DOCUMENTATION

012/MSS/2023/11/IS/IQOQ/OCR/HJ/01

OCR CODING INSPECTION

PT Hexpharm Jaya
(Mesin Blister Wonder)

Authorized Distributor:

PT MITRA SURYA SOLUSINDO

Address :
Ruko CBD Betos, Jl. Cut Meutia Blok J No. 02 Margahayu - Bekasi Timur
Telepon : 021-2945.0589 (Hunting) Fax : 021-2945.0587
Email : sales@mss-automation.co.id
 DOCUMENTATION

Document Number : 012/MSS/2023/11/IS/IQOQ/OCR/HJ/01

Customer : PT Hexpharm Jaya
Application System : OCR Coding Inspection
Location : Mesin Blister Wonder

Contents :

01. General Information

02. CE- Conformity Declaration
03. System Overview
04. Design Qualification
05. Installation Qualification
06. Operation Qualification
07. Conclusions

PT MITRA SURYA SOLUSINDO

Ruko CBD Betos, Jl. Cut Meutia Blok J No. 02 Margahayu - Bekasi Timur

Telepon : 021-2945.0589 (Hunting) Fax : 021-2945.0587

Email : sales@mss-automation.co.id
t
Down
Cognex vision systems and sensors help companies improve their manufacturing quality and performance.
Eliminating defects ... verifying assembly ... tracking and capturing information at every stage of production,
to make sure the entire process is completed correctly. Smarter automation using Cognex vision means fewer
production errors ... and that means lower manufacturing costs and higher customer satisfaction.

Cognex is the world’s most trusted vision company. With over half a million systems installed in factories
around the world, we have the experience and application knowledge to ensure that our vision system will do
exactly the job you need ... time after time after time.

From quality checking to lot tracking, from assembly inspection to robot guidance — Cognex
vision works tirelessly to optimize quality and drive down costs in many ways.

Reducing Improving
parts Quality
costs Productivity

Traceability
errors
COGNEX … SOLUTIONS FOR ALL APPLICATIONS
Cognex® machine vision systems perform tasks that are difficult or impossible for people to do
reliably and consistently — such as finding very small product defects on high-speed production
lines, capturing and recording complex identification information, and guiding robots. Without Cognex
vision systems, most products today could not be produced reliably and affordably on a large scale.

Inspect any product

COGNEX
The Most Complete Product Line
You may need more than one type of vision product to tackle challenging tasks — but you don’t want the complexity of dealing with
multiple vendors, or the difficulty of integrating their technologies. What you need is a machine vision company that offers a complete
line of products. And, again, that means Cognex. Only Cognex can support every vision need.

Vision Systems Vision Software Vision Sensors ID Readers Web and Surface
Rugged, all-in-one A library of powerful Easy, affordable 1D and 2D code reading Inspection
systems with an Cognex vision tools to sensors that replace and verification for Industry-leading
easy-to-use interface combine with the photoelectric sensors direct part mark or technology for
for configuring cameras, frame grabbers, for more reliable high-speed applications, detecting and
applications. and peripherals of inspection and in handheld or classifying surface
your choice. part detection. fixed-mount applications. defects in metals,
paper, plastics, non-
wovens, and glass.
 MEETING INDUSTRIAL CHALLENGES
From watches, to wafers, to webs … Cognex machine vision systems perform with the accuracy and
speed needed to keep pace with even the fastest production lines. Since 1981, Cognex has provided
successful vision solutions to companies around the world... it is the primary reason that manufacturers
consistently select Cognex.

Guide any automation

vision does it
Typical Industries and Applications
AUTOMOTIVE MEDICAL SOLAR
• Detecting part presence • Verifying completeness of kits • Checking for cracks, holes, and similar
• Orienting parts on feeder bowls in operating room defects on wafers
• Reading codes on parts • Providing surgical instrument • Monitoring cell color uniformity and
traceability inspecting for defects
SEMICONDUCTOR AND ELECTRONICS • Gauging medical parts • Measuring features, inspecting and
• Inspecting the quality of wafers and dies identifying modules and finished panels
PHARMACEUTICALS
• Verifying the correct assembly of
• Verifying the presence of safety seals PAPER, PLASTICS, NONWOVENS
components
on bottles WEB INSPECTION
• Inspecting PC boards and reading codes
• Verifying 1D, 2D, and date and lot codes • Performing online, real-time web
FOOD AND BEVERAGE inspection
• Performing character verification on
• Verifying the correct allergen label extremely distorted character strings • Maximizing yield and ensuring quality

• Reading and verifying 1D and 2D codes • Inspecting at every step in the process
GENERAL MANUFACTURING
• Detecting missing items METAL AND GLASS SURFACE
• Providing code reading for unit-level
product traceability INSPECTION
PACKAGING
• Performing automatic part recognition • Detecting, identifying, and visualizing
• Inspecting cap and label presence
and inspection defects
and position
• Sorting products by color • Performing multi-step classification with
• Locating objects on conveyors
patented technology
• Palletizing with automated systems
• Viewing real-time or stored images
and data
WE ARE EVERYWHERE YOU ARE
With globalization, outsourcing, and international joint ventures, more companies are manufacturing
their products at locations throughout the world. That’s why Cognex is everywhere our customers are.

Identify any part

ALL
Putting Customers First
Customers are our number one priority, and listening to them is always the first step. Cognex
sales engineers and application specialists are located around the world, to provide assistance
wherever and whenever needed.

And there are other resources available to our customers — including the expert personal
assistance of our partner system integrators (PSIs), who combine their vertical industry
knowledge and technologies to complement Cognex products. They not only build the
vision application, but also support it over time.

Our global network of automation solution providers (ASPs) comprises Cognex distributors
that have the expertise and ability to offer the most affordable do-it-yourself vision solutions.

An Array of Support Resources

Behind all of these vision professionals is a wealth
of Cognex support resources, including live, online,
and video-based training; online conferencing;
software downloads; our searchable web
knowledge base; and Cognex worldwide
technical support. Visit us at www.cognex.com.
 Companies around the world rely on Cognex vision to optimize quality and drive down costs.
Corporate Headquarters One Vision Drive, Natick, MA 01760 USA Tel: +1 508.650.3000 Fax: +1 508.650.3344

Americas Europe Asia

United States, East +1 508-650-3000 Austria +43 1 23060 3430 China +86 21 6320 3821
United States, South +1 615-844-6158 France +33 1 4777 1550 India +91 80 4022 4118
United States, West +1 650-969-4812 Germany +49 721 6639 0 Japan +81 3 5977 5400
United States, Detroit +1 248-668-5100 Hungary +36 1 501 0650 Korea +82 2 539 9047
United States, Chicago +1 630-649-6300 Ireland +353 1 825 4420 Singapore +65 632 55 700
Canada +1 905-634-2726 Italy +39 02 6747 1200 Taiwan +886 3 578 0060
Mexico +52 81 5030-7258 Netherlands +31 402 668 565
Central America +1 972-365-3463 Spain +34 93 445 67 78
South America +1 972-365-3463 Sweden +46 21 14 55 88
Brazil +55 11 9648-6400 Switzerland +41 71 313 06 05
United Kingdom +44 1908 206 000 www.cognex.com

© Copyright 2010, Cognex Corporation. All information in this document is subject to change without notice.
Cognex is a registered trademark of Cognex Corporation. All rights reserved. Printed in the USA. Lit. No. ML4002-0110
 Expert Guide

Vision Ensuring Quality in Pharmaceuticals Production

customer.
Introduction
Serialization data can be extracted from four layers of supply
In no other industry are the incentives to guarantee chain operations following the path of an individual medicine
product safety and packaging integrity as great as they are from manufacturing through final delivery. In the production
in the pharmaceutical industry. As a result, facility,
pharmaceutical product manufacturers have been “early each individual drug manufactured is marked with unique
adopters” in the successful deployment and use of serialization
machine vision technology. As the challenges become
greater and the stakes higher, pharmaceutical product
manufacturers need even more sophisticated machine
vision hardware and tools to stay compliant with
regulations, ensure customer confidence and mitigate
risks. At the same time,
these tools need to be easy to use and deliver even more
reliable and repeatable results.

What are the major production challenges

for the pharmaceutical industry?
Track and Trace
The Center for Medicine in the Public Interest (CMPI)
estimates that there are more than 25,000 pharmaceutical
packaging lines worldwide requiring modification to
implement effective track and trace technologies. Devising
and meeting industry-wide track and trace standards presents
substantial challenges to both manufacturers and machine
builders.
An effective track and trace solution requires implementing
three levels of functionality: print and verify, serialization
and track and trace. With this functionality in place,
manufacturers can systematically print and verify marking
numbers on all products, mark each product with a
unique serial number and create a central database of this
information. The central database allows manufacturers to
track and store the location and status of each product
as it travels through the supply chain until it is sold to the
 off as a more profitable product, costing manufacturers in
data. Any hierarchy-level information appearing on
lost revenue.
packaging such as blisters, folder cartons, bundles,
cartons, packages or containers also is recorded on
the production floor.
Since pharmaceuticals manufacturing often occurs in
several process stages, serialization information from
each process stage is collected and administered
throughout the manufacturing facility. Serialization
information is collected at the internal supply chain
level where data on product shipments between
manufacturing facilities is recorded for further
distribution. The process of delivering products to
distributors,
wholesalers, pharmacists and hospitals is recorded at
the external supply chain level. This multi-level approach
allows for an end-to-end product verification process.
Global serialization requirements present huge
challenges to pharmaceutical manufacturers. With as
many as 10 to 15 different country requirements, each
with a different timeline and technology, compliance is
becoming very complicated. Serialization solutions
can be especially effective when quality requirements
are high, when the product has an impact on
consumer health and safety, when there is a threat
of counterfeit products or when there is need for
a full product history.

Counterfeiting
According to estimates from the World Health
Organization, up to 15 percent of all medicinal
products in the world are counterfeit. On a
worldwide scale, perhaps millions of patients are not
receiving the therapeutic benefit of the authentic
product, and they run the risk of coming into contact
with materials which may be hazardous or toxic.
Counterfeit pharmaceuticals containing authentic
active ingredient(s) at inefficacious levels or in
undesirable chemical forms may lead to decreased
levels of bio-availability and the development of
resistant strains of disease. In other cases, unrelated
pharmaceutical products
have been altered or repackaged so they can be passed
Recent CMPI research estimates that activities related to
counterfeit drugs generate US$75 billion annually. CMPI 21 CFR Part 11
expects that figure to grow by 20 percent annually in the
Complying with the latest US Food and Drug
coming years, giving drug counterfeiters comparable administration (FDA) dictates on Electronic
revenue to some of the world’s largest health care Records/Electronic Signatures—21 CFR Part 11 and
companies. comparable pharmaceutical inspection cooperation
schemes enacted throughout the world have created
There is no single tool capable of confirming complete significant challenges for pharmaceutical manufacturers.
authenticity of pharmaceutical products. Several verification 21 CFR Part 11 requires that pharmaceutical
and inspection methods need to be applied simultaneously manufacturers pay extra attention to security measures
in order to build complete confidence in the process. associated with computer-based systems. This includes
fortifying access control measures as well as providing an
Defect Detection and Quality Control electronic trail for all transactions. The traceability
requirements have
To control costs, ensure product safety and maintain for all intents and purposes made the use of bar codes,
consumer confidence it is essential that pharmaceutical including 2-D barcodes and lot and date code verifiers
manufacturers control quality and prevent defective products and readers mandatory.
and packaging from entering the supply chain. Some of the Machine vision systems would fall under their definition of
quality checks performed on the production line include: a “closed system:” an environment in which access is
controlled by persons who are responsible for the content
of electronic records that are on the system. In this case
the FDA suggests that procedures and controls shall
include:
A) Validation of systems to ensure accuracy,
Cap/seal presence Empty glass
verification verification reliability, consistent intended performance and
the ability to discern invalid or altered records.
B) The ability to generate accurate and complete copies
of records in both human readable and electronic
Box/label inspection Label placement form.
C) Protection of records to enable their accurate and
ready retrieval throughout the records retention
period.
Final product D) Limiting system access to authorized individuals.
Particle inspection
inspection E) Use of secure, computer-generated, time-stamped
audit trails to independently record the date and
time of operator entries and actions that create,
modify or delete electronic records.
Alphanumeric, 1-D, and Component inspection
2-D code verification (stoppers/caps/glass) F) Use of operational system checks to enforce permitted
sequencing of steps and events, as appropriate.
G) Use of authority checks to ensure that only authorized
individuals can use the system, electronically sign a
record, access the operation or computer system
Liquid fill verification Seal surface integrity
input or output device, alter a record, or perform the
operation at hand.
H) Use of device (e.g., terminal) checks to determine, as
appropriate, the validity of the source of data input or
Product insert Stopper position
presence inspection operational instruction.
I) Determination that persons who develop, maintain, or
use electronic record/electronic signature systems
have the education, training and experience to
Presence of damaged Product quantity perform their assigned tasks.
product or packaging verification
J) The establishment of, and adherence to, written
policies that hold individuals accountable and
 responsible
for actions
initiated under
their
electronic
signatures, in
order to deter
record and
signature
falsification.
K) Use of appropriate controls
over systems
documentation including:
a. Adequate
controls
over the
distributio
n of,
access
to, and
use of
documen
tation for
system
operation
and
maintena
nce.
b. Revision
and
change
control
procedur
es to
maintain
an audit
trail that
documen
ts time-
sequence
d
developm
ent and
modificati
on of
systems
documen
tation.
 Four major environmental challenges on a pharmaceutical production line

Poor or variable lighting Part changeovers

Tight spaces Surface variation

(flat, curved, shiny, etc.)

Advanco’s customer is 100% satisfied that all 2-D codes are fully
Machine vision meeting the challenges readable before leaving the facility.
of the pharmaceutical industry
Serialization and Tracking
Advanco: Ensuring product traceability with advanced
2-D code reading
Advanco, a major international
integrator of item level
serialization and tracking
solutions deployed a complete
traceability solution featuring
Cognex In-Sight® ID readers to
ensure product traceability for a
global manufacturer that
produces and
distributes 60 million medicine boxes annually.
To achieve the required levels of traceability, Advanco
chose Cognex In-Sight ID readers because it is the only
system that can consistently
deliver accurate and reliable code reading. The Cognex
system is able to read multiple codes within one field of view
and overcome the challenges of reading blurred or distorted
codes on the production line.
In just 1.4 seconds, a Cognex In-Sight ID reader decodes all
2-D codes printed with inkjet onto the surface of each
medicine package in a single action. Any defective products
trigger an alarm and are removed. This procedure not only
ensures all packages ready for shipment are fully traceable,
but also improves production processes for both code
marking and wrapping operations as defects are addressed
immediately.
With the accurate and reliable read rates Cognex delivers,
Defect Detection
EISAI Machinery: 100% product quality entering the
pharmaceutical wholesale chain
High speed pharmaceutical
product testing company
EISAI Machinery GmbH,
has defined a machine that
uses two Cognex In-Sight
vision systems to inspect
delicate glass vials in
fractions of a second.
The Cognex-equipped machine can
check approximately 6,000 packages and in its
fastest version can even test up to 12,000 test units
per hour.
In this application, a Cognex In-Sight vision system
determines the cake height of the freeze-dried
contents and detects the presence of any foreign
objects on their surface. At the same time, it looks
for “splashings”or splatters caused by unwanted
boiling during the freeze-drying process. The In-Sight
overcomes vibration stresses without sacrificing
inspection speed.
An additional In-Sight system inspects the underside of
the glass vials for cracks. For freeze-dried products, the
vision system also checks the vials for unwanted
particles and “meltbacks” (condensate residue that
can arise during the freeze drying process of protein-
containing substances).
An In-Sight color vision system checks both the vial
cap and the flip-off seal, inspecting for the presence of
the parts, the color of the cover and, for aluminum
caps, the correct processing of the crimp. While the
glass containers rotate 360°, the In-Sight system
checks that the aluminum sleeves have been fitted
completely around the edge of the glass and the
stoppers are tightly inserted.
This system ensures that only the glass vials with 100%
product quality are distributed to clinics, pharmacies,
and medical practices worldwide.
Process Automation Code Verification
Automated Systems of Tacoma: Vision-guided robots help Sanofi-aventis: Ensuring compliance for pharmaceutical products
automate vial and syringe filling
Pharmaceutical products manufacturer Sanofi-aventis
Automated Systems of worked with Cognex vision systems to design
Tacoma, Inc. (AST) used a and implement a print and code
Cognex vision system to verification solution to ensure
develop an automated, compliance with GS1 codes
single-platform machine to fill vials, readability regulations,
syringes and other containers for completely eliminate operator
pharmaceutical manufacturers. errors caused by data input,
This machine features exact reduce product waste, and
positioning improve coding quality.
functionally to address each product’s unique size and type
This solution is designed as a mobile system, which can be
and eliminates the need to purchase multiple filling
adapted for packing lines and installed along the
machines, or tolerate lengthy changeovers when switching
production process, as required. A Cognex In-Sight vision
between container types.
system with track and trace software provides information to
An In-Sight Micro vision system precisely locates each a PC database to create an audit trail. As the products
container and stopper and provides the robots these pass along the line, the required codes are printed onto the
locations prior to processing. This approach allows for packaging.
rapid changeover from one container type or size to
A Cognex In-Sight vision system reads the printed data and
another by loading a new robot program, replacing the
verifies against the selected information camera at a speed
products carriers, and instructing the robot to change out the
of 300 parts per minute. The integrated track and trace
end of arm tooling. The system’s use of disposable materials
software delivers a ready-to-deploy data capture and
is used on all process contacting parts which also reduces the
verification solution designed to help pharmaceutical
changeover time, and eliminates the risk of cross
manufacturers achieve unit-level product traceability.
contamination.
Incorrect codes
Thanks to the In-Sight Micro, the machine can handle all are identified immediately and the offending product is
liquid packaging needs for many pharmaceutical companies, removed from the line. After batch completion, a production
contract manufacturers report is created to ensure complete product traceability and
and compounding pharmacies at hospitals at far less expense maintain operational efficiency.
than comparable solutions.

Machine vision tools for the pharmaceutical industry

inspect a part properly, the quality
PatMax® learns an object’s
manager can add that part to the
geometry using a set of boundary
TestRun database so the vision designer
curves that are not tied to a
can make whatever modifications are
pixel grid, and then looks for
required. In this way, the vision system
similar shapes in the image without
constantly improves its performance.
relying on specific gray levels. The
result is a revolutionary
improvement in the ability to
accurately find objects despite
changes in angle, size and
shading.

TestRun helps you deliver

continuous quality improvement.
Any time the vision system fails to
OCRMax™ powerful algorithm
prevents misreads, handles
process variations and
provides easy font
management.
It’s fast, easy to set up
and simple to use across
all platforms with minimal
training being required.

Track and Trace software

offers a data capture and
verification solution
designed to help achieve
unit-level product
traceability. Powerful
Cognex code reading and
verification software with a
pre-configured job file and
HMI interface make it easy
to exchange data with
third party systems for a
full serialization solution.
Packaging Quality Control Label Verification
Boehringer Ingelheim: Achieving perfect quality control Artur Theis GmbH: Pharmaceutical labels identification at
40,000 cartons per hour
Boehringer Ingelheim relies
on Cognex vision to achieve Artur Theis GmbH has
its quality control objectives: designed and deployed a
perfect printing quality machine that inspects high-
inspection on a production quality labels with different
line churning out around identification and information
300,000 blister packs and carriers including 1-D codes,
100,000 folding packs every genuine lettering and
day. holograms and bollinos. The
machine features the Cognex
The principal challenges facing Boehringer Ingelheim were
In-Sight
the very high speeds at which the blister packs move on the
Micro vision system with PatMax pattern matching technology
production line, the variable accuracy of inkjet printing on
because it provides extremely high repeat inspection accuracy
foils with irregular surfaces and
within specified tolerances and identifies possible defective
dirt, pressure, and sharp edges. In their production process,
products so they can be reliably removed.
the inspection functionality provided by Cognex VisionPro ®
software overcame these challenges and ensured one The new Artur Theis machine can affix labels, stickers, and
hundred percent error-free blister pack printing quality. bollinos to up to 200 different types of folding cartons and check
that they are in the correct position. If the labels and stickers are
Boehringer Ingelheim achieves perfect quality control by
not perfectly aligned to the central features of the folding
ensuring the detection of the printed undersides of the blister
cartons, then additional information such as use-by date,
foils in fractions of a second. The information is transferred
product, and lot numbers cannot be applied correctly. The In-
to the vision system so that it can perform a precise sample
Sight vision system meets the pharmaceutical industry’s
comparison. Depending on the product type, particular
increased level of automation demands by delivering far greater
examination is made of varying details which are applied—
precision than the human eye can provide.
including lot number and expiry date—in addition to
looking at pre- printed information. The intelligent vision PatMax technology featured in the In-Sight Micro system
software knows and recognizes all the relevant symbols and helped the machine perform flawless inspections on a large
letters and, on the basis of previously-taught parameters and variety of products with very different label shapes and colors
tolerance limits, assesses the quality of a product. by orient itself to certain predefined geometric features of the
cartons in order to set and precisely determine the position
of the labels and stickers in relation to it. PatMax pattern
matching technology determines all of the important position
values without errors—even under variable lighting and
position conditions
and despite changing angles, sizes, and shading.

The Cognex image processing library makes the machine

usable for an extremely wide variety of image processing tasks.
The calibration of new products is very simple and can be
carried out with no specialized training.

3000 United States, South +1 248 668 5100

Americas United States, West +1 650 615 844 6158 United States, Chicago +1 630 649 6300
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+44 1327 www.cognex.com
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0752
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78
Sweden +46 21 14 55
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All information in this document is subject to change without notice. All Rights Reserved.
Switzerland +41 71 313 06
Cognex, In-Sight, PatMax and VisionPro are registered trademarks of Cognex Corporation.
05 All other trademarks are the property of their respective owners.
Printed in the USA. Lit. No. VNEG4-201207
 Expert Guide

Optical Character Recognition Technology for the

Food & Beverage Industry

Legislation like the Bioterrorism Act and the EU’s General Food
Regulations worldwide drive the
Law that makes traceability compulsory for all food and feed
need for OCR businesses are only effective if the information being gathered
In May 2012, the United States Food and Drug can be accessed and shared easily with other stakeholders.
Administration (FDA) issued 24 mandatory food recalls for
reasons ranging from salmonella to undeclared almonds.
And it isn’t just happening in US markets. The
International Standards Organization (ISO) includes tracking
and labeling requirements for most agricultural products,
while Japanese law includes documenting everything from
agricultural chemicals to slaughterhouse operations (Abattoir
Law).
In September 2011, the US government notified domestic
and international food producers that food-tracking
requirements would become more stringent in the future,
and fines for non-compliance would become more severe.
(See Food Safety Modernization Act sidebar.)

The US Bioterrorism Act requires that facilities have systems

in place to provide product traceability so that any part of the
food chain can trace back their source one step, and trace
forward the food destination one step, on all food, within 24
hours. This requires a trail of information that follows each
food item.

In the EU, the Rapid Alert System for Food and Feed
(RASFF) warning system supports the traceability system
by enabling the rapid exchange of information whenever a
risk to food or feed safety is identified. If a member of the
network becomes aware of a potential risk to human health,
it notifies the European Commission, which immediately
transmits this information to the other members—and
beyond—so that corrective action can be rapidly taken.
In response, food producers and packagers are
looking at how they can use track and trace
technologies to document food production
automatically and give their management team better
insight at all levels of the supply chain in real time.
Barcodes are a traditional solution to track and trace
operations, but consumers cannot read barcodes. As a
result, many producers are turning to optical character
recognition (OCR) technology using vision systems that
can read alphanumeric text, as well as 1-D barcodes
and 2-D Data Matrix codes, to track food and beverages
from raw materials to packaged product at high speeds
and with greater accuracy than manual inspection or
barcodes alone.

Serious About Food Safety

The US Food Safety Modernization Act includes 19
new provisions that will impact the food-processing
industry. Several of these provisions are expected to
increase demand for machine vision. Upon request, the
FDA will gain expanded access to food production
facility records. The agency may obtain records for
tracking purposes or if there is reason to suspect a
potential public health risk. In addition, the FDA, in
coordination with the produce industry, will create a
new method of effectively tracking and tracing fruits
and vegetables to ensure that any contaminated
produce is located and recalled in a safe and timely
manner.
These new regulations apply to both domestic and
What is OCR Machine Vision? Benefits of OCR technology for the
While the specifics of each food recall in the US are varied, food & beverage industries
as were the producers’ costs and liability, one thing is OCR technology can benefit food & beverage manufacturers by:
certain—producers who do not have complete records of
• Accelerated response times – If there were issues in
the products they make and ship will pay more to correct
the supply chain, OCR gives manufacturers the
the situation than producers that do not. Simply put, you
information required to hone in rapidly and take
cannot manage what you do not know.
corrective action.
Machine vision systems equipped with OCR tools
• Reduced liability – Incorrectly marked packages
provide four key functions for food and beverage
that include allergens or contaminated food and
operations processing and packaging operations:
beverages can result in legal action and public
1. Presence. Check that product descriptions and health hazards. OCR documentation
tracking text have been printed on the product. can help identify the source of the problem back to the supplier.
2. Track and trace. Track ingredients and • Improved productivity – Automated OCR
packaged products throughout production. increases process efficiency by eliminating
3. Identification. Ensure the label matches the human intervention in more areas while
product, barcode and/or Data Matrix codes. improving accuracy and reliability.

4. Verification. Verify that the correct characters • Simplified production – OCR codes are also human
are printed clearly for customer safety and brand readable, augmenting the 1-D barcodes and 2-D data
management. matrix codes markings.

Vision systems accomplish these tasks by acquiring • Increased customer satisfaction and ensured
pictures of the product on the production line. Vision compliance – New regulations in developed markets
systems easily handle the high speeds found in food and require, or soon will require, 100% inspection,
beverage manufacturing and packaging lines. The images tracking, and tracing of food and beverages similar to
are then analyzed using the OCR tools on the vision the requirements of pharmaceutical products.
system that locates the text string and “reads” the
alphanumeric codes. These codes can include batch, lot
Tracking each step in your process
and date codes, as well as data for print and label OCR machine vision technology is a proven, mature
verification. Vision systems acquire and process these way to track food and beverage processing from the
codes in fractions of a second, then pass the extracted raw material stage to packaged product. Some of the
data to the factory network for the user to analyze and more common applications for OCR systems include:
store data, improving supply chain • Ingredient/raw material receiving
management and limiting liability in the event of a recall.
• Real-time production tracking
Simultaneously, the vision system can be programmed to do
• Date code accuracy and legibility
additional inspections; from ensuring safety seals are present
to reading barcodes or 2-D Data Matrix codes. Vision • Lot code and batch verification

systems can be configured to do one or multiple tasks, • Expiration date verification

depending on the requirement of the manufacturer. • Label verification
• Mold cavity print quality inspection and
verification (e.g., bottles and containers)
• Label placement, quality, and brand management
• Automated warehouse, picking, and shipping data management
• Expedited product returns and customer credits
 OCR Applications for Food & Beverage Manufacturers

OCR tools can verify sell-by date scratched, or with washed-out characters?
and batch codes on even the • Can it read text regardless of surface type, including
highest- volume production lines glass, metal, cardboard, ceramic, and plastic?

OCR tools need to have the

flexibility and robustness to read
many different code variations
on any type of surface

OCR tools deliver robust read

performance that distinguish
between mismatches and bad
reads

Six questions to ask when choosing

OCR technology in a vision system
With suitable lighting, the proper image acquisition device
configuration and seamless connectivity to a factory
network, food and beverage manufacturers can use the
OCR tools in a vision system to make immediate
improvements in productivity, product documentation, and
supply chain management. In addition, when looking for a
vision system to accomplish these goals it is important to
consider these critical points when evaluating OCR
software:

• Can the OCR software read any printed font?

• Can it read text when there is little contrast
between the text and background (colored text
or background noise)?
• Can it read text in spite of changing lighting
conditions that affect contrast?
• Can it read text with a lot of letter-to-letter
variation, skewed letters, or touching letters?
• Can it read text strings that are poorly printed,
 OCR tools read and verify To a machine, a picture of written text is nothing more than
the presence of allergen a collection of dots ranging from white to black and
information on food and thousands of grays in between. OCR tools recognize that
beverage packages to keep these dots form lines or strokes and that groups of strokes
consumers safer
together form letters. Tools such as OCRMax® from Cognex
use special segmentation rules that allow customers to train
the system on virtually any printed font with the exception of
scripts (cursive writing). OCRMax can even accommodate
OCR tools verify presence
letters that touch using advanced segmentation in conjunction
and correctness of strings so
that accurate information is with its classification and fielding functions.
communicated to the supply
chain

OCR tools allow a vision

system to read text even
when there is little
contrast between type
and background

Features to look for in an OCR tool

Pre-processing and image correction
Many OCR software tools will not include image
correction and filtering as part of their toolset,
requiring the user to use a separate tool for this step.
This additional step will likely slow down the system’s
inspection speed and slow down the production line.
The best machine vision systems feature pre-
processing and image correction in their OCR tool to
improve contrast, correct for changing lighting
conditions and filter out background noise in the
image. Including pre-processing and image correction
makes it easier to train the software on a new font,
program the system for different production lines and
operate the system as light conditions change
throughout the day.
Segmentation
 A cautionary example
In May and June 2011, a novel strain of Escherichia coli O104:H4 bacteria caused a serious outbreak of food-borne
illness focused in northern Germany. The outbreak resulted in 50 deaths, US$2.84 billion in human productivity
losses and US$306.2 million in compensation payments to affected farmers throughout Europe. In the end, this
catastrophic incident has underscored the importance of accurate product identification and traceability in the food
supply chain.

The ripple effect of this outbreak will be with us for a long time. Many consumers still mistrust fresh food. According to a
Neilsen survey, three quarters of Germans polled are demanding the producers and processers of food take more
responsibility for its safety. This responsibility begins providing adequate consumer information on the packaging of
fruits and vegetables, which is lacking even in the developed world. A recent analysis of the packaging of 2,100
products revealed that less than one percent of the fruits and vegetables offered at supermarkets feature details that
would allow the food to be traced through the supply chain. Implementing reliable, automated optical character
recognition functionality would provide major benefits for the food and beverage industries.

Classification and fielding The Future of OCR-enabled

Advanced OCR tools use segmentation as well as
classification and fielding to improve read accuracy.
vision systems in the
Classification refers to comparing different mathematical food & beverage industry
analysis of a specific letter to determine whether the letter is As government regulations and the public’s demand for safer
more likely to be the letter “B” or the number “8,” for products increase, more food and beverage manufacturers
example. OCRMax gives the user the ability to use two will need to deploy machine vision systems with OCR
different approaches to classifying each letter to deliver one functionality to address these challenges. OCR technology
of the highest OCR accuracy scores on the market. Fielding will need to be robust enough to solve applications in tough
functionality also helps improve read accuracy. Going back environments more consistently and reliably. It will also need
to the “B” versus “8” example, if a given text string holds a to be scalable and dynamic enough to adapt to changes in
date code, programmer user can specify to the tool that the production process. Ensuring the OCR functionality in
only letters will be numbers at a specific location. This gives your machine vision system is up to the task will put you on
OCRMax one more way to be sure that an “8” is a the path to regulatory compliance, limit liability and improve
number, and not a “B.” efficiencies all along the supply
chain—from accepting raw product to quality-checking the
final package and expediting customer returns.

Americas Europe
United States, East +1 508 650 3000 Austria +43 1 23060 3430 Turkey +90 212 371
8561
United States, West +1 650 969 8412 Belgium +32 2 8080 692 United
Kingdom
+44 1327 856
040 www.cognex.com
United States, +1 615 844 6158 France +33 1 4777 1550 Asia Corporate Headquarters
South One Vision Drive Natick, MA 01760 USA
United States, +1 248 668 5100 Germany +49 721 6639 0 China +86 21 5050
Detroit 9922 Tel: +1 508 650 3000 Fax: +1 508 650 3344
United States, +1 630 649 6300 Hungary +36 1 501 0650 India +9120 4014
Chicago 7840
 t to change without notice. All Rights Reserved.
Cognex, In-Sight and OCRMax are registered trademarks of Cognex Corporation.
All other trademarks are the property of their respective owners.
Printed in the USA. Lit. No. VNEG3-201207
Most problems start at the very beginning of a product’s journey—
on the production line. Getting it wrong there can have disastrous
consequences. However, with Cognex® machine vision technology
in place, you can instantly improve your production processes to
ensure you Make It Right™, every time.

The Right Products to Make It Right

Customers and consumers worldwide are demanding higher quality products than ever before. To achieve this, vision technology is the
key! Vision systems perform tasks that are practically impossible for people to do reliably and consistently, helping companies improve
processes and profitability. With so many types of vision technology available today, it can be a daunting task trying to figure out which
one is right for your particular application. Simply finding a system that can perform the necessary vision tasks is not enough; there are
several other factors that need to be considered to ensure a successful deployment.

There are three main types of vision technology available today—vision software, vision systems, and vision sensors. Cognex offers
industry leading solutions to help you Make It Right, every time.

In-Sight® vision systems are rugged, industrial systems that can solve virtually
any vision task. Available in a wide range of form factors, performance levels, and
resolutions to match the exact requirements of each application, In-Sight vision
systems offer a built in suite of communications capabilities for easy integration
with any PCL, robot, HMI or manufacturing system and are ideal for deployment by
manufacturing companies, OEMs, and system integrators.

Checker® vision sensors are the easiest and most affordable way to solve simple,
single-function vision tasks, such as determining the presence or absence of parts
in an assembly. Self contained, with built in lighting, optics, camera, processor, and
industrial interfacing in a package designed to fit into the tightest of spaces,
Checker is ideal for applications that are currently served by photoelectric sensors
and used extensively by both manufacturers and OEMs.

VisionPro® vision software offers the highest performance and most advanced
vision tools for even the most demanding of vision applications. VisionPro is
designed specifically for advanced system integrators and OEMs who prefer the
image acquisition flexibility and programmability that PC-based solutions provide.
Software Tools to Make It Right
Cognex's robust tool library—proven in more than 600,000 installations worldwide—spans
all vision needs. No matter what camera or frame grabber you use or what applications you
need, this broad-based, industrial-grade tool set helps you Make It Right. Cognex expansive for part and feature location,
toolset includes: provides accuracy and repeatability
• Pattern matching • Fixturing • 1-D barcode reading under the most challenging
• Inspection • Calibration • 2-D matrix code reading
• OCV/OCR • Caliper • 3D basis for such companion tools as
• Color segmentation • Edge detection • Non-linear calibration PatMax SA, PatMax XLC, Synthetic
• Color matching • Flexible flaw detection • Brightness PatMax, PatInspect®, PatFlex®,
• Color extracting • Pixel mapping • Contrast OCVMax™ and IDMax® covering the
• Identification • Polar unwrap • Pattern broadest range of pattern matching
• Line finder • Part location • Diameter and inspection in the industry.
• Circle finder • Measurement ... and more!
• Blob analysis • Robotic guidance

Make It Right in Action

DRIVE DOWN COSTS OPTIMIZE QUALITY ENABLE AUTOMATION

KWD Automobiletechnik uses a AFA Nordale uses Checker vision Ackley Machine Corporation uses
VisionPro 3D system to drive down sensors to enable the automation of Cognex In-Sight vision systems to
the costs of their accelerated welding their distinctively branded beverage print and inspect over 400,000
process. The VisionPro system also carton production process. Checker tablets per hour while providing
provides a complete solution for facilitates high-speed carton loading unique single tablet rejection
successful transport and quality and is able to read all of the different capabilities and delivering products
control of raw materials and finished labels without difficulty. of unprecedented quality.
products, further reducing costs.

Companies around the world rely on Cognex vision and ID to optimize quality, drive down costs, and control traceability.
Corporate Headquarters One Vision Drive Natick, MA USA Tel: +1 508.650.3000 Fax: +1 508.650.3344
Americas Europe Asia
United States, East +1 508.650.3000 Austria +43 1 23060 3430 China +86 21 5050 9922
United States, West +1 650.969.8412 Belgium +32 2 8080 692 India +91 80 4022 4118
United States, South +1 615.844.6158 France +33 1 4777 1550 Japan +81 3 5977 5400
United States, Detroit +1 248.668.5100 Germany +49 721 6639 0 Korea +82 2 539 9047
United States, Chicago +1 630.649.6300 Hungary +36 1 501 0650 Singapore +65 632 55 700
Canada +1 905.634.2726 Ireland +353 1 825 4420 Taiwan +886 3 578 0060
Mexico +52 81 5030-7258 Italy +39 02 6747 1200
Central America +52 81 5030-7258 Netherlands +31 208 080 377
South America +1 909.247.0445 Spain +34 93 445 67 78
Brazil +55 47 8804-0140 Sweden +46 21 14 55 88
Switzerland +41 71 313 06 05
United Kingdom +44 1327 856 040 www.cognex.com
©2011 Cognex, PatMax, In-Sight, Checker, VisionPro, PatFlex, and IDMax are registered trademarks
and CognexConnect and Make It Right are trademarks of Cognex Corporation. MIR-201108
Systems Overview OCR CODING INSPECTION

Table of Contents – Systems Overview

1. Systems Overview OCR Coding Inspection ..................................................................

Pre-Approved of this document

Name: Sig. and Date:
PT Mitra Surya Solusindo

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PT Hexpharm Jaya

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Systems Overview OCR CODING INSPECTION

SYSTEMS OVERVIEW

OCR CODING INSPECTION

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Design Qualification OCR CODING INSPECTION

Table of Contents – Design Qualification

1. Camera Specification ..............................................................................................

2. Mechanical Overview ..............................................................................................
3. Electrical Wiring Diagram ........................................................................................

Pre-Approved of this document

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Design Qualification OCR CODING INSPECTION

1 Camera Specification
1.1 In-Sight 3801MP Camera Specification

Bit depth 8-bit monochrome

Frames per Second 125 fps
Sensor Type 1/2.3” CMOS, global shutter
Sensor Properties 6.3 mm diagonal,
3.45 x 3.45 μm square pixels
Maximum Image Resolution (pixels) 1440 x 1080
Electronic Shutter Speed 19.5µs to 200.000 µs
Memory 4 GB
Lens Type C-Mount, Cognex High Speed Liquid Lens Autofocus,
or Cognex manual focus lens (used with Multi-Torch
Illumination accessory)
Trigger 1 opto-isolated, acquisition trigger input.
Discrete Inputs  1 opto-isolated, acquisition trigger input
 Up to 3 general-purpose inputs when connected to
the Breakout cable
Discrete Outputs  Up to 4 high-speed outputs when connected to the
Breakout cable
Status LEDs Pass/Fail LED and Indicator Ring, Network LED and
Error LED
Job/Program Memory 7.2 GB non-volatile flash memory; unlimited storage via
remote network device
Image Processing Memory 512 MB SDRAM
Network Communication 2 Ethernet ports, 10/100/1000 BaseT with auto MDIX.
IEEE 802.3 TCP/IP Protocol.
Supports DHCP, static, and link-local IP address
configuration
Power Consumption 24 V DC ± 10%, 2.0 A maximum
Power Output 24 V DC at 1.0 A maximum to external light
Material Die-cast aluminum and zinc housing
Finish Painted
Mounting Four M3 threaded mounting holes. See Accessories for
supported mounts.
Pattern: 38.5 × 58.5 mm (1.52 × 2.60 in)
Weight  In-Sight 3800 with no accessories attached: 570
g (20.10 oz).
 With 45 mm plastic C-Mount cover (COV-380-
CMNT-45): 625 g (22.0 oz.) - no lens included.

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Design Qualification OCR CODING INSPECTION

Ambient/Environment 0° C to 40° C (32° F to 122° F)

Temperature
Storage Temperature -20° C to 80° C (-4° F to 176° F)
Humidity <95% non-condensing
Protection IP67 with all cables properly attached (or the provided
connector plug installed), the IP67-rated cover, or Multi
Torch attachment properly installed
Shock (Packaging) IEC 60068-2-27: 18 shocks (3 shocks in each polarity
in each (X, Y, Z) axis) 80 Gs (800 m/s2 at 11 ms, half-
sinusoidal) with
cables or cable plugs and a 150 gram or lighter lens
attached
Vibration (Shipping and IEC 60068-2-6: vibration test in each of the three main
Storage) axis for 2 hours at 10 Gs (10 to 500 Hz at 100 m/s2 /
15 mm) with
cables or cable plugs and a 150 gram or lighter lens
attached.
Regulations/Conformity CE, FCC, KCC, TÜV SÜD NRTL, EU RoHS, China
RoHS

1.2 PC Hardware Requirement

Minimum
 Intel® Celeron® 1000M processor running at 1.8GHz (or equivalent)
 2GB of available RAM
 4GB of available hard-disk space
 Video card capable of displaying 1024 x 768 resolution at 24-bit color depth (the DPI
Display setting must be set to 96 DPI)
 Network Interface Card (at least 100Mbps) for connecting to an In-Sight vision system
 OS : Microsoft® Windows® 10 Professional (64-bit), Microsoft® Windows® 7
Professional, Service Pack 1 (64-bit)
 Microsoft .NET Framework 3.5 SP1 and 4.5

NOTE : The minimum hardware requirements are for PCs that will be connecting to a single low
resolution In-Sight vision system running at a slow production speed.

Recommended
 Intel Core™ i7 processor running at 2.7GHz (or equivalent)
 4GB of available RAM
 8GB of available hard-disk space
 Video card capable of displaying 1920 x 1080 resolution at 32-bit color depth (the
DPI Display setting must be set to 96 DPI)
 Gigabit Network Interface Card for connecting to In-Sight vision systems
 OS : Microsoft® Windows® 10 Professional (64-bit), Microsoft® Windows® 7
Professional, Service Pack 1 (64-bit)
 Microsoft .NET Framework 3.5 SP1 and 4.5
NOTE : The recommended hardware requirements are for PCs that will be used to simultaneously
connect to up to four In-Sight vision systems.

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Design Qualification OCR CODING INSPECTION

2 Mechanical Overview

3 Electrical & Rejector Wiring Diagram

1. Power Source

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Design Qualification OCR CODING INSPECTION

2. Sensor

3. I/O Camera

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Design Qualification OCR CODING INSPECTION

4. Lighting System

5. PLC

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Design Qualification OCR CODING INSPECTION

6. Rejector System

7. Interlock System

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Installation Qualification OCR CODING INSPECTION

Table of Contents – Installation Qualification

1. Pre-Installation Information...........................................................................
2. Installation and Start-up Procedure..............................................................
3. Installation Qualification checklist.................................................................
4. Installation Qualification completion.............................................................

Pre-Approved of this document

Name: Sig. and Date:
PT Mitra Surya Solusindo

Name: Sig. and Date:

PT Hexpharm Jaya

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Installation Qualification OCR CODING INSPECTION

1 Pre-installation information

1.1 Equipment description

OCR Coding Inspection is fully described in this document.

Moreover, this Validation Logbook contains detailed technical descriptions of this vision
system as built.

1.2 Identification of the equipment

Manufacturer : COGNEX
Ireland
Camera type : IN-SIGHT IS3801MP-00001-SA

1.3 Check of completeness

The table “lists of components“ on the following sheet(s) contains the mechanical and electrical
components which are determined by PT Mitra Surya Solusindo for this OCR Coding
Inspection (including accessories).
The list contains:

Ident. : if necessary the visible identification of the component at the OCR Coding
inspection.
Description : name/description of the component
Type : model/article name by the manufacturer
Manufacturer : name of the manufacturer

The components are checked. If there are any deviations, it should be listed in information
update and input data at table 1.3.4.

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 Installation Qualification OCR CODING INSPECTION
1.3.1 Table “list of components”

Status:
No. Description Type Manufacturer Qty
PASS FAIL
Cognex In-Sight 3801MP
1. IS3801MP-SA COGNEX 1  
SN : 1A2337PP628558
Cognex X-Coded Ethernet
2. CCB-84901-2001-05 COGNEX 1  
Cable
3. Cognex I/O Power Cable CCB-PWRIO-05 COGNEX 1  
4. Ring Light HPR2-100SW CCS 1  
5. Trigger Sensor LR-X100 Keyence 1  
6. All in One PC ASUS AIO A3402WBA ASUS 1  
Custom
7. Control Panel Custom 1  
(MSS)

8. Power Supply S8VK-C12024 Omron 1  

9. MCB Domae C4 Schneider 1  

10. PLC NX1P2 Omron 1  

VZWF-B-L-M22C-
11. 1-Way Valve Festo 1  
G14-135-1P4-10

12. Spray Nozzle F1/4-ALMA CYCO Air 1  

Mechanical Support
Custom
13. (Mounting Bracket Custom 1  
(MSS)
Camera, Lighting & PC)

Conclusion of test:
Test Results  PASS  FAIL
Comments/
Deviation:

Performed by:

Print Name Department

Signature Date

Reviewed by:

Print Name Department

Signature Date

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 Installation Qualification OCR CODING INSPECTION

1.3.2 All in One PC Specification

No Description Specification Status

1 PC Host Name HJ-Wonder  PASS  FAIL

2 Processor Intel® Core™ i7-1255U  PASS  FAIL
3 RAM 16GB  PASS  FAIL
4 Storage 512GB SSD  PASS  FAIL
5 Keyboard Wire Keyboard  PASS  FAIL
6 Input Device Wire Mouse  PASS  FAIL
7 Operating System Windows 11 Home SL 64 bit  PASS  FAIL
8 Cognex Camera Software In-Sight Vision Suite v23.2  PASS  FAIL

Conclusion of test:
Test Results  PASS  FAIL

Comments/
Deviation:

Performed by:

Print Name Department

Signature Date

Reviewed by:

Print Name Department

Signature Date

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Installation Qualification OCR CODING INSPECTION

1.3.3 Documentation Images

1.3.3.1 Cognex In-Sight 3801MP Camera

1.3.3.2 Cognex X-Coded Ethernet Cable

1.3.3.3 Cognex I/O Power Cable

1.3.3.4 All in One PC

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Installation Qualification OCR CODING INSPECTION

1.4 Documents and certificates

1.4.1 Documents

To complete the installation of the OCR Coding Inspection, system satisfactory, it is

important that the customer defines a specific location for the following documents:

Checked:
Document description
PASS FAIL

Declaration of Conformity  

System Overview  

1.4.2 Certificates

PT Mitra Surya Solusindo provides a Production certificate in the form of a (Final

inspection prior to delivery) Certification Declaration of Conformity, which located in
the Certification section of this document, along with all other certification
documents.

1.4.3 Safety instructions

Never changes the OCR Coding Inspection Cognex I/O Power Cable without prior
knowledge and training on the OCR Coding Inspection, it contains no parts which
can be maintained by the user. In the unlikely event you experience problems with
your OCR Coding Inspection System, please contact PT Mitra Surya Solusindo
Technical Support Department.

Review all safety and environmental precautions pertaining to any drugs, media or
chemicals, which are to be used in conjunction with this equipment.

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Installation Qualification OCR CODING INSPECTION

2 Installation and start-up procedure

2.1 Installation

With the OCR Coding Inspection in position, ensuring that the following conditions are met.

2.1.1 Check that the voltage on the model plate of the OCR Coding Inspection matches the
available power supply. The User must be informed of any incompatibility problems.

2.1.2 Ensure the In-Sight Camera in the correct position.

2.1.3 Ensure All In One PC Display on and show the inspection result.

2.1.4 Install and connect any options/accessories as recorded in 1.2 of this section.

2.1.5 Cables should be routed so that they do not touch the load receptor and such that they
cannot be damaged or hinder the daily operations of the load receptor.

2.2 Start-up procedure

2.2.1 Power ON the OCR Coding Inspection System. During power-up, the Camera will perform
a self-test routine and if successful is then ready to inspect the products.

2.2.2 Open-Job on All In One PC Display when the product will be running (Example:
Job2.jobx)

2.2.3 Select Job File based on production schedule (Select Job file on the All In One PC)

2.2.4 Click ONLINE in the All In One PC so the system can work (RUN),

2.2.5 Click OFFLINE in the All In One PC so the system cannot work (STOP RUN).

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Installation Qualification OCR CODING INSPECTION

3 Installation Qualification checklist

Observations
No Steps
(PASS/FAIL)

3.1 Equipment details recorded in part 1.3 of this section.  PASS

Comments:
 FAIL

3.2 Location of OCR Coding Inspection acceptable.  PASS

Comments:
 FAIL

3.3 Declaration of Conformity filed in the Certification section.  PASS

Comments:
 FAIL

3.4 Accessories or options connected/fitted.  PASS

Comments:
 FAIL

3.5 All equipment, parts & accessories complete.  PASS

Comments:
 FAIL

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 Installation Qualification OCR CODING INSPECTION

4 Installation Qualification completion

The Installation Qualification has been performed to the procedures as laid down in this section
describing OCR Coding Inspection Installation Qualification. All results having met the specified
parameters hereby certifies, the OCR Coding Inspection system detailed in Part 1.2 (Identification
of the equipment) of this section as having been successfully installed.

It is certified that the execution of the OCR Coding Inspection system detailed in Part 1.2
(Identification of the equipment) of this section is in compliance with the specifications stated on
the purchasing order.

Conclusion of test:

Test Results  PASS  FAIL

Comments/
Deviation:

Performed by:

Print Name Department

Signature Date

Reviewed by:

Print Name Department

Signature Date

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Installation Qualification OCR CODING INSPECTION

5 Deviation Report

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Operation Qualification OCR CODING INSPECTION

Table of contents – Operational Section

Operation Qualification

1 Purpose
2 Key Process Parameters
3 Qualification Strategy
4 Conclusion of the Operation Qualification

OQ-Tests

1. Test: Power Start/Stop Control Panel

2. Test: Open Camera Software

3. Test: Communication interface between Camera and PC

4. Test: Signalling Sensor

5. Test: Run OCR Coding Inspection Program

6. Test: Matrix of Authority

7. Test: Rejection System Program

 Test: No Coding

 Test: Bad Coding

 Test: Incorrect Coding

8. Validation Operations Qualification OCR Coding Inspection Completion

Pre-Approved of this document

Name: Sig. and Date:
PT Mitra Surya Solusindo

Name: Sig. and Date:

PT Hexpharm Jaya

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Operation Qualification OCR CODING INSPECTION

1. Purpose

Operation Qualification (OQ) of the OCR Coding Inspection System follows successful
completion of the Installation Qualification (IQ). The purpose of OQ is to verify the operation
of the equipment in the intended installation and provide operator familiarization of the
equipment.

2. Key Process Parameters

Definition: Parameters that may have an adverse effect upon the performance of the OCR
Coding Inspection System.

The Key Process Parameters associated with the Operation Qualification of the OCR Coding
Inspection system are defined by the acceptance criteria in the qualification checks.

3. Qualification Strategy

Operation Qualification will concentrate on the functionality of the installation and will build on
the level of assurance already provided by Mitra Surya Solusindo control systems and
procedures. The Operational qualification is directly linked to the current installed location of
the OCR Coding Inspection System.

Prior to completion of this Operation Qualification, the Installation Qualification (IQ) should
have been completed and documented below section 4 of the IQ-document.

The Operation Qualification of the OCR Coding Inspection will be carried out by several tests
which differ in

 Tests of the function of the OCR Coding Inspection Systems

 Verification of results defect to be expected

The objective, methodology and acceptance criteria, for each qualification test identified, are
detailed within the tables which follow.
The conclusion of each test has to be documented.

4. Conclusion of the Operation Qualification

The conclusion of the complete OQ has to be documented below the last test of the Operation
Qualification.

The completion of the Installation and Operational Qualification has to be documented

additional below in chapter “Certification” of this Document Project the OCR Coding Inspection
Systems.

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 Operation Qualification OCR CODING INSPECTION

1 Test: Power Start / Stop Control Panel

1.1 Objective of test

To ensure all devices get 24V DC input
Procedure of test
1.2 PASS/FAIL
Test step Excepted Result
1.2.1 Turn Selector Switch (on control panel) Camera will be ON.  PASS
On  FAIL

Conclusion of test:

Test Results  PASS  FAIL

Comments/
Deviation:

Performed by:

Print Name Department

Signature Date

Reviewed by:

Print Name Department

Signature Date

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 Operation Qualification OCR CODING INSPECTION

2 Test: Open Camera Software

2.1 Objective of test

To ensure Camera Software (In-Sight Vision Suite) can be opened in PC
Procedure of test
2.2 PASS/FAIL
Test step Excepted Result
 PASS
2.2.1 Turn ON PC PC will be ON.  FAIL
In-sight Vision Suite Software will be  PASS
2.2.2 Open Software In-sight Vision Suite
opened  FAIL

Conclusion of test:

Test Results  PASS  FAIL

Comments/
Deviation:

Performed by:

Print Name Department

Signature Date

Reviewed by:

Print Name Department

Signature Date

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 Operation Qualification OCR CODING INSPECTION

3 Test: Open Web HMI

3.1 Objective of test

To ensure Web HMI can be opened in PC (for Camera operational)
Procedure of test
3.2 PASS/FAIL
Test step Excepted Result
 PASS
3.2.1 Open Web Browser Web Browser will be opened.  FAIL
 PASS
3.2.2 Enter Camera IP (in the address bar) Camera Web HMI will be opened
 FAIL

Conclusion of test:

Test Results  PASS  FAIL

Comments/
Deviation:

Performed by:

Print Name Department

Signature Date

Reviewed by:

Print Name Department

Signature Date

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 Operation Qualification OCR CODING INSPECTION

4 Test: Communication interface Between Camera and PC

4.1 Objective of test

To check and ensure Camera integrate with Software in PC
Procedure of test
4.2 PASS/FAIL
Test step Excepted Result
In-sight Vision Suite will detect  PASS
4.2.1 Open Software In-sight Vision Suite
Camera on In-Sight Cameras section  FAIL
Camera will be connected with In-  PASS
4.2.2 Click Easy Builder Connect sight Vision Suite*  FAIL

* In-Sight Vision Suite can only be connected using Full Access User

Conclusion of test:

Test Results  PASS  FAIL

Comments/
Deviation:

Performed by:

Print Name Department

Signature Date

Reviewed by:

Print Name Department

Signature Date

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 Operation Qualification OCR CODING INSPECTION

5 Test: Signalling Sensor

5.1 The objective of the test

To check and ensure all input sensor working
Procedure of test
5.2 PASS/FAIL
Test step Excepted Result
Trigger source switch to Camera.  PASS
5.2.1 Click Image, change Source to Camera.
 FAIL
5.2.2 Click Online Button to switch Camera to Camera will switch to Online Mode.  PASS
Online Mode.  FAIL
When Camera receive a trigger signal,
the camera will capture image and  PASS
5.2.3 Trigger the sensor (run the machine)
result will be shown in the All In One  FAIL
PC.

Conclusion of test:

Test Results  PASS  FAIL

Comments/
Deviation:

Performed by:

Print Name Department

Signature Date

Reviewed by:

Print Name Department

Signature Date

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 Operation Qualification OCR CODING INSPECTION

6 Test: Run program OCR Coding Inspection

6.1 The objective of the test

Verify the OCR Coding Inspection Running Well.
Procedure of test
6.2 PASS/FAIL
Test step Excepted Result
6.2.1 Click Open Job Button, select job file Job file Name file will appear in the In-  PASS
and click Open to Load Job file to the Sight Explorer title bar.  FAIL
system
6.2.2 Click Online Button to switch Camera to Camera will switch to Online Mode.  PASS
Online Mode.  FAIL
6.2.3 Feeding product in the conveyor / Camera will inspect the product and the
 PASS
machine inspection result (OK and NG) will
displayed in In-Sight Explorer.  FAIL

Conclusion of test:

Test Results  PASS  FAIL

Comments/
Deviation:

Performed by:

Print Name Department

Signature Date

Reviewed by:

Print Name Department

Signature Date

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 Operation Qualification OCR CODING INSPECTION

7 Test: Matrix of Authority

7.1 The objective of the test

To check each user level previllages (Access using Web HMI)

Access Name Full Protected Locked

 PASS  PASS  PASS

Connect to Camera
 FAIL  FAIL  FAIL
 PASS  PASS  PASS
Open Job
 FAIL  FAIL  FAIL
 PASS  PASS  PASS
Save Job
 FAIL  FAIL  FAIL
 PASS  PASS  PASS
Delete Job
 FAIL  FAIL  FAIL
 PASS  PASS  PASS
Edit Parameter
 FAIL  FAIL  FAIL
 PASS  PASS  PASS
Switch View
 FAIL  FAIL  FAIL
 PASS  PASS  PASS
Online/Offline
 FAIL  FAIL  FAIL

Conclusion of test:

Test Results  PASS  FAIL

Comments/
Deviation:

Performed by:

Print Name Department

Signature Date

Reviewed by:

Print Name Department

Signature Date

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 Operation Qualification OCR CODING INSPECTION

8 Test: Rejection Systems Program

8.1 Objective of test

To Check and ensure Program working and detect the NG product.
Procedure of test
8.2 OK/NOK
Test step Excepted Result
8.2.1 Feeding bad product (No Coding) in Camera will detect NG product and  PASS
the conveyor / machine Rejector will reject the Bad Product.  FAIL
8.2.2 Feeding bad product (Bad Coding) in Camera will detect NG product and  PASS
the conveyor / machine Rejector will reject the Bad Product.  FAIL
8.2.3 Feeding bad product (Incorrect Camera will detect NG product and  PASS
Coding) in the conveyor / machine Rejector will reject the Bad Product.  FAIL

Conclusion of test:

Test Results  PASS  FAIL

Comments/
Deviation:

Performed by:

Print Name Department

Signature Date

Reviewed by:

Print Name Department

Signature Date

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 Operation Qualification OCR CODING INSPECTION

9 Test: Validation Operation Qualification OCR Coding Inspection

Completion

9.1 Objective of test

The Operational Qualification has been performed, reviewed and approved according to the
procedures established by COGNEX OCR Coding Inspection and laid down in this section,
describing OCR Coding Inspection operation and verification. All results, having met the
specified parameters, hereby certify the OCR Coding Inspection as having been successfully
qualified for operation.

Operation Qualification Completed  PASS  FAIL

Comments/
Deviation:

Performed by:

Print Name Department

Signature Date

Reviewed by:

Print Name Department

Signature Date

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Conclusions OCR CODING INSPECTION

Table of Contents – Conclusions

1. Conclusion ...............................................................................................................

Pre-Approved of this document

Name: Sig. and Date:
PT Mitra Surya Solusindo

Name: Sig. and Date:

PT Hexpharm Jaya

012/MSS/2023/11/IS/IQOQ/OCR/HJ/01 Page 1 of 2
Conclusions OCR CODING INSPECTION

Dear Sir/Madam,

Based on Installation Qualification and Operation Qualification test with Quality Departement PT

Hexpharm Jaya at .................. 2023, we can conclused that OCR Coding Inspection System

(Installation, program setup, training and commisioning) has been done by PT Mitra Surya Solusindo.

Thank you for all support from production, packaging and engineering team to make this project

successfully.

Your Sincerely,

Cikarang, ........................2023 Cikarang, ............................. 2023

.......................................... ……………………………………………
Cognex Div. Spv PIC Project
PT Mitra Surya Solusindo PT Hexpharm Jaya

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