Updated: Aug 11, 2019
Customer Complaints is not an easy process to manage. Complaints are normally generated by people and bodies outside of the organisation, require cross-team collaboration, and often require a response to external bodies. This generates several complexities and challenges when gaining information, when acting upon it, and when responding to the complainant. Here are some of the key things to consider when digitising this process.
Before we start, quick clarification: when we say “Customer Complaint” we mean an issue raised by a customer or distributor of a regulated instance or device, meaning that the handling of the complaint process must adhere to the regulations of FDA and other health authorities, as well as ISO requirements.
For the purpose of this discussion, we will divide our conclusion about Customer Complaint management into 3:
Although this is the first step of the process, handling it correctly can have tremendous effects on the efficiency of the process and the ability of the organization to improve product quality and learn from its mistakes.
If possible, we highly recommend using a Customer Care portal which will enable your customers to log complaints on their own, be aware of the investigation status, and streamline the usually back-and-forth questions that are often required at the intake phase of the Complaint handling.
Two main goals:
Gather all information: The intake step is critical because it is often done by users outside of the organization (i.e. distributer, customer, customer care team, etc.), and almost always by someone outside of the QA team. Therefore, gathering as much information as possible while you still have the attention of the person is critical to enable a proper analysis and a timely handling of the Customer Complaint. The digital form should be simple and straight forward, understandable to someone who sees it for the first time, and one that guides the user to share all of the information you’ll need in order to analyze and respond to the complaint.
Feed KPIs: gathering information in the correct format is just as important, as it will allow you to gain insights and KPIs from the process. Every piece of information which will later be used for your quality metrics should be gathered via some sort of a predefined list (i.e. checklist, drop down list, etc.) so that you can easily plug it into a reporting engine without worrying about typos, upper / lower case duplications, etc.
What sets Customer Complaints apart from other quality records is the necessity to evaluate it in 2 levels: Root Cause Analysis and Reportability.
Now, much has been said about analyzing the Root Cause, and there are many formats available for it, such as the 5Ys, 5M+1, and so on. I’ll only add that it is important to make sure that your digital solution enables and enforces the analysis method of your choosing. The Root Cause Analysis process itself is an important piece of information which can be later used for trend reporting and to analyze recurring issues / complaints, so you need to put the proper tools in place in order to capture important information.
While determining the Root Cause is an exercise which requires insights and maturity to be done properly, defining the reportability of the Complaint requires answering a questionnaire predefined by the governing authority in the market to which the Complaint applies. Therefore, by using technology tools such as digital decision trees you can enable your team to quickly and easily determine the reportability of the complaint. This way, more people can perform this step correctly and therefore complaints can be processed faster.
If you’ve done your investigation properly, found the root cause, and determined the reportability of the Complaint, the last step is to respond to the complainant and to the governing authorities if applicable.
We hear from a lot of QA leads that “consolidating” the information requires much of their time, after which they spend more time in “arranging” it to have all the bells and whistles that a formal letter should have.
However, you should know that if built properly, sending the response letter through your digital QMS should be a matter of clicking a button, because your eQMS should be the one “consolidating” and “arranging” the information. It’s not very difficult to do but will save you a lot of time once it’s in place.
Furthermore, if you’ve chosen to implement a Customer Care portal, response can be captured within the portal without the need to “consolidate”, “arrange”, and email. Customer may confirm his acceptance of the response within the portal, and that’s that!
Reporting to health authorities should be even easier than the repose letter, because today you can report the incident digitally via integrating to the authority’s information system so make sure you take advantage of this capability to save you valuable time.
The handling of Customer Complaints can be a challenge because they are often logged by people outside of your company, they require extreme cross-team collaboration, require thorough investigation and analysis of Root Cause and reportability, and last but not least: require a timely response to the person who logged the complaint.
Building a simple, user friendly Customer Complaints management system which will streamline the process, will support cross-team knowledge transfer, and will increase your team ability to resolve issues faster and provide a better customer service.
Feel free to share your thoughts and insights in the comments below!
Orr Zuck, CRO, email@example.com
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