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CONTENTS UNIT
1. INTRODUCTION TO QUALITY MANAGEMENT UNIT
8.EVIDENCE BASED DECISION MAKING UNIT
9. RELATIONSHIP MANAGEMENT |
APPENDIX _______________________________________________________________________________________________________________ 5 Whys – A method to finding the root cause that underlies a
particular problem. It encourages the troubleshooter to look beyond
ostensible reasons for defects and follow the chain of causality until the
underlying cause is identified. The «5» whys is just a rule of thumb – it may
take less than five questions to get to the root of a problem. Acceptable
Risk – Per
your organization's health and safety policy, a specific risk is acceptable
if it has been reduced to a level that the organization can absorb into
current operations. No treatment is considered possible, useful or necessary Adverse
event – Term
used in the healthcare industry to describe a change or event that is not
consistent with the desired or usual outcome. Affinity Diagram
– Facilitates
organization and consideration of a group of ideas of a particular issue
through a consensus decision within a team. They are used to organize verbal
information into some type of visual pattern, and starts with specific ideas
to help work toward broad categories. It can also help organize and give
structure to a list of factors that contribute to a problem, or identify key
areas where improvement is most needed within an issue. Alignment – Actions to
ensure that a process or activity supports the organization’s strategy, goals and objectives. Andon – A system incorporating signal
lights used in manufacturing settings to notify employees of a quality or
process problem. The alert may be activated manually by a worker using a pull
cord or button, or may be activated automatically by the production equipment
itself. ANSI – American
National Standards Institute – A private, nonprofit organization that promotes and
facilitates voluntary consensus to standards and conformity assessment systems.
It is the U.S. member body of the International Organization for
Standardization (ISO). It oversees the creation and use of thousands of norms
and guidelines and accredits programs that assess conformance to standards. ANSI/AIHA Z10-2005 – A
regulatory standard from the American Industrial Hygiene Association
developed to help companies create and maintain occupational, health and
safety management systems. The standard emphasizes continual improvement and
systematically eliminating the underlying root cause of deficiencies. APQP (Advanced Product Quality Planning) –
A quality process used for developing products,
initially developed in the automotive industry. Its purpose, according to the
Automotive Industry Action Group, is «to produce a product quality plan which
will support development of a product or service that will satisfy the
customer». The process focuses on devising quality plans and on gathering
customer feedback to use as actionable information. AS/NZS 4360 – Australian
standard that prescribes a seven-step process for performing risk management
and imbedding risk management into company culture. ASQ (American Society for Quality) – A
professional, nonprofit association that develops, promotes and applies
quality related information, technology and training for quality practitioners, professionals from
various industries, and everyday consumers. ASQ has more than 100,000
individual and organizational members. Assessment – A
systematic process of collecting and analyzing data to determine the current,
historical or projected compliance of an organization to a regulation or
standard. Assessments help companies measure the effectiveness of a quality
system. Audit – The assessment, inspection,
or examination of a quality system to determine compliance to requirements.
Performed onsite, an audit can apply to an entire organization or a specific
function, process or production step. Autonomation
– A feature of machine design that transfers some kind
of human intelligence to automated machinery, so that machines are able to
detect production defects and stop themselves so that problems can be
addressed as they occur rather than pushing them on down the line to be
addressed later. This approach eliminates overproduction, prevents defects,
and focuses attention on understanding the problem at its source and
preventing its recurrence. Basel II – An international initiative that requires
financial services companies to have a more risk sensitive framework for the
assessment of regulatory capital requirements. It aims to improve the
consistency of capital regulations internationally, make regulatory capital
more risk sensitive, and promote enhanced risk management practices among
large, internationally active banking organizations. Benchmarking – An
improvement technique by which a company compares itself against
best-in-class competitors. This involves determining how best-in-class
companies achieve their performance levels and using that information in
improving its own performance. Best practice – A method or
practice of performing a business process that is considered to be the best
way to improve an organization’s performance. Brainstorming – A group
process used to generate ideas within a group or team in a nonjudgmental
environment. Team or group members are presented with an issue and are asked
to be broad in their thinking about the issue at hand, and requested not to
criticize the thoughts of others. The purpose of brainstorming is to generate
a great deal of ideas about a central issue, and team members can interact
with each other to generate further ideas within a single brainstorming
session. Breakthrough improvement – A
dynamic, decisive movement to a new, higher level of performance. BS8800 – British standard that offers
a framework for organizations to manage occupational, health and safety
practices. It outlines strategies for minimizing risk of workplace incidents
and improving business performance. Calibration – Comparison
of an instrument to a standard of known accuracy to determine whether the
instrument’s performance varies from the required specifications. Cause and Effect Diagram – Also
known as an Ishikawa Diagram or a Fishbone Diagram – Diagram, illustrates the
relationship between an outcome and all influencing factors of the outcome.
This diagram displays the factors that are thought to affect a particular
output or outcome in a system – factors are often shown as groupings of
related sub factors that act in concert to form the overall effect of the
group displayed in the diagram. The Cause and Effect Diagram should be used
to identify potential causes of a problem or issue in an orderly way, and can
help answer questions such as «Why is our environmental quality management
system suddenly producing so much waste?» CCM (Concern and Complaint Management) – The
business processes involving the recording and resolution of issues arising
post-production. Certificate of compliance – A
written statement, generally given by a quality management department, which
states that the product being shipped meets the
customer’s specifications. Certified quality improvement associate (CQIA) –
An ASQ certification provided to those who have
passed a test confirming their knowledge of quality tools and their uses. Change management – The process
of requesting, evaluating, planning and implementing change to a system or
aspect of a business. It involves the processing of changes and enabling
traceability of the change process. Check Sheets – Forms used
to record the frequency of specific events during a data collection period.
It is a simple form that quality managers can use to collect data in an
organized matter and easily convert it into useful information quickly. CI (Continuous Improvement) –
The ongoing improvement of products, services,
environment, functions, communications and processes. This involves adopting
new activities and eliminating those which do not add value. The goal is to
increase effectiveness by reducing inefficiencies and waste. Complaint tracking – The process
of collecting customer complaint data, disseminating data to appropriate
parties for investigation, resolution, monitoring progress, and communicating
results. Compliance (regulatory) – The act of
conforming to prescribed specifications, regulations, or standards. Control Charts – Used to
measure sequential or time-related process performance and variability, such
as quality control in manufacturing. Control charts utilize a variety of
concepts – a typical chart contains a centerline, which represents the average
value of the quality characteristic corresponding to the in-control state of
data represented. The upper and lower control limits are drawn above and
below the centerline, which are chosen so that when a process that is seen as
«in control» is graphed, the sampling points are seen as falling between
them. Control Charts may indicate an out-of-control condition, either when
plotted points fall above or below the set control limits or when the points
display some pattern of behavior. Control plan – Written
descriptions of an organization’s systems that control part and process
quality by addressing the key characteristics and engineering requirements.
The plan is to control the product characteristics and the associated process
variables to ensure capability (around the identified target or nominal) and
stability of the product over time. Corrective action – Steps that
are taken to remove the cause or causes of an existing nonconformity or other
undesirable situation in the form of a problem solving process. Can be done
manually, or within CAPA software. COSO ERM – A framework
developed by the Committee of Sponsoring Organizations of the Treadway Commission (COSO) and Price Waterhouse Coopers
that helps organizations identify, assess, and manage risk. Cost of Quality – Methodology
that allows an organization to determine potential cost savings when process
improvements are implemented. It helps quality managers determine the extent
to which an organization's resources are expended on activities preventing
poor quality. Cost of Quality can also be assessed by viewing prevention
costs, appraisal costs, internal and external failures. It is an important
communication tool that describes the long-term impact of quality effort
within a specific organization. Once a quality cost system is established, it
should dynamically have positive impacts on the organization's mission,
objectives, and goals. Critical Processes – Processes
that present serious potential dangers to human life, health and the
environment or that risk the loss of significant sums of money or customers. Customer-supplier partnership – A
long-term relationship between a buyer and supplier characterized by teamwork
and mutual confidence. The supplier is considered an extension of the buyer’s
organization. The partnership is based on several commitments. The buyer
provides long-term contracts and uses fewer suppliers. The supplier
implements quality assurance processes so incoming inspection can be
minimized. The supplier also helps the buyer reduce costs and improve product
and process designs. CRM (Customer Relationship Management) –
A software system used to organize information about
customers and prospective customers. Defect – A product’s or service’s nonfulfillment
of an intended requirement or reasonable expectation for use, including
safety considerations. There are four classes of defects which pertain to the
level of issues caused by the defect. Deming Cycle – A
continuous quality improvement model popularized by statistician Edward Deming.
Also known as the PDCA Cycle, the model consists of four repetitive steps:
Plan, Due, Check, and Act, in order to drive continuous improvement. DHF – Design History File A
documentation artifact used in the medical device industry. It is a compilation
of records which describes the design history of a finished device including
the design activities used to develop the device, accessories, major
components, labeling, packaging and production processes. A DHF is required
for each type of device or family of devices that are manufactured according
to one DMR. DHR (Device History Record) –
FDA requirement for medical device manufacturers.
The DHR should reflect that all operations, processes, etc., described in the
master record have been accomplished for all finished devices manufactured
and includes: date(s) of manufacturing, quantity manufactured, quantity
released for distribution, any device identification(s) and control number(s)
used, the primary identification label and labeling used for each production
unit, and, the acceptance records which demonstrate the device is
manufactured in accordance with the DMR. DMR (Device Master Record) –
A compilation of records containing the device
specifications, production process specifications, quality assurance
procedures and specifications, packaging and labeling specifications and
installation, maintenance, and servicing
procedures and methods. Document control – A
system of managing, distributing, and controlling documents. Downtime – Lost
production time during which a piece of equipment is not operating correctly
due to breakdown, maintenance, power failures or similar events. ECO (Engineering
Change Order) – A document requesting changes or improvements
to a product or process. ECR (Engineering Change
Request) – A request to an Engineering department for a
change to a product design or an improvement to a process. EH&S
(Environmental, Health and Safety) – An
area concerned with the impact of the workplace on employees, customers,
suppliers, and the environment. EMI (Enterprise Manufacturing Intelligence) –
A centralized approach to gathering information
about manufacturing processes and using them to formulate strategies and
standardized responses. Environmental aspects – An element
of a facility’s activities, products, or services that interacts with the
environment. Environmental impacts – Any adverse
or beneficial change to the environment caused by a facility’s activities,
products, or services. FDA 21 CFR Part 11 – The FDA’s rule that defines the criteria
under which electronic document management records and signatures are
acceptable, i.e. equivalent to paper records. FDA 21 CFR Part 120 – 21 CFR Part 120 is part of the US Food and
Drug Administration's Code of Federal Regulations. It describes the
applicability of Hazard Analysis and Critical Control Point (HACCP) Systems
to any juice sold as such or used as an ingredient in beverages. See also
HACCP. FDA 21 CFR Part 820 /
Quality System Regulations – Describes current good manufacturing processes for the medical device
industry. Intended to ensure that finished devices will be safe and effective
for human use. Also known as the Quality System Regulation. Flowcharts – Graphic representations of the flow of
processes. Flowcharts display the order of activities using shape
visualizations that represent activities – the rounded rectangle indicates
the beginning or end of a process, boxes indicate action items, and diamonds
indicated decision points – all can be easily created, uploaded, imported and
viewed within ISO compliance software. Flowcharts can be used to communicate
the steps in a work process, identify areas that may be problem sources or
improvement opportunities. FMEA (Failure mode
effects analysis) – A systematized group
of activities to recognize, document and evaluate the frequency and severity
of every possible failure of a product or process and its effects, and the
identification and implementation of actions that could eliminate or reduce
the occurrence of the potential failure. Gantt chart – A bar chart
that displays planned work and finished work in relation to time. It
typically displays the work breakdown, total duration needed to complete
tasks, and the percent that has been completed. GFSI – The Global Food Safety Initiative
is coordinated by CIES – The Food Business Forum, launched May 2000. The
Global Food Safety Initiative (GFSI) is coordinated by The Food Business
Forum CIES. This forum is a global food network made up of approximately 400
retailers and manufacturers worldwide. GMP (Good manufacturing practices) –
Requirements governing the quality procedures of
FDA-regulated companies, including makers of foods, pharmaceuticals, and
devices. An important aspect is the documentation of processes that enables
traceability. GMS (Gage Management System) –
A system for monitoring, tracking, and calibrating
gages. GR&R (Gage repeatability and reproducibility) –
A statistical tool that evaluates the effectiveness
of a gauging instrument for a particular application. This is done by
determining whether the measurements are repeatable (there is close agreement
among a number of consecutive measurements of the output for the same value
of the input under the same operating conditions) and reproducible (there is
close agreement among repeated measurements of the output for the same value
of input made under the same operating conditions over a period of time). GRC (Governance, Risk Management, and Compliance) –
A term that describes the integrated approach
companies take to manage these three areas. HACCP – Hazard Analysis Critical Control Point – A
quality management system for effectively and efficiently ensuring food and
beverage control safety in the United States. HACCP-related regulations for
various sectors are established by the Department of Agriculture and the Food
and Drug Administration. Hazard Identification
– The process of recognizing a health and
safety hazard exists and defining its characteristics. Hazards – Identified by Haddon as a potential source of
bodily damage, hazards involve anything or any situation which may cause
harm, injury or ill health to a person. HIPAA – The Health Insurance Portability and
Accountability Act of 1996. Intended to streamline the conduct of electronic
healthcare transactions. It also addresses the security and privacy
of health data. Histograms – are bar chart representations used to plot
the frequency with which different values of a given variable occur.
Histograms evolved from a need to evaluate data that occurs at a certain
frequency, and are built to examine the characteristics of variation and are
used as a great visualization quality improvement tool for varying data.
Histograms are used to identify the range of variables, examine existing
patterns, and to suggest a central tendency in these variables. IGOG (Incoming Goods/Outgoing Goods
Control) – The quality assurance processes that
surround the receipt of materials and supplier goods and the output of
finished products. Inspection plan – A plan that outlines inspection
criteria, identifies the goals of the inspection, specifies the methods to be
taken, catalogues resources needed, and assigns responsibilities for
performing aspects of the inspection. Inspection Plan Management (IPM) – The implementation of strategies and
processes for the inspection of materials and goods. Interested Party – A person or group that has a stake in
the OH&S performance of an organization, from both inside and outside of
the workplace. Interested parties may be directly affected by the
organization’s OH&S performance or actively concerned about it. ISO 13485 – A standard published in 2003 that outlines the requirements for a
comprehensive management system for the manufacturing of medical devices. It
is based, in large part, on the principles of ISO 9000. ISO 14000 – A standard related to how companies address environmental management
issues. ISO 14971 – A standard that outlines risk management practices for medical device
manufacturers. Offers guidance for how to estimate and evaluate the
associated risks, to control these risks, and to monitor the effectiveness of
the controls. ISO 22000 – ISO and its member countries used the Quality Management System
approach, and tailored it to apply to Food Safety, incorporating the widely used
and proven HACCP principles into the quality management system. The resulting
standard is ISO 22000. Many companies will find parts of this document very
familiar. If your organization uses a HACCP system, you will be building from
that foundation. If your organization is ISO 9001 registered you will add
HACCP into that system. ISO 9000 – A family of
international quality management standards maintained by ISO. The set of
standards was developed to help companies document, monitor and improve their
quality systems. ISO certification is administrated by third-party registrars
and certification bodies. Initially published in 1987, the standards
underwent significant revision in 2000. ISO/TS 16949 – The
automotive quality system standard that harmonizes the supplier quality
requirements of the U.S., French, German and Italian automakers. It applies
to the design, development, production, installation and servicing of
automotive products. Just-in-time – A lean manufacturing technique that means
having the right part at the right place in the right amount at the right
time. It is intended to result in shorter cycle times, less inventory, low
work-in-process (WIP), and streamlined workflow. Kaizen – The Japanese term that refers to continuous
improvement, involving everyone at every level in an organization. The
strategy involves cutting costs, reducing quality problems, and speeding
delivery time. Kanban – A Japanese term for one of the primary tools of a
just-in-time system. Kanban is a signaling device
to trigger an action in order to maintain an orderly and efficient flow of
materials in a manufacturing process. Kanban cards
are the most common example of these signals. Key product
characteristic – A product or process
perimeter characteristic that can affect safety or compliance with
regulations, fit, function, performance or subsequent processing of product. KPI (Key performance
indicator) – A metric used to quantify a strategic
performance objective for an organization. Lean manufacturing – A school of thought focused on eliminating
waste in a manufacturing environment. Principles of lean manufacturing
include optimum automation, just-in-time supplier delivery disciplines, quick
changeover times, high levels of quality and continuous improvement. Lean Six Sigma A
business improvement methodology which combines aspects of Lean Manufacturing
and Six Sigma. It emphasizes efficiency and improved quality. MES (Manufacturing
Execution System) – An integrated set of
processing systems used to accomplish production. Can refer to software or a
set of integrated functions within the manufacturing company. MOM (Manufacturing
Operations Management) – The methodology that
emphasizes an integrated approach to streamlining manufacturing operations
across a company or enterprise. Mutual recognition
agreement (MRA) – A formal agreement providing reciprocal recognition of the validity of
other organizations» deliverables, typically found in voluntary standards and
conformity assessment groups. NCMR (Nonconforming
Material Report) – A document describing a defective material,
product, or part and how it is dispositioned Nonconformity – The deviation or nonfulfillment
of a specified requirement. OCEG «Red Book» – A publication from the Open Compliance and
Ethics Group that provides guidance for companies about the core processes of
integrated governance, risk and compliance. OEM (Original
equipment manufacturer) – A company that uses
product components or parts from a supplier company in order to build its own
products. OH&S (Occupational Health & Safety) –
Cross-disciplinary area within an organization
concerned with protecting the health, safety and welfare of people engaged in
work or employment: the goal of OH&S programs is to foster a safe work
environment. Occupational Health & Safety Management System
(OHSMS) – System used to
establish an OH&S policy and to manage OH&S risks. An organization’s
OHSMS is one part of a larger management system. Occupational Health & Safety Objective –
OH&S objectives are OH&S performance goals
that organizations set for themselves and wish to achieve. An organization’s OH&S
objectives should be both measurable and consistent with its OH&S policy.
Occupational Health & Safety Policy – An
organization’s OH&S policy statement expresses a commitment to the
implementation and ongoing maintenance of its OHSMS and the improvement of
its overall OH&S performance. OHSAS 18000 – An
international occupational health and safety management system specification.
Designed to help companies identify and control OH & S risks. Pareto chart – A bar chart that displays the most important
defects and their causes in descending order. It’s based on the principle
that 80% of effects come from 20% of the possible causes. PAS 22O – The ISO/TS 22002-1 is based on another
technical specification, PAS 220. The PAS 220 is published by British
Standards. It was developed to address concerns that the Global Food Safety
Initiative (GFSI) had about adding the ISO 22000 standard to
its list of benchmarked food safety standards. GFSI felt there was a need for
more specific requirements for PRPs. The PAS 220 was developed to address
this need. They benchmarked the registration scheme as FSSC 22000, which is a
registration that requires compliance with both ISO 22000 and the PAS 220. Plan-do-check-act
(PDCA) cycle – A
four-step process for quality improvement. In the first step (plan), a way to
effect improvement is developed. In the second step (do),
the plan is carried out, preferably on a small scale. In the third step
(check), a study takes place between what was predicted and what was observed
in the previous step. In the last step (act), action is taken on the causal
system to effect the desired change. The plan-do-check-act cycle is sometimes
referred to as the Shewhart cycle, because Walter
A. Shewhart discussed the concept in his book
Statistical Method From the Viewpoint of Quality Control, and as the Deming
cycle, because W. Edwards Deming introduced the concept in Japan. The
Japanese subsequently called it the Deming cycle. Also called the
plan-do-study-act (PDSA) cycle. PLM (Product Lifecycle Management) –
The processes that govern the entire lifecycle of a
product from its conception, through design and manufacturing, to service and
disposal. Prevention versus detection – A
term used to contrast two types of quality activities. Prevention refers to
activities for preventing nonconformances in
products and services. Detection refers to activities for detecting nonconformances already in products and services. Another
phrase to describe this distinction is «designing in quality versus
inspecting in quality». Preventative or Preventive Action – Also
thought of as a risk analysis process, these are steps that are taken to
remove the causes of potential nonconformities or other undesirable
situations that have not yet occurred. Preventive actions address potential
problems. Process – A set of
interrelated / interacting activities that transforms inputs into outputs Production Part Approval Process (PPAP) – The
process of approval for production parts, including production and bulk
materials. The purpose is to ensure that suppliers comply with design
specification and can perform consistently within the OEM’s quality system. Production Quality Management – The
overall system of technical activities that measures the attributes and
performance of a process, item, or service against defined standards to
verify that they meet the stated requirements established by the customer;
operational techniques and activities that are used to fulfill requirements
for quality. Also see Quality Control Quality Control – The overall system of technical activities
that measures the attributes and performance of a process, item, or service
against defined standards to verify that they meet the stated requirements
established by the customer; operational techniques and activities that are
used to fulfill requirements for quality. Quality management – A planned, systemized set of activities
to ensure that products and processes meet customer requirements. Quality Management system – The
processes used to design, manufacture and deliver products and services that
meet customer requirements in accordance with company policy. Quality plan – Documentation
that outlines the standards, quality processes and procedures related to a
specific product, service, or project. Quality policy – An
organization’s credo about its quality management practices and goals. Quality trilogy – A
three-pronged approach to managing for quality. The three legs are quality
planning (developing the products and processes required to meet customer
needs), quality control (meeting product and process goals) and quality
improvement (achieving unprecedented levels of performance). Reliability – The probability that a product or part will
adequately perform its purpose for a specific period of time in a specific
set of conditions. Repeatability – The variation in measurements obtained when a
person takes multiple measurements using the same equipment. Reproducibility – The variation that occurs when two or more
people measure the same item using the same technique. Responsible Care – The chemical industry’s global voluntary
initiative by which companies work to improve their health, safety and
environmental performance, and to communicate with stakeholders about their
products and processes. Return Material
Authorization – A
transaction by which the recipient of a product arranges to return defective
goods to the manufacturer or supplier in order to have the product repaired
or replaced. Risk – In general terms, the potential for loss. In a safety context, the
likelihood that exposure to a hazard (see definition of «Hazard», above) will
result in death, injury or disease to a person or damage to property. Risk Assessment – After a hazard is identified, an examination
of the associated risk is completed determining likelihood of injury or
illness being caused by the hazard. This can be conducted manually or with
assistance of risk management software, and is evaluated by the organization
to determine whether or not this risk is acceptable. Risk management – Performance of activities to mitigate the
chance of adverse events. Activities include risk identification, assessment,
prioritization and control. Root cause – An
identified reason for a defect or nonconformance that, if eliminated, will
prevent reoccurrence. Run Charts – Line graphs
that show data points plotted in the order in which they occur. This chart is
used to reveal trends and shifts in a process over time, show variation over
time, or identifies an improvement or decline in a process over time. It
examines both variables and attribute data. The run
chart shows the history and pattern of variation, and can be used to
summarize occurrences of a particular situation, identify trends or unusual
events, display measurement results over time, or determine a common cause
vs. special cause variation. Scatter Diagram – A chart in which one variable is plotted
against another to determine whether or not there is a correlation between
the two. Scatter Diagrams show pattern relationships between two quality and
compliance variables that are thought to be related, and the purpose of this
diagram is to demonstrate what happens to one variable when another is changed.
Scatter Diagrams are used to plot the distribution of information in two
dimensions, and are useful to rapidly screen for relationships between two
variables. Seiban – The name of a Japanese management practice taken from the words sei, which means manufacturing, and ban, which means
number. A seiban number is assigned to all parts,
materials and purchase orders associated with a particular customer job,
project or anything else. This enables a manufacturer to track everything
related to a particular product, project or customer, and facilitates setting
aside inventory for specific projects or priorities. That makes it an
effective practice for project and build to- order manufacturing. SIPOC diagram – A tool used by Six Sigma process improvement teams
to identify all relevant elements (suppliers, inputs, process, outputs,
customers) of a process improvement project before work begins. Six
Sigma – A methodology for
improving business performance by limiting process variation. The methodology uses information and
statistical analysis to identify and prevent defects. SMED (Single Minute
Exchange of Die) – A lean manufacturing
technique for reducing tool changeover times in order to improve flow. It is
also often referred to as Quick Changeover (QCO). SOx
(Sarbanes Oxley Act) – Legislation
developed in response to the Enron and Worldcom
financial scandals to improve financial record-keeping by public companies.
Administered by the Securities and Exchange Commission (SEC). SPC (Statistical process control) –
Confirmation by examination and provisions of
objective evidence that the particular requirements for a specific intended
use are fulfilled. SQF – Incorporates both HACCP and
ISO processes into its certification standard. Safe Quality Food Certification.
The SQF (Safe Quality Food) Program is a leading, global food safety and
quality certification program and management system, designed to meet the
needs of buyers and suppliers worldwide. The Program provides independent
certification that a supplier’s food safety and quality management system
complies with international and domestic food safety regulations. This
enables suppliers to assure their customers that food has been produced,
processed, prepared and handled according to the highest possible standards,
at all levels of the supply chain. Supplier quality assurance – Confidence
a supplier’s product or service will fulfill its customers» needs. This
confidence is achieved by creating a relationship between the customer and
supplier that ensures the product will be fit for use with minimal corrective
action and inspection. According to Joseph M. Juran,
nine primary activities are needed: 1. define product and program quality
requirements; 2. evaluate alternative suppliers; 3. select suppliers; 4.
conduct joint quality planning; 5. cooperate with the supplier during the
execution of the contract; 6. obtain proof of conformance to requirements; 7.
certify qualified suppliers; 8. conduct quality improvement programs as
required; 9. create and use supplier quality ratings. System – A set of interrelated /
interacting processes. Takt time – The average time required to produce a unit of
product for a given rate of demand. It is derived from the German word taktzeit which translates to cycle time. Throughput – The rate the system generates money through
sales, or the conversion rate of inventory into shipped product. Total Quality
Management – A
comprehensive and structured approach to organizational management that seeks
to improve the quality of products and services through ongoing refinements
in response to continuous feedback. TPS (Toyota
Production System) – A manufacturing
methodology developed by the Toyota Motor Company which falls under the
larger umbrella of «lean manufacturing». According to Toyota, the Toyota
Production System (TPS) was established based on two concepts: The first is
called «jidoka»(which can be loosely translated as «automation
with a human touch») which means that when a problem occurs, the equipment
stops immediately, preventing defective products from being produced; The
second is the concept of «Just-in-Time», in which each
process Type I error – An
incorrect decision to reject something (such as a statistical hypothesis or a
lot of products) when it is acceptable. Type II error – An
incorrect decision to accept something when it is unacceptable. Validation – Confirmation by examination and provisions of
objective evidence that the particular requirements for a specific intended
use are fulfilled. Verification – Confirmation by examination and provision of
objective evidence that specified requirements have been fulfilled Waste – Any activity that consumes resources and
produces no added value to the product or service a customer receives. Also
known as muda. Weighed Voting – A way to prioritize a list of issues, ideas
or attributes by assigning points to each item based on its relative
importance. Work in process – Items between machines or equipment waiting
to be processed. Working Sequence – One of three elements of standard work;
refers to the sequence of operations in a single process that leads a floor
worker to most efficiently produce quality goods. World-Class Quality – A term used to indicate a standard of
excellence: best of the best. Zero defects – A performance standard depicted by Crosby
that aims to reduce defects in order to directly increase profits: it is the
foundation of Six Sigma. |
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CONTENTS UNIT
2. GEOGRAPHY, NATURE, ENVIRONMENT UNIT
3. HISTORY: THE FIRST COLONIES IN NORTH AMERICA UNIT
4. HISTORY: THE EARLY USA UNIT
5. HISTORY: THE RISE OF THE USA UNIT
6. HISTORY: THE MODERN USA UNIT
8. POLITICS OF THE UNITED STATES |
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