Origami Complaint Management
Medical device companies are required to have robust internal complaint management procedures, as well as to report to regulatory authorities. Companies that conform to ISO9001 are also required to manage complaints, however the process is less prescriptive.
Create your complaint procedure and link it to applicable regulatory requirements.
Record complaint information including the source, the type of complaint such as product, installation, packaging, shipping.
Determine the validity of the complaint through documented justifications and notify the originator.
Valid complaints are investigated, root cause analysis (RCA) is performed and results are recorded.
Link corrective actions to your complaints, to ensure traceability between the complaint, the causes, and the actions being taken to resolve the problems. Where corrective actions require product fixes or recalls, these records can also be linked to the complaint, for end to end management and resolution of the complaint.
Serious complaints are reported to regulatory authorities. Use Origami to ensure that your company tracks and manages your communication with authorities. Authorities are independent and will decide how complaints may be required to be corrected.
Where a complaint correction is completed by a repair or replacement or other resolution, these actions and records should be linked to the complaint, not only for traceability, but to assess the impact on your business, and to update your risk assessments.
Where a complaint arises about a third party, such as a service partner, reseller, shipper, retailer, installer or other, the involvement of the third party is recorded. Corrections or corrective actions required by these organizations are recorded, assigned and tracked to resolution, as part of the complaint management process. Your risk assessments pertaining to these third parties should also be updated with the complaint, required actions and impacts to your business.
Complaints should be linked to product risk assessments, as evidence of failures. As input to management reviews, regular reviews of product quality metrics, including issues such as complaints, provide insight into whether or not customers are satisfied, and how to make improvements.
