Have you set your New Year resolutions yet? You didn’t leave your Quality Management System (QMS) off the list… did you? Just like we commit to better personal health and wellness in the new year, it’s the perfect time to commit to a QMS refresh by setting healthy quality goals. And we don’t mean the kinds that fizzle out by February; we’re talking achievable, actionable goals to help set quality professionals up for success all year long.
Here are four quality management goals to help kick off your list:
1. Build your quality network
With traditionally small teams, it’s easy for quality folks to feel isolated. But staying siloed is the quickest way to get into a quality management rut – a big no-go in the ever-evolving life sciences world. Instead, commit to building your network in 2024 and get involved in the global quality community where you can share challenges, swap insights, and create new best practices with your peers. From quality forums to conferences, there are plenty of quality community events – if you know where to look. Here are some of our favorites happening in 2024:
- RAPS Global Regulatory Strategy Conference | March 5 - 7, 2024 | Baltimore, MD: Regulatory and quality management often go hand-in-hand, making this a perfect conference for quality professionals looking to improve the way they approach regulatory strategy.
- KENX Validation University | April 24 - 26, 2024 | San Diego, CA: A 3-day conference and training program covering everything from Process Validation to CSA to Equipment and Facility Qualification for the life sciences industry.
- ASQ World Conference on Quality & Improvement | May 12 - 15, 2024 | San Diego, CA: WCQI brings together thousands of quality pros in manufacturing, biopharma, consulting, government, and more to learn and connect on all things quality management.
- Quality Leaders Forum | Ongoing | United States: Held monthly in 2024, our QLF series gathers together quality leaders across biopharma, CMO, CRO, and more for interactive discussions and workshops that center around quality best practices and emerging trends. Each month, the QLF event will take place in a new city, so be sure to sign up to get notified when it’s in a city near you.
- ISPE Annual Conferences | Ongoing | Global: The ISPE is a nonprofit association focused on scientific, technical, and regulatory advancement throughout the life sciences space. From biotechnology to manufacturing, they host a variety of conferences throughout the year in Europe, the US, and Asia.
2. Get the quality tools your team needs
Still juggling spreadsheets to keep track of training? Have your most important documents spread across a handful of different softwares (or worse, file cabinets)? Fighting with an eQMS that doesn’t do what you want it to? It’s past time for an upgrade.
Quality teams, especially those at life sciences companies, have far too much responsibility riding on their shoulders to be forced to use outdated tools. Instead, resolve to get an eQMS that actually fits your quality needs.
Sound easier said than done? Don’t worry, we’ve got the tools to help make it possible in 2024:
- eQMS 101 eBook: From eQMS basics to budgeting, this eBook has everything you need to get started with a new tool.
- How to Convince Your C-Suite to Invest in an eQMS: Learn how to get your CFO to say “Yes” to your eQMS request by proving ROI and impact.
- 4 eQMS Features You Shouldn’t Compromise On: Have an eQMS already? Make sure you’re not missing out on the key features it needs to have.
- eQMS Cost Comparison Worksheet: Don’t get tricked by hidden fees. Use this worksheet to help uncover and track the true cost of each eQMS in your search.
3. Pursue quality management-related certifications
As a quality person, you’re probably familiar with the term continuous improvement (and by “familiar” we mean “actively driving it at your organization”). But continuous improvement isn’t exclusive to your company’s quality processes.
This new year, set a goal to expand or refresh your quality knowledge with some helpful certifications. Not only will this help your own professional development, it’s a great way to stay on top of quickly changing industry. You may already know of some of the standards like the CQE or the CSSBB, but if you need some inspiration for additional courses to pursue, these are a few of the certifications ZenQMS QA team members have either completed or are in the process of securing:
- ASQ Quality Auditor Certification: What better way to improve audit preparation than to think like an auditor? This certification not only helps you understand how auditors approach the reviews of your companies, it also improves your own audit processes as you evaluate external vendors or your internal QMS.
- IBM Cybersecurity Analyst Professional Certificate: Don’t limit yourself to quality-exclusive certificates! If your company handles sensitive data (and many life science orgs do), this is a great course to help bolster your QMS with extra security compliance controls and data protection insights.
- EU GDPR Foundations Course: GDPR non-compliance can lead to hefty fines and legal challenges. Check out this course (enroll for free or purchase the exam to get certified) to better understand GDPR regulations and mitigate risk with more effective data management practices.
4. Be proactive with your quality health
Don’t wait for issues to escalate before you start improving the health of your quality management system. Just like in your own life, it’s always better to establish healthy habits proactively to avoid potential problems in the future. And what better time to do so than the new year? Here are a few ways to improve your QMS health in 2024:
- Do your pre-audit exercises: As a life sciences org, you’ll probably be audited this year (and if you’re a CRO or CMO, you’ll probably be audited often). Don’t wait until you’re notified of an impending inspection to get your ducks docs in a row. Take steps early in the new year to set your team up for a smooth, simple, and stress-free audit, such as:
- Set clear quality standards you can measure your organization against
- Determine your highest areas of quality risk and plan how you’ll mitigate them
- Train your team on good audit etiquette
- Set a consistent internal audit (e.g. mock audit) schedule
- Embrace eQMS yoga (a.k.a. configuration): This is a great time to evaluate if your eQMS is configured the way you want it to be. Are your standard workflows translating smoothly into your eQMS or do you find yourself adjusting the way you handle quality based on how the software is set up? If the latter, it may be time to adjust your eQMS configurations … or time to think about if you’re using the right platform for your team.
- Get a pulse check on your QMS: A QMS isn’t a “set it and forget it” deal. As regulations, needs, teams, and systems change, your QMS needs to adapt to keep pace. At the start of this year, do a pulse check on your eQMS and test that you have the right procedures in place – and that people are following those procedures. Look for any problems that might arise, like incorrect access levels, security issues, inefficient processes, etc., and then get a plan in place ASAP to address them.