Throughout the years, it has become imperative companies more closely examine the handling of investigations of deviations and CAPAs. However, the transparency of root cause analysis and impact assessment, along with associated actions, are still challenging for many companies.
A January 2017 article stated the U.S. Food and Drug Administration (FDA) sent international warning letters to five medical device companies and three pharmaceutical firms. The reasoning for those letters included “failure to identify requirements for CAPA procedures, CAPAs lacking detail about investigations, effectiveness checks conducted,” and more.
In one life sciences plant, the FDA determined the company failed to ensure all production deviations. The agency concluded the failure of a quality unit to exercise its responsibility to record and provide critical deviations counteracts established standards of compliance, quality, and purity.
The failure to define, review, and approve production and control records along with showing original data is part of current Good Manufacturing Practice (cGMP). The plant’s manufacturing equipment was found damaged, containing uncleanly residue and contaminants. FDA inspectors stated the plant did not outline cleaning procedures and equipment maintenance in detail, and demanded the company develop a validation study and report and evaluate deviations for all products. It also mandated the company identify and summarize the batches released without testing. FDA then requested an itemized report on impacts, as well as the evaluation of all production deviations—including an analysis of parameter failures that could be traced from deviation to proscribed time limits.
The Importance of Managing Events
In today’s Quality Management Systems (QMS), the ability to control and correct processes while demonstrating traceability is key to maintaining a high level of compliance with any regulatory organization.
In many cases, the ability to discern the overall impact of events is a subjective determination that can result in major errors and consumer health scares. It can also affect the overall compliance of the organization, leading to legal liabilities.
Many life science organizations struggle with the quality management skills needed to reduce the risk of a recall and help protect their brand from a recall’s potential damage. Beyond the financial burden, they also drastically increase the negative image of a brand.
Having a good QMS provides a proactive solution to handling risk by reducing the risk of recalls, but also helps to reduce the amount of downtime a recall can cause by offering the tools and support to resolve it as quickly as possible.
Traits of a Good Quality and Risk Management System
An intelligent automated software system can reduce and prevent recalls while limiting defective products from entering the marketplace by setting systems in place, proactively mitigating and resolving systemic issues that would lead to a recall.
A risk management solution that can provide the following is an efficient way to reduce negative events:
- Repeatability: The risk management solution should have the same methodology for all events regardless of how or when they occurred, creating a similar outcome.
- Objectivity: A risk management tool should quantify the decision-making process without any input from humans.
- Consistency: There should be confidence that the QMS is providing accurate outcomes every time.
- Automation: Automating a QMS eliminates the possibility of human error and keeps up with the fast pace of business.
Applying Risk Management
There are some tools that can help measure and reduce risk within an organization’s operations. These tools can be combined to identify high risk situations, prevent future risk of recalls, and translate data into important information to fuel decisions.
The Risk Matrix is one of the most commonly used tools for risk mitigation in the life sciences arena. With severity on the “x” axis and frequency on the “y” axis, assigning numerical values to events quantifies risk in a measurable and comparable way. Organizations can define acceptable ranges for risk and use that as a reference point for prioritizing actions and making decisions.
CAPA is a systematic way to reduce future risk. Through a root cause analysis, the underlying issue causing an adverse event can be determined. Then, corrective actions can be launched to contain and fix the problem and preventive measures can be taken to reduce the risk of the event recurring. Finally, an effectiveness check ensures the corrective and preventive measures are working to reduce risk.
Enterprise reporting gathers the data from quality processes and presents it in a cohesive manner. The data can also be exported for detailed analysis and close examination. Decision-makers can use this information to see challenges, measure improvements, and prioritize actions.
Traceability provides the capability to identify gaps by documenting existing serialization projects and the necessary future changes. Gathering requirements and proving documentation is critical for manufacturers’ audit management processes. Traceability helps manufacturers understand and document in easy-to-read reports, typically within 24 hours of verification requests.
By standardizing processes within a centralized quality management system, companies can focus on creating customized workflows to standardize critical processes and eliminate guesswork. In many companies, quality and safety are siloed. Over time, this can become chaotic and it becomes impossible to gather data, simply because some departments do not have access or share their systems with another area. Integrating quality and safety from an organizational standpoint to drive governance comes from both ends.
Enterprise reporting gathers data from business and quality processes and presents it in a cohesive and consistent manner. It allows users to export the data for detailed analysis and close examination so decision-makers can use this information to see challenges and measure improvements to prioritize actions.
Reporting provides information that can be displayed as useful and comprehensive graphs and charts for decision making, and also supports risk-based thinking. The data can then be exported for a more detailed analysis, allowing users to pinpoint exactly how certain decisions impact operations. The data can then be leveraged as a reliable platform to make decisions and defend them with necessary supporting information. The decisions from the analysis can be applied to evaluate and implement R&D product and process improvements, supporting patient/product safety and customer satisfaction.
Automated quality management solutions ensure audit trails are secure, computer-generated, and time-stamped. They can also incorporate any change management activities into electronic records. For any regulated industry, avoiding scrutiny and potential fines from regulatory bodies or agencies comes from having the due diligence to protect consumer safety. Having consistent systems and processes in place (along with well-trained employees) will help create and keep track of documentation and actions, and will facilitate avoiding events that otherwise could not have been averted.
Emily Ysaguirre is a marketing content writer for EtQ. She is responsible for developing and writing content for EtQ, a leading enterprise quality and compliance management software provider.