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RE: RE: RE: sop of change control Contribution from Chris Barnett written on 7/19/2008 at 12:14
Original contribution: RE: RE: sop of change control written by JD Mallet on 7/16/2008 at 09:41) Why do we control changes? In order to demonstrate that we are operating under a "state of control". It doesn't really matter WHO classifies changes, and in fact different departments may classify changes in quite different ways.
The important things are that:
a) Someone proposes a change, and justifies it based on sound business principles (open a change request)
b) All interested persons are identified - Manufacturing, Engineering, QA, QC, Logistics, Finance, Regulatory, Human Resources etc etc etc
c) The identified interested persons each assess the IMPACT of the proposed change, both on their own work and on what they believe other departments' work to be.
d) The impacts are discussed and agreed
e) Someone (usually Regulatory) verifies that the change either does or does not impact on any registration - factory licence, product licence, national safety approval, pollution control licence, a customer's requirement etc etc etc
f) Someone is identified as being responsible for carrying out the work to prepare for the change - writing a new SOP, building a new plant, installing a new coputer system, recruiting a new team etc etc etc.
g) Someone is identified as being responsible for approving, qualifying or validating the change, and generally making sure that the agreed work was completed.
h) If necessary, someone (often Regulatory) sends the relevant documents in to the relevant authority, or to a customer
i) The person identified as responsible for the change tells management that ALL the work has been completed, and someone (usually regulatory)confirms that ALL the permissions have been obtained.
j) IMPLEMENT THE CHANGE!!!! (and close the change request)
k) some weeks or months later, someone goes back and reviews whether or not the change was effective, cost savings were achieved, efficiency was improved, business continued as normal etc.
It is up t the company and the local competent authority whether they want to make a particular department responsible for any individual part of this process. Normally in Europe, the QP would need to be aware of any changes that affect any of the site or product licences, for example, some companies put a lot of the oversight onto QA's shoulders. You need to make up your own mind!
Chris
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