Improving Compliance At A Global Life-Science Client
by Chris Wubbolt
Client Situation:
A large, global pharmaceutical company determined its product complaint handling program was inefficient and considered a significant compliance risk by the Global Quality Management organization. Over 1000 product complaints were past due and the existing organization did not have basic tools in place to maintain a compliant quality system. The instructions describing how product complaints were to be handled were split into 12 different, often contradictory Standard Operating Procedures (SOPs). The product complaint group did not have a method or system to track due dates for investigating and closing product complaints, and the personnel within the department did not work together as a team to assure organizational objectives were met.
The client asked us to analyze their existing processes, systems, procedures, and personnel; provide recommendations for improvement; and implement the recommendations. The project required us to meet tactical business needs (e.g., investigating and closing new and existing product complaints) as well as address strategic initiatives, such as implementing a sustainable, effective product complaint management program.
What We Did:
We first focused on assuring existing product complaints did not pose a threat to product quality or patient safety. Therefore all existing complaints were assessed and prioritized based on their potential severity. Next, we prioritized based on the “age” of the product complaint. All product complaints were entered into an interim spreadsheet that was used to track their status. 
In parallel, daily “stand up” meetings were held to discuss the status of new and existing complaints and to assure product complaint team members were working together to reduce the existing number of overdue product complaints.We then developed functional flow charts to identify the “AS IS” product complaint process. Using appropriate metrics we identified inefficiencies within the existing product complaint process, which may adversely impact product quality, patient safety, and compliance. A “TO BE” functional flow chart was developed based upon input from the various stakeholders involved in the product complaint process, including manufacturing, distribution, quality control, and regulatory affairs.
The TO BE functional flow was used to develop a single, unified SOP which defined the new product complaint handling process. The functional flow charts were also used as input into a User Requirements Specification (URS) for a computer system which was implemented for entry, tracking, trending, and reporting of product complaints. A URS is required by regulatory agencies and identifies the “intended use” of the computer system. The computer system was implemented and validated in a manner fully compliant with regulatory requirements. A second SOP was developed to describe the operation and maintenance of the computer system.
Results:
The project resulted in some pretty significant results:
- Within 4 months of project completion the product complaint backlog dropped from 1000 overdue complaints to 100 complaints (open 30 days or less).
- The myriad of existing, contradictory and non-compliant SOPs had been reduced from 12 to 2.
- A new, fully compliant computerized system was implemented to manage the product complaint process. This system later became a model for the global product complaint handling system.
- Most importantly, the product complaint team gained new work skills and practices which allowed them to sustain the levels of compliance achieved.
