Hello Everybody,
I have been working in QA for 7 months now and have been tasked with updating our change control procedure. We are ISO13485 certified and also need to comply with FDA 21 CFR Part 820. We don't currently have enough controls in place with change - we are able to amend specifications, process and product without any input from QA/RA as these can be handled at departmental level so long as they don't impact on other areas.
As part of this procedure I am incorporating the following:
- Amended change classification system (minor, moderate, major/significant)
- QA review and approval of all changes
- Change control board approval for major changes
- Streamlining multiple change control procedures into one systematic procedure so we are taking a consistent approach.
However, with no previous experience I have no knowledge of how this would work out in practise. Ideally, I would like to escalate the larger changes to the change board for review and approval. This will be held on a weekly basis however I am now wondering whether this needs to be a physical meeting at all (Obviously for some it would be where resource, coordination, regulatory issues are more questionable).
As an alternative (where actions are straight forward), would it be appropriate to document the action plan within the change request form, which can then be approved electronically by QA and appropriate reviewers/impacted areas (CCB reps)? The change request form also includes reason, impact assessment, documentation, etc. and is currently already 4 pages long without the action plan. Is it standard practise to ask change initiators to document action plans with change requests? This seems like a quicker way of getting these approved.
Also, we don't currently inform our notified body of any changes we make to product/process. I have looked online but I am really struggling to distinguish between changes that require notification and those that do not. Does anybody know of any solid guidance on this, or an example decision tree/flow depicting how this decision is made in their own organisation? I'm also unsure as to "how" this communication should be provided to them, i.e. is email sufficient or should we have a controlled template for notifications to notified bodies?
I have to have this in place within 4 weeks as part of a NC so am slightly panicking now. I have come across this forum today so thought it would be worth a shot. I have tried to ask management for guidance on this but I can't seem to get a straight answer except for "it's up to you"
Thank you in advance for any help or guidance anyone can offer!
I have been working in QA for 7 months now and have been tasked with updating our change control procedure. We are ISO13485 certified and also need to comply with FDA 21 CFR Part 820. We don't currently have enough controls in place with change - we are able to amend specifications, process and product without any input from QA/RA as these can be handled at departmental level so long as they don't impact on other areas.
As part of this procedure I am incorporating the following:
- Amended change classification system (minor, moderate, major/significant)
- QA review and approval of all changes
- Change control board approval for major changes
- Streamlining multiple change control procedures into one systematic procedure so we are taking a consistent approach.
However, with no previous experience I have no knowledge of how this would work out in practise. Ideally, I would like to escalate the larger changes to the change board for review and approval. This will be held on a weekly basis however I am now wondering whether this needs to be a physical meeting at all (Obviously for some it would be where resource, coordination, regulatory issues are more questionable).
As an alternative (where actions are straight forward), would it be appropriate to document the action plan within the change request form, which can then be approved electronically by QA and appropriate reviewers/impacted areas (CCB reps)? The change request form also includes reason, impact assessment, documentation, etc. and is currently already 4 pages long without the action plan. Is it standard practise to ask change initiators to document action plans with change requests? This seems like a quicker way of getting these approved.
Also, we don't currently inform our notified body of any changes we make to product/process. I have looked online but I am really struggling to distinguish between changes that require notification and those that do not. Does anybody know of any solid guidance on this, or an example decision tree/flow depicting how this decision is made in their own organisation? I'm also unsure as to "how" this communication should be provided to them, i.e. is email sufficient or should we have a controlled template for notifications to notified bodies?
I have to have this in place within 4 weeks as part of a NC so am slightly panicking now. I have come across this forum today so thought it would be worth a shot. I have tried to ask management for guidance on this but I can't seem to get a straight answer except for "it's up to you"
Thank you in advance for any help or guidance anyone can offer!