Indra Putra Almanar

ISO 13485:2003: Implementation reference model from the Malaysian SMEs medical device industry

Purpose – The purpose of this paper is to provide an understanding on implementation and operation of ISO 13485:2003 – “Medical Devices – Quality Management System – Requirements for Regulatory Purposes” – in the perspective of medical device industries in Malaysia. The study is focused on the Malaysian Small and Medium Enterprises (SMEs) which currently have accredited to ISO 9001:2000 quality management systems.Design/methodology/approach – Literature research and comparative analysis between ISO 13485:2003 and ISO 9001:2000 standard and requirements. A reference model is developed to assist the Malaysian SMEs towards ISO 13485:2003 accreditation.Findings – Unlike ISO 9001:2000, ISO 13485:2003 stresses the safety and efficacy of medical devices that are being produced. For this reason risk management is an essential process that needs to be adopted into the ISO 13485:2003 quality management system. Moreover, to demonstrate the effectiveness of the ISO 13485:2003 implementation, this standard has placed ...

Preventive replacement schedule: a case study at a processing industry

The application of the preventive maintenance (PM) strategy to reduce machine breakdown problems has been discussed in many studies. One of the popular strategies that widely use it is preventive replacement (PR), which aims to determine the optimum replacement time. The critical issue, however, is that most studies assume the aging (lifetime) of a component to be time dependent. In reality, the failure of a component is influenced by an external factor (covariate). This paper presents the process of revising or updating the PR time by considering external factors (the covariates effect) by using the proportional hazard model (PHM). The revised PR time is determined based on the age replacement model (ARM) and block replacement model (BRM). The effects of the revised PR time on the reliability cycle and cost reduction for both ARM and BRM are compared. The results show that the application of ARM is more beneficial in terms of cost saving, while the application of BRM results in a higher reliability cycle. A corresponding case study in the processing industry is presented.

Implementation of dust control system using management and planning tools (MPT): A case study

Purpose – To introduce a research carried out in a real world for implementing a dust control system (DCS) for controlling the indoor air quality (IAP) on the production floor of one of the major electronics company in Malaysia.Design/methodology/approach – The paper is arranged as follows, a brief description of the significant of DCS in electronic industry and brief introduction to the electronic company as a case study company for introducing the DCS. The discussion on the characteristics management and planning tools (MPTs) that have been adopted as the analysing tools for assisting in the decision‐making process in identifying the problems and improvement strategies. It follows by the detail analysis phase regarding the implementation process that it as backbone for introducing the DCS. Finally a discussion about the result obtained from the MPT analysis on the techniques for identifying the root causes of the dust pollution problem as well as the best improvement strategies that can be adopted by th...

Mechanical Properties of Friction Stir Processed 1100 Aluminum Reinforced with Rice Husk Ash Silica at Different Rotational Speeds

This paper presents a study on friction stir processed 1100 aluminum withincorporation of rice huskash derived, amorphous silica particles and fabricated at different tool rotational speeds. During friction stirring amorphous silica powder was placed into a groove made in the joining line of Al 1100 plates. Friction stirringwas performed with clockwise tool rotational speeds of 600 rpm, 865 rpm, 1140 rpm or 1500 rpm with a constant 45 mm/min travelling speed and a 2° tilt angle. High rotational speed (1140 rpm) facilitated material flow in the stir zone, contributing to fine aluminum matrix grain size (30- 10μm) as a result of dynamic recrystallization. Stirring at this rotational speed also caused the fracturingrelated refinement of silica particles to 10μm particle sizethat isassociated with good distribution in the aluminum matrix. Reduction in wear rate of friction stir processed Al1100 with improved hardness was believed to be due to the presence of hard silicawith high interfacial strength and high hardness of recrystallized aluminum grains in the stir zone.

Optimization Processing Parameter of 6061-T6 Alloy Friction Stir Welded Using Taguchi Technique

Taguchi approach was applied to evaluate the processing parameter to determine the most influential control factors which will yield better tensile strength of friction stir welded joint of 6061-T6 aluminium alloy. The processing parameters involved are tool shoulder diameter, in mm (18 ,20, 22), tool rotational speed, in rpm (410, 865, 1140), and feed rate, in mm/min (22, 32, 45). Taguchi parametric design and optimization approach was used. Through the Taguchi parametric design approach, the optimum levels of process parameters were determined. The results indicate that the shoulder size, rotational speed, and feed rate are the significant parameters influencing the tensile strength and hardness of the joint. The predicted optimal values of tensile strength 6061-T6 aluminium alloy is 321.16 MPa. The results was confirmed by further experiments, where the experimented values for tensile strength is 301.28 MPa.

Ageing Characteristics of Equal Channel Angular Pressed Al-Mg-Si Alloy

This study investigated the effect of severe plastic deformation (SPD) and artificial ageing treatment on mechanical properties of cast Al-Mg-Si alloy. 6061-T6 aluminum alloy was remelted and casted into a rod of 13mm in diameter and 60mm in length. The rod samples were then subjected to equal channel angular pressing (ECAP) for SPD process, up to 2 passes, through Bc route. Cast and ECAPed samples were solution heat treated at 530 °C, quenched in water and held at 180 °C at various ageing time to determine the effect of artificial ageing. Cast alloy consisted of α phase grains that were surrounded by Mg2Si particles locating at the grain boundaries. The hardness increased with accumulative applied strain by 2-pass ECAP process with the value of 99.4 Hv. For heat treated samples, maximum hardness was achieved after 5-hour ageing.

Comparison of friction stir and tungsten inert gas weldments of AA6061-T6

In this research, 6061-T6 aluminum alloys were welded using friction stir welding and tungsten inert as techniques in order to investigate the microstructure and mechanical properties. FSW of aluminium alloys has showed better mechanical properties compared to the conventional welding, tungsten inert gas (TIG). FSW weldment did not show any pores at the nugget zone compared to fusion zone in TIG weldment which produced a lot of pores.

Single Step of Binder Thermal Debinding and Sintering of Injection Moulded 316L Stainless Steel

Metal injection moulding was performed with gas atomized 316L stainless steel powders. Feedstocks were prepared using a paraffin wax/polyethylene/stearic acid binder system and subsequently molded into tensile bar specimens. Solvent extraction done at 80○C has shortened the debinding process to 30 minute. Single step of thermal binder debinding and sintering was done in a vacuum furnace. Sintering at 1380○C has reduced the porosity and associated with grain growth that result in an increase in ultimate tensile strength to 444 MPa while the elongation increased to 29% before fracture.

Friction stir welding of 6061-T6 aluminum alloy

Friction stir welding (FSW) is a new and promising welding process which can produce low cost and high quality joints of heat-treatable aluminum alloys. This is because it does not require the consumable filler materials and can eliminate some welding defects such as crack and porosity. The main objective of the present work was to evaluate the processing parameter of friction stir welding (FSW) process for 6061-T6 alloy and to determine the properties of the obtained joints. Experiments have been conducted by varying the friction stir welding processing parameter ; tool rotational speed, in rpm (410, 865, 1140) and feed rate, in mm/min (22, 32, 45). The shoulder diameter of the tool for FSW was 18 mm. Microstructure, microhardness and tensile properties were investigated in this studied. The results showed that there was a variation of grain size in each weld zone which depends on the material and process parameters of FSW in the joint itself. The coarsest grain size was observed in the heat affect zone (HAZ), followed by the Thermo Mechanically Affected Zone (TMAZ) and the nugget zone. The highest hardness was reported on the nugget zone and maximum tensile strength was obtained on the sample with processing parameter 865 rpm rotational speed.

Mathematical Model for Multi-Component Forces and Torque Determination in Friction Stir Welding

Major works concentrated on the energy conversion from mechanical friction work to heat; emphasized on the immediate contact surface of work material and rotating welding tool but with no in-depth analytical study to relate the loads that are transferred to the work material and the welding fixture especially at early stage of heat generation. In this work, a mathematical model is developed to predict three-dimensional force components and axial torque of the rotating tool based on contact mechanic principle in relation to Al6061 temperature-dependent material properties. The model shows the ability to be possibly adapted for different metallic material and physical properties. It suggests the exerted torque and loads calculation endured by work material involving friction and shear mechanism of two static-dynamic contacting surface; rotating rotational tool and the fixed work material, to be used as one of the option for optimization of the welding process such as to determine the ratio of slip, non-slip contact condition through comparisons of experimental and computer simulation on the Friction Stir Welding process.