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 related to examination are defined.
8) Terms related to Examination
Terms related to Examination as defined in ISO 9000:2005 are:
8.1) Objective evidence
ISO 9000 definition:
“Data supporting the existence or verity of something”
NOTE: Objective evidence may be obtained through observation, measurement, test, or other means.
Objective evidence is information that shows or proves that something exists or is true. Objective evidence can be collected by performing observations, measurements, tests, or by using any other suitable method. Objective Evidence is physical evidence that someone, when reviewing an audit report, can inspect and evaluate for themselves. It provides compelling evidence that the review or audit was actually performed as indicated, and that the criteria for the audit/review was upheld. Objective evidence is any documented statement of fact, other information or record, either quantitative or qualitative, pertaining to the quality of an item or activity, based on observations, measurements or tests which can be verified. Any anomalies identified by an audit are documented in non-conformance reports. For a non-conformance report to be credible it must be backed up by objective evidence. Anomalies that lack credibility are unlikely to be followed up by management thus defeating the main purpose of an audit, that is: to identify problems and trigger corrective action on the quality management system.
ISO 9000 definition:
“Conformity evaluation by observation and judgement accompanied as appropriate by measurement, testing or gauging”
An inspection is the verification of product quality to pre-identified quality specifications before, during or after the production process. Prior to the manufacturing process, raw materials can be inspected to identify if the materials themselves meet specifications. During the manufacturing process, products are inspected at the factory to verify that quality requirements and specifications are being met. After production, goods can be inspected prior to loading and unloading to verify that the approved final product is shipped and received according to the buyer’s requirements. Inspections throughout the various stages of production can help both buyer and manufacturers monitor that quality requirements for the product are being met and support on-time delivery of quality products.
Stages of Product Inspection:
- Raw Material Incoming: This is an inspection of raw materials prior to production to verify that the quality specifications for materials are being met. Early in the production process, this inspection can help minimize wasted time, material costs and delayed shipment if specifications are not being met.
- Initial Production: With many production processes, much of the production set up is done at the front end to allow the review of product quality requirements before mass production begins. Verifying first run quality requirements can help product consistency and minimize wasted time, scrap product, rework and shipping delays.
- During Production: This inspection validates the initial production process has been maintained and that goods being produced continue to meet quality requirements. In the case of new raw materials, new operators, production lines or specification changes, this service can assess if requirements are being met during production.
- Final Random: This inspection takes place prior to shipment and assesses whether final product meets all quality specifications (i.e., color, workmanship, label, function, fit, packaging of product, etc.) and can be shipped without delay. The objective of this inspection is to identify any quality defects that would prevent shipment of inadequate product.
- Loading/Unloading: This inspection provides witness to the loading and unloading of product to verify that only the inspected and approved final product is shipped and received according to the buyers’ requirements.
- Sample Collection: Product samples are selected at a factory (or other sampling location) by an inspector for forwarding to a client or to a laboratory for testing. Sample Collection may be performed as part of a product inspection or as a separate service.
ISO 9000 definition:
“Determination of one or more characteristics according to a procedure.”
Test is a procedure intended to establish the quality, performance, or reliability of something, especially before it is taken into widespread use.Test is a measures to check the quality, performance, or reliability of (something), especially before putting it into widespread use or practice.Product testing is any process by means of which a researcher measures a product’s performance, safety, quality, and compliance with established standards. The primary element which constitutes an objective comparative test program is the extent to which the researchers can perform tests with independence from the manufacturers, suppliers, and marketers of the products.
Test are conducted to
- Determine if, or verify that, the requirements of a specification, regulation, or contract are met
- Decide if a new product development program is on track: Demonstrate proof of concept
- Provide standard data for other scientific, engineering, and quality assurance functions
- Validate suitability for end-use
- Provide a basis for technical communication
- Provide a technical means of comparison of several options
- Provide evidence in legal proceedings: product liability, patents, product claims, etc.
- Help solve problems with current product
- Help identify potential cost savings in products
ISO 9000 definition:
“Confirmation, through the provision of objective evidence, that specified requirements have been fulfilled.”
NOTE 1 The term “verified is used to designate the corresponding status.
NOTE 2 Confirmation can comprise activities such as
– performing alternative calculations,
– comparing a new design specification with a similar proven design specification,
– undertaking tests and demonstrations, and
– reviewing documents prior to issue.
Verification may be defined as the evaluation of whether or not a product, service, or system complies with a regulation, requirement, specification, or imposed condition.Verification is intended to check that a product, service, or system meets a set of design specifications. In the development phase, verification procedures involve performing special tests to model or simulate a portion, or the entirety, of a product, service or system, then performing a review or analysis of the modeling results. In the post-development phase, verification procedures involve regularly repeating tests devised specifically to ensure that the product, service, or system continues to meet the initial design requirements, specifications, and regulations as time progresses. It is a process that is used to evaluate whether a product, service, or system complies with regulations, specifications, or conditions imposed at the start of a development phase. Verification can be in development, scale-up, or production. This is often an internal process. It uses objective evidence to confirm that specified requirements have been met. Whenever specified requirements have been met, a verified status is achieved. In the context of this standard, the term verification is used in at least two different situations: design and development and purchasing. Design and development verification use objective evidence to confirm that design and development outputs meet specified input requirements. Similarly, objective evidence must be used to verify or confirm that purchased products meet specified purchasing requirements.There are many ways to verify that requirements have been met. For example, you could do tests, perform demonstrations, carry out alternative calculations, compare a new design specification with a proven design specification, or you could inspect documents before you issue them.
ISO 9000 definition:
“Confirmation, through the provision of objective evidence, that requirements for a specific intended use or application have been fulfilled.”
NOTE 1 The term “validated is used to designate the corresponding status.
NOTE 2 The use conditions for validation can be real or simulated.
Validation can be defined as the assurance that a product, service, or system meets the needs of the customer and other identified stakeholders. It often involves acceptance and suitability with external customers. Validation is intended to ensure a product, service, or system result in a product, service, or system that meets the operational needs of the user. For a new development flow or verification flow, validation procedures may involve modeling either flow and using simulations to predict faults or gaps that might lead to invalid or incomplete verification or development of a product, service, or system . A set of validation requirements, specifications, and regulations may then be used as a basis for qualifying a development flow or verification flow for a product, service, or system. Additional validation procedures also include those that are designed specifically to ensure that modifications made to an existing qualified development flow or verification flow will have the effect of producing a product, service, or system that meets the initial design requirements, specifications, and regulations; these validations help to keep the flow qualified. It is a process of establishing evidence that provides a high degree of assurance that a product, service, or system accomplishes its intended requirements. This often involves acceptance of fitness for purpose with end users and other product stakeholders. This is often an external process.
It is sometimes said that validation can be expressed by the query “Are you building the right thing?” and verification by “Are you building it right?”. “Building the right thing” refers back to the user’s needs, while “building it right” checks that the specifications are correctly implemented by the system. In some contexts, it is required to have written requirements for both as well as formal procedures or protocols for determining compliance.
It is entirely possible that a product passes when verified but fails when validated. This can happen when, say, a product is built as per the specifications but the specifications themselves fail to address the user’s needs.
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 achieved. The process of validation can be carried out under realistic use conditions or within a simulated use environment. In the context of this standard, the term validation is used in at least two different situations: design and development and production and service provision. Design and development validations use objective evidence to confirm that products meet the requirements which define their intended use or application. Production and service provision processes must be validated whenever process outputs cannot be measured, monitored, or verified until after the product is in use or the service has been delivered (by then it’s too late to do anything about output deficiencies and defects). In this case, validations use objective evidence to confirm that production and service provision processes are capable of producing planned results.
8.6) Qualification process
ISO 9000 definition:
“Process to demonstrate the ability to fulfill specified requirements.”
NOTE I The term “qualified” is used to designate them corresponding status.
NOTE 2 Qualification can concern persons, products, processes or systems.
EXAMPLE Auditor qualification process, material qualification process.
Qualification is an act or process to assure something complies with some condition, standard, or specific requirements. Qualifications tend to be smaller in scope than validations, tend to be less dynamic, and are frequently a subset of a greater validation initiative.Qualification process is an act or process to assure something complies with some condition, standard, or specific requirements.
A design verification verifies that a frozen (static) design meets top level product specifications.
A process validation validates that the on-going (dynamic) manufacturing process produces product that meets product/print specifications and consist of installation qualifications, operational qualifications, process performance qualifications, a product performance qualification and perhaps process verifications.
An installation qualification qualifies that equipment was installed correctly and are a subset of a process validation
ISO 9000 definition:
“Activity undertaken to determine the suitability, adequacy and effectiveness of the subject matter to achieve established objectives.”
NOTE Review can also include the determination of efficiency.
EXAMPLE Management review, design and development review, review of customer requirements and nonconformity review.
A review is an activity. Its purpose is to figure out how well the thing being reviewed is capable of achieving established objectives. Reviews ask the following question: is the subject of the review a suitable, adequate, effective, and efficient way of achieving your organization’s objectives? There are many kinds of reviews. Some of these include management reviews, design and development reviews, customer requirement reviews, and nonconformity reviews. Relative to the previous types of reviews, the focus of each review is as follows: quality management systems, design characteristics and specifications, customer requirements, and nonconformities, respectively.
The overall purpose of a management review is to evaluate the suitability, adequacy, and effectiveness of an organization’s quality management system, and to look for improvement opportunities. Management reviews are also used to identify and assess opportunities to change an organization’s quality policy and quality objectives, to address resource needs, and to look for opportunities to improve its products.
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