Kari Miller, Regulatory & Product Management Leader, Pilgrim Quality Solutions, an IQVIA company
With the pace at which business moves today, we’re not often provided the opportunity to revisit previous blog posts, reflect back on position statements, or re-examine our thoughts from a fresh perspective. However, recently an e-book that I authored two years ago, Finding Your Path to Quality Nirvana, was re-published, giving me the opportunity to reassess some of the questions that were posed within its pages.
In the e-book, I answered the following questions, and I wondered, now that time has passed, what came to be, and how some of the questions would be answered today.
- What is the current state of the regulatory and quality landscape for Life Sciences organizations?
- Pilgrim Quality Solutions assists companies in achieving a state of “Quality Nirvana.” What is a Quality Nirvana and why should life science organizations strive to reach it?
- What are the most common hurdles that organizations have to overcome to achieve this nirvana?
- In your opinion, how can companies best enable cultural change to achieve a quality-driven/focused culture?
- What is a “single source of quality truth” and how does it help to mitigate risks or identify opportunities?
- If you had to give one piece of advice to someone looking to implement an Enterprise Quality Management System (QMS), what would it be?
- How do you see the quality needs of the Life Sciences industry evolving over the next five years?
Regulatory and Quality Landscape
The regulatory landscape as described in the original version of the e-book was one of unprecedented change, and today, in particular, that could not be more accurate. The regulatory and standards changes originally looked at included Unique Device Identifier (UDI), ISO 9001:2015, ISO 13485:2016, Medical Device Single Audit Program (MDSAP), and EU Medical Devices Regulation (MDR) and EU In Vitro Diagnostics Regulation (IVDR).
UDI has been implemented by the FDA in a phased approach. Class II devices, for example, are due to comply with UDI requirements by September 2018, while Class I/unclassified devices will require labeling and GUDID transmission by September 2020 and direct marking by September 2022. The EU is still working to determine which UDI standard they will follow. Whether they follow the standard chosen by the FDA remains to be seen.
ISO 9001:2015 changes centered on performance and risk-based thinking. ISO 13485:2016 also emphasizes risk while now placing additional requirements on the extended supply chain, emphasizing supplier control processes and feedback mechanisms.
MDSAP is in place and accepted by Australia, Brazil, Canada, Japan, and the US. The aim of this initiative was to create “THE AUDIT” accepted by all regulatory authorities around the globe so as to reduce the regulatory burden on Medical Device companies.
EU MDR and EU IVDR are in their transition stage while Notified Bodies ramp up in preparation for the transition deadlines. Reporting volumes for Medical Device companies operating in the EU are sure to rise with the new device classifications and shortened reporting timeframes.
Concern is growing in the Cybersecurity and Data Privacy arenas as a result of regulators’ increased focus on Change Control, and the move to personalized medicine and devices. This is reflected in the introduction of the EU’s General Data Protection Regulation (GDPR), a topic not originally mentioned in the e-book. EU GDPR, which went into effect on May 25th, 2018, is aimed at protecting the personal information of EU citizens. Again, with the move towards personalized medicine, this will have an impact on Life Sciences organizations.
Other topics not mentioned in my original writings on Quality Nirvana are Artificial Intelligence, Machine Learning, and Real World Evidence. These advancements are sure to have an impact on Life Sciences organizations in the areas of security, data privacy, validation, and flexible processing, as they will automate decisions, gather more personal data, and store it all in the cloud.
Why Quality Nirvana?
Every organization needs a single source of quality truth. When that is achieved, the business can truly focus on what’s important: The Patient. Life Science organizations exist to heal. Their aim is to improve the quality of life for their customers (patients).
To achieve Quality Nirvana, a Global Enterprise QMS (QMS 4.0) is required to establish that single source of quality truth. It creates a common language across the organization’s value chain through harmonization of data, metrics, KPIs, and processes. Those organizations that do not have a single source of quality truth, but that operate with silos of quality data, are going to find it difficult to keep up with the pace of regulatory change we’re seeing around the globe. More importantly, they’re going to find that they are so focused on compliance that they’re not actually focused on quality. Organizations that achieve operational consistency and focus on improving quality, will improve compliance as a result.
Hurdles on the Way to Quality Nirvana and Quality Culture
Culture remains the biggest hurdle to Quality Nirvana. Is everyone in your organization focused on the achievement of customer (patient) expectations, the very definition of quality? It is the responsibility of Management and Quality to instill a culture of quality into the organization. This will take time and patience, with a focus on changing one behavior at a time.
Why the focus on one behavior at a time? Culture still remains very difficult to modify. Management and Quality professionals need to aid organizational understanding of the importance of quality and then compliance. In general, people resist change. Understanding the reason for change, and ultimately the value it brings to the patients they serve, will aid in this process. Quality must come out from behind the departmental walls of “Quality” and into the organization.
Inclusion is key to cultural change. Cross-functional team efforts to communicate and inspire changes in mindset, processes, and structures for managing quality is what it takes to move the culture needle. Information transparency, collaboration, and knowledge sharing are a must.
Single Source of Quality Truth: Risk Mitigation and Opportunity Identification
As stated previously, the single source of quality truth comes from a harmonized, enterprise-wide implementation of QMS. In the initial e-book discussion, it was stressed that harmonization is different than standardization where one size fits all. However, harmonization is also not throwing everyone’s considerations into one pot. There will always be those elements that are unique to a product, process, or country in which a product is registered, and a harmonized process will account for those. What a harmonized process should not do is provide multiple ways to do the same thing; that just adds complexity, increased risk of errors, and difficulty achieving performance measurements that can be used at a corporate, division, business unit, or site level.
As mentioned in the original discussion on attaining Quality Nirvana, a harmonized process has a common DNA strand at its core; the common data and measures create the common language of the organization. This common language allows the entire organization to see and understand where things are going well, where things need adjustments, and what adjustments others made for similar issues. Trending data allows for risk mitigation, and metric comparisons allow for the identification of improvements required on a site-by-site basis. A harmonized Enterprise Quality Management System (QMS 4.0) will act as an early warning system for the organization.
One Piece of Advice for Implementation of Enterprise QMS (QMS 4.0)
It should be no surprise that the one consistent piece of advice for effectively implementing QMS 4.0 is inclusion. It was referenced earlier, and is as important today as it was two years ago. However, two years later I would also incorporate these additional considerations (not replace previous considerations), as they are important to inclusion:
- Make sure the Enterprise QMS vision and goal of harmonization is clearly articulated.
- Make sure harmonization is clearly defined, including examples of what it is not.
- Make sure that the benefits of an Enterprise QMS are understood.
- Make sure everyone understands this means processes and procedures will change. They must change to achieve the goal of Enterprise QMS: a Single Source of Quality Truth.
- Automated Enterprise QMS cannot and should not simply duplicate manual systems. Doing so will simply build inefficiencies into the Enterprise QMS.
Next 5 Years
The pace of change and the pace at which information travels will continue to increase. Consumers will continue to be more informed and more demanding, insisting on value. Personalized medicine will continue to change who we’re interacting with and how. Mobility, the Cloud, and ever-changing technology will continue to drive security and data privacy concerns. But more than that, these factors will change the way we work. Therefore, they will impact the culture of our organizations.
Organizational Management and Quality professionals must prepare the organization for the shift in the way we work. Oversight, review and approval, will become primary skill sets as technology automates repetitive tasks. The training and inclusion of personnel as this shift occurs will be key to the future success of the organization, and ultimately, to the treatment of our patients by developing and delivering products that are safe and effective.
Find Your Path to Quality Nirvana
Life Science Technology Roadmap
Today’s leading organizations are harmonizing quality processes by implementing a next-generation, global Quality Management System. Find your path to Quality nirvana by downloading this Life Science Technology Roadmap white paper from LNS Research.