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Can a product deviation form be part of the change management program?

deviation change management

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Padfoot

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Posted 13 May 2021 - 06:57 PM

Hello everyone! I have a question regarding deviation vs change management. I currently have a program and form to complete for any temporary changes in process or procedures. I recently created a new form to fill out for any temporary changes, for example using a different box or shortening because we ran out of the one meant for that product. Can the product deviation form be part of the change management program or do I have to create a separate SOP for it?



SirraSingh

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Posted 14 May 2021 - 12:06 PM

Hi Dear, 

 

Both of the things are different, In product deviation you are handling the issues related with product either inhouse or from external. however, change control is for the changes control during the process or any other method. it may directly related with product or may not be. like a communication method. 

 

after a change control, the concern change will be parmanant and same should be followed in future. after this formality you will be able to update the concern SOP also. 

 

At the end, i am suggesting to create a another SOP for the change control, you may give reference into it of your temprary changes. 

 

hope your concern closed......... 



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