Kari Miller, Vice President of Regulatory & Product Management, Pilgrim Quality Solutions
Product Quality is a given in Life Sciences organizations; after all, the purpose of producing a medical device or pharmaceutical is to improve the life of the patient using the product. The backbone to producing quality goods is a Quality Management System (QMS) that, by definition, supports the processes focused on consistently meeting customer requirements and enhancing customer satisfaction.
In a global industry environment that is constantly evolving, it has become apparent that a new approach will be required if organizations are to achieve the goal implicit in that definition. The Quality Management System will need to simultaneously evolve beyond the role of company historian and expand its primary focus of achieving compliance. Quality data needs to be turned into information that is informed, actionable, proactive, and predictive. In other words, information that truly fosters a culture of quality.
Historically, within the Life Sciences, an organization’s level of quality has been gauged by its compliance with regulatory requirements. We’ve discussed in multiple blog posts this year the unprecedented level of change in regulatory requirements as well as the ever-increasing level of regulatory oversight. This pressure to demonstrate compliance and support regulatory reporting puts the focus on history, and the reporting of that history. We all know the rallying cry: “We’re being inspected by [insert favorite regulatory body here], rally the troops!” And everyone works to ensure that all the documentation needed is available. This is, however, a very rear-view mirror perspective and does little to enhance the customer experience or foster a culture of continuous improvement.
Looking for Answers
As product recalls, product bans, drug shortages, plant shutdowns, and enforcement actions continue to rise, the industry and regulators alike are looking for answers. Is the answer to the challenge of improving quality found in the data and documents? After all, we have a lot of data that we so carefully record within the quality system. However, the data is not the answer. Two themes that have gained mindshare in terms of improving quality in the Life Sciences industry are Quality Maturity Models and Metrics.
Quality Maturity Models
Quality Maturity Models focus on assessing the level of quality maturity within an organization and the QMS. Maturity Models aren’t new — CMMI and Crosby’s Quality Management Maturity Grid are just two that are well known. What is new is the renewed interest by industry analysts, regulators, and corporations in applying them to Quality Management Systems. All of them measure maturity by level, determined by how a company takes action: reactive, sporadic, proactive, measured and controlled, and future-oriented (improvement oriented, predictive) in a variety of categories which include, but are not limited to, Performance Management, Technology, Business Processes, Culture, and Strategy & Leadership. Applying Quality Maturity Models to QMS will provide organizations with a roadmap for the evolution of their QMS.
All Maturity Models reference metrics to varying degrees. The Quality Metrics that we will focus on are those that are receiving interest from an atypical source, the FDA. And it’s not just one division of the FDA, but both the Center for Devices & Radiological Health (CDRH) and the Center for Drug Evaluation & Research (CDER).
Looking to Transition
For Medical Devices, CDRH kicked off the Case for Quality in 2011 to determine how to shift focus from compliance to quality. This was driven by the lack of demonstrable improvement in patient safety over many years. The Case for Quality is part of CDRH’s 2016-2017 strategic priority to promote a culture of quality and organizational excellence. They worked with a variety of stakeholders, including industry, healthcare, patients, academia, and investors, to determine how to promote the use of practices that would result in informed decision making and action, as well as enabling the ability to predict product quality risk. The result was the establishment of a Quality Metrics initiative.
The initiative is currently focused on three measures, one from each major phase of the product lifecycle – pre-production, production, and post-production. Each phase elicits a metric that focuses on the Right-First-Time mentality:
- Pre-production: the metric will measure total number of changes (product and process) for each project to move towards zero post-design transfer changes.
- Production: the metric will be the Right-First-Time production result that many organizations already measure. This metric not only assesses production efficiency, it allows for the identification of opportunities for improvement.
- Post-production: a vast array of metrics are being assessed in the area of Complaints, Service Records, Medical Device Reporting, and Recalls.
CDER has embarked on a similar path for the Pharmaceutical industry. Their focus also zeroes in on quality of the product, and effectiveness of manufacturing, including site-level quality. The metrics that CDER intends to focus on are:
- Lot Acceptance Rate
- Product Quality Complaint Rate
- Invalidated Out-of-Specification (OOS) Rate
- Annual Product Review
- Additional metrics being assessed include CAPA Effectiveness and Process Capability
The goal in both branches of the FDA is to improve patient health and safety. These metrics will eliminate subjective opinion, and provide visibility and insight for continuous improvement at the site, enterprise, and industry level. In fact, the benchmarking and trending that will be possible within the Medical Device and Pharmaceutical industries will be unprecedented because of the availability of information needed for trend comparison across the industry.
Going forward, it won’t be enough for the Quality Management System to be the company historian, gathering data for the sake of compliance. That data needs to be turned into information. Information that is informed, actionable, proactive, and predictive. Information that truly fosters a culture of quality where customer expectations are always exceeded and customer satisfaction and safety are always achieved.
How does an organization achieve this quality nirvana? It starts with a decision to embark on the journey. The destination? Enterprise Quality Management (EQM) where data is structured and allows for proper aggregation and disaggregation, where measures and processes are harmonized. An EQM journey will guide your organization to a single source of quality truth that breaks down the silos within your organization and allows you to partner with the FDA and other regulatory bodies to improve life through quality within your organization and across the industry.
The Case for Quality System Transformation
Learn how compliance, quality system maturity, and a quality culture all feed into a successful global quality system.