Recently, White House experts outlined key lessons learned regarding the pandemic-based pharmaceutical supply chain. As part of this analysis, they cited the specific need to focus on maturity of quality management.
The dirty secret that many life science and medical device companies don’t want people to know is that, to date, quality management has mostly been based on paper AND an afterthought on key strategic initiatives such as product development.
Why is it? These companies did not have the tools, knowledge or talents to streamline the quality management process and make it digital, which made quality management increasingly difficult – especially in the midst of pandemic when many workers were forced to abandon their desks and work from home.
For those who believe that managing quality and creating a culture of quality within life science and medical device companies shouldn’t be a priority, here are some recent and well-known examples that point to the contrary :
- Recalled due to low levels of a carcinogen in sunscreen.
- Contamination of up to 15 million doses of a Covid-19 vaccine due to a manufacturing problem.
- Errors in a single lab’s Covid-19 testing that led to around 300 erroneous and misleading results in Massachusetts nursing homes.
What do these three examples have in common? Each is the result of poor quality control processes internally and in their supply chains. Yet the preceding examples are not intended to demean the companies involved; rather, they serve as benchmarks for what can and will go wrong if creating a culture of quality is not a priority.
Based on lessons learned from the pandemic and the growing likelihood that some companies will continue to embrace remote working, leaders in the life sciences and medical devices must prioritize creating a culture of security. quality from the start. To do this, they should consider prioritizing these actions:
- Change of mindset at the organizational level – Today, quality management is still seen as a burden. In order to change this inherently flawed mindset, leaders in life sciences and medical devices must prioritize the function of quality management and put the quality management team on a pedestal. Giving quality management a place at the leadership table is an important first step in making this change a reality.
- “Just say no” policy to data fragmentation – Quality management is not a âone-shotâ thing. Rather, this critical function affects all parts of a business and its supply chain. Adopting a paperless policy is a good start. If healthcare providers can switch to electronic health records, so can life science and medical device companies. A digital, cloud-based approach to quality management is essential to solving dangerous information and data fragmentation issues.
- Investing in talent and education âWith the growing demand for quality management skill sets, the labor pool is shrinking. Smart life science and medical device companies should invest in training their current workforce on emerging quality management best practices and tools. These organizations may also consider partnering with local universities and colleges to establish collaborations and quality management programs that will help meet the growing need for this invaluable skill.
It is also important to note that creating a culture of quality cannot simply be an internal initiative for a specific life science or medical device company – it must be a consideration for all partners with whom a organization collaborates to bring a product to market, from collaborators in clinical trials to manufacturers and distributors. A seemingly minor quality management error in any part of the supply chain can have a massive impact down the line for all parties involved, including consumers.
Changing the perception of quality management as a burden versus a business differentiator is not an overnight endeavor. Fortunately, the pandemic has brought to light just how devastating poor quality management can be, as well as the incredibly important impact of quality management when it comes to getting high-value products to market quickly, like vaccines.