March 10, 2020

Regulators such as FDA, European Commission (EC), ISO 13485  require a product complaint management system that is effective for resolving product quality issues and improving patient safety. Unfortunately, manufacturers are cited regularly by the FDA and notified bodies for deficiencies in the post-market complaint handling process.

The modern approach to investigating and resolving complaints can be condensed into six core categories. Each category represents a critical component that connects the complaint process interdependencies.

1 – Collection

According to FDA 21 CFR 820 and akin to the ISO 13485 definition, a complaint is “any written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness or performance of a device after it has been released for distribution.”

Consider the type of information that needs to be collected at the intake of the complaint. Collect as much relevant information as possible—this may be the only user interaction in the complaint process. Be forward-thinking to consider the functions that will participate in the investigation.

Furthermore, consider a process for soliciting and collecting information from any non-standard communications. For example, a product has been returned to a distributor with a letter indicating an unanticipated failure. A method must exist for collecting that information from the distributor because the letter is considered the complaint source.

2 – Consistency

Incoming complaint information must be collected and categorized with uniformity. Questions must be designed to gather all information relevant to the product. Creating one set of input fields creates standardization that enables identification of similar failures, product lots and other areas needed for trending and analysis.

In addition, adverse event and recall reporting have specific guidance for exactly what information needs to be reported electronically. Be sure to partner with pharmacovigilance functions to ensure an integrated process.

The same consistency should also be applied to questionnaires, return authorizations, or anywhere product, patient and complainant information is gathered. The information must be traceable to the source and recorded contemporaneously in line with data integrity guidance.

3 – Communication

Communication on the “state of complaints” should span the enterprise from senior management to individual contributors. Developing a standard for communication tailored for each stakeholder creates accountability based on roles and responsibilities. It’s essential to promote a culture that is responsive to complaints and values effective resolution.

Additionally, the customer reporting the event should be informed of the complaint status using form letters or via online queries using a web portal.

4 – Compliance

Organizations are generally considered compliant if they can demonstrate a connected progression of qualification, investigating, regulatory reporting, communicating, correcting issues and closing complaints (and non-complaints). In other words, manufacturers must demonstrate an effective process for tracking a complaint from intake through closure.

Good training and documentation practices demonstrate that the complaint management system and regulatory reporting follow applicable regulation and GMPs. This includes built-in audit trails and electronic signatures to streamline regulatory compliance and ensure audit-readiness and timeliness.

eMDR capabilities are built right into the system to streamline the process of MedWatch 3500A submissions for reporting critical or life-threatening events. Decision trees help establish reporting guidelines and ensure that the right reports are submitted within the necessary reporting timeframe, depending on country and incident type, taking the guesswork out of compliance with regulatory agencies.

The system walks you through every step of the process, preventing any gaps in the process and ensuring a closed-loop process for ensuring compliance.

5 – Control

Negative claims about performance or safety is a strong indicator of whether a manufacturing process is in control. An effective complaint management system should evaluate risk and resolve issues as fast as possible and make each iteration of a product cycle safer and more efficient.

Any changes to a company’s processes must be controlled using appropriate change control procedures. This is especially important for determining if a complaint requires a critical change. Initially, an analysis needs to be performed to get visibility into the impact of the change. Having that data inside a single database will help better make those decisions into things that need to change.

When entering a complaint into a QMS, risk score, trending and historical data can alert as to whether the issue is high risk or if similar complaints have been logged. The data determines the type of investigation that needs to be performed and whether it’s a systemic problem where a change request is required.

6 – Configurability

Modern complaint handling requires modern technology. Siloed systems are no longer effective, as they create gaps and delays in the investigation process. Manual strategies lead to overlooked or missing information that raises red flags concerning reliability and or public health. Those gaps and delays are the stepping-stones to non-compliance.

The time it takes to close a complaint is directly tied to the amount of time spent on failure investigation and corrective actions. For example, when a CAPA system is disconnected from a complaint management system, it is likely to delay closure due to a lengthy and/or unsuccessful failure investigation. This could create uncertainty about the validity of CAPA that could be found in an audit. Even worse, a connection between multiple failures could go undetected.

An automated QMS offers a configurable complaint handling process, creates a standardized and trackable path between the complaint, the failure investigation, and the CAPA process. The system uses alerts and notifications to keep each investigation on pace and assigns the correct “next steps” every time. Consistent data (see #2) allows advanced analytics and trendspotting.


Disconnected, uncontrolled practices can derail the agility and effectiveness of a complaint management system. The speed at which product quality issues need to be resolved requires a strategic, adaptable technology that promotes visibility throughout the cycle. A configurable system enables efficient execution and provides the ability to connect unlimited quality processes for consistent data and downstream management of complaints while centralizing all information required for compliance.

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