Locked lesson.
About this lesson
Exercise files
Download this lesson’s related exercise files.
Process FMEA Preparation.docx61.8 KB Process FMEA Preparation - Solution.docx
61.2 KB
Quick reference
Process FMEA Preparation
The first three steps of the Process FMEA process are preparatory steps needed to begin the actual analysis. These steps must be completed in the order shown for the analysis to proceed.
When to use
These three steps are done at the beginning of every Process FMEA analysis. They can all be accomplished in a few hours or they can take weeks to complete, depending upon the management practices of the organization and the complexity of the project.
Instructions
The first three steps of the Process FMEA process create the team and common understanding of the process that is being analysed. These steps are necessary in order to conduct the analysis steps.
Step 1. Select the operational process
This seems to be a very basic step, and it is. However, when working with long cross-functional processes, it is often best to separate it into several smaller processes. This makes the analysis more manageable because the breadth of the process being analysed is focused. If working with a generic process used with multiple products, it is acceptable to use one of the products as a surrogate for all the products, provided the one product really is representative of all the products. An example would be a painting process that is used to apply paint to many items that are part of a product. When doing the Process FMEA as part of a development project, this first step should be initiated as soon as the preliminary design of the manufacturing or operations process is complete, so that the FMEA can be completed and mitigation actions incorporated into the final design before production starts.
Step 2. Select the FMEA analysis team
The Process FMEA team members are selected because of their expertise with some of the process steps, the process technology, or the product that is being processed. If the process is being created for a new product, the team members are almost always members of the product development team. Even though the focus is on the process, at least one of the team members should be aware of the product design. In many organizations, a facilitator is also a team member to help the team reach consensus on each failure being evaluated.
Step 3. Prepare a process map
The third step prepares a process map. This map shows how each step of the process interacts with the other steps. Based upon the interaction, the functions of each step can be identified. The level of detail is normally conducted at the “work station” level. The item being processed goes from one workstation to another and the actions that happen at each work station is the list of functions for that workstation.
Hints & tips
- Complete the steps in the order shown. Each one builds on the previous one. The identification of the process makes it clear who would have the expertise to be on the team. And the team has the knowledge to create the process map which will be needed to start the analysis steps.
- Be sure to include SMEs from all the functions that are responsible for steps within the process.
- 00:04 Hello, I'm Ray Sheen.
- 00:06 It's now time to look at the Process FMEA.
- 00:09 Now many of the elements are similar to the Design FMEA, but
- 00:12 there are some important differences.
- 00:14 Let's start with the procedure to complete the Process FMEA.
- 00:18 We discussed the general procedure for preparing an FMEA in a previous lesson.
- 00:24 Let's be more specific now.
- 00:26 I'll start by bringing up the Process FMEA format.
- 00:29 There are two things to point out about the form, which highlight some
- 00:32 of the differences.
- 00:33 Notice there is an extra column on the far left side on the form for process step.
- 00:38 The Design FMEA started with the function column.
- 00:42 The Process FMEA will start with the process step, and
- 00:46 then talk about the function at each step.
- 00:49 The second big difference is in the detection portion of the form.
- 00:52 We have a column for both prevention and detection,
- 00:55 more about those when we get to that lesson.
- 00:58 And now the first step.
- 00:59 This step is essentially identical with the Design FMEA,
- 01:03 except you're defining a process for analysis instead of a product.
- 01:06 And you will enter this key information on the form in the upper left hand corner.
- 01:10 Our next step in the producer for
- 01:12 preparing a Process FMEA is also a familiar one.
- 01:16 That is to select an FMEA analysis team.
- 01:19 This team will be selected based upon the process that is being analyzed.
- 01:23 The third step before we are ready to start doing
- 01:26 analysis of failures is to map the process and list the process steps.
- 01:31 This step serves the same function as the Design FMEA step to create a block
- 01:35 diagram.
- 01:36 But since this is a Process FMEA,
- 01:38 we're creating a process map that involves all the process steps.
- 01:42 We'll look at each of these steps in more detail and
- 01:45 the remaining steps of the procedure we'll talk about on the next lesson.
- 01:50 We start with the selection or an operational process.
- 01:54 By operational process we mean the business process that you will be
- 01:57 analyzing.
- 01:58 Most of the time that is a manufacturing process.
- 02:01 But I have seen the Process FMEA used on administration business processes and
- 02:05 it does work for that setting also.
- 02:07 But 95% of the time we'll be talking about manufacturing or servicing a product.
- 02:13 Now it's important to include in your process all the steps
- 02:16 by all the departments that are involved with the process.
- 02:19 While most of the steps may be done by manufacturing operations,
- 02:23 some may be done by the quality operations.
- 02:25 Maybe some are done by IT, or maintenance.
- 02:27 And if it's a service process, you may have people from this batch shipping,
- 02:32 or even sales involved in the process.
- 02:34 The point is to include all the steps regardless of which department is
- 02:39 doing them.
- 02:40 If you're analyzing an existing process,
- 02:42 you need to decide what will be the start point and the end point of that process.
- 02:47 And then you will use the existing procedures or maps that define the steps.
- 02:51 When it's a new process, you'll need to do a little more work.
- 02:53 Create a concept of operations based upon the product design.
- 02:57 Will the parts be manufactured in-house or sourced?
- 03:00 Will you assemble at one location or will be multiple locations be involved?
- 03:05 Answering questions like these can help to set the boundaries for the analysis.
- 03:10 Just a note, usually a Process FMEA is focused on the activities at one facility,
- 03:15 not multiple facilities.
- 03:17 If it goes to a new location, a second Process FMEA is normally done for
- 03:22 that location.
- 03:23 Okay, now step 2, the FMEA analysis team.
- 03:27 Most of your team members will be subject matter experts on the process.
- 03:31 Either process designers or operators, and
- 03:33 make sure that you have an expert from all the departments involved.
- 03:37 It's also very helpful to have someone who is a product expert.
- 03:41 There will often be questions coming up about the critical parameters on
- 03:45 the product, and the product expert can explain these.
- 03:48 If product changes are desired, they can assess whether the change is practical.
- 03:52 And as we said with the Design FMEA, consider using a facilitator.
- 03:57 If you have many departments involved in the process, the facilitator's role
- 04:01 becomes even more important to ensure that one organization doesn't dominate
- 04:05 the analysis and overlook key failure modes in the other organizations.
- 04:08 Also, there may be people at very different levels in the org chart
- 04:12 involved.
- 04:12 And again the facilitator can be sure that there is a healthy debate and
- 04:16 every person's perspective is heard and understood.
- 04:20 The third predatory step is to create the process map of the process.
- 04:24 This is a pictorial list of all process steps
- 04:27 organizing order in which they occur.
- 04:29 There are many different mapping techniques.
- 04:32 If your organization has one, use it.
- 04:34 But word of caution, if your organization relies on the Lean Value Stream
- 04:39 map, be aware that style of map does not include parallel paths and loops.
- 04:44 But those are in your standard process you need to include them.
- 04:48 If the process already exists, walk the process to find every step.
- 04:53 You may have a procedure, and that procedure may even be accurate,
- 04:57 but there are often extra hidden steps that never make it into the procedure.
- 05:02 These steps can be full of potential failure modes.
- 05:05 As I mentioned, include parallel paths, rework and repair loops and branches.
- 05:10 Also be sure to include start up procedures, shutdown procedures and
- 05:14 maintenance procedures if they are part of the regular operation.
- 05:18 If the process does not yet exist you'll want to take the concept of operations
- 05:23 from step 1 and brainstorm the actual steps for the operational process.
- 05:27 Determine the start and end point,
- 05:29 then decide what must be done in between those points.
- 05:32 You may need to brainstorm the use of automation equipment,
- 05:35 both manufacturing and testing.
- 05:36 Talk with operators, better yet, have one of them on your team.
- 05:40 And simulate walking a product all the way through the process.
- 05:45 Well those are the preliminary steps.
- 05:48 Once we have the team and the process map, we're ready to start doing the analysis.
Lesson notes are only available for subscribers.
PMI, PMP, CAPM and PMBOK are registered marks of the Project Management Institute, Inc.