8D – Eight Disciplines of Problem Solving
Formal quality approach to react and manage rapidly unexpected complex problems within a company, while ensuring the continuity of flow and finding problem’s root causes in the same time.
API Q1 9th edition
Published in June 2013 by the American Petroleum Institute (API). It is a Quality Management System Specification for Manufacturing Organisations to the Petroleum and Natural Gas Industry. The ninth edition represents a major change and shift in quality management for oil & gas equipment manufacturers (introduction of over 85 new clauses and 5 entirely new sections). All API Q1 systems must be effective by June 2014.
It offers additional benefits such as an extended one-year implementation period, a close alignment with API Q2 (Services/ Supply Organisation), correlations charts highlighting differences between both editions, etc. It also allows companies to meet their own demand and their customer demand, to increase their revenues and overcome, their product credibility, to improve their operations and reduce risks within the organisation, to reduce their operating costs, etc.
APQP – Advanced Product Quality Planning
Structured method to help in the effective planning and design, and ensure the development of products and the continuous improvement to satisfy customers. Generally associated with the automotive industry, APQP can be applied to any industry where effective and timely project management is needed. It starts with a concept and ends with product and process validation (PPAP). APQP is comprised of one pre-planning stage and five sequenced phases that identify tasks and activities needed to discover any risks, weaknesses or potential failures at the earliest possible time and ensure that customer requirements are identified and satisfied.
It is important to mention that APQP and PPAP cannot be dissociated, as PPAP documents are the result of APQP (providing evidence that APQP has been successfully performed).
British private repository intended primarily for suppliers selling food products under branded distributors on the UK market, comprising the main big companies of the English distribution (e.g. Sainsbury, Walmart, Tesco). Based on the principles of HACCP and food safety, it aims to establish a common basis of food security requirements for manufacturers of private label products in the UK market and thus to standardise audits. BRC certification is obtained after a third-party audit, carried out by a certification body. The audit checklist contains requirements divided into chapters such as Management commitment, Plan for the control of food safety – HACCP, System of quality management and food safety, Requirements for site environment, Control product, Control of process, or Staff.
Periodic or specific purpose audit conducted by a qualified individual outside of the organisation that objectively determine the effectiveness of the organisation’s quality system.
FMEA – Failure Mode and Effects Analysis
Step-by-step approach, used to discover any possible point of failure and to ensure that potential risk to the customers has been identified and addressed throughout the product and process development cycle (tool implemented in APQP phase 2 for Design – DFMEA – and Phase 3 for Process – PFMEA).
Design and Process FMEA are customer-specific requirements within the automotive industry and a proven tool for all manufacturing concerns, such as aerospace, medical, alternative energy and food industries.
GMP – Good Manufacturing Practice
Part of the Quality Assurance, which ensures products are consistently produced and controlled to the quality standards requirements. It is designed to minimise risks involved in any production that cannot be eliminated through testing the final product (starting materials, premises, equipment, training, hygiene of staff).
HACCP – Hazard Analysis and Critical Control Point
Preventive system developed for the production and management of food safety and quality (beverage, distribution, sale, and restoration). It helps to provide consumers with top quality products and to avoid any negative effect on the health. Therefore, it helps to meet regulations and customers’ requirements as well as to strengthen the Quality Assurance System. It provides a clear methodology to develop a specific plan for food safety and assists in the development of new food products and new processes and in the identification of problem’s root causes.
IATF – International Automotive Task Force
Group of automotive manufacturers, which aims at providing improved quality products to automotive customers worldwide. IATF members include automakers from the United States and Europe.
IFS – International Featured Standard
Standard appeared in 2003 at the joint initiative of the HDE (German Federation of retail trade) and FDC (French Federation of retail and distribution), designed to ensure distributors and wholesalers safety and regulatory compliance of the branded products they market. Internationally recognised by the GFSI (Global Food Safety Initiative), it is based on management standard ISO 9001 quality, to which are added the principles of good manufacturing and the principles of HACCP. It is a commercial asset for suppliers as it reassures customers about the safety of the products they distribute and the processes leading to their development.
Periodic or specific purpose audit conducted by the company’s own staff that objectively examine its own activities or products to ensure the prosperity of their organisation. It provides independent assurance that the organisation’s risk management, governance and internal control processes are operating effectively.
Gives the organisational requirements for the existence of a Quality Management System (QMS). It provides companies with a framework for a systematic approach to managing their processes to consistently produce products (and services) that:
– Meet Customer orientation (customers’ expectations)
– Provide Staff Commitment and Motivation
– Support Process Approach
– Provide Continuous Improvement
ISO 9001:2008 is the current standard that provides all the requirements for a QMS that will be of benefit to the organisation, helping to manage its business effectively and put in place best practice methodology. It is the only standard in the ISO 9000 family that companies can be certified – although certification is not mandatory to apply the repository.Other standards in the ISO 9000 family cover specific aspects such as fundamentals and vocabulary, performance improvement, documentation, training or financial and economic aspects. This simple standard in its principles but rigorous in its requirements can be used by any type of organisation, whatever its size or its business.
International standard based on the requirements of ISO 9001 with additional medical device requirements (e.g.risk analysis, sterilisation). It specifies requirements for Quality Management Systems (QMS) for the medical industry, when organisations (manufacturers and distributors of medical devices) need to demonstrate its ability to provide medical devices and related services, complying with customer requirements and applicable regulatory requirements. Requirements include for example a control of special processes, clinical trials and long-term monitoring of these trials, or a medical device vigilance aiming to monitor incidents that may occur during or after their use. Organisations benefit from: an access to markets that recognise or require this certification, a transparency, a reduction or operational costs by highlighting process deficiencies, or an increase of the customer’s satisfaction by delivering quality products.
Quality standard-based the most widely used on continuous improvement of the Environmental Management System (EMS) for small to large organisations. It focuses on the development of an environmental policy meeting regulatory requirements, on the improvement of internal processes (e.g. production, IT, etc.) and the reduction of their environmental impacts. It aims at building a positive environmental image and at improving its environmental performance. It also helps to reduce cost of waste management and to save consumption of energy and materials.
The ISO 14001 standard is based on the Plan (becoming ISO 14001-compliant) – Check (checking and correcting errors) – Do (implementation and operation of the ISO 14001 standard within an organisation) – Review (review of the entire process by the organisation’s top management) – Improve cycle (cycle that never ends as an organisation continually finds ways to improve their EMS). The entire process can take several months to several years depending on the size of the organisation.
International system addressed to food safety management that contains several standards. It can be applied to any organisation (whatever its size or position) in the food industry and demonstrates the ability to control food safety hazards to prevent any unsafe food consequences. It helps organisations to prove to customers that they have an effective food safety management system in order to get more and more customer confidence.
International automotive functional standard focused on safety critical components, based on the Functional safety standard for automotive electric and electronic related systems. It helps to manage functional safety, to assign an acceptable risk level to a system or component, and to regulate the product development process (design, implementation, integration, verification, validation, etc.), through several requirements and recommendations.
ISO/ TS 16949
ISO technical specification based on ISO 9001:2008, which defines the Quality Management System requirements for designing, developing, manufacturing, installing, and servicing automotive-related products. It brings together standards from across Europe and the United States. It offers some benefits such as:
– Global recognition as a reputable supplier
– Customer satisfaction
– Cost reduction (customer specifications, operations – continual improvement of processes)
– Improve stakeholder relationships (including staff, customers and suppliers)
– Legal compliance (statutory and regulatory requirements impacts on the organisation and on customers)
– Improved risk management (greater consistency and traceability of products and services)
– Proven business credentials (independent verification against recognised standards)
– Ability to win more business (e.g. procurement specifications requiring certification as a condition to supply).
ISO/ TS 29001
Quality Management System for product and service suppliers in the oil & gas industry (petroleum, petrochemical, natural gas), prepared in cooperation with the American Petroleum Institute. This ISO Technical Specification represents an agreement between members of a technical committee. It does not replace the API Specification Q1. It helps to provide global consistency and continually improve assurance in quality of products and services (defect prevention, reduction of waste and variations, etc.). It also gives some benefits such as fulfilling customer specific requirements, a license to trade in the oil and gas industry, or enhancing brand reputation. It is applicable to manufacturers or services providers of oil and gas industry equipment and material, to purchasers of equipment, materials and services, and to organisations using the standard for assessments and certification.
MSA – Measurement System Analysis
Statistical tool used to verify and monitor the accuracy and quality of a measurement system (amount of total variation). It aims to validate that the measurement used to collect product and process data are valid. The following areas components of measurement error needs to be studied and quantified before establishing capability of a process making decisions from the data: Accuracy/ Bias, Resolution/ Discrimination, Linearity, Stability, or Repeatability and Reproducibility (Gage R&R).
Dutch certification system designed for all types of biomass (biofuels, power, heat, solid and gaseous biomass). This Dutch Technical Agreement (NTA) describes the requirements for sustainably manufactured biomass products and is recognised by the European Commission as a Renewable Energy Directive (RED) compliant since 2012. It is applicable to all organisations, which patently produce, convert, trade or use biomass for energy generation or as transporting fuel.
OHSAS 18001 – Occupation Health and Safety Assessment Series 18001
International system specification, developed by leading trade and international standards bodies, that specifies the method of implementation of a health and safety management in the workplace and its requirements. It aims to obtain a better risk management to reduce the number of accidents, minimise risks to their workforce and visitors on their premises, comply with legislation and improve performance. This standard enable organisations to establish processes and that covers the following elements:
– Planning for hazard identification, risk assessment and risk management
– Structure and responsibility
– Staff training & awareness,
– Consultation & communication of safety management systems
– Operational management
– Preparing for emergencies and solutions
– Measuring, monitoring and continually improving performance.
PMIS – Project Management Information System
System consisting of tools and techniques used in project management to deliver information. It documents and stores the project management plan, subsidiary plans and other documents or work products relevant for the project (materials, financial data, reporting purposes, etc.). It is used to communicate with each other, by collecting, combining and distributing information through electronic or manual systems. It includes all aspects of the project, from initiating to closing, supporting all change control procedures as well, and helps to plan, execute and close project management goals.
PPAP-Production Part Approval Process
Industry guidelines that detail the specific reports used for every phase of the planning and production process to ensure quality and efficiency with regard to part production. It highlights the evidence collected through APQP and validated with results from the first trial run (with correct tools, machines, processes, personnel, conditions that may affect part quality). Design Records, design FMEA, control plan, MSA, qualified laboratory documentation or records of compliance are some of the required PPAP elements.
QA – Quality Assurance
Aims to catch defects before they get into the final product. Systematic process of checking activities implemented with a quality system to see if a product or service under development is meeting specific requirements. It helps to increase customer confidence, company’s credibility, work processes and efficiency, as well as to better compete with others.
QC – Quality Control
Differs from Quality Assurance as it is an aspect of the Quality Assurance process, consisting of the observation techniques and activities used to fulfil requirements for quality (detection and measurement of the variability in the output’s characteristics attributable to a constant system, and of an evaluation which indicate needed corrective responses).
QHSE – Quality, Health, Safety and Environment
Area of technical expertise that controls aspects of occupational risks within the company to conduct an integrated management system. The person responsible for QHSE has to oversee the safety of employees, their prevention trainings, the respect of the standards and the reliability of facilities in the business.
Quality system standard, based on ISO 9000 with additional requirements and related to the automotive industry, focusing on helping suppliers ensure that they meet or even exceed their customer requirements. This company level certification has been replaced by ISO/ TS 16949, more process-oriented, which contains all of ISO 9001, QS 9000 and other European standards.
RCA – Root Cause Analysis
Process that helps guide people to find and understand the primary causes of a problem (physical, human organisational), aiming at determining missing or ineffective controls to solve the problem and to prevent recurrence of these non-conformances (what happened, why, how to avoid recurrence). Systems and events are interrelated (cause-and-effect processes) and trigger on each other. To discover the origin of the problem, RCA comprises five steps:
– Define the problem
– Collect data
– Identify possible causal factors (e.g. 5Why)
– Identify root causes
– Recommend and implement solutions.
SPC – Statistical Process Control
Industry-standard methodology, which measures key quality characteristics and controls statistically the related processes. This quality assurance element aims to control a measurable process developing the product and that fluctuates and tends to disrupt and degrade over time. It is a preventive method of quality management, bringing all processes required and maintained through a monitoring system, which indicates problems requiring further action. It helps to reduce variability and costs, respond quickly and effectively against non-compliant products and therefore to improve the process capability.
VDA 6.1 – Verband Der Automobilindustrie
German Quality Management System Audit initiated by the German Automobile industry (manufacturers and suppliers), composed of several standards and recommendations.