In 2013, FDA issued a 483 to an orthopedic implant manufacturer. Although their quality systems were generally compliant, a backlog of customer complaints and incomplete investigations left the manufacturer vulnerable to additional regulatory enforcement actions. The root causes of the complaints backlog were identified as:
• There were more complaints than existing staff could handle in a timely manner
• Investigations were being performed by inadequately trained staff with poor problem solving skills
• Existing complaint handling procedures did not provide a streamlined triage process for identifying the most crucial complaints.
To make matter worse, the backlogs resulted in delays filing MDRs by their deadlines, resulting in additional FDA concerns and potential erosion of the company’s excellent clinical reputation. Under the pressure of the 483, the company scrambled to re-assign existing staff to support the complaints staff in the short term. This did not work well, however, because the existing procedures were burdensome and newly-assigned staff weren’t familiar with the MDR decision-making process.
Fortunately, the company reached out to GCI for support. We work with Human Resources departments struggling to identify short-term staff with specific technical skills. We were able to quickly identify a sufficient number of appropriately trained resources for this critical, short-term project. Our network of industry contacts and our Balanced Teams approach enabled us to place the right resources in the right places for success, at a fair price. A more senior complaints specialist assisted in the revision of the existing SOPs to incorporate a streamlined triage approach. Checklists, templates, and a decision tree were implemented to ensure consistent and thorough complaint investigation and reporting practices. The investigation team of engineers collaborated with in-house subject matter experts to identify root causes and solutions to key product and process deficiencies uncovered during the investigations, and the complaints backlog was quickly rectified. Best of all, GCI’s presence allowed the resources originally diverted from their normal job duties to return to their posts, ensuring product would continue to be developed and launched timely. At the end of the project, GCI always makes our employee engineers available to our clients for hire, so the knowledge is not only transferred, it is retained in house.