REVISION RECORD SHEET

REV.NO 00 FOR P FMEA STUDY. DESC. OF AMENDMENT DATE OF AMENDMENT PROCEDURE INTRODUCED. -

TITLE : PROCEDURE

PR.NO : QP-02-02 PAGE NO : 1 OF 6 ISSUE NO : 01 REV NO : 00 DATE : 14.06.1997 REASON FOR AMENDMENT QS 9000 : 1995 UPDATION

DISTRIBUTED TO : SL.NO DESIGNATION NAME & SIGNATURE OF THE RECEIVER 1 2 3 4 5 6 7 8 9 10 11 PREPARED BY: APPROVED & REVIEWED AND RELEASE CONTROLLED BY:

QUALITY ASSURANCE PROCEDURE

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TITLE : Procedure for P FMEA Study.

Purpose : Scope : To establish procedure for conducting FMEA study. All the processes generating special characteristics. Definition of Key terms : 1. Failure : A Failure is that a component, assembly or system which does not meet the requirements or function in accordance with design intent e.g. not meeting the specification. 2. Failure mode : A Failure Mode is the manner in which a component, assembly or system failure occurs. e.g. how the component could not meet the specifications. 3. FMEA is defined as a systematized group of activities to : 4. Recognize & evaluate the potential failure of a product / process and its effects. 5. Identify actions which could eliminate or reduce the chance of potential failure occurring. 6. Document the process. 7. FMEA is required for a company where continuous improvement is emphasized for its product / process. 8. FMEA is a living document and shall be controlled as per Procedure No.QP-05-01 9. FMEA should be done by cross functional team chaired by a team leader. 10. Cross Functional Team should comprise of personnel from experts from different sections e.g. Quality, Production, Maintenance, Development etc.,as appropriate. 11. Advantages of FMEA : 12. Avoids late change crisis. 13. Reduces or eliminates chance of implementing corrective change. 14. Excellent technique for preventive action. 15. Interactive process which is never ending. At present only Process FMEA is considered since, design is not applicable.

Procedure :

QUALITY ASSURANCE PROCEDURE

TITLE : Procedure for P FMEA.
16. Process FMEA means :

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17. Potential means Anticipated in an analytical technique to assure that potential failure mode and their associated causes have been considered and addressed. Collection of teams thought as a process is developed. 18. Aims of Potential Process FMEA : 19. Identifying potential product related process failure mode. 20. Assessing the potential customer effects of the failures. 21. Identifying the potential mfg., or assembly process causes & process variables on which to focus controls for occurrence reduction or detection of the failure conditions. 22. Developing a ranked list of potential failure modes. 23. Documenting the results of the manufacturing or assembly process. Customer means - normally end user but can also be a subsequent or down stream manufacturing or assembly operation. 24. FMEA should be done for : QS - Requirement . 25. For all new parts / processes. 26. Changed parts / processes. 27. Carryover parts / processes in new application or environment. 28. Before or at feasibility stage. 29. Prior to tooling for production. 30. Process FMEA assumes the product as designed will meet the design intent : 31. Assemble a team (cross functional) 32. Assign responsibilities. 33. Develop flow chart for risk assessment. 34. Collect data / information. 35. Arrive at R. P. N. for each potential cause of failure. 36. Based on pareto rankings of R. P. N. S. for respective potential cause of failure, priortise preventive action directed first at highest ranked R. P. N.s and severity rank. 37. Formulate the recommended / preventive action for each potential failure cause after examining the inadequacy of the present / current design & process controls. 38. Implement actions & record results. 39. Estimate & record the new resulting serevity, occurance & detection rankings & calculate R. P. N.

40.

QUALITY ASSURANCE PROCEDURE

TITLE : Procedure for P FMEA.
41. Collect Data / Information. 42. Develop FMEA form.

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43. Process Function Requirements : 44. Description of the process (Eg. Gear Cutting, Broaching, Hobbing, etc.,) & purpose in brief. 45. Potential Failure Mode : 46. Potential Failure Mode is defined as the manner in which the process could potentially fail to meet the process requirements and / or design intent. It is also a description of non-conformance at that specific operation. 47. All incoming parts / materials are correct : 48. List each potential failure mode for the particular operation. 49. Assumption is made that the failure could occur, but not necessarily occur. Tips and thoughts (for C F T) : 50. How can the process / part fail to meet specification. 51. Regardless of engg. Specification, what would a customer consider objectionalbe. 52. Comparison of similar processes / customer claims. 53. Typical failure modes : 54. Bent, binding, burred, handling damage, cracked, deformed, dirty, improper setup, grounded, open cktd, short cktd, tool worn etc., 55. Potential effects of failure : 56. Effects of the failure mode on the customer. 57. Describe the effects of the failure in terms of what the customer might notice or experience. e.g. Noise, Erratic Operation, Rough etc., 58. If the customer is your next operation, then effect. e.g. cannot fasten, cannot mount, cannot face etc., 59. Severity : 60. Severity is an assessment of the seriousness of the effect of the potential failure mode to the customer. 61. Severity applies to the effect only. 62. Severity should be estimated on a 1 to 10 scale.

QUALITY ASSURANCE PROCEDURE

TITLE : Procedure for P FMEA.
63. Classification :

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64. To denote any special characteristics (Critical, Major, Key) that may require additional process control. 65. Potential Cause(s) / Mechanism of failure : 66. Potencial cause(s) or mechanism of failure is defined as how the failure

could occur, describe in terms of something that can be corrected or controlled. List every conceivable failure cause assignable to each potential failure mode. The causes should be described so that remedial efforts can be aimed at those causes which are relvant. Only specific errors or malfunctions should be listed. e.g. Improper Heat Treat - time, temperature; Improper Torque over, under. Ambiguous phrase should not be used e.g. Operator Error, Machine Malfunction. 67. Occurance (o) : . 68. Occurance is how frequently the specific failure cause / mechanism is projected to occur only occurances resulting in the failure mode should be considered for ranking estimate the likelihood of the occurance on a 1 to 10 scale. 69. Three types of process controls / features to consider : 70. Prevent the cause / mechanism or failure mode / effect from occurring or reduce their rate of occurance. 71. Detect the cause / mechanism & lead to corrective action. 72. Detect the failure mode. 73. Detection : 74. Detection is an assessment of the probability that the proposed current process controls will detect a potential cause / mechanism or subsequent failure mode. 75. Assumption - 4 : Assume the failure has occurred and then assess the capabilities of all Current Process Controls to prevent shipment of the part having this failure mode or defect a 1 to 10 sale is used.

QUALITY ASSURANCE PROCEDURE

TITLE : Procedure for P FMEA.
27. Risk Priority Number (R. P. N) : 28.

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R. P. N. Is the product of Severity (S), Occurance (O) & Detection (D) rankings i.e. R. P.N. = (S) x (O) x (D)

R. P. N. will be between 1 & 1000 This value should be used to rank order the concern in the process in the Pareto Fashion.

29.

Recommended Action(s) :

Action on 30. 31. Highest ranked R. P. N. / Severity high. Which could be Hazardous to manufacture / assembly personnel.

Permanent corrective action is required. Emphasis must be on preventing defects.