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EIS HNS1 M11 0322 Apply 5S procedure new (2)

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LG-KOICA Hope TVET College
Apply 5S Procedures
EIS HNS2 M11 0322
Nominal duration: 30 Hour
Mrs. Letay Teklay
Feb. 2023
Module Title:
Revision:
January 2023
Apply 5S Procedures
Table of Contents
Module description: ........................................................................................1
1. Overview of quality .................................................................................... 1
1.1. What is quality? ..................................................................................... 1
1.2. Quality management ..............................................................................2
1.3. Quality assurance .................................................................................. 2
1.4. Quality control ...................................................................................... 3
1.5. Quality system and continuous improvement ......................................... 4
1.5.1. What is a quality system? .................................................................... 4
1.5.2. Why have a quality system? ................................................................. 5
1.5.3. Implementing a quality system ............................................................. 8
1.5.3.1 Developing a mission and vision ........................................................... 9
1.6. Continuous quality improvement ........................................................... 10
1.6.1. Why is continual improvement important to an organization? .............. 14
1.6.2. When should continual improvement be started? ................................ 14
1.6.3. How should continual improvement be undertaken? ........................... 14
1.6.4. How does a company organize for improvement?................................. 15
1.6.5. What tools should be used?................................................................ 15
1.7. Elements of quality assurance .............................................................. 16
2. Overview of 5s .......................................................................................... 4
2.1. What is 5s? ........................................................................................... 4
2.2. Why is 5s needed? .................................................................................. 6
2.3. How did 5s develop? ............................................................................... 7
2.4. Explaining the 5s methodology ............................................................... 9
By: Letay Teklay
Dept. : Information Technology
Learning guide: 1st Version
Date: Feb. 20 /2023
Nothing goes right if technology goes wrong!
Page 2 of 33
Module Title:
Apply 5S Procedures
Revision:
January 2023
MODULE DESCRIPTION:
This module aims to cover the skills, attitudes and knowledge required by an employee or
worker to apply 5S procedures (structured approach to housekeeping) to their own job and work
area and maintains the housekeeping and other standards set by 5S. The unit assumes the
employee or worker has a particular job and an allocated work area and that processes in the
work area are known by the individual.
LEARNING OUTCOMES:
At the end of this module the trainees will be able to
Develop understanding of quality system
• Sort needed items from unneeded
• Shine work area
• Standardize activities
• Sustain 5S system
LO-1 Develop understanding of quality system
1. Overview of Quality
1.1. What is Quality?
The term "quality" has a relative meaning. This is expressed by the ISO definition: "The totality
of features and characteristics of a product or service that bear on its ability to satisfy stated or
implied needs". In simpler words, one can say that a product has good quality when it "complies
with the requirements specified by the client". When projected on analytical work, quality can be
defined as "delivery of reliable information within an agreed span of time under agreed
conditions, at agreed costs, and with necessary aftercare". The "agreed
Conditions" should include a specification as to the precision and accuracy of the data which is
directly related to "fitness of use" and which may differ for different applications. Yet, in many
cases the reliability of data is not questioned and the request for specifications omitted.
Many laboratories work according to established methods and procedures which are not readily
Changed and have inherent default specifications. Moreover, not all future uses of the data and
reports can be foreseen so that specifications about required precision and accuracy cannot
even be given. Consequently, this aspect of quality is usually left to the discretion of the
laboratory. However, all too often the embarrassing situation exists that a laboratory cannot
evaluate and account for its quality simply because the necessary documentation is lacking.
By: Letay Teklay
Dept. : Information Technology
Learning guide: 1st Version
Date: Feb. 20 /2023
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Apply 5S Procedures
In the ensuing discussions numerous activities aimed at maintaining the production of quality
are dealt with. In principle, three levels of organization of these activities can be distinguished.
From the top down these levels are:
1. Quality Management (QM)
2. Quality Assurance (QA)
3. Quality Control (QC)
1.2. Quality Management
Quality Management is the assembly and management of all activities aimed at the production
of quality by organizations of various kinds. In the present case this implies the introduction and
proper running of a "Quality System" in laboratories. A statement of objectives and policy to
produce quality should be made for the organization or department concerned (by the institute's
directorate). This statement also identifies the internal organization and responsibilities for the
effective operation of the Quality System.
1.3. Quality Assurance
Proper Quality Management implies consequent implementation of the next level: Quality
Assurance. The ISO definition reads: "the assembly of all planned and systematic actions
necessary to provide adequate confidence that a product, process, or service will satisfy given
quality requirements." The result of these actions aimed at the production of quality, should
ideally be checked by someone independent of the work: the Quality Assurance Officer. If no
QA officer is available, then usually the Head of Laboratory performs this job as part of his
quality management task. In case of special projects, customers
may require special quality assurance measures or a Quality Plan.
1.4. Quality Control
A major part of the quality assurance is the Quality Control defined by ISO as "the operational
techniques and activities that are used to satisfy quality requirements. " An important part of the
quality control is the Quality Assessment: the system of activities to verify if the quality control
activities are effective, in other words: an evaluation of the products themselves.
Quality control is primarily aimed at the prevention of errors. Yet, despite all efforts, it remains
inevitable that errors are be made. Therefore, the control system should have checks to detect
them. When errors or mistakes are suspected or discovered it is essential that the "Five Ws" are
trailed:
- What error was made?
- Where was it made?
- When was it made?
- Who made it?
- Why was it made?
By: Letay Teklay
Dept. : Information Technology
Learning guide: 1st Version
Date: Feb. 20 /2023
Nothing goes right if technology goes wrong!
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Module Title:
Revision:
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Apply 5S Procedures
Only when all these questions are answered, proper action can be taken to correct the error and
prevent the same mistake being repeated.
The techniques and activities involved in Quality Control can be divided into four levels of
operation:
1. First-line control: Instrument performance check.
2. Second-line control: Check of calibration or standardization.
3. Third-line control: Batch control (control sample, identity check).
4. Fourth-line control: Overall check (external checks: reference samples, inter laboratory
exchange programs).
Because the first two control levels both apply to the correct functioning of the instruments they
are often taken together and then only three levels are distinguished. This designation is used
throughout the present Guidelines:
1. First-line control: Instrument check / calibration.
2. Second-line control: Batch control
3. Third-line control: External check
It will be clear that producing quality in the laboratory is a major enterprise requiring a
continuous human effort and input of money. The rule-of-fist is that 10-20% of the total costs of
analysis should be spent on quality control. Therefore, for quality work at least four conditions
should be fulfilled:
- Means are available (adequate personnel and facilities)
- Efficient use of time and means (costs aspect)
- Expertise is available (answering questions; aftercare)
- upholding and improving level of output (continuity)
1.5. Quality system and continuous improvement
1.5.1. What is a Quality System?
A quality system is the method an organization uses to make sure that the services it provides
are delivered as intended and meet the needs and expectations of stakeholders.
The processes that guide the way that things are done by a service provider are a key part of its
quality system. These processes direct the activities
of management and staff: what is to be done, when it is to be done, how it is to be done, for
whom it will
be done and by whom it will be done.
A stakeholder is anyone that has an interest, involvement or investment in the organization. For
services funded under the National Aboriginal and Torres Strait Islander Flexible Aged Care
Program, stakeholders include:
By: Letay Teklay
Dept. : Information Technology
Learning guide: 1st Version
Date: Feb. 20 /2023
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Module Title:
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•
service users, their families and friends
•
service staff/management/Board
•
the community
•
governments which fund the service
•
Other service providers.
Your stakeholders will have different needs and expect different things from your service. For
example:
•
service users and the community might expect that:
•
they can get the service they need when they need it
•
they can afford the cost of the service
•
their needs are met by qualified staff
•
the service is provided in a culturally safe and respectful way
•
governments which fund the service expect it to meet:
•
conditions of funding set out in the funding agreement
•
program guidelines
•
Any relevant regulatory requirements.
1.5.2. Why have a Quality System?
Most service providers believe that they provide a good service. However, it may be hard to
show this if they do not have an effective quality system.
An effective quality system includes systems and processes to:
•
Clearly identify the needs and expectations of stakeholders
•
plan and deliver the agreed services
•
check that the services delivered meet stakeholders’ needs and expectations
•
check that the services delivered are reliable and of a consistently high standard
These systems and processes are important in ensuring:
• Sustainable service delivery: A systems and process approach does not rely on one
person’s or a few peoples’ knowledge about what,
By: Letay Teklay
Dept. : Information Technology
Learning guide: 1st Version
Date: Feb. 20 /2023
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Module Title:
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Revision:
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when, how and to whom services are delivered. Rather, the ‘what, when, how and to whom’ is
written down and is available to all who may need to know.
A systems and process approach supports the delivery of the right service, at the right time, to
each person being cared for, by staff trained to provide the service. This should not change
because staff join or leave the organization.
• Consistent practice: We all hear, interpret and respond to information differently. For
example, if you ask four people to wash the bathroom floor, all four will probably do this task
differently, unless they are given specific instructions.
A systems and process focus supports service delivery that is planned, documented,
implemented, reviewed and evaluated. The use of documented systems and processes helps to
make sure that staff understand the organization’s way of delivering services.
This reduces the chance of people complaining that ‘no one seems to know what to do’ and
‘every staff member does things differently’.
An effective quality system provides tools and information to help an organization show how it
monitors, reviews and evaluates the services delivered. In short, it helps the organization to
show how it:
• measures the quality of the service provided; and
• Tries to continually improve services and outcomes for all stakeholders. An effective quality
system has processes to pick up if the way things are done may need to be changed.
The need for action or change might come about because of feedback from service users, an
accident or incident that has happened, by new policy or change in policy from a funding body,
or by the results of file audits.
For example, an audit of service user files might identify that care plans are not consistently
reviewed six monthly. Action might include:
contacting staff/calling staff together to discuss practice, recirculating the review policy and
procedure and more regular file auditing until improvement is noted.
Implementing a quality system can seem like a big task when starting. It is very important to
take the time to plan how your service will develop the quality system and who will be involved.
You will find some examples
below of things to do in the planning phase to get you started. Your service might choose to
make a checklist of these things to work through with other staff.
Examples of things to do when planning a quality system:
•
list your services stakeholders
•
check that you have a copy of all funding agreements
•
list all the regulations that your service must meet (see the
‘Resources’ section of this guide)
By: Letay Teklay
Dept. : Information Technology
Learning guide: 1st Version
Date: Feb. 20 /2023
Nothing goes right if technology goes wrong!
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Module Title:
Revision:
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•
decide who should be involved in setting up your quality system: think about those people
who know most about your service and how it works
•
ask these people to gather to talk about what systems and processes you have in place
now
•
work out how much of what you ‘do’ is written down
•
think about what else should be written down for staff
•
think about what else should be written down for the
Board/Committee
•
•
think about what else should be written down for service users
decide who is going to help with doing this and what their job will be
•
work out how long it will take to finish the job
•
plan regular gatherings to talk about how the work is going
•
decide how you will share information with service users and staff: it might be in writing
for some stakeholders or talked about at a gathering for others
•
decide the best ways for getting feedback from service users to check that they are
receiving the service that was planned to be provided and that the service is what your service
users want from your service
•
decide the best ways for getting feedback from staff to check that what is written down is
what your staff do
•
decide how you will collect this feedback, who will be responsible for recording it and
looking at it
•
plan how your service can best use feedback to improve the services you provide
•
Think about the best person in your service to be responsible for getting back to people
to tell them how the service has used their feedback.
What are the best ways to involve not only management and staff, but other stakeholders such
as service users, their families and the community in this process?
You might involve these other stakeholders by asking them about how they want to receive
information from the service and how and to whom in the service they would like to give
feedback.
All services do some things differently. Are there other things that your service might need to
think about in this planning phase because of your location, staff, service users or community?
1.5.3. Implementing a Quality system
An effective quality system must have ways to:
By: Letay Teklay
Dept. : Information Technology
Learning guide: 1st Version
Date: Feb. 20 /2023
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• Check that your service is doing what it says it will do and is doing it in the way you said it
would be done. That is, that the service is meeting its aims.
• Keep checking that stakeholder needs are being met.
The key steps in implementing an effective quality system include developing:
o Mission and Vision statements
o a Strategic Plan
o Policies and procedures.
Each of these steps is discussed in detail in the following pages.
1.5.3.1. Developing a Mission and Vision:
The first step in implementing a quality system is to be clear about what your service is trying to
achieve – what is the purpose and aim of your service?
The mission statement is usually a short statement about the purpose of an organization.
The vision statement looks to the future and is a statement about what your service wants to
achieve for its service users, the community and other stakeholders.
Some organizations also have a values statement which describes their approach to service
delivery, or their way of doing business.
Example Statements:
Mission Statement:
To make sure that all Aboriginal and Torres Strait Islander aged people get quality aged care
services that are culturally safe and available when they need them.
Vision Statement:
Our clients, their families and the community will have better health and well- being because of
the services we provide.
Values Statement:
-Our Board/Committee will understand cultural safety and use good governance practices to
ensure our service offers quality services that are continually improved.
-We will involve our clients, their families and the community in our service planning and review.
-We see each client as an individual with unique needs.
-We will make sure that each client’s needs are met in a culturally safe way.
By: Letay Teklay
Dept. : Information Technology
Learning guide: 1st Version
Date: Feb. 20 /2023
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Mission, Vision and Values statements should reflect what your service is about. As many
stakeholders as possible should be involved in having a say about them.
1.6. Continuous Quality Improvement
Once a quality system has been developed and implemented the next step is to make sure that
the results achieved for stakeholders are continually improved.
Continuous quality improvement (CQI) is about making ongoing (continuous)
effort to improve the quality of services and outcomes for stakeholders.
CQI focuses on improving systems, rather than on the performance of people or things. CQI is
used in all types of organizations as a way of leading and
managing the service; it is used to test how well systems are working, the quality of care being
given and to bring about lasting improvement.
The key elements of CQI include:
•
accountability
•
linking evaluation to planning
•
achieving improvement through incremental steps
•
being driven by input from all levels of staff, management and other stakeholders
•
a commitment to team work
•
Continuous review of progress. CQI can improve:
• accountability
• staff input and confidence
• services for clients
• the ability to recognize and meet changes in service need
• Information management, client tracking and documentation systems. To be effective, CQI
must be a strong focus within an organization that is understood and accepted by all staff and
management.
CQI should involve a variety of people, including:
• service users, families and careers
• staff and volunteers
• members of the Board/Committee of Management
• community members
By: Letay Teklay
Dept. : Information Technology
Learning guide: 1st Version
Date: Feb. 20 /2023
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• Advocates.
One way of introducing CQI is by using a quality
cycle. The quality cycle involves steps to continually evaluate and improve services and the
results for stakeholders.
The CQI model shown below is known as the ‘Plan-Do-Check-Act’ cycle.
Figure 1: Plan-Do-Check-Act Cycle - This figure shows four circles labelled Plan, Do, Check and
Act with arrows indicating that CQI does not stop and is never finished.
The circle shows that CQI does not stop and is never finished.
CQI is ongoing because there will always be opportunities for improvement, with better results
seen as each cycle is completed.
The four steps of the CQI model (quality cycle) are as follows:
Step 1: Plan
Plan what it is that you want to change or achieve. Work out what the goal is and then what you
need to do to meet it.
Step 2: Do
put the systems and processes to make the change or reach the goal in place.
Step 3: Check
Look at the results. Did the change work/was the goal achieved?
Step 4: Act
If the last step (check) found that the change was working or the goal was achieved, continue
with implementing it into your systems.
If the last step found that the change was not working or the goal not achieved you will need to
decide why it did not work and repeat the cycle, starting by planning what you need to do.
The quality cycle helps to identify opportunities for improvement. However sometimes quality
improvement activities result from ‘gaps’ that are found in
systems and processes. Action is then taken to ‘fix’ the gap (corrective action).
Corrective action might be taken in response to a complaint, feedback, an accident or incident
or where performance has not met the required standard.
Opportunities for improvement and corrective actions usually identify:
• practice and/or service delivery that does not reflect the services policy and procedure
• Where policy and/or procedure need to be reviewed or changed. An effective quality system
must have processes to make sure that opportunities for improvement are identified,
documented and reported, and that the action taken is timely and appropriate.
By: Letay Teklay
Dept. : Information Technology
Learning guide: 1st Version
Date: Feb. 20 /2023
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These processes usually include:
•
stakeholder feedback processes
•
stakeholder complaint processes
•
Incident and accident reporting
•
identification of hazards
•
staff appraisal process
•
staff grievance and disciplinary processes
•
a file auditing process.
For example, corrective action might be taken in response to the findings of service user file
audits. File audits are a quality activity and a way of checking that what staff do matches what is
written in policy and procedure. File audits might look at practices around assessment, care
planning and/or review of service user needs or staff files to check selection, recruitment and
induction processes.
A file audit involves looking at the documents in the files to check that they are completed as
required by a services policy and procedure. This usually involves using an audit tool, which is
similar to a ‘checklist’ to record the audit findings.
The audit findings should then be reported and any necessary action taken where opportunity
for improvement in documentation is identified. How the reporting and follow up occurs will
depend on each services quality system and way of doing things. For example, a manager
might select one file each week to audit and discuss the results at staff meetings.
1.6.1. Why is continual improvement important to an organization?
All managerial activity is either directed at control or improvement. Managers are either devoting
their efforts at maintaining performance, preventing change or creating change, breakthrough or
improvement. If businesses stand still
they will lose their competitive edge, so improvements must be made to keep pace and stay in
business.
1.6.2. When should continual improvement be started?
Every system, program or project should have provision for an improvement cycle. Therefore
when an objective has been achieved, work should commence on identifying better ways of
doing it.
1.6.3. How should continual improvement be undertaken?
Measurement
There is no improvement without measurement. An organization must
establish current performance before embarking on any improvement. If it does not, it will have
no baseline from which to determine if its efforts have yielded any improvement.
A ten step sequence
By: Letay Teklay
Dept. : Information Technology
Learning guide: 1st Version
Date: Feb. 20 /2023
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There are ten steps to undertaking continual improvement:
1. determine current performance
2. establish a need to improve
3. obtain commitment and define the improvement objective
4. organize the diagnostic resources
5. carry out research and analysis to discover the cause of current performance
6. define and test solutions that will accomplish the improvement objective
7. produce improvement plans which specify how and by whom the changes will be
implemented
8. identify and overcome any resistance to the change
9. implement the change
10. put in place controls to hold new levels of performance and repeat step one
Whose responsibility is it?
No one in the organization, from top to bottom, is exempt from the responsibility for
improvement. It is a normal component of all employees' jobs to search out ways of improving
performance. Furthermore, no one is expected to do this without help and support from others.
1.6.4. How does a company organize for improvement?
Most continual improvement programs are executed by teams that either diagnose problems,
search for solutions or implement changes. These teams may be within departments or crossfunctional. However, there needs to be a steering group of managers which directs the teams
towards their goal, and above all provides the environment for success.
1.6.5. What tools should be used?
The portfolio of tools used for continual improvement should be those which enable an
organization to execute the ten steps above. These include:
• Ishikawa fishbone diagram to examine cause and effect
• failure mode and effects analysis to predict failure and prevent its occurrence
• Pareto analysis to identify the few influences on a situation which have the biggest impact
• force field diagram to display the forces for and against change
• charting techniques to demonstrate whether improvement is being achieved
Changing the culture
By: Letay Teklay
Dept. : Information Technology
Learning guide: 1st Version
Date: Feb. 20 /2023
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Continual improvement is far more than a set of techniques. For many organizations, it involves
a radical change in attitudes. The defense of the status quo, and resistance to innovation,
cannot be treated as normal management behavior. A fear of reprisals for reporting problems
has to be replaced by congratulating people for identifying an opportunity to improve. Hoarding
of good ideas within departmental walls must be a thing of the past as people share their
knowledge and experience in the search for greater collective success.
1.7. Elements of quality assurance
Quality Assurance (QA) is a way of preventing mistakes or defects in manufactured products
and avoiding problems when delivering solutions or services to customers. QA is applied to
physical products in pre-production to verify what will be made meets specifications and
requirements, and during manufacturing production runs by validating lot samples meet
specified quality controls. QA is also applied to software to verify that features and functionality
meet business objectives, and that code is relatively bug free prior to shipping or releasing new
software products and versions.
Quality Assurance refers to administrative and procedural activities implemented in a quality
system so that requirements and goals for a product, service or activity will be fulfilled. It is the
systematic measurement, comparison with a standard, monitoring of processes and an
associated
feedback loop that confers error prevention. This can be contrasted with quality control, which is
focused on process output.
Two principles included in Quality Assurance are: "Fit for purpose", the product should be
suitable for the intended purpose; and "Right first time", mistakes should be eliminated. QA
includes management of the quality of raw materials, assemblies, products and components,
services related to production, and management, production and inspection processes.
Suitable quality is determined by product users, clients or customers, not by society in general.
It is not related to cost, and adjectives or descriptors such as "high" and "poor" are not
applicable. For example, a low priced product may be viewed as having high quality because it
is disposable, where another may be viewed as having poor quality because it is not disposable.
Quality Assurance elements
1-Leadership
2- Training
Building facilities, equipment
Design and installations
4-Technical Standards
5-Written procedures
6-Validation
7- Housekeeping, Pest control
By: Letay Teklay
Dept. : Information Technology
Learning guide: 1st Version
Date: Feb. 20 /2023
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Sanitization & Maintenance
8- Materials
9- Making operations
10- Packing operations
11- Storage & Handling of
Finished products
12- Laboratory Control
13- Process Control
14- In process & Finished Product
Release & control
15- Records
16- Self-improvement program
17-Consumer & Customer
Learning & Response
18-Quality system Results tracking and improvement
19-Accountability for contractors
1. Leadership
Clear Communication of a Commitment to Quality “Right First time” product
- Establishes Clear Responsibilities for Quality
- Gaps Identified and Acted on Promptly
-Organizational Design & Capability
-Recognition of Quality Contributions
What to Check?
• The performance behavior of leadership demonstrates a commitment to quality
• Leadership ensures quality responsibilities are adequately staffed for all areas of the business
Is there a quality improvement process? Does management play a role in this effort?
2. Training
It is combination of Education, Training and Practical experience.
By: Letay Teklay
Dept. : Information Technology
Learning guide: 1st Version
Date: Feb. 20 /2023
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ls are capable of doing the job
Part of Continual Improvement
n
To promote efficient operations
ability within the organization
What to Check
functions
assessment)
loyees have received training in contamination prevention (i.e.,
proper handling of product)
sponsibilities and
expectations
ng in special skill areas such as microbiology, statistics
etc.
3. Building Facilities, Equipment Design &Installation
What to Check?
•
The facility does not have design flaws that lend itself to contamination
•
Facilities are adequate lit, ventilated for the work being done
• Sufficient space must be provided around and beneath equipment to facilitate proper
operation, maintenance, cleaning, and sanitization and prevent mix-ups
•
Facilities designed to handle micro susceptible products
(Ex. water, packing line equipment
4. Technical Standards
What to Check?
• Procedures are in place to ensure that only current, approve specifications and standards are
being used
• Approved, current formula cards & specifications are being used to produce and/or package
the product
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Dept. : Information Technology
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Date: Feb. 20 /2023
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• Specifications are defined and tested against to ensure the quality and safety of the product
• The product meets all regulatory requirements
• Validated test methods are being used to evaluate raw materials, bulk and finished product
• Stability testing has been conducted to support the stability of the finished product
• Master standards are used to evaluate product quality
5. Written Procedures(SOP)
What to Check
• Approved procedures covering all appropriate Operations/regulations are current and in place
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• Written procedures match actual practice?
• Approved procedures are reviewed regularly
What Needs to Be Validated?
•
Products/processes
•
Laboratory/testing methods
•
Storage conditions (e.g. HVAC - Heating, Ventilating, Air Conditioning)
•
Cleaning & sanitization procedures
•
Computer systems
•
Other critical procedures
7. Housekeeping, Pest control Sanitization & Maintenance
What to Check?
•
Evidence of effective pest control procedures
– No evidence of infestation
– Electrocutes in place
– Rodent traps visible
•
Evidence of leaky walls, roofs or ceilings exist or nor chipping, flaking paint is evident
•
Evidence of effective housekeeping in the facility
•
Exterior doors (including dock doors) are closed when not in use, or insect screens are
used to protect openings
•
Evidence of standing water in & around building
By: Letay Teklay
Dept. : Information Technology
Learning guide: 1st Version
Date: Feb. 20 /2023
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•
The warehouse has a neat and orderly appearance
8. Storage & Handling of Finished Product Loading Operations Delivery vehicle Inspection
Nothing goes Vehicles free from:
• Strong odors, Structural damage, Pests, Dirt, water or other contamination
• Other unauthorized goods or materials Load Protection
– Standard loading procedures
– FLT driver training
– Void fillers & other devices
– No loose items
– Vehicle not over-loaded
What to Check?
• Approved product is segregated from product pending and rejected product in the warehouse
• Procedures are in place to ensure that approved product is shipped to the appropriate location
• Approved product is shipped on a FIFO basis
9. Laboratory Controls
What to Check?
• Equipment is qualified prior to use to ensure that it is operating within the appropriate ranges
• Equipment is maintained to ensure that it is functioning properly and prevents product
contamination
• Test methods being used are validated or have demonstrated the ability to produce consistent,
reliable results
• A procedure exists for handling out-of specification results
• Staff would be competent to perform the analyses required for the new product
Records
Cleaning & Sanitizing records are available to demonstrate cleaning &
sanitizing of equipment and for traceability for problem solving
• Making & packing Master Production Records are kept for each lot of product produced to
ensure traceability and reproducibility of the batch
• Records are maintained documenting testing conducted on the product and corresponding
results to support the approval and release of the product
• Out-of-specification investigations and deviations to the making and packing operations are
appropriately documented.
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• Consumer complaint investigations are appropriately documented
• Records are kept on all receipts and usage of materials
• Records of maintenance and calibration operations are documented
LO-2 Understanding and applying 5s
2. Overview of 5s
2.1. What is 5S?
5S is the name given to a methodology developed in Japan by Toyota for organizing, cleaning,
developing, and sustaining a productive work environment. The 5S methods, when correctly
applied, substantially reduce waste and optimize all aspects of productivity by maintaining an
orderly and efficient workplace. 5S is a key element of the Lean Manufacturing methodology.
The 5S name is derived from five Japanese words, which when translated into English, the
closest equivalent words start with the letter S. The five functions identified by 5S are known as
Pillars.
The 5S Pillars are defined and identified in the following table.
Closest English Translation Direct Japanese Translation Japanese Word Variations Used
Sometimes Equivalent Words Used Sometimes in Definitions Extended Meaning
Sort Seiri Sorting Clean up, Tidiness, Classify, Simplify Organization Sort out what is
needed and what is not needed. Set In order Seiton Straighten, Set
Arranging, Orderliness,
Configure Arrange essential items in order for easy access Shine Seisô Sweeping,Sweep,
scrub Neatness, Cleanliness, Clean and Check Keep machines and work areas clean
Standardise Seiketsu Standardizing, Standardization, Systemizes, Standards Discipline,
Conformity, Make Visual Make cleaning and checking a routine practice Sustain Shitsuke
Sustaining, Self-discipline Ongoing Improvement, Custom and Practice Make the 5S's a way of
life. Requires discipline.
5S is occasionally and incorrectly characterized as a standardized cleanup or a housekeeping
methodology. However, this is very misleading because organizing a workplace goes way
beyond any clean and tidy type philosophy.
In recent times a Sixth S has been introduced by some organizations to help further highlight
and drive Safety aspects in the workplace.
2.2. Why is 5S needed?For many years now industry has recognized that good housekeeping is
fundamental to a safe working environment.
Over the years productivity has become more efficient through the use of planning,
organizational and system tools that include:
•
MRP – Material Requirements Planning
•
MRPII – Manufacturing Resource Planning
•
JIT – Just In Time
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•
TQC – Total Quality Control
•
Kanban – A signaling system to trigger an action, e.g. replace stock
•
TPM – Total Productive Maintenance
•
QFD – Quality Function Deployment
•
Kaizen – An incremental approach to Continuous Improvement
•
Lean Manufacturing – Optimizing productivity
Although it is beyond the scope of this guide to specifically discuss any of the above
methodologies, they are mentioned here because the 5S methodology influences all of them
and is a key element in several of them.
2.3. How did 5S develop?
The evolution of some of the world’s best practices and standards in the manufacturing industry
were started in Japan at the turn of the 20th century by Sakichi Toyoda the founder of the
Toyota textile factory with looms that stopped when a thread broke.
Sakichi’s response to this problem was to have one of his workers watch the loom where the
thread tended to break, so that firstly, the break could be fixed immediately to reduce down time
and secondly, to identify what was causing the break so it could be fixed permanently. This is
considered by many to be the beginning of Autonomation, i.e. intelligent automation or
automation with a human touch - the
first step towards making a manufacturing process more efficient.
-In-Time (JIT)
Toyota is considered to have started the JIT methodology in 1934 when the company moved
from textiles to vehicle manufacturing. Kiichiro Toyoda, Sakichi’s son and the founder of Toyota
cars, managed the engine casting works where there were numerous problems with the
manufacturing process and quality.
In 1936, when Toyota won its first truck contract with the Japanese government the processes
hit new problems. The on-going problems and a substantial contract caused Kiichiro to take a
different approach to resolving the manufacturing problems and From this he developed the
Kaizen improvement teams.
Toyota Production System (TPS)
During the post Second World War years a delegation from Toyota lead by Taiichi Ohno, an
engineer, visited the United States to study its commercial enterprises. They visited several
Ford Motor Company plants because Ford was an industry leader at the time. The Toyota
delegation was unimpressed with the ineffective methods, the large amounts of inventory and
the uneven amounts of work being performed in various departments within the factory.
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However, on their visit to Piggly Wiggly, an American supermarket, the delegation was inspired
by how the supermarket only reordered and restocked goods once they’d been bought by
customers. They were particularly impressed with a simple idea used in an automatic drink resupplier – when the customer wants a drink, he takes one and another replaces it.
Taiichi Ohno used the lessons of the United States visit and built on the already existing internal
schools of thought and spread their breadth and use into what has now become the Toyota
Production System (TPS). Taiichi Ohno, Shigeo Shingo and Eiji Toyoda developed the system
between 1948 and 1975. TPS included the expansion of the JIT methodology, which was the
precursor to the more generic Lean Manufacturing.
The main goals of the TPS are to:
• Design out overburden
• Eliminate inconsistency
• Eliminate waste
Through the use of TPS Toyota:
• Reduced lead times
• Reduced costs
• Reduced stock holdings
• Improved quality
This enabled Toyota to become one of the ten largest companies in the world. It is currently as
profitable as all the other car companies combined and became the largest car manufacturer in
2007.
The Toyota Production System has been compared to squeezing water from a dry towel. What
this means is that it is a system for thorough waste elimination. Here, waste refers to anything
which does not advance the process, everything that does not increase added value.
2.4. Explaining the 5S Methodology
Overview
5S is typically associated with other key industry tools such as, Kaizen, Lean Manufacturing and
Continuous Improvement programs. However, it can stand alone and will work in any
environment, e.g. the workplace, your home, your PC and even in your own head.
5S is a philosophy and a way of organizing and managing the workplace, especially a shared
workplace (like a shop floor or an office space) and keeping it organized.
5S is a system to improve efficiency by eliminating waste, improving flow, reducing process
unreasonableness and optimizing productivity through maintaining an orderly workplace and
using visual cues to achieve more consistent operational results.
5S is a method of cleaning up and organizing the workplace using its existing configuration.
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The key targets of 5S are workplace morale and efficiency. The assertion of 5S is, by assigning
everything a location, time is not wasted by looking for things. The correct ordering of items or
activities promotes a smooth work flow. Tools should be kept at the point of use so workers do
not have to repetitively move or bend to access materials. Flow paths can be altered to improve
efficiency. Additionally, it is quickly obvious when something is missing from its designated
location. The benefits of this methodology come from deciding what should be kept, where it
should be kept, and how it should be stored.
5S is a cyclical methodology designed for continuous improvement as illustrated by the
following diagram.
Although the process of applying the 5S principles is best illustrated with a circular diagram
because it is a continuous process, there is a logical sequence for implementing the 5S
methodology.
For example, it would not be very sensible to spend time tidying and rearranging everything on
a work bench if many of the items currently on the bench are not required for your current job.
The following diagram illustrates how to use the 5S process for:
• Implementation
• Continuous improvement
• Disposal decisions, as required
The Five S’s are discussed in detail on the following section using the implementation
sequence. The first step is Sort.
Sort (Seiri) Overview
Sort is the first step in the 5S process. This task refers to the practice of identifying all the items
you need to fully and safely perform your current job function and the removal of any
unnecessary items from your workplace.
The workplace includes all areas or space for which you are responsible, e.g. bench top, under
the bench, shelves, draws, shop floor, storage containers attached to machinery, walls and
building supports.
Unnecessary items can be tools, equipment, materials, rubbish or anything
that is causing clutter, with clutter being anything that is not essential for your current job
function.
The Sorting process can also creating more space in which to work and move around in and
have the effect of a general cleaning and tidying to the area involved.
You will need a ruthless approach to this task, but do not be careless and avoid keeping items
for JIC (Just in Case) reasons.
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Categorizing Unwanted Items
The Sort visual method of identifying unwanted items is called Red Tagging. This involves
placing a red tag on selected items that are not needed in your workplace. You could just place
a red tag on everything to be moved from your work area to a designated holding area for
unwanted items. However, a more beneficial approach is described below.
All the items identified as being unnecessary can be categorized as follows.
1. Rubbish
This can be immediately disposed of in the appropriate waste container.
2. Wrong Location
Items to be returned to their correct location – can be done immediately
3. Green Tag
Items identified as needed, but not by your work area – attach a Green Tag (sample below) and
place in the holding area identified for surplus and unwanted items.
This could include items that are used in your work area, but you either rarely use them so they
can be stored at another location or you don’t need multiple quantities of the same item.
4. Yellow Tag
Items identified as something that may be needed, but are only to be kept for a short time
before disposal – attach a Yellow Tag (sample below) and place in the holding area identified
for surplus and unwanted items
This could include damaged tools that may be repairable if they are still needed, out of date
items that could be recycled
or materials that could be used in another area
5. Red Tag
Items identified as clearly not having or no longer having any useful purpose in your work area –
attach a Red Tag (sample below) and place in the holding area identified for surplus and
unwanted items
This could include items that may be, but are not necessarily rubbish because they could have a
rework or scrap value. If not, the decision should made
quickly for disposal as rubbish.
Holding / Disposal Area
Leaving items in a designated holding / disposal area for a short time, typically no more than
two weeks, allows you time to recover any item that you discover you do need.
The temporary location of items in this area also allows time for the appropriate people to make
the necessary, redistribution, repair, scrap or rubbish assessments.
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Some items, like unwanted chemicals, will have to be identified for disposal in accordance with
the appropriate environmental procedures
The Advantages of Sort
If the Sort methodology is fully implemented in your workplace, you will recognize the following
changes and improvements.
1. More space in all work areas that can be left as desired working space or used for new
equipment to aid productivity.
2. Less clutter making it easier and safer to do your job.
3. Fewer hazards when moving around your workplace.
4. Improvements in work flow, quality and productivity.
5. Many tasks can become simplified.
6. Time is not wasted looking for tools and material.
7. Unnecessary storage does not form walls making communication more difficult.
8. No unnecessary tools, equipment and materials to get in the way.
9. Easier to identify tools and equipment that need maintenance.
10. Future purchases and the introduction of new items into the workplace are done with more
care and consideration.
Summary
The practice of Seiri can be succinctly described as:
• Keeping the essential
• Storing the useful
• Discarding everything else
Discarding should be without concern because everything that remains should promote
productivity.
The old adage of, When in doubt, throw it out, can be readily applied to the practice of Seiri.
Set In Order (Seiton) Overview
Set in Order is the second step in the 5S process. This task refers to the practice of creating
efficient and effective storage methods for arranging items so that they are easy to use and to
label them so that they are easy to find and store.
Set in Order can only be implemented after Sort has cleared the work area of unneeded items.
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Set in Order means arranging the tools and equipment in an order that promotes work flow.
Tools and equipment should be kept where they will be used and the process should be ordered
in a manner that eliminates extra motion.
Preparing Storage Locations
Ask yourself the following questions:
• What do I need to do my job?
• Where should I locate this item?
• How many of this item do I need?
This optimized approach to organizing your workplace requires a series of visual controls to be
really effective. These can include:
•
Shadow boards for tools and light weight equipment indicating where every item is
stored and readily known if it is missing
•
Painted lines on floors outlining work areas and other specific locations
•
Modular shelving and cabinets with the space on them and in them purpose built for
what they are required to store
•
Open storage is preferred – only use doors when absolutely necessary
•
Label all shelves and cabinets so that items stored in them is always easy to locate and
can be returned to its correct storage location.
Imagine how much easier and simpler a menial task like needing a broom would be if it was
always stored in the same location. Spending ten minutes walking around asking other people if
they knew where the broom was just so you could clean up something that was only going to
take about 30 seconds, would be grossly inefficient.
Establishing Specific Locations for Items
Ask yourself the following questions:
• Why are items located where they are?
• Where should each item be?
• Are tools and equipment easy to see, easy to get and easy to return?
Frequently used items should be the most accessible. All items should be sequenced logically
and in order of use with consideration given to reducing bending, stretching and excessive
movement. Heavy items should have a permanent and convenient location or be fitted with
wheels.
This orderly approach to arranging workplace items will contribute to you creating a consistent
and more efficient way to carry out tasks because what you need will always be where you need
it. This can help eliminate several types of waste, e.g:
• Your energy
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• Excessive inventory
• Defective products
• Caused by unsafe conditions
If similar work areas were consistently organized in the same way, this approach to
standardizing the workplace would mean that you could perform tasks in another work area.
You would find it just as easy to use as your own because you would immediately know where
all the required items were stored and that they would be in good working order.
Organization and design in the workplace promotes:
• Efficiency
• Safety
• Positive attitudes
Summary
The practice of Seiton can be succinctly described as:
• Keeping tools and equipment where they are used
• Ordering items to eliminate unnecessary motion
• Allocating locations for each item
• Labelling each location to identify what is stored there
Shine (Seisô) Overview
Shine is the third step in the 5S process. This task refers to the practice of thoroughly cleaning
the work area including tools and equipment.
Shine can only be effective after you have removed the clutter (Seiri) and organized (Seiton)
your work area. In some instances it may be practical to shine some items at the same time as
performing Set in Order.
Daily follow-up cleaning is necessary in order to sustain this improvement. At the end of each
shift, the work area should be cleaned and all items restored to their place. This makes it easier
to remember what goes where and for other people to find things because they know where
they are located.
The key point is that maintaining cleanliness should be part of the daily work - not an occasional
activity initiated when things get too messy. Everybody is happier and more productivity in a
clean environment.
It is important that Shine applies to the whole workplace. For example, it would be inappropriate,
perhaps even careless, to have a maintenance task to perform on a precision product that was
sitting on a spotless work bench and then all you had to complete the repair were dirty greasy
tools. As lack of care tends to extend through all things, tools of this nature could also be of
questionable repair.
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The Basic Principles of Shine
The following functions are necessary for a successful Shine program.
1. Determine the assignment of the cleaning tasks – who is responsible for which areas.
2. Schedule who is to clean what and at which times on which days.
3. Specify what equipment is needed for each Shine task.
4. Specify how each item is to be cleaned.
5. Where possible schedule small cleaning tasks to be completed as a quick fill-in task to help
prevent Shine activities becoming a burden on production.
Remember workplace cleanliness is the responsibility of everybody who works in the space.
The Benefits of Shine
Working in a clean environment enables you to:
• More readily notice changes in equipment and identify problems before they become a fault
or a breakdown that could lead to expensive repairs and loss of production, i.e. preventative
maintenance
• Ensure that tools and equipment are always ready to use
• Work more safely and more productively with less effort
• Have a positive attitude about your workplace
• Maintain a better standard of health
• Create a good impression that will have a positive effect on everybody who is involved with
your work area
A Full Shine Program
A full Shine program discusses establishing a shine method for each item in each area. This
includes such elements as agreeing to an inspection at the beginning of each shift, establishing
exactly how each activity within the program is to be carried out. The aim is to internalize the
activities as much as possible to minimize the downtime needed to keep the facilities clean.
A full Shine program also discusses the preparation required to make sure that the required
cleaning equipment is always available and always ready for use. The set up for this has been
compared to Formula One maintenance teams preparing to change tires. Obviously, this is an
extreme example, but the point is one of common sense. It would be silly to allocate
minutes to brush clean an item of equipment if the operator has to spend 4 minutes finding the
brush.
Summary
The practice of Shine can be succinctly described as:
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• Maintaining cleanliness daily, not just occasionally
• Making cleanliness a part of the work, not an extra task
• Cleaning is done by everybody
• Everything is to be cleaned
Standardize (Seiketsu) Overview
Standardize is the fourth step in the 5S process. This task refers to the practice of standardizing
best practice in your work area by developing methods to maintain the achievements of the first
three steps and to prevent the reoccurrence of the old bad habits.
Once you have made the effort to tidy, organize and clean the work area, you need to ensure
your efforts and new found disciplines are not slowly lost. This means creating a consistent and
standardized approach to workplace tasks with everybody being fully aware of their
responsibilities.
This is the stage where 5S can fail if you underestimate how difficult it can be to maintain what
has been achieved up to this point. Continued training for the required discipline to become a
habit is essential.
Standardize can be referred to as the means by which the first three steps are maintained. It is
a control method and not a doing activity.
Tools for Making 5S a Habit
5S needs to be a habit to be successful. This is achieved, firstly by following a set of procedures
to develop the habit, and secondly by integrating the 5S
routines into your daily workplace schedule so that you are almost performing them
automatically without much thought being required.
The following points are guidelines that should be included in a 5S procedure. This list is not a
procedural sequence, as this will depend on the requirements of your workplace, nor is it
exhaustive. It can vary or be added to depending on your workplace situation.
1. Write a clear and easy to understand procedure explaining what is expected of everybody
to maintain their work area to the required 5S standard.
2.
Assign job responsibilities for the first three steps (i.e. Sort, Set In
Order and Shine) and integrate them into regular work tasks.
3. Develop a 5S Job Cycle – This is essentially a schedule for the regular maintenance of the
5S methodology and typically involves the use of charts and other visual aid signs in appropriate
locations in the workplace.
4.
Develop 5S checklists to assist with ensuring complete and timely checks.
5.
Develop 5 minute 5S tasks that can be integrated with normal workplace tasks.
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6. Introduce random 5S Audits to assist with maintaining a constant standard. When using the
random audit approach, it is the 5S way to praise good work and constructively highlight areas
for improvement. No negativity.
7. Use red tagging if required to help bring 5S back on track – help prevent the accumulation
of unneeded items.
8. Use people from other areas to help identify 5S slippage, as required, because a fresh eye
will notice bad habits creeping back, e.g. notice if equipment and materials are getting dirty.
Summary
The practice of Seiketsu can be succinctly described as:
• Operating consistently
• Everybody knowing their responsibilities
• Detecting and correcting abnormalities immediately
Sustain (Shitsuke) Overview
Sustain is the fifth step in the 5S process. This task refers to the practice of maintaining the
cultural change in the workplace and reviewing the 5S standards. Once the previous 4S's have
been established they become the new way of operating.
However, when an issue arises such as a suggested improvement, a new way of working, a
new tool or a new output requirement then a review of the first four S's is appropriate.
Sustain is by far the most difficult S to implement and achieve. It is human nature to resist
change and many organizations have found themselves with a dirty cluttered workplace after
just a few months following their attempt to implement 5S. The tendency is to return to the
status quo and the comfort zone of the old way of doing things.
Sustain is a program for continuous improvement and focuses on defining a new status quo and
standard for work place organization to prevent a gradual decline back to the old ways of
operating.
Once fully implemented, the 5S process can increase moral, create positive impressions on
customers and increase
efficiency and organization. You will feel better about where you work, the effect on continuous
improvement can lead to less waste, better quality and faster lead
times. Any of which will make your
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organization more profitable and competitive in the market place.
Difference between Standardize and Sustain
There is a fundamental difference between Standardize and Sustain. Standardize introduces a
formal and consistent program to ensure that the benefits of successfully implementing, Sort,
Set in Order and Shine are maintained. While Sustain is the mechanical means by which 5S is
monitored and refined. It is a set of approaches used to help make 5S second nature to people
in the workplace by continuously applying good practice, cleaning and organization.
The method by which Sustain is achieved largely depends on the ongoing commitment of
management, the workforce and the culture already in place.
Creating the Conditions for Ongoing Improvement
5S cannot change the way of the world. There will still be things like breakages and spills in the
workplace. The lessons of 5S can help:
• Identify the causes
• Rectify the problem
• Reduce the possibility of the same problem reoccurring Keep records that identify potential
workplace problems and the known causes. Build resolutions into the 5S maintenance program.
There are many procedures and guidelines that can be implemented in your workplace to
sustain the 5S program. These can include the following and other measures depending on the
requirements of your workplace.
1. A 5S training program to aid the understanding necessary to maintain the
5S methods.
2. Management needs to fully support and understand the program.
3. The company needs to create and promote the correct environment.
4. Production plans need to ensure that time is available. People need to be comfortable about
stopping production tasks to perform their scheduled
5-minute 5S tasks.
5. The 5S Audit program must ensure that any findings requiring action are carried out.
6. Tools for sustaining 5S include maintenance cards, signs, posters, newsletters, pocket
manuals, team and management check-ins, performance reviews and department tours.
7. The 5S Maintenance Cards should be protected and displayed in an obvious place to be
completed after each inspection.
8. The 5S checklists should contain a list of agreed items for each work area.
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9. Inspections of a work area should only take a couple of minutes. If longer is required
improvements are probably needed to the work area concerned.
10. The person inspecting must be committed to and fully understand the 5S
methodology.
11. If anything in a work area is missing, needs repair or replacement, the person responsible
for that work area should take corrective action immediately.
12. There needs to be a program of reward and recognition for people who have put in the effort
to support 5S by maintaining their work area in accordance with the required procedures.
13. The constant review process demands that the schedules are updated and clearly visible to
everybody concerned.
14. There should be a 5S area, operated by the 5S Coordinator, where individuals or work
teams can obtain supplies, information and assistance for their 5S tasks.
Summary
The practice of Shitsuke can be succinctly described as:
•
Making 5S a way of life
•
Focusing on continuous improvement
•
Eliminating bad habits
The 5S Benefits Summary
The key benefits of the improved processes supplied by the 5S methodology are:
•
Reduced set-up times
•
Reduced cycle times
•
Greater efficiency in achieving goals
•
Increased floor space
•
Lower safety incident / accident rate
•
Fewer hazards
•
Greater readiness for new tasks
•
Less wasted labor
•
Less spending on replacing lost or damaged items
•
Better equipment reliability
•
Less stress
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•
Greater self-esteem
Using 5S for Waste Management
The five steps of 5S can be readily applied to the requirements of waste management at any
time.
Categories of Waste
Fundamental to the successful implementation of 5S is recognizing the thing we call Waste. To
accomplish this, you can identify the problems using the following seven categories or forms of
waste known by the acronym COMMWIP.
This is explained in the following table.
Seven Forms of Waste
Examples of Waste
Correction
Re-doing a report, repairing a part or re-
doing a service
Over-production
Running unneeded copies
Movement of Material
Taking more steps than necessary to
complete a task
Motion – excess for people
Material being routed through many steps
Waiting
Waiting to do work or items waiting on a
process
Inventory
Old office or business supplies that no
longer have value but are still being stored
Process / Procedure – lack or faulty
Re-doing things because of a cumbersome procedure
There are examples of waste all around us that are just taken for granted. Once you gain an
understanding of a problem, you can begin to identify waste encountered everywhere in your
daily lives.
Benefits of Waste Control
Good waste management and control can see over a 50% improvement in inventory, but with
the application of 5S there are many other benefits. These include:
• Improved organizational efficiency
• Reduced waste in all forms
• Cutting hidden and direct costs
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Dept. : Information Technology
Learning guide: 1st Version
Date: Feb. 20 /2023
Nothing goes right if technology goes wrong!
Page 32 of 33
Module Title:
Revision:
January 2023
Apply 5S Procedures
• Cutting down employee frustration when, the system doesn’t work
• Improved speed and quality of work performance
• Improved safety
• creating a visually attractive environment
Visual Workplace and Waste Control
The visual workplace established by the implementation of 5S helps to reduce or eliminate
many different kinds of waste in the workplace.
For example, proper signs may stop numerous people from having to ask directions. Proper
labels for tools, equipment and supplies may help you to choose the correct part during
maintenance, thus reducing the risk of an injury because something could fail later.
By: Letay Teklay
Dept. : Information Technology
Learning guide: 1st Version
Date: Feb. 20 /2023
Nothing goes right if technology goes wrong!
Page 33 of 33
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