SOP or system Work Instruction? Controlled Document - Where does one draw the line?



I have a somewhat puzzling issue

Where does one draw the line between a general machine or task item "For your information" sheet and a document that needs to be a controlled system work instruction?

The reason for my question - we have set up the normally needed "work instructions" which we control within the system - and are now developing what is called Standard Op procedures information sheets. (Similar to a piecwork IRD job write-up.)

These will be posted at each machine within the plant.... The information contained on the SOP sheets is very generic and are not directly step by step task information

Clean chips from vices
turn on machine
Load Programming
push cycle start
Align spindles
set spindle speed
Inspect and record part quality X times per X hours of operation.
Place parts in proper containers
Tag loads when finished
Turn in time card for each job ran.
Clean your area at 2 hour intervals end of shift.etc.

It was never our intention to use them as "ISO system docs due to the fact that they will soon become "known factors" for qualified operators and have no direct impact on specific "Product quality". BUT they will be included as On the Job Training criteria and our employees periodically tested and evaluated in their use.

Given that the new standards call for increased focus on proving effectiveness of training.. Should they now be individually listed in the system sign-off authorized and controlled because they are used as proof of training effectiveness?


Fully vaccinated are you?
If your question is do you have to control these? I would think yes - they're training documents.

However, I'm not sure how you can use them as proof of training effectiveness.

barb butrym

Quite Involved in Discussions
Have done the like ...used them as training documents (points to be sure to cover in training/ a lesson plan), they are under control as such...then used as a tool by the training coordinator much like am audit check list where the task is observed/scored, using the document as the measure..........

Not my favorite way of doing things, but it met the need of the client and gave me an out ...i didn't have to trash what someone spent years producing as procedures....ones that were loaded guns/suicide !!!!!

barb butrym

Quite Involved in Discussions
Rethink having them hang at the work site....

Maybe as a reminder wouldn't be too painful come audit in "Have you cleaned the chips from the vices?"


This is interesting - the different viewpoints. Here is how I have handled this with success. Make a 'Template' for the document that carries a control. This control is for the format and areas of content only. Then you add your information and once this is done you apply a number and revision just to the information. For example, I would control a form that has a specific structure (fields, etc.) with a control on the lower left corner (my Quality Bulletin would be QuaBul-1-10/00 -1 being revision of the format of the form and 10/00 being when it was put into use). The form would have two available fields, one for number and one for rev. For the first Quality Bulletin I issue, it becomes number 1, rev 1 and also has a specific title - usually subject matter related. My control system would show the form being controlled, but I have a separate list of Quality Bulletins issued, their number, the current revision, and where distributed. Also, in this particular example, my Quality Bulletins also have an expiration date or some other indication as to how long the information should be considered valid (up to 'maintained until further notice').


Are we saying that it is not a standards document control violation to

1) keep SOP writeups in a controlled doc format (such as training manuals)use them for job training / task qualification.

2) Make copies of the SAME information without the controled form template .. give it a print date timeframe or expiration date Title it as a Q bullet or FYI information sheet?
THEN hang it on each machine or work station?
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