Effective complaint handling is a priority. Improper complaint handling can impact the effectiveness and quicker resolution to FDA-483 observations and also the daily improvement of important business processes. The best way to reduce variability in process that can cause FDA-483, out of specification limits, or just process inefficiency is to proactively measure key results and/or characteristics. But even with the best metrics and Quality system can have inadequate process results that yield a complaint and require an investigation. This can be anywhere in product cycle from raw material to a customer using the finish product.
Handling complaints efficiently and effectively is important on several fronts. First priority is to eliminate re-occurring errors as quickly as possible. But, a good compliant system will go beyond compliance and is an excellent way to discover hidden inefficiencies or causes to poor a performing process, e.g. drive continual improvements. This system can also be excellent method to support customer allegiance by responding to customer feedback. Handling complaints in a timely and effective manner will demonstrate to the customer that we have their best interest as well as patient safety in mind. The following are key points to keep in mind when handling both internal and external customers’ complaint.
- Timeliness–The clock is ticking. Be sure to document the complaint as soon as possible. Delaying even one day seriously impacts our ability to resolve the complaint in a timely manner and will jeopardize a customer‘s future results, safety, and allegiance. Set agreed upon and appropriate timeframes for handling complaints based severity. Use technology and simplification when possible to support the timeliness of the other 5 points.
- Acknowledgement– Once you’ve documented the complaint and have a complaint reference number, corrective action number, let the customer know. The sooner the better. Determine at this point if the compliant is re-occurring to the customer or for the process.
- Facts- We’re a science company serving science customers. It’s important to collect enough facts to effectively drive the investigation. Leave emotions and speculations out of your problem statement. If the customer has not provided enough information, it is the person’s job handling the compliant to solicit the facts that are needed. Delivery dates, sales order numbers, pictures, copies of documents (BOLs, packing lists, deviation reports, previous occurrences), etc. are all critical tools to launch an effective investigation and to resolving a complaint. Do this quickly-the clock is ticking.
- Updates– Oftentimes complaints are driven by criticality. In these instances efforts should be directed at meeting the customer’s immediate needs. This may require providing an interim solution while we are working on their complaint. This might include providing replacement material, providing the customer with timely return instructions (if the manufacturer requires material or a sample back for analysis), isolating inventory to keep the same material out of the customer’s warehouse, or even stopping the entire process. All this should be documented in the corrective action as this will become part of the final follow up report.
- Resolution– Once the root cause has been established, corrective actions have been identified, and actions to prevent recurrence (if warranted) are in place, and then execute. Be sure all this is documented in a complaint system and the improvement systems, if lean tools were used for problem solving. Remember, in the cGMP world, if it’s not documented, it didn’t happen.
- Follow up– This is the verification stage to ensure sustainability. The customer needs to know exactly what we’ve done to resolve their issue and the steps we’ve take to keep it from recurring. This can be in the form of a formal final report, the provision of a vendor report, metrics showing an acceptable stable process, or in some instances a simple recap in an email will suffice depend on the complaint. In each instance though, it’s important that we receive acknowledgement from the customer that they are satisfied that we have handled their complaint in an efficient, acceptable manner.