R
820.198 Complaint files
The requirement states in part, "Complaints are evaluated to determine whether the complaint represents an event which is required to be reported to FDA under part 803 or 804 of PART 820 QUALITY SYSTEM REGULATIONS".
At what point does a Customer's call into a Service Department become a Complaint.
Does it only become a complaint if the issue being raised has caused Death, Serious Injury or the potential of Death, Serious Injury?
Or
If the Customer calls the Service Department for clarification or to schedule equipment repair or preventive maintenance, does this register as a complaint and if not does it have to be recorded?

The requirement states in part, "Complaints are evaluated to determine whether the complaint represents an event which is required to be reported to FDA under part 803 or 804 of PART 820 QUALITY SYSTEM REGULATIONS".
At what point does a Customer's call into a Service Department become a Complaint.
Does it only become a complaint if the issue being raised has caused Death, Serious Injury or the potential of Death, Serious Injury?
Or
If the Customer calls the Service Department for clarification or to schedule equipment repair or preventive maintenance, does this register as a complaint and if not does it have to be recorded?