Quality Management

Quality is the totality of features and characteristics of a product or service that is a degree of excellence of the result of works or activities, or goods highest standard on its ability to satisfy stated. The ISO (International Organisation for Standardisation) defined that the Quality of an object can be determined by comparing a set of inherent characteristics against a set of requirements. If those characteristics meet all requirements, high or excellent quality is achieved but if those characteristics do not meet all requirements, a low or poor level of quality is achieved. So, the quality of an object depends on a set of characteristics and a set of requirements and how well the former complies with the latter.

Quality Management is the management activities of an organisation that is to make sure an organisation, product or service is consistent, and the company does things to a high standard. The Quality Management determines quality policies, objectives, plans, and responsibilities including quality control (QC), quality assurance (QA), and quality improvement through the inspections and audits.

Quality Assurance (QA) is a work process to make sure that the produced goods or services results are fully met the quality requirement. The Quality Assurance System is a preventive and proactive work process through establishment of plans and procedures, and auditing the implementation, and monitoring and controlling of a corrective action requirement.

Quality Control (QC) is a work process of checking and inspection for goods or results (outputs/ outcomes) of the activity or work quality against the specifications and standards.

Quality Plan is a set of quality related plan document for a specific case or project to achieve the QMS (Quality Management System) that includes the quality practices, resources, and activities relevant to a particular product, process, service, contract, or project. The Quality Plan is used to meet statutory, regulatory and customer requirements, to optimise use of resources in meeting quality objectives, to minimise the risk of nonconforming to the requirements and many other purposes.

Quality Policy is a set of documents developed by the top management regarding the company quality matters that includes an overall intention, objective, and direction of the organisation. The Quality Policy expresses the top management's commitments to the quality management system (QMS) and allows managers to set quality objectives. The company Quality Policy should be based on ISO’s quality management principles and compatible with other policies, and consistent with its vision and mission.

Quality System is an organisational structure including responsibilities, procedures, processes, and resources for an implementation of company quality management that will ensure an efficient and effective method of producing a desired product and service.

Quality Management System (QMS) is a system operation by an organisation with the company quality policy, plan, procedures and standards to achieve the company goals and objectives in the quality.

Quality Surveillance is the continuing monitoring of all aspects of production processes that is a planned and scheduled manner without impeding product delivery. The Quality Surveillance is based on performance and risk to maintain the efficiency and quality of the processes.

Compliance is an act or a process of obeying an order or meeting a rule, specification, procedure, or request.

Concession is the act of giving up reaching agreement that is the official permission to carry out a particular type of business by a government or company.

Conformity is the behaviour followed the standards that is expected by a group or society.

Consequence of Failure (CoF) is defined for all consequences in safety, economy and environment that is evaluated as the outcomes of a failure based on the assumptions that such a failure will occur. A CoF analysis estimates failure consequences resulting from a failure mode due to the identified damage mechanisms that is to categorise assets based on the potential failure significance. (Refer to the Probability of Failure (PoF))

Cost of Poor Quality (COPQ) is the direct and indirect costs associated with any activity that is incurred to remedy defects discovered before the product or service is delivered to the customer and incurred to remedy defects discovered by customers. A COPQ is the financial qualification of any loss or waste that is a refinement of the concept of quality costs from the effort to study the concept of tailored quality costs of While Feigenbaum of IBM in the 1960s.

Defect is a type of nonconformities, or a fault or problem on the products or services that occurs when the work is not performed correctly or fail to meet the specified requirement.

Defects per Million Opportunities (DPMO) is a measure of the number of errors occurring in a business or manufacturing process that is average number of Defects per Unit (DPU) observed during an average production run divided by the normalised one million of opportunities, expressed in parts per million. The Six Sigma methodology aims for a maximum of 3.4 defects per million opportunities.

ISO 21500:2012 provides Guidance for Project Management and can be used by any type of organisation, including public, private or community organisations, and for any type of project, irrespective of complexity, size, or duration. It provides high-level description of concepts and processes that are considered to form good practice in project management. Projects are placed in the context of programmes and project portfolios, however, ISO 21500:2012 does not provide detailed guidance on the management of programmes and project portfolios. Topics pertaining to general management are addressed only within the context of project management.

ISO 9000 family addresses various aspects of Quality Management and contains some of ISO’s best known standards. The standards provide guidelines and tools for companies and organisations who want to ensure that their products and services consistently meet customer’s requirements, and that quality is consistently improved.

Standards in the ISO 9000 family include:

ISO 9001:2015 - sets out the requirements of a quality management system,

ISO 9000:2015 - covers the basic concepts and language,

ISO 9004:2009 - focuses on how to make a quality management system more efficient and effective,

ISO 19011:2011 - sets out guidance on internal and external audits of quality management systems.

Measuring Equipment (or Tool) includes all the things needed to carry out a measurement process that can be instruments and apparatuses as well as all associated software, standards, and reference materials.

Performance Test is a test or an examination of the plant capacity and quality to achieve the desired results that is to verify the plant meets the specifications and contractual requirement. The Performance Test requires a system or plant to actually perform a task or activity, rather than individual performance tests or inspections referring to specific parts.

Probability of Failure (PoF) is the measure of the likelihood that includes a confidence levelling with regard to the damage rates and mechanisms, and the effectiveness of the inspection program. A PoF is estimated both qualitatively and quantitatively as failure frequencies of different types of mechanisms in the operating system. In Risk Based Inspection (RBI) analysis, a PoF exampled failure frequencies of an event per unit as ranking categories from 1 (very low) to 5 (very high). (Refer to the Consequence of Failure (CoF))

Process-Based Quality Management System is focused on the product quality and organisational satisfy that is a quality management system (QMS) to improve organisational efficiency and effectiveness by which organisations improves safety and quality in produced outputs.  

Qualitative is based primarily on description and relating to measured by the quality of something rather than its quantity.

Quality Adjustment is the process or result of the process of estimating that removes any price differential attributed to a change in quality by adding or subtracting the estimated value.

Quality Check is the intensive review in the quality matters to test, inspect, or ask questions in order to find out the highest level of accuracy possible. (e.g., visiting a service at a pre-arranged time)

Quality Circle is the structured employee involvement groups operating in designated work areas that meets regularly to identify work related problems and to suggest solutions or improvements to management. Generally, the Quality Circle is a small group gathering, led by the supervisor or the manager who presents the solutions to the management. The Quality Circle aims to give individual members the opportunity to contribute to problem-solving and have an emphasis on teamwork and collaboration.

Quality Index is the evaluation of key factors which contribute to make up the appropriate quality as a weighted mean of all available quality indicators.

Quality Manual is a document (manual) including the company quality policy and quality systems of a company and organisation.

Quality Objective is the company quality goals that intends to achieve the value of products, services and processes. The Quality Objective is a basic quality management process to establish a set of quality objectives.

Quality Record is the documented specific information of a quality management system that relates to the quality performance, procedures, and work instructions.

Rework is 1) to change a piece of writing in order to make it more suitable for a particular purpose; 2) a process required to correct defects or nonconforming items to meet the specified requirement prior to repair, replacement, etc. the Rework is an integral part of quality management, helping organizations meet quality standards, reduce waste, and enhance customer satisfaction by ensuring that products or services conform to predefined quality criteria. (Also, called as the Redo Work)

Root Cause is the reason for non-conformance or system failures that leads to an incident, unsafe act, or condition resulting in a non-conformance. The Root Cause should be permanently eliminated through a continuous process improvement to prevent an undesirable outcome.

Six Sigma (6σ) is a statistical quality control applied to business strategy. The Six Sigma (6σ) is originated by Motorola in 1986.

Standard is a written document of the level of quality providing requirements, specifications, guidelines, work processes, or characteristics. The Standard is agreed and accepted for the required particular purpose that can be used consistently, internationally, and widely to ensure the whole international businesses for materials, products, work processes and services. Standards help to identify, develop, evaluate, and provide access the applicable codes, regulations, and laws that affects a process or facility safety and quality requirements.

Tolerance is 1) a capacity to accept the existence of opinions or behaviours that one dislikes or disagrees with; 2) willingness to accept the uncertainty arising from the physical and environmental differences; 3) In economics, the level of risk or uncertainty that an investor or market participant is willing to accept. In Quality Control, a Tolerance limit is a measure used to ensure the uniformity or quality of manufactured products that is defined as a specific proportion of the population at a given confidence level.

Total Quality Control (TQC) is the practice of the quality control and management that is to develop, design, produce and service a quality product from design to delivery it with the most economical, useful, and satisfactory to the consumer. A TQC is the application of quality management principles to all areas of business that approaches to the long-term business success with continuous improvement in all aspects of an organisation as a standard process.

Total Quality Management (TQM) is a quality management approach that seeks to provide long-term success by providing unparalleled customer satisfaction through the constant delivery of quality services. TQM requires all members of an organisation participate in improving processes, products, services, and the culture in business processes. TQM was developed by William Deming, a management consultant whose work had a great impact on Japanese manufacturing.

Traceability is the ability to discover information about where and how a product was made including the history, distribution, location, and application of products, parts, materials, and services that is documented and recorded identification. The Traceability system records and follows the trail from suppliers and are processed and ultimately distributed as final products and services.

Test is to check, measure, or find out the ability, capability, or suitability of the specific requirement, quality performance of work, or the reliability of work process that is an examination, assessment, determination, verification, or evaluation of the item object such as a material, product, system, or person, etc. The Test result confirms the specified requirement and acceptability for the further work or activity proceeding.

Inspect means to look at closely and carefully in order to discover information, especially about their quality or condition. Inspection is the ​act of ​measuring process ​carefully involving examining, gauging, testing the material, equipment, or activity in accordance with the procedures and specifications to ensure its conformance with specific requirements. The Inspection may be performed visually or with special tools or equipment, and the results are usually compared to specified requirements and standards.

Field Inspection is a conformity assessment activity that verifies on site activities' compliance with approved plans and specifications, code, and product standard requirements. The Field Inspection provides oversight and inspection of construction activities to ensure proper quality and quantity of materials and equipment, workmanship, adequacy of contractor's methods, procedures, operations, and safety standards by evaluating the efficiency and detecting potential technical problems. The Field Inspections are: Pre-Production Inspection; During Production Inspection, and Final Product Inspection.

Shop Inspection is carried out inspection activities in the manufacturing shop during the manufacturing process that involves physically verifying and ensuring and conforming equipment and material to the requirements of the purchase order prior to release for shipment. Generally, the Shop Inspection activities are: document review (e.g., ITP (Inspection and Test Plan), Material Certificates), visual quality and quantity inspection, Non-Destructive Testing (NDT), Destructive Examination or Testing, packing, marking and loading inspection, etc.

Inspection and Test Plan (ITP) is the inspections and testing plans and procedures document which is used in a manufacturing shop for the procured equipment and material. An ITP working process starts with an agreement between the purchaser and manufacturer, and the manufacturer provides the inspection and test plan and procedures to the purchaser, which explains the equipment specification and related information such as cost and schedule impact. Before the start of manufacturing, the purchaser must provide an acceptance of the Inspection and Test Plan (ITP) to the manufacturer.

Inspection Level is classified into a desktop inspection (review of the inspection report or result), visiting (witness) and resident inspection. In ISO 2859, General Inspection Level (GI): Level I (Low sampling, suitable for very good quality levels); Level II (Normal sampling, suitable for normal quality levels); Level III (High sampling, suitable for lower quality levels). The Inspection level is a part of statistical sampling plans, which are used to determine the number of units to inspect and the criteria for acceptance or rejection based on the results of the inspection.

Inspection Types may be a document (inspection and testing report) review; visual inspection; Non-Destructive Testing (NDT) using a science and industrial technology such as Liquid Penetrant Testing (PT); Radiographic Testing (RT); Ultrasonic Testing (UT), etc., for inspection of manufactured components and products, and Destructive Examination or Testing under the most severe operating conditions.

Examination is the ​act of ​looking at or ​considering something ​carefully in ​order to ​discover something, and is a detailed inspection or study.

Acceptance Test is the test, inspection, and examination work process to check the meeting of requirements for the scope of work, specification, function, capability, performance, and completeness. The Acceptance Test can be performed at the manufacturer's shop (FAT) and at the site (SAT), and User Acceptance Test (UAT).

Factory Acceptance Test (FAT)

Audit is a systematic evidence gathering process that is to inspect and measure of the technical qualities and financial expenditures, and work processes to determine whether a performance is being effectively implemented based on the system by independent either internal or external.

Audit Checklist is a checklist document that contains numbers, statements, or other evidence to be used and found in the audit.

Audit Criteria is a criteria document and used as the reference items that is compared against audit evidence to determine how well they are being met. The Audit Criteria includes company policies, plans, procedures, requirements, and other forms of documented information. 

Audit Evidence is the evidence document includes records, factual statements, and other verifiable information that is related to the audit criteria being used.

Audit Finding is the result from an audit process that evaluates the audit evidences and compares it against an audit criteria. Audit Findings show that the audit criteria are being met (conformity) or not being met (non-conformity). The Audit Finding can be identified and developed as the best practice or improvement opportunity. 

Audit Interview is a method of gathering information and finding evidence through a series of questions and observations. The Audit Interview is a final stage of the audit process and a basis of analysis and interpretation of information finding in the audit.

Audit Programme (Program) is a set of audits schedule that is planned and carried out within a specific time frame.

Audit Risk

Abel Tester (or Abel Closed-Cup Tester) is a laboratory instrument of the closed cup flash tester that works by heating a small sample of the liquid in a closed cup until its vapours ignite when exposed to an open flame. The Abel Tester is used to test the flash point of kerosene and other potential hazards of liquid which have a flash point of -30°C ~ 70°C. The flash point is the lowest temperature at which the vapours of a liquid will ignite when exposed to an open flame or another ignition source.

Bottle Test is an analytical procedure in which a chemical is added to samples of a water-oil emulsion to determine the most effective and quantity of chemical needed to separate the emulsion into oil and water fractions.

Certification System is an auditable work process of the project documentation that ensures the facilities are constructed, commissioned and handed over to an owner in accordance with the specifications, procedures, and contractual requirements including engineering and design output; documented as-built; inspected and tested; and handed over all facilities with necessary documentation. (Refer to the Mechanical Completion Certificate (MCC), Provisional Acceptance Certificate (PAC), Final Acceptance Certificate (FAC), etc.)

Checking Rule is a logical condition or a restriction to the value of a data item or a data group that defines the checking procedure to be used for the availability check in individual applications.

Hydrostatic Test Package is a set of procedure documentation used to Hydrostatic Test for the strength and integrity of a pressure vessel or piping system by water or another liquid at a specified pressure. The Hydrostatic Test Package documentation includes the Hydrostatic Test Diagram (mark-up P&IDs), ISO drawings, test pressure calculations, test and inspection reports, and punch lists, test procedures, etc. The Hydrostatic Test Package is an essential component of quality assurance and safety testing in oil and gas, chemical and petrochemical processing, pipeline, and power generation plant.

Hydrostatic Test Pressure is the holding pressure for a specific amount of time to visually inspect the stationary equipment or piping system for leaks. ASME Code B 31.3 provides the basis for test pressure. The minimum Hydrostatic Test Pressure for metallic piping shall be as per the following equation: Pt=1.5 * Pd * (St/Sd) where, Pt=minimum test gauge pressure, Pd=internal design gauge pressure, St=allowable stress value at test temperature, Sd=allowable stress value at design temperature. The Hydrostatic Testing Pressure is normally 30% higher than the design pressure whereas a pneumatic testing pressure is normally 10% higher than the design pressure.

Improvised Explosive Device (IED) is a homemade bomb constructed and deployed other than in the military action that is designed to cause death or injury by using explosives alone or in combination with toxic chemicals, biological toxins, or radiological material.

Material Certificate

American Society for Nondestructive Testing, Inc. (ASNT) is the world's largest technical society for Nondestructive testing (NDT) professionals. (www.asnt.org)

ASTM International (known until 2001 as the American Society for Testing and Materials), over 12,000 ASTM standards operate globally. Defined and set by us, they improve the lives of millions every day. Combined with our innovative business services, they enhance performance and help everyone have confidence in the things they buy and use. (Source: http://www.astm.org/)

International Organization for Standardization (ISO) is an independent, non-governmental membership organization and the world's largest developer of voluntary International Standards, and develops and publishes International Standards (Source: www.iso.org/).

ISO 9000 Quality management
ISO 14000 Environmental management
ISO 3166 Country codes
ISO 26000 Social responsibility
ISO 50001 Energy management
ISO 31000 Risk management
ISO 22000 Food safety management
ISO 27001 Information security management
ISO 45001 Occupational health and safety

International Register of Certificated Auditors (IRCA) is the leading professional body for management system auditors. The IRCA is the leading professional body for management system auditors. IRCA represents 10,000 registered auditors in over 120 countries and every year, over 60, 000 delegates attend an IRCA approved training course. (Source: www.irca.org)