Part 2: The Quality System

Question 1

For any quality system, all quality-related activities begin with:

A) sales and distribution
B) process planning
C) customer needs
D) product design

Answer 1

C - Customer needs

Throughout the product life cycle, understanding and identifying customer needs is the first and most important step in any quality-related activity

Question 2

A quality manual generally consists of four tiers or layers that include:

A) policies, procedures, instructions, and records
B) policies, documentation, instructions and records
C) documentation, implementation, compliance, accuracy
D) compliance, accuracy, clarity, and records

Answer 2

A - Policies, Procedures, instructions, and records

The 1st or top ties represents policies
The 2nd tier represents procedures
The 3rd tier represents work instructions
The 4th tier represents a record of results

Question 3

One major component of a quality system is:

A) supplier management
B) implementation of a documented quality system
C) contractor assessment
D) auditing of suppliers

Answer 3

B - implementation of a documented quality system

Effective implementation of a quality system that has been review and approved for release is one of the two major components of a quality program. The other component is documentation of procedures and instructions of the quality system.

Question 4

Once a quality manual is complete, a final review is in order. The reviewed copy should be endorsed and authorized for release by:

A) suppliers
B) customers
C) top management
D) the chief quality officer

Answer 4

C - Top Management

Top management is responsible for endorsing the content of the finalized quality manual as well as authorizing its release for use.

Question 5

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 for making the documents readily available to the general 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

Answer 5

B - a process is in place for making the documents readily available to the general public

Documents do not have to be made readily available to the general public

Question 6

ISO 9001:2015 is:

A) a national standard
B) an international standard
C) an industry specific standard
D) none of the above

Answer 6

B - an international standard

Question 7

The critical characteristics of any documentation of a quality system are:

A) compliance, implementation, and clarity
B) compliance, clarity, and procedures
C) procedures, accuracy and clarity
D) compliance, accuracy and clarity

Answer 7

D - Compliance, accuracy and clarity

Without these components, users will lose confidence in the documentation

Question 8

Which of the following is NOT one of the standard in the ISO 9000 Quality Management Systems family?

A) Fundamentals and Vocabulary
B) Continual Improvement
C) Requirements
D) Guidelines for Performance

Answer 8

B - Continual Improvement

Continual improvement is not one of the standards, but one of the eight quality management principles emphasized in the standard

Question 9

The ISO 9000 series of standards emphasizes eight quality management principles. Which of the following would be categorized as one of those principles?

A) Understanding the customer needs
B) Use of technical language in all technical descriptions
C) Use of different terms and vocabulary
D) None of the above

Answer 9

A - Understanding the customer needs

Customer focus is a key quality management principle emphasized in the ISO 9000 family. Choices b and c refer to criteria for all ISO 9000 terms and definition - and are illustration of what not to do. In writing terms and definition, technical definitions should be avoided, and coherent vocabulary agreed on and understood by all users (current and potential)

Question 10

Which of the following ISO standards are NOT requirements, but guidelines only?

A) ISO 9000
B) ISO 9001
C) ISO 9004
D) All of the above are requirements

Answer 10

C - ISO 9004

ISO 9004 consists of suggestions only, guidelines but not requirements for certification

Question 11

The Malcolm Baldrige National Quality Award consists of how many key criteria for performance excellence?

A) 14
B) 8
C) 7
D) 4

Answer 11

C - 7

The seven criteria are: 
Leadership
Strategic Planning
Customer and Market Focus
Measurement, Analysis, and Knowledge Management 
Human Resource Focus 
Process Management 
Business/Organizational Performance Results

Question 12

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:

A) An internal quality audit
B) An external quality audit
C) A third-party quality audit
D) None of the above

Answer 12

A - An internal quality audit

If the auditor is an employee of the company to be audited, then we refer to this as and internal audit. It is necessary that the person who will conduct this audit is not related to or involved in the activity that is being audited.

Question 13

The most comprehensive type of audit is the:

A) quality system audit
B) product quality audit
C) process quality audit
D) service quality audit

Answer 13

A - quality system audit

A quality system audit is an audit of the entire system. The other three are more specific and smaller in scope.

Question 14

Which of the following would be a purpose for a quality audit?

A) To meet requirements for certification to a management standard
B) Verification of conformance with contractual requirements
C) To contribute to the improvement of the management system
D) All of the above are reasons for a quality audit

Answer 14

D - All of the above

Purposes for quality audits include:
To meet requirements for certification to a management standard
Verification of conformance with contractual requirements
To contribute to the improvement of the management system
To obtain and maintain confidence in the capability of a supplier

Question 15

A quality audit has been conducted and some corrective measures are recommended. The party responsible for planning and implementing these measures is:

A) the auditee
B) the lead auditor
C) management where the corrective measures are needed
D) line workers where the corrective measures are needed

Answer 15

A - The auditee

The organization or company being audited (auditee) is responsible for making sure the corrective measures are identified and addressed

Question 16

Corrective action and verification that nonconformities have been addressed is:

A) always carried out
B) often poorly completed
C) unnecessary and causes more stress than it is worth
D) none of the above

Answer 16

B - often poorly completed

Actually taking corrective action when nonconformities have been identified is the one step in the process that is most often poorly executed.

Question 17

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:

A) the opening meeting (or pre-examination)
B) the closing meeting
C) the audit itself
D) it is not necessary for the auditor to explain this information to the auditee

Answer 17

A - the opening meeting

Generally an audit is carried out in three steps:

(1) pre-examination - the auditor explains the objectives of the audit, introduces team members to senior management and so on
(2) a “suitability” audit is conducted - comparison of documented procedures to the reference standard selected
(3) implementation of the quality system is examined in depth, which may involve recommending corrective measures

Question 18

Who is responsible for the accuracy of the final audit report?

A) auditee
B) client
C) lead auditor
D) none of the above

Answer 18

C - Lead auditor

The lead auditor is responsible for the accuracy as well as the validity of the final report

Question 19

The auditee will begin improvement efforts to address any problems or corrections identified by the audit. A follow-up audit to verify results of this improvement effort:

A) should be agreed on by all parties: client, auditor, auditee
B) is not necessary or recommended
C) is conducted by someone in the company when there is time
D) none of the above

Answer 19

A - should be agreed on by all parties: client, auditor, auditee

A follow up audit is necessary to determine whether the problems and recommended corrections have been addressed. All three parties should arrange and agree on a follow-up audit.

Question 20

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:

A) operating costs
B) appraisal costs
C) failure costs
D) quality costs

Answer 20

C - failure costs

An increase in prevention costs, resulting in a decrease in defects, nonconformities, and so on, will result in a decrease in failure costs due to the reduction of defects and nonconformities.

Question 21

Correction of data entry errors, specimen processing, and cost of reeducating staff in a laboratory before delivery of the results to the customer are examples of:

A) prevention costs
B) appraisal costs
C) internal failure cost
D) external failure cost

Answer 21

C - internal failure cost

Since the data error correction, reprocessing, and reeducation occur before delivery of the product or service, the cost incurred would be and internal failure cost

Question 22

In one your, 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:

A) prevention cost
B) appraisal cost
C) internal failure cost
D) external failure cost

Answer 22

B - appraisal costs

Costs associated with activities performed to uncover or identify deficiencies (such as in personnel proficiency) are considered appraisal costs

Question 23

Money spent on review of suppliers is:

A) prevention cost
B) appraisal cost
C) external failure cost
D) internal failure cost

Answer 23

A - prevention cost

Costs associated with activities related to supplier reviews are known as prevention costs

Question 24

As failure costs decrease, what typically happens to appraisal activities?

A) appraisal activities increase
B) appraisal activities decrease
C) there is no relationship between the two
D) appraisal activities will remain the same

Answer 24

B - appraisal activities decrease

As failures are uncovered and corrected, appraisal activities will generally decrease, although appraisal activities will not and should not be completely eliminated. The type of appraisal activity can change.

Question 25

Test equipment depreciation is an example of

A) prevention cost
B) appraisal cost
C) external failure cost
D) internal failure cost

Answer 25

B - appraisal cost

Question 26

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?

A) $12,000
B) $92,000
C) $77,000
D) $65,000

Answer 26

C - $77,000

The items that would be considered for appraisal costs include test equipment and material inspection, so cost would be $12,000 + $65,000 = $77,000

Question 27

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?

A) $12,000
B) $92,000
C) $77,000
D) No external failure cost was reported

Answer 27

D - No external failure cost was reported

None of the costs listed are external failure costs. In-plant scrap and rework is an internal failure cost.

Question 28

A quality system audit is to be conducted. This is an examples of a(n):

A) prevention cost
B) appraisal cost
C) external failure cost
D) internal failure cost

Answer 28

A - Prevention cost

Quality audits fall under prevention costs

Question 29

The first step in developing a training program is:

A) design and development of the curriculum, or training plan
B) developing the lesson plan
C) conducting a pretest for the participants
D) assessing the need for the training

Answer 29

D - assessing the need for the training

Before developing and implementing any training program, a needs analysis should be conducted to determine whether the training is actually needed and , if so, what it should consist of.

Question 30

Which of the following is NOT a reason for failure of a training program?

A) Inadequacy of the leader/trainer
B) Different knowledge levels of the participants
C) training is problem oriented rather than technique oriented
D) overly complex language

Answer 30

C - training is problem oriented rather than technique oriented

Frank Gryna noted that it was best if the participants could apply the training during the course to a problem of interest (be problem oriented).

Question 31

Pretests and posttests are useful tools in a training program for:

A) assessing learning and retention
B) assessing the learner’s reaction to training
C) identifying the weakest employees
D) none of the above

Answer 31

A - assessing learning and retention

Pretests and posttests can be very useful for determining participant learning and retention of material.