Personal Notes on Production Floor vs. Documented Work Instructions

[Wes Bucey]

In Reply to Parent Post by Helmut Jilling

Being "aware of" the work instructions existing is not sufficient. Using one's own notes in place of them introduces a lot of potetntial risk. In limited cases, it may well be ok, but if there is a lot of it, it will likely get out of control.

But Sidney is right, an auditor has to evaluate whether there is a problem, not just judge to his own preconception. If they are a record, they might be ok. Like a lab notebook, a lot of old machinists like to keep notes.

The company also should ask why the operator perceives a need to make notes and documents. Are the official instructions lacking? Are they unclear? Ask him why he makes "reference" notes. (I hate that word). There might not be a need, or there may be a legitimate need. That will be your clue to enhance the official work instructions.

Why not ask the operator directly why he needs the notes?
Added in edit:
"auditor ask operator"

[Ajit Basrur]

In Reply to Parent Post by Helmut Jilling

Being "aware of" the work instructions existing is not sufficient. Using one's own notes in place of them introduces a lot of potetntial risk. In limited cases, it may well be ok, but if there is a lot of it, it will likely get out of control.

But Sidney is right, an auditor has to evaluate whether there is a problem, not just judge to his own preconception. If they are a record, they might be ok. Like a lab notebook, a lot of old machinists like to keep notes.

The company also should ask why the operator perceives a need to make notes and documents. Are the official instructions lacking? Are they unclear? Ask him why he makes "reference" notes. (I hate that word). There might not be a need, or there may be a legitimate need. That will be your clue to enhance the official work instructions.

Totally agree with you Helmut - I do not allow my plant personnel to make their private notes. They should always refer to the controlled version of the WI / procedure to stay "compliant". In my industry of Pharmaceuticals, this practise of private notes is strictly prohibited.

[Helmut Jilling]

In Reply to Parent Post by Wes Bucey

Why not ask the operator directly why he needs the notes?
Added in edit:
"auditor ask operator"

I usually do. And encourage clients to do the same. It can be very informative to the Quality guy and shows up gaps in the system.

[Wes Bucey]

In Reply to Parent Post by Ajit Basrur

Totally agree with you Helmut - I do not allow my plant personnel to make their private notes. They should always refer to the controlled version of the WI / procedure to stay "compliant". In my industry of Pharmaceuticals, this practise of private notes is strictly prohibited.

But see - you are bringing in a bias from pharma industry which is bolstered by regulations precluding non-documented work. Much higher risk of life, health, safety issues in pharma than cutting hair ribbons to size and having notes about how frequently to sharpen blade.

[Ajit Basrur]

In Reply to Parent Post by Wes Bucey

But see - you are bringing in a bias from pharma industry which is bolstered by regulations precluding non-documented work. Much higher risk of life, health, safety issues in pharma than cutting hair ribbons to size and having notes about how frequently to sharpen blade.

I agree that Pharma is a high risk area and thus we can not afford to slip but the same logic can be extended to other industries, right ? When we talk about the QMS, the very intent of having controlled documentation is to bring in consistency and reduce variation within the process.

If people start making their private notes, the entire "essence" of controlled documentation is defeated.

[Sidney Vianna]

In Reply to Parent Post by Ajit Basrur

If people start making their private notes, the entire "essence" of controlled documentation is defeated.

Yes. But if an auditor really wants to positively impact this organization, I agree with Wes that the question begging to be asked is: Why, Mr./Ms. operator, do you need these notes? After all, according to the OP, the official work instructions exist and ARE READILY available.

In Reply to Parent Post by Fenway Frank

My company has documented work instructions for these tasks, and the instructions are readily available. Interestingly, the notes were right on track with the documented instructions.

Until one understands why the operator would resort to personal notes, when (in theory) the information s/he needs is "right there", chances are, we won't be able to fix the problem.

[Wes Bucey]

I just had an epiphany about this topic as I was shaving this morning!

I am certain I know exactly why the operator has private notes substantially in agreement with the official documentation.

I am certain the organization, in its zeal to have "controlled copies," refuses to allow enough copies to be made for each operator to have his/her own copy, hence the operator, in an effort or desire to be more efficient and not waste time trotting over to the official copy, has jotted down personal notes copied from the official document. Individual operators may or may not be able to express this to an auditor (mostly fear of retaliation), but odds are some martinet with a distorted view of the reasoning behind controlled copies has decided HIS interpretation is the only interpretation when it comes to determining how many controlled copies can exist

[Helmut Jilling]

In Reply to Parent Post by Wes Bucey

I just had an epiphany about this topic as I was shaving this morning!

I am certain I know exactly why the operator has private notes substantially in agreement with the official documentation.

I am certain the organization, in its zeal to have "controlled copies," refuses to allow enough copies to be made for each operator to have his/her own copy, hence the operator, in an effort or desire to be more efficient and not waste time trotting over to the official copy, has jotted down personal notes copied from the official document. Individual operators may or may not be able to express this to an auditor (mostly fear of retaliation), but odds are some martinet with a distorted view of the reasoning behind controlled copies has decided HIS interpretation is the only interpretation when it comes to determining how many controlled copies can exist

You might have something there. When I identify this issue during an audit, the Qulaity Manager usually wants to immediately snatch them away and reprimand the poor guy. I usualy suggest he calms down, and understands that the guy had a perceived need for the notes. I always recommend that he determines what there is a perceived need, and goes from there. The operator may actaully have a valid reason for having them, then the Q Mgr. can help make it legitimate.