Quality Standards Systems

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Quality Standards

Quality standards refer to sets of guidelines, systems, methods, requirements, and


specifications followed by an organization to ensure consistent process and product quality.
Mostly prevalent in manufacturing, quality standards are established by industry regulatory
boards to help drive customer satisfaction and maintain compliance. Globally, ISO quality
standards are the most widely accepted set of standards applicable to various industries.
Importance of quality standards
Any product or service that’s free from any manufacturing defect, deficiency, or process
variation is considered of good quality. This is achieved through the holistic process of quality
assurance and quality control.
Thus, to ensure and maintain good manufacturing practices, a set of manufacturing quality
standards must be established and followed for the purpose of uniformity across the entire
manufacturing process.
• Continuous improvement of quality outcomes
• Efficient adherence to regulatory requirements and compliance
• Reduced process variation and product defects
• Improved worker productivity and safety
• Enhanced customer satisfaction
• Seamless flow of operations
Principles of quality standards

• Customer focus
This guides the organization in ensuring that customer needs and expectations are met by
setting quality standards aligned with them.
• Leadership
This pertains to the organization’s commitment to implement leadership principles across the
organization to promote a healthy culture of collaboration.
• Engagement of People
This is key to maintaining worker engagement toward providing better value to the
organization and customers.
• Process Approach
This refers to the way of treating all projects and processes as part of a holistic functioning
system to drive all efforts into sustaining the business.
• Improvement
This emphasizes the need for an organization to continuously improve by encouraging
proactive innovation and consistent recognition of successful initiatives.
• Evidence-based Decision-making
This empowers people to value the importance of data and analysis and how they can put them
into practical applications such as maintaining quality standards.
• Relationship Management
This enables organizations to look at the overall supply chain management and how it affects
the processes, stakeholders, and suppliers.
Quality Systems
A quality management system (QMS) is a collection of business processes and procedures
which aims to ensure that the quality of products or services meets or exceeds customer
expectations. Such systems are typically repeatable and measurable, and rely on continuous
improvement.
A structured and documented management system describing the policies, objectives,
principles, organizational authority, responsibilities, accountability, and implementation plan
of an organization for ensuring quality in its work processes, products (items), and services.
A quality management system (QMS) is defined as a formalized system that documents
processes, procedures, and responsibilities for achieving quality policies and objectives. A
QMS helps coordinate and direct an organization’s activities to meet customer and regulatory
requirements and improve its effectiveness and efficiency on a continuous basis.
ISO 9001:2015, the international standard specifying requirements for quality management
systems, is the most prominent approach to quality management systems. While some use the
term "QMS" to describe the ISO 9001 standard or the group of documents detailing the QMS,
it actually refers to the entirety of the system.
Benefits of Quality Management Systems
• Meeting the customer’s requirements, which helps to instill confidence in the
organization, in turn leading to more customers, more sales, and more repeat business
• Meeting the organization's requirements, which ensures compliance with regulations
and provision of products and services in the most cost- and resource-efficient manner,
creating room for expansion, growth, and profit
These benefits offer additional advantages, including:
• Defining, improving, and controlling processes
• Reducing waste
• Preventing mistakes
• Lowering costs
• Facilitating and identifying training opportunities
• Engaging staff
• Setting organization-wide direction
• Communicating a readiness to produce consistent results
Elements and requirements of a QMS
Each element of a quality management system helps achieve the overall goals of meeting the
customers’ and organization’s requirements. Quality management systems should address an
organization’s unique needs; however, the elements all systems have in common include:
• The organization’s quality policy and quality objectives
• Quality manual
• Procedures, instructions, and records
• Data management
• Internal processes
• Customer satisfaction from product quality
• Improvement opportunities
• Quality analysis
Quality Management System (QMS) Principles.
Establishing and implementing a QMS
Before establishing a quality management system, your organization must identify and manage
various connected, multi-functional processes to help ensure customer satisfaction. The QMS
design should be influenced by the organization’s varying objectives, needs, and products and
services provided. This structure is based largely on the plan-do-check-act (PDCA) cycle and
allows for continuous improvement to both the product and the QMS. The basic steps to
implementing a quality management system are as follows:
• Design and Build
The design and build portions serve to develop the structure of a QMS, its processes, and plans
for implementation. Senior management should oversee this portion to ensure the needs of the
organization and the needs of its customers are a driving force behind the systems development.
• Deploy
Deployment is best served in a granular fashion by breaking each process down into
subprocesses and educating staff on documentation, education, training tools, and metrics.
Company intranets are increasingly being used to assist in the deployment of quality
management systems.
• Control and Measure
Control and measurement are two areas of establishing a QMS that are largely accomplished
through routine, systematic audits of the quality management system. The specifics vary
greatly from organization to organization depending on size, potential risk, and environmental
impact.
• Review and Improve
Review and improve detail how the results of an audit are handled. The goals are to determine
the effectiveness and efficiency of each process toward its objectives, to communicate these
findings to the employees, and to develop new best practices and processes based on the data
collected during the audit.
International Organization for Standardization
The International Organization for Standardization (ISO) is an international nongovernmental
organization made up of national standards bodies; it develops and publishes a wide range of
proprietary, industrial, and commercial standards and is comprised of representatives from
various national standards organizations.
• In addition to producing standards, ISO also publishes technical reports, technical
specifications, publicly available specifications, technical corrigenda, and guides.
• The ISO plays an important role in facilitating world trade by providing common
standards among different countries.
• ISO standards cover all fields, from healthcare to technology to manufacturing to
security to the environment.
Basic Requirements of ISO 9001
• Procedure to cover all processes in the business.
• Monitoring process to ensure effectiveness.
• Keeping adequate record.
• Defect verification and appropriate correction.
• Regular review of individual processes.
• Facilitating continual improvement.
Benefits of ISO Registration
• Increase in internal quality: reduction of scrap, rework etc.
• Production reliability: measure of breakdowns, time and shift management etc.
• External quality: acceptance by customers, less claims, return of goods.
• Time performance: marketing, delivery, production time etc.
• Cost of poor quality: scraps and rework.
Elements of ISO 9000 Quality System
The ISO-9000 norm is made of 20 different elements referring to different operations and
therefore to different parts of the company's organization. A useful exercise consists indrawing
a mapping between the company's functions and the elements of the norm.
1. Management Responsibility
In order to have a coherent approach to quality, the initiative and the control should come from
the top management. It insures you will get the product the marketing claims is selling.
Practically, the management is required to define a policy and objectives (i.e., a strategy in
terms of defect, delay, service ...); to define an organization (who's doing what and who's
reporting to whom and when); and to review the system (that is, to define review meetings and
procedures for checking whether the organization and the objectives remain adequate).
2. Quality System
The first component of the quality system is the set of procedures which will be used to
guarantee the quality in accordance with the policy and the objectives defined above. These
procedures, the way they are organized and the way they work together must be described
formally (Say what you do). Most of the procedures will be described in the following sections.
3. Contract Review
Quality here means that when a contract is signed, it will be fulfilled as contracted. This means
that only clear contracts will be accepted; that any difference between the offer and the contract
will be checked; that any modification of the contract will be taken into account adequately
and that, above all, we have the means for fulfilling the contract. Again, clear procedures are
needed here. Examples: ordering a PC with an English version of Windows (get an English
PC with English plugs !!!) Modify the order to get a QWERTY keyboard (the preloaded
software still assumed an azerty keyboard)
4. Design Control
This part is proper to the ISO 9001 norm (not in ISO 9002). To control the design, you must
first define the successive phases of the conception (the route), their organization and their
interfaces. You must then describe the acceptance/selection procedures used in each phase (this
allows the design to be proved). A special effort must be devoted to the input and to the output
of the design. Show how the input (of the design) is checked as being: legal - coherent -
complete - in agreement with the contract) and show how the output of the design is checked
as being legal, coherent and in agreement with the requirements.
These procedures must namely specify:
• How you check that output is correct (have the procedures been followed?);
• how you check that output is conformable to requirements;
• How you manage subsequent changes in the design.
• Note on the level of details needed.
• compare the level of job descriptions in a pizza hut, every job is clearly described;

5. Document Control
This ensures that documents are available and accessed by who needs them. It also ensures
that the right version has been obtained and is in use. This is in favour of using rather
procedural form to distribute documents. Example: school (communication of important and
unimportant information) For very important changes, one may ask to return or destroy the old
versions.
6. Purchasing
The question here is how you guarantee that the products you buy are of quality. In order to
Solve it you need: Prod 2100-2110 Total Quality Management to define which guarantee your
subcontractors must present.
To check these guarantees and to record your measures. In order to guarantee the products,
you get are those you wanted, you need:
• To define clearly the purchase data.
• To make a control or to get the assurance one is done.

7. Customer-Supplied Material
How do you handle the products which are supplied by the customers? (Example: containers,
material to be sent). Detail the procedure you use to inform the customer of any loss or damage.
8. Product Identification and Traceability
If necessary, define clear procedure for identifying a product from the moment it has been
received up to the moment it has been installed again. The two basic operations are: Identify
(give a unique number, maybe a lot number) and Trace (where it has been, with which
components it has been manufactured,) Examples: bar code systems; carriers must be able to
trace all the products (DHL)
9. Process Control
Here you need to plan all the processes (production, installation, services) which have an
impact on quality. This means:
• To write the procedures;
• To define what are the adequate tools and environment;
• To define the norms and check whether some equipment should not be certified
• To define how the process must be controlled and on which basis;
• To define the maintenance.

10. Inspection and Testing


You need to verify that the product you are producing satisfies the requirements. Describe
which parameters will be measured, where and how. If needed, describe also the machines
required for these measurements and describe the actions to be taken if something is not okay
(NOK). You can distinguish between the checks at the input, during processing and at the end.
If some necessary checks are skipped, then the product must be traceable and marked explicitly
as such in order to find it back later if needed. If you use sampling plans or acceptance
intervals, for Example: taste coffee.
11. Inspection, Measuring, and Test Equipment
You must ensure that the adequate testing equipment is used and that they are adequately
calibrated. You therefore need:
• To list the needed testing/measuring equipment and for each.
• To determine the required accuracy.
• To determine the operating conditions (warehousing, calibration,).

12. Inspection and Test Status


You must ensure that the controlled items are properly marked (identified) and recorded.
Define how to recognize not tested products, tested products ok, tested products not okay
(nok). Define which charts must be used for processes and how to record them. Prod 2100-
2110 Total Quality Management
13. Control of Non-conforming Product
You need to ensure that the adequate actions are taken for non-conforming products in order
to avoid using or delivering them. Tell also how they will handled afterwards.
14. Corrective Action The treatment of non-conformance must follow the following general
scheme:
• Describe clearly the problems (which test did fail, which criteria was used ...);
• Define immediate short-term responses and avoid new not okay (NOK);
• Identify the basic reason for the non-conformance;
• Define long-term corrective actions;
• Define the follow-up of these actions.

15. Handling, Storage, Packaging and Delivery


We must ensure that the product remains ok from the final test up to its delivery. The following
operations are relevant:
• Handling (how to manipulate it);
• Packaging (including identifying and labelling);
• Storing (conditions on the storage area);
• Preserving (not getting stolen or taken inadvertently);
• Delivery (use the right carrier mode and conditions).

16. Quality Records All the actions related to quality must be recorded and stored. The
objectives are:
✓ To prove you are behaving well (for certification audit);
✓ To provide you with the material needed for conducting quality improvement actions.
You should thus:
• Define how you will store these documents.
• Define how you will organize these documents.

17. Internal Quality Audits.


The need for internal audits must be clear to everybody. If you want a system to work well you
should check it from time to time. These audits must be performed by internal people who
have been trained and who are not in direct contact with the audited services. They must check
whether:
• The asks are performed as documented and well;
• The proper documents and material are used;
• The procedures are adequate (to review the efficiency of the quality system).
• You may refer to ISO 10011 for how to conduct audits.

18. Training
The training of all your people is a requirement if you want your organization to improve. With
respect to ISO-9001, you must:
• Be sure the worker can use the new machine that has been bought.
• Be sure the worker can follow the procedures which have been defined. Practically, the
training requires a complete planning.
19. Servicing
Examples of services are: a help line, a full service one year guarantee, the formation of the
customer for using the product. The notion of quality for a service is not different than that of
a product. You must: Select the quality of the service (the performance);
• Discuss what is really needed to reach these performances;
• Define the requirements, the formation, for achieving the performances.
20. Statistical Techniques
With reference to the points 9 or 10, you defined earlier how the processes (9) and how the
products (10) would be tested. These tests could be based on sampling plans or statistical
process control (SPC). In both cases, you must motivate the technique you use and describe
how you parameterize the method. Refer to the part of the course on statistical techniques.

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