1. This site uses cookies. By continuing to use this site, you are agreeing to our use of cookies. Learn More.
Dismiss Notice
You must be a registered member in order to post messages and view/download attached files in this forum.
Click here to register.

Is validation of training tools required?

Discussion in 'ISO 13485 and ISO 14969 – Medical Devices QMS' started by HeathW, Mar 26, 2021.

  1. HeathW

    HeathW New Member

    Joined:
    Mar 26, 2021
    Messages:
    3
    Likes Received:
    0
    Trophy Points:
    1
    Hi all, and my first post here.

    We are having an internal debate and the question comes up "Is formal validation required for tools used in a training exercise?". Some of the tools in question here are customized software tools for training purposes only.

    Of note, after training each participant is required to pass a quiz showing comprehension of the training materials.

    We have an FDA class III medical device.

    Thanks all!
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

    Joined:
    Jul 30, 2015
    Messages:
    5,086
    Likes Received:
    2,553
    Trophy Points:
    112
    Location:
    In the "Rust Belt"
    Can you show that they don't pass before the training and do after the training?
     
    HeathW likes this.
  3. HeathW

    HeathW New Member

    Joined:
    Mar 26, 2021
    Messages:
    3
    Likes Received:
    0
    Trophy Points:
    1
    For a little more info, the training tooling mimic parts of our system.

    Hmmmm, we hadn't thought about having the users take a quiz *before* training. Is that commonly practiced? It's an intriguing idea!
     
  4. yodon

    yodon Well-Known Member

    Joined:
    Aug 3, 2015
    Messages:
    198
    Likes Received:
    115
    Trophy Points:
    42
    Regarding training, you need to be able to assess effectiveness using methods "proportionate to the risk associated with the work for which the training or other action is being provided." You need to be able to justify why the "quiz" is demonstrating effectiveness (proportionate...).

    As far as validation of the tools go, any software used in implementation of the QMS should be considered for validation. Validation, also, should be commensurate with the risk associated with the use of the software. If failure of the tools could lead to risk (to patients or regulatory compliance) then the extent of validation should be robust. If risk is low, validation efforts can be pared down. Without knowing more about the software, it's hard to be more specific. I always recommend a Master Validation Plan that establishes your risk-based strategy.
     
    HeathW likes this.
  5. Andy Nichols

    Andy Nichols Moderator Staff Member

    Joined:
    Jul 30, 2015
    Messages:
    5,086
    Likes Received:
    2,553
    Trophy Points:
    112
    Location:
    In the "Rust Belt"
    It should be common practice, but isn't! Qualified trainers - people who really understand training adults will always tell you that pre-testing is vital.
     
  6. HeathW

    HeathW New Member

    Joined:
    Mar 26, 2021
    Messages:
    3
    Likes Received:
    0
    Trophy Points:
    1
    Thanks yodon for these gems of info from 13485. There's definitely quite a bit of subjectivity to an assessment. There's always the checkbox approach, but in this case it feels like assessing effectiveness of the training is our best approach as opposed to a tool validation for tools used only in training. I'll see what I can find in terms of a good sample for a master validation plan.