ASQ CQA Certification Exam Definitions 199 Questions with Verified Answers
ASQ - CORRECT ANSWER American Society for Quality
ISO 19011:2011 -
... [Show More] CORRECT ANSWER sets out guidance on internal and external audits of quality management systems
ISO 9000:2015 - CORRECT ANSWER Describes the fundamental concepts and principles of quality management which are universal
Audit - CORRECT ANSWER Systematic, independent and documented process for obtaining evidence and evaluating it objectively to determine the extent to which the criteria are fulfilled
Audit client - CORRECT ANSWER Organization or person requesting an audit. Determines the scope of the audit. Jointly determines the purpose and criteria of an internal audit with the lead auditor.
Audit conclusion - CORRECT ANSWER Outcome of an audit, provided by the audit team after consideration of the audit objectives and all audit findings
Audit criteria - CORRECT ANSWER Set of policies, procedures or requirements
Audit evidence - CORRECT ANSWER Records, statements of fact or other info, which are relevant to the audit criteria and verifiable
Audit findings - CORRECT ANSWER Results of the evaluation of the collected evidence against criteria
Audit plan - CORRECT ANSWER Description of the activities and arrangements for an audit
Audit Program - CORRECT ANSWER Set of one or more audits planned for a specific time frame and directed towards a specific purpose
Audit scope - CORRECT ANSWER Extent and boundaries of an audit. Normally defines the organizations and time period for the audit. Can include physical locations, departments, products, processes, or systems, exclusions, timelines, relevant polices or procedures, and applicable regulations or contracts.
Audit team - CORRECT ANSWER One or more auditors conducting an audit, supported if needed by technical experts
Auditee - CORRECT ANSWER Organization being audited
Auditor - CORRECT ANSWER Person with the competence to conduct an audit
Part I - CORRECT ANSWER Auditing fundamentals
Part I A - CORRECT ANSWER Types of quality audits
Part I B - CORRECT ANSWER Purpose and scope of audits
Part I C - CORRECT ANSWER Criteria to audit against
Part I D - CORRECT ANSWER Roles and responsibilities of audit participants
Part I E - CORRECT ANSWER Professional conduct and consequences for auditors
Product or Service Audit - CORRECT ANSWER Examination of a particular item or service (hardware, processed material, software) to evaluate whether it conforms to requirements (that is, specifications, performance standards, and customer requirements).
Conducted at completed stage of production and has passed final inspection.
Can also measure quality of item going to customer (product quality audit).
Technical exam of the form, fit and function of a completed item after final inspection.
Process audit - CORRECT ANSWER Verifies that procedures are working within established limits. It examines an activity to verify that the inputs, actions, and outputs are in accordance with defined requirements. It is very focused on a single activity.
General Audit Types - CORRECT ANSWER 3 discrete types are product (which includes services), process, and system
Process audit technique - CORRECT ANSWER Audit method of following process steps
System audit - CORRECT ANSWER Exam conducted on a management system. A documented activity performed to verify, by exam and evaluation of objective evidence, that applicable elements of the system are appropriate and effective and have been developed, documented and implemented in accordance and in conjunction with specified requirements.
It encompasses all the practices of a facility that assist in providing an acceptable product or service that is safe and conforms to applicable local, regional, national, and international requirements
A S M E - CORRECT ANSWER American Society of mechanical engineers
Desk Audit or Document Review - CORRECT ANSWER An audit of an organization's documents. It can be done prior to or in conjunction with other audit methods but must be performed prior to auditing a new area to verify documents meet requirements before activity observation.
Audit classifications - CORRECT ANSWER Internal or external dependent on the auditor - auditee relationship
Internal audits - CORRECT ANSWER First party audits of an organization's products, processes, and systems conducted by employees of that organization. Per ISO 9000:2008 they must be scheduled and carried out by independent personnel
External audits - CORRECT ANSWER Can either be second or third party audits. Audits of an organization's products, processes, and systems conducted by individuals who are not employees of the organization.
First Party Audit - CORRECT ANSWER A K A internal audit. Performed within an organization to measure its strengths and weaknesses against its own procedures or methods and / or against external standards adopted (voluntary) or imposed (mandatory) on the organization. Must be performed by employees with no vested interest in the area being audited. Conducted on behalf of the organization itself for management review.
Second party audit. - CORRECT ANSWER External audit performed on a supplier by a customer or by a contracted organization on behalf of a customer. Surveys can be used as a method for this type of audit. Retention requirements are determined solely by the audit client
Third party audit - CORRECT ANSWER An external Performed by an organization independent of the customer-supplier relationship and is free from any conflict of interest. An example would be an audit by a regulatory agency. May result in certification, registration, approval, license, citations, etcetera.
Audit purposes - CORRECT ANSWER Certification, performance, compliance, conformance, follow-up
Certification Purposes for audits - CORRECT ANSWER For Approval to manufacture and / or market product in a specific area, or for customer requirements
A N A B - CORRECT ANSWER A N S I - A S Q National Accreditation Board is the U S accreditation body for management systems. It accredits certification bodies for I S O 9001, I S O 13485, I S O / T S 16949 Q M Ss, I S O 14001 E M Ss, as well as for several other conformity requirements standards.
I S O 9000 - CORRECT ANSWER Set of international standards on quality management and quality assurance developed to help companies effectively document the quality system elements to be implemented to maintain an efficient quality system. They are not specific to any one industry and can be applied to organizations of any size. It is a series, or family, of standards which can help a company satisfy its customers, meet regulatory requirements, and achieve continual improvement. It is considered a first step, a base level of a quality system and not a complete guarantee of quality. The family contains 9001:2015 (Q M S requirements, fundamentals and vocabulary), 9004:2009 (Q M S - sustained success) and 19011:2011 (auditing)
I S O 13485 - CORRECT ANSWER Requirements for comprehensive Q M S for design and manufacture of medical devices
I S O / T S 16949 - CORRECT ANSWER Technical specification aimed at development of Q M S that provides for continual improvement, emphasizing defect prevention and the reduction of variation and waste in automotive supply chain.
I S O 14001 - CORRECT ANSWER Specified requirements for an effective environmental management system. It provides a framework that an organization can follow, rather than establishing environmental performance requirements
Performance Purpose for audits - CORRECT ANSWER Audit designed to promote improvement and to be used for the achievement of continuous improvement and increase customer satisfaction.
Conformance / compliance purpose for audits - CORRECT ANSWER Evidence that organization meets its internal standards or external requirements
Follow-up audit - CORRECT ANSWER Audit to verify corrections were made and corrective actions were taken to address previous audit findings. Usually combined with next routine audit to keep cost down but based on risk or importance of the original finding.
Common audit elements - CORRECT ANSWER 1 - purpose and scope
2 - document review
3 - preparation for review
4 - data collection (the audit)
5 - audit report
6 - audit follow up
Audit Reasons - CORRECT ANSWER 1 - provide input to make informed decisions
2 - keep informed of actual or potential risks
3 - identify opportunities for improvement
4 - assess training effectiveness and equipment capability
5 - provide management support to quality, environmental, safety and other programs
6 - ensure ongoing compliance to refs and standards
7 - determine system and process effectiveness
8 - identify system and process efficiencies
A S 9100 - CORRECT ANSWER International management system standard for aircraft, space and defense industry which provides a comprehensive quality system for providing safe and reliable products to the aerospace industry and addresses civil and military aviation requirements.
Audit purpose - CORRECT ANSWER Client's responsibility to determine. And is dependent on the type of audit.
Capability - CORRECT ANSWER Ability of an organization, system or process to realize a product that will fulfill the requirements for that product
Characteristic - CORRECT ANSWER Distinguishing feature
Competence - CORRECT ANSWER Demonstrated personal attributes and demonstrated ability to apply knowledge and skills
Concession - CORRECT ANSWER Permission to use or release a product that does not conform to specified requirements
Conformity - CORRECT ANSWER Fulfillment of a requirement
Continual improvement - CORRECT ANSWER Recurring activity to increase the ability to fulfill requirements
Correction - CORRECT ANSWER Action to eliminate a detected nonconformity
Corrective action - CORRECT ANSWER Action to eliminate the cause of a detected nonconformity or other undesirable situation
Customer - CORRECT ANSWER Organization or person that receives a product
Customer satisfaction - CORRECT ANSWER Customer's perception of the degree to which the customer's requirements have been fulfilled
Audit scope - CORRECT ANSWER The extent and boundaries of an audit. Normally includes a description of the physical locations, organizational units, activities and processes, and time period covered. May specify areas not to be included as well.
Deming cycle - CORRECT ANSWER A K A: P D C A, P D S A, or shewhart cycle. The plan-do-check (study)-act cycle is a 4 step model for carrying out change. Just as a circle has no end, this cycle should be repeated again and again for continuous improvement. Auditing provides the info needed for the check-study step.
Audit criteria - CORRECT ANSWER Universal term that describes the reference used by an auditor against which evidence collected during the audit can be compared. A set of policies, procedures, or requirements used as a reference against which audit evidence is compared. Requirements may be generated by various stakeholders or interested parties. Determined during the audit initiation step.
Performance standards - CORRECT ANSWER The documents that contain the norms or criteria against which an activity is measured. The 4 levels are policies, manuals, procedural documents, and detailed documents.
Policies - CORRECT ANSWER Performance standard which can include corporate policy statements, international and national quality system standards, regulatory standards, and business sector standards
Manuals - CORRECT ANSWER Performance standard which can include corporate and plant manuals. One may exist for each function, Department, or division.
Procedural documents - CORRECT ANSWER Performance standard which includes step-by-step requirements for doing a job
Detailed documents - CORRECT ANSWER Performance standard in which these documents such as drawings, purchase orders, product specifications, and inspection plans, contain specific requirements or instructions.
Audit basis - CORRECT ANSWER A K A: reference standards, audit criteria or performance standards against which an audit must be performed. These reference documents may include management system, product or process standards, contracts, specifications, organization policies and objectives, and laws and regulations.
Standards - CORRECT ANSWER Industry criteria voluntarily adopted as an audit basis or to obtain membership to industry organizations
Contracts - CORRECT ANSWER An audit basis in a second party audit which states the specified requirements that must be met between two parties
Specifications - CORRECT ANSWER An audit basis normally used when conducting product or service audits to see if they are in compliance with the specified requirements
Policies and objectives - CORRECT ANSWER An audit basis of the compliance to a company's internal standards and objectives
Laws and regulations - CORRECT ANSWER An audit basis to ensure compliance to applicable rules imposed by regulatory agencies whether general or specific.
Audit participants - CORRECT ANSWER 3 key people of an audit who interrelate: the client, auditor, and auditee
Client - CORRECT ANSWER Audit participant that has requested or commissioned the audit.
Auditor - CORRECT ANSWER Audit participant who plans and carries out the audit. May be internal or independent to the organization.
Auditee - CORRECT ANSWER Audit participant to be audited.
Lead auditor or audit team leader - CORRECT ANSWER Auditor responsible for managing the audit. Jointly determines the purpose and criteria of an internal audit with the client.
Escort - CORRECT ANSWER An auditee assigned to accompany the audit team members
Coordinator - CORRECT ANSWER An auditee who is in contact with the lead auditor or audit program manager in order to arrange for the audit
Audit program manager - CORRECT ANSWER Person responsible for the audit program
Ethics - CORRECT ANSWER Basic philosophical conclusions about whether conduct and behavior are right or wrong. Moral principles by which an individual is guided. Affects professional conduct and professional conduct affects credibility.
Professional conduct - CORRECT ANSWER Manner in which auditors conduct themselves. Auditors must be objective, courteous and honest
Liability - CORRECT ANSWER The degree of legal responsibility an individual or company has in a given situation.
Code of ethics - CORRECT ANSWER Formal set of standards for conduct. A S Q's code of ethics includes fundamental principles, relations with the public, relations with employers, customers, clients and relations with peers.
I I A - CORRECT ANSWER Institute of Internal Auditors
Effectiveness - CORRECT ANSWER The degree of conformance to the stated requirements. Inspection records provide factual data on how well a product confirms to requirements.
Time plots of process output - CORRECT ANSWER Quantitative data including metrics, trend analysis, cycles, and patterns of data.
Initiation Step of Audit - CORRECT ANSWER Objectives, scope and criteria are defined at this stage of the audit process.
Audit purpose - CORRECT ANSWER Performed for two basic reasons: to determine if requirements are being met and to determine if there are opportunities for improvement
Part II A - CORRECT ANSWER Audit prep and planning
Part II B - CORRECT ANSWER Auditbperformance
Part II C - CORRECT ANSWER Audit reporting
Part II D - CORRECT ANSWER Audit follow up and closure
Defect - CORRECT ANSWER No -fulfillment of a requirement related to an intended or specified use
Dependability - CORRECT ANSWER Collective term used to describe the availability performance and its influencing factors: reliability, performance, maintain ability performance and maintenance support performance.
Design and development - CORRECT ANSWER Set of processes that transforms requirements into specified characteristics or into the specification of a product, process, or system
Deviation permit - CORRECT ANSWER Permission to depart from the originally specified requirements of a product prior to realization
Document - CORRECT ANSWER Information and it's supporting medium
Effectiveness - CORRECT ANSWER Extent to which planned activities are realized and planned results achieved
Efficiency - CORRECT ANSWER Relationship between the result achieved and the resources used
Grade - CORRECT ANSWER Category or rank given to different quality requirements for products, processes, or systems having the same functional use
Part III A - CORRECT ANSWER Auditor characteristics
Part III B - CORRECT ANSWER On site audit resource management
Part III C - CORRECT ANSWER Conflict resolution
Part III D - CORRECT ANSWER Communication and presentation techniques
Part III E - CORRECT ANSWER Interviewing techniques
Part III F - CORRECT ANSWER Team dynamics
Information - CORRECT ANSWER Meaningful data
Infrastructure - CORRECT ANSWER System of facilities, equipment and services needed for the operation of an organization
Inspection - CORRECT ANSWER Conformity evaluation by observation and judgement accompanied by measurement, testing or gauging
Interested party - CORRECT ANSWER Person or group having an interest in the performance or success of an organization
Management - CORRECT ANSWER Coordinated activities to direct and control an organization
Management system - CORRECT ANSWER System to establish policy and objectives and to achieve those objectives
Measurement control system - CORRECT ANSWER Set of interrelated or interacting elements necessary to achieve metrological confirmation and continual control of measurement processes
Measurement process - CORRECT ANSWER Set of operations to determine the value of a quantity
Measuring equipment - CORRECT ANSWER Measuring instruments, software, measurement standard, reference material or auxiliary apparatus or combination thereof necessary to realize a measurement process
Metrological characteristic - CORRECT ANSWER Distinguishing feature which can influence the results of measurement
Metrological confirmation - CORRECT ANSWER Set of operations required to ensure that measuring equipment confirms to the requirements for its intended use
Metrological function - CORRECT ANSWER Function with organizational responsibility for defining and implementing the measurement control system
Part IV A - CORRECT ANSWER Audit program management
Part IV B - CORRECT ANSWER Business and financial impact
Nonconformity - CORRECT ANSWER Non-fulfillment of a requirement
Objective evidence - CORRECT ANSWER Data supporting the existence or verity of something
Organization - CORRECT ANSWER Group of people and facilities with an arrangement of responsibilities, authorities and relationships
Organizational structure - CORRECT ANSWER Arrangement of responsibilities, authorities and relationships between people
Part V A - CORRECT ANSWER Basic quality and problem solving tools
Part V B - CORRECT ANSWER Process improvement techniques
Part V C - CORRECT ANSWER Basic statistics
Part V D - CORRECT ANSWER Process variation
Part V E - CORRECT ANSWER Sampling methods
Part V F - CORRECT ANSWER Change control and configuration management
Part V G - CORRECT ANSWER Verification and validation
Part V H - CORRECT ANSWER Risk management tools
Preventative action - CORRECT ANSWER Action to eliminate the cause of a potential nonconformity or other undesirable potential situation
Procedure - CORRECT ANSWER Specified way to carry out an activity or a process
Process - CORRECT ANSWER Set of interrelated or interacting activities which transforms inputs into outputs
Product - CORRECT ANSWER Result of a process
Project - CORRECT ANSWER Unique process consisting of a set of coordinated and controlled activities with start and finish dates, undertaken to achieve an objective conforming to specific requirements, including the constraints of time, cost and resources
Qualification process - CORRECT ANSWER Process to demonstrate the ability to fulfill specified requirements
Quality - CORRECT ANSWER Degree to which a set of inherent characteristics fulfills requirements
Quality assurance - CORRECT ANSWER Part of quality management focused on providing confidence that quality requirements will be fulfilled
Quality characteristic - CORRECT ANSWER Inherent characteristic of a product, process or system related to a requirement
Quality control - CORRECT ANSWER Part of quality management focused on fulfilling quality requirements
Quality function deployment - CORRECT ANSWER A customer driven product or service planning process. It is a methodology for translating customer requirements into company requirements at each stage, from concept definition to process engineering and production and into the marketplace
Quality improvement - CORRECT ANSWER Part of quality management focused on increasing the ability to fulfill quality requirements
Quality management - CORRECT ANSWER Coordinated activities to direct and control an organization with regard to quality
Quality management system - CORRECT ANSWER Management system to direct and control an organization with regard to quality
Quality manual - CORRECT ANSWER Document specifying the quality management system of an organization
Quality objective - CORRECT ANSWER Something sought, or aimed for, related to quality
Quality plan - CORRECT ANSWER Document specifying which procedures and associated resources shall be applied by whom and when to a specific project, product, process or contract
Quality planning - CORRECT ANSWER Part of quality management focused on setting quality objectives and specifying necessary operational processes and related resources to fulfill the quality objectives
Quality policy - CORRECT ANSWER Overall intentions and direction of an organization related to quality as formally expressed by top management
Record - CORRECT ANSWER Document stating results achieved or providing evidence of activities performed
Regrade - CORRECT ANSWER Alteration of grade of a non-conforming product in order to make it conform to requirements differing from the initial ones
Release - CORRECT ANSWER Permission to proceed to the next stage of a process
Repair - CORRECT ANSWER Action on a nonconforming product to make it acceptable for the intended use
Requirement - CORRECT ANSWER Need or expectation that is stated, generally implied or obligatory
Review - CORRECT ANSWER Activity undertaken to determine the suitability, adequacy and effectiveness of the subject matter to achieve established objectives
Rework - CORRECT ANSWER Action on a nonconforming product to make it conform to the requirements
Scrap - CORRECT ANSWER Action on a nonconforming product to preclude its originally intended use
Specification - CORRECT ANSWER Document stating requirement
Supplier - CORRECT ANSWER Organization or person that provides a product
System - CORRECT ANSWER Set of interrelated or interacting elements
Technical expert - CORRECT ANSWER Person who provides specific knowledge or expertise to the audit team
Test - CORRECT ANSWER Determination of one or more characteristics according to a procedure
Top management - CORRECT ANSWER Person or group of people who directs and controls an organization at the highest level
Traceability - CORRECT ANSWER Ability to trace the history, application or location of that which is under consideration
Validation - CORRECT ANSWER Confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled; reproducibly
Verification - CORRECT ANSWER Confirmation, through provision of objective evidence, that specified requirements have been fulfilled
Work environment - CORRECT ANSWER Set of conditions under which work is performed
Reproducibility - CORRECT ANSWER The variability due to different operators using the same instrument
Observation - CORRECT ANSWER An isolated discrepancy in an insignificant part of the quality system. An isolated event in an unimportant area
Minor nonconformity - CORRECT ANSWER Occasional, insignificant lapses
Audit disclaimer - CORRECT ANSWER Auditing is a sampling process and the audit team cannot say that no nonconformities exist or that their findings are a total representation of the total state of the quality system; said at the exit meeting
Concern - CORRECT ANSWER Items that have the potential to become a noncompliance.
Steps of a corrective action - CORRECT ANSWER 1 - define, 2 - brainstorm potential causes, 3 - gather data, 4 - perform investigation, 5 - determine corrective action, 6 - implement corrective action and 7 - verify effectiveness
Paraphrasing - CORRECT ANSWER Communication feedback technique used by an auditor to demonstrate understanding of interview responses
Objective evidence - CORRECT ANSWER Data such Physical properties, info from 5 senses, documents, records, and interviews used as part of fact gathering process
Interview process steps - CORRECT ANSWER 1 - put at ease, 2 - explain purpose, 3 - find out what is done, 4 - analyze what is done, 5 - make a tentative conclusion, and 6 - explain next step
Quality Loss Function (QLF) - CORRECT ANSWER The parameter or dimension whose deviations from an ideal value are associated with poor quality
Suboptimization - CORRECT ANSWER The optimization of one process component at the expense of the performance of other components or the entire system
5 S - CORRECT ANSWER One tool in kaizen which involves cleaning, organizing, and maintaining a manufacturing work area
Value stream map process - CORRECT ANSWER The product or service delivered to the customer is identified. The team walks the process end to end drawing the steps and labeling with take time, cycle time, and number operators. Work in progress and the physical and informational flows are drawn. A value add timeline is then added at the bottom of the map.
Noncompliance - CORRECT ANSWER Within the scope of an ISO 9001 Audit a trip hazard is an example of one
Effectiveness - CORRECT ANSWER The degree of conformance to the stated requirements. Inspection records provide factual data on how well the product conforms to requirements.
System Efficiency evaluation - CORRECT ANSWER Directed at how well resources are being used. For example, reviewing records on material utilization when established cost objectives are not being met.
Quantitative data - CORRECT ANSWER Examples include timeplots, metrics, trend analysis, cycles and patterns.
Audit types - CORRECT ANSWER Three discrete kinds which are product (which includes services), process, and system.
Audit benefits - CORRECT ANSWER Verification of conformance to requirements such as management system, regulatory and contractual, identification of risks and monitoring of risk treatments, identification of opportunities for improvement, verification that projects were implemented according to plan, determination of readiness of new products and processes, verification of system effectiveness, identification of inefficiencies and ineffective controls, verification of corrective actions and their effectiveness, identification and reporting best practices, and advancing the achievement of organization objectives
Standards - CORRECT ANSWER International and/or national industry mandates.
Specifications - CORRECT ANSWER Normally used when conducting product or service audit of specified requirements
Contracts - CORRECT ANSWER The purchase order or legal agreement between two parties which state specific requirements that must be met.
Policies and objectives - CORRECT ANSWER Internal requirements for quality, environmental, and/or safety program
Laws and Regulations - CORRECT ANSWER General or industry specific requirements imposed by third party regulatory agency
Conflict of interest - CORRECT ANSWER A situation in which the concerns or aims of two different parties are incompatible. A situation in which a person is in a position to derive personal benefits from actions or decisions made in their official capacity
Confidentiality - CORRECT ANSWER The state of keeping or being kept secret or private
Confidentiality agreement - CORRECT ANSWER Also known as a non-disclosure agreement, a contract between two or more parties where the subject is a promise that information conveyed will be maintained in secrecy
Confidentiality techniques - CORRECT ANSWER Rely on memory and not written notes, audit around, certification by auditee, or view parts of which are not proprietary
Security clearance - CORRECT ANSWER An official determination that an individual may access classified or proprietary information [Show Less]