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ELECTRICAL & ELECTRONIC ENGINEERING PROGRAM

FACULTY OF ENGINEERING

UNIVERSITI MALAYSIA SABAH

KE 30005
INDUSTRIAL TRAINING
SEMESTER 2 (2015/16)
INDUSTRIAL TRAINING TECHNICAL
REPORT

PREPARED BY:
Ramanan A/L Thangasalvam (BK13160570)

PREPARED FOR:
Dr. Ahmad Mukifza Bin Harun
Executive Summary

The company that I was assigned to undergo the industrial training with was RC
Precision Engineering Sdn. Bhd. which is a well establish company in the field of
engineering. The company processes include contract manufacturing, machine
parts fabrication, machine assembly, machine refurbishment, servicing and
maintenance, supply of technical man-power as well as manufacture of nonimplantable medical devices. Mr. Mohamad Faris Bin Rosli was assigned as my
Industrial Supervisor in RC Precision.
I was given training and tasks as per the training plan provided to me by the
Industrial Supervisor upon discussion with the Top Management. I was given task of
preparing the ISO documents of the company for the first two weeks which was
successfully completed. The next two weeks I was given the task of preparing the
technical documentation for European Commission CE Marking approval of the
WundPlusTM wound cleaning medical device developed by the company. The
technical documentation included the Technical file or also known as the Design
Dossier of the medical device as well as the product profile of the medical device.
From week 5 to week 8, I prepared the documentation for the approval for human
clinical trial with the device that are the Clinical Trial Protocol and the Investigator
Brochure. I was also exposed and trained on the Solidworks software and was
givens task of 3D designing a gear which was successfully done along with a
thermoflask bottle design. On week 9 I was sent to an external customer site to
assemble the main control panel for a ultrasonic surgical equipment cleaning
machine which was successfully done.
The training period was very brief was all activities or tasks had to be done
quickly for on-time completion as well as a lot of time was taken in preparing the
handwritten activity log. However, a lot of valuable knowledge applicable for future
use such as in my final year project as well as knowledge essential for future
employment success was gained. The weakness of the training can be solved by
increasing time span of the training as well as allowing a typed weekly summary
report instead of a written daily activity log which can be uploaded into the LI portal
of the engineering faculty. As an overall conclusion, the industrial training was a
2

success and provided very valuable knowledge both in terms of leadership as well
as technical qualities.
Title

Industrial Training Technical Report for the


Industrial Training at RC Precision
Engineering Sdn. Bhd. for Duration of 10
Weeks between 27th June 2016 to 2nd
September 2016

Acknowledgment

It was a great pleasure to have been able to do my industrial training in RC Precision


Engineering Sdn. Bhd. I would like to thank the management of the company for
giving me the opportunity to undergo my industrial training with the company as
well as for providing the platform and tasks as part of the training which was very
beneficial in enhancing my knowledge as well as allowing me to make-use of the
knowledge that I have learned from my degree.
Firstly, I would like to thank my parents for giving encouragement, enthusiasm
and invaluable assistance to me as well as being a supportive presence and
providing for my daily needs. Without all this, I might not have been be able to
complete this the industrial training successfully. Secondly, I would also like to
thank my Industrial Supervisor, Mr. Mohamad Faris Bin Rosli for supporting me as
well as guiding me through the industrial training as well as giving the industrial
based engineering knowledge that I need to strive in being a successful engineer.
Thirdly, I would like convey a special thanks to Dr. Razak Mohd. Ali Lee, Deputy
Dean (Student Affairs) as well as the Industrial Training coordinator for the Faculty of
Engineering of UMS, for giving me the opportunity to do my industrial training in the
company RC Precision by approving my industrial training application.
Lastly, I would like to express my deepest thanks to Dr. Ahmad Mukifza Bin Harun as
the industrial training advisory for the Electrical & Electronics Engineering Program
(HK02) who has helped me a lot in dealing with industrial training placement. He
had continuously followed up with me and my fellow course-mates on the status of
industrial training application until we all we successfully enrolled to respective
companies.

A single paper isnt enough for me too express my thanks and gratitude for all of
them. Finally I would like tho thank all others whose names I have not mentioned
but have played a role in my successful completion of the industrial training.
Table of Contents

Contents

Pag
e

Cover Page
Executive Summary
Title
Acknowledgment
Table of Contents
Chapter 1: Introduction
Chapter 2: Job training, experience and accomplishments
Chapter 3: Project Activities
Chapter 4: Critical Analysis
Chapter 5: Suggestion/Resolution & Conclusion
References/Bibliography
Appendices
Appendix A: RC Precision Organization Chart
Appendix B: Steris CaviwaveTM Ultrasonic Cleaning System Technical

1
2
3
4
5
6
11
13
37
39
41
42
42
43

Specification
Sheet and Structural Schematic
Appendix C: LI-2 Industrial Training Commencement Form
Appendix D: Industrial Training Plan

Chapter 1: Introduction
5

49
50

The name of the company is RC Precision Engineering Sdn. Bhd. The company is
located in the Free Industrial Zone at Bayan Lepas, Pulau Pinang. The company is as
fully Malaysia owned company. It was established in 1993 and was co-founded by
four of the company directors. The four founders are as follows where the Managing
Director of the company is Mr. Ravichandran A/L Manikam Achari, the Human
Resource Director of the company is Mr. Ong Yong Ching, the companys Business
Unit Director is Mr. Tan Ghin Seng and the companys Finance Director is Mr. Chew
Kai See. These are the four co-founders of the company RC Precision Engineering
Sdn. Bhd.
The company provides contract manufacturing and sub-contract manufacturing
services to local as well as foreign Original Equipment Manufacturing (OEM)
companies in assembly of components and machines. The company provides
services for the following industries which are the automotive, semiconductor
systems,

food

packaging

machinery,

processing

machinery,

ultrasonic

machinery,

bio-banking

and

glove

cleaning

medical

manufacturing
machinery,

devices.

The

machinery,

discrete

company

wire

component

also

provides

engineering services to local multinational companies in jig fixtures, equipment


design, fabrication, equipment refurbishment & servicing as well as manufacturing
and assembly of disinfection and surgical medical equipment cleaning device and
components.
Apart from just providing engineering services, the company also a big industrial
player in man-power supplies. The company also provides skilled manpower to
multinational companies in manufacturing field and to warehouse management
companies.
For the past two years, the company has begin to venture the industry of
medical devices. The company is in the process of producing its own medical device
which is a wound cleaning medical device with the proprietary name WundPlus TM.
The company has also in-place futuristic plans of expending its growth in the
medical device industry my designing and developing a fully automated Wound
6

Management System which is an automation system that allows wounded patients


to undergo wound cleaning effectively by means of robotic technology and is
pushing to complete the development of this system by 2020. The figure below
shows the core capabilities of the company.

The company has a wide range of technical personnel with the knowledge and
technical abilities to support the processes of the company and well as provide
quality services. The current number of staff in the company is 223 personnel all of
whom are Malaysians. The trained technical team of technicians and engineers are
well prepared with the skill of electrical assembly as well as mechanical assembly of
various equipment technology. The expertise of the companys personnel lye in the
are of high precision and high speed mechanical handling system, high precision
heavy duty main frame system, pneumatic (control system, value, manifold and
system configuration), main control electrical panels and control systems, PLC
7

system for industrial machines and functions as well as medical device design and
development. The figure below shows the employee chart of the company till 2013.
Now the employee count is 223.

The company has been certified with ISO 9001 Quality Management Systems
since the year 200 as well as certified with ISO 13485 Medical Device Quality
Management System since the year 2014. RC Precision Engineering Sdn. Bhd. was
listed by its German suppliers as a Tier One Automotive company in 2014. More
recently this year 2016, RC Precision received the SME 100s award for the category
of being the most innovative.
The vision of RC Precision Engineering Sdn. Bhd. is to acknowledge that service
excellence concept must be the key part of the organizations basic structure and
operation besides creating a long-lasting and trustworthy relationship with all their
valued customers. The mission f RC Precision Engineering Sdn. Bhd. is to maximize
customer satisfaction through the provision of quality filled services with value
8

pricing as well as on time delivery of product to customer. The company strives to


achieve its vision and mission.
The company has a large international client base namely in Italy, Germany,
United States of America, Japan, China and many more. The figure below shows the
assembly business model of the company.

I had undergone the Industrial Training at the Technical & Administration


Department of the company. I was assigned to work under the Assistant Manager of
the company which is Mr. Mohamad Faris Bin Rosli who was my Industrial Supervisor
during the period of my training. The activities that I carried out for the Industrial
Training was as stated in the training plan given by the Industrial Supervisor.

The scope of the industrial training tasks assigned by the Industrial Supervisor.
The objectives of the training was to complete the training criteria as stated in the
training plan and was to be obtain industrial experience in the field of engineering
for mechanical and electrical design and assembly as well as gaining technical
knowledge in the preparation of industrial documentation.

Chapter 2: Job training, experience and accomplishments

10

During the Industrial Training I was exposed to a variety of knowledge as well as


was able to apply the knowledge that I had gained from my degree course. I was
exposed to ISO standards which nowadays is an essential requirement for
compliance in companies and other organizations. I was able to gain knowledge on
the ISO 9001 standard such as that which UMS is certified with as well as the ISO
13485 standard. This knowledge was gained when I did the companys ISO
documentation for all its processes.
Apart from the knowledge on ISO standards, I also gained the knowledge on
medical device requirements, types and characterization of medical devices and
other medical device related information. This was possible by my task on doing the
technical documentation for the medical device that is being made by the company
which is a wound cleaning medical device called WundPlus TM. I was able to learn the
concept and principle of operation of the device. I was also able to troubleshoot the
device in term of its output pressure as well as calibrate and set the output pressure
of the device to the optimum pressure value. The detailed information on this is
discussed in Project Activities chapter. I was also able to understand the
requirements for subjecting a medical device to a clinical trial on humans. This was
possible when I did the task of preparation of Investigator Brochure as well as
Clinical Trial Protocol for the WundPlusTM medical device which was assigned to be
by my Industrial Supervisor. I used my mathematical knowledge on Numerical
Methods as well as Probability and Stochastic Processes to mathematically
determine the human subject population size for a clinical trial. Probability as well
as Gaussian distribution methods were used in the population size estimation which
is discussed in more detail in the Project Activities chapter.
I was also briefed on how the logistics system of the company works. The
processes for customs declaration of goods during in-coming and outgoing of
shipment was explained to me during the Industrial Training.

11

I was also exposed to the basic knowledge of 3D designing using the software of
Solidworks. I was taught on the functions available in Solidworks as well as the use
of the basic shapes in Solidworks to design simple as well as complex structures. I
was assigned to create a customized gear design using Solidworks as well as a
thermoflask bottle. The 3D design of both the gear and thermoflask bottle were
completed successfully. I was able to understand the basic uses of the shapes as
well as the steps to create these designs beginning from a simple 2D sketch to a
complex extruded 3D design.
I was briefed on the use of PLCs (Programmable Logic Controllers). I was taught
on the types of PLCs available in the market and those most commonly used in
industries. Asian countries were said to commonly use PLCs manufactured by
Mitsubishi, Omron, Keyence and Panasonic whereas companies in Europe as well as
the USA commonly use Allen Bradley PLCs. I was also taught on how to do a PLC
ladder program and the structures used in to wire a PLC ladder.
Finally I was exposed to the assembly of a main control panel for a ultrasonic
cleaner system for cleaning hospital surgical equipment. I gained the knowledge of
the components available in industrial machines. Moreover, I also learned how to
determine the gauge of the wire needed as per the maximum amperage of a
machine. In other words, I gained the knowledge of industrial machine assembly.

Chapter 3: Project Activities


12

eek(s) :

1 to 2

1. Location
All activities for the first week and second week of industrial training was carried out
at the industrial training company at Bayan Lepas, Penang. No off-site work had
taken place during the first two weeks.
2. Activity/Task
On the first day of training, I was briefed about the company and its scope of
operation by the company human resource staff. I was then introduced to my
industrial supervisor who was assigned to had a discussion guide me through the 10
weeks of industrial training. I got the signature of industrial supervisor for the LI-2
for as part of proof of reporting for duty on the day as stated by UMS. We discussed
on the training plan and the supervisor had set the training plan for me.
As per the training plan provided by the industrial supervisor, I was assigned the
task to do the ISO (Internal Standards Organization) documentation for the company
for the first two weeks. The standards that the company is certified for is ISO 9001
which is the standard for Quality Management System and ISO 13485 which is the
standard for Medical Device Quality Management System which is required for the
company as it produces medical devices. Both the standards have undergone major
changes to newer versions. The earlier standard changed from the 2008 version to
2015 while the latter standard changed version from its previous version in 2003 to
the most current version in 2016. The companys ISO documents have to be up-todate to support the processes of the company and to ensure all processes are
carried out effectively as well as ensuring product quality. The medical device
standard is essential for the company as the company is prototyping a wound
cleaning medical device. For manufacturing and marketing medical devices,
compliance to the medical device standard is a must.

13

3. Procedure/Methods
The documents were changed by refering to the new versions of the ISO 9001
and ISO 13485 standards. The new versions were compared with the previous
version to understand the changes. The required changes were then noted
down. The figures below show the two standard that were refered.

4. Result/Achievement

14

All the major documents were changed. The new version of the ISO 9001
standard stresses more on the risks for all processes as well as external
process controls such as the control of supplier of assembly and production
parts. Risk assessment was done for all processess and the relevant plan of
action for all risks were determined. All other ISO 9001 changes to documents
were made.
The medical device standard has additional requirements on medical
device design controls. The design procedure was re-design and included all
the new requirements such as design changes control, design transfer, design
history file. The design changes control is essential to ensure that changes
made to the design are continuously recorded and the latest design made
available. This will help to ensure analysis of design related issues. The
design transfer is required for transferring design records to the production
site for mass production purposes. Design transfer ensures that the latest
design and specifications including the latest methods and instructions of
assembly are provided to the production. Finally, the design history file is a
file that will contain all the design information each particular model of
medical device. All relevant changes as noted were made to the documents
where relevant to the ISO 13485 standard.
I also designed the proper design and development process flow for the
company as per the FDA (Federal Drug Authority) of the United States of
America (USA) Design and Development Guidance Document. The design and
development flow is as seen in the figure below.

15

16

5. Conclusion
All the company document were changed as required to suite the latest versions of
the ISO 9001 and ISO 13485 standards. I had gained a better understanding on the
processes of the company both in-terms of administrative processes as well as
technical processes. The task was completed as planned.
eek(s) :

3 to 4

1. Location
All activities for the tasks assigned on the third and fourth weeks of industrial
training was carried out at the industrial training company at Bayan Lepas, Penang.
No off-site work had taken place during these two week.
2. Activity/Task
For the third and fourth weeks as per the training plan, I was given the task of
preparing the technical documents for the medical device manufactured by
the company which goes by the proprietary name of WundPlus TM. The
company is manufacturing a wound cleaning device and plans to go for CE
marking which is product certification with European Commission recognition.
For CE marking a product profile as well as a technical file is needed. The
technical documentation is required for the device as in the figure below.

17

3. Procedure/Methods
For the preparation of the technical documents especially the Technical file,
the European Medical Device Directives (MDD 93/42) requirements for the
Technical file was reviewed. As well as the European MEDDEV guidance
documents were also reviewed.
I also had to understand the device related information to be able to do
the Technical file. Thus I understood the design layout, the electrical and
mechanical schematics as well as the complete technical information of the
medical device. The device was a prototype and required inspection to ensure
it functions as intended.
The device is a wound cleaning medical device and as stated above it
goes by the proprietary name of WundPlus TM. The device uses saline solution
that is better known as solution of sodium chloride that is subjected on the
wounds of patients at high pressure to clean debris and pathogens off the
wounds for ease of wound treatment. The pressure of the device is provided
by a medical air compressor as in the figure below. This air compressor is
supplied together with the machine.

18

However, the company was yet to do further research on the safe


pressure range that can be subjected on the human wound. Too high
pressures may be harmful to the human tissues as well as too low a pressure
may be ineffective in cleaning debris off the wound. Hence, I studied and
reviewed literature and existing clinical data related to pressurized wound
cleaning to undertsand the suitable pressure range that should be set for the
device for the wound cleaning. Also I had to test the device output pressure
and record the reading to ensure that the device output pressure is within the
optimum pressure range.
4. Result/Achievement
The Techical file successfully completed as per the European requirements.
The product profile which is a simplified version of the Technical file was also
successfully completed in the given time frame.
I also reviewed a significant amount of literatures as well as clinical data
to find the optimum pressure range. As per the reviewed data, the optimum
pressure range was determined to be between 4 psi to 15 psi. Psi is also a
19

unit of pressure similar to Pascal (Pa). Psi is also known as pounds per square
inch. 1 psi is equal to 100000 Pa or 100 kPa or also 0.1 Mpa.
Finally, I had to inspect and test the medical device. The device was
inspected and no issues were found with the functionality of the electrical
and mechanical components such as the relays, peristaltic pump, blow valve,
solenoid valve, flow sensor or meter as well as the air regulator. The output
pressure of the device was also tested to ensure the value of pressure coming
out of the output nozzle. Since solution of saline sprays out of the nozzle at a
high pressure, thus, also having speed, the pressure was calculated using the
followinf fornula, P = pv2/2, where P is the output pressure, p is the density of
the solution or liquid that is in the units of kg/m 3 and v is the speed of the
pressurized jet lavage of the solution coming out of the nozzle that is in the
unit of m/s. An anemometer that is a device that can meassure air speed was
used to measure the speed of the solution coming out of the nozzle. The
density of the solution is known from the supplier of the solution. Using these
information as well as the stated formula, the output pressure was
determined, recorded and tabulated. The pressure was found to be exceeding
the optimum range where the results that were obtained were between
pressure of 25 psi to 30 psi. The input pressure was reduces and the output
pressure tested again to determine its value. The input pressure was
continued to be reduced and output tested as means of calibration and
troubleshooting until the range of input pressure to obtain the optimum
output pressure was determined.
5. Conclusion
As a conclusion, I learned the European medical device requriements as well
as got to understand the device and its principle of operation. I also had the
chance of troubleshooting the device to get the desired output pressure. The
task given was successfully completed.
eek(s) :

5 to 8

20

1. Location
All activities for the tasks assigned between the fifth to eight week of industrial
training were carried out at the industrial training company at Bayan Lepas, Penang.
No off-site work had taken place during these four weeks.
2. Activity/Task
During the previous two weeks, the wound cleaning device was inspected,
tested and calibrated. The company then wanted to send the device for
clinical trial conduction. However, for clinical trial to be conducted, the
company has the apply to the Clinical Research Centre as well as to get the
approval of the Medical Research Ethics Committee (MREC). To do so some
essential documents need to be prepared to be submitted to the CRC and
MREC for review and approval. Two major documents that is a must for
submission are the Investigator Brochure and the Clinical Trial Protocol. I was
given the task by the company to prepare these two documents for the
submission.
I was also exposed to the basics of solidworks and was though of how to
design solid parts. I was then given the task of designing a 3D object using
Solidworks.
3. Procedure/Methods
The Investigator Brochure was designed based on reference with the ISO
14155:2011 standard for Clinical Investigation of Medical Device on Humans
Subjects and Good Clinical Practices. The guidance for Investigator Brochure
preparations is given in Annex B of the standard.
The Clinical Trial Protocol was prepared from the guidance document
available on the website of the Clinical Research Centre (CRC). However, the
human subject population size for the clinical trial need to be estimated to
obtain a high chance of success in the clinical trial results. The population
21

size was determined using the method of probability and standard normal
distribution or Gaussian distribution.
Finally, as part of the task for 3D part design in Solidworks. I had designed
a gear using the basic shapes in Solidworks. First the gear was sketched
using the shapes. After sketching the shape of the gear, the gear sketch was
extruded from the middle point of the reference axis to produce the 3D shape
of the gear. Apart from designing a gear, I also designed a 3D thermoflask
bottle and a bottle cap as well as joined the two 3D parts using the part
assembly

in solidworks. The two 3D parts were joined using the mate

function in the part assembly.


4. Result/Achievement
The Investigator Brochure was completed for the medical device of the
company and was compliant to the Annex B of the ISO 14155 standard. The
Clinical Trial Protocol was also completed as per the guindance document of
the Clinical Research Centre of Malaysia. The population size of study subject
were also mathematically calculated. The calculations were as studied in the
degree subjects of Numerical Methods as well as Probability and Stochastic
Processes.
The clinical trial is to compare between the two ways of wound cleaning that
is by the conventional method of Swabbing (control group) and the
WundPlusTM device (investigational group). Two hypotheses are formed,
which are the null hypothesis which states that the mean amount of
resources used for the WundPlusTM is more than or equal to that used in
Swabbing and an alternative or research hypothesis that states that the
mean value of resources used for the WundPlusTM is lesser compared to that
used in Swabbing.
There are two types of decision errors that can be made that are the Type
I error and the Type II error. The Type I error occurs when the WundPlusTM is
said to consume less resources compared to Swabbing while this statement is
22

false and the vice versa is true, thus, the null hypothesis is rejected in this
type of error. The probability of making a Type I error is also known as an
Alpha-error and is denoted by the symbol. The Type II error occurs when
the WundPlusTM is said to consume more resources compared to Swabbing
while the statement is false and the vice versa is true. The probability of
making a Type II error is also known as Beta-error and is denoted by the
symbol. In this case for Type II error, the null hypothesis is accepted. The
probabilities of these two types of errors factor heavily into all sample size
calculations for the hypothesis tests
For the power consideration of the study, the statistical power for the
study is defined as the probability of rejection of the null hypothesis when it
is false, in other words, it can be mathematically represented as 1 - .
The following formula was used in the estimation of population size for the
trial:
N > [ Z(2PQ) + Z(PiQi + PcQc) ]2
D2
N indicates the sample size for each study group. In this case, we have two
study groups which are the control group (Swabbing) and investigational
group (WundPlusTM), thus, the each of the two groups will have N number of
subjects. Z and Z are the standards normal distributions or Gaussian
distribution variants also known as Z scores related to (Type I error) and
(Type II error) respectively. The values of Z and Z can be obtained from the
Standard Normal Distribution Table of Z scores. Pi is the probability that the
WundPlusTM uses less resources as compared to Swabbing while Qi is the
probability as opposed to Pi and both are related by the equation, Qi = 1 - Pi.
Pc is the probability that Swabbing uses less resources as compared to the
WundPlusTM while Qc is the probability opposed to Pc and both are related by
the equation, Qc = 1 - Pc. D is the difference between Pi and Pc, thus, can be
expressed as, P = Pi - Pc. The two other variable in the formula are P and Q
where P is the mean probability of using less resources, thus, can be
23

expressed as, P = (Pi + Pc)/2. Similarly, Q is the mean probability of using


more resources, thus, can be expressed as, Q = (Qi + Qc)/2.
To enable estimation of the population size, it is required that we
reasonably assume the values of and . By convention, is given the value
of 0.05, i.e., the chance of rejecting the null hypothesis when it is true is 1 in
20. The determination of depends on the claim for the device. In the case
that the WundPlusTM medical device is to be proven to be more efficacious
compared to Swabbing, the value of has to be less restrictive (than higher)
as compared to ( > ). However, it should never be greater than 0.20.
Hence, the value of was set as 0.15.
Upon obtaining the values of and , their respective Z scores were
determined from the Standard Normal Distribution Table. The corresponding
values of Z and Z are determined. First Z was determined form the table
as seen below. was set as 0.05 and as seen from the table, the closest
value to 0.05 is 0.0494 as indicated by the arrow. The corresponding value of
Z was then found to be -2.58 as indicated by values circled in red.

The value of Z was similarly determined. From the table below, the
value closest to 0.15 (value of ) was determined to be 0.14917 as indicated
by the arrow. Thus, the corresponding value of Z was found to be -1.04 as
indicated by values circled in red.

After obtaining the values for Z and Z, assumptions were made on the
values of Pi and Pc. Since the desired outcome is for WundPlusTM to use
lesser resources as compared to Swabbing, the value of Pi shall be higher
24

than Pc. Therefore, the values for Pi and Pc were assumed to be 0.85 and 0.7
respectively. With the values of Pi and Pc available, the values of Qi, Qc, D, P
and Q were obtained from the relations as mention earlier. Qi and Qc were
found to be 0.15 and 0.3 respectively, D was found to be 0.15, whereas, the
values obtained for P and Q were 0.775 and 0.225 respectively. The value of
N was then calculated by substituting the values obtained for all variables in
the formula above.
N > [(-2.58)(2(0.775)(0.225)) + (-1.04)((0.85)(0.15) + (0.7)(0.3)) ] 2

>

201.22 202
(0.15) 2
The numerical value for the number of subjects in each study group, N,
obtained was 202 subject per study group. Since two study groups are
involved in the study, each study group will have 202 subject and the total
number of subject for the clinical trial will be 404 subjects.
The statistical power is calculated to be, 1 - = 1- 0.15 = 0.85 = 85%
The statistical power is high enough to ensure that the null hypothesis is
successfully rejected, thus, having an increased chance for success in the
clinical trial results. This is how the population size was estimated.
The figure below show the 3D gear that I had designed using Solidworks.

25

The figure below shows the thermoflask bottle that I had designed using
Solidworks.

The figures below shows the thermoflask bottle-cap that I had designed using
Solidworks.

26

The figure below shows the complete thermoflask bottle & bottle-cap
assembly that I had done on the part assembly in Solidworks. The bottle and
bottle-cap were joined using the mate function in the Solidworks part
assembly.
27

5. Conclusion
I was able to understand the requirements for testing a medical device on humans
and the relevant steps that need to be taken as well as the documents needed for
conducting a medical device clinical trial on humans by having succesfully
completed preparing the Investigator Brochure as well as the Clinical Trial Protocol.
Moreover, I was able to apply my undestanding on the mathematical subjects that I
had learned in my degree course to calculate the human study subjects population
size as seen in the results section where methods from Numerical Methods as well
as Probability and Stochastic Processes were used to numerically estimate the
population size as well as estimate the chance of success of the clinical trial when
the calculated population size is used. I was also able to understand the use of
Solidworks and create 3D objects and assemblies as desired which may be helpful
for the future such as for my final year project. The tasks and activities for this
period was successfully completed.

eek(s) :

28

1. Location
I was sent out to an external customer site at Autocity Juru, Penang. The
name of the customer company is Advanced Ceramics Technology (ACT) or
also more famously known as Crest Ultrasonics.
2. Activity/Task
The company that I had done my Industrial Training which is RC Precision
Engineering had been handed the project for assembly of several machines
types produced by the company. However, assembly process has to be
carried out at the customers location due to the strict controls of the
customer not to allow their design and production procedure from being
leaked out. I was assigned to assemble the control panel for one of the
machines assembled by my industrial training company which was the Steris
Caviwave Pro Ultrasonic Cleaning System as seen in the figure below.
R

Steris Caviwave R Pro Ultrasonic Cleaning System


R

29

The machine is used to sterilize surgical equipment and implants by means of


micro-mechanical

scrubbing

using

high

frequency

ultrasonic

waves.

Ultrasonic cleaning at higher frequencies creates an abundance of minute


vacuum bubbles which allow for cleaning to occur. These bubbles implode on
and inside surgical device surfaces in a process defined as cavitation. This
micro-mechanical scrubbing action is able to reach small crevices, irregular
surfaces, and internal passages to ensure proper and consistent cleaning. As
mentioned earlier I was given the task of assembling the main control panel
for the machine. The time frame taken to assemble the control panel was
around 5 days. I was briefed on the main control panel design layout by the
customer representative before beginning the assembly process.
3. Procedure/Methods
On the first day after the control panel design and layout brief, I went through
the design layout myself to make-sure I really understand the layout so that
no or minimal errors are made. After understanding the layout, I begin the
control panel design by cutting the din rail that is used to place the
component on the control panel. The din rail is as seen in the figure below.
Upon cutting the din rail, stud welding was done on the panel frame
which was then followed by drilling and tapping for drilling holes and tapping
with the required tap size of screws for attaching with the main machine
structure after component placing and wiring is done. Size of screw and
fasteners follow the American ANSI standard, thus, is stated in inches. The
drill bit size used for drilling is 3.4mm and for a related drill bit size the
corresponding tap size used is 8.32 inches. The stud welding and drill and tap
are as shown in the figure below. A connector for 3-phase power supply was
also stud welded onto the main control panel metal frame which can also be
seen in the figure below.

30

Stud

Din

3-phase power supply

Drill &

On the second day, I had to place the components of the ultrasonic


cleaner machine main control panel as per the design layout. The control
panel consists of the components as in the figure below and uses PLC
(programmable logic controller) as its main controller. PLCs are widely used
controller in the automation industry and for the Steris machine the PLC used
was the Mitsubishi PLC. A miniature memory caset is inserted into the PLC at
a designated slot on the PLC. The memory caset is used to store the PLC
program, in other words, it acts similar as a memory card. A fully labelled
figure of the main control panel can be found in the Results/Achievement
Section.

31

As can be seen in the figure above, Screw Clamp Din rail terminal blocks
were used in then control panel. The screw clamp terminal blocks are spring
loaded and designed to guarantee electrical continuity even when screw are
loosened unintentionally. The main benefits of this type of terminal block is
that it maintains the circuit continuity due to the presence of the pull-out
proof cable termination combining spring loaded terminal and hook type
ferrule. The connection is also vibration proof. Space is also saved in the
control panel using this type of terminal block. End-plates are used to
separate terminals with different uses and functions so that they do not
contact each other which can damage the machine function. Stopper are
used to hold the component on the control panel frame tightly so that they
are static and do not move or become disorientated when moved.

32

Contactors are used in the main control panel. A contactor is an


electrically controlled switch used for switching an electrical power circuit,
similar to a relay except with higher current ratings. The maximum amperage
of the Steris machine is 33 amperes, thus, for high current function of the
machine the contactor is used. A contactor is controlled by a circuit which has
a much lower power level than the switched circuit. Contactors come in many
forms with varying capacities and features. Unlike a circuit breaker, a
contactor is not intended to interrupt a short circuit current. Contactors range
from those having a breaking current of several amperes to thousands of
amperes and 24 V DC to many kilovolts. The physical size of contactors
ranges from a device small enough to pick up with one hand, to large devices
that are approximately a meter on a side. Contactors are used to
control electricmotors, lighting,

heating, capacitor banks,

thermal

evaporators, and other electrical loads. A single pole relay is also used in the
control panel and is connected to the panel using the relay base that is
attached to the din rail.
Another component used was a door switch that was stud welded juz
below the PLC. The door switch is used for saferty purposes. The door switch
has three configuration that is common, normally closed and normally open.
The door switch is set as normally open when the control panel door is
opened and is set to normally closed when the control panel door is closed,
this is to ensure safety of user in the case the user opens the panel door
when the machine in ON. For purpose of inspection of the machine while it is
ON, the door switch can be set to common to allow the machine to be ON
even when the panel door is open. A buzzer alarm is also connected to the
main control pannel.
On the third day, I had to do the wiring for the main control pannel. The
wiring was done as seen in the above figure and complete wiring is as in the
figure in the results section. The maximum current in the machine is 33
amperes, thus, the gauge of the wire used was determined from the table as
in the image below. As can be seen for a maximum amperage of 33 amperes
the ampacity as in the below figure is set as 40 amperes. At ampacity of 40
33

amperes the american wire gauge (AWG) used in 8 AWG and the wire
diameter is 10 mm2. Connections were done for the PLC input and output as
well as other connection for all the components. The wiring colour also
follows the american wire colour code where black colour is for power, red
wire is for 110 VAC supply, blue wire is for 24VDC supply, 0 VDC is wired
using the white-blue wire strip. White wire is used for the neutral connection
of three-phase or single-phase supply. The ground connection is made using
the green wire or at times ground connection can be made using the greenyellow wire.

On the fourth day, I had to prepare the overlay for the Steris machine
control panel door front which is as seen in the figure below. The overlay is
actually the fron cover of the machine which was pasted onto metal frame
34

using M3 glue which is used to stick metal and other material on another
metal surface. The overlay consists of the company name and machine name
as well as the label of the function of the push buttons.. After placing the
overlap, the front of the control panel door was cover with tape as seen in the
figure below to protect from dust. A touch scree monitor was installed on the
control panel door. The monitor seen on the front cover is the Pro-face touch
screen panel. A Pro-face touch screen is also used for easy user interface for
using the Steris machine. The wire connections for the two momentary push
buttons were also made. One push button is for ON/OFF function whereas the
other push button is for activating the touch screen. Upon making the
connection, the push buttons were then installed on the front of the control
panel door.

On the fifth day, the any remaining wire connections were made and the
wire connections were first checked by me for any error or misconnection as
well as any missed connections. I did the checked refering to the design
layout. After I had checked the connections, the supervisor and senior
production officer verified my connections. The connections were verified to
be correct and the panel was ready for installation.

35

4. Result/Achievement

Terminal
Block

PLC & Contactor


Connection

Buzzer/Al
arm

Stoppe
r
Groundi
ng
Neutr
al

PLC

Single Pole
Relay
Contac
tor

Door
Switch
Alert Read
Screen Push
Button

Main Power
On/Off Push
Button

Touch Screen TTL


Connection

36

The resulting final and complete connections is as seen in the figure above.
The complete main control panel comprises of the components as labelled
above and as discussed in the procedure section which is the PLC, contactor,
single pole relay, screw clamp terminal blocks, high voltage connector for
three-phase, TTL connection for touch screen, normally open momentary
action push buttons, buzzer alarm, door switch etc. The panel is ready to be
assembled with the full metal frame with all the mechanical components.

37

Main
Disconnect

The main control panel was then connected to the machine. The structure
of the machine upon installation of the control panel of the Steris Caviwave
Pro Ultrasonic Cleaning System is as seen in the figure above. The arrow in
the figure indicates the main disconnect which is used as a safety measure to
disconnect the three-phase supply to the main control panel.

38

5. Conclusion
Completed the task given by supervisor and company production leader. Main
control panel for the Steris Caviwave Pro Ultrasonic Cleaner System was completed
in just less than one week. Connection were done properly and got positive
feedback from production leader and supervisor. However, the main control panel
design layout was not allowed to be taken and was not included in the report. Only
the dimensional diagram was provided. Successfully completed the given task.

Chapter 4: Critical Analysis

39

There was two major weakness to the Industrial Training. The first major weakness
of the training was the time frame for the training in that it was too short. Tasks
were required to be completed as fact as possible to be able to complete the tasks
within the 10 weeks time frame. Moreover, the daily log book was the second
weakness of the training whereby for each day one hour was needed to be spent
just to prepare the daily activity log this is because the activity log needs to be
handwritten and then we need to get the signature of the Industrial Supervisor as
part of verification of the daily log. The Industrial Supervisor will have to review my
report first before signing my activity log for each single day. In other words, the
daily activity is time consuming and that time can be used for doing the jobs or
tasks assigned during the industrial training.
There were several strengths from the Industrial training, especially in terms of
the knowledge gained. The industrial training enabled the chance of exposure to
industrial based knowledge which is essential when university student enter the
employment phase of life. The experience gained during this industrial training will
be very helpful when applying for jobs as the knowledge gained can be included in
my curriculum vitae.
Moreover, the knowledge such as the knowledge of using Solidworks that was
gained during the industrial training will be very helpful for my final year project. I
can use my knowledge of 3D designing using Solidworks to create the required solid
structures of specific dimensions for my final year project and I can use a 3D printer
to print the designed structures which I can then later use to assemble by project.
This knowledge can also help me when I pursue a job after completion of my study
as most engineering jobs require knowledge of software nowadays and one of the
most common Software knowledge that engineering companies seek in their
employees is knowledge in design software such as AutoCAD and Solidworks.
The mos significant strength of the industrial training was that it enabled me to
test my knowledge that I had gained thus far from my studies in UMS. I was able to
apply my knowledge in Numerical Methods as well as Probability and Stochastic
Processes in estimating population size of human study subjects when I prepared
40

the Clinical Trial Protocol during the industrial training. Moreover, I was able to use
my electrical knowledge while reading electrical diagrams as well as electrical
schematics of industrial machines and other electro-mechanical devices. This was
relevant when I was assigned the task for the assembly of the main control panel of
the ultrasonic surgical equipment cleaning machine where I had to understand the
design layout of the control panel as well as the wiring schematics of the machine
which I had successfully done, thus, enabled me to complete the assembly as well
as the wiring of the main control panel within one week.
Overall, the Industrial Training was suitable and relevant with the engineering
knowledge that I had gained from my degree. The Industrial Training was very
beneficial as I was able to gain more valuable and essential engineering knowledge
as well as leadership qualities from the training. I was also given allowance for the
Industrial Training which was also an added benefit of the training.

Chapter 5: Suggestion/Resolution & Conclusion

41

The weaknesses of the industrial training are as stated in the Critical Analysis
chapter above. Two weakness were identified which was the short time span of the
industrial training which is only for 10 weeks and the second weakness was the time
consumption of the handwritten daily activity log.
The first problem can be solved by dedicating more time for industrial training
at least for a time frame of three months which can be done during the end of the
eighth semester. However, this is not for me to decide but decision is to be made by
the course level industrial level coordinator and the UMS Engineering Faculty
industrial training coordinator, all I can do is to provide a suggestion.
The second problem can be solved by implementing a weekly summary report
of all the activities done for the whole week. This will enable students to minimize
the time in writing the report and they can focus dedicate more time in completing
the assigned tasks as the industrial training time frame is already short. The faculty
can also develop typed weekly report format so that student can type the weekly
summary report instead of writing in and if possible the student can be asked to
upload the weekly report on the sktm.ums.edu.my/li platform and a deadline for
uploading the weekly report can be given, for instance, a deadline for weekly report
submission by Friday 11.59 pm of every week. This will help avoid delays to the
report submission and reduce the required paperwork to be submitted.
Overall the industrial training was very good especially in terms of the exposure
to new knowledge as well as being able to test the knowledge I had from the degree
course. The organization RC Precision Engineering was very supportive and
dedicated in the provision of the training. Instilling leadership and technical
industrial knowledge was their main goal. The tasks given by the organization were
challenging as well as required a lot of time as well as a lot of read-up and technical
understanding to complete. However, the tasks were able to expose me to the
actual practices in industries. My Industrial Supervisor was a very supportive and
knowledgeable presence as well as helping me throughout the Industrial Training. I
was also given allowance by the company for my work which was an added bonus
from the industrial training apart from the knowledge gained.

42

As a conclusion, the Industrial Training was successfully completed as were the


tasks given by the company. The visit of the UMS Academic Visitor was also
successfully completed and the relevant forms which are LI-3A, LI-3B, LI-3C as well
as LI-3D were provided to the UMS visiting lecturer. The industrial training technical
report as well as all necessary documents were completed and ready for
submission.

References/Bibliography

43

1. Industrial Training Handbook 2014 Edition, Faculty of Engineering, University


Malaysia Sabah.
2. RC Precision Engineering Company Profile
3. RC Precision company website http://www.rcprecision.com.my/qualitysystem.
4. Steris company website https://www.steris.com/products/ultrasonicwashers/caviwave-proultrasonic-cleaning-system.

Appendices

44

Appendix A: RC Precision Organization Chart

Appendix B: Steris CaviwaveTM Ultrasonic Cleaning System Technical Specification


Sheet and
45

Structural Schematic

46

47

48

49

50

51

Appendix C: LI-2 Industrial Training Commencement Form

52

Appendix D: Industrial Training Plan

53