Customer Complaints are written, electronic, or oral communication regarding alleged deficiencies in the identity, quality, durability, reliability, usability, safety, or performance of a product offered by CENTOGENE. These complaints may concern products that have been released from CENTOGENE’s control or relate to services that impact the performance of such products.
Each employee from CENTOGENE can potentially receive a complaint from a customer via personal communication, over phone, fax, regular mail (post), or via email. Each employee is responsible that those complaints are immediately forwarded (within 24 h) to the Customer Support department (customer.support@centogene.com) providing a detailed description of the issue.
Customer Support gathers and monitors all information related to patient safety and customer satisfaction, which may include feedback or complaints concerning CENTOGENE’s products and services. Customer Support or the employee in contact with the customer answers the customer that the complaint was received and is being processed. Internally, a Quality Event is initiated to document the initial information and description.
All relevant details are entered into the event. The information is assessed to determine whether it is feedback or a complaint.
In the case of valid complaints, the issue will be investigated and resolved by providing the Customer Support with the necessary actions to address the complaint. During the investigation a root cause analysis (e.g., 5-Why, Ishikawa) and risk analysis is conducted, and determined whether the in vitro Diagnostic Medical Device (IVD*) complained about was the cause of the complaint. Additionally, it is examined if other IVDs, processes, pieces of equipment, patient samples, etc. are affected by the issue and whether there have already been previous complaints with the same issue.
After the root cause was determined, immediate actions/corrections are taken and strategies and actions aimed at preventing future occurrences or reducing the frequency of the issues are developed.
If the complaint is or could be affecting IVDs and might be a reportable event, the Person Responsible for Regulatory Compliance (PRRC) and the Quality Management Representative (QMR) are informed immediately – at latest within 1 business day after becoming aware of that complaint.
To determine whether the event might be reportable, the following is considered:
Upon receiving the appropriate resolution, the Customer Support communicates this with the customer and completes the event documentation.
On request, an 8D Report can be issued.
As a last step it is decided whether a Corrective Action and Preventive Action (CAPA) is required according to defined criteria and the event is closed.
*IVD: Includes CE-marked IVDs and in-house IVDs (LDTs)
Complaint received → Answer to customer and event opened → initial assessment (feedback/complaint) → Investigation and risk evaluation including root cause analysis, risk analysis, and immediate actions → IVD reporting decision → Complaint resolution → CAPA decision and event closed
