Measure Phase Process Discovery

Measure Phase Process Discovery
Now we will continue in the Measure Phase with “Process Discovery”.

Measurement System Analysis
Process Discovery Detailed Process Mapping Cause and Effect Diagrams FMEA Wrap Up & Action Items Process Capability Measurement System Analysis Six Sigma Statistics Welcome to Measure Process Discovery The purpose of this module is highlighted above. We will review tools to help facilitate Process Discovery. This will be a lengthy step as it requires a full characterization of your selected process. There are four key deliverables from the Measure Phase: (1) A robust description of the process and its workflow (2) A quantitative assessment of how well the process is actually working (3) An assessment of any measurement systems used to gather data for making decisions or to describe the performance of the process (4) A “short” list of the potential causes of our problem, these are the X’s that are most likely related to the problem. On the next lesson page we will help you develop a visual and mental model that will give you leverage in finding the causes to any problem.

Overview of Brainstorming Techniques
A commonly used tool to solicit ideas by using categories to stimulate cause and effect relationships within a problem. It uses verbal inputs in a team environment. Problem or Condition The Y The X’s (Causes) l Categories Material Measurement Environment People Machine Method The Problem Cause and Effect Diagram You will need to use brainstorming techniques to identify all possible problems and their causes. Brainstorming techniques work because the knowledge and ideas of two or more persons is always greater than that of any one individual. Brainstorming will generate a large number of ideas or possibilities in a relatively short time. Brainstorming tools are meant for teams, but can be used at the individual level also. Brainstorming will be a primary input for other improvement and analytical tools that you will use. You will learn two excellent brainstorming techniques, cause and effect diagrams and affinity diagrams. Cause and effect diagrams are also called Fishbone Diagrams because of their appearance and sometimes called Ishikawa diagrams after their inventor. In a brainstorming session, ideas are expressed by the individuals in the session and written down without debate or challenge. The general steps of a brainstorming sessions are: Agree on the category or condition to be considered. Encourage each team member to contribute. Discourage debates or criticism, the intent is to generate ideas and not to qualify them, that will come later. Contribute in rotation (take turns), or free flow, ensure every member has an equal opportunity. Listen to and respect the ideas of others. Record all ideas generated about the subject. Continue until no more ideas are offered. Edit the list for clarity and duplicates.

Cause and Effect Diagram
Products Measurement People Method Materials Equipment Environment Transactional Policy Procedure Place Categories for the legs of the diagram can use templates for products or transactional symptoms. Or you can select the categories by process step or what you deem appropriate for the situation. Problem or Condition The Y The X’s (Causes) l Categories Material Machine The Problem Cause and Effect Diagram A cause and effect diagram is a composition of lines and words representing a meaningful relationship between an effect, or condition, and its causes. To focus the effort and facilitate thought, the legs of the diagram are given categorical headings. Two common templates for the headings are for product related and transactional related efforts. Transactional is meant for processes where there is no traditional or physical product; rather it is more like an administrative process. Transactional processes are characterized as processes dealing with forms, ideas, people, decisions and services. You would most likely use the product template for determining the cause of burnt pizza and use the transactional template if you were trying to reduce order defects from the order taking process. A third approach is to identify all categories as you best perceive them. When performing a cause and effect diagram, keep drilling down, always asking why, until you find the root causes of the problem. Start with one category and stay with it until you have exhausted all possible inputs and then move to the next category. The next step is to rank each potential cause by its likelihood of being the root cause. Rank it by the most likely as a 1, second most likely as a 2 and so on. This make take some time, you may even have to create sub-sections like 2a, 2b, 2c, etc. Then come back to reorder the sub-section in to the larger ranking. This is your first attempt at really finding the Y=f(X); remember the funnel? The top X’s have the potential to be the critical X’s, those X’s which exert the most influence on the output Y. Finally you will need to determine if each cause is a control or a noise factor. This as you know is a requirement for the characterization of the process. Next we will explain the meaning and methods of using some of the common categories.

The Measurement category groups Root Causes related to the measurement and measuring of a process activity or output: Examples of questions to ask: Is there a metric issue? Is there a valid measurement system? Is the data good enough? Is data readily available? The People category groups Root Causes related to people, staffing and organizations: • Are people trained, do they have the right skills? Is there person to person variation? Are people over-worked? Measurement Y Please read the slide.

The Materials category groups Root Causes related to parts, supplies, forms or information needed to execute a process: Examples of questions to ask: Are bills of material current? Are parts or supplies obsolete? Are there defects in the materials? • How is this performed? Are procedures correct? What might unusual? The Method category groups Root Causes related to how the work is done, the way the process is actually conducted: Y Method Materials Please read the slide.

Display Slide: Equipment The Equipment category groups Root Causes related to tools used in the process: Examples of questions to ask: Have machines been serviced recently, what is the uptime? Have tools been properly maintained? Is there variation? The Environment (a.k.a. Mother Nature) category groups Root Causes related to our work environment, market conditions and regulatory issues. Is the workplace safe and comfortable? Are outside regulations impacting the business? Does the company culture aid the process? Y Equipment Environment Please read the slide.

WHICH X’s CAUSE DEFECTS?
Classifying the X’s The Cause & Effect Diagram is simply a tool to generate opinions about possible causes for defects. For each of the X’s identified in the Fishbone diagram classify them as follows: Controllable – C (Knowledge) Procedural – P (People, Systems) Noise – N (External or Uncontrollable) Think of procedural as a subset of controllable. Unfortunately, many procedures within a company are not well controlled and can cause the defect level to go up. The classification methodology is used to separate the X’s so they can be used in the X-Y Matrix and the FMEA taught later in this module. The Cause and Effect Diagram is an organized way to approach brainstorming. This approach allows us to further organize ourselves by classifying the X’s into controllable, procedural or noise types. WHICH X’s CAUSE DEFECTS?

Chemical Purity Example
Measurement Manpower Materials Training on method (P) Raw Materials (C) Incoming QC (P) Insufficient staff (C) Measurement Method (P) Skill Level (P) Multiple Vendors (C) Measurement Capability (C) Adherence to procedure (P) Specifications (C) Work order variability (N) Chemical Purity Startup Inspection (P) Room Humidity (N) Column Capability (C) Handling (P) RM Supply in Market (N) Nozzle type (C) Purification Method (P) Shipping Methods (C) Temp controller (C) Data collection/feedback (P) This example of the cause and effect diagram is of chemical purity. Notice how the input variables for each branch are classified as Controllable, Procedural and Noise. Methods Mother Nature Equipment

Cause & Effect Diagram - SigmaXL®
Below is a Cause & Effect Diagram for surface flaws. The next few slides will demonstrate how to create it in SigmaXL ®. The Fishbone Diagram shown here for Surface Flaws was generated in SigmaXL®. We will now review the various steps for creating a Cause & Effect Diagram using the SigmaXL® statistical software package.

Cause & Effect Diagram - SigmaXL ®
Select “SigmaXL >Templates and Calculators>DMAIC and DFSS Templates>Cause & Effect (Fishbone) Template” Select “SigmaXL >Templates and Calculators>DMAIC and DFSS Templates>Cause & Effect (Fishbone) Template”. Take a few moments to study the worksheet. Notice the six groups are the classic bones for a Fishbone. Enter each Cause under the appropriate heading: People, Method, Material, Machine, Measurement, and Environment. You may enter up to 2 Sub-causes for each Cause.

Fill in the template as shown above. Click the “Fishbone Diagram” button to generate the Cause and Effect Diagram.

You may modify the results to add data, however due to the simplicity of the template it is recommended that you add to the template and recreate the chart. Please read the slide.

Cause & Effect Diagram Exercise
Exercise objective: Create a Fishbone Diagram. Retrieve the high level Process Map for your project and use it to complete a Fishbone, if possible include your project team. Don’t let the big one get away!

Overview of Process Mapping
In order to correctly manage a process, you must be able to describe it in a way that can be easily understood. The preferred method for describing a process is to identify it with a generic name, show the workflow with a Process Map and describe its purpose with an operational description. The first activity of the Measure Phase is to adequately describe the process under investigation. Finish Step A Inspect Step B Step C Step D Start Process Mapping, also called flowcharting, is a technique to visualize the tasks, activities and steps necessary to produce a product or a service. The preferred method for describing a process is to identify it with a generic name, show the workflow with a Process Map and describe its purpose with an operational description. Remember that a process is a blending of inputs to produce some desired output. The intent of each task, activity and step is to add value, as perceived by the customer, to the product or service we are producing. You cannot discover if this is the case until you have adequately mapped the process. There are many reasons for creating a Process Map: - It helps all process members understand their part in the process and how their process fits into the bigger picture. - It describes how activities are performed and how the work effort flows, it is a visual way of standing above the process and watching how work is done. In fact, process maps can be easily uploaded into model and simulation software where computers allow you to simulate the process and visually see how it works. - It can be used as an aid in training new people. - It will show you where you can take measurements that will help you to run the process better. - It will help you understand where problems occur and what some of the causes may be. - It leverages other analytical tools by providing a source of data and inputs into these tools. - It identifies and leads you to many important characteristics you will need as you strive to make improvements. Individual maps developed by Process Members form the basis of Process Management. The individual processes are linked together to see the total effort and flow for meeting business and customer needs. In order to improve or to correctly manage a process, you must be able to describe it in a way that can be easily understood, that is why the first activity of the Measure Phase is to adequately describe the process under investigation. Process Mapping is the most important and powerful tool you will use to improve the effectiveness and efficiency of a process.

Information from Process Mapping
Process inputs (X’s) Supplier requirements Process outputs (Y’s) Actual customer needs All value-added and non-value added process tasks and steps Data collection points Cycle times Defects Inventory levels Cost of poor quality, etc. Decision points Problems that have immediate fixes Process control needs By mapping processes we can identify many important characteristics and develop information for other analytical tools: These are more reasons why Process Mapping is the most important and powerful tool you will need to solve a problem. It has been said that Six Sigma is the most efficient problem solving methodology available. This is because work done with one tool sets up another tool, very little information and work is wasted. Later you will learn to how to further use the information and knowledge you gather from Process Mapping.

1 2 3 There are usually three views of a process: Process Mapping
What you THINK it is.. 1 What it ACTUALLY is.. 2 3 What it SHOULD be.. There are usually three views of a process: The first view is “what you think the process is” in terms of its size, how work flows and how well the process works. In virtually all cases the extent and difficulty of performing the process is understated. It is not until someone Process Maps the process that the full extent and difficulty is known, and it virtually is always larger than what we thought, is more difficult and it cost more to operate than we realize. It is here that we discover the hidden operations also. This is the second view: “what the process actually is”. Then there is the third view: “what it should be”. This is the result of process improvement activities. It is precisely what you will be doing to the key process you have selected during the weeks between classes. As a result of your project you will either have created the “what it should be” or will be well on your way to getting there. In order to find the “what it should be” process, you have to learn process mapping and literally “walk” the process via a team method to document how it works. This is a much easier task then you might suspect, as you will learn over the next several lessons. We will start by reviewing the standard Process Mapping symbols.

Standard Process Mapping Symbols
Standard symbols for Process Mapping (available in Microsoft Office™, Visio™, iGrafx™ , SigmaFlow™ and other products): A RECTANGLE indicates an activity. Statements within the rectangle should begin with a verb A DIAMOND signifies a decision point. Only two paths emerge from a decision point: No and Yes An ELLIPSE shows the start and end of the process A PARALLELAGRAM shows that there are data An ARROW shows the connection and direction of flow 1 A CIRCLE WITH A LETTER OR NUMBER INSIDE symbolizes the continuation of a flowchart to another page There may be several interpretations of some of the Process Mapping symbols; however, just about everyone uses these primary symbols to document processes. As you become more practiced you will find additional symbols useful, i.e. reports, data storage etc. For now we will start with just these symbols.

Process Mapping Levels
Level 1 – The Macro Process Map, sometimes called a Management level or viewpoint. Level 3 – The Micro Process Map, sometimes called the Improvement level or viewpoint. Similar to a level 2, it will show more steps and tasks and on it will be various performance data; yields, cycle time, value and non value added time, defects, etc. Level 2 – The Process Map, sometimes called the Worker level or viewpoint. This example is from the perspective of the pizza chef Calls for Order Pizza Correct Customer Hungry Take Order Make Pizza Cook Pizza Box Pizza Deliver Pizza Customer Eats Before Process Mapping starts, you have to learn about the different level of detail on a Process Map and the different types of Process Maps. Fortunately these have been well categorized and are easy to understand. There are three different levels of Process Maps. You will need to use all three levels, and you most likely will use them in order from the macro map to the micro map. The macro map contains the least level of detail, with increasing detail as you get to the micro map. You should think of and use the level of Process Maps in a way similar to the way you would use road maps. For example, if you want to find a country, you look at the world map. If you want to find a city in that country, you look at the country map. If you want to find a street address in the city, you use a city map. This is the general rule or approach for using Process Maps. The Macro Process Map, what is called the Level 1 Map, shows the big picture, you will use this to orient yourself to the way a product or service is created. It will also help you to better see which major step of the process is most likely related to the problem you have, and it will put the various processes that you are associated with in the context of the larger whole. A Level 1 PFM, sometimes called the “management” level, is a high-level process map having the following characteristics: Combines related activities into one major processing step Illustrates where/how the process fits into the big picture Has minimal detail Illustrates only major process steps Can be completed with an understanding of general process steps and the purpose/objective of the process The next level is generically called the Process Map. You will refer to it as a Level 2 Map and it identifies the major process steps from the workers point of view. In the pizza example above, these are the steps the pizza chef takes to make, cook and box the pizza for delivery. It gives you a good idea of what is going on in this process, but could can you fully understand why the process performs the way it does in terms of efficiency and effectiveness, could you improve the process with the level of knowledge from this map? Probably not, you are going to need a Level 3 Map called the Micro Process Map. It is also known as the improvement view of a process. There is however a lot of value in the Level 2 Map, because it is helping you to “see” and understand how work gets done, who does it, etc. It is a necessary stepping stone to arriving at improved performance. Next we will introduce the four different types of Process Maps. You will want to use different types of Process Maps, to better help see, understand and communicate the way processes behave.

The Linear Flow Process Map
Types of Process Maps The Linear Flow Process Map As the name states, this diagram shows the process steps in a sequential flow, generally ordered from an upper left corner of the map towards the right side. The Deployment-Flow or Swim Lane Process Map The value of the Swim Lane map is that is shows you who or which department is responsible for the steps in a process. This can provide powerful insights in the way a process performs. A timeline can be added to show how long it takes each group to perform their work. Also each time work moves across a swim lane, there is a “Supplier – Customer” interaction. This is usually where bottlenecks and queues form. There are four types of Process Maps that you will use. They are the linear flow map, the deployment or swim lane flow map, the S-I-P-0-C map (pronounced sigh - pock) and the Value Stream Map. While they all show how work gets done, they emphasize different aspects of process flow and provide you with alternative ways to understand the behavior of the process so you can do something about it. The linear flow map is the most traditional and is usually where most start the mapping effort. The Swimlane Map adds another dimension of knowledge to the picture of the process: Now you can see which department area or person is responsible. You can use the various types of maps in the form of any of the three levels of a Process Map.

Process Maps – Examples for Different Processes

The SIPOC “Supplier – Input – Process – Output – Customer” Process Map
Types of Process Maps The SIPOC “Supplier – Input – Process – Output – Customer” Process Map The SIPOC diagram is especially useful after you have been able to construct either a Level 1 or Level 2 Map because it facilitates your gathering of other pertinent data that is affecting the process in a systematic way. Process r See Below Call for an Order Answer Phone Write Order Sets Price Confirm Order Address & Phone Order to Cook Level 1 Process Map for Customer Order Process Outputs Bake order Order confirmation Data on cycle time Order rate data Order transaction Delivery info Customers Cook Accounting Suppliers ATT Phones Office Depot TI Calculators NEC Cash Register Requirements Order to Cook < 1 minute Complete bake order Correct bake order Correct address Correct Price Complete call < 3 min Inputs Pizza type Size Quantity Extra Toppings Special orders Drink types & quantities Other products Address Phone number Time, day and date Name Volume The SIPOC diagram is especially useful after you have been able to construct either a Level 1 or Level 2 Map because it facilitates your gathering of other pertinent data that is affecting the process in a systematic way. It will help you to better see and understand all of the influences affecting the behavior and performance of the process. You may also add a requirements section to both the supplier side and the customer side to capture the expectations for the inputs and the outputs of the process. Doing a SIPOC is a great building block to creating the Level 3 Micro Process Map. The two really compliment each other and give you the power to make improvements to the process.

The Value Stream Map Types of Process Maps
Process Steps Size of work queue or inventory Process Step Time Parameters Step Processing Time Days of Work in queue Process Performance Metrics The Value Stream Map is a specialized map that helps you to understand numerous performance metrics associated primarily with the speed of the process, but has many other important data. While this Process Map level is at the macro level, the Value Stream Map provides you a lot of detailed performance data for the major steps of the process. It is great for finding bottlenecks in the process. Aggregate Performance Metrics The Value Stream Map is a very powerful technique to understand the velocity of process transactions, queue levels and value added ratios in both manufacturing and non-manufacturing processes.

Process Mapping Exercise – Going to Work
The purpose of this exercise is to develop a Level 1 Macro, Linear Process Flow Map and then convert this map to a Swim Lane Map. Read the following background for the exercise: You have been concerned about your ability to arrive at work on time and also the amount of time it takes from the time your alarm goes off until you arrive at work. To help you better understand both the variation in arrival times and the total time, you decide to create a Level 1 Macro Process Map. For purposes of this exercise, the start is when your alarm goes off the first time and the end is when you arrive at your work station. Task 1 – Mentally think about the various tasks and activities that you routinely do from the defined start to the end points of the exercise. Task 2 – Using a pencil and paper create a Linear Process Map at the macro level, but with enough detail that you can see all the major steps of your process. Task 3 – From the Linear Process Map, create a swim lane style Process Map. For the lanes you may use the different phases of your process, such as the wake up phase, getting prepared, driving, etc. Exercise.

A Process Map of Process Mapping
Define the scope for the Level 2 PFM Identify supplier requirements Identify all X’s and Y’s Determine approach to map the process Select the process Complete Level 1 PFM worksheet Create Level 1 PFM Create the Level 2 PFM Identify VA/NVA steps Perform SIPOC Create a Level 3 PFM Add Performance data Identify customer requirements Process Mapping follows a general order, but sometimes you may find it necessary, even advisable to deviate somewhat. However, you will find this a good path to follow as it has proven itself to generate significant results. On the lessons ahead we will always show you where you are at in this sequence of tasks for Process Mapping. Before we begin our Process Mapping we will first start you off with how to determine the approach to mapping the process. Basically there are two approaches: the individual and the team approach.

Process Mapping Approach
Select the process Using the Individual Approach Start with the Level 1 Macro Process Map. Meet with process owner(s) / manager(s). Create a Level 1 Map and obtain approval to interview process members. Starting with the beginning of the process, pretend you are the product or service flowing through the process, interview to gather information. As the interview progress, assemble the data into a Level 2 PFM. Verify the accuracy of the Level 2 PFM with the individuals who provided input. Update the Level 2 PFM as needed. Determine approach to map the process If you decide to do the individual approach, here are a few key factors: You must pretend that you are the product or service flowing through the process and you are trying to “experience” all of the tasks that happen through the various steps. You must start by talking to the manager of the area and/or the process owner. This is where you will develop the Level 1 Macro Process Map. While you are talking to him, you will need to receive permission to talk to the various members of the process in order to get the detailed information you will need. We will expand on the team approach next. Complete Level 1 PFM worksheet Create Level 1 PFM Using the Team Approach Follow the Team Approach to Process Mapping Define the scope for the Level 2 PFM

Select the process Using the Team Approach Start with the Level 1 Macro Process Map. Meet with process owner(s) / manager(s). Create a Level 1 Map and obtain approval to call a process mapping meeting with process members (See team workshop instructions for details on running the meeting). Bring key members of the process into the process flow workshop. If the process is large in scope, hold individual workshops for each subsection of the total process. Start with the beginning steps. Organize meeting to use the “post-it note approach to gather individual tasks and activities, based on the macro map, that comprise the process. Immediately assemble the information that has been provided into a Process Map. Verify the PFM by discussing it with process owners and by observing the actual process from beginning to end. Determine approach to map the process Process Mapping works best with a team approach. The logistics of performing the mapping are somewhat different, but it overall it takes less time, the quality of the output is higher and you will have more “buy-in” into the results. Input should come from people familiar with all stages of process. Where appropriate the team should include line workers, supervisors, design engineers, process engineers, process technicians, maintenance, etc. The team Process Mapping workshop is where it all comes together. Complete Level 1 PFM worksheet Create Level 1 PFM Define the scope for the Level 2 PFM

Select the process The Team Process Mapping Workshop Add to and agree on Macro Process Map. Using 8.5 X 11 paper for each macro process step, tape the process to the wall in a linear style. Process Members then list all known process tasks that they do on a post-it note, one process task per note. Include the actual time spent to perform each activity, do not include any wait time or queue time. List any known performance data that describe the quality of the task. Place the post-it notes on the wall under the appropriate macro step in the order of the work flow. Review process with whole group, add additional information and close meeting. Immediately consolidate information into a Level 2 Process Map. You will still have to verify the map by walking the process. Determine approach to map the process In summary, after adding to and agreeing to the Macro Process Map, the team process mapping approach is performed using multiple post-it notes where each person writes one task per note and, when finished, place them onto a wall which contains a large scale Macro Process Map. This is a very fast way to get a lot of information including how long it takes to do a particular task. Using the Value Stream Analysis techniques which you will study later, you will use this data to improve the process. We will now discuss the development of the various levels of Process Mapping. Complete Level 1 PFM worksheet Create Level 1 PFM Define the scope for the Level 2 PFM

Steps in Generating a Level 1 PFM
Select the process Creating a Level 1 PFM 1. Identify a generic name for the process: For instance: “Customer Order Process” 2. Identify the beginning and ending steps of the process: Beginning - customer calls in. Ending – baked pizza given to operations 3. Describe the primary purpose and objective of the process (operational definition): The purpose of the process is to obtain telephone orders for pizzas, sell additional products if possible, let the customer know the price and approximate delivery time, provide an accurate cook order, log the time and immediately give it to the pizza cooker. 4. Mentally “walk” through the major steps of the process and write them down: Receive the order via phone call from the customer, calculate the price, create a build order and provide the order to operations 5. Use standard flowcharting symbols to order and to illustrate the flow of the major process steps. Determine approach to map the process You may recall that the preferred method for describing a process is to identify it with a generic name, describe its purpose with an operational description and show the workflow with a Process Map. When developing a Macro Process Map, always add one process step in front of and behind the area you believe contains your problem as a minimum. To aid you in your start, we have provided you with a checklist or worksheet. You may acquire this data from your own knowledge and/or with the interviews you do with the managers / process owners. Once you have this data, and you should do this before drawing maps, you will be well positioned to communicate with others and you will much more confident as you proceed. A Macro Process Map can be useful when reporting project status to management. A macro-map can show the scope of the project, so management can adjust their expectations accordingly. Remember, only major process steps are included. For example, a step listed as “Plating” in a manufacturing Macro Process Map, might actually consists of many steps: pre-clean, anodic cleaning, cathodic activation, pre-plate, electro-deposition, reverse-plate, rinse and spin-dry, etc. The plating step in the macro-map will then be detailed in the Level 2 Process Map. Follow the graphic below to learn the steps in creating a Level 1 PFM. Complete Level 1 PFM worksheet Create Level 1 PFM Define the scope for the Level 2 PFM

Exercise – Generate a Level 1 PFM
The purpose of this exercise is to develop a Level 1 Linear Process Flow Map for the key process you have selected as your project. Read the following background for the exercise: You will use your selected key process for this exercise (if more than one person in the class is part of the same process you may do it as a small group). You may not have all the pertinent detail to correctly put together the Process Map, that is ok, do the best you can. This will give you a starting template when you go back to do your project. In this exercise you may use the Level 1 PFM worksheet on the next page as an example. Task 1 – Identify a generic name for the process. Task 2 - Identify the beginning and ending steps of the process. Task 3 - Describe the primary purpose and objective of the process (operational definition). Task 4 - Mentally “walk” through the major steps of the process and write them down. Task 5 - Use standard flowcharting symbols to order and to illustrate the flow of the major process steps. Define the scope for the Level 2 PFM Determine approach to map the process Select the process Complete Level 1 PFM worksheet Create Level 1 PFM Exercise.

Exercise – Generate a Level 1 PFM
1. Identify a generic name for the process: 2. Identify the beginning and ending steps of the process: 3. Describe the primary purpose and objective of the process (operational definition): 4. Mentally “walk” through the major steps of the process and write them down: 5. Use standard flowcharting symbols to order and to illustrate the flow of the major process steps on a separate sheet of paper. If necessary, you may look at the example for the Pizza order entry process.

Example Template for Generating a Level 1 PFM
Identify a generic name for the process: (I.E. customer order process). Identify the beginning and ending steps of the process: (beginning - customer calls in, ending – pizza order given to the chef). Describe the primary purpose and objective of the process (operational definition): (The purpose of the process is to obtain telephone orders for Pizzas, sell additional products if possible, let the customer know the price and approximate delivery time, provide an accurate cook order, log the time and immediately give it to the pizza cooker). Mentally “walk” through the major steps of the process and write them down: (Receive the order via phone call from the customer, calculate the price, create a build order and provide the order to the chef). Use standard flowcharting symbols to order and to illustrate the flow of the major process steps on a separate sheet of paper. Please read the slide.

Defining the Scope of Level 2 PFM
Calls for Order Customer Hungry Take Make Pizza Cook Box Deliver Eats Customer Order Process Define the scope for the Level 2 PFM Determine approach to map the process Select the process Complete Level 1 PFM worksheet Create Level 1 PFM With a completed Level 1 PFM, you can now “see” where you have to go to get more detailed information. You will have the basis for a Level 2 Process Map. The improvements are in the details. If the efficiency or effectiveness of the process could be significantly improved by a broad summary analysis, the improvement would be done already. If you map the process at an actionable level, you can identify the source of inefficiencies and defects. But you need to be careful about mapping too little an area and missing your problem cause, or mapping to large an area in detail, thereby wasting your valuable time. The rules for determining the Level 2 Process Map scope: From your Macro Process Map, select the area which represents your problem. Map this area at a Level 2. Start and end at natural starting and stopping points for a process, in other words you have the complete associated process.

Defining the Scope of Level 2 PFM
Identify all X’s and Y’s Create the Level 2 PFM Perform SIPOC Identify supplier requirements Identify customer requirements The rules for determining the scope of the Level 2 Process Map: a) Look at your Macro Process Map, select the area which represents your problem. b) Map this area at a Level 2. c) Start and end at natural starting and stopping points for a process, in other words you have the complete associated process. When you perform the process mapping workshop or do the individual interviews, you will determine how the various tasks and activities form a complete step. Do not worry about precisely defining the steps, it is not an exact science, common sense will prevail. If you have done a process mapping workshop, which you will remember we highly recommended, you will actually have a lot of the data for the Level 3 Micro Process Map. You will now perform a SIPOC, and with the other data you already have, will position you for about 70 percent to 80 percent of the details you will need for the Level 3 Process Map.

SIPOC diagram for customer-order process:
Building a SIPOC SIPOC diagram for customer-order process: Process r See Below Customers Call for an Order Answer Phone Write Order Sets Price Confirm Order Address & Phone Order to Cook Customer Order: Level 1 process flow diagram Outputs Bake order Order confirmation Data on cycle time Order rate data Order transaction Delivery info Cook Accounting Inputs Pizza type Size Quantity Extra Toppings Special orders Drink types & quantities Other products Address Phone number Time, day and date Requirements Order to Cook < 1 minute Complete bake order Correct bake order Correct address Correct Price Complete call < 3 min Name Volume Identify all X’s and Y’s Create the Level 2 PFM Perform SIPOC Identify supplier requirements Identify customer requirements Suppliers r ATT Phones Office Depot TI Calculators NEC Cash Register The tool name prompts the team to consider the suppliers (the 'S' in SIPOC) of your process, the inputs (the 'I') to the process, the process (the 'P') your team is improving, the outputs (the 'O') of the process, and the customers (the 'C') that receive the process outputs. Requirements of the customers can be appended to the end of the SIPOC for further detail and requirements are easily added for the suppliers as well. The SIPOC tool is particularly useful in identifying: Who supplies inputs to the process? What are all of the inputs to the process we are aware of? (Later in the DMAIC methodology you will use other tools which will find still more inputs, remember Y=f(X) and if we are going to improve Y, we are going to have to find all the Xs.) What specifications are placed on the inputs? What are all of the outputs of the process? Who are the true customers of the process? What are the requirements of the customers? You can actually begin with the Level 1 PFM that has 4 to 8 high-level steps, but a Level 2 PFM is even of more value. Creating a SIPOC with a Process Mapping team, again the recommended method is a wall exercise similar to your other Process Mapping workshop. Create an area that will allow the team to place post-it note additions to the 8.5 X 11 sheets with the letters S, I, P, O and C on them, with a copy of the Process Map below the sheet with the letter P on it. Hold a process flow workshop with key members. (Note: If the process is large in scope, hold an individual workshop for each subsection of the total process, starting with the beginning steps). The preferred order of the steps is as follows: 1. Identify the outputs of this overall process. 2. Identify the customers who will receive the outputs of the process. 3. Identify customers’ preliminary requirements 4. Identify the inputs required for the process. 5. Identify suppliers of the required inputs that are necessary for the process to function. 6. Identify the preliminary requirements of the inputs for the process to function properly.

Identifying Customer Requirements
Identify all X’s and Y’s Create the Level 2 PFM Perform SIPOC Identify supplier requirements Identify customer requirements You are now ready to identify the customer requirements for the outputs you have defined. Customer requirements, called VOC, determine what are and are not acceptable for each of the outputs. You may find that some of the outputs do not have requirements or specifications. For a well managed process, this is not acceptable. If this is the case, you must ask/negotiate with the customer as to what is acceptable. There is a technique for determining the validity of customer and supplier requirements. It is called “RUMBA” standing for: Reasonable, Understandable, Measurable, Believable and Achievable. If a requirement cannot meet all of these characteristics, then it is not a valid requirement, hence the word negotiation. We have included the process for validating customer requirements at the end of this lesson. The Excel spreadsheet is somewhat self explanatory. You will use a similar form for identifying the supplier requirements. Start by writing in the process name followed by the process operational definition. The operational definition is a short paragraph which states why the process exists, what it does and what its value proposition is. Always take sufficient time to write this such that anyone who reads it will be able to understand the process. Then list each of the outputs, the Y’s, and write in the customer’s name who receives this output, categorized as an internal or external customer. Next are the requirements data. To specify and measure something, it must have a unit of measure; called a metric. As an example, the metric for the speed of your car is miles per hour, for your weight it is pounds, for time it is hours or minutes and so on. You may know what the LSL and USL are but you may not have a target value. A target is the value the customer prefers all the output to be centered at; essentially, the average of the distribution. Sometimes it is stated as “1 hour +/- 5 minutes”. One hour is the target, the LSL is 55 minutes and the USL is 65 minutes. A target may not be specified by the customer; if not, put in what the average would be. You will want to minimize the variation from this value. You will learn more about measurement, but for now you must know that if something is required, you must have a way to measure it as specified in column 9. Column 10 is how often the measurement is made and column 11 is the current value for the measurement data. Column 12 is for identifying if this is a value or non value added activity; more on that later. And finally column 13 is for any comments you want to make about the output. You will come back to this form and rank the significance of the outputs in terms of importance to identify the CTQ’s.

Identifying Supplier Requirements
Identify all X’s and Y’s Create the Level 2 PFM Perform SIPOC Identify supplier requirements Identify customer requirements The supplier input or process input identification and analysis form is nearly identical to the output form just covered. Now you are the customer, you will specify what is required of your suppliers for your process to work correctly; remember RUMBA – the same rules apply. You will notice a new parameter introduced in column 2. It asks if the input is a controlled input or an uncontrolled input (noise). The next topic will discuss the meaning of these terms. Later you will come back to this form and rank the importance of the inputs to the success of your process and eventually you will have found the Critical X’s.

Controllable vs. Noise Inputs
Screens in Place Oven Clean Ingredients prepared Key Process Outputs Noise Inputs Process Room Temp Moisture Content Ingredient Variation Controllable Inputs Procedural Inputs Correct Ingredients Properly Cooked Hot Pizza >140 deg “Make Pizza” Process Oven Temp Bake Time Ingredients Recipe For any process or process step input, there are two primary types of inputs: Controllable - we can exert influence over them Uncontrollable - they behave as they want to within some reasonable boundaries. Procedural - A standardized set of activities leading to readiness of a step. Compliance to GAAP (Generally Accepted Accounting Principals). However, even with the inputs we define as controllable, we never exert complete control. We can control an input within the limits of its natural variation, but it will vary on its own based on its distributional shape - as you have previously learned. You choose to control certain inputs because you either know or believe they have an effect on the outcome of the process, it is inexpensive to do, so controlling it “makes us feel better” or there once was a problem and the solution (right or wrong) was to exert control over some input. You choose to not control some inputs because you think you cannot control them, you either know or believe they don’t have much affect on the output, you think it is not cost justified or you just don’t know these inputs even exist. Yes, that’s right, you don’t know they are having an affect on the output. For example, what effect does ambient noise or temperature have on your ability to be attentive or productive, etc? It is important to distinguish which category an input falls into. You know through Y=f(X), that if it is a critical X, by definition, that you must control it. Also if you believe that an input is or needs to be controlled, then you have automatically implied there are requirements placed on it and that it must be measured. You must always think and ask whether an input is, or should be controlled or if it is uncontrolled. Pizza Size Ingredient Types/Mixes Volume Every input can be either: Controllable (C) - Inputs can be adjusted or controlled while the process is running (e.g., speed, feed rate, temperature, and pressure) Procedural (P) - Inputs can be adjusted or controlled while the process is running (e.g., speed, feed rate, temperature, and pressure) Noise (N) - Things we don’t think we can control, we are unaware of or see, too expensive or too difficult to control (e.g., ambient temperature, humidity, individual)

Exercise – Supplier Requirements
The purpose of this exercise is to identify the requirements for the suppliers to the key process you have selected as your project. Read the following background for the exercise: You will use your selected key process for this exercise (if more than one person in the class is part of the same process you may do it as a small group). You may not have all the pertinent detail to correctly identify all supplier requirements, that is ok, do the best you can. This will give you a starting template when you go back to do your workplace assignment. Use the process input identification and analysis form for this exercise. Task 1 – Identify a generic name for the process. Task 2 - Write an operational description for the process Task 3 - Complete the remainder of the form except the Value –Non value added column. Task 4 - Report out to the class when called upon, Identify all X’s and Y’s Create the Level 2 PFM Perform SIPOC Identify supplier requirements Identify customer requirements Exercise.

The Level 3 Process Flow Diagram
You have a decision at this point to continue with a complete characterization of the process you have documented at a Level 2 in order to fully build the Process Management System or to narrow the effort by focusing on those steps that are contributing to the problem you want solved. In reality, it is usually just a few of the process steps that are the root cause areas for any given higher level process output problem. If your desire is the latter, there are some other Measure Phase actions and tools you will have to use to narrow the number of potential X’s and subsequently the number of process steps. To narrow the scope so it is relevant to your problem consider the following: Remember using the pizza restaurant as our example for selecting a key process? They were having a problem with overall delivery time and burnt pizzas. Which steps in this process would contribute to burnt pizzas and how might a pizza which was burnt so badly it had to be scrapped and restarted effect delivery time? It would most likely be the steps between “place in oven” to “remove from oven”, but it might also include “add ingredients” because certain ingredients may burn more quickly than others. This is how, based on the Problem Statement you have made, you would narrow the scope for doing a Level 3 PFM. For your project, the priority will be to do your best to find the problematic steps associated with your Problem Statement. We will teach you some new tools in a later lesson to aid you in doing this. You may have to characterize a number of steps until you get more experience at narrowing the steps that cause problems; this is to be expected. If you have the time you should characterize the whole process. Each step you select as the causal steps in the process must be fully characterized, just as you have previously done for the whole process. In essence you will do a “mini SIPOC” on each step of the process as defined in the Level 2 Process Map. This can be done using a Level 3 Micro Process Map and placing all the information on it or it can be consolidated onto an excel spreadsheet format or a combination of both. If all the data and information is put onto an actual Process Map, expect the map to be rather large physically. Depending on the scope of the process, some people dedicate a wall space for doing this; say a 12 to 14 foot long wall. An effective approach for this is to use a roll of industrial grade brown package wrapping paper, which is generally 4 feet wide. Just roll out the length you want, cut it, place this on the wall and then build your Level 3 Process Map by taping and writing various elements onto the paper. The value of this approach is that you can take it off the wall, roll it up, take it with you and then put it back on any wall; great for team efforts. A Level 3 Process Map contains all of the process details needed to meet your objective: all of the flows, set points, standard operating procedures (SOPs), inputs and outputs; their specifications and if they are classified as being controllable or non-controllable (noise). The Level 3 PFM usually contains estimates of defects per unit (DPU), yield and rolled throughput yield (RTY) and value/non-value add. If processing cycle times and inventory levels (materials or work queues) are important, value stream parameters are also included. This can be a lot of detail to manage and appropriate tracking sheets are required. We have supplied these sheets in a paper and Excel spreadsheet format for your use. The good news is the approach and forms for the steps are essentially the same as the format for identifying supplier and customer requirements at the process level. A spreadsheet is very convenient tool and the output from the spreadsheet can then be fed directly into a C&E matrix and an FMEA (to be described later), also built using spreadsheets. You will find the work you have done up to this point in terms of a Level 1 and 2 Process Maps and the SIPOC will be of use, both from knowledge of the process and actual data. An important reminder of a previous lesson: You will recall when you were taught about project definition where it was stated that you should only try to solve the performance of only one process output, at any one time. Because of the amount of detail you can get into for just one Y, trying to optimize more than one Y at a time can become overwhelming. The good news is that you will have laid all the ground work to focus on a second and a third Y for a process by just focusing on one Y in your initial project.

Process Inputs (X’s) and Outputs (Y’s)
Identify VA/NVA steps Create a Level 3 PFM Add Performance data You are now down at the step level of the process, this is what we call the improvement view of a process. Now you do exactly the same thing as you did for the overall process, you list all of the input and output information for steps of the process you have selected for analysis and characterization to solve your problem. To help you comprehend what we are trying to accomplish we have provided you with visualization for the inputs and outputs of the Pizza restaurant.

Process Inputs (X’s) and Outputs (Y’s)
Requirements or Specs. C /N Y’s All fields complete Size Weight Ingredients correct >140F No burns Any process, even a pizza restaurant process can be characterized. This visualization shows many of the inputs and outputs and their requirements. By using the process and the process step input and output sheets, you get a very detail picture about how your process works. Now you have enough data to start making informed decisions about the process performance. The next lesson pages will describe how you determine if a process task, activity or step is a value added step or not.

Identifying Waste NVA NVA NVA NVA
Identify VA/NVA steps Create a Level 3 PFM Add Performance data Call for an Order Answer phone Asks for more? Greetings and mention specials Calculate price Rewrite Order Order still OK? Gets address & phone # Add to Order Give order to Cook Rewrite order Yes No Request order from customer Writes on scratch pad Asks cook for time estimate Inform customer of price/time Thanks customer & hangs up Completes order from from note pad Another call waiting Writes time on scratch pad Confirm order 1 New order? Verify with notes 2 OK Not OK 3 NVA NVA When we produce products or services, we engage process-based activities to transform physical materials, ideas and information into something valued by customers. Some activities in the process generate true value, others do not. The expenditure of resources, capital and other energies that do not generate value is considered waste. Value generation is any activity that changes the form, fit or function of what we are working on in a way that the customer is willing to pay for. The goal of testing for VA vs. NVA is to remove unnecessary activity (waste) from a process. Hint: If an action starts with the two letters “re” it’s a good chance that it’s a form of waste, i.e. rework, replace, review, etc. Some non-value activities cannot be removed; i.e., data collection is required to understand and plan production activity levels, data must be collected to comply with governmental regulations, etc. (even though the data have no effect on the actual product or service) On the process flow diagram we place a red X through the steps or we write NVA or VA by each step. NVA NVA Each process activity can be tested for its value-add contribution Ask the following two questions to identify non-value added activity: Is the form, fit or function of the work item changed as a result of this activity? Is the customer willing to pay for this activity? NVA NVA NVA

Definition of X-Y Matrix
The X-Y Matrix is: A tool used to identify/collate potential X’s and assess their relative impact on multiple Y’s (include all Y’s that are customer focused) Based on the team’s collective “opinions” Created for every project Never completed Updated whenever a parameter is changed To summarize, the X-Y is a team-based prioritization tool for the potential X’s WARNING! This is not real data, this is organized brainstorming!! At the conclusion of the project you may realize that the things you thought were critical are in fact not as important as was believed. The X-Y Matrix is a great tool to help us focus, again it is based on team experience and “Tribal” knowledge. At this point in the project that is great although it should be recognized that this is NOT hard data and as you progress thru the methodology don’t be surprised if you find out thru data analysis that what the team thought might be critical turns out to be insignificant. The great thing about the X-Y Matrix is that it is sort of an unbiased way to approach definition around the process and WILL give you focus.

The X-Y Matrix is this Prioritization Tool!
The Vital Few A Six Sigma Belt does not just discover which X’s are important in a process (the vital few). The team considers all possible X’s that can contribute or cause the problem observed. The team uses 3 primary sources of X identification: Process Mapping Fishbone Analysis Basic Data Analysis – Graphical and Statistical A List of X’s is established and compiled. The team then prioritizes which X’s it will explore first, and eliminates the “obvious” low impact X’s from further consideration. The X-Y Matrix is this Prioritization Tool! This is an important tool for the many reasons we have already stated. Use it to your benefit, leverage the team and this will help you progress you thru the methodology to accomplish your ultimate project goal.

The “X-Y Matrix” This is the X-Y Matrix. You should have a copy of this template. If possible open it and get familiar with it as we progress through this section.

Using the Classified X’s
Breakthrough requires dealing primarily with controllable X’s impacting the “Y”. Use the controllable X’s from the Fishbone analysis to include in the X-Y Matrix. The goal is to isolate the vital few X’s from the trivial many X’s. Procedures and Noise X’s will be used in the FMEA at the end of this module. However: All procedures must be in total compliance. This may require some type of effectiveness measure. This could reduce or eliminate some of the defects currently seen in the process (allowing focus on controllable X’s). Noise type inputs increase risk of defects under current technology of operation and therefore: Increase RPN on the FMEA document from an input. Help identify areas needing investment for a justified ROI. Please read the slide. *Risk Priority Number

List X’s from Fishbone Diagram in horizontal rows
X-Y Matrix: Steps List X’s from Fishbone Diagram in horizontal rows Use your Fishbone Diagram as the source and type in the Inputs in this section, use common sense some of the info from the Fishbone may not justify going into the X-Y Matrix inputs.

List Y’s in columns (including Primary and Secondary metrics).
X-Y Matrix: Steps List Y’s in columns (including Primary and Secondary metrics). Weight the Y’s on a scale of 1-10 (10 - highest and 1- lowest). Enter your primary metric and any other secondary metrics across into this area. Weight these output variables (Y’s) on a scale of 1-10 you may find that some have the same weight which is just fine. If, at this time, additional metrics come to the surface, which is totally common, you may realize that you need to add secondary metrics to your project of even refine your primary metric.

X-Y Matrix: Steps For each X listed, rank its effect on each metric based on a scale of 1, 3 or 9. 9 = Highest 3 = Marginal 1 = None For each X listed along the left, rank its effect on each corresponding metric based on a scale of 0, 1, 3 or 9. You can use any scale you choose however we recommend this one. If you use a scale of 1 to 10 this can cause uncertainty within the team…is it a 6 or a 7, what’s the difference, etc?

X-Y Matrix: Steps “Ranking” multiplies the rank of each X by the Weight of each Metric. The product of that is added together to become the “Ranking”. The template we have provided automatically calculates and sorts the ranking shown here.

Click the Demo button to see an example.
Shown here is a basic example of a completed X-Y Matrix. You can click “Demo” on your template to view this anytime.

Click the Summary Worksheet
Example Click the Summary Worksheet This is the Summary Worksheet. If you click on the “Summary” tab you will see this output. Take some time to review the worksheet.

Fishbone Diagram Exercise
Exercise objective: Create an X-Y Matrix using the information from the Fishbone analysis. Using the Fishbone Diagram created earlier, create an X-Y Matrix. Present results to your mentor. Exercise.

Give me an “F”, give me an “M”……
Definition of FMEA Failure Modes Effect Analysis (FMEA) is a structured approach to: Predict failures and prevent their occurrence in manufacturing and other functional areas which generate defects. Identify the ways in which a process can fail to meet critical customer requirements (Y). Estimate the Severity, Occurrence and Detection (SOD) of defects Evaluate the current Control Plan for preventing these failures from occurring and escaping to the customer. Prioritize the actions that should be taken to improve and control the process using a Risk Priority Number (RPN). Failure Modes Effect Analysis or FMEA [*usually pronounced as F-M-E-A (individual letters) or FEMA** (as a word)] is a structured approach to: read bullets. FMEA at this point is developed with tribal knowledge with a cross-functional team. Later using process data the FMEA can be updated and better estimates of detection and occurrence can be obtained. The FMEA is not a tool to eliminate X’s but rather control the X’s. It is only a tool to identify potential X’s and prioritize the order in which the X’s should be evaluated. Give me an “F”, give me an “M”……

In 1974 the Navy developed MIL-STD-1629 regarding the use of FMEA
History of FMEA History of FMEA: First used in the 1960’s in the Aerospace industry during the Apollo missions In 1974 the Navy developed MIL-STD-1629 regarding the use of FMEA In the late 1970’s, automotive applications driven by liability costs, began to incorporate FMEA into the management of their processes Automotive Industry Action Group (AIAG) now maintains the FMEA standard for both Design and Process FMEA’s The “edge of your seat” info on the history of the FMEA! I’m sure you will all be sharing this with everyone tonight at the dinner table!

Types of FMEA’s System FMEA: Performed on a product or service product at the early concept/design level when various modules all tie together. All the module level FMEA’s tie together to form a system. As you go lower into a system more failure modes are considered. Example: Electrical system of a car, consists of the following modules: battery, wiring harness, lighting control module and alternator/regulator. System FMEA focuses on potential failure modes associated with the modules of a system caused by design Design DFMEA: Performed early in the design phase to analyze product fail modes before they are released to production. The purpose is to analyze how fail modes affect the system and minimize them. The severity rating of a fail mode MUST be carried into the Process PFMEA. Process PFMEA: Performed in the early quality planning phase of manufacturing to analyze fail modes in manufacturing and transactional processes that may escape to the customer. The failure modes and the potential sources of defects are rated and corrective action taken based on a Pareto analysis ranking. Equipment FMEA: used to analyze failure modes in the equipment used in a process to detect or make the part. Example: Test Equipment fail modes to detect open and short circuits. There are many different types of FMEA’s. The basic premise is the same.

FMEA’s: Improve the quality, reliability and safety of products.
Purpose of FMEA FMEA’s: Improve the quality, reliability and safety of products. Increase customer satisfaction. Reduce product development time and cost. Document and track actions taken to reduce risk and improve the process. Focus on continuous problem prevention not problem solving. Please read the slide.

Who Creates FMEAs and When?
The focused team working on a breakthrough project. ANYONE who had or has a role in defining, executing, or changing the process. This includes: Associates Technical Experts Supervisors Managers Etc. Process FMEAs should be started: At the conceptual design phase. Process FMEAs should be updated: When an existing design or process is being changed. When carry-over designs or processes will be used in new applications and environments. When a problem solving study is completed and needs to be documented. System FMEAs should be created after system functions are defined but before specific hardware is selected. Design FMEAs should be created when new systems, products and processes are being designed. FMEA’s are a team tool like most in this phase of the methodology. They are applicable is most every project, manufacturing or service based. For all intensive purposes they will be used in conjunction with your problem solving project to characterize and measure process variables. In some cases the FMEA will manifest itself as a management tool when the project concludes and in some cases it will not be appropriate to be used in that nature.

RISK!!! As a means to manage…
Why Create an FMEA? As a means to manage… RISK!!! We want to avoid causing failures in the Process as well as the Primary & Secondary Metrics . FMEA’s help you manage RISK by classifying your process inputs and monitoring their effects. This is extremely important during the course of your project work.

The FMEA… This is an FMEA. We have provided a template for you to use.
# Process Function (Step) Potential Failure Modes (process defects) Potential Failure Effects (Y's) SEV Class Potential Causes of Failure (X's) OCC Current Process Controls DET RPN Recommend Actions Responsible Person & Target Date Taken Actions 1 2 3 4 5 6 7 8 9 This is an FMEA. We have provided a template for you to use.

The first column is the Process Step Number. 1 2 3 4 5 Etc.
FMEA Components…# # Process Function (Step) Potential Failure Modes (process defects) Potential Failure Effects (Y's) SEV Class Potential Causes of Failure (X's) OCC Current Process Controls DET RPN Recommend Actions Responsible Person & Target Date Taken Actions The first column is the Process Step Number. 1 2 3 4 5 Etc. The first column highlighted here is the “Process Step Number”.

FMEA Components…Process Step
# Process Function (Step) Potential Failure Modes (process defects) Potential Failure Effects (Y's) SEV Class Potential Causes of Failure (X's) OCC Current Process Controls DET RPN Recommend Actions Responsible Person & Target Date Taken Actions Enter the Name of the Process Step here. The FMEA should sequentially follow the steps documented in your Process Map. Phone Dial Number Listen for Ring Say Hello Introduce Yourself Etc. The second column is the Name of the Process Step. The FMEA should sequentially follow the steps documented in your Process Map. Phone Dial Number Listen for Ring Say Hello Introduce Yourself Etc.

FMEA Components…Potential Failure Modes
# Process Function (Step) Potential Failure Modes (process defects) Potential Failure Effects (Y's) SEV Class Potential Causes of Failure (X's) OCC Current Process Controls DET RPN Recommend Actions Responsible Person & Target Date Taken Actions This refers to the mode in which the process could potentially fail. These are the defects caused by a C,P or N factor that could occur in the Process. This information is obtained from Historical Defect Data. FYI..A failure mode is a fancy name for a defect. The third column to the mode in which the process could potentially fail. These are the defects caused by a C, P or N factor that could occur in the Process. This information is obtained from Historical Defect Data. FYI..A failure mode is a fancy name for a defect.

FMEA Components…Potential Failure Effects
# Process Function (Step) Potential Failure Modes (process defects) Potential Failure Effects (Y's) SEV Class Potential Causes of Failure (X's) OCC Current Process Controls DET RPN Recommend Actions Responsible Person & Target Date Taken Actions This is simply the effect of realizing the potential failure mode on the overall process. It focuses on the outputs of each step. This information can be obtained in the Process Map. The fourth column highlighted here is simply the effect of realizing the potential failure mode on the overall process and is focused on the output of each step. This information is usually obtained from your Process Map.

FMEA Components…Severity (SEV)
# Process Function (Step) Potential Failure Modes (process defects) Potential Failure Effects (Y's) SEV Class Potential Causes of Failure (X's) OCC Current Process Controls DET RPN Recommend Actions Responsible Person & Target Date Taken Actions This ranking should be developed based on the teams knowledge of the process in conjunction with the predetermined scale. The measure of Severity is a financial measure of the impact to the business of realizing a failure in the output. The fifth column highlighted here is the ranking that is developed based on the teams knowledge of the process in conjunction with the predetermined scale. Severity is a financial measure of the impact to the business of a failure in the output.

Ranking Severity Effect Criteria: Severity of Effect Defined Ranking Hazardous: Without Warning May endanger the operator. Failure mode affects safe vehicle operation and/or involves non-compliance with government regulation. Failure will occur WITHOUT warning. 10 With Warning involves non-compliance with government regulation. Failure will occur WITH 9 Very High Major disruption to the production line. 100% of the product may have to be scrapped. Vehicle/item inoperable, loss of primary function. Customers will be very dissatisfied. 8 High Minor disruption to the production line. The product may have to be sorted and a portion (less than 100%) scrapped. Vehicle operable, but at a reduced level of performance. Customers will be dissatisfied. 7 Moderate Minor disruption to the production line. A portion (less than 100%) may have to be scrapped (no sorting). Vehicle/item operable, but some comfort/convenience item(s) inoperable. Customers will experience discomfort. 6 Low Minor disruption to the production line. 100% of product may have to be re-worked. Vehicle/item operable, but some comfort/convenience item(s) operable at a reduced level of performance. Customers will experience some dissatisfaction. 5 Very Low Minor disruption to the production line. The product may have to be sorted and a portion (less than 100%) re-worked. Fit/finish/squeak/rattle item does not conform. Most customers will notice the defect. 4 Minor Minor disruption to the production line. A portion (less than 100%) of the product may have to be re-worked online but out-of-station. Fit/finish/squeak/rattle item does not conform. Average customers will notice the defect. 3 Very Minor have to be re-worked online but in-station. Fit/finish/squeak/rattle item does not conform. Discriminating customers will notice the defect. 2 None No effect. 1 The Automotive Industry Action Group, a consortium of the “Big Three”: Ford, GM and Chrysler developed this criteria. If you don’t like it develop one that fits your organization just make sure it’s standardized so everyone uses the same scale. * Potential Failure Mode and Effects Analysis (FMEA), Reference Manual, Pgs Chrysler Corporation, Ford Motor Company, General Motors Corporation.

Applying Severity Ratings to Your Process
The guidelines presented on the previous slide were developed for the auto industry. This was included only as a guideline....”actual results may vary” for your project. Your severity may be linked to impact on the business or impact on the next customer, etc. You will need to define your own criteria… and be consistent throughout your FMEA Let’s brainstorm how we might define the following SEVERITY levels in our own projects: 1, 5, 10 The actual definitions of the severity are not so important as the fact that the team remains consistent in its use of the definitions. The next slide shows a sample of transactional severities.

Sample Transactional Severities
Effect Criteria: Impact of Effect Defined Ranking Critical Business Unit-wide May endanger company’s ability to do business. Failure mode affects process operation and / or involves noncompliance with government regulation. 10 Critical Loss - Customer Specific May endanger relationship with customer. Failure mode affects product delivered and/or customer relationship due to process failure and/or noncompliance with government regulation. 9 High Major disruption to process/production down situation. Results in near 100% rework or an inability to process. Customer very dissatisfied. 7 Moderate Moderate disruption to process. Results in some rework or an inability to process. Process is operable, but some work arounds are required. Customers experience dissatisfaction. 5 Low Minor disruption to process. Process can be completed with workarounds or rework at the back end. Results in reduced level of performance. Defect is noticed and commented upon by customers. 3 Minor rework at the back end. Results in reduced level of performance. Defect noticed internally, but not externally. 2 None No effect. 1 Shown here is an example for severity guidelines developed for a financial services company.

FMEA Components…Classification “Class”
# Process Function (Step) Potential Failure Modes (process defects) Potential Failure Effects (Y's) SEV Class Potential Causes of Failure (X's) OCC Current Process Controls DET RPN Recommend Actions Responsible Person & Target Date Taken Actions Class should categorize each step as a… Controllable (C) Procedural (P) Noise (N) This information can be obtained in the Process Map. Controllable – A factor that can be dialed into a specific setting/value. For example Temperature or Flow. Procedures – A standardized set of activities leading to readiness of a step. For example Safety Compliance, “Lock -Out Tag-Out.” Noise - A factor that can not be dialed in to a specific setting/value. For example rain in a mine. Recall the classifications of Procedural, Controllable and Noise developed when constructing your Process Map and Fishbone Diagram? Use those classifications from the Fishbone in the “Class” column, highlighted here, in the FMEA.

Potential Causes of Failure (X’s)
# Process Function (Step) Potential Failure Modes (process defects) Potential Failure Effects (Y's) SEV Class Potential Causes of Failure (X's) OCC Current Process Controls DET RPN Recommend Actions Responsible Person & Target Date Taken Actions Potential Causes of the Failure refers to how the failure could occur. This information should be obtained from the Fishbone Diagram. The column “Potential Causes of the Failure”, highlighted here, that refers to how the failure could occur. This should also be obtained from the Fishbone Diagram.

FMEA Components…Occurrence “OCC”
# Process Function (Step) Potential Failure Modes (process defects) Potential Failure Effects (Y's) SEV Class Potential Causes of Failure (X's) OCC Current Process Controls DET RPN Recommend Actions Responsible Person & Target Date Taken Actions Occurrence refers to how frequently the specified failure is projected to occur. This information should be obtained from Capability Studies or Historical Defect Data - in conjunction with the predetermined scale. The column “Occurrence” highlighted here, refers to how frequently the specified failure is projected to occur. This information should be obtained from Capability Studies or Historical Defect Data in conjunction with the predetermined scale.

Ranking Occurrence Probability of Failure Possible Failure Rates Cpk
Very High: Failure is almost inevitable. < 0.33 10 0.33 9 High: Generally associated with processes similar to previous processes that have often failed. 0.51 8 0.67 7 Moderate: Generally associated with processes similar to previous processes that have experienced occasional failures but not in major proportions. 0.83 6 1.00 5 1.17 4 Low: Isolated failures associated with similar processes. 1.33 3 Very Low: Only isolated failures associated with almost identical processes. 1.5 2 Remote: Failure is unlikely. No failures ever associated with almost identical processes. 1 in 2 1 in 3 1 in 8 1 in 20 1 in 80 1 in 400 1 in 2,000 1 in 15,000 1 in 150,000 1 in 1,500,000 1.67 1 The Automotive Industry Action Group, a consortium of the “Big Three”: Ford, GM and Chrysler developed these Occurrence rankings. Potential Failure Mode and Effects Analysis (FMEA), Reference Manual, Pg Chrysler Corporation, Ford Motor Company, General Motors Corporation.

FMEA Components…Current Process Controls
# Process Function (Step) Potential Failure Modes (process defects) Potential Failure Effects (Y's) SEV Class Potential Causes of Failure (X's) OCC Current Process Controls DET RPN Recommend Actions Responsible Person & Target Date Taken Actions Current Process Controls refers to the three types of controls that are in place to prevent a failure in with the X’s. The 3 types of controls are: SPC (Statistical Process Control) Poke-Yoke – (Mistake Proofing) Detection after Failure The column “Current Process Controls” highlighted here refers to the three types of controls that are in place to prevent a failures. Ask yourself “how do we control this defect?”

FMEA Components…Detection (DET)
# Process Function (Step) Potential Failure Modes (process defects) Potential Failure Effects (Y's) SEV Class Potential Causes of Failure (X's) OCC Current Process Controls DET RPN Recommend Actions Responsible Person & Target Date Taken Actions Detection is an assessment of the probability that the proposed type of control will detect a subsequent Failure Mode. This information should be obtained from your Measurement System Analysis Studies and the Process Map. A rating should be assign in conjunction with the predetermined scale. The “Detection”, highlighted here is an assessment of the probability that the proposed type of control will detect a subsequent failure mode.

Ranking Detection Almost Impossible Detection
Criteria: The likelihood that the existence of a defect will be detected by the test content before the product advances to the next or subsequent process Ranking Test content must detect < 80% of failures 10 Very Remote Test content must detect 80% of failures 9 Remote Test content must detect 82.5% of failures 8 Very Low Test content must detect 85% of failures 7 Low Test content must detect 87.5% of failures 6 Moderate Test content must detect 90% of failures 5 Moderately High Test content must detect 92.5% of failures 4 High Test content must detect 95% of failures 3 Very High Test content must detect 97.5% of failures 2 Almost Certain Test content must detect 99.5% of failures 1 The Automotive Industry Action Group, a consortium of the “Big Three”: Ford, GM and Chrysler developed these Detection criteria. Potential Failure Mode and Effects Analysis (FMEA), AIAG Reference Manual, Pg Chrysler Corporation, Ford Motor Company, General Motors Corporation.

Risk Priority Number “RPN”
# Process Function (Step) Potential Failure Modes (process defects) Potential Failure Effects (Y's) SEV Class Potential Causes of Failure (X's) OCC Current Process Controls DET RPN Recommend Actions Responsible Person & Target Date Taken Actions The Risk Priority Number is a value that will be used to rank order the concerns from the process. The RPN is the product of, Severity, Occurrence and Detect ability as represented here… RPN = (SEV)*(OCC)*(DET) The “The Risk Priority Number”, highlighted here is a value that will be used to rank order the concerns from the process. We provided you with a template which will automatically calculate this for you based on your inputs for Severity, Occurrence and Detection.

FEMA Components…Actions
# Process Function (Step) Potential Failure Modes (process defects) Potential Failure Effects (Y's) SEV Class Potential Causes of Failure (X's) OCC Current Process Controls DET RPN Recommend Actions Responsible Person & Target Date Taken Actions Recommended Actions refers to the activity for the prevention of a defect. Responsible Person & Date refers to the name of the group or person responsible for completing the activity and when they will complete it. Taken Action refers to the action and effective date after it has been completed. The columns highlighted here are a type of post FMEA. Remember to update the FMEA throughout your project, this is what we call a “Living Document” as it changes throughout your project.

FMEA Components…Adjust RPN
# Process Function (Step) Potential Failure Modes (process defects) Potential Failure Effects (Y's) SEV Class Potential Causes of Failure (X's) OCC Current Process Controls DET RPN Recommend Actions Responsible Person & Target Date Taken Actions Once the Recommended Actions, Responsible Person & Date, Taken Action have been completed the Severity, Occurrence and Detection should be adjusted. This will result in a new RPN rating. The columns highlighted here are the adjusted levels based on the actions you have taken within the process.

OK Team, let’s get that FMEA!
FMEA Exercise Exercise objective: Assemble your team in order to create a FMEA using the information generated from the Process Map, Fishbone Diagram and X-Y Matrix. Be prepared to present results to your mentor. OK Team, let’s get that FMEA! Exercise.

At this point, you should be able to:
Summary At this point, you should be able to: Create a high-level Process Map Create a Fishbone Diagram Create an X-Y Matrix Create an FMEA Describe the purpose of each tool and when it should be used Please read the slide.

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