Understanding variation
shows the sources variation that affect most manufacturing processes. Different lots of
material may vary a strength, thickness or moisture content, for example, cutting tools have
inherent variation in their strength and composition. During manufacturing, tools experience
wear, vibrations cause changes in machine settings and electrical fluctuation cause variation in
power. Measurement gauges and human inspection capabilities are not uniform. Even when
measurements of several items by the same instruments are the same, it is due to a lock of
precision in the measurement instrument, extremely precise instrument always reveal slight
differences.
Some of the operational problems created by variation include the following
- Variation increases unpredictability: if we don’t understand the variation in a system,
we cannot predict its future performance.
- Variation reduces capacity utilization: if a process has little variability, then managers
can increase the load on the process because they do not have to incorporate slack in to
their production plans.
- Variation contributes to a “Bullwhip” effect: this well-known phenomenon occurs in
supply chain, when small changes in demand occur, the variation in production and
inventory levels becomes increasingly amplified upstream and distribution centers,
factories and suppliers, resulting in unnecessary costs and difficulties in managing
material flow.
- Variation makes it difficult to find root causes: process variation makes it difficult to
determine whether problems are due to external factors such as raw material or reside
within the processes themselves.
- Variation makes it difficult to detect potential problems early: unusual variation is a
signal that problem exist; if a process has little inherent variation, then it is easier to
detect when a problem actually does occur.
The complex in interactions of these variation in material, tools, machines, operators,
and the environment are not easily understood. Variation due to any of these individual
sources appear at random; individual sources cannot be identified or explain. These
factors are present as a natural part of a process and are referred to as common causes
of variation. Common causes are a result of the design of the product and production
system and generally account 80 to 95 percent of the observed variation in the output
of production process. Therefore, common cause variation can only be reduced if the
product is redesigned, or if better technology or training is provided for the production
process.
The Funnel Experiment was devised by Dr. Deming to describe the adverse effects of
making changes to a process without first making a careful study of the possible causes
of the variation in that process. He referred to such process “worsening" efforts as
“tampering.”
Quality Management System
According to ASQ online glossary, a QMS can be considered a mechanism for managing
and continuously improving core processes to “achieve maximum customer satisfaction
as the lowest overall cost to the organization”
A QMS provides a basis for documenting processes used to control and improve
operation, drive innovation, and achieve the following objectives.
- Higher product conformity and less variation
- Fewer defects, waste, reworks and human error
- Improve productivity, efficiency and effectiveness
QUALITY POLICY- a formal document that demonstrates a commitment to achieving
high quality and meeting customer expectation.
The core of QMS is focused in creating the goods and services that customers want.
Therefore, a QMS should include processes for identifying customer requirements,
product planning and design processes, purchasing procedures, methods and
technology for controlling the production of goods and services throughout the supply
chain, inspection and testing, disposition of nonconfirming product, and maintenance
and validation of measuring and test equipment.
A quality manual is a document that defines the quality management system of an
organisation and demonstrates how the quality management system should function.
Quality manuals may vary in format and detail, in order to fit the scope and complexity
of your organisation.
Many ways exist to structure QMS, many organization start with the ISO 9000 FAMILY OF
STANDARDS, The ISO 9000 family consists of the world's best known standard for quality
management systems (QMS), ISO 9001, along with a set of supporting standards on quality
management,
In some foreign markets, companies will not buy from suppliers who are not certified to the
standards. For example, many products sold in Europe, such as tele communication terminal
equipment, medical devises, gas appliances, toys and constructions product require product
certification to assure safety. Often, ISO certification is necessary to obtain product
certification.
The standards became especially important when the treaty on European union was signed at
Maastricht, the Netherlands in 1992, establishing free trade between member countries and
making quality a key strategic objective.
The standards were intended to meet five objectives
1. Achieve, maintain and seek continuously improve product quality including services in
relationship to requirements.
2. Improve the quality of operations to continually meet customers and stakeholders
stated and implied needs.
3. Provide confidents to internal management and other employees that quality
requirements are being fulfilled and that improvement is taking place.
4. Provide confidence to customers and other stakeholders that quality requirements are
being achieved in the delivered product.
5. Provide confidence that quality system requirements are fulfilled.
The ISO 9000 family of standard focus on developing, documenting, and implementing
procedures to ensure consistency of operation of performance in production and service
delivery processes, with the aim of continual improvement, and supported by fundamental
principle of total quality.
The standards consist of three documents
1. ISO 9000,2005 – fundamental and vocabulary. This document provides fundamental
background information and established definition of key terms used in the standards.
2. ISO 9001, 2008- requirements. This is the core document that provides the specific
requirements for a quality management system to help organization consistently
provide products that meet customer and other regulatory requirements.
3. ISO 9004, 2009- guidelines for performance improvements. This Documents provides
guidelines to assist organization in improving and sustaining their quality management
system.
The ISO 9001,2008 requirements provide a structure for a basic quality assurance system. It
consists Four Major Areas:
1. Management responsibility
2. Resource management, ensure that an organization provides sufficient, facilities and
training resources.
3. Product realization, refers to controlling the product\service process from receipt of an
order through design, material procurement manufacturing or service delivery.
4. Measurement, analysis, and improvement, focuses on control procedures for assuring
quality in products and processes, analysis of quality related data, and correction,
prevention and improvement planning activities.
ISO 9000 has three principal benefits
1. It provides discipline
2. It contains the basics of a good quality system
3. It offers a marketing program
