August 10, 2022

From food and beverage to electronics to CPG, there’s not a single type of manufacturer that’s immune to customer complaints. While customer complaints are never something an organization wants to see, there is an upside. When utilized properly, the identification and resolution of customer issues can serve an important quality function. Quality complaint handling can go a long way in actually improving product quality as a whole within your organization.

Far too often, manufacturers view customer complaints as another burden to deal with. In other instances, companies rush to establish a complaint handling system to “check the box” in complying with ISO 9001 quality management standards. In both cases, manufacturers are reactive instead of proactive. Unfortunately, this mindset acts as a huge barrier to quality improvement.

It is vital to have an effective quality management system for timely management and resolution of issues. A robust system allows you to leverage customer feedback and turn complaints from a problem into an opportunity for improvement. This article looks at challenges inherent in complaint management, and why an enterprise quality management system (EQMS) is vital in ISO environments.

Customer Quality Complaint Handling and ISO

To appreciate the value of complaint management, you must understand why ISO 9001 and similar standards (ISO 13485, ISO 29001, etc.) require it to begin with. Many manufacturers use ISO 9001 in conjunction with ISO 10002. Standards in ISO 10002 focus on customer satisfaction and guidance for implementation of an effective complaint management process.

ISO 9001, one of the most widely used ISO standards, defines a complaint as an expression of dissatisfaction with a product or service filed by a customer and received by an organization. In the medical device industry, ISO 13485 describes the term in even more detail. It defines a complaint as a “written, electronic, or oral communication that alleges deficiencies in the identity, quality, durability, reliability, usability, safety, or performance of a medical device.” In both standards, it is made clear that it is the responsibility of the manufacturer to thoroughly address customer complaints.

5 Common Challenges of Customer Quality Complaint Handling

Manufacturers get feedback all the time, both positive and negative. However, customer complaints must take precedence over other types of feedback. Why? Complaints can indicate serious quality and safety issues. That’s why customer quality complaint handling is an essential part of compliance and key to building an effective QMS.

Every manufacturer wants to be able to resolve complaints in a timely manner. Unfortunately, that’s easier said than done. Here are some of the most common challenges manufacturers face with customer quality complaint handling. They are most prevalent in companies that use paper-based systems and/or siloed electronic systems.

1: Lack of Procedures or Inadequate Procedures

Even if your company is small, it’s best to formalize a customer quality complaint handling process. Furthermore, if you plan to get ISO certification, you’re definitely going to need written procedures. If you already have ad hoc procedures in place, you can improve the process by putting them in writing and creating an SOP. In addition, you’ll need a person or a team responsible for handling complaints.

Effective complaint procedures should include how you will receive, review, and evaluate complaints. The designated person/team should document all complaints and related activities and make the process an integral part of a quality management system (QMS). Furthermore, all employees involved in the complaint handling process should receive training on SOPs. This fosters consistent interpretation and execution of the procedures and aligns with certification requirements.

An automated QMS guides the intake, prioritization, processing, investigation, resolution, and reporting of complaints. Furthermore, a QMS can manage any change requests that result from CAPAs, as well as timely re-training.

2: Multiple Sources of Complaints

Customer complaints may come from email, phone, fax, social media, or your company’s website. In addition, sales representatives and field service may also receive feedback. One downside of using a manual system is that without a consistent reporting procedure, critical complaints may sit in someone’s inbox or voice mail without a procedure in place for gathering and processing them in a timely manner.

A big advantage of a QMS lies in the ability to provide a cohesive structure for capturing all complaints from different sources. Within the system, users can go to one single place to input complaints. Then, based on initial risk criteria, the QMS begins the routing process without any other intervention.

A QMS will help you reduce the lifecycle of the complaint process by consolidating multiple sources of complaints under a single platform. Search and retrieval of complaints, KPIs, trend reports, analytical data are available in one place. Furthermore, in the event of an external audit, all records are electronically accessible without leaving the desktop.

3: Delays in Addressing Customer Quality Complaints

Delayed responses to customer complaints can negatively impact your brand and business. Timeliness is particularly crucial for electronics and other manufacturers and suppliers in the technology space where change happens fast, and where innovation and new products can disrupt the market overnight. To remain competitive, you must be able to address quality issues in real-time.

Manual systems are simply inadequate for the time-sensitive demands of manufacturing. A paper-based process is full of bottlenecks stemming from misplaced or overlooked complaints and incomplete or inaccurate information from manual input. Unconnected systems face the challenge of information getting stuck in silos without any means for consolidation and efficient escalation.

A customer quality complaint handling solution can streamline the complaint lifecycle. A robust, automated system can provide standardized forms to avoid intake errors. Automated forms can assist your organization in helping to make sure the information is complete. An automated collection and routing process means you’ll be able to investigate and resolve quality complaints faster.

4: Ineffective Tracking of Complaints

Unconnected systems for quality management make tracking complaints a time-consuming obstacle. First, lack of visibility and human error can significantly slow down the investigation process. Second, there is no efficient means to track documentation, deadlines, and the overall status of open complaint records. Finally, the inability to triage complaints properly and consistently may cause legitimate complaints to fall through the cracks. All of these conditions create missed opportunities for correcting issues faster and at a lower cost.

If you don’t have a standard process for handling complaints, evaluate an integrated system that connects the complaint process to the corrective and preventive action (CAPA) and other critical quality processes. Managers will be able to track the status of all complaints from initiation to completion. The system will enable them to proactively assign tasks and review the current status of open complaints, therefore enabling them to address issues faster.

5: Inability to Spot Quality Trends

Manufacturers that use deprecated methods to manage customer complaints lack the ability to view trends and real-time data. Instead, most of the effort is spent collecting information (filling in forms and data entry) instead of mitigating issues.

With an automated customer quality complaint handling system, you can put all that data to work for faster and better decisions. A robust system will include analytics and reporting tools to let you view, filter, and interact with complaint data. In addition, you can categorize complaints efficiently through standardized fields, which make KPIs measurable and actionable. For example, fields can be standardized for complaint type, product category, location, department and risk level.

Choose an enterprise-wide system with the capability to draw analytics across multiple product lines and business units. Generate reports on a regular basis to gain actionable insights and increase management oversight. Analytics can help you formulate an effective strategy to mitigate and prevent customer issues from recurring.


To conclude, if your organization is ISO certified or follows ISO standards, effective complaint handling is more than just a good business practice – it’s necessary for compliance. Equip your team with the right customer quality complaint handling system. Choose a solution with advanced tools and best-practice workflows that foster consistent and effective complaint handling. With a robust system, you will be able to resolve quality problems better and faster. As important, you will be able to gain insights from customers that guides better quality issue resolution through informed decision-making.


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.

Related Reading: How an EQMS can Reduce CAPA and Complaint Observation Trends