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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.

Contact us

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

Insights

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 evolution, data 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.

Contact us

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!

"(Required)" indicates required fields

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

Insights

How can a company comply with data integrity guidelines?

12 Jun 2020
The basic thought is clear: collect, process and store your data in a complete, consistent and accurate manner. That may seem simple, but it is not. Following the ALCOA+ principles or developing a data governance strategy can help.

How often does it happen that there are multiple copies, that the original document is overwritten or that errors occur during the collection of data? There may even be a data breach without anyone knowing about it. These practices can lead to polluted and outdated data, compromising data integrity.

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.

How can a company act in accordance with regulatory guidelines?

Nathalie: There are two things a company can implement to work accordingly:

1. Work according to the ALCOA or ALCOA+ principle. This is a framework that pharmaceutical companies use to ensure data integrity. The ALCOA principle applies to both paper documents and electronic/digital data. The acronym stands for:

    • Attributable: when data (or e.g. a product) is produced, it must always be clear where, when, how and by whom. If an adjustment has been made, it must be clear why. This means that there must always be a link to the source of the data, e.g. a person or computer. This can be done by using a barcode, QR-code, user ID (username with password) or a signature with date.
    • Legible: the data must always be legible and permanently accessible throughout the data lifecycle.
    • Contemporaneous: data is recorded the moment the data is being produced. The date and time must be chronological.
    • Original: original data or ‘primary/source data’ is the source of the data. The first data point where the data was produced/measured.
    • Accurate: accurate data is error-free, complete and correct. Each modification is documented.
    • +Complete: All data, including repetition or re-analysis, must be complete.
    • +Consistent: all elements of the data, e.g. 3 consecutive batches of data must have a date and time indication that is consecutive.
    • +Sustainable: data must be recorded on controlled worksheets, lab logbooks or electronic media (no post-its or personal notes that could be lost).
    • +Available: data should always be accessible and available for review.

Nathalie: “If a company can apply these ALCOA+ principles, they are handling the data in a correct manner but then there is no strategy or framework within which the entire company can work. Setting up a data governance strategy is important. It must be an integral part of the quality management system and inherent to your corporate DNA. This way, you increase the support base among the employees and the company creates a real commitment”.

2. Creating a data governance strategy

“Data governance is the sum of the processes & procedures to ensure that data, irrespective of the format in whih they are gerenated, are recorded, processed, retained and used to ensure the record throughout the life cycle of the data. Data governance ensures good management of records and data throughout the regulated undertaking. Data governance encompasses the people, processes and technology required to achieve consistent, accurate and effective data handling.” (Source: ISPE GAMP Guide: Records and Data integrity)

Think of data governance as the who, what, when, where and why of the organization’s data. A data governance program is therefore not a ‘nice-to-have’ for a life sciences company but is fundamentally part of the company. It is important that the management understands, supports and communicates the concept of data governance to the employees. There must be a sufficiently large support base and a distinct corporate culture of safety & quality. Implementing a successful data governance strategy requires careful planning, the right people, the right tools and technology.

Another aspect of data governance is the protection of company and customer data. This of course should have a high priority. Data breaches are almost everyday occurrences and governments put a stop to them with laws that protect our private data. A data management program builds in controls to protect data and help organizations comply with compliance regulations.

Need help to comply with data integrity guidelines?

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

Contact us

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!

"(Required)" indicates required fields

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

Insights

Data integrity in the pharmaceutical industry

10 Jun 2020
Advanced process digitalization, often refered to as Industry 4.0, started a revolution in the pharmaceutical industry. The amount of data circulating has strongly increased in recent years and this trend will continue. The question then arises: what impact does this have on data integrity?

While in the past everything was written down on paper and then stored in the filing cabinet, this has now changed with the advent of email, automation, the cloud, big data and AI. This digitization creates many business opportunities but the chance of something going wrong in the data process flow is increasing. It raises the question for the pharmaceutical industry: how can we still guarantee the safety and quality of the product?

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.

What is data integrity?

In the context of a GxP environment, data integrity can be defined as maintaining and ensuring the accuracy and consistency of data throughout its lifecycle. This, of course, in compliance with legal requirements. Data integrity is a crucial aspect of the design, implementation and use of any system that stores, processes or retrieves data.

Data integrity is in line with the GxP standards, which can be the (c)GMP, (current) good manufacturing practices, GLP (good laboratory practices), GCP (good clinical practices) or the GDocP, the good documentation practices. To support Data Integrity during the full life cycle of the data, some key concepts in the GMP requirements are summarized in the form of the acronym ‘ALCOA’ or the ‘ALCOA+’ principles.

It should not be confused with data security or data quality. These are only a part of the data governance strategy. Nor is it a synonym for privacy legislation such as the GDPR. However, it can help your company to comply with this privacy regulation.

Why is data integrity important?

Data and its integrity are extremely important to ensure patient safety, the quality of pharmaceutical products and the integrity of company data within the life sciences industry. In addition, data integrity is closely related to the reliability of your organization. Within a GxP environment, the provision of evidence in accordance with legislation and regulations is particularly important to demonstrate the safety and efficacy of a product, for example in the event of legal disputes.

Why is there an increasing focus on the guidelines by regulators?

There has always been a strong focus on patient safety, data reliability and product quality, both within the pharmaceutical industry and the medical devices or healthcare industry. However, in recent years there has been an increase in data breaches and misuse of GMP guidelines, especially in the Asian market (e.g. ‘testing into compliance’ or false data laboratories). As a result of these breaches, the guidelines have been strengthened and there is more monitoring and control of compliance with the guidelines.

In January 2015, the MHRA published new guidelines in the document ‘GMP Data Integrity Definitions and Guidance for Industry’. Later that year, the HMA (Heads of Medicines Agencies) and the EMA (European Medicines Agency) proposed the ‘EU Medicines Agencies Network Strategy to 2020’. This is a five-year strategy for European regulators in which data integrity checks are mandatory in order to prevent fraud.

Subsequently, in 2016, the FDA (Food & Drug Administration) published its guidelines, ‘Data Integrity and Compliance with cGMP’. Although these guidelines are not binding, a great deal of focus is placed on data integrity during audits and inspections by the FAGG, the EMA, the FDA or suppliers.

What could be reasons for violating the guidelines?

The reasons can be very diverse and we can even say that 80% of the breaches happen unknowingly:

  • the pressure to produce and guarantee business continuity
  • a lack of awareness or knowledge
  • the corporate culture does not fully support the concept
  • insufficient resources or budget, inadequate technology or processes
  • …

Even with a data governance program implemented, individuals can still choose to defraud or falsify data. It is important to know that regulators make no distinction between human error and fraud/falsification when assessing.

What could be the consequences of non-compliance?

  • the patient may be in danger
  • strict audits or a temporary stop in production
  • loss of reputation and reliability
  • bad data that cannot be used for analyses or strategic decisions
  • recalls, ban on export or production for an indefinite period or cessation of activity
  • prosecution

We can state that although these guidelines are not binding, it would be a big mistake not to follow them because the consequences are too big.

Need help to develop & implement a data integrity strategy?

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

Contact us

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!

"(Required)" indicates required fields

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

Insights

What is AI, Artificial intelligence?

30 Apr 2020
Artificial intelligence. What is AI? What is the impact of artificial intelligence on business? The impact is significant when it comes to productivity, as it optimises use of time, safety and accuracy.

AI every day

AI is now part of our day-to-day lives. In the morning, we sit at the breakfast table, drink a cup of coffee and ask Siri or Alexa to tell us the news for the day or put on a morning playlist. The thermostat in your home can tell what the weather is like outside, while your robotic lawnmower monitors your garden at night and knows exactly where to cut the grass during the day. This is all powered by AI.

AI grasmaaier

Artificial intelligence

The term ‘artificial intelligence’ is an overarching term for various methods of rendering intelligent a device, application software suite and so on.  If you manage to make a device do what you want it to do without having to explicitly assign it the task, this is an example of artificial intelligence.

There are various terms that are frequently mentioned in the same conversation. Examples include ‘machine learning’ and ‘deep learning’.

Machine learning

Machine learning uses algorithms to collect data so it can learn and make predictions based on this. This type of artificial intelligence does not give the machine any instructions. Instead, the machine learns to perform tasks based on the amount of data it has and the algorithms it uses. There are many ways for businesses to take advantage of machine learning: facial/object recognition, pattern/emotion detection, product advice, voice-to-text conversion, natural language interpreting, data structuring and more.

Nine examples of artificial intelligence: machine learning

Amazon machine learning
Amazon Machine Learning

Deep learning

This type of artificial intelligence goes a step further. It is more complex and is based on a neural network – the human brain is a good example of one. There are many hidden layers between the input and the output, meaning the raw data is easy to process and structure. It can also recognise patterns that the human brain is unable to detect.

An example: AlphaGo trained itself to become an unbeatable Go master (against human opponents) in just three days.

AI in your business

It is clear that artificial intelligence will have a major influence on productivity in industries and companies and on production processes.

Use of time

AI can optimise how employees use their time by analysing their situation and offering tips. AI can take on tasks so that machines do not require downtime and to reduce the amount of errors. Employees can focus more on work that is of greater benefit to the company instead of having to perform repetitive manual tasks.

Safety

Tasks in difficult-to-reach areas that are hazardous to human health can be performed by machines instead.

Accuracy

As AI can process huge amounts of data in much less time than people, it enables analyses to be performed and justified decisions to be made without the fear of failure, doubt or influencing factors entering the picture.

Is your business ready for AI?

Contact us below, and we’ll gladly help you implement the right AI tools to help your business flourish.

Contact us

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

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

Insights

8 benefits of a certified ISO 9001 quality management system

25 Apr 2020
The introduction of an ISO 9001 quality management system typically gives an organisation more order and structure, which is usually to the benefit of the quality of its products and services.

Why should you consider a certified ISO 9001 quality management system?

On the one hand, we see that organisations are often forced or feel obliged to implement a certified ISO 9001 quality management system. More and more clients demand that their suppliers work in accordance with the ISO 9001 standard.

On the other hand, we see that increasing numbers of organisations set up a certified ISO 9001 management system on their own initiative. These organisations want to become more professional and make the quality of their products and services clear, measurable and controllable in order to distinguish themselves from other suppliers.

In any case, the introduction of the quality framework typically gives an organisation more order and structure, which is usually to the benefit of the quality of its products and services.

The eight benefits of a certified ISO 9001 quality management system

As an organisation, you can always choose to work in accordance with the ISO 9001 standard, but you can also choose to be certified by an independent party (such as a certification body). In practice, we see eight major benefits in choosing a certified ISO 9001 quality management system:

  1. You have objective proof that your organisation attaches great importance to quality and that you have it checked regularly by an independent party. This commitment increases confidence in your organisation.
  2. You achieve higher operating efficiency. Organisations that consider quality management to be an integral part of their business operations usually achieve higher operating efficiency than those that do not.
  3. A certified ISO 9001 quality management system increases the quality of your services and raises your staff’s awareness.
  4. A certified ISO 9001 quality management system ensures clear processes and (communication) structures, tasks and responsibilities throughout the entire organisation. This increases the involvement of your staff, which improves the working atmosphere and reduces the pressure of work.
  5. You can detect and identify problems in good time, which means that you can quickly take steps to avoid the same mistakes in the future.
  6. You make it clear to your staff, your partners, your clients and the outside world that customer satisfaction is at the core of your business.
  7. Being ISO 9001 certified, gives you a positive company image, raising you up to the level of your competitors or perhaps even a level higher.
  8. It is possible also in your commercial interest, seeing that more and more clients demand that their suppliers work in accordance with a certified ISO 9001 quality management system.

Interested in the challenges a quality manager faces? Check out our article here.

Our advice? Go for it!

Are you considering working in accordance with the ISO 9001 standard? Fantastic! But don’t take half measures. We recommend that you implement a certified ISO 9001 quality management system right away.

Contrary to what many organisations still think, implementing a certified ISO 9001 quality management system is much less drastic than you might imagine at first. Do you still have any questions or doubts? We would be pleased to help you!

Who is Luc Marivoet, our quality expert?

Luc Marivoet is Prevention Counselor & Quality Officer at Pauwels Consulting. He has over 25 years of experience in quality management positions. In these positions, he provided support and supervision in an international context (Europe and Asia). Luc now uses his experience to set up, implement, monitor and follow up certified ISO 9001 quality management systems and Supplier Quality Assurance activities. Luc is currently working at a Belgian engineering office specialized in rail infrastructure and technology for the implementation of an integrated management system (ISO 9001 & ISO 45001). He also teaches QHS Management Systems (ISO 9001 and ISO 45001).
Do you have a question or comment for Luc? Contact Luc here.

Contact us

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

Insights

Is Industry 4.0 the new OpEx?

20 Apr 2020
This question will be answered with yes or no depending on where it is asked, more specifically at which company department or hierarchical level it is asked. In any case, Industry 4.0 and Operational Excellence (OpEx) seem to be strongly connected. Read on to find out more.

The (classic) story of Operational Excellence or Six-Sigma

Usually the answer is yes because the input and development of Industry 4.0 projects (or transformations) are the result of studies and analyses using quite a few OpEx tools. The obvious focus areas here are process and lead times. Concepts such as (non-)added value or business added value are all presented at the same time.

This is perfectly in line with the considerations about or striving towards a lean process aiming to eliminate all waste or reduce it as much as possible. Many have heard about the acronym TIM (R) WOOD and know all the abbreviations such as 5S, SMED, VSM and OEE. For those tools Operational Excellence is the objective. They want to achieve the level of World Class Manufacturing (WCM) companies.

“Following a lean path is step 1, but that is no guarantee that the process or service provision will flawlessly deliver the right quality and quantity.”

However, when a lean path is carefully followed on a daily basis, this still does not guarantee that the process or service will flawlessly deliver the right quality and quantity. Machines can malfunction or break down, people often work at a different pace on Monday mornings than on Friday afternoons. Companies often use the Six-Sigma methodology to identify variations in their processes or services. A lot of information is collected (from historical data) or a data collection plan is set up to gather missing information. All this is done in the hope of finding the root cause of any variations in order to eliminate them. In another article we give tips for successful Operational Excellence projects.

Undoubtedly many companies today still either measure and store huge amounts of data in an ERP/MES environment and often do very little or nothing with it, or they measure too little or even nothing at all and are actually blindly reproducing the routine that developed over time day after day.

One company may have loads of KPIs and graphs that may or may not be shared with employees and/or visitors, whereas the other company may have hardly any. One company may use KPIs to position or adjust its direction, and another company may not respond until its financial services department makes a remark that something is going on. One company will base its investments on data, while another will follow a proverbial gut feeling due to a lack of data and therefore a lack of analysis.

Industry 4.0, a logical and modern sequel to OpEx

When a company decides to make more data-driven decisions, Industry 4.0 comes into play.In that case, the answer to the question ‘Is Industry 4.0 a new name for Operational Excellence?’ is usually no.

However, Industry 4.0 seems to be the logical expansion and further evolution of all OpEx tools, whereby having sufficient measurement data available quickly in an easy and visually interpretable format is a must. If we want to achieve sufficient data quickly and easily in an operational context, the next obvious step is automation: the automation of the measurement, analysis and presentation of measurement data in order to manage operations better and base strategic decisions on data.

Many companies still collect a lot of measurement data manually on paper. This data is then entered into Excel files so it can be analysed and presented to managers and/or management. This often means that several people use and manipulate the data – with all possible manipulation errors associated with it – before the measurement data is transformed into useful information that hopefully answers a question or resolves a problem. However, what often happens is that new questions or problems arise as a result of different interpretations of this information. There are many reasons why Operational Excellence can fail: read them why operational excellence may fail.

“That is exactly where Industry 4.0 can/will make a difference. Automating the measurement and processing of measurement data will be much faster and more accurate.”

business intelligence

Industry 4.0 can and will make a difference there. Various measurement automation applications exist already. Some are simple and easily accessible, but others are more complex and therefore slightly more expensive. They make measurement data processing much faster and more accurate. For example, if we use Power BI instead of MS Excel, data can be displayed flawlessly and often individually adapted to the user’s needs in real time on the user’s mobile device.

For example, a CEO who is waiting for their flight at the airport can check online and in real time whether the strategic objectives are on track, while a maintenance supervisor can help analyse a technical problem in the field from home at night. Dreams can come true if the old methods of pen, paper and Excel are replaced by (often simple) new technological applications.

The road to Industry 4.0

Of course, taking the next step in the OpEx story towards Industry 4.0 requires a change within the company: this change starts at management level, but also involves the people on the shop floor every day. It is cultural change, and that takes time.

Industry 4.0 is about more than just installing some extra measuring sensors and PLCs. The hardware modifications are often the easiest and quickest to implement. Devising and analysing the architecture required in advance is much harder. What do we want to measure/know? How often are we going to take measurements? Who needs this information? How are we going to visualise the data? Should the information and visualisation also be accessible in real time and remotely? How much data volume will we have to process? How will we process and store the data? Is Excel still powerful enough? Will data need to be exchanged with other software packages? Will the data be allowed/required to make immediate adjustments in the process with or without human interaction? Will data be used for AI, AR or VR? What about back-up and online security? The list of questions goes on, and all of them need to be carefully considered in advance. It is also best to perform a risk analysis before any action is taken. Only the right considerations in advance will determine the success of the result after implementation. This may look like we are trying to find solutions for problems that don’t exist, but experience has taught us that decisions are often made too quickly or too unilaterally. And this only increases the cost of retrofitting.

“Only the right considerations in advance will determine the success of the result after implementation. This may look like we are trying to find solutions for problems that don’t exist, but experience has taught us that decisions are often made too quickly or too unilaterally.”

It is clear that all these competencies of Operational Excellence, change management, architecture and ICT are hardly ever present in a single person. This also explains why many (large) companies are hesitant to get on with 4.0. A lack of budget or resources is often suggested, but it is more likely that people are having difficulties with the awareness process: a belief that a few years from now, Industry 4.0 will mean the difference between leading the way and simply surviving in the industry at a regional and international level.

“The internal safeguarding and transfer of the knowledge and competence provided by an external partner are crucial to good cooperation. A company must (be able to) retain its individuality rather than become dependent on external know-how.”

It is clear that companies eager to take this step must be able to mobilise their employees, top down and back. They often hire a reliable partner to do this. The external partner must be able to deploy the right people to provide expert guidance during all the advance considerations, the implementation, training and coaching and any subsequent follow-up. The internal safeguarding and transfer of the knowledge and competence provided by this external partner are crucial to good cooperation. A company must (be able to) retain its individuality rather than become dependent on external know-how. Awareness and belief are what this is all about.

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Kris van Nieuwenhove operational excellenceKris Van Nieuwenhove is an operational excellence expert at Pauwels Consulting. He has over 15 years of experience with Black Belt and Green & Yellow Six Sigma projects in various sectors. He gives himself 200% each time and loves to coach others in their OpEx role. Providing change management and a team with the right tools are crucial to the success of a project.

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9 reasons why OpEx may fail

23 Mar 2020
Operational Excellence (OpEx) is a popular philosophy among organizations that want to improve and maintain their efficiency. Despite its popularity though it is not easy to give a clear and unique definition of this domain.

For the purpose of this article, I will define Operational Excellence as

“the effort and actions that a company puts in place through standardized processes to drive its conviction to deliver towards the customer the requested product or service at the requested moment at the lowest production effort/cost and price the customer wants to pay for it.”

I am always surprised to hear that so many organizations are struggling with Operational Excellence. In fact, I regularly hear about situations where OpEx does not produce the expected results. Interestingly, we can often bring back the failure of OpEx efforts to one or more of the 9 reasons described in this article.

Knowing these reasons and keeping them in mind along the way has helped me greatly in achieving satisfactory results in the OpEx projects I have been involved in over the years. I hope the information in this article will help you too.

9 REASONS WHY OPERATIONAL EXCELLENCE MAY FAIL

1. The company leaders don’t know enough about Operational Excellence and they “start with OpEx” for the wrong reasons.

Sometimes companies start OpEx initiatives because “everyone is doing it” or because competitors invest in Operational Excellence. Similarly, local branches of a company are often forced to start with OpEx because the company headquarters has decided that’s the way to go. In such cases, organizations often don’t have the required knowledge, expertise and resources to start and get good results with OpEx.

Lesson 1: Only start with OpEx if you are convinced that OpEx will give you good benefits and if you have sufficient OpEx knowledge, expertise and resources on board. Don’t know whether you’re ready yet or whether OpEx is right for you? Or do you need help with the preparation and/or implementation of OpEx? Look for reliable external partners! The lack of knowledge, expertise and resources within your own organization should never be a showstopper for the optimization of your processes.

2. OpEx is often considered as a collection of tools rather than a culture

Do you think that implementing a lean or six-sigma program will give you Operational Excellence? Then you are wrong, and you are not alone! Operational Excellence is a philosophy, a company culture. If you want to reap the true benefits of OpEx you will need more than a few shiny tools or methodologies. You will need (among other things) a model for leading the cultural change that comes with any OpEx introduction.

Lesson 2: Operational Excellence is more than a collection of methodologies and tools. Your whole organization has to be on board in order for the project to succeed. Operational Excellence can offer many benefits to an organization, but it is just as strong as its weakest (often the human) link.

3. There are not enough people with the right soft skills to support cultural change

Many companies think that having a few knowledgeable people in the organization is enough to implement successful Operational Excellence programs. This is not the case. The implementation and success of OpEx initiatives should never be dependent on a few people with the right soft skills and expertise. OpEx initiatives should come from and be embraced by everyone in the organization, no matter his or her education, skills, expertise and position in the company.

Lesson 3: Operational Excellence requires more than a few people with the right soft skills and expertise. Working on an OpEx project is a team effort. You need the support of your entire organization to get the desired results.

4. Operational Excellence is implemented top-down with little or no attention for bottom-up feedback.

Most companies implement OpEx in a top-down manner. As said before, however, the entire organization has to be on board for OpEx initiatives to be successful. More often than not, organizations have little or no attention for feedback coming from the shop floor. In such cases, employees and first-line-management can quickly switch from a cooperative “Plan Do Check Act” mentality towards a passive “I’ll only do what they have told me” mentality.

Lesson 4: Since Operational Excellence is a team effort, it is important to pay attention to feedback from all people involved. Everyone has to be on board and stay on board. You don’t have to implement all feedback, but make sure that people feel heard and understood, and that you act on the best feedback to make your OpEx initiatives even more successful.

5. Operational Excellence is introduced in the wrong way

Every colleague, machine, production line, department and process has its own specific characteristics. As a result, it is usually not a good idea to ‘generalize’ the implementation of Operational Excellence efforts. Some people and departments may favour a big bang approach, others may favour a step-by-step approach, still others may favour a process-oriented or a department-oriented approach. Forcing one approach upon everyone is usually a recipe for disaster.

Lesson 5: Try to implement OpEx with the approach that resonates most with the people, processes and working environments involved. This can be a different approach for different people and different departments. Try to keep the implementation process going by using the right tools for the right people at the right time.

6. There are too many changes in a short period of time

Organizations that invest in Operational Excellence often want to see results fast. As a result, they often initiate too many changes in a short period of time. In such cases, people often can’t absorb, understand, accept and practices the changes in the right manner before the next changes are introduced. This is a potential source of errors, safety risks and instability. Eventually this will lead, among other things, to a lower level of Operational Excellence.

Lesson 6: Take your time to implement Operational Excellent initiatives. Make sure that every initiative is understood, accepted and practiced before moving on to the next big change. Great companies have a good foundation. The same goes for Operational Excellence.

7. The line managers don’t show enough involvement

The most important task of line managers is to assure that the production and services keep running. As a result of our fast changing world, figurative fire-fighting becomes the “general modus operandi” these days. If line managers have to put most of their effort in fixing issues, they are often less interested in the implementation of new Operational Excellence initiatives. In such cases, they can’t offer the support and enthusiasm that is needed to inspire their colleagues on the shop floor.

Lesson 7: Make sure that your line management is enthusiastic about your OpEx efforts. If you don’t have their approval, you won’t see much change on the floor.

8. Losing sight of the role of the customer as part of OpEx

Most companies exist by the grace of their clients. Clients, after all, pay for products and services. So if a company’s prices are too high (due to inefficient processes and low Operational Excellence), it will put itself out of business.

Lesson 8: Question yourself continuously and continue looking for ways to improve your Operational Excellence. This way you can improve your position in the market and your overall market share. Always ask the question “Does the customer want to pay for this?”.

9. Considering Operational Excellence as a one-off thing

Companies often implement a few OpEx tools and methodologies and consider the implementation date as the end date of their Operational Excellence process. Operational Excellence, however, never ends. In order to be truly successful, everyone in the company has to keep on questioning the way things are done, and how they can be done in a more efficient and better way.

Lesson 9: Operational Excellence is a never-ending story. In order to be successful, companies and people have to take time to challenge the status quo. This is not easy in a fast changing world, but it is necessary if you want good results from your Operational Excellence efforts.

HOW TO IMPLEMENT SUCCESSFUL OPEX PROGRAMS.

I hope that this article can help you avoid some pitfalls with regard to the implementation of Operational Excellence I have seen along the way. In any case, always try to make sure that:

  • your company is ready for Operational Excellence initiatives before implementing them
  • you implement Operational Excellence for the right reasons
  • you have sufficient (internal and/or external) knowledge and expertise and (soft) skills
  • you leave room for people to embrace the required changes in company culture
  • you listen to feedback from everyone involved
  • you adapt your implementation strategies to the people and processes involved
  • you introduce your initiatives in succession, not all at the same time
  • your line management is able to inspire their team members
  • you implement the right processes to improve the customer experience
  • you continue investing in Operational Excellence

Kris Van Nieuwenhove – Pharma Services and OpEx Consultant @ Pauwels Consulting

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6 tips for successful OpEx projects

23 Mar 2020
In this article, we want to go one step further: we will give you 6 tips to increase your chances of success with your next OpEx project. The tips in this article are based on our own experience in Operational Excellence projects in various projects across many industries. We hope that these tips will help you with your next OpEx projects.

In our previous article we wrote about 9 pitfalls to avoid when planning and implementing Operational Excellence (OpEx) in your organization. In this article, we want to go one step further and share our tips for successfull OpEx projects.

1. Stimulate the generation of ideas for improvement on the shop floor

Most organizations implement Operational Excellence projects in a top-down manner: management decides to invest in OpEx and the rest of the company has to follow. This is a sensible approach, but please don’t forget to solicit and listen to feedback from the shop floor. It will greatly improve your chances of success.

After all, the shop floor is where the money is made and where improvement starts. Your operators and managers can provide you with first-hand feedback to optimize your processes, so listen to them and keep them motivated. In short,

  • have motivated and critically thinking operators on the shop floor
  • stimulate a culture of continuous improvement
  • reward bottom-up feedback and personal contributions to change
  • communicate your company’s vision and goals clearly to your entire workforce

2. Learn and motivate first-line management to identify ideas for improvement

Your operators can provide you with valuable feedback to further optimize your processes. But if they have no one to turn to, these ideas may go to waste. To ensure a good flow of ideas for improvement from the shop floor to management, invest in:

  • managers with the right soft skills and (OpEx) training in first-line management
  • clear and efficient bottom-up communication channels from the shop floor to management
  • incentives for structural improvements identified by operators and first line managers

3. Implement quick wins as soon as possible in your OpEx project

Small changes often have the biggest impact on your OpEx project. One of the best ways to motivate people is to listen to them, implement their feedback (if useful) and let them know the results of their input. So try to:

  • implement small changes (Kaizen) as soon as possible. This is essential to motivate your workforce and to nurture a culture of continuous improvement.
  • make sure to communicate the results of the implementations as soon as possible (if possible in less than a week) to motivate your workforce to keep coming with new ideas for improvement.

4. Define and align clear company goals and long-term improvement projects

An Operational Excellence project requires having clear company goals for the long term. So please make sure to have these goals in place and make sure that everyone in the company knows the priorities and importance of these goals. So:

  • define and communicate your company vision. This vision should state where your company is now and where you want it to be in 3 to 5 years. Describe your goals as SMART as possible.
  • implement a transparent process for capturing and prioritizing larger improvement proposals to support your company goals. The priorities of these improvement proposals will be determined by the priorities of your company goals.

5. Take care of your OpEx project governance

All too often, the implementation phase is where improvement projects die a quiet death. In the face of shifting priorities, resource scarcity and disputes between departments, improvement projects can end up delayed, cancelled or even worse – rewritten to such a degree that they have nothing to do with the original idea anymore.

The successful implementation of improvement projects requires:

  • An effective process for capturing project goals and deliverables and estimating their costs and dependencies
  • An effective selection process for projects to avoid having too many ongoing projects at the same time
  • Full support of higher management to sort out interfering priorities and departmental issues
  • Full personal accountability from all the members of the project team to bring the project to a good end

6. Track the effectiveness of changes in the long term

Many improvement projects end up implemented, and some even do so within budget and before their due date. But the true effectiveness of an improvement project can only be measured on the shop floor, and only in the long term, long after the project was ‘delivered’.

Nevertheless, it is of critical importance to keep tracking the true effectiveness of a change. Not doing so, or not acting on an ineffective change, will hurt the credibility of the OPEX program and the continuous improvement culture. Thus, the people on the shop floor may lose their motivation to highlight and implement possibilities for improvement.

Successful tracking of the effectiveness of projects is very important and it requires at least:

  • the establishment of clear KPIs that are in line with company goals and project goals
  • bottom-up communication channels between and active involvement of the ‘people on the floor’ and the management at the top of the firm

OPERATIONAL EXCELLENCE IS A PEOPLE’S BUSINESS

We said it before and we will probably say it again, but operational excellence is a people’s business. One of the most important takeaways from the projects we have been involved in can be summarized as:

  • making sure that everyone is informed and on the same page
  • stimulating involvement of everyone in the company
  • rewarding the involvement of everyone in the company
  • celebrating results with everyone in the company

In other words: make sure you have a good model to manage “the (cultural) change”.

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Maxime van Belle Content Marketeer
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Operational Excellence at Metaco

14 Feb 2020
Our Operational Excellence consultant Bilal was given the opportunity at Metaco to analyze the current cost price calculation and formulate a new one taking into account all costs. Furthermore, he had to optimize the working method, the general safety, the storage procedure, the business and production processes. Kris, his senior OpEx colleague, looks back on the project with great satisfaction.

Operational Excellence (OpEx) is a popular philosophy among organizations that want to improve and maintain their efficiency. Despite its popularity though it is not easy to give a clear and unique definition of Operational Excellence. For the purpose of this article, I will define Operational Excellence as:

“The effort and actions that a company puts in place through standardized processes to drive its conviction to deliver towards the customer the requested product or service at the requested moment at the lowest production effort/cost and price the customer wants to pay for it.”

I am always surprised to hear that so many organizations are struggling with Operational Excellence. In fact, I regularly hear about situations where OpEx does not produce the expected results. Interestingly, we can often bring back the failure of OpEx efforts to 9 causes. I, therefore, adhere to a number of principles that ensure the success of the project almost 100%. With these causes & success factors in mind, Bilal and I achieved good results during the Operational Excellence business case at Metaco.

9 reasons why Operational Excellence fails and how you can avoid these pitfalls

1. The company leaders don’t know enough about Operational Excellence and they “start with OpEx” for the wrong reasons.

Sometimes companies start Operational Excellence initiatives because “everyone is doing it” or because competitors invest in Operational Excellence. Similarly, local branches of a company are often forced to start with OpEx because the company headquarters has decided that’s the way to go. In such cases, organizations often don’t have the required knowledge, expertise and resources to start and get good results with OpEx.

Lesson 1: Only start with OpEx if you are convinced that it will give you good benefits and if you have sufficient OpEx knowledge, expertise and resources on board. Don’t know whether you’re ready yet or whether OpEx is right for you? Or do you need help with the preparation and/or implementation of OpEx? Look for reliable external partners and learn from Operational Excellence business cases! The lack of knowledge, expertise and resources within your own organization should never be a showstopper for the optimization of your processes.

2. OpEx is often considered as a collection of tools rather than a culture

Do you think that implementing a lean or six-sigma program will give you Operational Excellence? Then you are wrong, and you are not alone! Operational Excellence is a philosophy, a company culture. If you want to reap the true benefits of OpEx you will need more than a few shiny tools or methodologies. You will need (among other things) a model for leading the cultural change that comes with any OpEx introduction.

Lesson 2: Operational Excellence is more than a collection of methodologies and tools. Your whole organization has to be on board in order for operational excellence to succeed. Operational Excellence can offer many benefits to an organization, but it is just as strong as its weakest (often the human) link.

3. There are not enough people with the right soft skills to support cultural change

Many companies think that having a few knowledgeable people in the organization is enough to implement successful Operational Excellence programs. This is not the case. The implementation and success of OpEx initiatives should never be dependent on a few people with the right soft skills and expertise. OpEx initiatives should come from and be embraced by everyone in the organization, no matter his or her education, skills, expertise and position in the company.

Lesson 3:  A good Operational Excellence business case requires more than a few people with the right soft skills and expertise. Operational Excellence is a team effort. You need the support of your entire organization to get the desired results.

4. Operational Excellence is implemented top-down with little or no attention for bottom-up feedback.

Most companies implement OpEx in a top-down manner. As said before, however, the entire organization has to be on board for OpEx initiatives to be successful. More often than not, organizations have little or no attention to feedback coming from the shop floor. In such cases, employees and first-line-management can quickly switch from a cooperative “Plan Do Check Act” mentality towards a passive “I’ll only do what they have told me” mentality.

Lesson 4: Since Operational Excellence is a team effort, it is important to pay attention to feedback from all people involved. Everyone has to be on board and stay on board. You don’t have to implement all feedback, but make sure that people feel heard and understood, and that you act on the best feedback to make your OpEx initiatives even more successful.

5. Operational Excellence is introduced in the wrong way

Every colleague, machine, production line, department and process has its own specific characteristics. As a result, it is usually not a good idea to ‘generalize’ the implementation of Operational Excellence efforts. Some people and departments may favour a big bang approach, others may favour a step-by-step approach, still, others may favour a process-oriented or a department-oriented approach. Forcing one approach upon everyone is usually a recipe for disaster.

Lesson 5: Try to implement OpEx with the approach that resonates most with the people, processes and working environments involved. This can be a different approach for different people and different departments. Try to keep the implementation process going by using the right tools for the right people at the right time.

6. There are too many changes in a short period of time

Organizations that invest in Operational Excellence often want to see results fast. As a result, they often initiate too many changes in a short period of time. In such cases, people often can’t absorb, understand, accept and practices the changes in the right manner before the next changes are introduced. This is a potential source of errors, safety risks and instability. Eventually, this will lead, among other things, to a lower level of Operational Excellence.

Lesson 6: Take your time to implement Operational Excellent initiatives. Make sure that every initiative is understood, accepted and practiced before moving on to the next big change. Great companies have a good foundation. The same goes for Operational Excellence.

7. The line managers don’t show enough involvement

The most important task of line managers is to assure that the production and services keep running. As a result of our fast-changing world, figurative fire-fighting becomes the “general modus operandi” these days. If line managers have to put most of their effort in fixing issues, they are often less interested in the implementation of new Operational Excellence initiatives. In such cases, they can’t offer the support and enthusiasm that is needed to inspire their colleagues on the shop floor.

Lesson 7: Make sure that your line management is enthusiastic about your Operational Excellence efforts. If you don’t have their approval, you won’t see much change on the floor.

8. Losing sight of the role of the customer

Most companies exist by the grace of their clients. Clients, after all, pay for products and services. So if a company’s prices are too high (due to inefficient processes and low Operational Excellence), it will put itself out of business.

Lesson 8: Question yourself continuously and continue looking for ways to improve your Operational Excellence. This way you can improve your position in the market and your overall market share. Always ask the question “Does the customer want to pay for this?”.

9. Considering Operational Excellence as a one-off thing

Companies often implement a few OpEx tools and methodologies and consider the implementation date as the end date of their Operational Excellence process. Operational Excellence, however, never ends. In order to be truly successful, everyone in the company has to keep on questioning the way things are done, and how they can be done in a more efficient and better way.

Lesson 9: Operational Excellence is a never-ending story. In order to be successful, companies and people have to take time to challenge the status quo. This is not easy in a fast-changing world, but it is necessary if you want good results from your Operational Excellence efforts.

Discover the added value of Operational Excellence for your organisation! 

Read our ready-to-use tips in this Operational Excellence business case.


Download our Metaco business case

How to implement successful Operation Excellence programs

I hope that this article can help you avoid some pitfalls with regard to the implementation of Operational Excellence I have seen along the way. In any case, always try to make sure that:

  • your company is ready for Operational Excellence initiatives before implementing them
  • you implement Operational Excellence for the right reasons
  • you have sufficient (internal and/or external) knowledge and expertise and (soft) skills
  • you leave room for people to embrace the required changes in company culture
  • you listen to feedback from everyone involved
  • you adapt your implementation strategies to the people and processes involved
  • you introduce your initiatives in succession, not all at the same time
  • your line management is able to inspire their team members
  • you implement the right processes to improve the customer experience
  • you continue investing in Operational Excellence

Meet Kris van Nieuwenhove
Kris van Nieuwenhove operational excellence
Kris Van Nieuwenhove is a Pharma Services / Operational Excellence consultant at Pauwels Consulting. He has over 15 years of operational experience in leading and coaching co-workers and he has been involved in various Six Sigma Green and Black Belt projects. Kris specializes in OpEx, coaching Yellow and Green Belts, culture change management, visual management and communication and facilitating and leading Kaizen events.
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