EMEA Office
Louizalaan 489
1050 Brussels
Belgium
06:42
Introduction, Validation Principles to comply with GaMP5 Requirements
27:40
Deliverables Expected for SaaS Validation
40:05
Who is Responsible for What (Vendor vs. Sponsor)
46:30
Special Considerations for eQMS SaaS vs. Other Saas Systems
48:50
Q&A Session
In this free session, Angel Buendia, Scilife’s Knowledge Manager, and Lesley Worthington, Communication and Leadership Coach will guide you through the essentials of embedding quality into every facet of your organization. They will explain why a robust quality culture is essential and outline the steps needed to achieve it.
How do we change or influence people's mindsets and beliefs?
To influence someone, you have to know them. That’s the critical thing. This is why we need relationships—because if we don’t know the other person, we can’t figure out what matters to them. Influence is really about an exchange. You're going to offer something valuable to the other person in return for what you need, which is most likely their cooperation. To gain their cooperation, you need to understand what you can give them, and you can't do that if you don't know them.
You need them to adopt certain beliefs and share a vision, but what do they need? You have to know that.
They might need reassurance that adopting these ideas will actually make their lives easier. They might simply need to know that you are aware of their concerns. It's important to figure out what matters to each person; it’s an individual situation. It’s not about saying, "Here’s how I’m going to influence upper management." Instead, it’s, "Here’s how I’m going to influence Bob," or "Here’s how I’m going to influence Susan." You need to think of each person individually and figure out what matters to them.
You want to build a human relationship with people. Whether you're riding up the elevator together, walking to the car park together, or sharing small talk—you should know a little bit about the human side of them. One of the best ways to build a relationship is to find something in common, like kids, pets, or the car you drive. For people to trust you, they’ve got to like you, and people like others who have things in common with them—people who are nice and who listen.
So basically, you’re doing everything you can to make people like you, so there’s a better chance they’ll trust you, and in turn, a better chance that you’ll be able to influence them.
What should you do if people know why they should care but still don’t care?
If they really don’t care, then you haven’t figured out how to show them why they should care. You might think you know why they care, but you haven’t hit the mark yet. Ask yourself, “What motivates this person? What drives them? What do they care about?” You can’t make them care by simply telling them logically why they should care. Humans are emotional before they are logical, and they don’t like being told what to do. People care when what you're saying resonates with them. So, you need to get to know them well enough to figure out how to present what you want in a way that resonates with them, so they "get it" and want it too.
If they’re acting like they don’t care, it’s because they don’t care—yet. You haven’t figured it out yet. Watch that person, study them, talk to others... Sometimes people wonder, "How am I supposed to influence my CEO, who doesn’t even work in the same building as me?" You can learn a lot about people even without meeting them. You can learn from the people they’re connected with, anything they’ve written, or any public speaking they’ve done. You can understand how people think easily enough, even if you’re not rubbing elbows with them.
How do you improve accountability in the new generations? I keep noticing less and less accountability being taken, which in turn reduces the acceptance of responsibility for the quality culture. While trust is a major factor, it seems the new generations find it hard to embrace.
The principles of communication are timeless. Humans operate by certain laws—whether they’re older generations or newer ones. If there’s an issue with accountability, it likely stems from a problem with trust and communication. Perhaps they’re unaware of the expectations? Or maybe someone doesn’t know how to give proper feedback? In this case, education is key. From the moment someone joins your company, it’s your first opportunity to not only help them understand what quality is all about but also to start building a strong relationship with them.
Building trust is a slow process—it's done person by person, conversation by conversation. Staying engaged with younger employees and helping them feel a sense of belonging and ownership almost always leads to them stepping up. People, regardless of their generation, want to belong and find meaning in their work. If you can help them see the shared vision and make them feel involved and important, you might be surprised at how they rise to meet the expectations you set for them.
How do you rebuild clarity and trust when trust has been broken for a long time?
Rebuilding trust is a slow process. You need to assess each relationship individually and determine what requires attention. Is there a broken relationship that needs repairing? Make a plan for that. Are there new relationships that need to be built? Make a plan for that as well. Study the organizational chart—both formal and informal—and identify where alliances exist. Consider how you can leverage your existing relationships to create new ones and rebuild trust. By being strategic about this, you'll start to notice things you hadn’t before and gain insights into which relationships are key and how you can work on strengthening those in particular.
How do you sustain a quality culture?
Education and training are key, but ongoing communication about quality is even more crucial. You want to get to the point where quality is such an everyday thing that it's not a big deal and is almost boring.
That will happen when quality comes up all the time. In every status meeting, include a brief mention of quality—not as a big issue or crisis, but as a regular reminder. Talk about quality regularly and in a calm, non-stressful way. The idea is to normalize thinking about quality, so it becomes a habit, not something only considered during a crisis or an annual audit.
Another good idea is to continue recognizing and rewarding "good" quality behaviors. A well-designed reward and recognition system keeps people motivated to maintain quality as a daily focus.
The first two QMS principles are 1. Customer Focus and 2. Leadership. So, in your Step 1 "Vision," would you say Customer Focus (or even better, "Purpose") should be included in your Vision step?
It really doesn't matter—there’s no single "right" way to approach this. If you naturally think in terms of traditional quality management categories and that’s how you want to create your vision, then go for it. The reality is that your vision for Customer Focus is about how individuals in your organization behave and communicate to ensure customers are the focus, so you’ll cover it in the four categories I mentioned either way. If you prefer to create an elaborate and detailed vision of "Purpose," then do that. What matters is clarity and ultimately action, so whatever moves you closer to action is the right approach for you.
The reason I use the four categories—leadership commitment, employee engagement, education and training, and communication—is to encourage thinking beyond the traditional confines. This approach allows your mind to explore where it needs to go. Ultimately, it’s about people. If you’ve identified a gap in "Purpose," addressing it might not result in dramatic change in practical terms. You may end up with a clearer purpose, but the goal is to go beyond that and focus on what’s actually happening with people in real life. Otherwise, it becomes just a theoretical exercise that looks good on paper but doesn’t lead to real change. If you feel your "Purpose" is unclear, then starting there makes sense.
The ultimate goal is to have a well-run quality management system that supports a successful business, ensuring the production and distribution of good, safe products. You’re free to use traditional quality management principles if they help you think comprehensively, or you can take a fresh approach if that encourages more comprehensive thinking. It all depends on what kind of thinker you are. Some people need lots of structure; others, like me, prefer to let their minds run freely. I believe it’s important not to be constrained by existing methods, tools, or ways of thinking.
How do you instill a quality culture in a startup? Any thoughts?
I think it’s actually easier in a startup because it’s simpler to build relationships with people in a smaller environment. The big challenge with startups is that the founder often wants to race ahead with their brilliant idea and may view quality as just a red-tape function. So, in startups, educating those at the top—especially about their responsibilities—is crucial. Terms like ISO, GMP, and QMS are often just jargon to most people, and they probably don’t know the differences (though they might not admit it). Taking the time to help them understand what’s required by law, what’s not, and where the authority comes from that imposes these responsibilities is really important.
When having these conversations, it’s essential to convey that you understand what matters to them and that you’re there to support them, not hinder their efforts. They need, early on, to understand your role in helping their company thrive and succeed so don't be shy about making that crystal clear.
How can you engage people when you work in a high performance organisation, which also has its problems?
I’m not entirely sure of the exact question, but I’ll give it a shot. Engaging people in any organization, high-performing or not, comes down to making them feel like they matter. People need to feel seen, heard, and appreciated—it’s a basic human need. We need to recognize their contributions, listen to their ideas, and help them see the impact of their work. When people feel important and know they’re making a difference, they’re more likely to be motivated, committed, and willing to go the extra mile.
It’s not just about tasks, goals, and that sort of thing—it goes beyond that. It’s about creating an environment where everyone feels their voice matters and their efforts are valued. If you treat people this way, you’ll see good engagement, even in an organization that faces challenges.
How do you get people who are just working for a paycheck to "buy in"?
You have to help them find meaning in their work. Make them feel like they’re part of something bigger than themselves. Get them involved and participating; reward them; give them opportunities to contribute in ways that make them feel important, valued, and valuable—like they have a real stake in the outcome. Offer chances for growth and stepping up. And one of my favorites—ask them directly what would make their work better.
Some people view a quality culture as extra work on top of their existing responsibilities. How do you overcome this resistance?
That's the biggest problem - resistance. It's crucial to understand where this resistance is coming from. Is it simply a reluctance to change? If that's the case, you might need to explore change management strategies.
More often, the resistance stems from concerns about increased workload. People might fear that implementing a quality culture will add to their already overwhelming tasks. This fear can also be due to the unknown—concerns about lacking the necessary skills, knowledge, or understanding of what the quality culture entails.
To address this resistance, it's important to identify its source. Typically, the fear is that the quality culture will create more work. The best way to overcome this is by demonstrating how a quality culture can alleviate these concerns. Show them how it will integrate with their daily tasks and potentially reduce their workload. Highlight how a quality culture can make their work easier and more fulfilling by reducing mistakes, improving processes, enhancing efficiency, and fostering better collaboration.
Involving people in the process is also crucial. Seek their input and listen to their concerns. When people feel engaged and see that their feedback is valued, they are more likely to cooperate. Help them understand the benefits of a quality culture and how it can positively impact their work.
If we have a large remote workforce, how can we keep them engaged in our Quality Culture when they’re not physically present?
This is indeed a significant challenge. To address it, the key is "clarity." In a remote workforce, building relationships and trust can be more difficult, so it's essential to emphasize clarity. Ensure that your core values and principles are clearly communicated, so consistency is maintained across different locations around the world. Make sure everyone understands the company's vision.
Additionally, avoid trying to force a one-size-fits-all approach. Recognize and accommodate cultural and local differences. While the core message should remain the same, be flexible and adapt as needed to fit local contexts.
One effective strategy is to establish quality champions at each site—individuals who represent and advocate for quality locally. This is especially useful even at a single site where departments may be distanced from quality initiatives. These champions can help spread the message about quality because employees are more likely to listen to someone they know personally rather than an unfamiliar "quality person." Leverage existing relationships and trust, and ensure that your quality champions are strong communicators who clearly understand and convey the message.
EMEA Office
Louizalaan 489
1050 Brussels
Belgium
US Office
Scilife Inc.
228 E 45th St. RM 9E
New York, NY 10017
EMEA Office
Louizalaan 489
1050 Brussels
Belgium
US Office
Scilife Inc.
228 E 45th St. RM 9E
New York, NY 10017
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