HI John
Did you ever resolve this issue? I am in the same spot!
Change Control Decision Tree - When medical devices that are approved with a PMA
Did you ever resolve this issue? I am in the same spot!
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i am also having same issue. i appreciate your help, if you could get it sorted.
thanks.
indubioush
Ah ha!
What problem are you trying to solve, Asmatam?
Hi Indubioush, i am looking for a decision tree for when to raise change control/order and when it is only document change. thanks
indubioush
Ah ha!
Sorry, but that doesn't tell me the problem you are trying to solve.
(apologies for participating in a very old thread, but if this has come back to life...)
The simplest change control process in a Quality System "requires" only two reviewers:
Ideally, change control is not engaged until the change is ready to be made. If change control is engaged "too soon", then the roster of people under the first bullet cannot be known. No checklist of approvers will really help (construct a good change) so early in a possible change. If changes have to be pre-approved prior to doing any meaningful work on the change... a checklist might help scope the eventual change, but you would still have to revisit it at the time the change is to be reviewed and approved.
When it comes time to apply change control, the approvers should be well known based on the areas impacted by the content of change... sometimes areas are impacted by a change but are neutral on the content. In my experience: approver checklists get longer each time someone makes a change and forgets to consult with a potentially impacted department. "Always fight the last battle" as the saying goes.
The simplest change control process in a Quality System "requires" only two reviewers:
- The person(s) responsible for the area(s) affected by the change
- An independent (quality) reviewer
Ideally, change control is not engaged until the change is ready to be made. If change control is engaged "too soon", then the roster of people under the first bullet cannot be known. No checklist of approvers will really help (construct a good change) so early in a possible change. If changes have to be pre-approved prior to doing any meaningful work on the change... a checklist might help scope the eventual change, but you would still have to revisit it at the time the change is to be reviewed and approved.
When it comes time to apply change control, the approvers should be well known based on the areas impacted by the content of change... sometimes areas are impacted by a change but are neutral on the content. In my experience: approver checklists get longer each time someone makes a change and forgets to consult with a potentially impacted department. "Always fight the last battle" as the saying goes.
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