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Change Management SOP and associated forms

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Problem Form.doc



when we want to initiate a change, whoever wants to change completes a form of what they want to change and why. This is then discussed by our upper management (Medical and Administrative Directors and BB supv.  The decision is made to change or not.  This is a process control function and should be a part of your process control procedure.  I'll attempt to attach my form, but I have been very unsuccessful at doing so in the past.  The form is the major driving force behind my Quality Plan, whether it be for non-conformances, changes, MedDir allowance for going out of SOP, etc.


I have to give credit to Ellen LaChance in Bangor, Maine for allowing me to use her format for this form - generously donated to me at an AABB inspection many years ago.  See, inspections are a 2 way street of educational opportunity.

Edited by David Saikin
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Here is the change control form we use. I am not sure if we used some ideas from AABB best practices or a form we saw on the internet. We have used this for a few years... when we implemented the TANGO, changed our policy for Weak D testing, and our computer upgrade.


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