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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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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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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Insights

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.

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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Joke Roggeman Welcome Officer

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?

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Joke Roggeman Welcome Officer

Insights

Best practices & pitfalls for implementing a data governance program

26 Jun 2020
Data governance programs must be an integral part of the pharmaceutical quality system and are a fundamental part of the company. What are the pitfalls & best practices from which we can learn?

These following weeks, our Data Integrity Expert, Nathalie Wellens, will explain the concept of data integrity, its evolution, data governance strategies or programs, how to implement a data governance framework in your company and remediation solutions.

Nathalie, which best practices can you share with us?

  • Management engagement is crucial: top management needs to understand and support the concept of data governance. If this is not the case, the program is at risk because insufficient budget, time and resources are allocated. In addition, success is not guaranteed in the long term.
  • Introduce the program with as little disruption to the normal course of business as possible. Instead of forcing employees to perform new tasks, it may be wise to build on existing roles and responsibilities. Otherwise, there is a risk that the program will not be ‘accepted’ by your employees. Data owners are recognized for their relationship with the data, which reinforces their commitment.
  • Vision and training is important. Demonstrate what the added value of data governance can be for someone’s job and how it can help that person do a better job. Emphasize the importance of their contribution and that they are an important part of the data governance program.
  • Benchmark your data governance program with industry best practices. This can answer the question ‘Is my company ready for this?
    • What are you currently doing in support of the best practices?
    • Where can you make optimizations in relation to these best practices?
    • What is the gap between what your company does and the best practice?
    • What is the risk of this gap?

This process can help your company to draw up a list of risks and ‘quick fixes’. The benchmark can be an action plan to address the pain points of your current data integrity plan.

  • Get rid of bad data circulating within your company. Bad data is:
    • inaccurate: the data has spelling errors, missing information, empty fields,…
    • non-compliant: the data does not comply with legal standards.
    • not checked: data that cannot be continuously monitored cannot be used.
    • unsecured: data vulnerable to hacking or breaches.
    • static: data that is never updated becomes outdated and cannot be used.

If your business strategy is data-driven, bad data can lead to bad decision making. The same goes for product quality.

  • Document and measure your data governance efforts. Define basic KPIs to evaluate the success of the strategy and your efforts.

 

Nathalie, can you identify some pitfalls we need to watch out for? 

Certainly, a common pitfall is the assumption that data governance is a project that needs to be assigned to the IT department. Data circulates throughout your company, not just the IT department. It is important to have representatives from all departments in your Data Governance team.

In addition, data security should not be confused with data governance and it should not be assumed that this is only a topic for IT service providers, multinationals or data warehouses. Data has several sources, it can be digitally recorded and stored in the cloud, but it can also be written down on paper and stored in an archive.

Sometimes there is an assumption that data governance stops once all remediation actions have been performed. Of course, this is not the case, data governance and data integrity is not a one-off project. The amount of data that is generated and the way in which we deal with it continues to evolve. It is therefore important to ensure that the data governance framework is correctly applied and regularly evaluated.

(Sources: Varonis & Talend)

Need help to implement your data governance program correctly?

Our experienced Data Integrity experts would be happy to assist you.

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!

Contact us

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Joke Roggeman Welcome Officer

Developing a data governance strategy for your company

18 Jun 2020
A data governance strategy is also sometimes referred to as a data governance framework or program. Data governance provides formal management of records and data throughout the data lifecycle.

It includes the people, processes and technology needed to achieve consistent, accurate and effective data processing. Data governance systems must be an integral part of the pharmaceutical quality system and are a fundamental part of the company. It must cover the following aspects: organization, control, supporting processes, business processes and IT architecture & infrastructure (Source: ISPE GPG Data Integrity – Key concepts).

data governance strategy

These following weeks, our Data Integrity Expert, Nathalie Wellens, will explain the concept of data integrity, its evolutiondata governance strategies or programs, how to implement a data governance framework in your company and remediation solutions.

Nathalie, why is it important to have a strategy in place?

  • It protects the data against cyber attacks, data breaches or infractions.
  • Centralised systems and standardised procedures decrease your data management & data governance costs.
  • Increases the ROI of a data analysis.
  • Modern business is driven by data. Using this data for better decision making and improved communication, can in turn lead to a competitive advantage.
  • It makes it easier to comply with regulations.
  • Relieves the workload of the IT department to protect all data.
  • It allows you to better prepare for audits.

There are many advantages to implementing a framework, but of course, there are also a number of downsides or challenges.

Data governance requires a company-wide mandate to implement the framework, it requires resources and especially time from your employees. Make sure that this investment pays off.

It is part of a broader quality and risk policy. This means that the different teams, processes or procedures need to be aligned with each other. In addition, change is sometimes difficult, invest sufficient time in sensitizing, motivating and training your employees.

Keep in mind that a framework must remain flexible and simple for ‘users’. If procedures or processes hamper business efficiency or work activities, they need to be adapted. Moreover, it can be difficult to select the right technologies and tools. Get professional support or use resources like Gartner and ask for references.

How to set up your data governance strategy?

  1. Research all current data governance practices within your company and the regulatory framework

It’s quite possible that there are already data governance practices within your company e.g. in the IT department. Compare the status of current efforts and the required regulatory framework. Let this report be a starting point to determine your strategy and write a business case.

The different regulators may have varying views on some aspects of Data Integrity compliance, but they all pay attention to these general topics:

  • Organization
  • Data lifecycle
  • System lifecycle
  • Audit trail
  • Security & access control
  • Date & time indication
  • Contractor / Vendor / 3rd party

Write a comprehensive business case about the necessary resources, procedures, processes, time, costs but also what the ROI of the effort will be (savings). This will create a financial ‘value overview’ that can be used when pitching your data governance strategy to your management. Align your data governance strategy with your business strategy, IT strategy & quality standards.

2. Assign data governance roles

The basis for each program is to define business roles and responsibilities. The goal is to set up an enterprise-wide governance structure. Not all roles are necessary, so choose a structure that works for your company.

  • The Chief Data Officer is responsible for the data governance strategy.
  • The Data Owner bears direct responsibility for the data. This person must have knowledge of the device, application or system. He/she is also closely involved in the protection of data integrity. In addition to these ‘operational’ data owners, you can also appoint ‘tactical’ data owners. They are responsible for a domain or topic and must facilitate communication with stakeholders.
  • The Data Steward ensures the correct implementation and enforcement of the procedures and is responsible for the training courses.

The data governance committee draws up the policies and procedures together with the stakeholders. Data governance requires a top-down approach, think of this when composing the committee (Source: Dataversity).

3. Develop a Roadmap

Create a document with the different phases of the strategy implementation. Each phase describes precisely what needs to be done and who carries what responsibility. In addition, determine the timing for each phase of the implementation.

4. Determine the control measures

It is important for companies to maintain control over the data governance program. It should be taken into account that a data governance program is not a one-off activity. It is an ongoing program that needs to be continuously evaluated & adjusted. The control measures include factors such as defining automated workflow processes, collecting feedback on those processes and applying the processes to the governance structure.

5. Roll-out of the framework and evaluation

Now it is time to implement the complete framework and let all procedures & processes take effect. The Data Governance team makes sure that the program is effective and meets the predefined requirements. Use the set KPI’s and control measures to assess the program.

Need help in developing a solid data governance strategy?

Our experienced Data Integrity experts would be happy to assist you.

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!

Contact us

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

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Joke Roggeman Welcome Officer