Good Afternoon - We are a Core Team in the Stryker Neurovascular Organization. We Develop and Manufacture Precision Devices used for complete Stroke Care. We are pleased to be here and honored to represent Stryker at the ASQ World Conference. 1
Stryker Neurovascular has facilities across the country we are located in West Valley, Utah at the base of the beautiful Wasatch Mountain Range. Our claim to fame is the Greatest Snow on Earth. We hosted the 2002 Winter Olympics. In addition to a rather large, salty, in-land lake, we are also home to the Church of Jesus Christ of Latter Day Saints (The Mormons.) 2
Project and Team Selection 3
Management was responsible for identifying the key performance indicators. The core team was responsible for supporting management s objectives. Together, the Core Team and Management selected our project. 4
Stryker is a dynamic company that focuses on customers needs and employee development. Our ability to save lives with the products that we manufacture has been our main objective, and is what drove our project. Improving quality, reducing costs, and growing the business was, and is the key to our long term success. 5
We are the Assembly Area Core Team for Guidewire Manufacturing. Our Core Leadership Team, including representatives from multiple functions, was ready to take action and drive all aspects of the project. With our combined expertise we were able to solicit support and take action that would not have been possible, or nearly as effective prior to our common efforts. 6
How Was The Gap Or Opportunity Brought To The Attention Of The Project Identification Group? We were faced with obvious challenges that needed attention. By starting our Lean Journey and taking one step at a time, we were able to take a methodical approach toward developing positive results and enhanced Business Performance. 7
The existing layout of the department gave us significant opportunities for improvement, such as freeing-up controlled environment space for new products, Reducing WIP and Cycle Time, improving Efficiency and Yield, and eliminating steps that add no value to the process. 8
The area of the organization that offered the greatest project potential was the clean room assembly area; which provided a wide range of opportunities. The CEA Assembly is the area of the organization with the largest space, the highest number of processes, the most employees, and the greatest potential for improvement opportunities. 9
The data generated to help select the project was gathered from spaghetti diagrams and Opportunities Burst Plots. They offered us numerous prospects to eliminate waste, and improve flow. 10
The methods used to assess and prioritize the need were the core metrics of yield, quality, and output. A red dot is an indicator that we were not meeting our goal. We review our core metric results on a weekly basis with our management group. 11
The method of assessing performance to goals is what drives the organization. When off target, the company requires a recovery plan. This project was undertaken as one of the plans to achieve those performance goals. As an example: A growing backorder occurred early in 2012. A large amount of overtime and hard work was required to build enough product to get back on-schedule. This drove the need to find a better, more efficient production process. 12
We have very specific goals that we measure and monitor on a daily basis. These areas have a high degree of impact on our business. 13
The measures of yield, labor efficiency, lead time, and production output were all identified to be affected by several types of waste. We determined that eliminating or minimizing the waste would drive improvement in the stated measures. 14
The performance measures of Yield, Lead Time, Production Output, and Net Labor efficiency rarely met the goals set by the organization. Furthermore, there was not enough space in the clean room to allow for new products. A successful project would enable the clean room to achieve the measures and provide enough space to Introduce new products. 15
The various Stakeholders were identified from the General Functions for which they were responsible. Stakeholder status was identified based on the relative importance of the process input derived from the individual Stakeholder Group, or the significance of the process output provided to a specific Stakeholder Group. 16
Based on their significance to the project and the relevance to the Core Team Mission, the Stakeholders were identified, and categorized as either Internal or External, and the relative compositions of the Stakeholder Groups were identified. 17
Several skills were needed to successfully complete this project. The improvement skills needed were an understanding of lean manufacturing and project management. A successful implementation also relied on an in-depth understanding of the equipment, the process, and the people. The improvement also had to meet all regulatory requirements. As can be seen from the table, most of the skills needed came directly from the team. 18
In order for the project to be successful all internal stakeholders needed to have a basic understanding of Lean Principles. They needed to know why the changes were being made and how it affected them. The stakeholder knowledge of Lean was obtained utilizing internal Lean experts to train all stakeholders. 19
The additional knowledge and skills needed for a successful project were gained through the use of experienced, skilled fabricators. Other operational changes needed were better material storage, improved equipment access, effective work station design, and various facility modifications. We used our own internal resources to meet these needs. 20
Extensive lean training was conducted for the Core Team and Product Builders by our in-house Industrial Engineer. We made extensive use of lean concepts and principles in the planning stages of this project to assure that we had a viable plan to be successful from day one, and to sustain the results for the long term. 21
Before the project started, a core team was formed and moved to the production floor. With representatives from each function on the core team, we were able to solicit support and take action that would not have been possible, or nearly as effective prior to our combined efforts. 22
The expectation determined ahead of time was a crossfunctional team. Our core team and production team formed a four cornerstone of talent and expertise comprising the collective skills to efficiently manage key responsibilities. 23
The deadline for this project was a major organization transfer that occurred in August 2012. The team was given a solid date to implement the improvements without affecting production. The improvement project was given a two week timeframe to implement, and absolutely had to be ready by the due-date. 24
Before the project started the team was moved to one central location. The team was strategically set up with the different functions of manufacturing engineer, production supervisor, engineering technician, and quality engineer. By selecting these roles, functions in the team were predefined. Being in one central location allowed for free, and constant communication among the team at the point where decisions could have the most impact. 25
Current Situation and Improvement Opportunity Analysis. 26
The team had 5 goals. Some were given directly from management such as: Free up space for new products and meet established core metric goals. The others were goals set by the team after analyzing the process. These additional goals were as follows: Reduce Work in Process between processes, Remove the need for a scheduler between stations, and Reduce the amount of raw material inventory. 27
The additional benefit was an introduction of our Lean culture. The Culture of Lean is the People Lean requires engaged and responsible employees at all levels, who are able and willing to: Shift, Adapt, Think as a business person, Take responsibility, Address problems, and Contribute to the success of all. 28
There are many different methods for driving improvements, such as 6 Sigma, 4D Problem Solving, which is a variant of 8D, Lean Tools, and the Problem Solving Roadmap. Many of these programs use similar tools and similar approaches. The key is to understand which method works for your project. 29
Our Core Team had years of collective experience using the tools. This experience gave the team the preparation they needed to move ahead. 30
We selected Lean Manufacturing Principles and Methods by virtue of its reputation, company endorsement, and definition which is: A systematic approach to identifying and eliminating waste through continuous improvement, and flowing the product by the pull of the customer 31
Data were generated by monitoring individual operator performance. Equipment was assessed to see what the capacities were and to determine what equipment could be eliminated. Finally, a spaghetti map was generated to see the flow of parts, people, and materials. 32
The team identified improvement opportunities in flow, space, Work-in-process, line-balancing, movement, and scrap. 33
We used the following tools to identify the improvement opportunities in the production area: 7 Wastes, Takt Time, Value Stream Mapping, Bottleneck Analysis, Visual Management, Performance Management, 5S, and Standardized Work. 34
In addition to team experience, the Core Team also brought in Subject Matter Experts to train on optimum use of the tools. 35
The Lean Manufacturing tools used for determining the Final Root Cause were the same tools used to determine the Possible Root Cause. These Tools were used because the improvements were readily identifiable. 36
The data generated was taken from product builder input, who are the ultimate experts of the process; from Spaghetti mapping, and from equipment assessment. A Value Stream Map was also generated to determine cycle times, inventory, communication flow, and material connections. 37
The value stream map identified big opportunities in inventory reduction as well as communication flow. 38
As shown in the table, numerous final improvement opportunities were identified. A few examples are: a reduction of overall lead time, reduced footprint to allow room for new products and improving efficiency of the product builders. 39
The final improvements were validated by submitting multiple proposals to our stakeholders for approval that addressed identified issues and concerns. 40
The evidence that the improvement opportunities were validated was done through our change procedure, which utilizes a Process Change Assessment Form that we call a PCAF. Each PCAF analyzes any change to Equipment, Process, or Environmental Impact and must be reviewed by Subject Matter Experts representing Quality, Engineering and Manufacturing. 41
The work breakdown structure and Gantt chart shown above represent the scope and deliverables of the project. The initial project scope and timing were verified and approved by the stakeholders through numerous buy-in meetings and the above timeline. Confidence and trust were gained through details execution planning and risk mitigation. 42
During the Improvement Opportunity Phase of the Project, Stakeholders were identified and input solicited. We gauged the level of excitement and commitment to the project and tried to determine what interactions would take place as the project was formalized. 43
As the Project was further scoped and defined, concerns were identified with the various stakeholder groups and specific resulting actions were formulated. The concerns ranged from: the very basic resistance to any change, to any potential impact on production schedules, to assuring that quality compliance was maintained, and the overall projected length of the project. Frequent opportunities for feedback were used throughout to address the concerns. 44
The appropriateness of team membership was confirmed through defined roles and expectations. Management routines were confirmed using kick-off meetings to communicate expectations. Any changes to the agreed plan were communicated back to the stakeholders for buy-in. 45
Improvement Development 46
Lean tools such as the 7 wastes, Takt time, Kanban, Value stream mapping, Bottleneck analysis, Visual management, Performance Management, 5S, and Standardized work were utilized to identify the possible improvements. 47
The assembled Team had several years of collective experience using the tools. The Core Team also brought in Subject Matter Experts to train on better utilization of the tools. This gave the team the preparation they needed for the improvement development. 48
We selected Lean Manufacturing Principles and Methods by virtue of its reputation, company endorsement, and definition which is: A systematic approach to identifying and eliminating waste through continuous improvement, and flowing the product by the pull of the customer 49
Standard Work and 5S chosen to reduce motion and scrap. Visual management and Bottleneck analysis chosen to reduce WIP and improve flow. Value Stream Mapping chosen to balance the line, determine Future State, and identify Kaizen events. Takt time chosen to ensure the line is balanced to meet customer pull. 7 Wastes chosen to reduce the wastes in the production line. 50
The data used to determine possible Improvements is as follows: The data included monitoring individual operator performance; equipment was assessed to evaluate their capacities and to determine what equipment could be eliminated. Finally, a spaghetti map was generated to see the flow of parts, people, and materials. 51
Possible improvements identified utilizing the current and future state map included focused on visual controls, product flow, reducing WIP, travel distance, cycle time reduction and opening up space for new products. 52
The evidence that showed the improvements were possible instead of final was comparing before and after spaghetti diagrams to identify bottle-necks and Product Flow Challenge. The team was able to balance the line by reviewing the analysis and proposing a more optimal layout. 53
The core team had extensive knowledge and experience utilizing lean methods and tools Members of our team included a Black Belt, Green Belt and ASQ certifications. Each member of the Team also received internal training in each of the Lean Manufacturing elements described above, including Lean Overview, Value Stream Mapping, Lean Culture, Kaizen, 5S, and Kanbans. 54
The two tools that were of the most value in our lean journey were a value stream map and spaghetti diagram. The Value Stream map gave a concise method to show the current situation and provide direction for improvements. Spaghetti diagrams provided an easy method to visualize improvements and communicate them to management. 55
Using spaghetti mapping and value stream mapping, the final improvement was able to be visualized prior to implementation. As an example, shown on the slide is a final state value stream map showing the improved communication flow. 56
The Final Improvements for the project are: Space, flow, workstation layout, and inventory control. This can be seen on the graphs going from the current state to the proposed future state. 57
The final improvements were validated by assessing the impact to the product and process on all key elements. 58
The final improvements were approved through our Process Change Assessment approval by Subject Matter Experts representing Quality, Engineering and Manufacturing. 59
Two additional benefits were anticipated. The team knew that removing the waste would reduce defects. This was believed to reduce the number of product-related nonconformities. 60
The other potential benefit was a reduction in errors found in the shop floor paper work (Device History Record). This was not anticipated prior to implementation. 61
The data were generated and confirmed using Lean Tools such as Spaghetti mapping, and resource assessments, including equipment and personnel. The team believed that improving flow and focus on wastes elimination will lead to fulfilling management s objectives for the project. 62
Justification for the improvement was done with management Review Meetings. Management gave final approval for the implementation during those meetings. 63
The correctness of the scope, deliverables and timing were verified by developing a work break down shown as the Gantt chart and a detailed checklist of implementation tasks. 64
During the Solution/Implementation Phase of the Project, Stakeholders were further involved and solicited for Project help and guidance. Continued enthusiasm and commitment to the project was gauged and even solicited in order to maintain momentum towards the ultimate project goals. 65
As the Project Improvement began to be implemented, the concerns were re-evaluated with the various Stakeholder Groups and Resulting Actions were updated. The main concerns continued to focus on adherence to the Project Schedule and maintaining adequate supplies of raw components and finished devices to service Distribution and Customer needs. 66
The team was carefully selected based on roles and experience. Management Routines were confirmed by having established weekly and monthly meetings. There were no changes made to team membership during the project. 67
Implementation and Results Verification 68
During the Implementation of the Project, Stakeholders were kept informed, and solicited for Project help and guidance. The key mechanisms for information flow to the various Stakeholders included Daily, Weekly, and Monthly Lean Reviews, PCAF Plan routing, Status Reports distributed to satellite groups, and All Hands meetings for local groups. 69
During the Implementation of the Project, Stakeholders continued to be involved and solicited for Project help and guidance. Continued enthusiasm and commitment to the project was gauged and even solicited in order to maintain momentum towards the completion of the Project. 70
To anticipate resistance, numerous meetings were held with Stakeholders over several months to discuss the project, review proposed plan, review issues, risks, and determine timing to complete our plan. Final approval was obtained from all members of senior staff after they had full and complete confidence in our plan. This project presented a high risk if it were not executed properly from a product supply and product quality perspective. 71
The main resistance encountered by the team was the original implementation timeframe, originally slated for two weeks, which was too long for customer demand. Due to customer demand, management challenged the team to compress the schedule to only three days, over a weekend (Friday, Saturday and Sunday). 72
The actual resistance was identified using meetings with management. As part of the meetings, management would bring up concerns and the team would be tasked with proposing solutions in later meetings. 73
The actual resistance from stakeholders was addressed through careful planning (down to the hour) and kick-off meeting with the teams. A checklist was posted in the areas shown on the layout. The team would check tasks off as completed. 74
We knew we were successful in addressing resistance because the team communicated daily with management on the status and risk of the project. The team was able to complete all tasks on time per schedule. 75
The various Stakeholder Groups expressed their Buy-In in numerous ways, and in varying levels of support. From the Customer who has voiced approval through increasing sales of our products, to the PCAF Plan Approval that documents all the elements of the change and associated approval. Various Stakeholders manifest Buy-in each day when approving Lot History Record Documentation. Additional stake holder such as Suppliers accept and fulfill Purchase Orders in support of the business and as a direct result of the Project outcome. 76
Constant communication with stakeholders ensured buy-in to the project. Furthermore, an assessment of the potential areas of impact were approved by the stakeholders. 77
The system that was changed in order to implement the improvement was utilizing manufacturing assistants and trainers to monitor the process to ensure In-Process Kanbans were sustain and the line remained balanced. 78
the team knew the trainer s view of the process was very valuable as they would see every step in motion. To measure and manage performance on the implementation plan, daily morning meetings were conducted with the trainers after implementation to review metrics and provide feedback to the team on how the system was working. 79
The results of our project can be summarized as follows: Space We freed up 1950 Sq. feet of space for new products. Quality We saw a 42% decrease in product affected Nonconformities. Scrap Scrap was reduced from 9% to 2%. Output Productive Output increased 18% Finally, we saved 8819 labor hours in one year, which equated to $190,000 in savings. 80
The team exceeded the goal to free up space in the Clean Room, and was able to meet every core metric goal for several months in a row. The design of the new process was such that there could be no space for excess raw materials and excess work in progress. This in turn created better flow, which connected each step together and eliminated the need for a scheduler for each process step. 81
A significant benefit was the ability to consistently meet customer demand we met or exceeded our output goal for 10 months in a row we did so with no overtime or staggered shifts which was the norm prior to the 10 month period. 82
Soft benefits may be difficult to measure However, we can attest to the value that we place on every aspect noted here. Many of these are at the core of our success and will assure that we hold onto our gains. They will also allow us to continue to push ahead in our lean journey. Some of the prominent Soft Benefits include: Empowered Employees, Improved Morale, Elimination of Bottlenecks, and Recognition for all of the Stakeholders in the process. 83
The additional anticipated benefit of reduced non-conformities was realized. As can be seen by the graph, the non-conformities went to almost zero. The amount of paper work errors decreased dramatically, and in part due to this project, the errors were reduced to zero in some selected weeks after the completion of the Project. 84
Preservation and Stakeholder Communication. 85
The system implemented, as mentioned earlier, was the better utilization of trainers to ensure the line remained balanced. Daily meetings were started with the trainers to discuss concerns and issues. 86
The change in roles resulted in strategically locating the Manufacturing Assistants and Trainers throughout the process. This drove a culture change wherein the Manufacturing Assistants and Trainers are more fully integrated into the process. Both are now readily available to assist and support Product Builders, and to keep the line flowing. 87
One of the methods used to ensure the benefits were sustained was regular meetings with management. There were established, weekly and monthly meetings with management to review key metrics and discuss issues and further potential improvements. 88
The evidence that the improvements became part of the organizations culture and operating strategy can be seen in the sustained improvement in core metrics over several months. Management also used the success of this project to drive other core teams to make similar changes. 89
The completed project was visible to everyone walking by the area. Product builders were shown the expected improvements in advance of the project; therefore, on day one of the new layout they were able to sit down and go to work right away. The results were communicated to management using the weekly and monthly management meetings. Meetings were held with the other internal stakeholders prior to the implementation so that they new exactly what to expect and what was needed of them when the improvements were made. 90
Our Core Team was awarded Stryker s site annual innovation and financial Award. This program recognizes outstanding team performance that helped drive Stryker s success and goal of being the world s most admired, fastest growing company. This is awarded to Stryker employees or teams that embody Stryker s innovation culture. 91
And finally, the Journey Continues Another improvement was implemented in late 2013, and we are working on the next improvement. Thank You. 92