COMPLAINT HANDLING

Regardless of the industry, complaints and adverse events are inevitable, however, it’s the handling of these events that makes the difference in terms of continual improvement and compliance. With AuditMan, you can record, track, and manage customer complaints. This includes all traceability aspects (e.g. regulatory reporting 21 CFR 803), root-cause analysis and field safety corrective actions (FSCAs and recalls).

Complaints

Both reactive and proactive customer feedback can be recorded in AuditMan and followed up. This is one of the QMS processes that affects several other processes that are centralised in the platform.

Design Change

In some cases, product complaints or adverse events lead to minor/major design changes to fix inherent design shortcomings.

Process Change

In several cases, complaints can hint to process changes such as manufacturing or quality inspection processes.

Complaint Handling

Adverse Events

Incidents and adverse events form a special kind of feedback that – if not handled appropriately – can lead to major nonconformances. AuditMan has a dedicated component for recording adverse events.

Data Analysis

It is a requirement of both ISO 9001 and ISO 13485 that issues must be analysed to reveal any negative trends. These become more evident in AuditMan.

Regulatory Affairs

Each regulatory jurisdiction has its own specific criteria for determining if an adverse event is reportable. AuditMan helps keeping track of these events.