1. HEATING, COOLING & WATER HEATING PRODUCTS
DSQR Training FMEA
Sean McGraw
Corporate Quality

2. FMEA Training Objectives
Understand a FMEA
Recognize different types of FMEA’s and benefits FMEA’s provide
Understand the components of a FMEA
Recognize and prioritize risks

3. FMEA Training Definition - FMEA
- Failure Mode and Effects Analysis (FMEA) is a systematic process for identifying potential and/or known failures, problems and errors from the system, design process and/or service with the intent to eliminate them or minimize the risk associated with them (American Society of Quality).
Summary:
Identify ways the product or process can fail and eliminate or reduce the risk of failure

4. FMEA Training A Structured Approach
Identifying the ways in which a product or process can fail
Estimating the risk associated with specific Failure Modes
Prioritizing the actions that should be taken to reduce the risk
Evaluating the design validation plan (Product) or current control plan (Process)

5. FMEA Training FMEA – Is / Is not
It is:
Systematic approach to identifying known or potential failures, errors, or problems
Complementary to the design process and/or product development
Means to minimize or eliminate potential failure modes
Is not:
The sole problem solver; used in combination with other problem solving tools (opportunity not solution)
One and done endeavor; needs to be treated as a living document throughout the product life.

6. FMEA Training FMEA - Benefits / Shortfalls
Helps identify potential failure modes early in product development
Helps in development of manufacturing/assembly control plans
Creates priority for product/process improvement
Risk management tool
Greater organizational support contributes to a more robust product/process
Shortfalls
Individual vs. Team development
Check in the box development vs. improvement to product/process
Late development of FMEA prevents impact to product/process development
Not continually updated

7. FMEA Training FMEA - Types
System FMEA
Evaluates/analyzes systems in conceptual stages
Design FMEA
Evaluates/analyzes product design and failure related to design issues
Process FMEA
Evaluates/analyzes manufacturing processes and failures related to manufacturing of the product
Service FMEA
Evaluates/analyzes services prior to reaching the customer

8. FMEA Training Assumptions
For a process FMEA, it is assumed that the design is correct. The product designed will meet the designed intent (AIAG FMEA Manual).
At any process step during the development of the FMEA, it should be assumed that the incoming materials/parts are correct to that process step (AIAG FMEA Manual).

9. FMEA Training Risk Priority Number (RPN)
The output of a FMEA is the “Risk Priority Number”
The RPN is a calculated number based on information you provide regarding three criteria each rated on a scale of 1 to 10.
- How severe is the effect of the failure - How often will the failure occur - The current ability to detect the failure before reaching the customer
RPN = Severity X Occurrence X Detection
It is used to rank failures and help ensure the highest RPN’s are addressed first.
Action should be taken on items with a Severity rating of 9 or 10.
Rheem Target RPN is 100

10. FMEA Training Where do Risks Come From?
Potential Safety Hazards
Poor Control Plans & SOP’s
Unclear Customer Expectations
Cumulative Risk
Vague Workmanship Standards
Poor Process Capability
Machine Reliability
Raw Material Variation
Measurement Variation (Online and QC)
Poorly Developed Specification Limits

11. FMEA Training Class Exercise
Using the information provided, calculate the risk priority number (RPN) for each failure mode
Identify potential failure modes that may require action based on individual ratings provided

12. FMEA Training Inputs - PFMEA
Process Flow Diagram(s)
Control Plans
Process History / Inspection test data
Process technical procedures
Previous/Similar PFMEA’s
Engineering Drawings
Field Service Data
Tooling & Setup Sheets
Customer Complaints

13. FMEA Training Definition of Terms - Failure Mode
Failure Mode - The way in which a specific part, sub-assembly, or system could potentially fail to meet design/processing intent or customer requirements.
Can be associated with a defect (in discrete manufacturing) or a process input variable that goes outside of the specification. - Anything that an operator can see that’s wrong is considered a Failure Mode
Examples - Temperature too high - Incorrect PO number - Surface contamination - Pits on substrate - Paint too thin

14. FMEA Training Definition of Terms – Process Function
Process Function – Anything that the evaluated process step does to meet the process function or requirement
Example: Steel Top Head
Flue hole (ID)
2 coupling holes

15. FMEA Training Definition of Terms – Effect
Effect - The effect of the failure on customer requirements (what they may notice). This can include the next downstream operation, assembly station or consumer (end item user).
Examples: - Temperature too high: damage component - Incorrect PO number: accts receivable traceability errors - Surface contamination: poor substrate - Paint too thin: poor coverage

16. FMEA Training Definition of Terms – Cause
Cause - How the potential failure may occur in terms of something that can be controlled/corrected.
Examples:
Temperature too high: Thermocouple out of calibration
Surface contamination: Excess flux from hand soldering
Incorrect PO number: Typographical error
Pits: High particle count in clean room
Paint too thin: High solvent content

17. FMEA Training Definition of Terms – Current Controls
Current inspections or manufacturing controls in place which will detect a failure mode as early as possible
Controls consist of audits, checklists, inspection, laboratory testing, training, SOP’s, preventive maintenance, etc.
Controls meant to reduce/eliminate occurrence of the cause should be considered when estimating the occurrence rating not detection rating
Prevention consists of fool-proofing, automated control, set-up verifications, etc.

18. FMEA Training Step by Step
1. Identify team members
2. Identify input data
3. Obtain process flow chart
4. Identify process functions
5. For each process Input, determine the ways in which the input can go wrong (these are failure modes)
6. For each failure mode, determine the effects & corresponding severity rating
7. Identify potential causes of each failure mode & corresponding occurrence rating
8. List current process controls for each cause & corresponding detection rating
9. Calculate the RPN for each
10. Determine recommended actions to reduce high RPN’s, responsibility, & timeline for completion
11. Take appropriate actions and document
12. Recalculate RPN
13. Revisit as required during product life

19. FMEA Training Step by Step
For each critical (high value) process input, determine the ways in which the input can go wrong
Example: One area of high risk in a manufacturing process is Heat Staking of a Latch Assembly. We will analyze the “Loose Weld”, even though there are many more potential failure modes.

20. FMEA Training Step by Step
6. For each Failure Mode associated with the inputs, determine Effects
These effects are internal requirements for the next process and/or to the final customer. In this case we will look at one effect, even though there can be several

21. FMEA Training Step by Step
7. Identify potential causes of each Failure Mode As in most cases, we have several causes for one failure mode / effect combination

22. FMEA Training Step by Step
8. List the Current Controls for Each Cause For each Failure Mode/Cause we list how we are either preventing the cause and/or detecting the Failure Mode

23. FMEA Training Class Exercise
Stamping Press ( Process Step / Input )
Stamp a 90 o bracket for a refrigerator door bottom hinge
Punch 2 holes for mounting to refrigerator cabinet
Punch 1 hole for assembling hinge pin for door mounting
Using the form provided, write down the key inputs from a specific process step (Input)
List two or three ways that input can go wrong (Failure Mode)
List at least one Effect of the failure mode
For each failure mode, list one or more causes of the input going wrong (Cause)
For each Cause, list at least one method of preventing or detecting the cause (Current Controls)

24. FMEA Training Scoring
There are a wide variety of scoring “anchors”, both quantitative or qualitative.
Two types of scales are 1-5 or 1-10
The 1-5 scale makes it easier for the teams to decide on scores
The 1-10 scale allows for better precision in estimates and a wide variation in scores The 1-10 scale is generally considered to be the best option

25. FMEA Training Severity - Defined
An assessment of the seriousness of the effect of the failure.
Severity does not apply to the failure mode, just the effect.
Scored once for all effects using the most severe rankings.

26. FMEA Training Severity - Scoring
Effect
Customer Effect
Assembly Effect
Ranking
Hazardous without warning
Affects safe operation without warning
May endanger operator without warning 10
Hazardous with warning
Affects safe operation with warning
May endanger operator with warning 9
Very High
Item inoperable
100% of product scrapped or repair time greater than 1 hour 8
High
Item operable but at a reduced level of performance
Product may have to be sorted with repair time ½ - 1 hour 7
Moderate
Item operable but performance reduced
Product may have to be sorted with repair time less than ½ hour 6
Low
Slight customer dissatisfaction
Product may have to be reworked on line 5
Very Low
Defect noticed by 75% of customers
Portion of product may have to be reworked 4
Minor
Defect noticed by 50% of customers 3
Very Minor
Defect noticed by 25% of customers 2
None
No discernible effect
No effect 1
*** Severity does not apply to the failure mode, just the effect.

27. FMEA Training Class or Characteristic
A classification column may be utilized
Used to indicate special characteristics such as key, critical, significant, etc.
Useful for identifying characteristics that may require additional/specific/special controls unique to the process
The indicator can be a special symbol that can be unique to denote safety, governmental, or specific action

28. FMEA Training Occurrence – Defined
The chances that a specific cause will occur over the life of the design
Occurrence should be considered over the product’s expected lifespan not for a specific period of time.

29. FMEA Training Occurrence - Scoring
Probability
Likely Failure Rates
Ranking
Very High; Persistent Failures
> 100 per thousand 10
50 per thousand 9
High; Frequent Failures
20 per thousand 8
10 per thousand 7
Moderate; Occasional Failures
5 per thousand 6
2 per thousand 5
1 per thousand 4
Low; Relatively Few Failures
0.5 per thousand 3
0.1 per thousand 2
Remote; Failure is Unlikely
< 0.01 per thousand 1
*** Occurrence should be considered over the products expected life not a specific period of time.

30. FMEA Training Detection - Defined
Can current or proposed controls listed detect a potential cause before the part or component leaves the manufacturing operation or assembly location.
Operator inspections or random quality audits are unlikely to detect isolated defects(result in high ranking).

31. FMEA Training Detection - Scoring

32. FMEA Training Assign & Calculate
9. Assign Severity, Occurrence and detection ratings to each Cause and Calculate RPN’s We are now ready to transfer the worksheet input to the FMEA form. You can just copy and paste the worksheet columns into the appropriate FMEA form columns. The team then starts scoring each row to compute the RPN values.

33. FMEA Training Assign & Calculate
10a. Identify High RPN’s
- If necessary, you can Pareto Chart the RPN’s

34. FMEA Training Recommended Actions
What to do about the high RPN’s
For recommended actions, consider things such as:
Data collection / SPC
Mistake – proofing
Process improvements
Process control/evaluation improvements
Process or design revisions are required to reduce occurrence.
A design change or process revision is required to address reducing the severity rating.
Improvements in evaluation techniques can be utilized to improve the detection rating.

35. FMEA Training Recommended Actions
10b. Determine Recommended Actions to Reduce High RPN’s and assign responsibilities for implementation.

36. FMEA Training Class Exercise
Using the FMEA started on your project, rate each Failure Mode, Effect, Cause, and Current Controls.
Calculate the RPN
For the top 3 RPN’s discuss recommended actions and assign responsibility for implementation.
List top three actions on a flip chart to present to the class.

37. FMEA Training Update
11. Take Appropriate Actions and Document 12. Recalculate RPN’s
We have recorded the action taken and the impact on the RPN.
Notice that this is a nice way to track past activities.
The FMEA should be re-evaluated by the group as new
Recommended actions are identified, completed and recorded

38. FMEA Training Philosophical Approach Focus on safety issues
Assume incoming material is perfect and process is not good
Assume process is perfect and incoming material is not good

39. FMEA Training Gained knowledge of FMEA’s
Looked at the steps to developing FMEA’s
Identified Risk prioritization / Recommended actions
Understand possible need for periodic reviews