Tuesday, May 26, 2009


Management Issues: QUALITY REPORTING

A screen shot of software in use showing the field for complaint intake information.


Effectively Manage Your Quality Complaints

How to handle complaints, investigations, and adverse event reporting

Q uality is an ever-growing problem in the fields of pharmaceuticals, medical devices, medical diagnostics, and biologics, and its negative impact significantly affects manufacturers as well as their patients, employees, and investors. Furthermore, as the world's dependence on medicine increases-along with the trend toward pervasive personalized medicine-the reins of quality become harder for many firms to hold on to. While this is partly due to poor products, much of the problem arises from the inadequate quality of manufacturers' reporting infrastructure.

It is true that regulatory bodies across the globe impose regulations and guidelines for manufacturers to follow for managing, reporting, and resolving complaints, investigations, and adverse events. Unfortunately, many companies simply haven't invested heavily enough in their quality staffs, systems, and procedures to ensure quality products and practices. This situation has to change in order to better protect patients, manufacturers, and investors. The best solution involves better testing, higher quality manufacturing, and a holistic quality management program across the entire product development life cycle.

Incident Management Challenges

Life sciences manufacturers-whether they produce drugs, devices, diagnostics, or biologics-introduce products to their target market once they have received the proper regulatory approval, a step that typically follows more than 15 years of diligent research, development, and testing. While this approval indicates that the product is safe or medically necessary to a target population, negative incidents can result from the use of accessories and processes related to the product itself, including its formulation, labeling, delivery, or packaging, among other possibilities.

These complaints come to manufacturers through call centers established to handle customer issues, via the company's Web site or e-mail address, or from field service during on-site visits by the vendor. By law, manufacturers and service providers are required to have a quality management program in place to act on such problems, but many of these so-called programs are disjointed, fostering inconsistencies and information flow breakdowns. Without a centralized system and processes, critical information can easily be lost or mismanaged. And let's not forget just how serious the implications of erroneous quality management can be to all constituents involved.

When a centralized, automated, and fully integrated quality management process and reporting system is not in place, many issues arise that put a serious strain on a company's quality management efforts. These challenges can result in some very serious consequences. Ineffective quality monitoring of complaints, investigations, and adverse event reporting, as well as decentralization of systems and procedures, can lead to the following:

  • Poor data quality: Inconsistent and incomplete reporting of adverse events, coupled with inadequate links to a company's corrective and preventive action (CAPA) system, make proper and accurate information sharing difficult. This can lead to data inconsistency, preventing relevant departments from benefiting from the information. It can also cause confusion with regard to which incidents are reportable as adverse events.

  • Inefficient response and reporting: Slow and redundant workload can delay corrective and preventive action efforts and stall closure of investigations.

  • False findings: Failure to properly investigate and determine the root cause of the complaint or adverse event can result in false findings, leading to inadequate corrective or preventive action.

  • Inadequate corrective and preventive action: Data for trending and reporting to identify improvement areas are used ineffectively.

The negative impact of these mistakes can lead to serious outcomes, including patient harm or death, product withdrawal, and negative financial and brand impact to the organization.


To curb this trend toward inconsistent and insufficient quality monitoring practices, regulators across the globe have published regulatory guidances and imposed regulations for quality management. Chief and most pervasive among the regulations is the U.S. Food and Drug Administration's 45 CFR part 46, which ensures protection for human research subjects. Under this regulation, manufacturers in the life sciences field must report all "adverse events that are unanticipated problems and unanticipated problems that are not adverse events," according to the Office for Human Research Protections and the Department of Health and Human Services.

For an event to be deemed an unanticipated problem, it must be unexpected, must be related or possibly related to participation in the research, and must suggest that the research places subjects or others at a greater risk of harm than was previously known or recognized. If the event meets all three of these criteria, then it is considered unanticipated and must be reported.

Most Common Drug Quality Complaints

A ccording to the Food and Drug Administration's Center for Drug Evaluation and Research Facts and Figures for fiscal year 2006, the following were the most common drug quality complaints and adverse events reported:


When a centralized, automated, and fully integrated quality management process and reporting system is not in place, many issues arise that put a serious strain on a company's quality management efforts. These challenges can lead to some very serious consequences.

Other policies exist within each industry subset. In the pharmaceutical industry, the FDA mandates that each company must have a system for implementing corrective and preventive actions resulting from the investigation of complaints, product rejections, non-conformances, and so on. It also requires a structured approach to the investigation process, with the objective of determining root cause, as noted in the FDA's May 2007 guidance document, "Pharmaceutical Quality System." In the medical device industry, there is a medical device reporting (MDR) regulation that requires the filing of an MDR whenever an adverse event occurs for products undergoing remedial action.

The biologics industry also has regulations for quality monitoring. The Bioresearch Monitoring (BIMO) Program was created to monitor all aspects of the conduct and reporting of FDA-regulated research. Given these and a number of other regulations and guidance documents, it is easy to see the challenges manufacturers face in maintaining quality management of their products.

The violation of each of these regulations triggers a warning letter from the governing body to the manufacturer, containing instructions on how to become compliant with regard to the specific complaint or adverse event. Depending on the severity of the event and its ubiquity, a warning letter can go as far as initiating a lawsuit, requiring product recall, or recommending post-marketing surveillance, further data research, or the conduct of a phase IV trial, among other possibilities. In the ideal scenario, all of these warnings would be tied directly into the manufacturer's CAPA system so that the company could develop a corrective action plan to address the violations and prevent any future complaints or adverse events.

Software One Solution

Fortunately, there are comprehensive quality management systems available to automate all of these functions and requirements for manufacturers. These software programs can provide a centralized, consistent, and standardized intelligent mechanism for recording, tracking, and trending customer complaints, investigations, and adverse event reporting according to regulatory standards.

Recently, many companies have received warning letters for inconsistencies in their quality management procedures as well as for failure to properly investigate and determine root causes for complaints and adverse events. Companies have also been warned for having deviant processes set up to decide what is reportable as an adverse event and what is not, for late closure of investigations and submission of regulatory reports, and also for inadequate links to a CAPA system. The impact of these deficiencies on any company-and their potential effect on the people who use the company's products-can be quite substantial in this industry.

A screen shot of complaint tracking software showing the field that allows users to show complaint frequency in a pie chart.

A qualified quality management system helps a manufacturer by automating and streamlining all complaint, investigation, and adverse event-related issues across the organization-with centralization of data. This system keeps the company compliant with ever-increasing regulations, ensures patient safety, maintains a strong bond with customers and the public, and avoids litigation.

By implementing a Web-based quality management system, organizations can avoid these problems and, at the same time, improve overall data integrity and consistency, increase work flow efficiency and precision, keep patients safe and investors satisfied, and maintain a positive relationship with customers and the public at large. In short, these systems help life sciences manufacturers avoid negative publicity and maintain credibility in the eyes of the public because potential problems are caught and handled immediately upon receipt.

More specifically, here are the many areas in which a quality management system can help an organization.

  • Compliance: Within 15 to 30 days of a complaint of adverse event notification-depending on event severity and type-the manufacturer must report the incident to the regulating bodies. Having a centralized, standardized, and compliance-adhering system to help automate this process makes it far easier to remain compliant, both externally and internally.

  • Safety: Quality lies at the very core of product safety-safety in development and consumption/utility. Moreover, without timely, high quality data, safety resolutions can be less than optimum and may even lead to serious harm. An integrated quality management system ensures data integrity and consistency through secure entry, validation, and integration with other systems such as electronic data interchange or enterprise resource planning. This standardization enables timely and accurate complaint and adverse event assessments, structured root cause analyses, and appropriate corrective and preventive actions.

  • Workflow performance: The right quality management system can help ensure workflow efficiency, consistency, and precision across the organization. No more ad hoc reporting and tracking of complaints and adverse events. These items are immediately captured and put into a strict, pre-set, government-compliant system with clear standard operating procedures. This ensures proper and timely performance across the workflow life cycle, from complaint notification and assessment to investigation, regulatory reporting, root cause analysis, corrective action, preventive action, and effectiveness check.

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