Compliant. Connected. Complete.

Tech Paper:
MasterControl Customer Complaints™

Effective Complaint Handling As a

Compliance and Quality Management Tool
Introduction
The 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 Standards

The 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 Handling

While 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.

MasterControl Customer Complaints ™ Page  Tech Paper

 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 Solution

MasterControl 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.

MasterControl Customer Complaints ™ Page  Tech Paper

 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; and
• shorter 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.

MasterControl Customer Complaints ™ Page  Tech Paper

 Figure 3 - Real-time analytics and reporting increases management oversight on the quality
system 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.

MasterControl Customer Complaints ™ Page  Tech Paper

 • 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.

MasterControl Customer Complaints ™ Page  Tech Paper

Conclusion
If 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 Customer Complaints ™ Page  Tech Paper

MasterControl Inc.
6340 S. 3000 E. Suite 150
Salt Lake City, UT 84121

P. 800.825.9117
F. 801.942.7088
www.mastercontrol.com