Controlled document training requirements and structure

[brandon.gingrich]

We are just an early stage start-up company in the process of implementing a 13485/FDA QSR compliant quality system so our documents are in quite a state of flux. As such I don't necessarily want to have to have people complete a read and review and sign off on training on every new revision made to controlled documents as the system evolves, unless of course they are important changes.

I guess my question is two fold:

1. I don't think there's any reason to have rigorously documented read and review training on every new revision at this stage. Is this correct?

2. Does anyone have an insightful/elegant solution on how to structure the requirement to review changes to controlled docs? I was thinking maybe some sort of "revision type" could be specified with categories like minor, moderate, major changes etc.


Thanks in advance.

 

[Mikishots]

Re: Controlled document training requirements/structure

We are just an early stage start-up company in the process of implementing a 13485/FDA QSR compliant quality system so our documents are in quite a state of flux. As such I don't necessarily want to have to have people complete a read and review and sign off on training on every new revision made to controlled documents as the system evolves, unless of course they are important changes.

I guess my question is two fold:

1. I don't think there's any reason to have rigorously documented read and review training on every new revision at this stage. Is this correct?

2. Does anyone have an insightful/elegant solution on how to structure the requirement to review changes to controlled docs? I was thinking maybe some sort of "revision type" could be specified with categories like minor, moderate, major changes etc.


Thanks in advance.

To be clear, a read and review would never be considered training. If this was the case, I could read a detailed procedure for, say, surgery, but that does not make me qualified, competent or trained by any stretch of the imagination, even if I could recite it word for word from memory.

My own acid test: if the modification affects multiple aspects or sections in a document and involves a change to the process itself, re-training for process/document key users is required.

Revisions that do not change the process itself are considered minor, and are typically not considered trainable changes.

 

[kgott]

Re: Controlled document training requirements/structure

We are just an early stage start-up company in the process of implementing a 13485/FDA QSR compliant quality system so our documents are in quite a state of flux. As such I don't necessarily want to have to have people complete a read and review and sign off on training on every new revision made to controlled documents as the system evolves, unless of course they are important changes.

I guess my question is two fold:

1. I don't think there's any reason to have rigorously documented read and review training on every new revision at this stage. Is this correct?

2. Does anyone have an insightful/elegant solution on how to structure the requirement to review changes to controlled docs? I was thinking maybe some sort of "revision type" could be specified with categories like minor, moderate, major changes etc.


Thanks in advance.

1. I don't think there's any reason to have rigorously documented read and review training on every new revision at this stage. Is this correct?

Thats right, the training requirement can be achieved by going through the changes with a group of people at a taem meeting or putting a memo on notice board. Sending an email to the required persons advising the nature of the changes also achieves the objective.

Obtaining evidence that the required persons have been informed of the changes is a little different. The team meeting method needs to be documented in the minutes of the meeting and getting each person to sign a meeting attendance record will seal the deal.

Saving the email with its list of addresses as a record in an appropriate file is usually considered to be adequate.

Some may argue that getting each person to sign a record that they have been advised of the changes is required and they may well be right. This is ideal but is ofen not a realistic option in many situations.

Getting an email from supervisors that they have informed the right people of the changes is about the most practicable for most organsations.

There are issues with all solutions but expereince will teach you that the method that is the most practicable is going to be the most enduring.