hero header image Mario Wijker | How to build a strong culture of quality



Mario Wijker | How to build a strong culture of quality

⭐ Introduction

The newest episode of Career Diaries by Elemed is really special – it addresses a critical topic faced by medical device, IVD, pharma and biotech companies… and beyond! Namely, how to build a strong culture of quality. A strong culture of quality in place can help an organisation predict problems before they arise. How to go about transforming the culture of quality at your own organisation? Well, here’s where our expert guest comes in…

Introducing Mario Wijker, SVP RA/QA at Bio-Rad, who sat down with Elena to discuss improving quality and the steps needed to build a strong culture of quality. This is good advice both for leaders and other quality professionals, so make sure to keep reading!

Here are some of the key learnings from the podcast, and actionable steps that can be taken to start improving your company’s culture of quality. If you want more, listen to the full podcast to discover all of the secrets that Mario shares.

🔎 What is a culture of quality?

A culture of quality is tailored differently to each organisation, depending on the risk profile of products and what they’re trying to do in the market. There is no one size fits all approach when it comes to creating a strong culture of quality. The essence of a strong culture of quality is making sure that all employees are always aiming to do the right thing and to try and do it right the first time.

Alongside this, if the organisation is thinking critically about how things can
be done better, and then executes on that, you will start to see a healthy
culture of quality emerge. Employees raising their hands when they see something is wrong, or better, when something is about to go wrong, and having meaningful and constructive conversations, obviously without retaliation, on how to do things better is the ultimate people-related outcome of having a healthy quality culture. The financial-related outcome is a significant reduction in intervention and remediation costs. Which is something that most companies surprisingly do not measure on a routine basis.

🧐 Step 1. Assess your company’s existing quality culture

You need to focus on the right areas to evaluate your quality system, through complaint management and nonconformance management. And then starting to find answers to the following questions: How are you doing on recalls? What are you spending on recalls and field actions? Then you need to start making it transparent on what that typically costs. Once you start asking the right questions and focusing on improving critical areas, you will be able to start planting the seeds for a healthy quality of culture.

💻 Step 2. Start with basic metrics

At the start of developing a strong culture of quality, it’s important to focus on what your company doesn’t have. Here are some basic metrics and models that allow you to monitor your quality system’s performance in real time. One idea that can really help you see where costly issues and bottlenecks are building is by conducting interviews with employees in critical positions in the company at all levels so from the junior production engineer to the CEO. This does not need to be a 2-hour interview but some basic questions can help you get a really good picture of where the big issues are, what the trends are, and if you are in reactive or proactive mode.

💫 Step 3: Take your configuration management up a level

Whenever an error is made in an organisation, and that error gets signed off in a lifecycle management system, the cost to remediate that error grows substantially and exponentially. Keep in mind that this applies not only to product errors, design errors, or production errors. This also applies to documentation errors. To counter this, you need to work on building a highly-responsive ecosystem where you can effectively monitor different stages of product development. Start small with some metrics and indicators, and then you build that out until eventually, you reach an overview on demand, where you can see exactly what’s happening anywhere in your quality system. So that when something bad is happening, you can act immediately, not weeks later, when you’ve already distributed this product to a lot of customers. The end goal is to reach a predictive quality management system, where you are using the data effectively to address problems before they have a material impact.

✨ Step 4. Include diversity of thought

In order to effectively be able to spot problems, and work on solutions, it’s important to have diversity of thought around the table. A balance of viewpoints can really a team’s ability to debate and problem-solve, it’s perfectly fine to have someone who is a perfectionist with a real eye for detail, and someone who wants to run through things quickly. Having different opinions can result in a superior product or service. It’s a good idea to introduce diversity of thought into your reviews, whether it’s a design review or a document review – get those different perspectives in, because sometimes you don’t know what you don’t know and that can end up being painful.

💬 Step 5. Get the message across

For a healthy culture of quality to be able to permeate an organisation, it’s important that the leadership team buy into it. In helping spread the message through the rest of the company, find the right ambassadors that you can rely on. These can be people that may not always have high leadership roles but are influential in getting the message across. This is crucial because, without them, it is just the quality person shouting from the corner of the room. Try and promote quality yourself within the organisation as much as you can, and talk to quality leaders that want to improve the culture of quality on a continual basis, they will also want to get involved.

The key is to get people across the company thinking about the end result, the outcome of a product or service on a patient, and how each step in a long process can be critical to the end result. At the end of the day, working in a life science company that wants to advance scientific discovery, or at a diagnostics company that impacts people’s health, the patient, end user and the customer must always be at the forefront of what we do.

🎙️ Summary

There is no quick solution to instantly developing a strong culture of quality, but there are steps that can be implemented to make strides toward achieving it. Once more and more employees are sharing the message and actively promoting quality within the organisation, and by applying the right monitoring metrics that give you a predictive overview, you will be on the way to reaching the type of culture of quality that all organisations should aspire to. Focusing on hiring the right people – those that always have the end-user or patient in mind and aligning other departments to the importance of quality and a strong culture of quality – will result in safer product launches, fewer errors, and potentially high sums saved through effectively spotting issues before they escalate.

If you’re excited about more quality wisdom and want to learn from someone who really knows about developing a strong culture of quality, then check out the full podcast with Mario Wijker now or watch it on our Youtube channel.

Say goodbye to wasting time and money on digitising your regulatory activities.


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