It takes significant effort to gather and analyze complaint data, and to use it effectively in monitoring the performance of the Quality Management System (QMS).
There are many areas of the quality system where significant analysis work has already been done during the pre-market phase. The answers to many post-market questions are often already written in the pre-market data.
One area of the quality system that often involves a great amount of resources is the compliant system. A good portion of the complaints received will end up having a long-term relationship with the quality personnel assigned to it. Time is needed to give it your full attention and resolution. An effective quality manager will be able to identify the time that has already been spent during pre-market analyzing product functionality and failures, and use the data for each and every compliant report, complaint investigation and within the complaint trending analysis.
The following is a general walk-through of complaint and customer feedback systems, and where opportunity lies to use applicable pre-market data to save time resources within your quality department.
Opportunity: The key here is to complete this step during complaint intake, or the opportunity is missed. The product risk analysis documentation uses precise technical language to describe potential failure modes. When this information is not referenced and used in complaint documentation, the quality assurance individual is forced to try and explain what happened in relation to the product functionality. Since this work has already been done, it is an unnecessary compromise in both data integrity (it was written by the subject matter experts in the risk analysis documentation) and time resource (for the quality assurance individual).
Opportunity: In addition to the potential failure modes, the risk analysis documentation also describes the potential resulting risk to the user/patient, impact on the system and impact on the environment. Referencing this information while receiving each complaint will give the person documenting the complaint a better chance at including important applicable details. Significant time can be wasted in trying to "investigate" the complaint after it is received to determine things that may already be known by the person reporting the complaint.
Opportunity: This is the biggest time saver — the risk assessment of all known failures and risks has already been made. Don’t miss this! Each potential failure mode or issue of the risk analysis includes a risk assessment. It is described using terms such as severity and potential patient risk. When that failure or issue actually happens during use of the product, there is no need to re-analyze its risk. Simply transfer the applicable information from the risk analysis to each complaint report when it occurs. You will only need to add information if there is a newly identified risk or impact (e.g., it is currently missing on the risk analysis).
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Opportunity: The reporting assessment is also already identified on the risk analysis. The severity rating of the failure or issue has a corresponding definition that describes how serious the risk to the patient is (i.e., death or serious injury, minor injury, etc.). The regulatory reporting decision can be made by just identifying the applicable severity ranking, instead of it turning into an exhaustive review of all the complaint details. Also, medical professionals are typically co-authors or reviewers of the risk analysis, and their time is often hard to secure. If they have already made a risk assessment of the particular failure mode, why have them repeat the assessment each time it occurs?
Jake Walton is the corporate operations and quality manager at MasterControl. Jake has worked in the quality and regulatory industry for over 10 years and is a Certified Quality Auditor, as well as a Certified Quality Process Analyst (CQPA) with the American Society for Quality (ASQ). Well-versed in medical device, laboratory, pharmaceutical and ISO regulations, he has been a featured speaker at the ASQ Annual Symposium and the Utah Technology Council’s regulatory conference. Throughout his tenure, he has hosted over 250 external audits by customers, the U.S. Food and Drug Administration (FDA), European Qualified Persons (QPs), notified regulatory bodies (ISO), Taiwan FDA, and the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA).