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Interview: Pauwels Consulting’s Bold Leap into Space with ATG Europe

21 Jan 2024

Pauwels Consulting’s strategic acquisition of a majority stake into ATG Europe marks a significant development in the industry. Joining the conversation are Bert Pauwels, CEO of Pauwels Consulting, Roger Lemmens, COO of Pauwels Consulting, Gian Carlo Coletta, CEO of ATG Europe, Massimiliano Mazza, COO of ATG Europe, and Alberto Donadoni, Chief Commercial Officer at ATG Europe. Their collective insights offer a deep dive into the synergies, vision, and shared values behind this transformative business move.

Who is ATG Europe?

Gian Carlo Coletta, CEO of ATG Europe:

“ATG Europe stands as a beacon of innovation and excellence in the aerospace and big science sectors. From our modest beginnings in 1969, we’ve grown into a formidable force in the industry. Our focus has always been on pushing the boundaries of what’s possible, a pursuit that has seen us leading the charge in value-added engineering consultancy, services and solutions in thermo elastics, composite structures, and other cutting-edge areas.”

Bert Pauwels, what was the driving factor behind adding an aerospace-focused company like ATG Europe to Pauwels Consulting?

Bert Pauwels, CEO Pauwels Consulting:

“This acquisition of a majority stake aligns with Pauwels Consulting’s long-term vision. We began 24 years ago focusing on IT consultancy and rapidly expanded into Life Sciences and Engineering. Venturing into the Space industry is a natural progression for us. We always consider what added value our specialists can bring to the market, and we’ve already established successful relationships in IT, Engineering, and Life Sciences. My discussions with ATG Europe’s management have sparked numerous strategic ideas for better supporting our customers.

Risk mitigation is crucial in our volatile economy, where external factors often impact business segments. By diversifying our solutions and services, we can maintain team cohesion during slower economic times without compromising overall performance. The business world is cyclical, but with smart organization, we can navigate these cycles effectively.”

Gian Carlo Coletta, CEO at ATG Europe, Bert Pauwels, CEO Pauwels Consulting, Alberto Donadoni, CCO at ATG Europe and Roger Lemmens, COO Pauwels Consulting Is space becoming a commodity? We’ve reached a point where rockets are being launched somewhere every day.

Massimiliano Mazza, COO of ATG Europe:

“Firstly, there’s a significant distinction between non-profit organizations like ESA and NASA and their commercial counterparts. ESA’s primary goal is to establish a competitive aerospace ecosystem in Europe on a global scale. A unique aspect of ESA’s mission is ensuring every contributing member state benefits, with contributions leading to investments in local economies and access to extensive technical knowledge and facilities, a foundation laid since ESA’s inception in 1975.

This commitment impacts how we operate. Unlike commercial entities that may prioritize efficiency, our ecosystem focuses on creating hardware components suitable for a broad range of applications. Our specifications are more comprehensive and intricate compared to the more singular focus of commercial projects. For example, in the Ariane project, we collaborate with over 15 countries on component development, which are then transported to launch sites like Kourou. While this approach incurs additional costs, it aligns with ESA’s principle of inclusive space exploration.

This model has also inspired new collaborative methods. For the upcoming ExoMars mission, we have developed a crucial parachute component for the release of the parachute and allows a smooth Mars landing, prompting us to explore innovative collaboration models across Europe. To streamline this process, we’ve invested in the ‘Space Campus Noordwijk Avatar,’ a 3D lab offering VR and AR facilities for all involved parties. This not only facilitates the transition from concept to component but also serves training purposes. Working with ESA’s complex requirements presents unique opportunities for ATG Europe to distinguish itself in the sector.”

Massimiliano Mazza, Chief Operating Officer at ATG Europe

Gian Carlo Coletta, CEO of ATG Europe:

“I also want to emphasize Belgium’s significant role in ESA, despite being a smaller country, illustrates that space exploration isn’t just a commercial commodity. Belgium’s investment in ESA reflects a broader commitment to space science and industry, reinforcing the idea that space exploration transcends mere commercial pursuits. Our consistent contributions position us as a key player in the industry, driven by a belief in the importance and potential of space exploration.”

What is ATG Europe’s strategy for capitalizing on the emerging opportunities in the “cislunar” economy?

Alberto Donadoni, Chief Commercial Officer at ATG Europe:

“Researching “cislunar economy” reveals the potential of utilizing resources and strategic locations between Earth and the Moon for economic gain. The concept of space-based biomanufacturing and pharmaceutical research has transitioned from a mere vision to reality, as we’ve significantly reduced transportation costs. Increasingly, new market entrants seek our solutions and products, operating at a pace that surpasses the public sector and drives innovation rapidly. We envision serving a broad spectrum of clients, from the public sector to commercial space entities, all while maintaining our high standard of quality.

As rocket launches and space technology become more commonplace, a variety of companies are emerging that offer services leveraging this hardware. For example, insurance companies are using satellite data to provide farmers with models to protect their crops and harvests effectively. Similarly, governments are utilizing satellite data for organizing aid and response in the aftermath of major disasters like earthquakes.”

Roger Lemmens, COO Pauwels Consulting, the transition to a solutions-focused approach has been a key topic in this acquisition. How do you see this shift impacting Pauwels Consulting, especially in Life Sciences, Engineering, and IT?

Roger Lemmens, COO Pauwels Consulting:

“The evolution towards a solutions-centric approach marks a significant stride for Pauwels Consulting across all our domains. In Life Sciences, Engineering, and IT, moving beyond offering mere services to providing holistic solutions is transforming how we engage with our clients. For instance, in Life Sciences, our integration with ATG Europe enables us to leverage space-based platforms for advanced pharmaceutical research, providing innovative solutions that were previously unattainable. In Engineering and IT, this shift means we are not just executing projects but also strategically involved in the planning and development phases, ensuring a more integrated and efficient solution for our clients. This holistic approach allows us to address complex challenges in a more cohesive manner, ultimately enhancing the value we deliver to our clients.”

Massimiliano Mazza, can you share any significant upcoming milestones for ATG Europe?

Massimiliano Mazza, COO of ATG Europe:

“In mid-2024, we’re excited about a major milestone where a rocket equipped with our patented ATG technology will be launched. This technology outperforms current standards, as we’ve developed rocket parts that uniquely balance superior thermoelastic properties with minimal mass. The principle is straightforward yet impactful: the lighter the rocket’s structural components, the greater the payload it can carry into space with less fuel. While other companies might produce similar parts, our technology stands out in terms of quality and the extent of weight reduction. This innovation not only reduces costs but also significantly enhances payload capacity. With the ongoing competition for lightweight yet robust components, ATG Europe is proud to be at the forefront with this advanced technology.”

How was the initial personal interaction between Pauwels Consulting and ATG Europe? Was there an immediate connection from the beginning?

Bert Pauwels, CEO Pauwels Consulting:

“From the very first meeting, there was an undeniable sense of magic in the air. For me, successful partnerships go beyond just numbers; they’re rooted in what I like to term as an ‘inter-human click.’ This is about aligning on deeper company values that extend far beyond mere words on a website’.

Alberto Donadoni, Chief Commercial Officer at ATG Europe:

“In our initial meeting, we engaged in open and constructive dialogue about our values and strategic direction, setting the stage for ATG Europe’s next evolutionary phase. We recognized the need for a paradigm shift as our organization grows. As we approach the milestone of 500 ATG Europe employees, the necessity to enhance our mental approach, support structures, back-office operations, and systems becomes imperative. Partnering with Pauwels Consulting offers a solution. Their experience in scaling and developing business strategies presented us with an opportunity to leverage new tools and insights for business development.

Aligning with Bert Pauwels on what he said earlier on risk mitigation strategies, we acknowledge our focus on public procurement, contrasting with Pauwels Consulting’s strength in B2B sectors. This partnership brings an essential element of diversification to ATG Europe, especially crucial as we navigate the commercialization of space exploration. Our commitment to maintaining quality in the public sector remains steadfast even as we expand into new markets.

Many organizations struggle to adapt quickly when merging, but with Pauwels Consulting, we found a partner that understands our unique business challenges and is adept at navigating new domains with significant synergistic potential but leaving the freedom to operate autonomously. Their ability to comprehend and integrate into areas unfamiliar to them, yet ripe with opportunity, has been a key factor in the successful blending of our two companies.”

Massimiliano Mazza, how do you view the less apparent synergies between ATG Europe and Pauwels Consulting, beyond the obvious ones?

Massimiliano Mazza, COO of ATG Europe:

“It’s essential to look beyond the obvious when considering synergies. Our approach, shared with Pauwels Consulting, focuses on harnessing existing potential while preserving each company’s unique culture. We need to adapt, certainly, but not by imposing forced changes.

ATG Europe’s growth is a testament to our robust business model, which I believe adds significant value to the Pauwels Consulting . The real synergy lies in understanding how our business models can complement each other. Many mergers fail because they don’t prioritize customer interest. Our goal is to communicate to our customers the benefits of this collaboration, ensuring that it positively impacts their business, rather than just telling a compelling story.”

What are ATG Europe’s thoughts on the concept of “business synergy” and “people synergy”?

Gian Carlo Coletta, CEO of ATG Europe:

“At its core, the union of our two companies allows Pauwels Consulting to immediately step into the realms of space and big science. However, the fundamental catalyst for this alliance was our strong initial rapport with Bert Pauwels. His vision and profound respect for people resonate closely with our values. Frankly speaking, our greatest asset is our people. Unlike selling cars or constructing buildings, our business thrives on the expertise of our team, which adds significant value to our customers.

This mutual respect for our teams was a key factor in deciding to join forces with Pauwels Consulting. The next step is to nurture this shared principle and develop a unified strategy that prioritizes the interests of our customers.”

Massimiliano Mazza, COO of ATG Europe:

“From our initial meeting with the Pauwels team, it became evident that Pauwels Consulting’s strengths in bio medics, pharmaceuticals, and life sciences align well with ATG Europe’s capabilities. A key area for collaboration is the innovative testing of medicines, where traditional Earth-based lab tests have limitations. ATG Europe’s access to the International Space Station (ISS) for zero-gravity experiments offers a unique opportunity to enhance pharmaceutical research. This partnership is more than theoretical; it’s a practical step towards revolutionizing medical treatment testing.

Additionally, Pauwels Consulting’s expertise in civil engineering and project management complements our emerging role in the fusion energy sector. With the development of fusion reaction plants, Pauwels Consulting’s long-standing civil engineering knowledge becomes invaluable. This synergy excites us as we explore and combine our skills and solutions to benefit our customers.”

And how does the Pauwels Consulting perceive the synergies between Pharma and Space, especially in the context of this acquisition?

Roger Lemmens, COO Pauwels Consulting:

 “The synergies between Pharma and Space are particularly exciting and innovative. With ATG Europe’s expertise in space technologies and our strong background in Pharma, we are positioned to explore ground breaking opportunities in pharmaceutical research and development. The microgravity environment of space offers a unique platform for drug development and testing, potentially leading to more effective treatments. These synergies allow us to push the boundaries of what’s possible in medical science, offering new solutions to age-old problems. The combination of ATG Europe’s space capabilities with our extensive experience in Pharma creates a powerful platform for innovation, setting the stage for ground breaking advancements in healthcare.”

Is it accurate to say that the space aviation industry is transitioning from providing services to offering comprehensive solutions?

Massimiliano Mazza, COO of ATG Europe:

“Absolutely, our shift towards providing complete project solutions has been a strategic focus in response to market demands. ATG Europe specializes in delivering cutting-edge space composites, encompassing everything from engineering to production. Our involvement often begins early in the project cycle, particularly in structural and thermal engineering, a testament to the trust we’ve earned over the years. Our comprehensive capabilities allow us to perform thorough assessments and audits, enhancing our clients’ return on investment.”

Bert Pauwels, CEO Pauwels Consulting:

“Pauwels Consulting is aligning with these market changes, transitioning from offering basic services to all-encompassing solutions. This shift is particularly significant in the Life Sciences sector, where we’re expanding our expertise. Integrating our knowledge in Life Sciences with our skills in Engineering and IT enables us to not only meet but surpass client expectations. Our cross-disciplinary approach allows us to deliver diverse, effective solutions, providing clients with comprehensive and efficient services. Partnering with ATG Europe strengthens our commitment to adding value throughout the project lifecycle, from conception to completion.”

What about ATG Europe’s approach in sectors beyond space, like Big Science, and your leadership in areas like Thermo Elastics and Composite Structures?

Gian Carlo Coletta, CEO of ATG Europe:

“Our unique market position is largely thanks to our in-house team, capable of handling entire projects from start to finish, not just offering consultancy. This dual capability in providing top-tier consultancy to ESA and F4E and advanced engineering skills sets us apart. Our long-term investment in this area is our best validation. One of our management team’s proudest achievements is successfully combining consultancy and project execution, breaking down barriers between these divisions for a more cohesive approach to serving our clients. This strategy offers real added value, moving beyond theoretical models to practical, impactful solutions.”

How do ATG Europe attract all that high quality people?

Alberto Donadoni, Chief Commercial Officer at ATG Europe:

“Space and Big Science are very appealing for young people, a lot of them are mechanical engineers who are more interested in building a rocket ship than a road. And I say this without scolding the wonderful Pauwels Consulting Engineering colleagues who are doing a remarkable job at so many landmark constructions site as bridges and tunnels all over Europe. It’s just that we reach that small percentage of engineers who dream to get their work to space and nuclear fusion.

Our Dutch office is near the TU Delft, the biggest pool of talent in space science and engineering. We have a strong collaboration with them feeding a continuous flow of talent that would like to develop its talents. If you’re interested in aerospace and structures than we’re number one on many students list of dream company to work for. We’re also in the sweet spot where our company is big enough to matter to our customers but offer each of our colleagues enough impact on the projects and consultancy we offer. None of them is a single element, they are all aware that it’s the combination of individual talents that brings us to the next level.”

The current management of ATG Europe stays in the driver seat and step into the new partnership, how important is this for you Roger?

Roger Lemmens, COO Pauwels Consulting:

“The decision to retain the current leadership team of ATG Europe in our partnership with Pauwels Consulting is a momentous one. It demonstrates our unwavering confidence in their capabilities and in the collective prowess of the ATG Europe team. This decision goes beyond being a strategic business move; it is a heartfelt acknowledgment of the human factor that is integral to our success.

Leaders such as Gian Carlo, Massimiliano, and Alberto possess an intimate understanding of the unique strengths, work culture, and challenges specific to ATG Europe. Their leadership has played a pivotal role in the company’s accomplishments and resilience.

By keeping this leadership team at the helm, we are reaffirming our dedication to preserving the values, practices, and culture that have been firmly established at ATG Europe. This is vital to ensure that the distinctive qualities of ATG Europe not only endure but also continue to guide the trajectory of our shared future.

This approach is a tribute to what sets ATG Europe apart, all the while exploring new avenues for growth and progress through the combined resources and strengths of Pauwels Consulting.”

Gian Carlo Coletta, how would you describe the company culture at ATG Europe?

Gian Carlo Coletta, CEO of ATG Europe:

“I can say without patting ourselves on the back that we have an excellent company culture: friendly, open driven by a flat organisation. We do work hard but the never forget to celebrate birthdays and successes. My door is literally always open, and I have the habit to jump into offices to feel the temperature and learn what they are working on.”

Which brings us to company values, it seems that the “Shoot for the moon” value of Pauwels Consulting already paved the path to this deal but does ATG Europe recognizes themselves in the Pauwels Consulting values?

Alberto Donadoni, Chief Commercial Officer at ATG Europe:

“Absolutely, there’s another Pauwels’ Value that aligns perfectly with our company’s culture, and that’s “challenge the status quo.” Every step we’ve taken to elevate ATG Europe has been rooted in thinking outside the box. It all starts with identifying the customer’s pain points, comparing them to their constraints, gaining a deep understanding, and then presenting solutions that check all the boxes. The pace of progress has evolved rapidly, and our ability to adapt swiftly is ingrained in our DNA.

Now, let’s talk about the “We are a strong family” value of Pauwels. We boast an exceptionally outspoken and brilliant group of employees who can’t be easily fooled, and transparency is the cornerstone of our interactions. We treat people with fairness, just like in any close-knit family, but we go the extra mile by encouraging them to face daily challenges head-on. It’s the strong bond among ATG colleagues that empowers them to excel in an increasingly complex environment day in and day out.”

Bert Pauwels, could you comment on the importance of having Andera Partners on your side as a new investment partner?

Bert Pauwels, CEO Pauwels Consulting:

“The involvement of Andera Partners is a significant milestone for Pauwels Consulting. Their investment and support are pivotal in our strategy to accelerate the growth and development of our group. Andera Partners brings not only financial backing but also strategic insights and a network that enhances our capabilities. Their belief in our vision and commitment to our growth is a testament to the potential they see in Pauwels Consulting. This partnership is instrumental as we integrate ATG Europe and expand our reach, allowing us to venture into new markets and domains with confidence and a strengthened foundation.”

To conclude, there is a Latin saying going back 2000 years: “per aspera ad astra” which translated means “through hardships to the stars,”

Bert Pauwels, CEO Pauwels Consulting:

“That’s very applicable to how you build a business. Just like the journey to the stars is not without its challenges, the path to building a successful company is paved with obstacles and learning experiences. Every difficulty we encounter and overcome fortifies our resolve and enhances our capabilities. At Pauwels Consulting and ATG Europe, we embrace these challenges, knowing that they shape us into a more resilient and innovative organization, better equipped to serve our clients and achieve our goals. This philosophy has been integral to our growth and success, guiding us as we expand our services and expertise, particularly in the dynamic fields of Life Sciences, Engineering, and IT.”

Gian Carlo Coletta, CEO of ATG Europe:

“And remember, in the universe of Space and Big Science, the sky’s not the limit – it’s just the beginning!”

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maxime_van_belle
Maxime van Belle Content Marketeer
+32 9 324 70 80
contact@pauwelsconsulting.com

Insights

Avoiding the Car Crash of Knowledge Loss

11 Jul 2023
Discover the importance of knowledge transfer and organizational development, as external consultants seamlessly integrated into workflows help mitigate the disruptive effects of retirement. Delve into sustainable strategies for knowledge transfer and talent management. Take part in the dialogue to reshape the future of talent management and create a meaningful, long-lasting impact.

Imagine driving for the first time a car with just written directions. How long would it take before you hit a wall? That’s why a live aid comes into play. An instructor is there with you every step of the way. They don’t just tell you; they also observe, correct, and encourage you. They make a potentially disastrous situation a great learning opportunity by their expertise and real-time guidance.

Knowledge centers

In the same way, integrating learning into the workflow in our professional lives requires more than written pre-read instructions. As a keynote speaker at our latest Pauwels Consulting Customer Round Table, Cathleen Heimberg of Showpad, a renowned Learning & Development Specialist, made this point. Pharma, biotech, and engineering industry representatives contributed to the discussion with their unique perspectives. We explored not only knowledge curation but also how external consultants play a crucial role as “a drive instructor” in these processes, as well. And while the concept of “knowledge centers” is a solution to most of our customers we should not shy away from admitting the considerable challenges that come with implementing these platforms.

Cathleen Heimberg
Cathleen Heimberg, Showpad

“When the consultant leaves, we need to start all over again.” This sentiment is one that echoes through organizations across industries when external consultants complete their engagements and bid farewell. The departure of a consultant can often leave behind a void, disrupting the workflow and creating a sense of starting from scratch. This phenomenon highlights the need for a more sustainable and integrated approach to knowledge transfer and organizational development.

The impact of natural de-staffing

The departure of external consultants is not the only challenge organizations face when it comes to knowledge transfer and organizational development. Our customers bring an additional dimension to this problem, particularly with the natural de-staffing caused by the retirement of their own workforce. One of our customers is currently confronting a significant knowledge drain, as a whole generation of baby boomers, who constitute one-third of their workforce, is set to retire within the next two years. This impending wave of retirements further emphasizes the importance of implementing sustainable strategies for knowledge transfer and ensuring the continuity of operations.

Our panel of customers addressed how the knowledge drain resulting from impending retirements, organizations can benefit from the involvement of subject matter expert consultants. These consultants play a crucial role in organizing, maintaining, and distributing knowledge transfers for customers who are facing significant workforce changes due to retirement. “Embedded” consultants possess a deep understanding of the organization’s specific needs and can develop tailored strategies to capture and preserve critical knowledge. By actively engaging in the transfer of expertise, these consultants help mitigate the disruption caused by retirements, ensuring a smoother transition and minimizing the sense of starting from scratch. Their expertise and dedication contribute to a more sustainable and integrated approach to knowledge transfer and organizational development, enabling organizations to effectively navigate the challenges posed by an aging workforce.

Talent management and knowledge curation

The panel acknowledged that the absence of a well-planned knowledge transfer mechanism means that organizations must retrace their steps and rebuild the understanding from scratch. Tom Kiebooms, our senior consultant, and subject matter expert in MES and Digitalisation, shared his ground-level experiences, reinforcing the critical importance of talent management and knowledge curation. A small detail can make all the difference; when a Pauwels Consulting employee attends a training, it’s common for his colleagues who work directly for our customers to attend as well.

Having the consultant aboard embeds the knowledge into the workflow and the main reason for this is known to all: we’re losing the war for talent. As one senior panelist put it: “We’re fighting for talent using methods that failed last time.” A point challenged by Koen De Borle, Business Unit Manager Training Programs at Pauwels Consulting. Talent is available, but it needs to be reskilled to be a perfect match for the customers. In comes the Training Program: new ways of working require us to upskill and reskill ourselves, particularly when it comes to self-management skills such as active learning, flexibility, leadership, and social influence. To meet the ambitions and talent of customers, Pauwels Consulting creates training programs tailored to the needs of today’s clients and focusing on the expertise of tomorrow.

Shared talent pools

Koen De Borle concludes: ‘It is no longer the case that staffing is just a solution to a resource problem. Consulting as a service not only satisfies urgent organizational needs, but also contributes to our customers’ strategic growth. In the ongoing war for talent, knowledge sharing in workflows, talent pools shared among multiple customers, and subject matter experts play a vital role in customer success. Establishing communities of practice or internal networks can facilitate the exchange of knowledge and experiences among employees. These forums provide a platform for ongoing learning, collaboration, and problem-solving. By nurturing a culture of knowledge-sharing, organizations can minimize the impact of consultant departures and foster a sense of collective expertise.”

Koen De Borle, Pauwels Consulting

The collaborative approach outlined above is not only essential for ensuring business continuity but also a recipe for achieving substantial return on investment (ROI) for our customers. It begins by actively listening to the explicit and implicit needs of our clients. Whether we call it co-business development or by any other name, a tailored approach is the X factor that differentiates true success for all parties involved from mere staffing solutions. By understanding and addressing the unique requirements of each customer, we can deliver outcomes that go beyond mere resource provision and create long-term value. This customer-centric approach forms the foundation for building lasting partnerships and achieving mutual success.

5 moments of need

This collaborative mindset brings us back to the hypothetical exercise of driving a car with only written instructions. Cathleen Heimberg introduced the panel to the “5 Moments of Need” learning and development methodology, developed by Conrad Gottfredson and Bob Mosher. This method focuses on addressing performance needs at the moment of learning and the moments of applying or changing knowledge in the workflow. As a certified 5MoN Designer she pointed out the five different learning needs of a person.

  1. New: When individuals are learning something for the first time.
  2. More: When individuals need to deepen their knowledge or skills.
  3. Apply: When individuals need guidance while performing a task or applying knowledge.
  4. Change: When individuals need support to adapt to a change in processes, tools, or technologies.
  5. Solve: When individuals encounter a problem and need to troubleshoot or find a solution.

Solutions that work are according to Cathleen Heimberg:

  1. Blend Learning Modalities: Utilize a blended learning approach to deliver training content. Combine traditional training methods, such as instructor-led sessions or e-learning courses, with performance support tools, job aids, microlearning, and on-the-job training. This enables employees to access the right information and support at the moment of need.
  2. Integrate with Workflow: Integrate training materials and resources directly into the workflow to make them easily accessible. This can include embedding job aids or knowledge repositories within software applications, providing quick-reference guides, or using mobile apps that offer on-demand learning and performance support.
  3. Provide Just-in-Time Support: Offer performance support tools or resources that can be accessed at the moment of need. This might include interactive online guides, videos, searchable knowledge bases, or chatbots that provide real-time assistance and answers to questions.
  4. Continuous Reinforcement: Implement strategies to reinforce learning and encourage continuous improvement. This can involve ongoing assessments, knowledge checks, performance reviews, refresher courses, communities of practice, or mentoring programs.
  5. Measure Effectiveness: Regularly evaluate the effectiveness of training interventions by measuring performance improvements, employee feedback, and business outcomes. Use this data to refine and improve the training programs over time.

Training in the workflow

Koen De Borle describes this as vital underlaying principles in the Pauwels Consulting training program. “The key is to make training resources easily accessible, contextual, and available at the point of need. By integrating training with the workflow, employees can seamlessly access the information they require, reducing the time spent searching for answers and enabling them to perform tasks more effectively, a vital underlaying principle in the Pauwels Consulting training program.”

This customer round table has resulted in all panel members seeing an opportunity to transform knowledge sharing and embrace a new approach that will help both our consultants and their customers succeed in the future. It was evident that the enthusiasm in the room was palpable as we concluded the thought-provoking session. The commitment to advancing our industries and fighting the talent war is unwavering. The journey does not end here. During the second session, we will continue this vital dialogue and gain even more insights into talent management. Together, we can reshape the future of talent management and make a lasting impact.

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maxime_van_belle
Maxime van Belle Content Marketeer
+32 9 324 70 80
contact@pauwelsconsulting.com

Insights

Tips Lean IPD

10 Jan 2023
Lean IPD allows you to complete large construction and infrastructure projects faster and cheaper. These Lean IPD tips increase your chances of success:
  1. Select the right partners.
  2. Start on time.
  3. Involve all parties.
  4. Illustrate the benefits.
  5. Change and people management are crucial.
  6. Consult external experts.

Essential tips for optimal success with Lean IPD

Lean IPD is a relatively new but highly efficient method for delivering large construction and infrastructure projects within time and budget. Lean IPD combines principles from Lean Management with intelligent contracts between different builders.

Lean IPD contracts ensure that all builders benefit from a quick and cost-effective project. The more risk the partners take and the faster and more economical they deliver, the more profit they can make.

Sounds good, of course, and the following Lean IPD tips will give increase the chances of a successful project even further. 

6 tips for successfully applying Lean IPD

1. Select the right partners

Lean IPD depends on good cooperation between all partners in the construction or infrastructure project. All partners must be reliable, willing and able to cooperate optimally. Otherwise, a Lean IPD project becomes loss-making for all parties involved. Everybody wins or everybody loses.

Therefore, think carefully in advance about the criteria that will be used to choose potential partners.

2. Start on time

Lean IPD expects you to make clear agreements with all partners early in the project. Each party must think carefully and disclose their costs, the lead time of the works and the risks they can take.

Only when everyone has put their cards on the table, the Lean IPD contract is drawn up and the project can begin. The sooner there is clarity, the better.

3. Involve all parties from the beginning

Lean IPD assumes that you come to good agreements with all builders early in the process. After all, all partners sign the same common contract. The information and choices of one builder can influence the choices of another.

Therefore, involve all parties from the start in determining timelines and risk appetite. Adding parties to the contract at a later date is usually less easy.

4. Make sure everyone understands the benefits of Lean IPD

Lean IPD is only successful when all parties are committed to the project in the best possible way. To achieve this, all parties must understand the benefits of Lean IPD, both for the project (fast and budget-friendly delivery) and for their own company (increased profits).

The added value of Lean IPD is determined by the risk all stakeholders are willing to take. If they are sure of their delivery capabilities and cooperation, then they can put more money at risk for the chance to make more profit from the project.

5. Provide good change management and people management skills

Since a lot is decided beforehand and the interests of all parties are fixed in one common contract, changes during the project are often extra sensitive.

Provide a project manager with good change management and people management skills who uses open communication to get all partners to accept and comply with necessary changes during the project.

6. Make use of external experts

When different parties need to be aligned, it can be useful to call on an external party who can stand back and objectively view and reconcile different points of view.

External experts can also play different roles in the different phases of Lean IPD projects:

  • during the preparation phase, an external expert can help with risk simulations and contract negotiations.
  • during the project, an external expert can help align (the external interests of) the various parties.
  • after the project is completed, an external party can objectively look back on the project and collect lessons learned. Towards future projects, this can be particularly useful.

More Lean IPD tips?

Are you interested in Lean IPD? Do you want to make your construction or infrastructure projects more efficient? Contact us without obligation. Our Lean IPD experts are happy to help you.

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maxime_van_belle
Maxime van Belle Content Marketeer
+32 9 324 70 80
contact@pauwelsconsulting.com

Insights

The benefits of Lean IPD

28 Nov 2022

What are the benefits of Lean IPD?

Thanks to Lean IPD, large construction and infrastructure projects run much more efficiently. This can lead to more profit for the builders and designers, and savings and a faster delivery for the client. A win-win situation for all parties!

What are the benefits of Lean IPD?

Lean IPD offers many advantages for clients, builders and designers of large construction and infrastructure projects. The reason is simple: every party sits at the table from day 1. When all parties communicate openly about their project costs and the desired profit they want to make, 1 contract can be drawn up that unites the interests of the whole project team.

In this article, we discuss the specific benefits of Lean IPD for owners, builders and designers during large construction and infrastructure projects. 

Why should you choose Lean IPD?

General benefits of Lean IPD

In the United States, Lean IPD has already proven that it can make large construction and infrastructure projects run more efficiently. By uniting the interests of owners, builders and designers into 1 contract, everyone works towards the same goal.

If the project goes well, everyone makes a profit. If something goes wrong, all parties share in the extra costs. The exact amounts are laid down in the risk/reward plan, which is an integral part of the contract that all parties sign.

Wondering if Lean IPD would benefit your projects too? Let’s find out!

Advanages of Lean IPD for the construction team

Lean IPD offers several benefits to construction partners.

First, more thought is given to each step of the process, as all parties constantly consult with each other. As a result, everyone works together more efficiently, saving time and resources. That gives builders the opportunity to deliver the project earlier and/or under budget. We’ve said it before: this allows the partners to make additional profits.

Moreover, the builders will never make a loss. How is that possible? The client always continues to pay the necessary costs, even if they were not initially included in the budget. So as a builder, you will always at least break even. Lean IPD therefore offers you unprecedented certainty.

As an owner, that cost guarantee probably seems like an unpleasant prospect. But don’t forget that you only have to start using your own funds as a last resort. For the first unforeseen costs, you can call on the contingency, and later on the profit at risk. You will only have to pay extra yourself when these funds are exhausted, which is extremely rare in practice.

Advantages of Lean IPD for the owner

There are many disadvantages to traditional working methods for owners. Uncertainty about the final cost and effective completion date, possible penalty clauses in contracts….

These disadvantages are resolved by Lean IPD, where most projects are realized faster and for a lower budget. The builders communicate transparently about costs and profits, and work together more closely. As a result, there are fewer unexpected costs, and you have a better idea in advance about the final price of your project.

By the way, did you know that Lean IPD projects are delivered 19% faster on average? As a result, your factory can go into production sooner, for example, and therefore start generating profit sooner.

Conclusion

The benefits of Lean IPD are clear for each party. By motivating the team, a Lean IPD project runs smoother and more efficiently, allowing everyone to make more profit.

Want to learn more about Lean IPD ? Find out here if Lean IPD would benefit your projects. Want to delve into the risk/reward plan? You can do so in this blog post. In our next article, we will take a look at the pitfalls of Lean IPD, and present possible solutions. Stay tuned!

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Insights

Lean IPD contract

21 Nov 2022

What is special about a Lean IPD? 

In a Lean IPD contract, the builders, designers and the client sign the same contract. In this, everyone communicates openly about their estimated costs and profit demand. They put that profit “at risk,” allowing them to increase their profit, but also lose it. That motivates everyone to work together more efficiently and economically. 

How do you create a Lean IPD contract?

To implement Lean IPD, your construction or infrastructure project and working methods must meet a number of conditions. Here’s how to draw up a conclusive Lean IPD contract, and what you need to do so.

The basics of Lean IPD

Lean IPD aims to make construction and infrastructure projects more efficient. The methodology can be boiled down to 3 basic pillars: an aligned contract, lean construction and a project culture that focuses on collaboration.

If each party follows this philosophy, everyone can reap the benefits. Otherwise, every party involved experiences disadvantage. With Lean IPD, you win together, or you lose together.

The ground rules of Lean IPD are established in a Lean IPD multiparty contract between all parties involved.

Lean IPD multiparty contract

A Lean IPD multiparty contract, as the name suggests, is a contract with multiple parties. In traditional construction projects, the client signs a contract with the designers, and another contract with the builders. Those parties then often subcontract with other companies, which again have separate contracts.

With Lean IPD, the client, the designers and the builders all sign the same contract: an ‘integrated form of agreement’. Other parties involved join the project as subcontractors or co-sign the original contract.

When the builders or designers hire other parties, they get to choose whether they sign a traditional contract, or have the subcontractors join the Lean IPD contract.

Risk and reward

In a unified Lean IPD contract, a maximum price is set for the entire project. That maximum price consists of all costs and overhead, the profit all the partners want to make, and a contingency for unforeseen costs.

In Lean IPD contracts, the construction team puts their profit ‘at risk’. If everything goes according to plan, then the construction partners can increase their profit. If the project misses the deadline or costs more, the construction partners break even. Unforeseen (overhead) costs are always guaranteed to be paid by the owner, even if they were not planned in advance.

Risk/reward plan

Those risks and rewards are moulded into a risk/reward plan. This is a crucial part of a Lean IPD contract. 

Profit at risk

As mentioned above, construction partners put their intended profit at risk at the start of the project. All partners report their profit amount, and those amounts are added up to 1 large lump sum amount. The entire team agrees to put (part of) that amount ‘at risk’.

Ideally, each party should put their target profit 100% at risk. Why? Because then they can also get the biggest bonus. If they put only 75% at risk, the parties also get only a maximum of 75% of the bonus to which they would otherwise be entitled.

What if things go well?

If all goes well, then all parties receive their requested profit in full at the end of a project.

If things go even better and a project is delivered too early and/or (way) under budget? Is the contingency not fully utilized? Were smart cost savings made during the project? Then the amount saved is distributed as additional profit to all contractors and the owner.

A nice bonus, and a very good incentive to work together even better and more efficiently.

What if things go wrong?

When unexpected costs come up, the owner initially uses the contingency to pay for those extra costs. Has that amount been used up as well? Then he draws on the combined profit lump sum – made up from the ‘profit at risk’ of all parties – to pay the costs.

It does not matter which party spends more than expected: all parties lose part of their profit if the owner has to use the lump sum to pay for unexpected costs.

This encourages all parties to work well together to avoid problems. This is completely different from traditional projects, where blame is often placed on each other to avoid penalties.

Contingency  

So how do you determine the contingency amount? 

Current uncertainties

At the beginning of a project, your view of the total cost is not yet clear. At that point, you will set the contingency higher than when you are further advanced in the design phase of the project.  

You also need to look at the budgets and cost proposals of all parties. Is one partner setting their costs too high so they can ‘save’ later and get more profit? Then you can set the contingency lower to keep the cost from spiralling out of control.  

Future uncertainties

Do you know in advance that certain things will need to be figured out on the spot? Or do you anticipate a problem with your building application? Then you can set your contingency higher to absorb those costs.  

However, try to avoid this. Find out in advance what the problem is and foresee a solution. Otherwise, you will probably provide too much or too little money. In that case, you as the client will have to pay more anyway.  

Can you really not solve the problem or uncertainties at the beginning of the project? Then provide a larger amount for the contingency, but be specific in the contract. What do you (not) expect from the solution, and what do you (not) want to pay for? This way, you already prepare the change order (modification of the contract), and you will have fewer big surprises and/or time-consuming discussions later. 

Reward  

What if the parties are entitled to additional profit? In a Lean IPD contract, you specify how any extra profit will be divided between the owner and the construction parties.  

For example, you can take into account the contingency amount. The smaller the contingency, the more risk the project team has of losing their profit. In that case, they earn a larger share of the extra profit. Is the contingency relatively large? Then the owner can claim a larger piece of the extra profit for themselves.  

You can also choose to work with tranches. The first 2% savings go to the owner, the next 3% extra profit is shared among everyone else, and so on….  

Finally, you can also opt that profits from savings are shared among all parties up to a certain limit. Often owners choose to pay everyone until they have made 50% or 100% more profit than they first intended. After that, the remaining amount goes to the owner anyway. 

Change orders

Of course, things can still change when the contract is already signed. That is why we have change orders. These are changes to a project that will lead to changed results, delivery terms or costs. Change orders are only later included in the contract.

There are 3 changes that can lead to a change order:

  • Problems with the government: An institution is being difficult regarding a permit, legislation is changing….
  • Unexpected obstacles: Sometimes the team does enough preliminary research and still run into unexpected problems. This leads to a change order only if they really could not discover or research the problem beforehand. Otherwise, the responsibility is borne by all parties in the project, and the owner can pay for those unexpected costs with the contingency or the profit lump sum amount.
  • Assignment changes: The owner can change the assignment when the project is already underway.

Errors, coordination problems, wrong resources and methods, equipment replacement… do not trigger a change order. These problems are all solved in Lean IPD with money from the contingency and profit at risk. 

Conclusion

A Lean IPD contract is very different from traditional construction and infrastructure contracts. The owner, designers and builders sign the same contract, communicating openly about their (expected) net costs and desired profits. That information is put into a risk/reward plan.

In a limited number of cases, that contract can be modified with change orders, but usually the costs for unforeseen challenges in the project are paid for with the contingency and profit at risk lump sum amount.

Is the contingency amount not (fully) used? Then the project team and the project owner are paid additional profit. This encourages everyone to make the project as economical as possible, thus increasing the profit for everyone.

Are the contingency and the profit at risk used up, and will additional costs be required to complete the project? Then the owner will continue paying the costs of the construction team, so the project partners will always break even.

Want to know more?  

In our next article, we will elaborate on the benefits of Lean IPD in construction projects. Then we will discuss possible problems and their solutions, and give tips on how to apply Lean IPD successfully. 

Do you want to know more about Lean IPD or utilize Lean IPD in your next construction or infrastructure project? Contact us. Our Lean IPD project team is happy to think along with you.  

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Pauwels Blog

What is Lean IPD?

14 Nov 2022

What is Lean IPD? 

Lean IPD makes construction and infrastructure projects more efficient. With Lean IPD, all (main) parties sign 1 multiparty contract. Thanks to a risk/reward plan, all parties can potentially lose or double their profit. This encourages everyone to work together efficiently and deliver the project on time and within budget.

What is Lean IPD?

Most industries are becoming more productive. Except for the construction industry, where productivity has actually been declining in recent years. This shows a clear need for a new way of working to make construction projects more efficient. Enter Lean IPD.

Lean IPD stands for Lean Integrated Project Delivery. This way of working is based on 3 components:

  • Aligned contract: The client, the design team and the builders of a (construction) project sign a single contract together. Within this contract, they can increase their profit margin when they cooperate efficiently, but also lose their profit when the construction project is delayed. In this way, all parties are encouraged to finish the project on time and within budget. Everyone wins, or everyone loses. 
  • Lean Construction: All parties work with streamlined processes and strive to continually improve these processes. The workflow should be as efficient as possible.
  • Collaborative culture: It is crucial that all parties work together as effectively as possible and keep one goal in mind: the project.

So all parties work together to achieve the same goal. This efficiency generally improves project results and makes projects more cost-effective, as there are fewer delays or budget overruns.

Is Lean IPD useful for you? 

Do you need Lean IPD for every project? No. Lean IPD is especially useful for projects: 

  • that will cost more than €750,000 due to their complexity,
  • that involve multiple parties,
  • that operate with multiple delivery schedules.

In short, Lean IPD is especially useful for large, complex projects.

Where is Lean IPD being used? 

In the United States, Lean IPD has been well established for a decade, as most large construction projects (for example hospitals) there use Lean IPD by default. Meanwhile in Europe, Lean IPD is already well established in Great Britain and Poland. The rest of Europe is soon to follow.

An increasing number of large projects are also carried out in Belgium using the Lean IPD methodology. And when large companies start implementing it, smaller companies that are working on the same project have to follow. This way, the methodology becomes more and more widespread. A well-known example of a Belgian Lean IPD project is the Oosterweel Link.

However, there is still much room for improvement. In 2022, Lean IPD is still not the standard way of working in Europe. This is unfortunate, because it offers advantages for all parties involved directly and indirectly. For example, the faster an infrastructure project is completed, the sooner road detour and traffic jams are over and traffic can flow optimally again.

What are the benefits of Lean IPD? 

Lean IPD ensures that the various parties are better aligned. This leads to more reliable projects that are completed faster and where all parties are better rewarded. 

This allows construction partners to potentially make some extra profit. Additionally, the risk/reward plan gives them extra security as they will never lose money when the project doesn’t go according to plan. 

End clients will see their project finalized faster, and probably with less costs.

What are the pitfalls of Lean IPD? 

Of course, the benefits are there only when Lean IPD is done right. But things can also go wrong.

  1. Wrong partners: A project completely depends on the quality and reliability of the partners. A bad BVOA (Best Value Option Analysis) may throw a spanner in the works in this regard.
  2. No overview: As an owner, you need to map out in advance what your project would cost if you went for the traditional way of working. That way, you can better assess whether your Lean IPD partners are asking a correct price.
  3. Immediate cost: As the owner, you pay for design costs from day 1, long before the construction phase can begin. This has a positive effect on the group dynamic between the different construction partners, but a negative effect on your cash flow.

Tips & tricks

Are you interested in implementing Lean IPD? The following tips will help you get started:

  1. Start on time. It takes time to find the right partners and to draw up a good Lean IPD contract.
  2. Involve all parties in this new philosophy from the beginning and make sure everyone understands the benefits of Lean IPD.
  3. Change management and people skills are crucial in this process. After all, every decision affects a lot of parties. Everyone must feel comfortable with the decisions in order to continue to work well together.
  4. Consider hiring an outside party to manage the Lean IPD process. This person can look at different points of view objectively and unite them more easily compared to someone who is or appears biased.

Conclusion  

Are you interested in Lean IPD and do you want to run your next project more efficiently? Contact us! We are happy to guide you through the entire process.

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Harmonized Structure (HS) succeeds the High Level Structure (HLS)

20 Aug 2021

At Pauwels Consulting, we are experts at implementing management systems (ISO 9001, ISO 14001, ISO 45001) in different companies and organizations. So, when we heard about the successor of the High Level Structure (HLS), the Harmonized Structure (HS), we were enthusiastic. Now our consultants can help you even better. Haven’t you heard of High Level Structure yet, or are you interested in the benefits of Harmonized Structure? Luc Marivoet, one of our QHSE experts, tells us everything there is to know about this new standardized way of drafting ISO standards.

Hi Luc. Please remind us: what is the High Level Structure exactly?

Luc: Remember the time when we used to work with various management systems (ISO 9001, ISO 14001, …) which were different in terms of terminology and structure? Well, that changed in 2012, when a set of core elements was introduced to ensure these management systems would follow the same structure: the High Level Structure. Thanks to this set of 10 universal sections, it is much easier for companies to integrate different management systems.

And now the High Level Structure has a successor?

Luc: Yes, indeed, the Harmonized Structure has replaced the High Level Structure in May 2021. That means that from now on, the Harmonized Structure will be used for drafting new ISO management system standards and future revisions of existing ISO management system standards.

Interesting! What exactly is new in the Harmonized Structure?

Luc: You’ll be relieved to hear that the core elements of the High Level Structure remain the same for the Harmonized Structure. In essence, the change is mostly about a few clarifications and nuances that have been introduced. I’ll give you a quick overview per chapter:

  1. Scope – From now on, ISO management system standards should also specify the intended result of the implementation of specific management systems like ISO 9001, ISO 14001 and ISO 45001.
  2. Normative references – Nothing has been changed here.
  3. Terms and Definitions – The terms and definitions should be integrated into all ISO management standards.
  4. Context of the organization – §4.2 Understanding the needs and expectations of interested parties – You can now decide for yourself or consciously determine which requirements and expectations of interested parties you’ll establish in your management system. Of course, you still have to comply with the applicable statutory and regulatory requirements.
  5. Leadership – This chapter was also left unchanged.
  6. Planning – Planning of changes (§6.3) will become a common requirement for all ISO management system standards.
  7. Support – Documented information (§7.5) has been given a more neutral approach. The distinction between ‘retaining’ and ‘maintaining’ information disappears.
  8. Operation – Everything remains the same here.
  9. Performance evaluation – Nothing has changed in this chapter either.
  10. Improvement – The Harmonized Structure puts more emphasis on proactively initiating improvements rather than identifying possible improvements from a preventive nature.

Does this mean that we can also expect a revision of ISO 9001:2015?

Luc: No, and that is surprising, considering a new version of ISO 9001 has been published approximately every 7 years since ISO 9001:1987. That means the review process is normally initiated every 5 years. So why hasn’t the process been started yet? Well, a survey revealed that most users were in favor of leaving ISO 9001:2015 unchanged. After all, the structure of ISO 9001:2015 is well put together and not outdated. A revision simply wouldn’t provide added value.

I do have to add that it probably won’t take another five years to initiate the review process. Standing still is going backwards, after all! As of now, all eyes are on 2023 to start the process, which means we can probably expect the new ISO 9001 version in 2025 or 2026.

Can we expect any other ISO-related updates?

Luc: Well, we already know the ISO 14001:2015 won’t get a revision either this year. But we do have more exciting news about another standard: ISO/TC 283, the ISO technical committee responsible for the on-going development of ISO 45001, has recently launched the 2021 ISO 45001 user survey. The questionnaire gauges what sections work well and which ones still need improvements, like parts that might be too difficult or onerous, or not profound and thorough enough. Additionally, the committee wants to know where adjustments might be needed to reflect the changing world of work.

Why is this 2021 ISO 45001 user survey so significant?

Luc: It is significant for two reasons. Mainly, this is the first time this many organizations can provide feedback on ISO 45001, as the transition from OHSAS 18001 to ISO 45001 has finally been completed and many organizations have now fully implemented this standard. Secondly, ISO will start to consult national standards bodies regarding a possible revision of the standard. That means they need to know what areas of the standard would need to be improved during a revision. Do you want to contribute to this revision, or do you feel that ISO 45001 doesn’t need a revision yet? You can fill out the 2021 ISO 45001 user survey here: https://www.smartsurvey.co.uk/s/TFN8IQ/.

Thank you for this update, Luc. Where can people find you if they need more information on the transition from High Level Structure to Harmonized Structure, and all things ISO management standards?

Luc: You can reach me directly at luc.marivoet@pauwelsconsulting.com or through contact@pauwelsconsulting.com. Don’t be shy and mail me with any questions. Glad to help!

Luc Marivoet

Who is Luc Marivoet?

Luc Marivoet is QHSE Manager at Pauwels Consulting. He has worked in quality management for over 30 years. As a Senior QHSE Consultant, he uses his experience on various projects for international Engineering and Life Sciences companies for the implementation, monitoring and follow-up of ISO 9001 (quality) and ISO 45001 (health & safety) management systems. Luc also teaches QHS Management Systems (ISO 9001 and ISO 45001).

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From strategy to implemented data governance framework

03 Jul 2020
Once you have worked out a strategy to ensure the data integrity of your products, it is time to convert the strategy into a practical data governance framework and implement it.

How do you go from a strategy to an implemented data governance framework?

Nathalie: Normally you have already taken the first step during the preparation of your strategy. Researching all existing SOPs and current practices within your company. You can benchmark your results against the industry best practices and regulations you need to comply with. This is the starting point from which you can proceed.

Review all current procedures and practices

Talk to your employees: how do the systems, devices or applications work, what data do they generate, what is the input, what is the output, ask for manuals, what are the current procedures and processes, check your employees’ knowledge of data integrity, see if there are any data risks, etc. Involving all operational colleagues from the start leads to greater commitment.

Determine the data domains

The next step is to determine the data domains applicable within your industry. This can differ from sector to sector e.g. customer or product data domains. Within these data domains, are data elements such as systems and applications that generate important reports and essential data or describe business methods. In doing so, you look for what is critical and important to your business.

Inventory all systems & devices

Inventory all devices and systems that generate data, assign a data domain and categorize according to the GAMP classification or similar (sufficient for an audit!) and describe why you choose that category.

What is the GAMP classification?

Nathalie: The GAMP guidelines (ISPE, good automated manufacturing practices) are guidelines for validating automation systems. They help you draw up the documents needed to validate the systems and to guarantee the quality of these systems. The latest version is the GAMP-5 which focuses on risk control and better quality management. These GAMP 5 guidelines describe the boundaries of the categories into which all systems can be categorized.

  • Category 1: Infrastructure software: these are usually operating systems on which applications are installed (Windows, Linux, custom, …). These operating systems are qualified but not validated, it is the applications that are validated.
  • Category 2: Standard software that is not configurable: also called ‘off-the-shelf-software’. This software can be easily installed and does not need to be adapted to your business needs. This category also includes software that can be configured but has a standard configuration in your company.
  • Category 3: Configurable software: these are software applications that are configured according to your specific business needs. This is the largest and most complex category to validate.
  • Category 4: Tailor-made software: these are software packages written from scratch especially for your company.

The choice for a GAMP classification or similar categories depends on the industry and the devices & systems in your company. The GAMP-guidelines apply to the pharmaceutical sector. If you work within a non-pharmaceutical sector, you are not required to use the GAMP categories. Then you can also rely on the USP classification:

  • standard equipment with no measurement capability or usual requirement for calibration, where the manufacturer’s specification of basic functionality is accepted as user requirements. Conformance of Group A equipment with user requirements may be verified and documented through visual observation of its operation. E.g. a simple pipette.
  • standard equipment and instruments providing measured values as well as equipment controlling physical parameters (such as temperature, pressure, or flow) that need calibration, where the user requirements are typically the same as the manufacturer’s specification of functionality and operational limits. The conformance of Group B instruments or equipment to user requirements is determined according to the standard operating procedures for the instrument or equipment and documented during IQ and OQ. Examples of equipment in this group are melting point apparatus, pH meters, thermometers,…
  • Group C includes instruments and computerized analytical systems, where user requirements for functionality, operational, and performance limits are specified for the analytical application. The conformance of Group C instruments to user requirements is determined by specific function tests and performance tests. Installing these instruments can be a complicated undertaking and may require the assistance of specialists. A full qualification process, as outlined in this document, should apply to these instruments. Examples of instruments in this group include the following: high-pressure liquid chromatographs, mass spectrometers,…

Mapping the data process flow

Mapping the data process flow is part of good data lifecycle management. All phases (5) of the data lifecycle, from initial data creation, capture & registration to processing including transformation or migration, review, reporting & use, retention & retrieval, and destruction, must be controlled and managed to ensure accurate, reliable and compliant records and data.

data lifecycle

The data process flow is a visual representation of how data flows through the processes and systems of the company (input, output, storage points and routes between two ‘destinations’). This flow must be documented in a ‘data audit trail‘, a log file of everything that happens and may affect the final product (as determined by the risk assessment).

Need help with implementing your data governance framework?

Our team of Data Integrity Experts is happy to help.

Contact us

Create a data integrity questionnaire

A questionnaire can vary between 50 and 100 questions. Keep in mind the commitment of your company and the type of equipment when drawing up the questionnaire, e.g. you cannot make the same demands on a computer as on a thermometer. The security of the computer must be much better and the data output is different. Make sure your questions cover the full scope!

The FDA prepares an annual paper with the minimum requirements to be followed. In addition, your questionnaire must comply with the ALCOA(+)-principle and it can be useful to take into account the interpretation or focus of the auditors. Place the focus wherever they do. It is not so bad if the questionnaire is not perfect to start with, you can make adjustments along the way.

Examples of questions:

  • Attributable: is the source of the data defined? Is the data owner documented?
  • Legible: is the data always accessible to the authorized persons? Is the data centrally stored & managed?
  • Contemporaneous: is a timestamp registered?
  • Original: is the original data stored? Are adjustments logged in the data audit trail?
  • Accurate: is this the correct data (error-free)?

Perform the GAP assessment 

Test each device, system or application against the questionnaire. Based on the answers you can determine where the GAPs lie between the current status and the desired status.

Perform a risk analysis 

Assign a risk level to the GAPs based on these risk factors. Not every GAP is a point of action or issue. Based on the risk analysis you determine priorities for the remediation phase. Normally, low degree risks are acceptable, there is no obligation to take further action. It is up to your company to determine how strictly you handle data integrity.

Use a risk scale of 1-10 or 0-100 and take 3 factors into account:

  • Degree of severity: Consider the worst possible consequence of failure due to the degree of injury, property damage, system damage and corporate reputation loss that could occur E.g. 1 (low) – 5 (very high).
  • Occurrence: How many times did the GAP occur and what is the ‘probability’ that the GAP will occur, e.g. 0 (technically not possible to occur) – 4 (certainly possible).
  • Detectability: also called ‘effectiveness’, is a numerical subjective estimation of the effectiveness of the controls to prevent or detect the cause or malfunction before the malfunction reaches the customer. E.g. 1 (will be detected during production) or 4 (there is no detection mechanism).

The remediation phase

Work out technical solutions to solve the risks, allocate resources, adjust data ownership if necessary and rewrite SOPs to eliminate GAPs. There are three types of controls: technical, procedural & behavioral. You should always start with the technical checks during the remediation phase. Determine short, mid and long term actions. These adjustments should lead to better control over the process, the GxP data or systems.

Mid-term checks for high data integrity risks can be:

  • Additional data oversight
  • A second witness of the data registration
  • Checking the audit trail
  • Restricted management of user access
  • Adjusting operational procedures

Introduce procedural controls to establish general data integrity requirements:

  • Archive
  • GdocP
  • Backup/recovery processes

Technical checks to ensure data security:

  • Badge limited access
  • Unique ID/password
  • Audit trail
  • User access management

In addition, electronic data is certainly more reliable and easier to check than paper-based data. Also, try to avoid a hybrid system of electronic data & paper documents. Switch to the digitization of data as much as possible.

Remediation actions must be defined, documented and followed up in accordance with the company’s CAPA and risk management procedures.

Follow-up phase

Once all solutions have been implemented, a new risk assessment will be necessary to ensure that the expected residual risks are acceptable. You perform this risk assessment on a regular basis to ensure that data integrity can be guaranteed and that you are prepared for data integrity audits.

A risk-based and pragmatic approach

In order to address the growing need of the industry to implement data integrity in a smart and efficient way, Pauwels Consulting has developed a unique data governance program. The program combines a thorough pre-assessment with subsequent transition according to the well-known PDCA cycle. GAP assessments and associated actions are carried out in parallel across each department with continuous feedback loops and include alignment of all DI-related documentation (e.g. URS, data handling procedures, etc…).

Our risk-based and pragmatic approach embeds strong leadership and proper behavioral management. It is designed to achieve and sustain DI cultural excellence across the entire organization. Proper training is crucial so our Data Integrity team has compiled a variety of training modules that can be tailored to achieve these goals, together!

 

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Reboarding your employees and team

02 Jul 2020
During and after every crisis there is uncertainty and anxiety. Even among your employees or colleagues. Working from home has an impact: limited social contact, little oxytocin (cuddle hormone) to combat stress and creating new habits. That's why reboarding is crucial.

It takes about 21 days to learn new habits but it takes at least as long to get rid of them. So you can’t expect your employees to ‘just’ pick up their traditional working life again. That’s why reboarding your employees and an action plan is important! (Source:Voka)

Personal support

In recent months, everyone has been forced to change their work and private routines. This could have led to a lot of stress or worries. On the other hand, some people have been confronted with, for example, loneliness or illness. This is where reboarding comes in. It is your job to reassure employees, inform them well and stimulate team spirit.

The same goes for a colleague who returns after a depression, burn-out, personal loss, long-term unemployment or illness. It is your job to provide personal follow-up for these employees, whether or not in cooperation with HR, Mensura or another welfare service. Schedule daily, weekly and monthly 1-on-1 follow-up interviews to follow up the person and address issues in a timely manner. Proper reboarding of your employees pays off in the long run and reduces the risk of a relapse.

Initially, some flexibility towards working from home / in the office is necessary. Many employees have enjoyed the benefits of working from home. Don’t just refer teleworking to the proverbial bin upon return, but be open to continue to allow homeworking for those who feel good about it. Discuss this topic with your colleagues and create guidelines. If your employees are teleworking full-time, it can seem difficult to manage a remote team. But that doesn’t have to be the case, read our useful tips on leading a remote team.

reboarding remote team feedback follow-up

Organisational focal points

Are there things to take into account when restarting your activities or reintroducing employees to the workplace? What questions will your employees have? Prepare yourself by collecting information and creating a (digital) information package:

  • Holidays & holiday allowance
  • Consequences of refusing to work
  • Child care, (corona) parental leave, educational leave, sick leave, job application leave,…
  • Extra-legal benefits e.g. compensation for teleworking
  • Temporary employment, part-time work or unemployment
  • Early retirement
  • Hospitalization insurance
  • Contact details of HR, an internal confidential counsellor and the internal prevention service, but also of partners such as Mensura, the social secretariat, your insurance company, a trade union,…

Make sure the information available for everyone on an intranet or other communication tool. In addition, it is important to support the employee with a reboarding plan, to help him/her with the paper mill and to provide the necessary documents.

Ensure a safe and stimulating environment

When reboarding after a pandemic, returning to the office can be difficult to facilitate, so which office prevention measures are best to take?

  • use safety screens
  • create sufficient distance between seats in work and dining areas;
  • inform your employees about hygiene & safety measures at work: use awareness posters, use stickers or make a short video;
  • hand out mouth masks;
  • make sure anti-bacterial hand gels and disinfection spray is available;
  • keep frequently used doors open and optimize the flow throughout the office;
  • limit the use of meeting rooms;
  • encourage homeworking: provide your employees with quality hardware & good communication tools to telework without worries.

When reboarding an employee after e.g. sick leave or long-term unemployment, it can be nice to provide the employee with extra training to catch up. So that they can get back to work confidently and with the necessary knowledge.

Appointing a buddy to someone who recently started after a long absence can help minimize stress or anxiety. The buddy re-introduces & guides this person, but can also act as his/her internal confidant.

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What’s the best way to lead your remote team?

02 Jul 2020
We all worked massively from home during the corona crisis and now that life is getting back to 'normal', voices are rising to transform the traditional work schedule and provide more time for teleworking.

This means that as a team leader you have to coach a team remotely. That may seem like a difficult challenge, but it doesn’t have to be. We have some tips to make remote working & leading a remote team, a success.

Your remote team & the daily operations

  • Schedule a daily status meeting with your team via video call (preferably). The purpose of this meeting is to discuss the progress, explain what you will be doing that day, give feedback and check if your team is experiencing issues.

You can use a Kanban board to keep an oversight of tasks, deadlines and who will be doing what: ‘incoming requests’, ‘scheduled for this week’, ‘in progress’, ‘paused’, ‘waiting for feedback’, ‘task completed’ and ‘canceled’. This should not feel like a ‘control moment’ so don’t reprimand your team members for not completing a task (without a deadline).
You can use a project management tool like Monday, Trello or Wrike, but a Google spreadsheet or calendar is also possible.

  • Schedule a 1-on-1 video call if you feel that your employee needs the extra feedback. You should consider these individual conversations as ‘sacred’ and don’t just cancel them.
  • Communicate! It goes without saying that you should keep regular contact with your team members. There may be feelings of loneliness, insecurity or isolation. So use video calls as often as possible.
    • working from home gifAlthough e-mail is an efficient channel, it can also lead to confusion or frustration. Therefore, be sure to use video calls for a complex assignment or message.
    • Organize a digital Friday evening drink, pizza lunch or a coffee and a half-hour on Monday to have a chat, just like you would in the office.
    • Communicating and motivating can also be done via GIFS or memes, which are ideal for communicating emotions and are fun to watch.
  • Be open to transforming the traditional ‘9 to 5’ into flexible working days and discuss this with your colleagues. It goes without saying that working from home can involve an adapted work schedule, e.g. you take a two-hour lunch break to do the shopping, you start much earlier because you are not in a traffic jam, the children have to be picked up at 4 pm, you work more productive in the evening because you are less disturbed by the baby, etc.Make clear agreements with your employees about what you expect from them in terms of accessibility, tasks and deliverables.
  • Focus on results, not on how they got them. It is not possible to control every aspect of teleworking. There is no need for you to do this. Therefore, focus on results and not on the number of hours worked or activities.
  • Make sure that your remote team does not become too big. If that is the case, you can split up into smaller teams according to functions/department/skill set/… A smaller team can act swiftly and is more efficient.

Communication tools

As an employer, invest in quality hardware for your employees that they can take home with them: laptop, laptop bag, extra screen, extra keyboard, mouse, docking station, desk material, etc.

Provide your colleagues with good communication tools such as Microsoft Teams, Slack, Google Hangouts, Zoom or Skype, which stimulate collaboration. In addition, it is important that you invest in up-to-date software in order to work more productively: e-signing for contracts, a CRM/ERP package, intranet, time registration, etc.

Create communication channels for teams or departments to enhance the group atmosphere e.g. a fun channel and a business channel.

Would you like to brainstorm? Then you can use tools such as Mural, Miro, Google Docs, the drawing function in One Note, FunRetro,…

Involve your IT department. Ask them which applications are possible and if a support chat can be set up? So that employees with IT problems can be helped quickly and focus on their core business.

Creating enjoyable workspaces 

If your employees work from home, it is important that they have a comfortable spot where they can work productively. It’s your job to encourage your colleagues to create a workplace thatsparks energy. What does a good home office look like?

  • It’s quiet.
  • working remotely - remote teamsThere’s a lot of greenery: plants in the workplace make your employees 15 to 19% more productive, according to research. Your concentration increases and greenery in your workplace makes you happier.
  • A good screen at eye level.
  • Good light, close to a window or with good lighting. Tilt the screen away from the light to minimise backlight. Preferably, don’t sit in front of the window as this can cause glare.
  • It is important to have sufficient fresh air, this stimulates concentration, so open a window or go for a walk during breaks.
  • Ideally, you should have a sitting or standing desk! Do not crawl into bed with your laptop or sit at the coffee table, this is bad for your posture.
  • Try to maintain a clean desk policy, especially if you have a small desk or when you are sitting in your living room.
  • Inform your employees about ergonomics:
    • Raise your screen with a box or pile of books (watch out for overheating).
    • Choose a quality chair, and if necessary, use a cushion for a better fitting backrest.
    • Keep your feet flat on the floor. Is your office chair too high? Then you can support your feet with a box or tray.
    • Stand up every 20-30 minutes, stretch or walk around the house: movement is healthy, sharpens your focus and helps your body to reduce stress hormones (stroking pets also helps).

feedback

  • Encourage your employees to take a break now & then to keep their concentration sharp. At the office, your day will break by itself, you will see someone in the corridor or talk to a colleague in the coffee room. After a meeting, you walk back to your desk, which is like taking a break. Maybe you have lunch with your colleagues every day. You probably don’t do these things at home, so it is important to schedule a break. Go outside for a while or do something fun. (source: Frankwatching)

Not only setting up a remote office is important, but also making a remote work schedule. It can be good for your employee to draw up a work schedule in which work time and breaks are planned. This makes it easier to have clear arrangements with your family about family time.

Do you need to hire someone for your remote team?

Then there are a number of things to take into account when screening candidates for your remote team:

  • Can-do mentality: recruit people who are doers. You don’t have to give doers any tasks, they look for ‘work’ themselves or know what they have to do and carry it out. The only thing you have to do as a manager is to focus on leadership and providing guidance.
  • Reliability: recruit people you can trust so you don’t have to worry about what they are doing.
  • Look for people with a gift for writing: working remotely means communicating a lot via e-mail or chat. That’s why language skills and the ability to express yourself is an added value.
  • Recruit people who feel good about working from home and don’t mind having less direct collegial contact.
    (Source: Zapier)

Some extra advice when hiring: appoint a ‘buddy’ to your starter to ensure a good follow-up the first days.

 

Do you need support in finding new people for your remote team?

Contact us

Contact us

Do you have any questions for us? Let’s get in touch!

"(Required)" indicates required fields

maxime_van_belle
Maxime van Belle Content Marketeer
+32 9 324 70 80
contact@pauwelsconsulting.com

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