You are requested by top management to establish an audit program of the quality systems in each branch plant of your firm. Which of the following schemes would you use in selecting the audit team to optimize continuity, direction, availability, and technology transfer?
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All volunteer audit staff.
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Hybrid audit staff (a proportion of answers a and b above).
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An outside consulting firm.
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A bin contains 40 pills with a weight of 3.1 gm. each, 30 pills weighing 3.2 gms each and 10 pills weighing 3.3 gms each. The weight of an average pill is found from 
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What is the standard deviation of the following data? 3.2, 3.1, 3.3, 3.3, 3.1
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Which of the following statements is always true about an effective design review?
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It occurs when the design is complete.
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It is informal in order to brainstorm more ideas.
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It is based on defined criteria.
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It is conducted by the development team.
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Correct answerC
ExplanationAn effective design review ensures that the design meets certain established criteria and standards. This helps in objectively evaluating the design to find any discrepancies or improvements needed. The other options are not necessarily true for every effective design review: A: Design reviews can occur at various stages, not just when the design is complete. B: While brainstorming might be part of the process, an effective review should have structure and defined criteria. D: The review can involve multiple stakeholders, not just the development team.
Which of the following tools can be used to communicate performance data in time sequence?
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Correct answerC
ExplanationA control chart is used to communicate performance data in a time sequence. It displays data points over time, allowing for the analysis of trends, shifts, and variations in the process. This tool is effective for monitoring process stability and performance. References: "Statistical Quality Control" by Eugene L. Grant and Richard S. Leavenworth, which details the use of control charts in quality control processes.
Given the following probabilities 1 or more defects = .70 2 or more defects = .35 3 or more defects = .15 4 or more defects = .03 What is the probability of 2 or fewer defects?
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A production line has job aids that outline, step by step, how to perform the tasks of the job. This is followed by each of the operators working on the line. This is an example of _______
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Correct answerC
ExplanationStandardized work involves documenting and following the best practices for performing tasks on the production line. Job aids that outline step-by-step instructions ensure consistency and quality in task performance. This practice helps in maintaining uniformity and reducing variability in the production process. References: Lean manufacturing literature, such as "The Lean Manufacturing Pocket Handbook," describes standardized work as a core principle for ensuring efficiency and quality.
When nonconforming items are found, which of the following actions should be taken first?
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Correct answerC
ExplanationWhen nonconforming items are found, the first action should be to identify and label them clearly. This prevents further processing or use and ensures proper handling of these items. Identification is critical before taking any further actions such as retesting, destruction, or returning to the supplier. References: ISO 9001:2015, Clause 8.7 - Control of Nonconforming Outputs, which specifies the need for clear identification and segregation of nonconforming products.
Which of the following distributions have the set of all real numbers as their domain?
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Question 10
Single choice
Which of the following quality system provisions is of the greatest concern when preparing an audit checklist for a vendor qualification system audit?
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Drawing and print control.
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Training level of inspectors.
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Calibration of test equipment.
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Question 11
Single choice
Which of the following is the correct test statistic to use for a paired-sample t test? 
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Correct answerC
ExplanationThe correct test statistic for a paired-sample t test is used when comparing the means of two related groups. The formula for the paired-sample t test is: t=dsd/nt = \frac{\bar{d}}{s_d / \sqrt{n}}t=sd/nd Where: d\bar{d}d is the mean of the differences between the paired observations. sds_dsd is the standard deviation of the differences. nnn is the number of pairs.
Question 12
Single choice
Which of the following statements is true about control charts?
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They are used to identify the root cause of process problems.
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They are used to identify which products to inspect.
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They enable production to use process improvements to reduce unit costs.
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They provide a common language for discussing process performance.
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Correct answerD
ExplanationControl charts are primarily used to monitor process behavior and provide a common language fordiscussing process performance. They help in identifying variation within a process and distinguishing between common cause and special cause variations. While they can suggest areas for further investigation, their primary role is not to identify root causes or decide which products to inspect. References: "Quality Control" by Dale H. Besterfield, which details the use and purpose of control charts in process improvement.
Question 13
Single choice
The equation below represents the: 
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Lognormal probability density function.
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Normal probability density function.
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Exponential probability density function.
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Question 14
Single choice
If the probability of a success on a single trial is 0.2 and 3 trials are performed, what is the probability of at least one success?
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Question 15
Single choice
Information that is received by upper management, is often distorted. Which of the following actions is effective in countering this problem? I - Stop killing the messenger. II - Establishing an open door policy. III - Practice management by walking around.
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Question 16
Single choice
If the stated value of a standard is 0.050. and the measurement error is 0.002, which of the following sample data sets shows the greatest precision?
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0.049. 0.048, 0.050, 0.054
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0.050. 0.051. 0.049. 0.045
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0.050.0.056, 0.047. 0.048
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0.055. 0.052. 0.054. 0.056
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Correct answerD
ExplanationPrecision refers to the consistency of repeated measurements. The data set 0.055, 0.052, 0.054, 0.056 shows the greatest precision as the values are closely grouped together, indicating a high degree of repeatability and low variability.
Question 17
Single choice
Reliability prediction is 1. The process of performance estimation. 2. The process of estimating the probability that a product will perform its intended function for a stated time. 3. The process of telling "how you can get there from here".
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Question 18
Single choice
Who has primary responsibility for determining the purpose and scope of an audit?
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Correct answerA
ExplanationThe client, or the party commissioning the audit, has the primary responsibility for defining the purpose and scope of the audit. The client sets the objectives, scope, and criteria to ensure the audit meets their specific needs and requirements. The audit manager and auditor may assist in refining the scope and purpose but the initial determination lies with the client. References: The ASQ "Auditing Handbook" and ISO 19011:2018 guidelines on auditing management systems outline the client's role in defining audit scope and objectives.
Question 19
Single choice
An increase in the overall length of a recently qualified metal component has been observed and the quality engineer suspects that the storage temperature could be a factor that has affected the overall length. Which of the following tools could be used to assess this relationship?
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Correct answerB
ExplanationA scatter diagram is used to assess the relationship between two variables. In this case, it can be used to analyze the relationship between storage temperature and the overall length of the metalcomponent. A scatter diagram helps in visualizing any correlation between the two variables. References: "The Quality Toolbox" by Nancy R. Tague, which provides descriptions and uses for various quality tools including scatter diagrams.
Question 20
Single choice
Inspection operations typically
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Help in assuring satisfactory quality.
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Reduce the usability of the product or service involved.
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Require precise equipment in most instances.
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Occur between all manufacturing operators.
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Question 21
Single choice
A test-retest study is performed to a coordinate measuring machine (CMM) using a working standard of 100.00 ?0.001 mm (95% confidence). The length of the standard is measured 30 rimes. The mean and standard deviation of the measurements are x = 107.88: mm and 5 = 2.497 mm. All of the measurements are made are the same location on the standard and are taken by the same technician, who mounts and dismounts the unit for each measurement. The necessary correction for the CMM is estimated to be ____
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Correct answerA
ExplanationThe correction for the CMM is determined by the difference between the measured mean and the standard value. The necessary correction is calculated as follows:Correction=Standard ValueMeasured Mean\text {Correction} = \text{Standard Value} - \text{Measured Mean}Correction=Standard ValueMeasured MeanCorrection=100.00107.88=7.88 mm\text{Correction} = 100.00 - 107.88 = -7.88 \text{ mm} Correction=100.00107.88=7.88 mm The correction should be applied in such a way to adjust the measurements to the standard value.
Question 22
Single choice
What percentage of the area under the standard normal curve is included within (+/-) 1.5 standard deviations from 0?
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Question 23
Single choice
Which of the following elements describes the combination of the severity and probability of occurrence of harm?
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Correct answerC
ExplanationRisk describes the combination of the severity and probability of occurrence of harm. In the context of quality management, risk assessment involves evaluating both how severe the potential harm could be and the likelihood of it occurring, to manage and mitigate potential failures effectively. References: Failure Mode and Effect Analysis (FMEA) by ASQ Quality Press. ISO 31000: Risk Management Guidelines.
Question 24
Single choice
Which of the following types of "voice" is most effective in written communication?
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Correct answerA
ExplanationIn written communication, using the active voice is most effective because it is clear and direct. Active voice makes it easier for the reader to understand who is doing what, leading to less ambiguity. For example, "The manager approved the request" is clearer than "The request was approved by the manager." Reference: "The Elements of Style" by Strunk and White, which advises using active voice for clarity and precision in writing.
Question 25
Single choice
A company has received many customer complaints due to damaged units being received at the customer's distribution center. After a thorough investigation, it is determined that the units' packaging is insufficient. The company decides that a potential solution is to add reinforcements to the unit packaging to resolve the issue. Which of the following actions is most appropriate?
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Outsource packaging testing
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Consider implementing the solution on similar products
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Correct answerB
ExplanationWhen a potential solution, such as adding reinforcements to packaging, is identified, the most appropriate action is to pilot the solution. Piloting allows the company to test the effectiveness of the solution on a smaller scale before full implementation, ensuring that it resolves the issue without unintended consequences.
Question 26
Single choice
Findings and observations are audit terms. The best relationship between these terms is which of the following?
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Observations are broader in scope than findings.
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Observations are seen; findings are discovered.
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Observations generally support findings.
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Findings are reported in writing, observations are reported verbally.
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Question 27
Single choice
Which of the following is the BEST method to developing materials for a training program on the gaps in performance?
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Secure a workshop trainer.
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Review a record of activities.
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Set up a one shot case study.
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Allocate employees for training.
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Question 28
Single choice
What order do the following corrective action steps normally take for nonconforming product? I - Analyze the problem. II - Assign responsibility. III - Take preventive action. IV - Evaluate potential importance. V - Investigate possible causes.
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Question 29
Single choice
The first and most important step, in establishing a good corporate quality plan is
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Determining customer requirements.
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Determining manufacturing process capabilities.
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Evaluation vendor quality systems.
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Ensuring quality participation in design review.
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Question 30
Single choice
Analysis of data on all product returns is important because I - Failure rates change with length of product usage. II - Changes in design and in customer use are often well reflected. III - Immediate feedback and analysis of product performance becomes available.
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Question 31
Single choice
A process that is in statistical control has the following characteristics. X 122 J? = 2! n = 5 What are the upper and lower control limits for the A'chart of this process?
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Question 32
Single choice
Several units from a random sample of units produced on Line 3 were found to be defective. Which of the following actions should be taken next?
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Segregate the defective units
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Measure all units produced on the line
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Ask someone to disposition the defective units
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Measure the units again to confirm they are defective
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Correct answerA
ExplanationWhen several units from a random sample are found to be defective, the immediate next action should be to segregate the defective units. This step is crucial to prevent defective units from being mixed with non-defective units, ensuring that they do not reach customers or proceed further in the production process. Segregating defective units helps in identifying the extent of the issue and facilitates further investigation and corrective actions.
Question 33
Single choice
A process produces rejects at a rate of 6. If multiple samples of 5 are drawn from a population of 100.000. what is the expected number of rejects per sample?
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Correct answerA
ExplanationThe expected number of rejects per sample can be calculated using the reject rate and the sample size. Given a reject rate of 6% (or 0.06) and a sample size of 5: Expected number of rejects per sample = 0.06 * 5 = 0.3 References: Montgomery, D.C. (2009). Introduction to Statistical Quality Control. Wiley. ASQ. (n.d.). Basic Quality Tools. Retrieved from (https://asq.org/quality-resources/basic-quality-tools)
Question 34
Single choice
Which of the following tools specifies the use of a feedback cycle?
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Correct answerD
ExplanationThe Plan-Do-Check-Act (PDCA) cycle specifies the use of a feedback cycle. It is a continuous loop of planning, doing, checking, and acting, aimed at continuous improvement and problem-solving in quality management.
Question 35
Single choice
Which table should be used to determine a confidence interval on the mean when standard deviation is NOT known and the sample size is 10?
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Question 36
Single choice
The primary focus of design FMEA (DFMEA) is to
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identify personnel responsible for implementation
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predict failure frequencies
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minimize measurement variation
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Correct answerD
ExplanationDesign Failure Mode and Effects Analysis (DFMEA) is a systematic method for evaluating a design to identify potential failure modes, their causes, and effects, and to prioritize the actions to mitigate these failures. Identify Personnel Responsible for Implementation: While important for action plans, it is not the primary focus of DFMEA. Predict Failure Frequencies: DFMEA does consider failure frequencies, but the primary goal is to address and mitigate failures. Minimize Measurement Variation: This is more relevant to process control and not the primary focus of DFMEA. Mitigate Failure Modes: The main objective of DFMEA is to identify potential failure modes and implement actions to reduce or eliminate the risks associated with these failures. This involves analyzing the design to foresee where it might fail and taking preventive measures to improve reliability and safety. References: Quality engineering and risk management texts, specifically those discussing the principles and objectives of DFMEA.
Question 37
Single choice
A process capability analysis can best be used to ______
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define the acceptance quality limit for incoming material
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compare alternative processes or equipment
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prevent supplier deficiencies
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identify which attributes data to measure
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Correct answerB
ExplanationProcess capability analysis evaluates how well a process can produce output within specified limits. It measures the inherent variability of a process relative to its specification limits. This analysis is valuable for comparing the capabilities of different processes or equipment to ensure they meet required specifications. It helps in selecting the most appropriate process or equipment by providing quantitative data on their performance. References: ASQ's "Certified Quality Engineer Handbook" outlines the use of process capability analysis for comparing processes and equipment.
Question 38
Single choice
The sample size for ANSI ASQ Z1.4. Level II plan is based on the
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size of the lot to be inspected
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size of the batch to be manufactured
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average size of production lots
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decision of the quality assurance manager
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Correct answerA
ExplanationANSI ASQ Z1.4 provides sampling procedures and tables for inspection by attributes. The sample size for Level II inspection is determined based on the lot size to be inspected. This standard specifies how to choose sample sizes and acceptance numbers based on lot size to ensure statistically valid sampling. References: ANSI/ASQ Z1.4-2008 "Sampling Procedures and Tables for Inspection by Attributes" explains how sample sizes are derived from lot sizes.
Question 39
Single choice
Any group, designing a quality information system (QIS) to collect product data, must consider which of the following items? I - How the results will be used. II - The frequency that results must be reported. III - The allowable data error variation.
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Question 40
Single choice
Which of the following tools can be used to communicate performance data in time sequence?
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Correct answerC
ExplanationA control chart is used to communicate performance data in a time sequence. It is designed to plot data points chronologically to identify trends, variations, and patterns over time, which is essential for process monitoring and improvement. References: "Introduction to Statistical Quality Control" by Douglas C. Montgomery, which explains the application and interpretation of control charts in quality control.
Question 41
Single choice
What is the probability of an item failing in less than 5 hours if it has a constant failure rate of 1/hour?
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Question 42
Single choice
Risk control includes making decisions using which of the following pieces of information?
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Acceptable levels of risk
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Fault tree analyses results
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Correct answerA
ExplanationRisk control involves making decisions using information about acceptable levels of risk. This process helps ensure that the risks associated with various activities are managed within tolerable limits, balancing the potential impact with the organization's risk appetite.
Question 43
Single choice
The effectiveness of corrective action can best be assessed by
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assuring that the appropriate processing documentation is changed to reflect the action taken
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changing the data collection system to capture the results of the corrective action
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redefining the applicable inspection, test, or process control requirements
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measuring the results of the corrective action
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Correct answerD
ExplanationThe effectiveness of corrective action can best be assessed by measuring the results of the corrective action. This involves evaluating whether the action taken has successfully addressed theroot cause of the problem and has led to a measurable improvement in the quality metrics or process performance. References: ASQ Quality Press: The Certified Quality Engineer Handbook. Total Quality Management by Dale H. Besterfield.
Question 44
Single choice
Which of the following equations is used to calculate the upper control limit for an average chart?
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Correct answerC
ExplanationThe equation to calculate the upper control limit (UCL) for an average chart (X-bar chart) is X + D4 R. Here, X is the process mean, D4 is a control chart constant that depends on the sample size, and R is the average range of the samples. This formula helps in determining the upper threshold beyond which a process is considered out of control. References: "Introduction to Statistical Quality Control" by Douglas C. Montgomery, which provides detailed explanations on control charts and their calculations.
Question 45
Single choice
Which of the following actions or techniques is MOST useful in determining the original fundamental cause of a product or process nonconformance?
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Question 46
Single choice
A box contains 27 black and 3 red balls. A random sample of 5 balls is drawn without replacement. What is the probability that the sample contains one red ball?
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Question 47
Single choice
The critical value of the t-distribution is
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Always greater than the critical value of the normal distribution.
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Always less than the critical value of the normal distribution.
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Not related to the critical value of the normal distribution.
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Approaches the critical value of the normal distribution as the degrees of freedom increase.
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