We shall try to define and understand some of the terms used in quality management system. The standard ISO 9000:2005 is the basis on which the terms are defined.
4) Terms relating to Process and Products
Terms relating to Process and Products are defined as:
ISO 9000 definition:
“set of interrelated or interacting activities which transforms inputs into outputs”
NOTE 1: Inputs to a process are generally outputs of other processes.
NOTE 2: Processes in an organization are generally planned and carried out under controlled conditions to add value.
NOTE 3: A process where the conformity of the resulting product cannot be readily or economically verified is frequently referred to as a “special process”.
A process is defined as sequence of interdependent and linked procedures which, at every stage, consume one or more resources (employee time, energy, machines, money) to convert inputs (data, material, parts, etc.) into outputs. These outputs then serve as inputs for the next stage until a known goal or end result is reached. A process is a set of activities that are interrelated or that interact with one another. Processes use resources to transform inputs into outputs. Processes are interconnected because the output from one process becomes the input for another process. In effect, processes are “glued” together by means of such input output relationships.
Organizational processes should be planned and carried out under controlled conditions. An effective process is one that realizes planned activities and achieves planned results.The process approach is a management strategy. When managers use a process approach, it means that they manage the processes that make up their organization, the interaction between these processes, and the inputs and outputs that tie these processes together.A special process is any production or service delivery process that generates outputs that cannot be measured, monitored, or verified until it’s too late. It’s often too late because deficiencies may not be obvious until after the resulting products have been used or services have been delivered. In order to prevent output deficiencies, these special processes must be validated in order to prove that they can generate planned results.
ISO 9000 definition:
“result of a process”
NOTE 1: There are four generic product categories, as follows:
-software (e.g. computer program, dictionary);
-hardware (e.g. engine mechanical part)
-processed materials (e.g. lubricant).
Many products comprise elements belonging to different generic product categories. Whether the product is then called service, software, hardware or processed material depends on the dominant element. For example, the offered product “automobile” consists of hardware (e.g. tires), processed materials (e.g. fuel, cooling liquid), software (e.g. engine control software, driver’s manual), and service (e.g. operating explanations given by the salesman).
NOTE 2: Service is the result of at least one activity necessarily performed at the interface between the supplier and customer and is generally intangible. Provision of a service can involve, for example, the following:
-an activity performed on a customer-supplied tangible product (e.g. automobile to be repaired);
-an activity performed on a customer-supplied intangible product (e.g. the income statement needed to prepare a tax return);
-the delivery of an intangible product (e.g. the delivery of information in the context of knowledge transmission}
– the creation of ambiance for the customer (e.g. in hotels and restaurants).
Software consists of information and is generally intangible and can be in the form of approaches, transactions or procedures.
Hardware is generally tangible and its amount is a countable characteristic . Processed materials are generally tangible and their amount is a continuous characteristic. Hardware and processed materials often are referred to as goods.
NOTE 3: Quality assurance is mainly focused on intended product.
A product is the output of a process.Products can be tangible or intangible. ISO 9000 lists four generic product categories: services, software, hardware, and processed materials. Many products combine several of these categories. For example, an automobile (a product) combines hardware (e.g. tires), software (e.g. engine control algorithms), and processed materials (e.g. lubricants). Service is always the result of an interaction between a service supplier and a customer and can take many forms. Service can be provided to support an organization’s own products (e.g. warranty service or the serving of meals). Conversely, service can be provided for a product supplied by a customer (e.g. a repair service or a delivery service). Service can also involve the provision of an intangible thing to a customer (e.g. entertainment, transportation, or advice). While software is intangible, and includes things like approaches and procedures, hardware and processed materials are tangible and are often referred to as goods. Product realization refers to all the processes that are used to bring products into being.A product starts out as an idea. The idea is realized or actualized by following a set of product realization processes.
ISO 9000 definition:
“Unique process, consisting of a set of coordinated and controlled activities with start and finish dates, undertaken to achieve an objective conforming to specific requirements, including the constraints of time, cost and resources”
NOTE 1: An individual project can form part of a larger project structure.
NOTE 2: In some projects the objectifies are refined and the product characteristics defined progressively as the project proceeds.
NOTE 3: The outcome of a project can be one or several units of product
Project can be defined as a planned set of interrelated tasks to be executed over a fixed period and within certain cost and other limitations.The Project Management Institute’s Body of Knowledge defines a Project as, “A temporary endeavor undertaken to create a unique product, service, or result.” Temporary means that every project has a definite beginning and a definite end date. Unique means that the product or service is different in some distinguishing way from similar products or services. By examining this definition we understand that projects are:
- Time-bound and have a customer.
- Have clear beginning and end states. These can be as short as half a day or be as long as a number of years. Longer projects are often broken down into phases or stages. Each one becoming a project onto itself.
- Follow a specific cycle of Initiation, Definition, Planning, Execution and Close
In comparison processes are on-going with no clearly defined beginning and end states, Customer driven are repeatable. Project Management is the application of knowledge and expertise to the development of Project Scope and a Project Plan, which meets or exceeds stakeholder requirements.
4.4) Design and Development
ISO 9000 definition:
“Set of processes that transforms requirements into specified characteristics or into the specification of a product, process or system”
NOTE 1: The terms “design” and “development” are sometimes used Synonymously and sometimes used to define different stages of the overall design and development process.
NOTE 2: A qualifier can be applied to indicate the nature of what is being designed and developed (e.g. product design and development or process design and development).
Design and development is a process (or a set of processes). This process uses resources to transform requirements (inputs) into characteristics or specifications (outputs) for products, processes, and systems.You may treat design and development as different stages of a single integrated design and development process or you may treat design and development as two (or more) separate processes. You may also use the terms design and development inter changeably interchangeably if they mean the same thing in your organization. Design and development review is a set of activities whose purpose is to evaluate the suitability, adequacy, effectiveness, and sometimes the efficiency of a set of characteristics or specifications. Design and development review can be used to evaluate product, process, and system characteristics or specifications. In this context, an effective set of characteristics or specifications is one that has the potential to achieve planned results or realize planned activities.
Design and development validation is a process. This process uses objective evidence to confirm that products meet the requirements which define their intended use or application. Whenever specified requirements have been met, a validated status is achieved. The process of validation can be carried out under realistic use conditions or within a simulated use environment.
Design and development verification is a process. It uses objective evidence to confirm that design and development outputs meet design and development input requirements. Whenever specified input requirements have been met, a verified status is achieved.
ISO 9000 definition:
“Specified way to carry out an activity or a process. ”
NOTE 1: Procedures can be documented or not.
NOTE 2: When a procedure is documented, the term “written procedure” or “documented procedure” is frequently used.The document that contains a procedure can be celled a ‘procedure document”.
A procedure can be defined as a fixed, step-by-step sequence of activities or course of action (with definite start and end points) that must be followed in the same order to correctly perform a task. Repetitive procedures are called routines.A procedure is a way of carrying out a process or activity. According to ISO 9000, procedures may or may not be documented. However, in most cases, ISO 9001 expects you to document your procedures.Documented procedures can be very general or very detailed,or anywhere in between. While a general procedure could take the form of a simple flow diagram, a detailed procedure could be a one page form or it could be several pages of text. A detailed procedure defines and controls the work that should be done and explains how it should be done, who should do it, and under what circumstances. In addition, it explains what authority and what responsibility has been allocated, which inputs should be used, and what outputs should be generated.
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