Eight local sites with heterogeneous, non-interfaced systems which recorded the nature of complaints in different ways it difficult for Boehringer Ingelheim to track and evaluate incoming customer complaints from beginning to end. To make matters worse, a further nine sites planned to introduce new software solutions to handle complaints or to replace existing solutions.
“The increasingly global nature of sales channels and growing legal requirements meant it was essential to simplify and accelerate the exchange of information between sites,” says Project Manager Kathrin Wöhlbier, describing the challenge. What the company needed was a standardized solution for processing complaints from pharmacies, patients and the authorities and the Global Complaint Management System (GCoMS) project was therefore introduced in summer 2003.
All the necessary tools at its disposal
GCoMS was implemented on the basis of SAP R/3 4.6C standard software which handles global planning and distribution at Boehringer Ingelheim. The implementation focused on quality reporting which supports all the functions needed to develop the required application. For instance, immediate measures can be initiated, actions such as sending samples can be set in motion, and the complaint can be accurately classified according to the location, nature and cause of the defect. What’s more, with SAP Business Workflow and integration in MS Office applications such as Outlook and Word, there were no longer any barriers to more efficient complaints processing.
If a specified event occurs, SAP proactively sends the appropriate information to all relevant areas of the company by e-mail. In addition, customer letters can be generated automatically during the complaints process from a selection of Word templates. Depending on how the complaint is graded, the solution can also start the escalation process and involve all organizational units affected. This enables Boehringer Ingelheim to ensure that employees processing complaints worldwide have access to all the relevant information without delay.
To exploit the solution’s full potential for achieving improved performance and cutting costs, Boehringer Ingelheim brought consulting companies quintessenz and CetaCon on board with the aim of validating/qualifying existing software, delivering the process design and quickly implementing the solution based on this.
Business Process Excellence achieved
The globally standardized complaints management project at Boehringer Ingelheim was implemented in line with Business Process Excellence (BPE) methods. BPE calls for processes to be embedded in an overall strategic concept rather than existing in isolation and for integrative process dependencies to be taken into account when these processes are realized. The “Global Complaints Process” project was set up at Boehringer Ingelheim in summer 2003. A team of international experts began by compiling a catalog of the various requirements and the project got underway in September of the same year. After just a short time, GCoMS was up and running in Germany as early as January 2004.
“Such a rapid implementation would not have happened without using the SAP standard quality reporting tools and SAP Business Workflow, not to mention the extensive expertise of our consulting partners quintessenz and CetaCon,” explains Christoph Dechow. As project manager, Dechow and his team were responsible for technical implementation of the company’s requirements. “Working with standard software means system maintenance and the ongoing costs will remain manageable even in the future.” After a successful consolidation phase in Germany, the team embarked on the global rollout in March 2004. By the end of 2005, Boehringer Ingelheim plans to process all complaints worldwide with GCoMS.
The implementation of a standardized process for complaints management simplifies processing and evaluation enormously. When a complaint is logged in the SAP solution by a sales office, all the necessary information is added and the complaint is pre-categorized. If the pre-categorization points to a potentially critical defect that could possibly lead to a market recall, the organizational units responsible are automatically informed by e-mail. If not, the global SAP solution automatically sends the information to the appropriate production site for the affected product which then handles all further processing operations. These are logged centrally by the SAP solution. At the end of this chain, the administrator at the sales unit receives a progress update, and is then able, using the SAP solution and Office integration, to compile a report for the complainant and thereby finalize the complaint process.
Boehringer Ingelheim investigates every single complaint, determines the nature, location and cause of the defect and stores this information in the report by means of harmonized master data. Serious defects can be tackled directly with corrective actions, e.g. shutting down a machine. In addition, Boehringer Ingelheim generates Corrective Action Preventive Actions (CAPAs) from the complaints and uses these to help avoid quality defects in the future. However, these actions are managed outside the actual complaints process to avoid prolonging it further. Boehringer Ingelheim also places great value on the fact that the system employed by the SAP solution to record and process complaints meets the requirements of authorities such as the US Food and Drug Administration (FDA). A relevant action log for the complete GCoMS ensures that any amendments that occur during complaints processing are logged in accordance with CFR 21 Part 11 (US health authority regulations on electronic records).
A process of continual improvement
The global solution for complaints processing is highly beneficial to the company. Standardizing all previously utilized solutions alone has led to massive cost savings. “We reached the Return on Investment, which was calculated on the basis of an analysis of the solution’s potential, in under two years,” says Christoph Dechow.
What’s more, standardizing master data helped to significantly improve data quality. The level of information won has increased, and the company has managed to speed up local and consolidated enterprise reporting significantly. By leveraging the SAP Business Workflow, complaints processing times were reduced by 36 percent.
Defined KPI (Key Performance Indicator) systems allowed Boehringer Ingelheim to substantiate the previously calculated potential for performance enhancement and cost reduction at process level. But that’s not all. “These KPIs enable us to perform the necessary process controlling and further develop global complaints processing through a process of continual improvement,” says Dechow, looking to the future.