If you are required to have traceability then you must keep records that verify these outputs have been identified and their status. If you are unable to identify a part or its status during production without a route sheet, then having a route sheet is required for your organization.
In the same way, if your customer requires lot tracking, then you need to have a lot control process and records for lot traceability. This concept applies to the service industry as well and can be in the form of a project log or status report. Within our Forms Package or included with our Identification and Traceability Procedure , we offer the documentation templates needed to ensure the requirements around identification and traceability are met. This definition recognizes that all of us operate in an uncertain world.
Sometimes we get positive results and sometimes we get negative results and occasionally we get both. Because of this, we need to reduce uncertainty as much as possible. Uncertainty or lack of certainty is a state or condition that involves a deficiency of information and leads to inadequate or incomplete knowledge or understanding. In the context of risk management , uncertainty exists whenever the knowledge or understanding of an event, consequence, or likelihood is inadequate or incomplete.
While this definition argues that risk can be positive as well as negative, a note acknowledges that "the term risk is sometimes used when there is only the possibility of negative consequences".
Risk-based thinking refers to a coordinated set of activities and methods that organizations use to manage and control the many risks that affect its ability to achieve objectives. Risk-based thinking replaces what the old standard used to call preventive action.
A service is an intangible output and is the result of a process that includes at least one activity that is carried out at the interface between the supplier provider and the customer. Service provision can take many forms. Conversely, it can be provided for a product supplied by a customer e. It can also involve the provision of an intangible thing to a customer e. A statutory requirement is defined by a legislative body and is obligatory.
A strategy is a plan for achieving an objective. A supplier is a person or an organization that provides products or services. Suppliers can be either internal or external to an organization. Internal suppliers provide products or services to people within their own organization while external suppliers provide products or services to other organizations.
Examples of suppliers include organizations and people who produce, distribute, or market products, provide services, or publish information. It prefers, instead, to use the term external provider. A system is defined as a set of interrelated or interacting elements. A management system is one type of system. It is a set of interrelated or interacting elements that organizations use to formulate policies and objectives and to establish the processes that are needed to ensure that policies are followed and objectives are achieved.
The term top management normally refers to the people at the top of an organization. It refers to the people who provide resources and delegate authority and who coordinate, direct, and control organizations. However, if the scope of a management system covers only part of an organization, then the term top management refers, instead, to the people who direct and control that part of the organization. Traceability is the ability to identify and trace the history, distribution, location, and application of products, parts, materials, and services.
A traceability system records and follows the trail as products, parts, materials, and services come from suppliers and are processed and ultimately distributed as final products and services.
Validation is a process. It uses objective evidence to confirm that the requirements which define an intended use or application have been met. Whenever all requirements have been met, a validated status is established. Validation can be carried out under realistic use conditions or within a simulated use environment. There are several ways to confirm that the requirements which define an intended use or application have been met. For example you could do tests, you could carry out alternative calculations, or you could examine documents before you issue them.
Verification is a process. It uses objective evidence to confirm that specified requirements have been met. Whenever specified requirements have been met, a verified status is achieved. There are many ways to verify that requirements have been met. For example you could inspect something, you could do tests, you could carry out alternative calculations, or you could examine documents before you issue them. ISO Introduction. Quality Management Principles. Outline of ISO Standard.
Overview of ISO Standard. Plain English Quality Management Checklist. ISO Environmental Library. Home Page. Our Libraries. A to Z Index. Our Customers. How to Order. Our Products. Our Prices. Our Guarantee. Praxiom Research Group Limited help praxiom. Updated on April 15, First published on November 25, Legal Restrictions on the Use of this Page Thank you for visiting this webpage.
You are welcome to view our material as often as you wish, free of charge. And as long as you keep intact all copyright notices, you are also welcome to print or make one copy of this page for your own personal, noncommercial , home use. But, you are not legally authorized to print or produce additional copies or to copy and paste any of our material onto another web site or to republish it in any way. All Rights Reserved. A udit criteria Audit criteria are used as a reference point and include policies, requirements, and other forms of documented information.
A udit evidence Audit evidence includes records, factual statements, and other verifiable information that is related to the audit criteria being used.
A udit findings Audit findings result from a process that evaluates audit evidence and compares it against audit criteria. A udit program An audit program or programme refers to a set of one or more audits that are planned and carried out within a specific time frame and are intended to achieve a specific audit purpose.
C haracteristic A characteristic is a distinctive feature or property of something. C ompetence Competence means being able to apply knowledge and skill to achieve intended results. C omplaint In the context of ISO , a complaint refers to an expression of dissatisfaction with a product or service and is filed by a customer and received by an organization.
C oncession A concession is a special approval that is granted to release a nonconforming product or service for use or delivery. C onformity Conformity is the "fulfillment of a requirement". C ontinual improvement Continual improvement is a set of recurring activities that are carried out in order to enhance performance.
C ontract A contract is a binding agreement between two or more parties. C orrection A correction is any action that is taken to eliminate a nonconformity. C orrective action Corrective actions are steps that are taken to eliminate the causes of existing nonconformities in order to prevent recurrence.
C ustomer A customer is anyone who receives products or services outputs from a supplier. C ustomer satisfaction Customer satisfaction is a perception. D ata The term data is defined as any facts about an object. D efect A defect is a type of nonconformity. D esign and development Design and development is a process or a set of processes that uses resources to transform general input requirements for an object into specific output requirements.
D etermination To determine means to find or to identify the value of a characteristic. D ocumented information The term documented information refers to information that must be controlled and maintained and its supporting medium. E ffectiveness Effectiveness refers to the degree to which a planned effect is achieved.
F eedback The term feedback is used to refer to a comment or an opinion expressed about a product or service or an interest expressed in a product or a service. F unction A function is a role that is performed by a unit of an organization. I mprovement Improvement is a set of activities that organizations carry out in order to enhance performance get better results.
I nformation system In the context of this ISO standard, an information system is a network of communication channels used within an organization.
I nfrastructure The term infrastructure refers to the entire system of facilities, equipment, and support services that organizations need in order to function. I nnovation Innovation is a process that results in a new or substantially changed object.
I nterested party An interested party is anyone who can affect, be affected by, or believe that they are affected by a decision or activity. I nvolvement Involvement occurs when people share objectives and are actively engaged in and contribute to their achievement. Knowledge Knowledge is a collection of information and a justified belief that this information is true with a high level of certainty.
M anagement The term management refers to all the activities that are used to coordinate, direct, and control organizations. M anagement system A management system is a set of interrelated or interacting elements that organizations use to formulate policies and objectives and to establish the processes that are needed to ensure that policies are followed and objectives are achieved.
M easurement Measurement is a process that is used to determine a value. M easuring equipment Measuring equipment includes all the things needed to carry out a measurement process. M onitoring To monitor means to determine the status of an activity, process, or system at different stages or at different times. N onconformity Nonconformity is a nonfulfillment or failure to meet a requirement. O bject An object is any entity that is either conceivable or perceivable. O bjective An objective is a result you intend to achieve.
O bjective audit evidence Objective audit evidence is information that is verifiable and generally consists of records and other statements of fact that are relevant to the audit criteria being used. O bjective evidence Objective evidence is data that shows or proves that something exists or is true. O rganization An organization can be a single person or a group that achieves its objectives by using its own functions, responsibilities, authorities, and relationships.
Since the topic of this page is traceability in the entire supply chain, this section describes identification and traceability. Identification is an especially important concept in these requirements. This identification means a common recognition shared among the entire production processes or the entire supply chain.
Assume that you have a chip used for manufacturing a TV, for instance. The basics of identification are to ensure that this chip is recognized as the same one whether it exists by itself or is built in a product, and to allow everyone to know the current status of the chip, whether it has passed inspection or is under inspection, or in what process it is being worked on.
For that purpose, a traceability system identifies objects by using a representation format such as serial numbers or lot numbers, as well as the transfer medium such as labels and RF tags. This ensures the quality and safety of the product. A lot of electronic control systems have been introduced to the manufacturing sites, such as industrial robot control using programmable logic controllers PLCs which is indispensable for factory automation FA.
IEC is a functional safety standard for such electronic and electrical systems. It is a generic term for the functional safety standards concerning electrical, electronic and programmable electronic systems in all industries. Its basic idea is to ensure safety and prevent accidents and disasters by adding functional equipment to protect human life, health, and environment region from hazardous events.
0コメント