All quality-related complaints, oral or written, should be recorded and investigated under a written procedure. Complaint records should give the complainant's name and address; the name, title where relevant and phone number of the person submitting it; the nature of the complaint including API name and batch; the date received; initial action with dates and who took it; follow-up action; the response sent with its date; and the final decision on the batch. Records should be kept to evaluate trends, product frequencies and severity so that further or immediate corrective action can be taken. A written procedure should define when a recall should be considered and should name who evaluates the information, how a recall starts, who is informed and how recalled material is handled. Where the situation is serious or could threaten life, the relevant local, national or international authorities should be told and their advice sought.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.