CQA 2

measures of which of the following provides attribute data? 1. temperature in degrees 2. attendance at meetings 3. weight in pounds 4. length in metric units

# 2

audit program objectives generally include all of the following EXCEPT: 1. supporting the objectives of the organization 2. ensuring audits are performed in a timely manner 3. presenting meaningful results to those who will act upon them 4. making the best use of hte organization's resources by selecting auditors that have time to audit

# 4

after an external audit, the auditee may be asked to evaluate which of the following auditor skills or elements of an audit? 1. interviewing, interaction, accuracy of audit report 2. audit scheduling, auditor training records, observing an audit 3. communication, listening, checklist prep 4. clarity of past audit reports, # of findings, lack of bias

#1

mgmt of an internal audit program should consider all of the following EXCEPT: 1. taking ownership of the quality assurance program 2. supporting company objectives, goals, strategies 3. assuring that audits are a means to evaluate company performance 4. weighing costs vs. benefits of conducting an audit

#1

which of the following indicates a quality system is effective? 1. the required system is in place and continuous improvement is evident 2. an audit was conducted and no nonconformances were found 3. an audit report states that the intent of the standard is being met 4. no corrective action requests have been issued for a specified period of time

#1

which of the following is LEAST important for an auditor to exhibit? 1. remaining calm throughout audit 2. displaying honesty and forthrightness 3. adhering to the original audit plan 4. working in a planned and systemic manner

#3

an internal audit schedule should be prioritized on the basis of all of the following criteria EXCEPT: 1. cost of activities 2. risk of activities 3. size of the auditee's dept 4. mgmt's request

#3 size of the auditee's dept

audits are conducted against a performance standard to ensuer which of the following? - meaningful measurements - objectively evaluated performance - perceptive observations

1 and 2 only

which two of the following conditions must be met in order to infer statistical significance about the results of an audit sample? 1. the population must be homogeneous 2. the sample size must be greater than 10 3. the sample must be random 4. the sample must be taken from multiple locations

1 and 3

typically, which two of the following are more important to an auditor in maintaining his auditing competence? 1. understanding current standards for quality systems 2. attending audit closing meetings 3. networking with other auditors and auditing organizations 4. learning about changes to existing auditing techniques

1 and 4

auditor independence includes freedom from which of the following - bias - conflict of interest - external influence - previous exposure to the area

1, 2, 3

for 3rd party audits, which two of the following factors should be considered by the auditor when agreeing to the amount of time needed to complete corrective action? 1. the resources available to the auditor for determining when follow up can occur 2. the resources available to the auditee to enact the corrective action 3. the auditee's experience in project evaluation techniques 4. the # of findings recorded during the audit

2 & 4

audit team members are responsible for which two of the following - initiating the audit - remaining within the scope of the audit - compiling and analyzing evidence - recommending specific corrective actions

2 and 3

when a hostpital assesses a new medical device supplier to determine compliance with regulations, which type of audit is being performed?

2nd party

which of the following tasks is NOT part of configuration mgmt? 1. planninig 2. auditing 3. change control 4. testing

4 testing

which stmt best defines the relationship between Cp and Cpk when used in determining process capability?

Cp and Cpk should be used together b/c Cp measures the ability of the process to stay on target and Cpk measures the ability of a process to stay within specs

which of the following conclusions can be made by an auditor who observes that statistical process control (SPC) charts posted near operator workstations are done correctly and are regularly completed throughout the plant? -commitment of mgmt to quality is strong -processes are being improved continually -shop floor staff have been fully trained -SPC charts are available

SPC charts are available

in quality auditing, a finding is defined as

a conclusion of importance based on evidence

which of the following best desribes a frequency distribution?

a graph for presenting data along a scale of reference and the number of times each item occurs

a quality audit observation is defined as

a noted item of objective evidence found during an audit

which of the following is most important for an auditor to convey at an initial interview?

an interest in cooperation and open dialogue

when an organization sends its own auditor to another country to perform an audit of its subsidiaries, this is considered

an internal first party audit

which of the following represents a sound time mgmt technique?

anticipating needs and making them known to the auditee in advance

what should an auditor NOT do if he discovers an illegal activity at the auditee's site during an audit?

audit around the illegal activity if it is not part of the scope of the audit

an audit report should contain which of the following? -audit findings - root cause analysis - corrective action - re-audit schedule

audit findings

when calculating the cost savings of the audit program be sure to substract

audit program costs

within most organizations, the responsibility for planning and carrying out a programmed series of quality system audits rests within the

audit program mgmt functions

to determine whether a finding is a minor, isolated incident or a serious, chronic problem, an auditor should consult with the

audit team

durin ghte conduct of an audit, who is responsible for supplying the auditor with objective evidence?

auditee

generally, which of the following is the most meaningful way to trace a finished product?

backward from end point

the main purpose for conducting an opening meeting for an audit is to

clarify the audit objectives

which of the following authorities initially determines whether a 3rd party audit should be conducted

client

which of the following is most likely to request an audit?

client

who makes the final determination regarding the distribution of the audit report?

client

sampling procedures used in audits are designed to

conserve time in data collection

an auditee responds to a corrective action request by stating that the problem has never occurred before and is "not the norm for the operation." which of the following is the most appropriate action for the lead auditor? -note that the deficiency is the result of a random experience - contact the auditee to discuss his response - tell the auditee that his plan is unacceptable -schedule a follow up audit immediately

contact the auditee to discuss his response

communication by telephone is likely to be most effective when it is used for

corroborating information

the cost of quality categories that make up the price of conformance are

cost of prevention and cost of appraisal

when lower tier documents are compared to higher tier documents before the fieldwork starts, the comparison is called a

desk audit

a root cause analysis can best be described as a process that is used to

determine the basic reason for an undesirable condition

a cause and effect diagram is a useful tool for doing which of the following?

developing theories based on symptoms

which of the following audit strategies is a common technique to assess compliance to a specific requirement at all locations where that requirement is applicable?

element method

mgmt can best ensure support for the audit function from other depts by

emphasizing the importance and usefulness of audits to the organization

when an internal audit program is being formulated, the auditee's anxiety about the audit process is most likely to be reduced by which of the following?

ensuring that members of the organization have a general understanding of the audit procedures

if an auditor shows professionalism, trust integrity, confidentiality and discretion he is considered to be

ethical

an auditee has resonded to all requests for corrective action in a timely manner. which of the following is the next step for the auditor?

evaluate the adequacy of the responses

which of the following is a benefit of performing a system audit of a current supplier?

evaluating continuing conformance to quality standards

during an audit, the client learns that the auditor has recently completed a quality system audit of a major competitor. the client then questions the auditor about the competitor's audit results. the best action for the auditor to take is

explain to the client that it would be inappropriate to discuss the results of that audit

which of the following qualifications would contribute most to an auditor being able to function effectively in various industrial or service disciplines?

familiarity with technical standards and regs

the reason an auditor may accept a gift from one auditee and not another is b/c

he understands cultural differences

which of the following is the most useful graphical tool for promoting an understanding of process capability?

histogram

during the opening meeting, it is the auditee's responsibility to

identify safety requirements

when performing long term planning for the audit program it is most important to

identify that which may impact the future direction of the audit program

a quality audit contributes to improvement of the quality of a company's products and services by

identifying the need for corrective action

the difference between a product audit and the inspection process is

inspections generally make pass/fail decisions while product audits include a broader scope

the lead auditor may stop an introductory tour if

it begins to take too much time

what is a limitation of a canned checklist

it may be too inflexible

which of the following is the greatest benefit of an internal audit program to an organization?

it provides feedback for continuous improvement

the reason an auditor may choose to use the discovery method during an audit is b/c she

knows there is a problem but is not sure where it is

an auditee who objects to any part of an audit plan should first make those objections known to the

lead auditor

recognizing the need for a follow up audit is the responsibility of the

lead auditor

which of the following statistics would best describe the central tendency of a sample of data?

mean

in the following set of numbers 6, 7, 8, 9 10, the number 8 is the 1. mean 2. median 3. mode 4. mean and median

mean and median

process capability mesaures the ability of a process to produce product

meets design specs

which of the following would NOT normally be used as a major category in a cause and effect diagram?

modifications

a root cause of a nonconformance is defined as a problem that

must be corrected in order to prevent recurrence

if an audit escort for one area is repeatedly late or unavailable, what is the best option to the auditor?

notify the auditee mgmt of the consequences created by the delays

which of the following methods can an audit program manager use to establish consistency among auditors?

observe auditor performance during audits

which of the following is an example of a short term corrective action?

obtaining missing signatures on a purchase order

what are your defined responsibilities in the cal lab? this question is an example of what type of questioning technique?

open ended

the fraction of nonconforming products is plotted on which type of control chart?

p chart

the type of chart that presents the value of items in descending order is a

pareto chart

which of the following types of tools or techniques is considered qualitative? - histogram - frequency distributions - pareto charts - process observations

process observations

an auditee's procedures require that all design drawings be dated and signed. during a design review, an auditor notices that several drawings are signed but not dated. the missing dates are examples of what kind of data?

qualitative

while performing an internal audit, an auditor notices that an operator on one shift skips part of the documented procedure. in this situation, the auditor should do which o fthe folowing

question the operator about the observation

the objective evidence supporting an audit observation must be

recorded on working papers

quality auditors help companies improve their processes, products, and services by

reporting positive as well as negative evaluation results

national and international standards are examples of

requirements

during a second party audit an auditor observes a procedure that is relevant to the audit but has not been included on the checklist. the auditor should

review the procedure just like any other on the checklist

the most important item to check when auditing against a specification is the

revision level of the spec

which of the following factors related to scheduling would most directly affect the performance of an audit?

scope of the audit

an audit trail is necessary in order to

show how and when items were reviewed

which of the following requests by an auditor is likely to obtain the most objective evidence for verification?

show me the info you have received

if the upper control limit matches the upper spec limit and the lower control limit matches the lower spec limit

the Cp for the process is 1

during the closing meeting, what is the advantage of having the lead auditor be the only presenter of the audit findings?

the auditee will have one person with whom to interact and address comments to

auditors who audit outside their own country should be familiar with

the local customs at the audit site

which of the following best describes quality control?

the operational techniques and activities that are used to fulfill requirements for quality

quality system audits are directed at evaluating

the quality aspects of various segments of a company's overall approach to quality mgmt

which of the following indicates that a quality system is effective?

the required system is in place and continuous improvement is evident

why should auditors be involved in auditing for risk mgmt when auditing the organization's business processes?

they are familiar with the rules and regulation surrounding risk and familiar with conditions present in the organization

the auditor has the most independence from the auditee in which of the following types of audits

third party

auditors can use flowcharts in their work in order to

understand the overall process or system being audited

the BEST way to enhance the credibility of the audit function is to

use capable, well trained, experienced auditors

an auditee is likely to be most threatened by an auditor's use of which of the following interviewing techniques?

using a tape recorder to record an auditee's response

standard deviation measures

variation

in order to ensure that proprietary info remains proprietary an auditor can

verify the inputs and outputs of an undisclosed process without actually auditing the process

which of the following is the most fundamental role of the audit function?

verifying the effectiveness of the organization's quality system in preventing substandard performance

when the audit manager schedules an audit of a single dept she is scheduling a

vertical audit

When is it acceptable to grant an extension of the time frame for a corrective action?

when the corrective action plan requires more time than originally anticipated