FMEA

Failure Mode Effects Analysis - FMEA

The method of the FMEA - Failure Mode and Effect Analysis has been used for years in the automotive and manufacturing industry.

The risk analysis framework has been applied in a wide range of industrial sectors. The first areas of application were traditionally in product development. Based on this the integration of the production process planning and the production. In the automotive industry, the joint creation of FMEA for products and processes by Today customer, supplier and subcontractor are a natural part of a cooperation. 

The user is guided through the "10 Steps to Creation of the FMEA".

Step 1 - Review the process

• Use a process flow chart or an already existing value stream map to identify each part of a process

• List all process steps in a FMEA table

• If you think the list gets too long it might is. Use this chance to split up the process and cut the elephant. It makes more sense to work on smaller parts of the process instead of getting lost in the woods.

Step 2 - List potential failures

• Review all existing data and documents that can give you a hint about each component that can lead to a failure

• After having a complete list try to cut it down and to combine the parts of the initial list

• The chances are high that you will identify several potential risks of failures for each component

Step 3 - List potential effects of failures

• The effect is the outcome of a failure on the finished good or a process step

• It is common that not only one effect will occur for a single failure, don’t be suprised

Step 4 - Assign the level of failure to risks

• This is based on the consequences for each failure

• Think about the ranking as the worst impact that it can have

Step 5 - Assign the possibility of occurrence

• How high is the possibility of occurrence

• What impact will it have if occur

Step 6 - How can it be detected

• What are the chances that you will detect the failure before occurring

Step 7 - Calculate the RPN (Risk Priority Number)

• Severity (S)

• Severity x Occurence (S x O) = criticality

• Severity x Occurence x Detection (S x O x D) = RPN

Step 8 - Define the action plan

• With the decision making process followed by the prioritization from the RPN (Step 7) focus on the topics with the highest RPNs

• Follow a classic action plan by defining who will be doing what till when

Step 9 - Take action

• Get things done!

• Implement the defined improvement actions

• Follow the PDCA principle

  • Plan - done

  • Do - right now

  • Check - Step 10

  • Act - loop starts over

Step 10 - Re-evaluate the RPN

• Time to check on the impact of your actions

• Re-evaluate each potential failure identified and determine if the improvement measures have an effect or not

• If not follow the PDCA and start over with step 8

The FMEA is linked to all CIP and Kaizen activities - there is always something to improve.

7 Steps - Problem Solving

The 7 Steps problem solving is an analysis method that is typically used in the 0miles major customer complaints and warranty complaints: when risk analysis is necessary. The single steps are as follows:

1. Problem description / risks on similar products and processes

2. Define containment actions

3. Data collection (grasping the facts / failure mode analysis)

4. Identify possible Root Causes

5. Implement corrective actions

6. Evaluate effectiveness (Tracking Chart)

7. Lessons Learned 

Root Cause Analysis is one of the crucial and basic requirements in a quality system for continuous improvement. Its target is to recognize a deviation and its origins, resolve the issue so that it is not recurring and improve the quality of the product or processes. Root Cause Analysis always depends on time if you observe a deviation start asap your RCA-activities as no problem should be allowed to grow.

To gain a better understanding let us describe the 7 Steps in more details

1 Problem Description:

Capturing the deviation -  Ask the following questions:

1. What is the problem? (symptom; use illustrations to describe as clear as possible)

2. Why is it a problem? (content of complaint / definition of problem statement)

3. Where was it detected? (location of occurrence/Area of the product or process)

4. When was it detected?

5. Who detected it?

6. How was it detected?

7. How many defective / suspect parts?

Can the problem appear on other products or processes?

1. Other parts

2. Generic parts

3. Opposite hand

2 Define containment actions:

1. Use a Tracking Chart to list your counter measures

2. Track how many defective parts have been detected

3. List in Pareto format what kind of failures have been detected

4. Put in containment actions and responsible person

5. Define when the actions have been planned and implemented

Data collection (grasping the facts / failure mode analysis) get and check the valid documentation:

1. 1st part release

2. Maintenance records

3. Poka Yoke checks

4. Process parameters tracking charts

5. Work Instructions (SOI)

6. Control Plan

7. Drawings

8. Production information

9. Error collection sheet

10. First Time Through Report

11. Boundary sample

12. Ok part available

Ask the following questions:

1. Was it the correct process? - How should it be?

2. Was it the correct tool/fixture?

3. Was it the correct part?

4. Has something changed in the process?

5. Has something changed in the product design?

6. Is the process in control?

7. Do all product components meet quality requirements?

Collect pictures, evidences and records to support analysis.

3 Build the ISHIKAWA Diagram

1. List the problem to be studied in the "head of the fish".

2. Use an idea-generating technique (e.g., brainstorming) to identify the factors for non-conformance and non-detection within each category that may be affecting the problem and/or effect being studied.

3. Repeat this procedure with each factor under the category to produce sub-factors. Continue asking, "Why is this happening?" and put additional segments each factor and subsequently under each sub-factor.

4. Continue until you no longer get useful information

To learn more about the Ishikawa – read this article.

4 Identify the Root Cause

Analyze the results of the Ishikawa after team members agree that an adequate amount of information is provided for each major category. Do this by looking for those items that appear in more than one category. These become the “most likely causes".

For those items identified as the "most likely causes" the team should reach consensus on listing those items in priority order with the first item being the most “probable" cause. A useful method here is to allow each team member to allocate 3 points to their chosen root causes. The root cause with the most points can be taken for further analysis using 5 Why.

Once the most probable causes are drawn explain failure mechanism focusing on 2 aspects:

1. Cause of non-conformance

2. Cause of non-detection named

Use the 5 Why method for looking at the problem

5 Possible Actions

Create an action plan with countermeasures for non-conformance and non-detection to eliminate/minimize the effect

Do not forget about due dates and responsible persons (preferable only one person for one action)

6 Evaluate the effectiveness (Tracking Chart)

Put in permanent actions (+ responsibility) and make clear when the action has been planned, implemented and stopped. Track how many defect parts have been detected. After implementation of permanent actions remove containment measures only if there are no defects detected any more.

7 Lessons Learned

1. Visualize BEFORE and AFTER (KAIZEN REPORT)

2. Specify what needed to be documented (e.g. Standard Operating Instruction (SOI), etc.)

3. Grasp what you’ve learned (improvements in working and detection process)

4. Think about potential applicability in your organization (review similar design, equipment, components, processes, material or manufacturing processes).

Share what you have learned within your organization.

Some of the benefits of the Root Cause Analysis process are that you will identify which procedures will need to be changed, which documents describing those procedures will require modification and who will need to be trained or re-trained.

Finally, don’t forget that the root cause analysis process must lead to an effective corrective and preventive action plan. One without the other would mean that there is no certainty that the issue is solved and that the failure cannot reoccur.

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