Leveraging culture to make your quality transformation a success

Pharmaceuticals and Life Sciences (P&LS) organisations increasingly look to technology and AI to transform their Quality Management Systems (QMS). However, getting the right digital solution alone isn’t the answer, as over 70% of digital transformations fail¹. We explore the importance of leveraging culture to make quality transformation a success within the P&LS landscape, with insight from industry professional, Suzanne Abdulwahed. 

Organisations are rapidly transforming their Quality Management Systems (QMS) to become more digital by building trusted data, automating processes and leveraging Artificial Intelligence throughout the whole organisation, from clinical development to manufacturing. There is increasing pressure to continuously innovate and accelerate development timelines and to meet shifts in regulation and the evolving compliance landscape.  

As organisations turn to digital solutions to enhance accuracy, speed up product development and proactively identify and manage risks there is also the requirement for their people to rapidly adapt to the digital environment and absorb new ways of working. It’s paramount to invest in people - it will ultimately be people, enabled by digital solutions, that create enhanced quality outputs and better patient outcomes. 

In our experience, most quality transformations fail because not enough weight has been given to crucial ‘people’ elements throughout the change. Change is constant and is ever-increasingly becoming part of the norm, so a standard training, communication and engagement approach is no longer going to have the impact required. Instead, organisations need to consider how they utilise their culture as the driving force behind their quality transformation and think about this up front when defining their overall strategy.    

We believe that organisations that leverage their culture are the most successful; enabling their people to have the right capability, mindsets and behaviours to not only adopt new tools but to shape and continuously evolve the digital solutions, growing capability alongside. A quality, rather than compliance, mindset has never been more crucial. 

Culture is driven by behaviours – and activated across the organisation’s operating model and embedded through the lived experience of the workforce.  Everything works together as a system, which is why culture is powerful as it determines how an organisation will achieve its goals. We have established four key questions for organisations to consider when undertaking a quality transformation, to help your people navigate, embed and sustain new ways of working. 

1. Do you have a clearly defined culture? 

Does your organisation have a clearly articulated set of values and behaviours? These defined cultural elements are important to inspire and motivate people in your organisation, whilst providing clarity of expectations of how you want everyone to ‘show up’ and behave. They form the foundations for fostering quality, which ensures that excellence is embedded in behaviours, decisions and operations – providing a common purpose and way of working that all employees can understand, work towards, and live by. Each organisation’s defined culture will be different. However, if harnessed correctly, your culture can be a powerful source of energy and influence to amplify quality, making it resonate deeply within the daily actions of your employees. This is why it is imperative for organisations to be deliberate in aligning their quality vision to their organisation’s culture as this will make it tangible and easy for their people to understand. 

2. Is your culture what you think it is? 

Although important, a defined culture only provides the clear aspiration of how you want your people to act, but this does not indicate whether people truly show up in this way. The reality may be very different. Figuring out the ‘actual’ culture is important not only for assessing alignment with the defined culture but also for assessing the quality mindset that currently exists across your organisation. By understanding the ‘actual’ culture you also gain crucial insights into the existing behaviours that can either supercharge or hinder your quality transformation. Specifically, this insight helps to: 

• Understand any misalignment from the defined culture to uncover any potential challenges that may hinder quality, enabling you to shift behaviours and ways of working that act as barriers to change
• Identify areas of variation to ascertain if certain parts of the business are different to others, so that you can develop a truly tailored approach to embed quality-focused behaviours and ways of working
• Establish a baseline for measuring progress, enabling you to track both cultural transformation and the evolution of quality outcomes overtime; and 
• Engage your people in the quality journey, showing people that you care about what they think, taking into consideration their thoughts at the early stages of the transformation programme

For example, you may be expecting people to be living your defined culture of ‘being curious’ but they focus on following the status quo and defined processes without wondering why and are resistant to digital changes. Such behaviour might clash with efforts to embed quality, particularly in areas requiring innovation and/or digital transformation.  

By measuring how different the ‘actual’ culture is from your ‘defined’ culture, you gain valuable insights into the strengths and behaviours that support quality ways of working that you can utilise and maintain; and identify potential challenges and behavioural shifts that you can actively target and influence. This will allow you to focus your efforts on embedding quality where it matters most.   

3. What are the vital behaviours that will enable your quality transformation to be a success? 

Once you understand your ‘actual’ culture, you need to consider where you should focus your attention. Systematically assess the insights against a set of pre-established criteria that are aligned to your quality transformation goals. This ensures that your approach to cultural alignment directly contributes to embedding behaviours and practices that drive quality throughout the organisation.  

Behaviours have the biggest impact on cultural change. If you can get people to behave (or act) in a different way, or strengthen existing positive behaviours, you create a foundation to sustain new ways of working whilst driving better alignment with your ‘defined’ culture and your quality strategy. An optimised, digitally enabled QMS will only be successful if you can actively target behavioural shifts that embrace new ways of doing things and prioritise quality-centric thinking.   

However, changing people’s behaviours is hard, especially when your people are faced with a defined culture to follow, a digital transformation agenda, and the adoption of a holistic QMS simultaneously as part of your quality transformation. To mitigate overwhelm, you must instead target a few vital behaviours that align with your quality transformation goals allowing you to connect all these things together.  

It will not be possible to address every behavioural or cultural aspect, nor will it be a ‘quick fix’. By targeting just three or four vital behaviours, you can focus efforts where they matter most, driving repeated actions that evolve into habits over time. When these behaviours become habitual, people will naturally behave this way without having to think about it, embedding quality into their daily routines without requiring constant intervention. Targeting simple, clear changes in specific behaviours will create habits that lead to successful, long-term change.   

A behaviour-focused approach is key to deliver scalable and sustained change.  It bridges the gap between the organisational ‘defined’ culture and quality transformation efforts by linking clearly defined, vital behaviours to employees’ everyday activities. This enables people to adopt a quality mindset in a way that feels practical, real and actionable. 

4. How do you successfully embed and sustain these vital behaviours? 

You now need to put this into action and build targeted tactics that reinforce these vital behaviours while embedding quality into the fabric of your organisation’s culture. To do this successfully you need to build a comprehensive culture change strategy that considers how to: 

• Make it personal: Create a tailored approach that allows for differences in teams. You need to prioritise what matters to each team and focus on creating momentum, demonstrating how the vital behaviours directly support quality objectives and what this means for them during their everyday
• Build authentic leadership: Formal leaders of the organisation need to consistently role model the vital behaviours that connect culture to quality ways of working
• Create moments that matter:  Highlight the benefits of a quality-driven cultural transformation through sharing real success stories and by celebrating small wins along the way
• Build immersive engagement: Instil vital behaviours directly by creating enthusiastic engagement, such as escape rooms built around business processes or new technology
• Build capability: Behavioural aspects should be built into compliance, technical and leadership learning, so people truly learn how to embed the behaviours needed to consistently deliver quality excellence
• Reward role models: Reinforce the vital behaviours by rewarding those people who demonstrate the behaviours, as part of your formal performance reviews
• Listen and action: Measure the pulse of the organisation making changes to your plan if needed; considering small nudges that will reinforce behaviours and create habits

Your QMS, and wider operating model, must enable people in ‘activating’ the vital behaviours. For example, if you want people to be curious, you must ensure your formal processes and mechanisms enable flexibility for people to explore and test new ways of doing things.   

By embedding these tactics, you ensure vital behaviours that embed quality are activated across all levels of the organisation, driving measurable and lasting transformation.   

How Baringa can help you leverage your culture to achieve success 

With our extensive experience working across P&LS, alongside our culture and behavioural change expertise, we are well placed to navigate the complex P&LS landscape to help you think holistically about people, technology and your QMS to drive successful quality transformation. We can help you: 

• Set a holistic quality transformation strategy, including culture elements 
• Diagnose your existing culture and behaviours 
• Analyse which vital behaviours will have the most impact for your quality transformation 
• Embed these vital behaviours into your organisation’s mindset and ways of working 
• Ensure your QMS, and wider operating model, are aligned to the vital behaviours 

Together, we will deliver a meaningful and sustainable quality transformation that empowers your people and organisation to thrive.  Let us know how we can help you leverage your culture to make your quality transformation a success.

References

1. $2.3trillion Wasted Globally in Failed Digital Transformation Programs – Costly and Complex Business Strategies are ‘Not Necessary’