Following Order of Work Instructions

[Candi1024]

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

 

[Project Man]

It appears as if the simple answer is to update the work instructions to use the exemptions. But, I think the bigger issue may be that the procedure allows it but the method of achieving it is not clear (i.e. bracketing the steps that can be done in any order).
Logic can rule but not everyone thinks logically hence, clear work instructions.

 

[Ninja]

When dealing with both cases (sometimes order matters, sometimes not), play to the greater population.

In most of my procedures, order matters. All procedures and WI have numbered steps to be followed in order.
Sometimes (rarely) order doesn't matter...those sub-instructions say "The following steps can be done in any order"...and they are bullets, not numbered.

1. "Do this"
2. "Do that"
3. "The following may be done in any order
- thing
- thang
- this
- that
4. "do the next thing"
5. "do one more thing"

Logic ruling is pretty dependent on your employee base. That's a call for you to make (with consideration to medical requirements). Not everyone's logic is the same...but sometimes your culture fosters a working base level logic that works.

 

[Candi1024]

Yes, I do agree with both of you. The problem is, we have approximately 1000 different work instructions. Up until this past year, not a great amount of focus has been put on being very specific in having correct order, or exemptions of order.

This is definitely something we will work towards though. However it's going to take quite awhile, and we have this classified as a CAPA which is already in the effectiveness check stage. They did one round of redlines, but I think there is still a lot of work left to do. Woo hoo!

 

[Ninja]

...This is definitely something we will work towards though. However it's going to take quite awhile, and we have this classified as a CAPA which is already in the effectiveness check stage.

A great reason to play toward the majority...first step is to identify how many would actually get updated...it shouldn't have to be all of them. You might get lucky and only do 100.

If you've decided to make changes, and the changes aren't made yet...you might want to rethink what stage your CAPA is...should be easy enough to back it up to a work-in-process.

Never lose sight that the QMS is there to support you, not burden you. It is work...but choose carefully via risk assessment how high of a priority this gets. Are order of instruction mishaps causing significant damage daily?

 

[Candi1024]

A great reason to play toward the majority...first step is to identify how many would actually get updated...it shouldn't have to be all of them. You might get lucky and only do 100.

If you've decided to make changes, and the changes aren't made yet...you might want to rethink what stage your CAPA is...should be easy enough to back it up to a work-in-process.

Never lose sight that the QMS is there to support you, not burden you. It is work...but choose carefully via risk assessment how high of a priority this gets. Are order of instruction mishaps causing significant damage daily?

No, we don't have any significant damage. However, it was found during an audit, then second audit, that we were not following procedure. At no time did this cause us quality issues. All audit findings become a CAPA. All CAPAs become all encompassing and overextending with a 1 year time limit. Aren't large companies grand?

 

[Ninja]

At no time did this cause us quality issues.

Can't you just handle it in an overriding procedure by adding something like:
"Work instructions are not intended to dictate order of operations within a task"

If it is a paperwork chase, and adds no value to you, keep the solution as simple as you can and move onto something important.

 

[Candi1024]

Can't you just handle it in an overriding procedure by adding something like:
"Work instructions are not intended to dictate order of operations within a task"

If it is a paperwork chase, and adds no value to you, keep the solution as simple as you can and move onto something important.

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.

 

[Ninja]

The argument is that in some cases, (some say more than the majority of steps) it really does matter.

Matters so much that you've never had an issue.
Doesn't sound like something I'd want to spend a lot of time on.

Good luck with your sales pitch!

Next thing I would look at is whether it would take me more time to change the documents, or to convince others that it isn't worth doing.
At that point you are outside of QMS and into personality management.
Sometimes it's just easier to do something useless than to avoid it.

 

[Candi1024]

I really appreciate our conversation here! I know this seems small, but it really helps keep me sane.