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ASQ CQA Certification Exam Questions and Answers
Latest Update
ASQ - correct answer American Society for Quality ISO 19011:2011 - 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.
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
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.
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
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
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
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
ASQ CQA
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