuracy be a sufficient preventative action?

Actually I'm not sure what the current preventative action is, because just fixing all of them sounds like a corrective action to me. I'll find out more this afternoon.

Then comes into question the effectiveness check. Currently the effectiveness check is an audit (sample) which includes observing an employee to see if they follow the exact order of the procedure. ....
Keeping in mind that you said earlier you've not had any issues historically...pick the simplest way possible.

Call it CA, call it PA...call it continual improvement...call it George...can't see that it matters.

Effectiveness? Identify the single largest motivational factor for undertaking this huge effort...and measure effectiveness against that.
From the full chain above, it sounds like the main impetus is "Bob wants it".
The effectiveness check will be "Bob is happy". (worded all quality-like, though)

I would likely chalk this up to continual improvement.
For a CA, you (sorta) need a non-conformance that already happened, and it doesn't sound like that exists.
 

Candi1024

Quite Involved in Discussions
#16
Keeping in mind that you said earlier you've not had any issues historically...pick the simplest way possible.

Call it CA, call it PA...call it continual improvement...call it George...can't see that it matters.

Effectiveness? Identify the single largest motivational factor for undertaking this huge effort...and measure effectiveness against that.
From the full chain above, it sounds like the main impetus is "Bob wants it".
The effectiveness check will be "Bob is happy". (worded all quality-like, though)

I would likely chalk this up to continual improvement.
For a CA, you (sorta) need a non-conformance that already happened, and it doesn't sound like that exists.
We had audit findings on two separate occasions that picked up on small items that we did out of order. The CAPA was opened under, "not following procedures"

You make it sound simple, and it could be. Except for our audit team and upper management that expects us to "take this seriously" ie, put in more work than is required.

Time for: :beerdive:
 

Ninja

Looking for Reality
Staff member
Super Moderator
#17
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...
 

Candi1024

Quite Involved in Discussions
#18
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.
 

Ninja

Looking for Reality
Staff member
Super Moderator
#20
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.:nope:

Have a fun meeting!...weekend's comin!
 
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