Quality Management / Kaizen


The foundation of quality management based on continuous improvement = KAIZEN

KAIZEN is Japanese and means ‘improvement’, a management philosophy in quality when it comes to constantly make small improvements to constantly improve competitiveness!

KAIZEN is about evolution and not revolution. Small steps in the right direction rather than major changes that overturns the entire organization every six months.

KAIZEN is an ongoing process that should involve employees at all levels of the organization daily.

One thing is thinking mind – quite another to realize their benefits and anchor KAIZEN in the company’s daily operations and culture. In addition to the general barriers in the form of resistance to change KAIZEN is about people and corporate culture, and the result of continuous improvement leading to changes work procedures and processes. To fulfill the value of KAIZEN it is recommended to combine continuous improvement with LEAN.

Good KAIZEN leads to ongoing changes in employee tasks and processes and to maintain the momentum of the LEAN process and to avoid the new processes only leads to more errors, it is imperative that these be supported quickly and effectively with such a high degree of automation, self-service and decentralization as possible, which is rarely feasible in traditional standard systems.

When it manages to get everyone in the organization to think in small improvements every day, the value of the quality system/management tool is really understood! That is why it is important to involve all employees and especially during audits listen to their proposals concerning improvements, which will help to anchor the quality mindset by everyone and may give an indication that the management philosophy are understood and recognized.


Strategy that works !

The Strategy must be adapted to the current company for achieve value. The value is necessary for growth and survival in a global world. Every company provides measurable results when the defined strategy makes sense.

The 3 main basic elements of STRATEGY DEVELOPMENT:

MISSION: Why are we here? What’s the point?

VISION:   Where do we want to go?

VALUES: Formulation of process and implementation.

Areas to be included in the strategy process are: MANAGMENT, PRODUCTION, LEARNING AND COMMITMENT

To understand the link between strategy process and the result is important.

Without it, any process analysis, do not have any value to the managers.

 All senior managers have a natural focus on ensuring that the content of the strategy is working.

Fundamentally it is to focus on the process of development and implementation of strategy, since there is a direct linkage between strategy and business results. The strategic work makes a difference and must be done correctly from the start.

  1. Focus on the proces
  2. Perspective (resource- or market oriented?)
  3. Time Horizon (period lifetime planning)
  4. Life time (Strategic Plan)
  5. Top-down or bottom-up (depending on the style of leadership)
  6. Participants

After clarification of the above 6 points, the design of the Strategy can be defined.

Implementation of the strategy adopted is based on established initiatives based on key parameters to ensure effective priority setting and achieving success.

Design of strategy:

  • How do we create a picture of what the future holds?
  • What analysis of external and internal conditions are necessary?
  • How should the mission, vision, targets, values and success criteria be formulated?
  • What kind of workshops, seminars and meetings are necessary?
  • How should the strategy be communicated?
  • What channels and means should be used?
  • How to ensure implementation of the strategy and made necessary follow-up of targets and initiatives?

It is so IMPORTANT that the strategy process is selected with great care, since it can take years for an organization to get used to a new way of working with strategy

Equally important is to stick with the chosen design as it gives the organization an effective opportunity to improve and adjust the process.

The weakness of many strategy processes are if only one-sided focus have been on the development, where activities associated with the implementation and follow-up forgotten or mistakenly omitted.

Formulation and implementation of strategy is the company’s values.

The mission is the foundation and the vision is being pursued to realize using the defined strategy.

Based on the vision, there should be sets out a number of strategic objectives and areas of focus.

The analytical work could be focus on services, markets, customers, competitors, business model and risks.

Implementation of the strategy adopted, is based on established initiatives based on key parameters to ensure effective priority setting and achieving success.

Key Performance Indicators (KPI) should be set up to support the effective implementation and thus realizing a predetermined strategy.

Problems can arise if only one-sides focus on KPI’s at the risk of deployment fails. To prevent this, always focus on PLAN – DO – CHECK – ACT activities from the Quality Management Circle.

  • A strategy typically starts with establishing a vision.
  • The vision then broken down to a few targets to be challenging but achievable.
  • It is important that there is not talk about more than 2-3 goal, which in turn should be of paramount importance.
  • The next step is the preparation of plans
  • Implementation of plans
  • Evaluation of performance
  • Next, the diagnosis that makes it possible to capture learning and adjust the plan.


Degradation of the strategy elements is of great importance to managers and leaders understand the strategy and each can see their personal role in goal achievement.

The hallmark of a well-planned approach to strategy development and implementation is a continued emphasis on Kaizen (continuous improvement), while the link between the mission and the quality control system is supported, with associated milestones and checkpoints.

Also includes a broad involvement of the management team in the development and definition of objectives and means.

Note that it can typically take two to three years before the organizations are fully familiar with the strategy process. Even though it may seem simple and straightforward. Involvement of the management team is essential, as all feels ownership of the final plan succeed when they have the opportunity to influence decisions.

The strategy must never be a team project, as it is doomed to fail. It is the resonsibility of doing the strategy process and ensures that there will be given a clear choice.

A good idea is to include a planning coach, whose task is to challenge and to get managers up to speed. Along with the coach is responsible to preent any being too conservative or lost in the details. The coach must ensure that the process is moving forward and everyone keeps on track.

When including a coach or consultant in strategy process and implementation, the enterprise from the start, make the following clear:

  1. When, why and how a consultant/coach is preferred.
  2. Know what they want to get out of the collaboration.
  3. Is motivated to work for change and improvement.
  4. The process may involve criticism.
  5. Actively involved in the management of the task.

Strategy should make sense, for achieving high performance and effective results.

NOTE that the strategy process is the most important thing when ambitious goals had to be realized.

The 3 ways to develop the business

  • Optimizing/improving processes
  • Create outward Growth
  • New business model – both new process and new customers markets

The three ways are connected, only the tools are different!

Focus on sales, strategy, right time and timely dedication and diligence.

  1. Make a short time status on five growth initiatives
  2. Active participation from key people
  3. Costomize the project plan ; check questions
  4. Get the preview diagrams/flowcharts emerged from reports
  5. Visual representation of corporate status “into the future”
  6. New initiatives launched NOT until ready
  7. Continuous follow-up on agreed action !

PHASE 1: Eye opener

  • Taking stock
  • Find attractive, overlooked and undervalued opportunities
  • Common Process – Growth center
  • The pool of internal contributors increased – better commitment
  • Homework and meetings; facts and discussions
  • Documented and visible on readily available boards
  • 1-3 actions decided

Management Growth Drive: Are we targeted and adequately to the forefront?

Products and Product Development: At what products do we ear ou money and what should we focus on in the future?

Sales and marketing: Is the sales process optimally adapted to the opportunities that exist today?

Competition: Can we commit against our competitors and do we have a strong profile?

PHASE 2: Preparation

The target is to increase the success rate of the new initiatives

Different content e.g.:

  • Remove obstacles before new initiatives set in motion
  • Further assessment of options e.g. new markets
  • Design and develop sales materials
  • Provide new employee
  • Competence development
  • Growth coaching of the management team

PHASE 3: Initiative

The most important are:

  • Implementation of the 1-3 market-oriented growth projects
  • Take the direct route – harvest the “lowst hanging frut” at first = success
  • Larger and more complex growth initiatives

 Eye opener – Preparation – Initiative

What characterizes Excellent leadership?

Good governance and leadership is prerequisite before employees thrive and perform optimally. Unfortunately, success is not for everyone, as many leaders have widely different perceptions of good leadership. The best and most excellent managers have a fundamentally different understanding of workplace, company, and team dynamics.

Business is an ecosystem, not a battlefield.

Average managers see business as a conflict between companies, departments and groups. They build huge armies of ”troops” to order about, demonize competitors as ”enemies”, and treat customers as ”territory” to be conquered.

Extraordinary managers see business as a symbiosis where the most divers firm is most likely to survive and thrive. They naturally create teams that adapt easily to new markets and can quickly form partner ships with companies, customers … and even competitors.

 A company is a community, not a machine.

Average managers consider their company to be a machine with employees as cogs. They create rigid structures with rules and then try to maintain control by “pulling levers” and “steering the ship.”

Extraordinary managers see their company as a collection of individual hopes and dreams, all connected to a higher purpose. They inspire employees to dedicate themselves to the success of their peers and therefore to the community – and company – at large.

Management is service, not control.

Average managers want employees to do exactly what they’re told. They’re hyper-aware of anything that smacks of insubordination and create environments where individual initiative is squelched by the ”wait and see what the boss says” mentality.

Extraordinary managers set a general direction and then commit themselves to obtaining the resources that their employees need to get the job done. They push decision making downward, allowing teams form their own rules and intervening only in emergencies.

My employees are my peers, not my children.

Average managers see employees as inferior, immature beings who simply can’t be trusted if not overseen by a patriarchal management. Employees take their cues from this attitude, expend energy on looking busy and covering their behinds.

Extraordinary managers treat every employee as if he or she were the most important person in the firm. Excellence is expected everywhere, from the loading dock to the boardroom. As a result, employees at alle levels take charge of their own destinies.

Motivation comes from vision, not from fear.

Average managers see fear of getting fired, of ridicule, of loss of privilege as a crucial way to motivate people. As a result, employees and managers alike become paralyzed and unable to make risky decisions.

Extraordinary managers inspire people to see a better future and how they’ll be a part of it. As a result, employees work harder because they believe in the organization’s goals, truly enjoy what they’re doing and (of course) know they’ll share in the rewards.

Change equals growth, not pain.

Average managers see change as both complicated and threatening, something to be endured only when a firm is in desperat shape. They subconsciously torpedo change … until it’s too late.

Extraordinary managers see change as an inevitable part of life. While they don’t value change for its own sake, they know that success is only possible if employees and organization embrace new ideas and new ways of doing business.

Technology offers empowerment, not automation.

Average managers adhere to the old IT-centric view that technology is primarily a way to strengthen management control and increase predictability. The install centralized a way to strengthen management control and increase predictability. They install centralized computer systems that dehumanize and antagonize employees.

Extraordinary managers see technology as a way to free human beings to be creative and to build better relationships. They adapt their back-office systems to the tools, like smartphones and tablets that people actually want to use.

Work should be fun, not mere toil.

Average managers buy into the notion that work is, at best, a necessary evil. They fully expect employees to resent having to work, and therefore tend to subconsciously define themselves as oppressors and their employees as victims. Everyone then behaves accordingly.

Extraordinary manageres see work as something that should be inherently enjoyable – and believe therefor that the most important job of manager is, as far as possible, to put people in jobs that can and will make them truly happy.

Excellent leadership creates Winning-teams!



FMEA means Failure Mode Effects Analysis and is a proactive method of analysis. The method can be used to carry out in-depth analysis of a delimited working process for the purpose of implementation of improvements.

This method is useful when there in a department is suspicion that some processes contain unidentified risk factors. If several identified internal failures or adverse events related to a specific process are detected.

All potential risk factors has to be identified, both directly observed as indirectly that can not be readily seen. This assumes, of course, a professional and independent auditor, with extensive experience in analysis and auditing of business processes.

Any risk assessment can be made generally or at a specific process. At a general assessment there will be taking into account all the extensive measuring equipment, appliances, decor, applicable procedures, communication, learning and training of staff.

Detecting of any risks to a specific process, is directly comparable to audit of the process, where assessing the risk starts at first contact and continuous throughout the process. Is the whole process ‘In Compliance’ or is there any discrepancy in greater or lesser degree.

It is based on the following:

  • Procedures/Instructions/Specifications (availability)
  • Validity of appliances and Measurement
  • Working environment
  • Introduction, training and education
  • Communication
  • Barriers against failures

Objective evidence uncovered for established risk factors, the analyzes documented in subsequent reporting and last but not less important, prepared action plan for implementation of improvement measures.


Innovation Management

Innovation is when creativity succeeds!

Innovation means growth, and growth means existence. All other from schools, public institutions, companies and organizations must realize that their ability of existence is not given but must be created every day. And the best way to create it is to move with the times and be ahead with innovative solutions.

Innovation is like a train – if you standing still, you get run over. If you run forward you will reach the destination before others. If you skip on train itself, you will do it reasonably good, as long as you move like the rhythm of the train. If not, you risk dropping down. And if you fall asleep, you will be left behind!

How can you lead towards a objective, you do not know? It is possible when the motivation burns in the hearts and the vision lights up in the sky. Determine strategy and makes the vision visible so it is well known throughout the whole organization!

Through provocation increased tolerance and creating more innovation.

Innovation, when it is best is how to influence people through the process and let go of desire to control what is going to happen. The more you get people to act wisely and effectively on their own, the greater chance for success.
Innovation Management is basically characterized by the vision to influence rather than control.

Innovation is about finding the next wave of profitable growth for the company. To identify and hatch the business ideas that can have a decisive influence on the future of the company, while ideas for continuous performance improvement is captured and implemented.

Innovation management is management of the processes by which new products, new processes or new administrative procedures are created and implemented.

The frame for good innovation management can be established as 4R model, since in addition to motivation, which is the individual’s inner drive and desire to act, are four important factors.

4R model:

Relationships: Interaction, the relationship between two or more individuals – one should as a group would each other. Without fruitfully relationships no major innovations.

Reflection: Individual, consciously or unconsciously consideration – you do as an individual reflection. Reflection is a necessary component in creativity. And for someone difficult to master in a busy day.

Ritual: One or more activities that take place in a period and inclusive process, while there is awareness of what happens and how it happens. The process can take place at all levels, individually and simultaneously.

Result: Consequence or visible outcome. A target or objective achieved a solution to a problem – focus on what comes out of it.

Relationships, reflection, ritual and performance affect creativity and innovation.

Prerequisites for innovation:

  • Break down the walls and create a multi-disciplinary organization where work in projects and teams takes places.
  • Assign all employees a coach instead of a boss
  • Train a number of professional project managers and project managers
  • Train organization to work in projects, including the managers
  • Create a project-oriented organization with project teams and departments, with max. 10 to 12 people each.
  • Monitor that multidisciplinary teams always created
  • Create teams with a complementary group of persons
  • Be aware that the most appropriate persons are being selected and not always the same persons.
  • Develop procedures to manage development budgets, salaries, etc.
  • Talk open and honest.


Make a thorough description of the situation, what do we want and what we are dealing with? Prepare a SWOT analysis of the task and the team; assess strengths, weaknesses, opportunities and threats.

  • What is the greatest mistake we can make?
  • What is the greatest opportunity?

Discuss the challenge of the project and create consensus within the team about what the task is. Repeat regularly the purpose for the task and how to get it performed.


Analyze successes in order to find the underlying values. Find the values ​​that go again – common denominators for High Performance patterns.
Find the values ​​to be prioritized in order to achieve a 110% goal.
Find the values ​​that may prevent the team from reaching the goal and park them.
Find the strategic values ​​that are the few values ​​that must function 110% when the target is reached.

  • Strategic value is ‘heart’ of the possible future
  • Strategic values ​​creates energy and commitment


The objective/vision of the goal described, so everyone can see it for themselves and especially that everyone can see its place in reaching the target. Hence there will later be signed by the many paths from the target, and to where we are right now.

Be specific in description of objective

  • Part the objective up in milestones areas – such as leadership, organization, products, finance, information systems
  • Describe the objective
  • Be ambitious – 110%
  • We know that the objective is 110% when the participants said: “It will not be easy, but it can be done, and we must do it.”

Action plans and pilot projects

  • Set plan based on the objective – backwards
  • Describe milestones and criteria for meeting the objective
  • Describe the activities that lead from milestone to milestone
  • Describe pilot projects – implemented at max. 100 days with full focus on the strategic values.
  • Agree milestones and how to celebrate progress

Walk as you talk

All work best with new things when we can trust each other and the company. Be honest in all contexts. Show confidence, certain own weaknesses, so that others can have the opportunity to help where actually need it.

  • Be professional objectively – not political subjectively
  • See things from the company’s perspective rather than your boss
  • What you say about others – you always say to themselves
  • Help where you can: For the one who gives, given more.
  • Speak your mind in a proper manner – by recognizing that there is always at least one other way of looking at things.
  • See that the company treats people properly, even if you do not think they do a good job – we can all ports in the same situation.


What is Coaching?

Coaching can in all its simplicity be defined, as:

A method that through a process opens up the individual’s full potential, thereby areas of strength developing takes place.

Coaching develops the individual’s behavior and the learning process is crucial to the way the future being created.

Coaching is about:

  • To help others to find what they want, what prevents them from achieving it and help them to achieve this in an efficient, honest and funny way
  • To discover and exploit its full potential
  • To get the person to take action and get him or her to see and recognize what he or she not could before.
  • To focus on exactly what the person wants now and in the future.

Coaching is a proven and results-driven process helping you changing life and lead you where you want to be, or teach you how to change behavior and act differently.

Coaching is a method that through a customized process opened to other people’s potentials. This allows the client to develop and realize their own personal potential, actions, attitudes and personal goals.

Coaching is basically about starting up a development or change process. The Coach challenges and disturbs, which is important since many often find it difficult even to get started, set goals, hold on and finish with success. With the help of a coach who has a professional knowledge and skills, most people far more easily defined and implemented their goals.

Coaching is also about personal growth, where the dialogue that takes place between coach and client, results in a deeper insight and understanding of the focus person’s own previous elections. This gives the client the opportunity to make new choices at a higher level, providing new and better meaning, while setting a learning process.

Coaching operates on the emotional level, challenges the emotional intelligence and identified obstructions such as anger and fear, loosing up, and most importantly, supports the change.

Coaching is about asking the right questions so that the clients even identify the correct answers.

The Coach’s role is to be observant, provocative and understanding intermediary, by the use of questioning techniques, feedback, listening examples, information and reflections.


FDA Validation

ISO 9001- the series was the most common method up through the 90s and was used to create customer confidence. Confidence from customers is still the most important, but today companies focus on 0-failures philosophy, process optimization and minimization of wastage expressed through LEAN, Six Sigma or FDA validation (0-failures production).

Validation is to avoid failures opposite sorting.

When a company such as exporting food, dietary supplements, cosmetics, medical devices, pharmaceuticals or blood products to the United States, it is a requirement that the manufacturer validates the process to ensure flawless products.

NOTE that this is a legal requirement!

If the manufacturer not complies with this requirement, the FDA (Food and Drug Administration) can go to courts and demand the product removed from the market.

How to set up production to produce without failures?

Any failure freedom begins with product development, because failures and delays can be expected. Parallel to the development of a new product, validation can be carried out to ensure that the initial start-up results in a flawless issue, and the minimum cycle time. Troubleshooting avoided and the subsequent production results in lowest unit cost.

How to realize 0-failures production through FDA-validation?

A plan for process validation consists of 5 basic elements, see the table below:

1 IQ Installation Qualification Prove that production equipment, and other equipment are connected as prescribed and that alle supplies meet specifications. Note that it is not enough to refer to the supplier’s own testing equipment!
2 OQ Operationel Qualification Establish limits for process control that ensures production of approved products.
3 PQ Production Qualification Prove that the process is reproducible, as documented by completing 3 productions. These 3 productions shall be carried out in normally occurring production conditions. (eg. shiftwork). Statistics evidence within 95% confidence
4 PC Process Control (control and monitoring) Process Control, a key part of process validation “process monitoring and real-time process control”. The company must prove that the process is monitored and that there is a valid method to control when monitoring indicates a change. To respond in “real time”, ie. The current production. Collecting data is processed and presented to the operator who   can intervene immediately. Corrections can similarly be automatic when monitoring data are stored as evidence that the process has been in control.
5 ReVal Repetition of Validation Saved data from monitoring should be archived, as evidence that the process produces within specified limits. This will be sufficient evidence for a “renewal” of validation.


The LEAN Code

The five LEAN principles is the code to understand LEAN and thus the laws of nature within excellent process management.

The principles inspires to new ideas, about how we organize work processes.

1. Specify what creates value for the user

2. Identify the value stream, and remove the non-value adding activities

3. Create flow around the value-adding activities

4. Establishment of flow systems

5. Seek for perfection towards continuous improvement

Every time a consultant in collaboration with relevant professional groups, records a value stream, the experience of the participants enter a few steps back and the first will be very aware of the complexity of the workflow is. Then there is always someone who points out ‘This we could do simpler’.

Often the participants seem a bit astonished at how complex the overall process flow is when the individual is only used to look at its own efforts.

It is the beginning to think LEAN, and the first step in thinking about the improvements that are the basics of implementation of change management.


In every concrete processes, it is about identifying:

1. What activities those create value for the user/customer?

2. What activities do not create value for the user/client, but is necessary for the process flow, ex. records?

3. What activities do not create value for the user/customer and can therefore be removed?

Value added can in simplified terms occur in two ways. Either you can increase the quality and/or service to a specific service with existing resources. Or you can maintain the current quality service and optimize the use of resources – and thus free up resources for other purposes. Resources will often be, human resources, skills and time and also financial resources.

LEAN is another way of looking at processes, a way of thinking that helps to optimize the administrative and service-related processes that characterize many Danish companies and organizations.

LEAN has long since proved its worth in production environments, wastage detected and removed, process flow improved and failures prevented, for the benefit of continuous improvement and customer value maximizing.

LEAN can cause stress if responsibility and work is not clarified, insecurity when respective activities and responsibilities change character. This more important is the knowledge of process understanding, anchoring and transparency and not least involvement and guidance of employees throughout the project.

CommunicationCommunicationCommunication is crucial in order to achieve success through any project for execution and implementation of value-added improvements.

Are we aware of the risks?

When we think about risk in all business processes it often turns out to be significant.

SWOT [Strengths – Weakness – Opportunities – Treats] reveals the weakness and threats it faces, but also the strengths and opportunities are available.

  • Is the strategy of the company well known throughout the organization?
  • Are all employees informed about the vision/mission and goals?
  • Who are our closest competitors and in which direction have they chosen?
  • Continuously ensuring the company in being at the forefront?
  • Are we aware of expiring date of our patents?
  • Are there new products/services in pipeline?
  • Are we in compliance with FDA requirements? FDA = Food and Drug Administration
  • Have we ensured that all the equipment in the production is validated?
  • Are we using validated software?
  • What about IT security?
  • Is the customer satisfaction measurements contained in the strategy?
  • Do we know the real value of the inventory?

It is fundamental to any company’s competitiveness that it keeps abreast of risks, through continuous monitoring and identification of issues that may arise. Focus on risk management is essential, especially when companies operate at international level, with many comparable and competing companies.

Always doing what they are best at, and what it takes being even better? If they do not notify focus on risks, there is high probability that competitors show that they can deliver similar, or worse yet maybe even a better product or a better service?

Have we asked our customers / employee what they are happy with and where we can be better?

Ongoing focus at performance and development by identification all resources available and/or lack of training?

Customer satisfaction measurements are an excellent tool in implementing process improvements and setting up an overview facing all risk concerning the company and its products.

Risk Management and Quality Management being ‘a must’ in companies’ strategy to achieve best practice and high performance through all business processes.