Product Quality Complaint Rate by Product
| Definition | ‘Product Quality Complaint’ = Any complaint received that if confirmed would result in a failure to meet product specifications. This metric should count both confirmed and unconfirmed complaints of this type. |
| How to Calculate | Complaints per million (cpm) = Quality Complaints Received/ Million Units Distributed |
| Numerator = All Complaints received at manufacturer in the reporting month | |
| Denominator = Six Months Rolling Average of Individual Units Distributed containing drug product in the reporting month/one million | |
| How to Report | By Product only |
| Reporting should include both confirmed and unconfirmed complaints | |
| Firm should comment on or explain any trends observed or any seasonal effects. | |
| Unintended Consequences and Recommended Mitigation | Manufacturers might re-define Complaints vs. Inquiries. |
| Mitigation: Complaints definitions should not change in companies as a consequence of the reporting | |
| In general complaints received will be lagging compared to the product units distributed. Hence, variations in calculated results can be caused by variations in distribution pattern. | |
| Mitigation: Companies can comment on this in the reporting. | |
| Different countries have different ‘cultures’ for complaint ‘threshold’. Mitigation: The reporting is for product sold in the US only. |