Hello,
Most of our SOP's have who are responsible for the processes described in the SOP. However we currently don't have a Quality Manager or a Buyer. However those roles and responsibilities have been distributed so they are being met. My question is, when we get our surveillance audit is underway and our SOP's says the buyer is suppose to maintain the ASL or the Quality Manager is suppose to be in charge of maintenance of Calibrated equipment, but we dont have those positions filled. Will we be written up? and whats a way not to get written up, besides filling those positions? I thought of documenting who is charge of the responsibilities? is that necessary?
Most of our SOP's have who are responsible for the processes described in the SOP. However we currently don't have a Quality Manager or a Buyer. However those roles and responsibilities have been distributed so they are being met. My question is, when we get our surveillance audit is underway and our SOP's says the buyer is suppose to maintain the ASL or the Quality Manager is suppose to be in charge of maintenance of Calibrated equipment, but we dont have those positions filled. Will we be written up? and whats a way not to get written up, besides filling those positions? I thought of documenting who is charge of the responsibilities? is that necessary?