CQE Practice Exam Section 2|54 Questions with Verified Answers,100% CORRECT

CQE Practice Exam Section 2|54 Questions with Verified Answers For any system, all quality-related activities begin with: - CORRECT ANSWER customer needs A quality manual generally consists of four tiers or layers that include: - CORRECT ANSWER policies, procedures, instructions, and records The critical characteristics of any documentation of a quality system are: - CORRECT ANSWER compliance, accuracy, and clarity One major component of a quality system is - CORRECT ANSWER implementation of a documented quality system Once a quality manual is complete, a final review is in order. The reviewed copy should be endorsed and authorized for release by: - CORRECT ANSWER top management Which of the following is not a requirement for maintaining document control? a. A process is in place for distribution of revisions and removal of obsolete documents b. A process is in place to make documents readily available to the public c. A process ensures that documents are located so they are readily available where needed d. A process is in place for the generation, approval, and distribution of documents - CORRECT ANSWER b ISO 9001:2015 is - CORRECT ANSWER an international standard Which of the following is not one of the standards in the ISO 9000 Quality Management Systems family? - CORRECT ANSWER Continual Improvement The ISO 9000 series of standards emphasizes eight quality management principles. Whatwould be categorized as one of those principles? - CORRECT ANSWER understanding customer needs Which of the following ISO standards are not requirements, but guidelines only? ISO9000, ISO9001, ISO9004 - CORRECT ANSWER ISO 9004 The Malcolm Baldrige National Quality Award (MBNQA) consists of how many key criteria for performance excellence? - CORRECT ANSWER 7 A quality audit is to be conducted within a particular company. An employee of this company will be conducting the audit. This is an example of: - CORRECT ANSWER an internal quality audit The most comprehensive type of audit is the - CORRECT ANSWER quality system audit What are three things that would be a purpose for a quality audit? - CORRECT ANSWER To meet requirements for certification to a management standard, verification of conformance with contractual requirements, to contribute to the improvement of the management system A quality audit has been conducted and some corrective measures are recommended. The party responsible for planning and implementing these measures is: - CORRECT ANSWER the auditee Corrective action and verification that nonconformities have been addressed is - CORRECT ANSWER often poorly completed The lead auditor must explain to the auditee the objectives of the audit as well as the methods that will be used. This is usually done during - CORRECT ANSWER the opening meeting (pre-examination) Who is responsible for the accuracy of the final audit report? - CORRECT ANSWER lead auditor The auditee will begin improvement efforts to address any problems or corrections identified by the audit. A follow-up audit to verify the results of this improvement effort - CORRECT ANSWER should be agreed on by all parties: client, auditor, auditee A company increased prevention costs by making changes to its quality control area, and then nonconformities decreased. As a result, there was a reduction in: - CORRECT ANSWER failure costs Correction of data entry errors, specimen processing, and cost of re-educating staff in a laboratory before delivery of the results to the customer are examples of - CORRECT ANSWER internal failure costs In one year, the cost of proficiency testing for quality assurance by an external certified agency for all employees was $10,000. This cost would be categorized as - CORRECT ANSWER appraisal cost Money spent on review of suppliers is - CORRECT ANSWER prevention cost As failure costs decrease, what typically happens to appraisal activities? - CORRECT ANSWER appraisal activities decrease Test equipment depreciation is an example of - CORRECT ANSWER appraisal cost Last month, a local company reported the following quality costs: Training- $40,000 Material inspection- $12,000 Test equipment- $65,000 In-plant scrap and rework: $15,000 What is the total appraisal cost for last month? - CORRECT ANSWER $77,000 Last month, a local company reported the following quality costs: Training- $40,000 Material inspection- $12,000 Test equipment- $65,000 In-plant scrap and rework: $15,000 What is the external failure cost for last month? - CORRECT ANSWER none The first step in developing a training program is - CORRECT ANSWER assessing the need for training A quality system audit is to be conducted. This is an example of - CORRECT ANSWER prevention costs Which of the following is not a reason for failure of a training program: quacy of leader/trainer b. different knowledge levels of the participants c. training is problem oriented rather than technique oriented d. overly complex language - CORRECT ANSWER training is problem oriented rather than technique oriented Pretests and posttests are useful tools in a training program for - CORRECT ANSWER assessing learning and retention Understanding customer needs is - CORRECT ANSWER the first and most important step in any quality activity What is the first tier in a quality manual? - CORRECT ANSWER Policies What is the second tier in a quality manual? - CORRECT ANSWER Procedures What is the third tier in a quality manual? - CORRECT ANSWER Instructions What is the fourth tier in a quality manual? - CORRECT ANSWER Records What are three components that give users confidence in documentation? - CORRECT ANSWER Compliance, accuracy, clarity What are two major components of a quality system? - CORRECT ANSWER implementation that is reviewed and approved for release and documentation of procedures and instructions for the quality system What are top management's two responsibilities in document control? - CORRECT ANSWER Endorsing the content of final documents and authorizing them for release ISO9001:2015 covers - CORRECT ANSWER requirements for a quality management system ISO9001:2015 is for an organization that needs what two things - CORRECT ANSWER needs to demonstrate its ability to consistently meet customer and regulatory requirements and aims to enhance customer satisfaction through the effective application of the system What are the eight quality management principles of ISO9001:2015? - CORRECT ANSWER Customer focus Leadership People involvement Process approach Systematic approach to management Continual improvement Factual approach to decision making Mutually beneficial supplier relations What principle is emphasized in the ISO9000 family? - CORRECT ANSWER customer focus THE SEVEN MBNQA CRITERIA CATEGORIES - CORRECT ANSWER Leadership Strategy Customers Measurement, analysis, and knowledge management Workforce Operations Results Type of audit when the auditor works for the company being auditing - CORRECT ANSWER Internal audit What are the three steps of an audit? - CORRECT ANSWER Pre-examination, suitability, implementation Internal failure costs - CORRECT ANSWER Costs incurred to fix problems that are detected before the product/service is delivered to the customer. Appraisal costs - CORRECT ANSWER costs of the inspection and testing to ensure that the product or process is acceptable Costs of Quality - CORRECT ANSWER prevention costs, appraisal costs, internal failure costs, external failure costs Prevention Costs - CORRECT ANSWER costs associated with preventing defects before they happen external failure costs - CORRECT ANSWER costs that arise when a defect is discovered after the customer receives the service or product In-plant scrap and rework is - CORRECT ANSWER an internal failure cost training needs analysis - CORRECT ANSWER An evaluation of the current state in order to identify the steps needed to reach a future state. Frank Gryna - CORRECT ANSWER noted that it was best if participants could apply training to a problem of interest