Customer Quality Management: How the QMS Can Help

Customer complaints are a fact of life in any industry. Even though manufacturers would prefer not to receive any complaints, they do come with a silver lining. Managed effectively, they play an important role in improving your products and processes over time.

That is, for companies that take a proactive stance on customer quality management.

The problem is that too many companies take a “check the box” approach aimed solely at complying with regulations or standards such as ISO 9001. But if you’re just doing it to meet requirements, rather than in a genuine attempt to learn from complaints, you won’t be able to benefit from the hidden insights they reveal.

By establishing robust customer quality management processes within an automated quality management system (QMS), however, manufacturers can use complaints to their advantage.

Below, we look at how an automated quality management system (QMS) can help companies both ensure compliance and use complaints to improve their products, exploring topics such as:

• Common challenges in customer quality management
• Benefits of using a QMS for complaint handling
• Defining your complaint handling process in the QMS
• Leveraging data to improve product quality

Watch a free webinar on Document Management Best Practices for Life Sciences

Top Challenges in Customer Quality Management

Complaints can be an indicator of serious issues impacting product safety and quality. At the same time, creating an effective complaint management process is easier said than done—especially if you rely on paper-based processes or spreadsheets to manage quality.

Some of the top challenges in these companies include:

• Inadequate procedures: It’s not unusual to see FDA warning letters citing companies over lack of or inadequate complaint management procedures. Manufacturers using ad-hoc complaint procedures need to formalize them as part of a standard operating procedure (SOP). You should also establish a team or individual in charge of handling complaints, and ensure your team receives training on the complaint handling SOP.
• Diverse sources of complaints: Customers may lodge complaints in any number of formats, whether it’s email, phone, website forms, or social media. Some complaints may even provide negative feedback to field service representatives. The fact that complaints can sit in so many different places can make them difficult to track and handle in a standardized fashion.
• Delayed response: Manual tracking systems can lead to lost or forgotten complaints, as well as incomplete information. Because there is no way to consolidate complaint intake, this can hamper the timeliness of your response.
• Lack of visibility into complaint status: Poor tracking of complaints can slow down investigation and corrective action, allowing product issues to snowball into potentially larger—and costlier—problems.
• Poor use of data: Complaints provide valuable data that can be used to improve products, but with manual processes, much of the effort is focused on manual data entry. Lack of standardization can make it hard to identify trends and risks that need proactive attention.

Complaint Handling Regulations and Standards

Multiple regulations and standards address complaint handling, making customer quality management particularly important from a compliance perspective.

The U.S. Food and Drug Administration (FDA), for instance, requires formal complaint handling processes for both pharmaceuticals (21 CFR 211.198) and medical devices (21 CFR 820.198)

ISO 9001 and related standards such as ISO 13485 for medical devices also require that manufacturers:

• Proactively seek feedback from customers
• Evaluate customer satisfaction data
• Ensure management review of customer feedback, including complaints
• Have a process for monitoring, documenting, and reviewing complaints, as well as analyzing them to ensure corrective action when products don’t meet customer requirements

While ISO standards don’t explicitly state what the complaint handling process should be, it’s clear that the organization expects manufacturers to make it a priority. After all, ensuring products meet customer expectations gets to the heart of why ISO 9001 was created in the first place. To that end, ISO has published a separate standard, ISO 10002, that provides manufacturers with guidelines for the complaint handling process in particular.

Benefits of Using a QMS for Customer Quality Management

Disparate systems and siloed data are both huge contributors to ineffective customer quality management. By implementing an automated QMS with built-in tools for complaint management, companies can:

• Boost compliance: A solution based on industry best practices that supports ISO and regulatory compliance helps ensure audit readiness to avoid findings related to complaint management. An automated system demonstrates to auditors that you have a standardized approach to managing customer quality issues, and that problems aren’t likely to slip through the cracks.
• Streamline the process: An integrated QMS will allow you to create a closed-loop process from intake to review to resolution. This accelerates the process by removing manual handoffs and waiting time as complaint tasks are automatically routed to the next step and responsible individual.
• Improve visibility: A centralized system for monitoring complaints provides full visibility into where problems stand, so that complaints aren’t overlooked. Manufacturers get a bird’s eye view into open complaints and their risk level, so that high-risk complaints are prioritized accordingly.
• Ensure accountability: Built-in workflows get the right information to the right people at the right time. Teams can set due dates to ensure timely response, with escalations to managers when people don’t complete required tasks.

Defining Your Complaint Handling Process in the QMS

If you don’t already have a formal complaint handling process, a QMS can provide ready-to-use forms and best practice workflows that will give you a starting point. Those who already have an established process can create configured workflows that align with that process.

This process should, at a minimum, cover the following steps:

1. Intake: Collect all relevant data for investigation and analysis, using standardized forms to ensure the consistency of complaint data throughout the process.
2. Review: At this stage, the QMS can help you triage complaints to determine which require investigation, which ones are reportable for regulatory purposes, and which do not meet the criteria for a complaint.
3. Investigation: Valid complaints are routed to investigation based on risk thresholds and complaint type. Manufacturers can designate specific tools to use within the investigation, such as a 5 Whys or 8D.
4. Reporting: Your workflow should include guidance such as decision tree analysis to determine if the event should be reported to regulators, ensuring the report is submitted within the required timeframes.
5. Corrective action: The complaint record should link to any corrective actions taken as a result of the investigation. Establishing due dates, responsible parties, and escalation rules can help keep the process moving forward in a timely manner.

QMS Customer Quality Management Must-Haves

Complaint management is fast becoming a centerpiece of Quality 4.0 as manufacturers seek to modernize their operations and bring them in line with digital transformation initiatives. The question then becomes, how do you evaluate a customer quality management solution, and what functions are most essential?

At a high level, companies should look at three key elements, which we discuss below.

Efficiency and Integration

The QMS should streamline the complaint handling process from start to finish via functions such as:

• Integration: A fully integrated solution will allow you to link complaints to related processes such as corrective action, change management, document management, and supplier quality management.
• Flexible workflows: The QMS solution should provide unlimited drag-and-drop workflows you can configure to individual groups, roles, or employees, without the need for additional coding or validation.
• Risk management: The ability to add a risk assessment to complaints allows you to identify high-risk issues so they can be prioritized appropriately.

Reporting and Metrics

Customer complaints provide numerous data you can use to improve your products and processes. The QMS should help capture this data and present it in a way that makes it easy to use.

Dashboards configured by role or user, for instance, can show open tasks that individuals need to complete, while a manager’s dashboard might show high-level metrics for tracking complaints plant-wide.

The QMS should also make it simple to track performance metrics, identify patterns, and monitor trends, such as:

• Complaints associated with individual components, lots, or suppliers
• Complaints by cost center, location, division, and business unit
• Drill-down capabilities to view trends in products and problem types over time

Compliance Features

If you’re in an FDA-regulated industry such as medical device or pharmaceuticals, you’ll want to make sure your QMS has robust compliance features such as:

• Decision-tree evaluation of complaint reportability and regulatory reports to ensure you’re submitting the right reports at the right time, including for the U.S., EU, Canada, and Australia
• Direct eMDR submission for MedWatch 3500A adverse event reports, with data formatted, validated, and submitted automatically to the FDA.
• Time-stamped audit trails and electronic signatures compliant with 21 CFR Part 11
• One-click report generation to streamline FDA, ISO and other types of audits

Conclusion

Customer quality management represents an ongoing challenge for manufacturers looking to differentiate themselves in today’s evolving global marketplace. Manual methods of tracking complaints and issues are no longer enough to keep up, leading to the rising adoption of QMS-based complaint tracking. With the right solution in place, manufacturers can use complaints to improve visibility and customer satisfaction, leveraging customer quality issues downward in the long run.

Download a free brochure on AssurX Complaint Management to learn how to improve complaint handling processes

About the Author

Stephanie Ojeda is Director of Product Management for the Life Sciences industry at AssurX. Stephanie brings more than 15 years of leading quality assurance functions in a variety of industries, including pharmaceutical, biotech, medical device, food & beverage, and manufacturing.