Lean Six Sigma

Introduction

Lean six sigma is a well-known concept in today’s pharma. Originally, lean manufacturing and six sigma were two distinct improvement programs or philosophies that were first combined in one single approach around the turn of the century.
Lean manufacturing is a process improvement philosophy that identifies value from a customer perspective and designs and organizes processes that deliver right first time products, with optimal efficiency of resources.
Six sigma uses statistical techniques in a proven structured approach to increase capability of the available resources. The two philosophies are complimentary. A lean six sigma program combines both philosophies to make sustainable, tangible improvements to the current process.
Lean six sigma is most successful when embraced from the top of the organization. It is not a project, not a headcount reduction program, not a clean desk initiative and not the next flavor of the month. Lean six sigma is about improving processes, developing people and creating a continuous improvement culture in the organization. This change will not come overnight.

How can Progress-PME help you?

  • Do you want to solve repeated product rejects?
  • Do you want to reduce the lead time of your release process?
  • Do you want to reduce inventory without compromising supply reliability?
  • Do you want to align your internal communications with the flow of your primary process? 
  • Do you want sustainable process improvement results?

Progress-PME offers experienced lean six sigma green belt or black belt certified specialists and project managers who can help you simplify processes, reduce variation and increase the engagement of personnel. We offer:

  • Operational  Excellence program
  • Lean six sigma projects
  • Root cause investigations
  • Green belts or black belts
  • Making problems visible

Operational Excellene

But how do we make it stick? How do we make sure the resources invested in the improvement project have not been not a waste of time because we’re doing things like we were used to six months ago? How do we make results truly sustainable?  This is where you, senior leader and sponsor, play a pivotal role. Only senior managers are empowered to start the lean six sigma journey and change the culture.

Culture
Every organization has it, although we sometimes do not like parts of it. Values, beliefs, habits. Written and unwritten procedures, or ‘how things are done around here’. Not all improvement initiatives last and the chance of falling in old pitfalls due to culture are real. The vision of Progress-PME is that senior leaders must embrace, sponsor, encourage and support the lean six sigma or operational excellence program. Big companies like Baxter, J&J, Merck demonstrate that cultural transformation starts at the top.

Lean Six Sigma Deployment roadmap 
This is an example of how your lean six sigma deployment roadmap could be setup.

  1. Leadership commitment. Do we have a burning platform here? Is there a sense of urgency to embark on this journey?
  2. Agree deployment plan. Prioritize with the customer in mind. Link lean six sigma deployment targets to organizational goals. Identify quick wins to engage work force.
  3. Setup project infrastructure for lean six sigma improvements.
  4. Educate improvement staff (black belts, green belts).
  5. Create ownership, empower improvement staff and delegate accountability for results.
  6. Establish communication plans.
  7. Monitor results. Nourish the early stage of the journey and improve where needed
  8. Celebrate early successes.
  9. Communicate. Communicate
  10. Continuously improve the program

How can Progress-PME help you? 

Why choose Progress-PME for your lean six sigma journey, to remove operational waste, reduce variation in processes and to help you transform your organization’s culture to make sustainable improvements?
Because we have extensive experience in lean six sigma and we know the pharma industry like our back pocket. We know production, packaging, the QC-lab, QA, logistics, engineering and so on.
You know us from a CMC project, we executed and coordinated your validations  and qualifications, performed a QA-audit, managed your capital expense engineering project or we managed your department when you needed an interim manager.
You appreciate our no-nonsense attitude and our skills and expertise.
You will encounter these exact qualifications with our lean six sigma green and black belts. These enthusiastic continuous improvement professionals think in processes and are sensitive to both the shop floor team and the board room members. 

Lean six sigma projects

Progress-PME can help you with your Lean, Six Sigma or Lean six sigma project. Do you recognize any of the following issues in your processes?

  • The speed of the entire process is too low to meet demand
  • Process yield issues, defects, too much rework
  • Root cause investigations do not deliver root causes
  • Line change overs are too long
  • Stock or work in process is too high or becomes obsolete before consumption
  • Variation in process output is too high
  • Too many events, deviations and other compliance issues
  • Performance metrics are in red 

DMAIC
Most lean six sigma projects will follow the proven structured DMAIC phases towards the future state (Define, Measure, Analyze, Improve, Control). Each phase uses a set of techniques to move from the current state towards the future state with sustainable results. Depending on the problem to be solved and the scope, you can think of the following activities per project phase.

This phased approach is suitable be used for most improvement projects. If required, specific approaches, phasing can be discussed and agreed.
A typical DMAIC project can be executed in two to four months, depending on resource availability and complexity. 

PDCA
For smaller scale continuous improvements that do not require a DMAIC approach, other tools can be used to improve your processes.
W. Demings Plan-do-check-act (PDCA) cycle can be used to engage shop floor personnel in continuous daily problem solving. This is the platform where senior leaders can initiate a change in culture by enabling shop floor personnel in improving what they do each and every day. 

KAIZEN 
Kaizen events (Kaizen is Japanese and means “change for the better”) can be organized to have a team of empowered subject matter experts from multiple disciplines tackle a problem that is difficult to solve without having the team together for a couple of days. 

SMED 
SMED (Single-minute exchange of die) is a technique for creating rapid line change-overs. When a line is in change over, it is not producing product to satisfy customer demand.  Japanese expert on SMED, Shigeo Shingo, said: “It’s only the last turn of a bolt that tightens it – the rest is just movement.” How very true. The single minute does not mean a changeover has to be executed in one minute, but stands for single-digit, i.e. less than 10 minutes. SMED exercises using standardized work techniques can be
executed to minimize setup times and improve uptime on your
capacity constraint resources. 

Root cause investigation

During the weekend, or enjoying a holiday, or even in traffic, we may enjoy an unexpected event. Some of us like surprises. In pharma business, a surprise means trouble because when something unexpected happens, we are not in control. We investigate the unexpected event, incident or deviation to find the root cause(s). When the root cause is found, we try to prevent the root cause from happening again.
But all too often, root cause investigations are not executed properly and the root cause is not found. The event may re-occur and we perform another root cause investigation. We are running in circles and find it hard to step out of the tread mill.

How can Progress-PME help you?
Progress-PME has extensive experience in root cause analysis and can also help you to educate your teams on root cause investigations. Lean techniques like 5Y, Fishbone, FMEA, statistical tools are used to link the root cause to the adverse event and to eliminate the failure mode. In addition Progress-PME has developed a Root Cause analysis training based on customer needs which can be given in conjunction with your own trainers.

Green belt or black belt

You have heard the term green belt or black belt. But what does it mean and what is the difference?  Lean six sigma practitioners are trained at different levels, called belts. The terminology is similar to the belts in karate. The skills and experience increase with the belt colors from yellow belt to green belt to black belt to master black belt.

How can we help you?
Progress-PME has a team of black belts and green belts in house to support you. Green belts are trained and experienced in sustainable short term improvement projects with limited scope and complexity. Black belts are trained and experienced in more complex improvements projects across department or business unit boundaries. A black belt trains and coaches teams or individuals in continuous improvements.

Making problems visible

Lean Six Sigma is a continuous improvement philosophy for improving an organization’s performance. The method helps to systematically visualize problems in processes and then improve these. Shop floor personnel are engaged at length as part of this effort. After all, they know better than anyone how their work can be done smarter and better. The term ‘six sigma’ comes from statistics and indicates a quantity of errors. Six sigma means there is ‘near perfection’ because the number of defects per million possibilities amounts to no more than just over three. Lean Six Sigma was first introduced at Motorola in the 1980s as a solution for problems with customer satisfaction.Lean Six Sigma professionals work at different levels, which are designated by ‘Belts’: Yellow Belt, Green Belt, Black Belt and Master Black Belt. The Yellow Belt is familiar with the basic principles of Lean Six Sigma. The Green Belt works part time on optimizing the day-to-day activities in his or her work environment using the DMAIC project structure. The Black Belt is the project manager for improvement programs. They know and apply the tools of the DMAIC methodology. The Master Black Belt is an expert in large-scale and multidisciplinary process improvements and trains Black Belts and Green Belts.
Lean six sigma black belt and project manager Oscar Smit is enthusiastic about Lean Six Sigma. He started in 2003 with his Green Belt training, followed by Black Belt training. Since the time, he has been using Lean Six Sigma at Black Belt level. ‘You can actually look at “Lean” and “Six Sigma” as two separate programs’, he explains. ‘They are two different ways of implementing improvements. Six Sigma mainly concerns getting processes under control by minimising all the variables that have an influence on the process. “Lean” is based on creating flow and eliminating waste from the process.’

Oscar also emphasizes the power of employee engagement. ‘We talk a great deal with the people who do the work. Not from a conference room with flip-charts, but where the real action happens. The Japanese call that gemba, or “the place where it happens”. If something goes wrong somewhere, you have to go to the shop floor to see on location what went wrong and why. When you go see in person, it becomes clear what the problem actually is and you can make a start on identifying root causes and work on solutions. You will never manage to do that if you try to do this from behind a desk.’

‘Lean operations management’ or ‘Visual management’ is an important part of Lean, according to Oscar. ‘Many businesses work with lists in Excel. Although the information is in the file, it is not clear at first sight what the status of the process or the area is. “Lean operations management” or “visual management” provides the metrics or KPI’s that are relevant for the area.’A crucial part of Lean operations management is the good organization of a day-to-day communication and escalation model. Oscar: ‘The manager is on the shop floor regularly, for example daily. Managers have to be present in person at the place where the value is added to the product, to allow process owners to report the status of the process or KPI to their managers. If a problem arises that cannot be resolved with the participants in the meeting, the problem can be escalated within hours at a higher level to other functions or even to Management Team level. A problem can be escalated and returned – including direction – to the place where it was raised – within hours. With this escalation model you create visibility of senior managers on the shop floor and a rapid high-frequency feedback loop from and to higher management.’

‘Lean, was never intended as a reorganization instrument.’
Oscar wants to point out that ‘Lean’ is often wrongly associated with ‘redundancies’ and ‘reorganizations’. ‘That was never what “Lean” was intended for. It is intended to enable people to work smarter and better. The result of the method is that an employee requires less time for his or her work and therefore has time left over to take on other tasks. That is the idea behind “Lean”. It was never intended as a reorganization instrument. The great thing about Lean Six Sigma is that you get employees involved in the improvement program quite easily. That is because it appeals to our common sense and the changes are clearly logical and sensible, and that is because we invite employees themselves to contribute ideas. They are listened to and are given the chance to finally make the improvements they have long seen to be possible.