March 10, 2022
We live in a world of measurement and metrics. Running a successful business requires a thorough analysis on the work, sales, and financial results. Of course, identifying and tracking business metrics allows decisions to be made to enhance company performance and identify emerging problems before they become serious issues. But there is another set of metrics that should be on every company’s radar and that’s your Quality Score.
From traditional pharmaceuticals to start-up biotech companies, from medical devices to advanced diagnostics — and everything in between — high quality and insurance of the safety of products is at the heart of what moves these companies forward. Total control over quality at every stage of the product lifecycle is the key to success and to developing innovative advancements that enhance the lives of patients who use these products.
Authorities around the world strive for the execution of the required quality standards. That being said, manufacturing companies from pharma/biotech, medical devices/diagnostics, cosmetics, food, and nutrition rely on a sound quality management system, functioning quality control, and a forward-thinking department for quality assurance. Additionally, development and clinical trials are bound by strict regulations and companies have to ensure compliance.
For many, the answer is that they are more focused on compliance to regulations than to continually enhance the assurance of quality in all phases of their operation. They view the regulations as an obstacle – a hoop to jump through or a box to check. Countless companies are just trying to get by, looking for the path of least resistance to satisfy compliance.
Of course, compliance is very important and life sciences companies must demonstrate they are meeting required regulations. However, we can’t forget about quality and instilling the concepts of continuous quality improvement throughout all aspects of the organization. The most successful companies have embraced a company quality culture that is embraced and promoted by company leadership. However, this type of quality culture doesn’t happen overnight.
You’re probably thinking, “We have a QMS so we must be a quality-focused company.” Or maybe your reasoning is, “We have a QA team in place so we must be on the right path to high-quality.” Unfortunately, just because you have a QMS in place or a dedicated QA team, doesn’t mean you are a quality-focused company. It requires the right training, mindset, processes, technology, and forward thinking. The entire organization needs to be on the same page.
Questions you might want to consider include:
These are just a few of the many questions you should be asking yourself to determine if you are a quality-focused organization.
Until you assess where you are, it will be difficult to move forward. To help you understand the condition of quality at your organization, we have developed the Do You Know Your Quality survey -- a few short questions to help you evaluate your company’s focus and current state. The results of the survey include your Quality Score which can help you determine if you need to take action and what steps to take to get you in the best quality state you’ve ever been in. Think of your Quality Score as a helpful navigation tool that will guide you to quality and compliance success. It directly correlates to the ability of your organization to not just meet but exceed quality standards.
It's not enough to produce a safe product, that works as intended, and meets regulatory requirements. Today’s quality leadership must contribute to the firm’s reputation, competitive standing, profitability, and growth. Adding to the burden, your company’s industry, target market, role in the supply chain, size, and so many other factors intensify the pressure. Yes, it’s a complex web of codes, guidelines, standards, and practices that companies face but the ability to reduce risk and noncompliance costs is at your fingertips.
TAGS: Life Science Consulting
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