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Record Management - Does the QMS need to control templates of records?

#11
I think if you read points 7.5 its self-explanatory

Documented information of external origin determined by the organization to be necessary for the planning and operation fo the QMS shall be identified and appropriate and be controlled.
Documented information retained as evidence of conformity shall be protected from unintended alteration

keep it simple
 
#13
This is a topic that is starting to show a lot of heartburn for our management team.

They want a clear explanation of when to control forms. For example in our system, we have a blank production inspection form, this form is the base template on how the layout needs to be for adding the required inputs from the operator. They're wanting to prefill forms for each individual part number that is being machined and control each of these forms. So the original blank form is already controlled and then having a prefilled form for each part number has its own control.

Is this the correct process? Or is this adding too many headaches to the system and we should only be controlling the blank form? If you were to only control the blank for as the base template for the design and layout, are the prefilled forms for different part numbers considered uncontrolled until filled in to become a record?

Thanks for any information. Everyone has their own idea of these technicalities here and I'm trying to move us to a straight forward, this is how it's needing to be to conform.
Don't over complicate it. Control the original form. The prefilled form is just a transfer of information for convenience. Once it is completed with inspection data, it become a record and you can control by appropriate filing.
 
#14
Don't over complicate it. Control the original form. The prefilled form is just a transfer of information for convenience. Once it is completed with inspection data, it become a record and you can control by appropriate filing.
What management is having issues with understanding, is that how do the operators and end-users know that they are using the latest version of the prefilled form. That the prefilled form is being printed when the operators need them. How does management know that they aren't getting ahold of the prefilled form, that wouldn't be controlled, and changing the information? Since some of the parts being machined have been around for years. Is it explained by saying the operator is in charge of making sure they are recording the correct information as it relates to the part print?
 
#15
What management is having issues with understanding, is that how do the operators and end-users know that they are using the latest version of the prefilled form. That the prefilled form is being printed when the operators need them. How does management know that they aren't getting ahold of the prefilled form, that wouldn't be controlled, and changing the information? Since some of the parts being machined have been around for years. Is it explained by saying the operator is in charge of making sure they are recording the correct information as it relates to the part print?
The same way the know they operator is using the blank form and filling in the information. In addition, if you want to control it better, there are levels of control. Control at the source -- The computer they will be printed from. So you could, as you prefill them, then password protect them and put them in an accessible file for printing. Print, fill out inspection data, and file.
 
#16
Collect the data your system needs by controlling the system’s data collection devices (aka forms).
Yes, I'm planning on just adding the revision no and revision date to the footer of a form and maintaining a master list for all these formats. I'm hoping it will serve as a guideline for employees to use the latest version!
 

L.Soad

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#17
Yes, I'm planning on just adding the revision no and revision date to the footer of a form and maintaining a master list for all these formats. I'm hoping it will serve as a guideline for employees to use the latest version!
Just be carefull with that, people often like to make copies of forms on their computer and use them instead of your newer versions. i have this case in my company, we have technicians that are working on clients sites, and can have trouble to access documents on our server, so they kept copies of older versions.
 
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