A complaint from an end or intermediate customer may occur when something goes wrong and a defect is found in the product or service.

Complaints can concern any aspect of the drug or device, from a packaging defect to an unexpected reaction during use.

Complaint Management is part of the Good Manufacturing Practice (GMP) and is subject to inspection by regulatory bodies. It therefore requires a great deal of attention and adequate documentation.

Beyond this regulatory aspect, however, complaints management can also represent a competitive opportunity for Life Science companies. Through the Quality Risk Management approach, companies can put in place a robust and dynamic quality control system.

Moreover, the transversal management of complaints throughout the company can lead, with the support of digital systems, to greater awareness and involvement of internal stakeholders in a process of continuous improvement towards the quality and productivity of the company.

Handling complaints

Complaint management, as we have said, requires a lot of attention, a robust quality control system and supporting documentation. This enables comprehensive investigations to be carried out in order to achieve, if the defect is confirmed, prompt corrective action, such as withdrawing the entire batch from the market, and preventing problems from recurring in the future.

Complaints management is also subject to inspections by regulatory bodies. In spite of the existing guidelines outlining the way forward, there are still many Warning Letters issued by the FDA for poor complaint management.

Receiving and managing a complaint is the responsibility of the Quality Assurance department, which acts as a bridge for external stakeholders, to whom it must provide a response regarding the complaint, and for internal stakeholders, who it must interview and involve, especially during the investigation phase, in order to determine the root cause of the problem and organise response activities.

Continuous improvement through digital technology

Having centralised and organised documentation greatly facilitates the investigation phase of the complaint. This phase is divided into two parts: Document Analysis and Laboratory Investigation.

In analysing the documents, the QA team checks whether there have been previous complaints about the same batch and, if so, what the response was. If there have been no complaints, QA checks batch records for a deviation or non-compliance and then proceeds in greater depth to trace the root cause for a confirmed complaint or declare it unconfirmed. The investigation may also involve external suppliers, in the case of different packaging colour, for example, the root cause may be found in the supplier’s production process.

Having a centralised digital system for the whole company means that it is possible to trace back the related processes and all the documentation produced together with the owners and activities carried out, simply by searching for the batch number. This drastically reduces the search time, and at the same time, also increases compliance. With a centralised digital system, the documentation produced for the complaint remains archived and protected, accessible to authorised persons for potential requests during inspections and future investigations, as well as facilitating the final response to the customer and the extraction of KPIs.

Another difficulty that a digital system solves is the direct involvement of departments with assigned tasks. Indeed, there is often a tendency to rely solely on the Quality Assurance department to carry out the complaints process, when it actually concerns the whole company in terms of both cooperation during the investigation phase and any subsequent corrective and preventive action.

An opportunity for improvement here lies in the accountability of the whole company to the quality control system.

Risk Management as a Product Lifecycle Document

Using risk-based management to handle complaints can provide an opportunity for continuous improvement. When we launch a product we also create a risk management document containing the probability and severity of potential incidents that could occur when the product is on the market.

When we receive a complaint or even feedback, in addition to managing it, it is important to go back to that document and discuss with the people involved whether elements have been underestimated, overestimated or not considered. This discussion may, for example, reveal the need for further action beyond complaint management, such as opening a Change, conducting a new assessment re-evaluating the likelihood and severity of a risk or, perhaps, raising awareness of a particular process within the company.

The risk management document can become a true product lifecycle document that continuously strengthens and improves the system and the product.

In short, a living and dynamic document available to all departments concerned, not only those involved in the operational phase, but also for Top Management analysis.

Digitise complaints using a Workflow Management System

A Workflow Management System digitises business processes, bringing what happens in the offline world into a protected digital environment, where tasks can be assigned directly to owners and executed/recorded on the system to advance the process.

The advantage is that there is general monitoring of the process and its progress, with centralised and activity-related documentation.

Additionally, people are empowered and and directly involved in the activities, with deadlines and follow-up notifications that reduce the possibility of delays.

Two other major advantages are its integration with other complaint-related processes, such as CAPA, and with other systems, such as ERP, which provide up-to-date data on products.

Finally, a digital system allows you to extract dossiers, reports and KPIs for:

• giving a response to the customer, including the actions put in place by the company to address the complaint;
• providing complete documentation during an inspection;
• and constantly monitoring trends and performance in order to implement supporting actions.

PRAGMA4U

PRAGMA4U is a modular and scalable Workflow Management System platform that digitises work processes in compliance with FDA and cGxP guidelines.

It enables companies to: have documentation that is protected, always up-to-date, organised and linked to the source processes; assign and implement workactivities directly on the platform; easily share information between departments; keep processes under control using KPIs; and compile reports and dossiers that will be useful for inspections.

The platform can contain multiple processes, creating a true digital map of the company. It also integrates with other systems, such as ERP, simplifying the compilation and updating of data.