GETTING STARTED

Just as with anything else, before the FMEA begins there are some assumptions and preparations that must be taken care of. These are:

1. Know your customers and their needs.

2. Know the function.

3. Understand the concept of priority.

4. Develop and evaluate conceptual designs/processes based on your customer's needs and business strategy .

5. Be committed to continual improvement.

6. Create an effective team.

7. Define the FMEA project and scope.

1. UNDERSTAND YOUR CUSTOMERS AND THEIR NEEDS

A product or a process may perform functions flawlessly, but if the functions are not aligned with the customer's needs, you may be wasting your time. Therefore, you must:

• Determine all (internal or external) relevant customers.

• Understand the customer's needs better than the customers understand their own needs.

• Document the customer's needs and develop concepts. For example, customers need:

  • Chewable toothpaste

  • Smokeless cigarettes

  • Celery-flavored gum

  • ????

In FMEA, a customer is anyone /anything that has functions/needs from your product or manufacturing process. An easy way to determine customer needs is to understand the Kano model ” see Figure 6.3.

Figure 6.3: Kano model.

The model facilitates understanding of all the customer needs, including:

• Excitement needs: Generally, these are the unspoken "wants" of the customer.

• Performance needs: Generally, these are the spoken "needs" of the customer. They serve as the neutral requirements of the customer.

• Basic needs: Generally, these are the unspoken "needs" of the customer. They serve as the very minimum of requirements.

It is important to understand that these needs are always in a state of change. They move from basic needs to performance to excitement depending on the product or expectation, as well as value to the customer. For example:

• SYSTEM customers may be viewed as: other systems, whole product, government regulations, design engineers , and end user .

• DESIGN customers may be viewed as: higher assembly, whole product, design engineers, manufacturing engineers, government engineers, and end user.

• PROCESS customers may be viewed as: the next operation, operators, design and manufacturing engineering, government regulations, and end user.

• MACHINE customers may be viewed as: higher assembly, whole product, design engineers, manufacturing engineers, government regulations, and end user.

Another way to understand the FMEA customers is through the FMEA team, which must in no uncertain terms determine:

1. Who the customers are

2. What their needs are

3. Which needs will be addressed in the design/process

The appropriate and applicable response will help in developing both the function and effects.

2. KNOW THE FUNCTION

The dictionary definition of a function is: The natural, proper, or characteristic action of any thing. This is very useful because it implies performance. After all, it is performance that we are focusing in the FMEA.

Specifically, a function from an FMEA perspective is the task that a system, part, or manufacturing process performs to satisfy a customer. To understand the function and its significance, the team conducting the FMEA must have a thorough list of functions to evaluate. Once this is done, the rest of the FMEA process is a mechanical task.

For machinery, the function may be analyzed through a variety of methodologies including but not limited to:

• Describing the design intent either through a block diagram or a P-diagram

• Identifying an iterative process in terms of what can be measured

• Describing the ideal function ” what the machine is supposed to do

• Identifying relationships in verb-noun statements ” function tree analysis

• Considering environmental and safety conditions

• Accounting for all R & M parameters

• Accounting for the machine's performance conditions

• Analyzing all other measurable engineering attributes

3. UNDERSTAND THE CONCEPT OF PRIORITY

One of the outcomes of an FMEA is the prioritization of problems. It is very important for the team to recognize the temptation to address all problems, just because they have been identified. That action, if taken, will diminish the effectiveness of the FMEA. Rather, the team should concentrate on the most important problems, based on performance, cost, quality, or any characteristic identified on an a priori basis through the risk priority number.

4. DEVELOP AND EVALUATE CONCEPTUAL DESIGNS/PROCESSES BASED ON CUSTOMER NEEDS AND BUSINESS STRATEGY

There are many methods to assist in developing concepts. Some of the most common are:

1. Brainstorming

2. Benchmarking

3. TRIZ (the theory of inventive problem solving)

4. Pugh concept selection (an objective way to analyze and select/synthesize alternative concepts)

Figure 6.4 shows what a Pugh matrix may look like for the concept of "shaving" with a base that of a " razor ."

Eval. Criteria	Razor	A	B	C	D	E	F	G	H
Stubble length	D
Pain level	A
Mfg. Costs	T	-	+	+	+	-	S	+
Price/Use	U	-	S	-	+	-	S	S
Etc	M	+	S	-	S	-	S	+
Etc		S	S	-	S	-	+	-
Totals	-	2		3		4		1
	+	1	1	1	2		1	2
	S	1	3		2		3	1
+ : Better than the basic razor requirement
- : Worse than the basic razor requirement
S : Same as the basic razor requirement

Legend:

Evaluation Criteria: These are the criteria that we are comparing the razor with the other approaches.

Datum: These are the basic razor characteristics that we are comparing the other concepts to.

A: Chemical	B: Electric	C: Electrolysis
D: Duct tape	E: Epilady	F: Laser beam
G: Straight edge	H: ?

Figure 6.4: A Pugh matrix ” shaving with a razor.

5. BE COMMITTED TO CONTINUAL IMPROVEMENT

Everyone in the organization and especially management must be committed to continual improvement. In FMEA, that means that once recommendations have been made to increase effectiveness or to reduce cost, defects, or any other characteristic, a proper corrective action must be developed and implemented, provided it is sound and it complements the business strategy.

6. CREATE AN EFFECTIVE FMEA TEAM

Perhaps one of the most important issues in dealing with the FMEA is that an FMEA must be done with a team. An FMEA completed by an individual is only that individual's opinion and does not meet the requirements or the intent of an FMEA.

The elements of an effective FMEA team are:

• Expertise in subject (five to seven individuals)

• Multi-level/consensus based

• Representing all relevant stakeholders (those who have ownership)

• Possible change in membership as work progresses

• Cross-functional and multidisciplinary (One person's best effort cannot approach the knowledge of an effective cross-functional and multidisciplinary team.)

• Appropriate and applicable empowerment

The structure of the FMEA team is based on:

• Core team

  • The experts of the project and the closest to the project. They facilitate honest communication and encourage active participation. Support membership may vary depending on the stage of the project.

• Champion/sponsor

  • Provides resources and support

  • Attends some meetings

  • Supports team

  • Promotes team efforts and implements recommendations

  • Shares authority/power with team

  • Kicks off team

  • Higher up in management the better

• Team leader

  • A team leader is the "watchdog" of the project. Typically, this function falls upon the lead engineer. Some of the ingredients of a good team leader are:

    • Possesses good leadership skills

    • Is respected by team members

    • Leads but does not dominate

    • Maintains full team participation

• Recorder

  • Keeps documentation of team's efforts. The recorder is responsible for coordinating meeting rooms and times as well as distributing meeting minutes and agendas .

• Facilitator

  • The "watchdog" of the process. The facilitator keeps the team on track and makes sure that everyone participates. In addition, it the facilitator's responsibility to make sure that team dynamics develop in a positive environment. For the facilitator to be effective, it is imperative for the facilitator to have no stake on the project, possess FMEA process expertise, and communicate assertively.

Important considerations for a team include:

• Continuity of members

• Receptive and open -minded

• Committed to success

• Empowered by sponsor

• Cross-functionality

• Multidiscipline

• Consensus

• Positive synergy

Ingredients of a motivated FMEA team include:

• Realistic agendas

• Good facilitator

• Short meetings

• Right people present

• Reach decisions based on consensus

• Open minded, self initiators, volunteers

• Incentives offered

• Ground rules established

• One individual responsible for coordination and accountability of the FMEA project (Typically for the design, the design engineer is that person and for the process, the manufacturing engineer has that responsibility.)

To make sure the effectiveness of the team is sustained throughout the project, it is imperative that everyone concerned with the project bring useful information to the process. Useful information may be derived due to education, experience, training, or a combination of these.

At least two areas that are usually underutilized for useful information are background information and surrogate data. Background information and supporting documents that may be helpful to complete system, design, or process FMEAs are:

• Customer specifications (OEMs)

• Previous or similar FMEAs

• Historical information (warranty/recalls etc.)

• Design reviews and verification reports

• Product drawings/bill of material

• Process flow charts /manufacturing routing

• Test methods

• Preliminary control and gage plans

• Maintenance history

• Process capabilities

Surrogate data are data that are generated from similar projects. They may help in the initial stages of the FMEA. When surrogate data are used, extra caution should be taken.

Potential FMEA team members include:

• Design engineers

• Manufacturing engineers

• Quality engineers

• Test engineers

• Reliability engineers

• Maintenance personnel

• Operators (from all shifts)

• Equipment suppliers

• Customers

• Suppliers

• Anyone who has a direct or indirect interest

  • In any FMEA team effort the individuals must have interaction with manufacturing and/or process engineering while conducting a design FMEA. This is important to ensure that the process will manufacture per design specification.

  • On the other hand, interaction with design engineering while conducting a process or assembly FMEA is important to ensure that the design is right.

  • In either case, group consensus will identify the high-risk areas that must be addressed to ensure that the design and/or process changes are implemented for improved quality and reliability of the product

Obviously, these lists are typical menus to choose an appropriate team for your project. The actual team composition for your organization will depend upon your individual project and resources.

Once the team is chosen for the given project, spend 15 “20 minutes creating a list of the biggest (however you define "biggest") concerns for this product or process. This list will be used later to make sure you have a complete list of functions.

7. DEFINE THE FMEA PROJECT AND SCOPE

Teams must know their assignment. That means that they must know:

• What they are working on (scope)

• What they are not working on (scope)

• When they must complete the work

• Where and how often they will meet

Two excellent tools for such an evaluation are (1) block diagram for system, design, and machinery and (2) process flow diagram for process. In essence, part of the responsibility to define the project and scope has to do with the question "How broad is our focus?" Another way to say this is to answer the question "How detailed do we have to be?" This is much more difficult than it sounds and it needs some heavy discussion from all the members. Obviously, consensus is imperative. As a general rule, the focus is dependent upon the project and the experience or education of the team members.

Let us look at an example. It must be recognized that sometimes due to the complexity of the system, it is necessary to narrow the scope of the FMEA. In other words, we must break down the system into smaller pieces ” see Figure 6.5.

Figure 6.5: Scope for DFMEA ” braking system.