Uc 10
Uc 10
Uc 10
Learning outcomes:
LO1 : Confirm quality standards
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LO1 Establish and Confirm quality standards
What is Quality?
The ongoing process of building and sustaining relationships by assessing, anticipating,
and fulfilling stated and implied needs.
Quality is the customers' perception of the value of the suppliers' work output.
A product or process that is Reliable, and that performs its intended function is said to be
a quality product.
Quality is nothing more or less than the perception the customer has of you, your
products, and your services!
Quality is nothing more or less than the perception the customer has of you, your
products, and your services!
Quality policy
Quality policy is a document jointly developed by management and quality experts to express the
quality objectives of the organization, the acceptable level of quality and the duties of specific
departments to ensure quality.
Your quality policy should:
State a clear commitment to quality.
Recognize customer needs and expectations.
Be actively supported by senior management.
List the quality objectives you want to achieve.
Be understood by everyone in the organization.
Be consistent with your organization's goals.
Be maintained throughout your organization
Be applied throughout your organization.
Quality system
Develop a quality system and a manual that describes it. Your quality system should ensure that
your products conform to all specified requirements.
Your quality manual should:
State your quality policy.
List your quality objectives.
Provide an overview of your quality system.
Describe the structure of your organization.
Discuss your quality system procedures.
Introduce your quality documents and records.
Teach people about your quality system.
Control quality system work practices.
Guide the implementation of your quality system.
Explain how your quality system will be audited.
Quality Assurance
Quality Assurance is a system of management activities involving planning, implementation,
assessment, and reporting to make sure that the end product (i.e., environmental data) is of the
type and quality needed to meet the needs of the user.
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Quality Control
Quality Control is the overall system of operational techniques and activities that are used to
fulfill requirements for quality. The QC activities are used to produce and document the quality
of the end product.
Quality system procedures
Develop and implement quality system procedures that are consistent with your quality policy.
Develop your procedures for all areas of your quality system.
Document your procedures, and keep them up to date.
Each procedure should:
Specify its purpose and scope.
Describe how an activity should be carried out.
Describe who should carry out the activity.
Explain why the activity is important to quality.
Describe when and where it should be carried out.
Explain what tools and equipment should be used.
Explain what supplies and materials should be used.
Explain what documents and records should be kept.
Procedures may also refer to detailed work instructions that explain exactly how the work
should be done.
Manage quality
Quality is represented by how close the project and deliverables come to meeting the
client’s requirements and expectations. In other words, quality is ultimately measured by
the client.
Quality management system
Quality management system (QMS) standards establish a framework for how a business
manages its key processes. They can help whether your business offers products or services and
regardless of your size or industry. They can also help new businesses start off on the right foot
by ensuring processes meet recognized standards, clarifying business objectives and avoiding
expensive mistakes.
To comply with the standard you'll first need to implement a QMS. Implementing a QMS can
help your business to:
achieve greater consistency in the activities involved in providing products or services
reduce expensive mistakes
increase efficiency by improving use of time and resources
improve customer satisfaction
market your business more effectively
exploit new market sectors and territories
manage growth more effectively by making it easier to integrate new employees
constantly improve your products, processes and systems
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resource management - ensuring the people, infrastructure and work environment
needed to implement and improve quality systems are in place
product realization - delivering what customers want, looking at areas such as sales
processes, design and development, purchasing, production or service activities
measurement, analysis and improvement - checking whether you have satisfied
customers by carrying out other measurements of your system's effectiveness
LO2 Monitor implementation of quality
2.1 Maintenance of quality standards, system performance
"Do to others as you would have them do to you"
Have you realized the importance of Quality in your daily life.
Imagine the scooter/car you bought yesterday refuses to start today.
In every situation you must have chosen the "quality" brand with faith. You choose quality in
every walk of your life. Without Quality in each service you are receiving everyday you feel
miserable. We demand quality. Quality is important for YOU. So is for EVERYONE. When we
demand quality we have the duty to deliver quality also. As a member of society continuously
motivated for a "QUALITY" life we also do our part unconsciously. Imagine the satisfaction you
gain by giving proper directions to a lost person. You have given a quality service. We derive
tremendous satisfaction out of doing a good turn or quality work at any moment. Greater will be
our satisfaction if we extend this "Quality" aspect into each moment of our life.
Quality is more important than we realize. Quality makes life what it is.
We as professionals in software are responsible for the quality of our products. Imagine yourself
typing a 5 page document and the application crashes without saving your work. Imagine as a
data entry operator after entering 50 fields losing the data by pressing a wrong key. What it does
to you?
The faith placed in the product is shaken and you will be pretty scared to repeat the job despite
many reassurances. Faith once lost cannot be regained. As a software developer it may be a mere
bug to you. But to the user it is more than that. The quality of software depends on putting
quality at each stage of software development cycle.
Quality is not someone’s responsibility. It is everyone’s responsibility. A wrongly connected
transistor in 250 W music system can make it DUMB. A loosely fitted nut in a scooter can smash
the scooter. Quality at every stage of product development is essential for delivering a Quality
Product.
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LO3- Record Information
3.1 Ensuring basic information on the quality performance is to be recorded in
organizational procedures
Performance measures designed to move associates toward business goals can be a powerful
method for action. Because "you get what you measure," it is important to think through how and
what you measure so you can achieve the desired results. And measuring profitability is
attractive because it goes straight to the heart of every builder’s existence.
Performance measures of profitable builders are as varied as their business strategies. A good
place to start is examining your own business goals and tune-up your measures at the company
level. Then proceed to create department measures that align with company goals. Your
organization will be the winner.
Motivation in the Workplace
Motivation is the driving force by which humans achieve their goals. Motivation is said to be
intrinsic or extrinsic. The term is generally used for humans but it can also be used to describe
the causes for animal behavior as well. According to various theories, motivation may be rooted
in a basic need to minimize physical pain and maximize pleasure, or it may include specific
needs such as eating and resting, or a desired object, goal, state of being, ideal, or it may be
attributed to less-apparent reasons such as selfishness, morality, or avoiding mortality.
Job Satisfaction
Job satisfaction has been defined as a pleasurable emotional state resulting from the
consideration of one’s job; an affective reaction to one’s job; and an attitude towards one’s job.
Weiss (2002) has argued that job satisfaction is an attitude but points out that researchers should
clearly distinguish the objects of cognitive evaluation which are affect (emotion), beliefs and
behaviors.
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effectiveness by identifying and storing the items used, maintaining the area and items, and
sustaining the new order. The decision-making process usually comes from a dialogue about
standardization which builds a clear understanding among employees of how work should be
done. It also instills ownership of the process in each employee. The QCDSM program ensures
this will happen on a daily basis. In addition to QCDSM, members of senior management must
carry out periodic inspections of each target area. One common error by senior management is
never being visible on the factory floor.
5S provides the foundation for improving performance through continuous improvement. It
focuses on:
Increasing quality by removing waste from the workplace.
Provide reduction in operating costs by reducing non value added activities.
Improving delivery by simplifying processes and removing obstacles
Improving safety through improved housekeeping and identification of hazards
Provide an environment where continuous improvement is embraced through workers problem
solving and suggestions, thereby improving morale.
Simply put, 5S works best if the implementation of the program is based on the 5S Performance
Improvement Formula:
P=Q+C+D+S+M
Where;
P - Increase productivity.
Q - Improve product quality.
C - Reduce manufacturing costs.
D - Ensure on-time delivery.
S - Provide a safety working environment
M - Increase worker morale.
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LO4: Study causes of quality deviations
4.1 Determining quality Deviations and its Causes
A Standard Procedure for Quality Assurance Deviation Management
What is a Deviation?
A Deviation is a departure from standard procedures or specifications resulting in non-
conforming material and/or processes or where there have been unusual or unexplained events
which have the potential to impact on product quality, system integrity or personal safety.
Types of Deviations:
Following are some examples of deviations raised from different functional areas of business:
1. Production Deviation - usually raised during the manufacture of a batch production.
2. Quality Improvement Deviation - may be raised if a potential weakness has been identified
and the implementation will require project approval.
3. Audit Deviation - raised to flag non-conformance identified during internal, external, supplier
or corporate audits.
4. Customer Service Deviation - rose to track implementation measures related to customer
complaints.
5. Technical Deviation - can be raised for validation discrepancies. For example: changes in
Manufacturing Instruction.
6. Material Complaint - rose to document any issues with regards to non-conforming,
superseded or obsolete raw materials/components, packaging or imported finished goods.
7. System Routing Deviation - raised to track changes made to Bill of materials as a result of an
Artwork change.
When to Report Deviation:
A Deviation should be raised when there is a deviation from methods or controls specified in
manufacturing documents, material control documents, standard operating procedure for
products and confirmed out of specification results and from the occurrence of an event and
observation suggesting the existence of a real or potential quality related problems.
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Observations of a less serious or isolated nature that are not deemed Critical or Major, but
require correction or suggestions given on how to improve systems or procedures that may be
compliant but would benefit from improvement (e.g. incorrect data entry).
How to Manage Reported Deviation:
The department Manager or delegate should initiate the deviation report by using a standard
deviation form as soon as a deviation is found. Write a short description of the fact with a title in
the table on the form and notify the Quality Assurance department within one business day to
identify the investigation.
QA has to evaluate the deviation and assess the potential impact to the product quality, validation
and regulatory requirement. All completed deviation investigations are to be approved by QA
Manager or delegate. QA Manger has to justify wither the deviation is a Critical, Serious or
Standard in nature. For a deviation of either critical or serious nature QA delegate has to arrange
a Cross Functional Investigation.
For a standard type deviation a Cross functional Investigation (CFI) is not necessary. Immediate
corrective actions have to be completed before the final disposition of a batch. Final batch
disposition is the responsibility of Quality Assurance Department.
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Disclosing information obtained from employees without their written consent. An exception to
this prohibition however, is if an employee specifically threatens another person.
LO 5: - Complete documentation
5.1 Negotiation techniques and procedures
The challenge is increasing production while maintaining high quality. This process can be
difficult to measure, but best way to gauge quality is to first measure it. Use key performance
indicators (KPIs) to improve quality. KPIs help management to manage and measure both
production and quality.
Financial analysts and mangers also use KPIs as a measure of productivity.