Process Failure Mode and Effect Analysis

(PFMEA)

HISTORY:
Created by the aerospace industry in the 1960s. Ford began using FMEA in 1972. Incorporated by the Big Three (General Motors, Ford, Chrystler) in 1988. Automotive Industry Action Group (AIAG) and American Society for Quality (ASQ) copyright standards in 1993. PURPOSE: To take preventive actions (action to prevent occurrence of potential cause of failure) for manufacturing of products.

Process Failure Mode and Effect Analysis (PFMEA)

PFMEA process has following steps: 1. Identifying processes and product characteristics 2. Identifying failure modes 3. Effect analysis (severity no. & class) 4. Cause analysis (occurrence no.) 5. Control analysis (detection no.) 6. RPN (risk priority no.) and identifying actions 7. Results of actions and re-assessing RPN
Proc. No. Proc. / Func. Reqmt. Product Char. Potential failure mode Potential effects of failure S e v Class Potential causes / mechanism of failure O c c Current proc. Control (Prev) Current proc. Control (Det) D e t R P N Reco. actions Action Results Action taken S e v O c c D e t R P N

5 6

7 7 7 7

1. Identifying processes and product characteristics

Identify processes and product characteristics at the stage of making process flow diagram. All manufacturing processes must be covered. A process may consists of multiple activities within the process (e.g., locating, clamping, removal of job, placing of job in out-tray after operation, visual inspection by same operator who is running the operation etc.). Sampling inspections (set up verification, periodic verification etc.) shall not not be written as a separate process since these are control methods. 100% inspection or testing, if done at a separate station or by a different operator and the inspection / testing is of complex nature, then it shall be written as a separate process. Simple 100% inspections done by the machine operator shall not be written as a separate process. Product characteristics shall be outcome of the particular process and shall include BP (Blue print or final dimensions for the customer), IP (in-process dimensions, which will get processed further), ES (Engineering specification physical, metallurgical, chemical, mechanical, functional characteristics) and VP (Visual parameters).

Process Flow Diagram: Oprn. no. Process name Flow diagram Product characteristics Process characteristics Remarks

2. Identifying failure modes

Write the failure mode as not meeting the specific desired outcome. The failure mode can be existing or potential. If the desired outcome is a dimensional parameter, identify oversize and undersize as separate failure modes.

3. Effect analysis:

1. 2. 3.

This is done to identify the potential effects that a failure mode will create on further downstream processes / customer processes / application. Write the specific effects in following categories (do not write rejection as effect):
Effect on next processes Effect on internal assembly line or on customer assembly line Effect on application

The seriousness of the effect is ranked using Severity Number on a 1 10 scale as given in the following table (Severity Table). If the severity number is 9 or 10, mark CC (critical characteristics) in the class column and if the severity number is 8, mark SC (significant characteristics) in the class column.

Severity table:
Sev. No. 10 Effect on next processes / Assy. Can lead to accident and loss of life Effect on customer assy. line Can lead to accident and loss of life Effect on application / usage Can lead to accident and loss of life and will happen without warning

9
8 7 6 5 100% scrap Some scrap & some rework 100% rework Some rework and some accepted with deviation Fitment not at all possible Fitment possible with difficulty

Can lead to accident and loss of life but will happen with warning
Will completely stop the primary function of the application Will deteriorate the primary function of the application Will stop the functioning of the comfort / convenience items Will deteriorate the functioning of the comfort / convenience items Appearance problem and will be noticed by most of the customers

3
2 1 No effect No effect

Appearance problem and will be noticed by some of the customers

Appearance problem but will not be noticed by most of the customers No effect

4. Cause analysis (occurrence no.)

Potential causes that can create the failure mode are identified here. There can be 3 types of causes: Escape, Occur and System. Only occur causes should be identified in FMEA. Cause is identified based on technical knowledge of the process. While identifying the cause of a process, incoming material is assumed to be correct and only process parameter related causes are identified. If the incoming material variation leads to problem then verification of incoming material is to be considered as a process in FMEA. There can be more than one cause for a particular failure mode. Also there may be some common cause for different failure modes. Occurrence number: For existing process, occurrence number in 1 10 scale is assigned for every cause identified, based on knowledge of rejection ppm (cause wise) of six months. Use table A for this. For potential failures (failures which have not occurred even a single time in process), occurrence number may be estimated based on perception using table B as guideline. If we do not know which are the causes creating problem, put same occurrence number for all the causes.

4. Cause analysis (occurrence no.)

Table A
Rejection data (ppm) for particular cause >= 100,000 ppm Between 50, 000 and 100,000 ppm Between 20,000 and 50,000 ppm Occurrence number 10 9 8

Between 10,000 and 20,000 ppm

Between 5,000 and 10,000 ppm Between 2,000 and 5,000 ppm Between 1,000 and 2,000 ppm Between 500 and 1,000 ppm Between 100 and 500 ppm

7
6 5 4 3 2

Less than 100 ppm

Table B
Rejection data for potential failure modes
Very High: Persistent failures High: Frequent failures Moderate: Occasional failures Low: Relatively few failures Remote: Failure is unlikely

Occurrence number
10, 9 8, 7 6, 5, 4 3, 2 1

5. Control analysis (detection no.)

3 types of control can be there in a process: Type A, Type B and Type C. Type A control means, the defective part is detected and then only actions are taken. Example is periodic sampling inspection of product parameter in the shift. Defective parts needs to be segregated for this type of control. Type- B control means, the cause is detected before defective parts are produced and action is taken to remove the cause. Examples are periodic monitoring of molten metal temperature in PDC, machine stopping automatically when coolant flow is not adequate, assembly line stopping when the air pressure drops to prevent low torque in bolting. Type C control means, the cause is prevented. Examples are replacement of coolant filter at predetermined frequency, tool change at predetermined frequency, receiving inspection of input material. A type control is called detective control and B & C type controls are called preventive controls (refer FMEA table). Detection number: Effectiveness of type A control is given in 1 10 scale as detection number in FMEA. The effectiveness of type B and C controls will be reflected in occurrence number for potential failure modes.

5. Control analysis (detection no.)

Detection number is given as per table below:
Type of control No control Control done with indirect checks or visual inspection - sampling 100% Visual inspection of parts Detection number 10 9 8

100% Double visual inspection of parts

Sampling Inspection using Gauging 100% Inspection by gauging or Sampling inspection by instrument 100% inspection by instrument Error proofing in subsequent processes for detection. Error proofing in the manufacturing process for detection.

7
6 5 4 3 2

Error proofing to prevent the failure mode.

For all detective controls, sample size and frequency of check to be written in the FMEA column.

6. RPN (risk priority no.) and identifying actions

Risk priority number (RPN) is calculated by multiplying Severity no., Occurrence no. and Detection no.. Actions to be planned when Occurrence number is high and when RPN is high. The criteria of cut off limit of occurrence number and RPN value shall be decided based on customers expectations. Action plans to be mentioned in FMEA column with target date for implementation and responsibility.

7. Results of actions and re-assessing RPN

By taking actions, the detection number and occurrence number will be reduced and so RPN will also reduce. The severity number remains unchanged. After implementation of actions, the date of implementation and description of action to be written is FMEA column. Sev, Occ and Det numbers to be reassessed and RPN to be recalculated after implementation of actions. Control plan to be update based on changes in control methods in FMEA.

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