KP 2-3 (4622)

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INSTITUSI LATIHAN
KEMAHIRAN BELIA DAN SUKAN

KERTAS PENERANGAN
(INFORMATION SHEET)

KOD DAN NAMA EE-021-4:2012 ELECTRONIC PRODUCT DEVELOPMENT
PROGRAM /
PROGRAM’S CODE & NAME

TAHAP / LEVEL 4 SEMESTER 6

NO DAN TAJUK UNIT CU:03 ELECTRONIC PRODUCT QUALITY ASSURANCE
KOMPETENSI /
COMPETENCY UNIT NO.AND
TITLE

KOD DAN NAMA DED4622ELECTRONIC PRODUCT QUALITY ASSURANCE
SUBJEK/SUBJECT CODE
AND NAME

NO. DAN PENYATAAN 1. PREPARE ELECTRONIC PRODUCT QUALITY ASSURANCE
AKTIVITI KERJA / WORK REQUIREMENTS
ACTIVITIES NO. AND
STATEMENT 2. VERIFY PRODUCT COMPLIANCE REQUIREMENT
3. PRODUCE AUDIT REPORT

KOD WIM EE-021-4:2012/CU:03/KP(2/3)

TITLE : IDENTIFY PRODUCT COMPLIANCE REQUIREMENT
PURPOSE
: TO OBTAIN KNOWLEDGE ON COMPLIANCE REQUIREMENT
FOR ELECTRICAL AND ELECTRONIC PRODUCTS

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INFORMATION:

1. PRODUCT QUALITY IN MANUFACTURING PROCESSES

Product quality and reliability is built in during the manufacturing processes. Quality is
controlled by paying particular attention to the following points in order to prevent latent
defects in devices.

(a) Incoming Inspection
The quality of raw materials used in manufacturing processes must be confirmed to maintain
product quality and reliability. The following activities are performed to ensure this.

 Selection of manufacturers of raw materials used in manufacturing processes
together with regular meetings

 Incoming inspection for all raw materials

Materials that have not been inspected are not used in mass production. The main items
subject to incoming inspection are shown below, together with inspection methods.

(b) Process Control
Control points are determined within the actual manufacturing process to ensure that quality
is an integral part of the process. Process control involves specifying these control points
and control methods. The output is checked from key processes, and this data is subjected
to variation control using Statistical Process Control (SPC). The data is feedback continually
to support improvement activities.

Another key element of process control is manufacturing plant control. Manufacturing plants
are controlled through daily and periodic inspections, and the inspection results are used to
implement continuous improvements that enhance preventive maintenance.

Flowcharts are shown for a wafer process and typical FCBGA/PFBGA package assembly
process to illustrate manufacturing process quality control more clearly. The flowcharts are
used to create flow forms for each product, which are then used for control and
manufacture.

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EXAMPLE 1 :FLOWCHART FOR WAFER PROCESS

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EXAMPLE 2 :FLOWCHART FOR PFBGA PACKAGE ASSEMBLY PROCESS

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(c) Statistical Process Control (SPC)

SPC control is applied to special characteristics to determine the extent of variation within
manufacturing processes and to identify fluctuations in the early stages. The data obtained
is then fed back to the process to assist with process maintenance control.
SPC optimizes individual processes and process types to achieve consistent product quality.
A typical control chart is shown below.

Clicking on this alarm point in the system allows inspection of the defect status. This defect
status isretained as a record. The display can be switched from time-based to machine
number display, reducing thetime required to detect and resolve problems and ensuring
consistent process control.

(d) Operator certification
Employees involved in manufacturing processes are subject to operator certification.
Workers undergo training in various operational details and are allowed to participate in
actual operations only after certification and confirmation for the specified level of the
certification test. Workers are recertified annually to maintain worker skills.

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2. PRODUCT TRACEABILITY
Lotnumbersareprintedon thefrontofthe packageorincludedon chip tray labels.Note
thatlotnumbersmay be simplified ifthepackagesizelimitsthe
numberofcharactersthatcanbeprinted.Tracingisstill possibleeven withsimplifiednumbers.

<Typicallot numbermarked on package> (8) (9)
(1) (2) (3) (4) (5) (6) (7)

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<Key>
(1) Epsoncontrolcode
(2)(3)Manufactureyearcode: Lasttwodigitsofyear

(2003 in thisexample)
(4) (5)Manufacture week code: WeekcountedfromfirstThursday

ofmanufacture year
(in accordance with ISO8601)
(Week 9 in this example)
(6) (7) (8) (9)Epson control codes

This code allows tracing of manufacturing history and raw materials. The scope of
traceability is shown below.

Scope of tracebility Versi 2.0 (2016)

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3. PROCESS CHANGE CONTROL

Process improvements are performed on a daily basis in the mass production phase to
achieve even better productquality and reliability and to improve productivity. Accordingly,
process changes are unavoidable in such cases.Process change plans are prepared in
advance by the originating section, after which the plan and evaluationdetails are examined
by the multi-functional team, which determines whether the customer must be notified.
Thechange is implemented following evaluation and confirmation that there are no effects
on the product. Thisenables process control and quality.

Process changes deemed to affect quality and reliability for the customer are reported in
advance to the customerfor approval.

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4. PLANT AND MEASURING EQUIPMENT CONTROL

(a) Plant Control
Equipment used in manufacturing processes is rigorously inspected following selection for
the relevantprocess. Equipment accuracy is checked in daily or periodic inspections following
approval for massproduction use.

(b) Measuring Equipment Control
• Ensuring traceability
Measuring equipment used for measurements to check built-in quality and measuring
equipment used indesign validation and testing/inspection is calibrated. The calibration
process ensures traceability inaccordance with national standards. Calibrations are
performed both in-house and by externalcalibration organizations. In-house calibration is
performed to in-house primary standards whosetraceability to national standards has been
confirmed by certified employees with calibration training.External calibration is carried out
by contractors subject to control similar to suppliers or manufacturecontractors using quality
systems confirmed to be appropriate for traceability and calibration work.

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• Measuring equipment identification tags
Measuring equipment subject to calibration is identified using one of the tags shown below
to ensurethat everyone uses only the correct equipment. Measuring equipment available for
use is identified bytags 1 and 2. These are used to maintain and control the calibration
status under the periodic calibrationsystem.

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(c) Measurement system analysis (MSA)
Even measurement systems that have been calibrated with confirmed traceability to national
standards canstill produce variations in results obtained due to different measurers and
ambient conditions. Measurementsystem analysis (MSA) is therefore used to minimize these
factors and ensure the high reliability ofmeasurement systems used. This analyzes bias,
linearity, consistency, repeatability, and reproducibility tostatistically evaluate measurement
equipment.
5. NON-CONFORMANCE CONTROL, CORRECTIVE ACTION AND PREVENTIVE

MEASURES

5.1Non-conforming product control in manufacturing processes.
Products in manufacturing processes that fail to meet the specified standards are
classified as non-conforming and are handled as shown below (Figure 3) using product

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labeling and trouble sheets.

Figure 3

5.2Control of non-conforming products identified at customers or on the
market.
Problems are promptly analyzed as shown in the flowchart below (Figure 4) before
reporting the results to the customer.

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Figure 4

Conducting analysis using FIB

5.3Corrective action
Problems arising in manufacturing processes or at customer sites identified as posing the

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risk of large amount of loss, as constituting serious problems, or as problems requiring
shared learning, are subjected to separate registration control as major quality problems
(Figure 5). The details recorded for major quality problems includes not just causal
investigation and action, but also shared learning throughout the related section to
confirm corrective action status and confirm completion.

5.4Preventive Measures Figure 5

One preventive measure involves collating the analysis results of past problem cases and

adding these to check points highlighted in reviews for examination by the multi-

functional team. Another major activities is the use of FMEA. These activities are used to

prevent problem recurrence.

6. CONTINUOUS IMPROVEMENTS

At the start of each fiscal year, a business plan is established based on the review results
for the previous year, customer demands, and the company-wide policy. This plan
includes quality policies and quality targets. This business plan is then used to draw up
individual section plans and individual worker objectives. To achieve quality targets,
current conditions are identified at yield improvement meetings and quality meetings with
follow-up on the status of corrective action. This information is reported to management.
These overall activities to attain quality targets are used to promote continuing

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improvement and to increase product quality. Refer to Figure 6.

Figure 6

7. SUPPLIER CONTROL

Suppliers are generally categorized into suppliers of materials and components and
manufacturing subcontractors. In both cases, maintaining quality is of prime importance,
and suppliers are subject to the following three types of control.

(a) Supplier selection
When a request is issued to use a new supplier, selection is made by checking the
technical capabilities of the supplier and determining whether it has a quality assurance
system in place to ensure delivery of products of consistent quality. Following selection,
products are evaluated and the factory is audited from a number of perspectives by the
related sections to evaluate the supplier. Following confirmation that the supplier meets
standards of adequacy, a quality assurance standard is prepared and used to establish a
quality assurance system.

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(b) Daily control
The occurrence of quality problems or process changes are reported by the specified
forms in accordance with the quality assurance standard. The number of problems is a
major point considered in the supplier evaluations incorporated into periodic control
procedures, as mentioned below.

(c) Periodic control
Suppliers are evaluated at each fiscal year based on QCD (quality, cost, delivery) results.
These results are used to determine the supplier control level for the current year, and
guidance is administered when necessary, including audits. In addition, periodic
meetings, etc. are held at frequent intervals to ensure cooperation from suppliers to
improve quality.

8. INTERNAL AUDITS

To make sure the product complies with the manufacturing requirement, an audit of a
manufacturing process is a comprehensive examination of the process to verify that it is
performing as intended. Below requirement must be followed:

(a) Quality Assurance (QA) Checklist
Quality assurance (QA) is a system or program used to monitor and evaluate the aspects
of a project, service or facility to determine if quality standards are being met. To ensure
a QA system is operating properly, periodic QA audit checklists are created and reviewed.
QA checklists are marked beneficial or determine if room for improvement is needed.

(b) Quality Assurance (QA) Manual
If the there is an implemented program, the checklist determines if the quality manual
clearly defines responsibility and authority. The checklist should also show if plans are

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revised at regular scheduled times not going beyond 12 months. It states if there is a
means to control and record how compliance should be implemented, description of
service or product, specifications and compliance tolerances.

(c) Procedure
The QA checklist states if procedures are established to bring services or materials in
compliance. It may show work in progress and final inspection for acceptance. It also
states whether or not the organization completes a round of testing before placing
service or products in compliance. The checklist also shows if there are procedures for
the organization to handle or respond to field complaints, as outside individuals wait for
quality-assurance results.

(d) Filing
There should be filing protocol for service or materials out-of-compliance. The QA
checklist may determine if there is a file retention policy and a list of compliance close-
outs over period of time. The filing system also determines whether or not out-of-
compliance requests are filed properly.

9. DISCONTINUATION OF MANUFACTURE

The manufacture of existing products may be discontinued due to manufacturing facility
reorganization or productquality improvements. In these cases, the customer is generally
notified approximately one year in advance.The flowchart for the discontinuation of
manufacture is shown below.

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10.CLEANLINESS ACTIVITIES

Support for cleanliness activities also forms part of the duties of the Quality Assurance
Department. Theseactivities are described below.

(a) Importance of cleanliness activities
Seiko Epson products have achieved an outstanding reputation among our customers for
performance and reliability. The most important factor for integrating this reliability and
quality is maintaining andcontrolling cleanliness in the environment in which products are
made. Activities that ensure cleanliness inthe factory will become even more important in
the future, with the ever-increasing precision of productsand demand for higher levels of
quality control. Cleanliness activities for semiconductor manufacturer areparticularly
important, since particles or impurity ions encountered during the manufacturing processes
cangreatly affect product yield rates and reliability.

(b) Cleanliness goals
The four points below constitute the goals of cleanliness activities and support the
production work floor.

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1) Increase quality (eliminate quality problems and complaints attributable to
foreign matter)
This is treated as a major cleanliness item that helps prevent any direct
inconvenience to thecustomer.

2) Increase yield rates and contribution to F costs reduction
Reduce foreign matter and impurities to avoid generating non-conformances or
products requiringreworking. While this also reduces failure costs for manufacturer,
the primary goal is to enableprovision of products to customers at low cost and with
short lead times.

3) Preventive maintenance and life extension of production plant
The emphasis is on tackling problems at the source from the early stages, with daily
inspectionsperformed to avoid effects on production and delivery schedules caused
by plant stoppages whenproblems arise. Intensive maintenance extends the life of
plant equipment and allows sustainedproduction with depreciated plant equipment,
which in turn makes it possible to continue providinglow-cost products to customers.

4) Improve Customer Satisfaction
In addition to the importance of maintaining a clean manufacturing environment,
winning esteemfrom our customers helps boost our own levels of satisfaction.
Creating products from thecustomer’s perspective is important for ensuring reliability
and long-term use with peace of mind.

(c) Cleanliness activity support details
The following multi-faceted support is provided to ensure high quality product manufacture:

1) Training (New employee training and basic training)
Good quality products require both a good manufacturing environment and a workforce with
highawareness and knowledge of cleanliness.Product quality reflects workforce quality.
Training is vitally important.

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• New employees receive cleanliness training as part of the training program for
new employees.

• Cleanliness training is also provided at the appropriate intervals for everyemployee.

2) Cleanliness support in each production line
Instruction and support is provided for semiconductor manufacturing lines through
cleanlinessdiagnosis and patrols.

3) Supplier cleanliness support
Cleanliness training, instruction, and advising is also provided when necessary at the
manufacturinglines of subcontractors.

Cleanliness guidance session

QUESTION :

1. Give four (4) important things are required before the product can be manufactured.
_____________________________________________________________________
_____________________________________________________________________
_____________________________________________________________________
_____________________________________________________________________

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2. Explain two (2) important stages to select a suitable process in manufacturing.
_____________________________________________________________________
_____________________________________________________________________
_____________________________________________________________________
_____________________________________________________________________

3. Why chosen the right material are important to produce any product?
_____________________________________________________________________
_____________________________________________________________________
_____________________________________________________________________
_____________________________________________________________________

4. What is the Key Performance Index can be used to evaluate the effectiveness and
efficiency of manufacturing processes?
_____________________________________________________________________
_____________________________________________________________________
_____________________________________________________________________
_____________________________________________________________________
_____________________________________________________________________

REFERENCE:

1. P.Manimekalai (2007). Industrial Electronics. Petaling Jaya: IBS BUKU SDN. BHD
2. Sammy G. Shina (2002). Six Sigma for Electronics Design and Manufacturing. USA:

The McGraw-Hill Companies, Inc
3. http://www.epson.jp/device/semicon_e/tech/high_quality/pdf/assurance_handbook.p

df

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4. https://www.techopedia.com/definition/9038/quality-assurance-qa
5. https://www.diffen.com/difference/Quality_Assurance_vs_Quality_Control
6. http://www.businessdictionary.com/article/1046/quality-assurance-vs-quality-control-

d1412/
7. http://www-materials.eng.cam.ac.uk/mpsite/tutorial/non_IE/prodanal.html
8. http://www.semicon.toshiba.co.jp/eng/product/reliability/device/analysis/analysis3/1

186561_7838.html
9. http://www.chipmos.com.tw/_en/01_about/03_indetail.aspx?MainID=27&SubID=28

&SSubID=8
10. https://qualityinspection.org/product-compliance-101/

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