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srichar3

Change Control

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In the UK the MHRA who are the UK equivalent of the FDA licence all blood facilities and hospital blood banks. One area they are very big on is change control. I just wondered how much the AABB focus on this area as at the moment our laboratory does not have a specific documented process for change control. 

Thanks

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31st edition of the AABB Standards 5.1.1 Change Control:

The BB/TS shall have a process to develop new processes or procedures or to change existing ones.  This process shall include identification of specifications and verification that the specification have been met.  Before implementation,  the new or changed processes or procedures shall be validated. Stand 2.12 applies.

To show that your laboratory isn't changing things on the fly, it is important to have a controlled process in making changes.  AABB has a section on their website under the Accreditation Member Tools a Commendable Practices link.  You may be able to glean some information on how to set up a change control process for your laboratory.

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