Businesses worldwide are being tested in a crucible of quality. Companies in which quality was already fragile and inefficient have seen their processes go from lacking to completely broken during the COVID-19 crisis. Especially those companies in medical and related industries that have been directly involved in responding to the pandemic. As a result, the quality world has learned three key lessons from COVID-19—although not all the lessons are cautionary tales. Some exemplary cases provide hope for quality resilience, agility and success in the face of adversity.
Lesson #1: Supplier quality issues are exacerbated during emergency situations.
Supplier quality is always a crucial factor. But as manufacturers scramble to develop lifesaving products during a crisis that continues to cause large-scale supply chain disruptions, supplier quality is more important than ever. Issues of speed and scale are having a considerably larger impact during the present pandemic.
EpiGuard, the Norwegian manufacturer of the EpiShuttle transport system for infectious patients, learned firsthand how supplier challenges become magnified during a crisis when the coronavirus led to a spike in demand for its products. Due to the essential nature of the EpiShuttle, the company has been required to ramp up production of the protective Class 1 medical device despite the factory closures, social distancing mandates and work-from-home challenges its suppliers are experiencing.
“We have been working day and night contacting politicians and embassies trying to get parts in order to produce and highlighting that this (EpiShuttle product) is used for COVID-19,” said EpiGuard CTO Zaid Hamed.[i]
When new suppliers need to be qualified, it can be a challenge to get them up to speed quickly in a world where remote working is becoming the standard. A robust qualification process that’s aided by digital tools can be a lifesaver for companies like EpiGuard. Cloud-based solutions give companies the ability to effectively collaborate remotely with suppliers on specifications and incoming quality issues with desperately needed products.
Lesson #2: Quality must be extensible across an organization’s entire ecosystem.
As a company’s network of outsource partners and/or business unit sites expands or pivots to alternative sources during a crisis, quality must remain consistent and be pervasive. Companies that rely on disconnected or paper-based systems lack real-time visibility into current and accurate quality data and related activities across their ecosystems and therefore have no way of sustaining “pandemic proof” quality.
Having in place a digital, cloud-based quality management system (QMS) that fosters quality alignment between remote sites and systems is essential to maintaining quality extensibility as ecosystems shift, according to Bjorn Olsen, a QA/RA consultant with Malsen Medical who has been helping EpiGuard ramp up production and address distributor challenges in the coronavirus era. In cases where the company’s regular distributors in Scandinavia haven’t been available due to the effects of the novel coronavirus, Olsen said EpiGuard has turned to fallback options in Germany, France and England.
“We just have to source whatever we can get ahold of, but if their configuration is different, we may have to do rework on a specific part,” Olsen said. “We do all that within the (QMS) so we can make sure it’s tagged to the actual device being produced. Then we can see the whole history of that device, the configuration to which each device was built, which nonconformances we might have had, and any specific situations relating to the product release.”
Global quality alignment during the pandemic has proven to be equally as important in the critical area of laboratory testing. Nelson Labs, a global provider of microbiological and analytical lab testing, has been heavily involved in testing the efficacy of facemasks and respirators during the COVID-19 crisis. The company has seen a 3,900% increase in the number of tests performed in its 13 global lab sites since the outbreak of the novel coronavirus.[ii] A holistic QMS that connects data and aligns quality across a network of labs has been essential to the company’s response to the rising need for lab testing, according to Nelson Labs President Jeffrey R. Nelson.
“Every day we recognize the importance of consistent procedures that increase efficiency at each location and forms that ensure we are collecting the right information,” Nelson said. “We have to be ready to move fast, adapt quickly and do the things our team needs, our customers need and the world needs.”
Lesson #3: Flexible quality processes, systems and teams are critical in a crisis.
The ability to fill in gaps when new opportunities, obstacles or shortages occur makes all the difference in a company’s capacity to react quickly and stay ahead of competitors.
Fagron, a global leader in pharmaceutical compounding and personalized medicine, has demonstrated the importance of versatility as it has ramped up its processing of the relatively common steroid dexamethasone, which has recently proven to be effective in fighting the novel coronavirus in seriously ill patients.[iii] The company is a well-known provider of dexamethasone and is frequently called upon by compounding pharmacies during drug shortages. But since the drug in now in higher demand, the pressure on Fagron to boost available quantities has increased significantly.[iv] Thanks to robust yet flexible processes and the capabilities provided by a cloud-based QMS, Fagron can meet the rising demand, according to Matthew Seitz-Paquette, the company’s North America quality specialist.
“Dexamethasone is something that we’re able to source and supply to compounders around the world very rapidly, but it’s something that a large organization in traditional pharmaceutical manufacturing may struggle with,” Seitz-Paquette said. “Being in the cloud, we’re able to organize sourcing and documents and coordinate everything from our qualifying and auditing teams in China, Europe, South America and North America very rapidly.” [v]
When a crisis causes supplies to dwindle or forces companies to turn to alternative suppliers, the organizations that continually maintain flexible quality processes and systems are already positioned to thrive. For Nelson Labs’ teams, the COVID-19 pandemic has proved that communication and collaboration are essential to adaptability.
“Supply shortages have required our quality team to work with the production shortages and manage the changes properly,” Nelson said. “For example, quality leaders and operational leaders have been working together and communicating often, putting in pre-approved deviations so we can adjust to supplies.”
Advancing Quality Amidst a Pandemic
As companies attempt to normalize or adapt to the new environments and obstacles that will inevitably arise, there are several “next steps” that will enable them to confidently contend with the kinds of quality predicaments that have come to light during the pandemic:
- Ensure quality data connectivity.
As crisis-ready companies like EpiGuard, Fagron, Nelson Labs have learned, all affected parties can stay on the same page and there are fewer missed opportunities when quality data is completely connected throughout the ecosystem and across the product life cycle. For some organizations, this may entail a greater investment in advanced digital quality management tools that can integrate with their existing enterprise systems as well as with those used by contractors, vendors and other external partner organizations.
- Take steps to move beyond reactive and even proactive quality management and toward predictive quality management.
Predictive capabilities are waiting to emerge from disconnected documents—you just need the right methodologies and tools to unlock the potential hidden in your unstructured data. Organizations that adopt a data-driven, platform-enabled quality model can augment their capacity to yield real-time quality intelligence and predictive insights. Predictive technologies powered by machine learning and artificial intelligence are only in their infancy and have tremendous potential to create new and better opportunities for process control in the quality function. Any company that can harness the power of predictive technology today will have an edge over competitors tomorrow.
- Continually maintain high quality standards for supply chain partners.
When supply chains face challenges, the organizations that can establish effective communication, collaboration and transparency with supply chain partners are more likely to have greater visibility into their sources of materials, facilitate better quality processes, receive higher-quality materials and produce higher-quality products. An integrated, cloud-based QMS can help ensure quality consistency and greater visibility into all quality activities throughout the entire network.
When times get tough, quality is the last thing we can afford to sacrifice. And we can bank on the fact that new and different trials are waiting for us on the other side of the current pandemic. By learning from the COVID-19 crisis, quality professionals can be better prepared for the next set of inevitable challenges.
[ii] “Nelson Labs on Adaptability and Communication,” by David Butcher, MasterControl Insider, June 10, 2020.
[iii] “A cheap steroid is the first drug shown to reduce death in COVID-19 patients,” by Kai Kupferschmidt, Science Magazine, June 16, 2020.
[iv] “FDA Adds Dexamethasone to COVID-19 Temporary Compounding Lists,” FDA News, July 16,2020.
[v] “The New Ecosystem Dynamics: Digitization as a Driver of Global Quality Alignment and Innovation,” MasterControl webinar, July 15, 2020.