Complaints can come in to Medical Device companies from many different areas, including partner development companies, distributors, retailers, doctors, and patients. Despite best efforts and continuous improvements in product manufacturing and quality, receiving complaints from various sources is still unfortunately an expected reality for all companies. These complaints from create severe brand and reputational risk and need to be formally documented, investigated, tracked, and closed, often initiating other processes within quality systems such as CAPAs which will resolve the issue and/or prevent it from occurring again. Some complaints may be minor, but others may involve potential risk to patient safety or product quality and function, either of which could cause crippling damage to the company. Therefore it is critical that all complaints are properly recorded in an automated and integrated Complaints Management solution to ensure they are properly investigated and addressed, and any other follow up activities are initiated and tracked.
By implementing an automated Complaints Management Solution, the organization can ensure that all complaints are captured, investigated and tracked to resolution, to the satisfaction of all stakeholders, including the regulatory agencies. By being able to conduct trend analysis of complaints in one facility, preventative actions to be put in place in other facilities, ensuring that the same issues are not repeated elsewhere.
Automated forms, business rules and a dynamic workflow engine make up the basis of the QUMAS best practice Complaints Management Solution process, allowing for an action plan to be created and executed to the satisfaction of the complainant. Correspondence and audit trails are continuously recorded throughout the process so that all stakeholders are continuously aware of the status of the complaint. The ability to deliver a preconfigured report on the issue also removes the scramble to gather information necessary in making sure regulatory agencies are kept up to date.