Mark Hammar Competence: The competence requirements of a job are the required employee skills needed to adequately perform the job. The competence of the employee is the ability of their known skills and experience to satisfy the requirements of the job. Where the abilities, skills, experience and education of an employee do not fully satisfy the needs required to perform a job, training can be applied to bridge the gap and provide the additional required skills and knowledge. Look at Using Competence, Training and Awareness to replace documentation in your QMS for more information.
Conformity / Nonconformity / Defect: Conformity is the ability of a process output to satisfy the requirements it is desired to meet. The output may be a product, service, document, record, etc., and the requirements are those that the company has decided are required for the output article. Conformity is when the output meets the requirements, and inversely, nonconformity is when the output fails to meet one or more requirements. A defect is a synonym for nonconformity, but is normally used in relation to products.
Correction: When a nonconformity occurs, there are steps taken to correct the immediate problem. If a document is incorrect, an update is done on the document. If a drawing is wrong, the drawing is corrected. This addresses the immediate problem so that work can continue.
Corrective Action: When a nonconformity occurs that is systemic in nature, it is important to correct not only the immediate problem, but to find what the root cause of the problem is and correct it. The actions taken to correct the root cause of a problem are called a corrective action. For more information, see Seven Steps for Corrective and Preventive Actions to support Continual Improvement.
Customer Satisfaction: Customer satisfaction is how much your customer perceives that your product or service has met their requirements. This deals more with the way that a customer has interpreted the outcome of your product or service delivery than it does with how much you feel that your product or service has met every requirement stated.
Design Verification / Design Validation: Design verification is the act of taking the design outputs (drawing, specification, plans, documents, etc.) and comparing them to the design inputs (requirements for the design) to make sure that all requirements are met. This is mostly a paper exercise. Design validation occurs when you actually create a product or service and see that the actual outcome of the design meets the requirements. See ISO 9001 Design Verification vs Design Validation for more explanation.
Effectiveness: A comparison of the actual results and the planned activities. The effectiveness is how well the activities met the plan. These activities can be for any plan, but are often used in an ISO 9001 QMS for assessing a process outcome against the plan for the process.
Efficiency: A comparison of the results achieved and the resources needed to achieve the results. A process can be effective, but if it takes too many resources to achieve the results, the process may not be considered efficient.
Infrastructure: The physical surroundings required for a business such as buildings, utilities, process equipment, transportation services and IT systems.
PDCA Cycle: Plan-Do-Check-Act (also called PDCA) is a cycle that was originated by Walter Shewhart and made popular by Edward Deming – two of the fathers of modern quality control. This concept is a cycle for implementing change which, when followed and repeated, would lead to repeated improvements in the process it was applied to. Plan-Do-Check-Act in the ISO 9001 Standard
Preventive Action: A preventive action takes the same steps as a corrective action in correcting the root cause of a problem. However, it does so when the problem has not yet occurred as a nonconformity and is still a potential problem.
Procedure / Documented Procedure: The way that is specified to perform an activity or process. A procedure is a list of steps to take to make a process work properly, but need not be documented unless required. For a greater understanding of what needs to be documented, take a look at Mandatory Documentation Required by ISO 9001:2008.
Process Approach: Looking at an overall system as smaller, interrelated processes to focus efforts toward more consistent and predictable results on the individual processes of the system. Controlling and improving the individual processes can be a much easier and more effective way to control and improve the entire system.
Quality Management System: A Quality Management System, often called a QMS, is a set of internal rules that are defined by a collection of policies, processes, documented procedures and records. This system defines how a company will achieve the creation and delivery of the product or service they provide to their customers. For more details, see What is a Quality Management System.
Quality Manual: The Quality Manual is a document that defines the scope of the organization’s quality management system (including exclusions from the ISO 9001 requirements), lists or includes the documented procedures that are established for the QMS, and provides a description of how the processes of the QMS interact.
Quality Policy/Quality Objectives: The Quality Policy comprises the overall goals, intentions and direction that the management of an organization has identified for quality. Quality objectives are specific goals designed to support the overall Quality Policy and are specified for relevant employees and departments throughout the organization.
Regrade: A decision taken on nonconformity products or services to use them for another purpose than that intended. A good example of this is when a store offers “seconds,” or their products that contain a defect and are reduced in price.
Rework / Repair: Actions taken on a nonconforming product or service that will make it usable. A rework will cause the resulting product or service to fully meet requirements, while a repaired product or service will be usable, but will still fail to meet some requirements.
Risk: The result of uncertainty, or the chance that an event will occur. Assessing what to do with a risk involves predicting the resulting outcome of the potential event and deciding what to do about it should it occur. For more ideas on how this works, see The role of Risk Assessment in the QMS.
Scrap: A decision to dispose of nonconforming material that is unusable in any form. This may include salvage of some parts.
Traceability: The ability to track the history of a part or service. Depending on requirements, this can include being able to identify each sub-component and material batch that is used within a larger product.
Work Environment: The conditions within the company infrastructure that are needed to achieve conforming products or services. This is determined by the company and can include temperature, humidity, lighting, weather protection and noise.
