Jump to content

Featured Replies

Posted
comment_61804

Hello everyone!

 

I need to do a major overhaul of the SOPs where I work and the first one on my list is Change Management.

 

Anyone willing to share your SOP and associated forms with me?  I like to see what others are doing...

 

Thank you in advance for your help!

  • Replies 6
  • Views 2.3k
  • Created
  • Last Reply

Top Posters In This Topic

comment_61815

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

comment_61837

We don't have a separate SOP just for this (probably should), but we have a LIS "how to enter" procedure that sums up how we handle any changes in our computer system.

Change Control.doc

comment_61870

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.

CHANGE CONTROL REQUEST FORM.DOC

Create an account or sign in to comment

Recently Browsing 0

  • No registered users viewing this page.

Important Information

We have placed cookies on your device to help make this website better. You can adjust your cookie settings, otherwise we'll assume you're okay to continue.