1. Name, title Mohan Ponnudurai, Industry Solution Director
2. How does poor data affect quality in your industry?
Usually, poor data indicates that there are deficiencies somewhere in the company’s products or processes. The data itself is just data. However, the lack of critical data, the ability to obtain it when needed, and more importantly, the appropriate methodology to interpret data can significantly impact the company’s bottom line when the medical device industry’s core quality systems, complaint management, non-conformance (NC)/CAPA, change control and supplier control have systemic issues.
The lack of visibility and interpretation of data across all quality systems prevents the right root cause(s) of an issue to be identified. As a result, companies waste much time and effort not focused on the real issues so corrective actions or changes that are not correct at the start, don’t eliminate problems or keep them from reoccurring. Unfortunately, this negative cycle continues and companies find themselves in a perpetual state of being reactive, and are ultimately cited by regulators for systemic quality deficiencies in warning letters.
Additionally, if medical device companies are not proactively looking and trending their quality data in their operations, it’s likely that products are distributed to consumers with deficiencies, forcing the company to recall its products from store shelves, hospitals, homes and more. Depending on the severity of the defect and the significance on the safety impact to consumers, this could cost the company significant resources, budget and time invested in product investigations, re-worked/repaired products, or destroyed products. Product recalls often stem from quality issues that are neglected or unaddressed for a period of time before the product is out to the consumer.
3. What problems arise in this type of situation?
Often quality professionals working to support manufacturing environments are dealing with daily operational tasks developing quality procedures or processes, providing quality oversight to production activities, reviewing cGMP documentation, and performing internal or external audits. In this environment, trending production data or quality specific data is not always their first priority especially in a reactive environment where their focus is consumed with remediation activities. As an outcome, corrective actions and preventive actions (CAPAs) that are created tend to be short term fixes and do not eliminate or prevent issues from reoccurring.
Creating a process to trend data from the beginning of a product’s lifecycle can enable quality professionals to create a more proactive environment in which the company is positioned to have successful regulatory inspections any given time without massive efforts invested in inspection readiness preparations.
4. How can business intelligence and analytics solutions be used to address quality-related challenges?
Most analytics solutions apply an adaptable approach, Statistical Process Control (SPC), that can be used with any type of data and is aimed at continuous process improvement. Some examples using analytics on an operational level include a medical device company applying Pareto charts which can show a device’s most frequently occurring factors by graphing various types of product defects against the percentage of defects for each type. By doing this, it gives medical device companies deeper insights to better understand the variations within the product or process that’s causing the nonconformance and take better actions. Depending on what possibilities the observed trend indicates, this would allow medical device companies to quickly identify the source contributing to the nonconformance and focus efforts on a narrower scope such as going back to the design engineers in research and development and looking to indentify whether it’s an issue with the supplier or the material used or realizing if there is faulty equipment or an operator’s training issue.
On a strategic level, compliance and business executives use scorecards and dashboards in their Management Reviews for a quick snapshot of the company’s overall quality systems’ health where they can prioritize and pinpoint on the most pressing quality issues to make such decisions as retiring legacy products when re-design or enhancements will no longer bring desired company revenue targets or what device product innovations they need to invest back into Research and Development to enhance their product portfolio and maintain their global market shares.
Active and effective use of Analytics can provide the necessary foresight for medical device companies and manufacturers to focus on maintaining the quality of their brand products and trust with consumers while being more predictive in preventing the negative “snow-ball” momentum that lead to systemic quality issues.
5. How can TrackWise Analytics be used to progress each role in the medical device industry?
a. Quality Executives
TrackWise Analytics gives Quality Executives the ability to quickly view high level data to make strategic compliance and business decisions; how to best prioritize products whether it’s enhancing an existing product or creating innovative, new products.
This knowledge would also aid Quality Executives when dealing with compliance issues like recalls and help them determine the level of action depending on the significance of the issue and impact to consumer safety; when it’s necessary for a company to do a press release for a Class I recall (most severe recall); or concentrating in the destruction of products or addressing the issue out in the field using company resources or third party for re-work or repairs of defective devices. Score cards generated from TrackWise Analytics also help them to focus on global product issues across multiple product lines and divisions to see the value and performance of the product using statistical and historical performance models.
b. Quality Managers
TrackWise Analytics helps Quality Managers better confirm data and determine the level of compliance impact to the company by flagging any anomalies that need to be escalated to the senior management levels. They are often the ones also tasked with the responsibility of using Analytics solutions to interpret trends. This gives them the advantage of appropriately communicating and efficiently mobilizing global cross-functional areas for production holds or product containment activities not just at the manufacturing facilities but also at international distribution warehouses or sterilization or kitting centers or hospitals- thereby preventing costly recalls.
c. Quality Analysts
TrackWise Analytics enables Quality Analysts to identify large volumes of critical data from multiple quality data streams on domestic or international levels, to condense this broad collection of information into meaningful statistical charts/graphs that highlight the critical issues and display relevant trends as well as their relationship to other trends across other quality systems and/or the global supply chain. Since the TrackWise Analytics solution is more intuitive and does not require extensive technical training or a steep learning curve to apply standard statistical tools or complicated software, quality analysts can be average users who are more empowered to easily develop comprehensive and sophisticated trend reports in a short period of time.
d. Quality Data Consumers
Quality Data Consumers in the medical device industry can include General Managers (GMs), Production Managers or Supervisors, or Management in other cross-functional areas such as Product Labeling, Regulatory Affairs, Legal, Specific Business Divisions (Ex. Orthopedic, Radiological Imaging, Cardiovascular, In-vitro Diagnostics, etc.) They would typically be the receivers of trend information and are responsible for not only interpreting the Analytics Trend Reports but understanding the impact of those observed trends to their specific business areas, developing the plans to address them which may or may not involve working with a cross-functional senior management team for significant quality issues.
e. IT/System Owners
TrackWise Analytics is an add-on solution to TrackWise Solutions that would leverage existing TrackWise configuration, data, security model, and localization of global EQMS solutions without additional manual overhead. This allows IT/System Owners to require less resources and faster implementation times for more streamlined validation activities. Their ability to implement and validate the TrackWise Analytics solution enables companies-especially device companies that are known to have fast—paced, evolving production environments to reap the benefits of a solution that fosters a proactive quality culture sooner rather than later. TrackWise Analytics is a cost-effective, easy-to-use solution that provides the entire organization the most accurate data right at their fingertips.
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