Customer Complaint & Recall Record

Customer complaint and recall records document how an organisation manages product safety feedback and corrective actions throughout a product's market life. They include complaint registers (structured logs of customer complaints with product identification, issue description, severity, investigation, and resolution), field corrective action (FCA) records (formal recall or correction actions for distributed products, including affected scope, root cause, correction plan, and effectiveness verification), post-market surveillance reports (systematic monitoring of product performance, incidents, and trends after market release), and product incident reports (serious incident documentation, adverse event logs, and regulatory authority notifications). These records are the core evidence for post-market compliance obligations.

Product safety regulations require manufacturers to monitor products throughout their lifecycle — not just at the point of sale. The EU General Product Safety Regulation (GPSR) requires economic operators to have procedures for product safety incidents and corrective actions. CE marking requires post-market surveillance systems for most product categories. The EU Medical Device Regulation (MDR) mandates systematic post-market surveillance and vigilance reporting. For consumer products, complaint trends can indicate emerging safety issues that require corrective action before serious incidents occur. Documented complaint and recall records demonstrate that the manufacturer takes post-market obligations seriously and has systems in place to detect and address safety issues.

Complaint registers document each complaint with product identification, batch/lot/serial number, issue description, severity classification, investigation findings, root cause, corrective actions, and closure status — providing a complete traceable record from complaint to resolution. Field corrective action records document formal recall or in-market correction actions including scope of affected products, root cause analysis, correction plan, regulator notifications, and effectiveness verification. Post-market surveillance reports compile complaint data, incident trends, and emerging risk signals to assess whether products continue to meet safety requirements throughout their lifecycle. Product incident reports document serious incidents requiring regulatory notification — including incident timeline, root cause, corrective action, and follow-up with regulatory authorities.

Complaint logs, recall documentation, and post-market surveillance reports are uploaded to Sustalium. Evidence is linked to product safety frameworks including GPSR, CE marking, CPSIA, and sector-specific regulations (MDR, machinery regulation). Sustalium tracks investigation statuses and closure deadlines — ensuring that serious complaints are investigated and corrective actions are implemented within required timeframes. Complaint trends are monitored across product lines and frameworks, flagging potential systemic issues that require preventive action. For recall management, Sustalium tracks regulatory notification deadlines, recall completion status, and effectiveness verification — providing a structured evidence base for regulatory reporting.

The EU General Product Safety Regulation (GPSR) requires producers to have post-market surveillance procedures and to notify authorities of product safety incidents. CE marking directives require manufacturers to maintain post-market surveillance systems and to take corrective action when safety issues are identified. The EU Medical Device Regulation (MDR) mandates comprehensive post-market surveillance, vigilance reporting, and periodic safety update reports. The US Consumer Product Safety Improvement Act (CPSIA) requires reporting of product safety defects and corrective actions. The EU Machinery Regulation requires post-market surveillance for machinery products. The EU Battery Regulation mandates post-market surveillance for batteries. ISO 9001 and ISO 13485 require documented complaint handling and corrective action processes. The EU Cosmetics Regulation requires serious undesirable effect reporting.