mastercontrol customer complaints™: effective complaint handling as a compliance and quality...

Compliant. Connected. Complete. ™

Tech Paper:MasterControl Customer Complaints™

Effective Complaint Handling As a Compliance and Quality Management Tool

MasterControl Customer Complaints ™ Page � Tech Paper

IntroductionThe importance of customer complaints lies in the fact that every business exists because of its customers. Complaints and other feedback from customers offer a gold mine of information, which a company can turn into opportunities. For FDA-regulated and ISO-certified companies, complaints may indicate serious safety and quality issues, and their effective handling is not just a matter of good business practice but compliance.

The Food and Drug Administration, which regulates consumer products amounting to more than $1.4 trillion a year, considers consumer complaints an important alert system. The FDA can’t be everywhere at all times, so by necessity, it must rely partly on the public to help monitor the safety of food, drugs, medical devices, and other products that the agency regulates.

Although adherence to ISO standards is primarily voluntary, complaints are just as critical to ISO-certified companies. These organizations know that business is not just about selling products and services. They must assume responsibility for product quality and safety to earn customers’ trust and to succeed in the global market. In certain countries, ISO standards have been incorporated into law, making ISO conformance a regulatory requirement in those jurisdictions.

Regulations and StandardsThe FDA’s Quality System Regulation outlined in 21 CFR Part 820 requires medical device manufacturers to establish and maintain procedures for receiving, evaluating, and investigating complaints by a formally designated unit (Sec. 820.198).

The Current Good Manufacturing Practice regulations (CGMP) outlined in 21 CFR Parts 210-211, which cover drug and biologic manufacturers, require establishment of a procedure for reviewing and evaluating complaints about drug products (Sec. 211.198). The CGMP requirements for blood and blood components found in 21 CFR Part 606 also require maintenance of records of complaints of adverse reactions, a thorough investigation of each adverse reaction, and a written report of the investigation (Sec. 606.170). All three sectors (medical device, drugs and biologics, and blood/blood components) are mandated to report to FDA any complaints concerning death, serious injury, or adverse reaction.

Companies registered to ISO 9001:2000 and ISO 13485:2003 are similarly required to gather, examine, and investigate customer feedback and complaints as a way of monitoring problems pertaining to product quality.

Manual or Hybrid Complaint HandlingWhile the importance of customer-complaint management in attaining regulatory compliance is clear, implementing a system that is effective and efficient is far from simple. It may be especially challenging for companies that rely on manual or hybrid systems. Here are some of the common problems associated with such systems:

Lack of Standard Procedure – Customer complaints come from different sources (e-mail, phone, fax, letters, corporate Web site, sales reps, etc.) and are often addressed by different personnel. Without a standard mechanism to gather and process data from different sources, complaints may languish in someone’s “in” box or voice mail. Worse, complaints may get lost. Tracking complaints manually from unconnected sources is likely to be time-consuming and ineffective.

Unwarranted Legal Exposure – Without an effective tool for capturing data from complaints in a timely manner, the documentation required for regulated companies may fall through the cracks and correction of the problem delayed. Record keeping may be inadequate for the purpose of responding to a product liability lawsuit. Both the delay and the poor documentation of the steps taken by management to resolve the complaint could serve as ammunition for the opposing party in case of litigation.


Figure 1 - MasterControl Customer Complaints automates and integrates complaint handling with other quality processes to ensure the system is always ready for FDA inspections and ISO audits.

Inefficiency – A manual system is likely to be plagued by bottlenecks: misplaced or overlooked complaints coming from disparate sources, incomplete information, lack of follow up, and inadequate response. All of these can result in delayed and ineffective complaint resolution.

Lack of Customer Access – In a manual, decentralized system, a customer may have to talk to different departments before reaching the person with the proper authority to act on a complaint. This is a sure way to frustrate and push away customers, whose information may help prevent future complaints. FDA-regulated companies with inaccessible customer-complaint systems are likely to hear from the FDA itself since consumers and health care professionals may report product-safety and quality-related complaints directly to the agency.

Lack of Management Oversight and Strategy – Without the ability to track complaints and monitor resolutions, it is practically impossible for an organization to formulate an effective strategy for future complaint resolution. Managers who are unable to see the “big picture” are simply not equipped to fully understand customer concerns and prevent the issues that led to the complaints.

The MasterControl SolutionMasterControl Customer Complaints™, an integrated part of the MasterControl™ quality management suite, automates and manages the complaint-handling process in an efficient and cost-effective manner. Here is how MasterControl addresses key challenges in complaint management.


Figure 2 - MasterControl Customer Complaints incorporates a best-practice process in a pre-configured, multi-page form that automatically moves through the internal investigation step, and culminates with a resolution of the issue.

Sustained Compliance - MasterControl helps FDA-regulated and ISO-certified companies attain and sustain compliance by optimizing the complaint-handling process, speeding up complaint resolution, and keeping the overall quality system always ready for FDA inspections and ISO audits.

Increased Efficiency Through Automation and Standardization: MasterControl automates all tasks pertaining to customer complaints, including data collection, notification, follow-up, and escalation of overdue tasks. Standardization allows for:

proper logging of complaints;capture of complete information from across the enterprise, regardless of who gets the complaint;timely investigation;coordinated resolution; andshorter complaint (submission-to-resolution) lifecycle.

Simple Three-Step Process: This best-practice process is incorporated in a pre-configured, multi-page form that starts with the processing of a customer complaint, automatically moving to the internal investigation step, and culminating with a resolution of the issue.

•

•••••

•


Figure 3 - Real-time analytics and reporting increases management oversight on the qualitysystem and demonstrates appropriate control to regulatory agencies.

Centralized Repository: All documents related to customer complaints will be stored in a secure, centralized repository, making it easy to track them, and to retrieve them during an FDA inspection or an ISO audit.

Analytics and Reporting: MasterControl’s advanced analytics and reporting capability increases management oversight and demonstrates appropriate control to regulatory agencies. The solution includes the following customizable reports:

complaint summary; in-process complaints; complaints categorized by type, product, and department; trending categorized by complaint type, product, and department.

MedWatch Form: A customer complaint may turn out to be the reporting of an adverse event, which comes with its own set of regulatory requirements. This solution includes the FDA’s MedWatch 3500A form for mandatory reporting of adverse events, allowing a seamless handover to an adverse events specialist while ensuring that required data is immediately collected.

Solid Audit Trail: For companies covered by the FDA’s 21 CFR Part 11, MasterControl provides a secure, time-stamped audit trail as required by the regulation. MasterControl documents the identity of anyone who creates or modifies an electronic record, when the action occurred, and the changes made.

•

•

••••

•

•


Revision Control: MasterControl provides automatic revision control to ensure that only the current version of a document is available. When a user makes a change in the InfoCard (the MasterControl tool that provides basic information for every record), the user must enter a reason for the change. The software tracks all changes made to the InfoCard.

Integrated Quality Management Suite - MasterControl connects the customer-complaint process with other quality processes for holistic and more effective quality management.

Easy Access: MasterControl is Web-based so it can connect employees, customers, suppliers, and others involved in the customer-complaint process regardless of location.

Integrated Quality System: MasterControl connects complaint management to the rest of the quality system, providing links to corrective actions and adverse-event handling.

Integrated with other Systems: Via an external link, this solution can be integrated with other computer systems. For example, a link can be provided on a company Web site, within a CRM application (or any application that supports URL links), so employees, customers, or partners can easily initiate a customer complaint. This connectivity will help managers track a complaint from initiation to completion and give them the ability to proactively improve the complaint-handling process.

CAPA Integration: MasterControl provides the option to integrate customer-complaint handling with the corrective and preventive action process to automatically escalate any serious quality problem.

Enterprise-wide Solution - MasterControl can handle every department’s forms-based processes, making it an ideal enterprise-wide solution.

Integrates with Other Applications: MasterControl can integrate with other applications like ERP, LIMS, accounting, and human resources applications to connect not only these applications but more importantly the employees working in these respective departments.

Easy to Search: A standardized Google-like search window is available throughout the application, which means all authorized users throughout the organization can search and retrieve customer complaint-related tasks and documents.

Easy to Find: MasterControl’s Organizer, similar to Windows Explorer, is an easy-to-use tool that helps users find and access documents quickly. Every department can maintain its own Organizers and documents can be stored in multiple Organizers. System administrators can control and automatically update the documents through a dynamic link in the InfoCard.

Automation of Forms-Based Processes: Any forms-based process unique to a department (i.e., PTO forms for HR, customer satisfaction survey forms for Customer Service Department) can be automated. A department can keep the look and function of existing forms or create entirely new ones.

•

•

•

•

•

•

•

•

•


ConclusionIf handled properly, customer complaints can be turned into opportunities for quality improvement, and unhappy customers can be transformed into loyal ones. For FDA-regulated and ISO-certified companies, complaint management takes a higher level of importance and urgency because it’s a requirement for compliance.

Given that complaint handling is necessary for both compliance and for continuous quality improvement, organizations should take advantage of the latest technology to optimize customer-complaint management and to make it an integral part of the quality system. It makes good business sense for regulated companies to focus on the long-term value of an effective complaint system and to maximize its potential as a compliance and quality management tool. About MasterControl Inc.MasterControl Inc. has been at the forefront of providing quality management software solutions since 1993. Hundreds of companies worldwide use MasterControl to help ensure compliance with FDA regulations such as 21 CFR Parts 11, 210-211, 820, 606; ISO quality standards such as ISO 9000, ISO 13485, ISO 14000; and Sarbanes-Oxley Act requirements. In addition to providing off-the-shelf products, MasterControl also offers comprehensive technical and customer support, including product training, implementation, and validation services.

For additional industry white papers about automating quality and regulatory processes, visit www.mastercontrol.com, or call, 800-825-9117.

© 2006 MasterControl Inc. All rights reserved.

MasterControl Inc.��0 S. �000 E. Suite 1�0Salt Lake City, UT 8�1�1

P. 800.8��.911�F. 801.9��.�088www.mastercontrol.com

mastercontrol customer complaints™: effective complaint handling as a compliance and quality...

Documents