API Q1, Management of Change & Document Change Request

[nithindsilva4u]

Hi Colleagues,
When changing a QMS Procedure affecting product quality. What will be initiated first, MOC or Document change request?

 

[lanley liao]

Hi,Nithindsilva4u, You should do a MOC if you were changing a QMS Procedure affecting product quality. otherwise, you should do a document change request. The MOC was stated clearly in section 5.11.2 of API Spec Q1, First paragraph----"The organization shall use the moc process for any of the following that may negatively impact the quality of the product:"
I hope it can help you.

 

[Dhaval Chitre]

nithindsilva4u - well, I would first go with document change notice program where I can identify that whether it will affecting on quality of product negatively or not. If it is than, next step is MOC and if it isn't than staright away no need of MOC. Document change notice program document is enough.

In your case you have to do both. MOC and Document change request.

 

[badidi]

hi, to change a document you should follow the procedure control of document it exposes the way to change or creat a document and the control of version

 

[vijay_kumar85]

Hi,Nithindsilva4u, You should do a MOC if you were changing a QMS Procedure affecting product quality. otherwise, you should do a document change request. The MOC was stated clearly in section 5.11.2 of API Spec Q1, First paragraph----"The organization shall use the moc process for any of the following that may negatively impact the quality of the product:"
I hope it can help you.

Hi Liao,

Can you advice how to identify and assessment to know the particular changes not giving any negative impact ? currently we added this check point in MOC form itself and if negative impact is "Yes" then further Risk assessment process will start else will close in Part 1 itelf.

Can you advice is it correct and if you share alternative system highly appreciable