Extra Slides

Engine Troubleshooting Guide

Piston Scuffing Piston scuffing as a result of fuel flooding:Appearance: Piston with one sided, streaky, narrow piston wear areas and considerable scuffing along the entire skirt length. The piston rings may also exhibit burned spots.

Possible causes:

The oil film on the cylinder walls was washed away by excess fuel. • Piston and piston rings run dry. Scuffing first appears on the major thrust side;

finally, seizing appears.• Excess fuel is often the result of improper carburettor operation; either the

automatic choke failed to shut off soon enough, or a hand operated choke remained engaged too long.

• A defective fuel injection system (cold start enrichment), or ignition misfiring as a result of damaged spark plugs in individual cylinders, can lead to fuel deposits on the cylinder walls. At higher power levels, the resulting oil dilution usually leads to piston damage.

Engine-related causes:• Defective fuel injection system, incorrect ignition settings, defective spark

plugs

Failures in Crankshaft Contents Introduction Function of crankshaft Material for crankshaft Crankshaft Loading Failure modes Resonant Bending Fatigue Testing Visual Analysis Fillet Rolling method Conclusion References

Failures in Crankshaft Contents Function of crankshaft Material Selection for Crankshaft Materials/Manufacturing/Layout - Crankshaft Crankshaft Loading Crankshaft Failures Resonant Bending Fatigue Testing Visual Analysis Fillet Rolling method Conclusion References

Oil AnalysisMetals Wear Metal Source

Iron

Copper

Tin

Aluminium

Chrome

Lead

Silicon

Compression test

Compression test

Compression test

Compression test

Compression test

Compression test

• Pre-requisites delivered for the review:– Updated DDP, Industrialization plan if needed– Verification plan & protocol(s) updated when necessary

since the Phase 2a Design Review– Verification reports– Residual design anomalies– Validation Plan and/or Protocol(s)– Clinical Trials Plan & Protocol(s) as applicable– Product Safety Risk Management File updated (including

product and process bottom up as necessary– per the Safety Risk Management plan)– Design Freeze with preliminary DMR– Traceability Matrix– Any project change request occurring after the design

freeze, impact analysis and affected design– documents and Project Issue tracking

Product Development Process: Phase 3:

Validation

The goal of the Phase 3 is to confirm that the product meets its intended use and

customer needs and to prepare the launch of the product.

• Design validation:• Design validation shall ensure that the product conforms to pre-defined user needs and intended uses as established in the Product Requirements Document and shall include testing under actual or simulated use conditions.• Design validation shall be performed according to planned arrangements detailed in the Validation Plan(s) as established in the V&V Plan, validation protocols or procedures,Validation results shall be recorded including identification of the design, methods, the date, and the individuals performing the validation. All the Validation documentation shall be maintained in the Design History File• The Design Traceability Matrix shall be updated with validation test cases to confirm that all requirements have been adequately covered.

• Design validation shall address: Clinical or laboratory-based studies and/or performance evaluation as applicable Software and/or full system validation, as applicable Product packaging and labeling Device usability, as applicable The PRD needs of all relevant parties

• For anomalies discovered during validation that shall be corrected and retested, regression

• testing shall be established at an appropriate level through an impact analysis, to show that

• the design changes have not induced adverse effects to the previously tested functionality.

• Anomalies found during the validation activities shall be tracked. Any residual design• anomalies remaining at the completion of the validation activities shall be approved

by QA,• through the validation report. QA can previously review those anomalies in Anomaly

review• Board.• Pre-requisites delivered for the review:

– Updated DDP plan if needed– Last Verification reports when applicable– Validation / Clinical Trials plan & protocol(s) updated when necessary since the last Design

Review– Validation reports– Residual design anomalies– Product Safety Risk Management File updated – Final DMR & DHF for the Regulatory Files– Traceability Matrix– Any change request occurring after the design freeze, impact analysis and affected design

documents– Project Issue tracking

• Product launch process:• The product launch process is established to ensure

controlled commercialization of product.• A successful Phase 3 design review chaired by

Regulatory Affairs is a required prerequisite to• the Launch Review.• The decision to commercialize the product and the

scope of its launch shall be formalized in a launch memo• Pre-requisites delivered for the review:

– Phase 3 Design Review minutes, list of issues and corrective action items

– Declaration of Conformity– Registration obtained in 1st wave of countries; plan for

following countries– Servicing Readiness– Logistics / product clearance