U4 Flashcards
1
Q
Quality has always been a concern; in fact, the origin of systematic quality assurance lies in guilds (professional associations). Master craftsmen and journeymen were responsible for producing quality themselves. If they did not meet the quality requirements of customers, they were thrown out of the guild. Today, many firms seek to develop a competitive advantage.
A
2
Q
One way of establishing a competitive advantage is to?
A
offer the best quality.
3
Q
Closely linked to customer satisfaction, quality is of utmost importance for many firms. Satisfying a customer with a product or service is——————————-.
A
their core process
4
Q
Even if a firm is performing very well in terms of quality, how does it maintain the standard or ensure that the standard is improved?
A
Just as people do not become successful overnight, neither do firms.
Successful firms need to understand their stakeholders, the market, and the external environment
5
Q
They need to be creative and improve processes for achieving goals?
A
Because products and services are becoming increasingly complex so that people from different disciplines work on them together, a standardized approach is necessary.
6
Q
To do so, firms need to define and understand?
A
quality and systematically assess it in their organization, e.g., with the help of a quality management system.
7
Q
A quality management system (QMS) comprises of :
A
“the organizational structures,
responsibilities,
procedures,
processes,
and resources for implementing quality management”.
8
Q
In other words, a QMS consists of:
A
a methodology for ensuring that a manufacturer produces to the required specifications.
9
Q
The main reason for setting up a quality management system is to ?
A
reach the quality goals of a firm in a timely and transparent way and to secure the intended quality standard permanently.
10
Q
The quality management system ensures that?
A
a firm fulfills the expectations of interested parties.
11
Q
These can be internal parties like————————————-.
A
employees and managers or owners.
12
Q
Employees, for example,
A
value transparency and job security.
13
Q
Managers and owners appreciate?
A
the transparent organization and coordination of a QMS.
14
Q
The fact that a QMS assures quality and saves time is valued by?
A
external parties like customers, shareholders, and suppliers.
Their expectations are fulfilled, their risks reduced, and they become more trusting of the firm.
15
Q
A certified quality management system does not only increase trust, but can be?
A
the prerequisite for a contract?
16
Q
In short, a “QMS indicates that?
A
there is control, auditing becomes possible and it increases the transparency of the operations”
17
Q
There are several operational aspects that need to be considered when setting one up?
A
Because There are several demands on a QMS.
18
Q
The figure below shows that a QMS exists within an integrated management system of a firm, ?
A
because it must also take into account quality requirements concerning, e.g., risk, facility, or environmental management.
19
Q
image
A
20
Q
Norm?
A
A norm is a document from a recognized institution that offers rules, guidelines, or requirements for an activity or their results for voluntary use.
21
Q
A norm is a document from a recognized institution that offers?
A
rules,
guidelines,
or requirements for an activity or their results for voluntary use.
22
Q
Management (EFQM) voluntarily to stay:
A
competitive
and improve their performance
23
Q
Several types of norms exist on national, regional, or international levels, e.g.,?
A
ISO-norms on the internationa
l and EU-norms on the European level.
24
Q
These regional or international norms are trade barriers because?
A
firms are expected to comply with them, while promoting world trade because they assure a certain quality standard.
25
Moreover, they represent a clear means of
---------------- for all partners of the economic life and -----------------protection; ----------------------protection and employee protection would not be possible without -------------------.
communication
consumer
environmental
norms
26
ISO 9000 is a bundle of ?
international quality management standards.
27
These were developed to make sure that firms meet ?
customers’ needs
or needs of clients and partners while meeting legal and administrative requirements associated with a product or service.
28
In the USA, firms were required to assure their quality when?
supplying government procurement agencies or to win a contract.
29
This turned out to be difficult because ?
there were several different quality management frameworks.
30
The implementation of ISO 9000 reduced the difficulty of using ?
different quality standards and administrative procedures
31
The seven principles of quality management are specified in ISO 9000 and serve as?
the basis for the requirements of a quality management system.
32
These seven principles of quality management are the following:
==Customer focus. Because a firm is dependent on customers, it aims to meet and exceed customer requirements.
==Leadership. Managers should create conditions that facilitate reaching goals and quality objectives.
==Engagement of people. Everyone in an organization is competent, authorized, and committed to improving the organization and its value.
==Process approach. Quality management systems should follow a controlled process-oriented approach.
==Improvement. Successful companies improve continuously.
==Evidence-based decision-making. Decisions are based on the analysis of data and information.
==Relationship management. Organizations construct relationships to create value for all involved parties.
33
ISO 9000 thus lays?
the groundwork for further ISO norms.
34
It includes the ISO 9001 requirements on quality management systems for certification, as outlined in
the figure below, as well as the ISO 9004 norm.
35
image
36
image
37
ISO 9004 provides guidance on quality self-assessment methods in a wider context by including ?
provides guidance for systematic and continuous improvement of the overall performance of the firm
all relevant and interested stakeholders.
38
It is not a guideline for using ISO 9001, but?
provides guidance for systematic and continuous improvement of the overall performance of the firm.
39
ISO 9001:2015 consists of---------------------------------- that specify requirements for quality standards
seven clauses
40
The first standard, ISO 9001:
1987 was revised several times
41
The date of the introduction of the norm is placed
behind the colon.
42
In 2021, the current standard is
ISO 9001:2015
43
Today, ISO 9001 is?
the most widely used quality management system
with 1.2 million certificates worldwide
44
The main idea of ISO 9001 is ?
“that good products can only come from good processes and these can only be effective in a system” .
45
Customers should be able to rely on?
an expert third party to certify compliance with minimum requirements.
46
image
47
The numbers in parentheses refer to seven clauses in the standard. These are explained below:
--Clause 4 specifies internal and external topics in the context of the organization and specifies the requirements on a QMS in an organization.
--Clause 5 concerns leadership issues and is thus placed in the middle of the PDCA cycle, as it deals with roles, responsibilities, and authorization in the organization.
--Clause 6 deals with planning issues, like the identification of risk and chances, and the definition of measurable quality goals.
--Clause 7 deals with requirements of how the QMS can be supported by providing resources, competences, consciousness, and communication, and dealing with documentation.
48
--Clause 8 regulates the requirements for the provision of operations, e.g., how processes are broken down into sub-processes and which requirements are demanded for products and services in the development, production, sales, and after-sales phase.
--Clause 9 explains how requirements are evaluated, e.g., customer satisfaction and internal audits.
--Clause 10 emphasizes the need for continuous improvement for products and services. If there is non-conformity (an error), it should be corrected, and a repetition should be prevented.
49
Although it is not formally required, many firms seek to find a registrar for formal documentation, because?
firms often require their suppliers to be ISO 9001-certified.
50
This process can be difficult because there is no -----------------------------, but several registrars have agreements with ----------------------------------------- or other authorities. It is challenging to find a registrar that can be used in several of the ------------------------------------ where a firm conducts international -------------.
central authority
chambers of commerce
desired countries
trade
51
Although many firms that have introduced ISO 9001 have been very successful financially, there are also some drawbacks. One of the main obstacles with ISO 9001 is?
that it focuses on the delivery. In other words, if it is applied mindlessly by following “say what you do—do what you say,” procedures are only blindly followed and there is little room left for creativity
52
Further obstacles of ISO 9001 lie in overdocumentation, management reviews without:
influence or consequence,
internal auditing simply for compliance,
corrective and preventive action at a low level,
and failure to involve and engage employees in the QMS.
53
To overcome these obstacles and to succeed in innovation?
an agile management framework is required. Firms need to ensure that they stay innovative, especially when implementing a QMS.
54
Most firms treat the implementation of a QMS as a project that is?
planned one to two years in advance.
55
When introducing a QMS, it might be necessary to abandon all current documentation because?
it has become redundant. Each document needs to be checked to stay lean and flexible.
56
The following steps are conducted during a project timeline of 18 to 24 months:
1-The project starts when the decision is made.
57
First, top management needs to be dedicated and follow up on the project because awareness of top management closely relates to their knowledge about the purpose of a QMS and organizational culture.
Thus, after the project start, a situation analysis and an assessment of the organizational culture is usually conducted
58
There needs to be ---------------------------------------------------------------------------- on how to reach this goal. A QMS is based on the policy, and it should contain specifications on ------------------------------. Objectives and goals need to be defined, and the organization should assess its own ----------------------------------------- and the strengths and weaknesses of suppliers and clients. An assessment of the firmʼs external --------------------should also be completed.
a policy, a vision, and a strategic plan
quality requirements
strengths and weaknesses
environment
59
3-Further planning of a detailed project plan for the QMS implementation includes:
the scope of the project,
the required internal and external resources,
and its outcomes .
60
The documentation should assure ?
the efficacy of the QMS.
61
4-The QMS is developed and implemented.
62
The development includes the identification of ?
main processes and an understanding of the external and internal clients and suppliers of a process.
63
In the implementation phase, :
work processes are described
and later formally put into practice.
64
The employees must actively participate in the implementation and should be responsible for their own work so that?
they have an interest in the continuous improvement of the QMS
65
5-Internal audits and certification are administered.
66
Internal audits are required for ?'
After internal audits are completed, the firm is ready for either external audits or official certification
the implementation of certain quality standards, like ISO 9001.
67
This self-examination ensures that?
the QMS procedures are followed correctly.
68
After internal audits are completed, the firm is ready for?
either external audits or official certification.
69
6-The project is concluded, and the QMS is put into operation, if the certification was successful. whether the QMS is effective and whether it still complies with external and internal demands
70
It is important that the firm regularly checks ?
whether the QMS is effective and whether it still complies with external and internal demands
71
After the introduction of a QMS, an audit either as a self-assessment or?
from an officially registered external party is necessary.
72
The firm has put a lot of time and effort into the project, and whether the planned processes work as desired should be---------------------------.
evaluated.
73
An audit is a “systematic, independent and documented process for obtaining objective evidence and evaluating it objectively to?
determine the extent to which the audit criteria are fulfilled”.
74
We can distinguish between internal, which are also called ?
“first party” audits, and external, or “second party” or “third party,” audits.
75
Internal audits are performed by the firm’s own, but ?
independent, employees
76
Internal audits are the “motor” of a quality management system, and ISO 9001 requires?
Third party audits are conducted upon request of the management by other certified external parties who specialize in audits with certain standards
the implementation of internal audits as part of a self-assessment.
77
External audits are carried out by a party with an interest in the company, e.g., ?
by an important customer who wants to ensure that the work is carried out as specified in the contract.
78
For both types, the principle of independence is
-------------. Independence means that the person who performs the job task is not the ------------------------------- who audits, especially when it is an -------------------. An independent person is more likely to assess correctly.
crucial
same person
internal audit
79
whether or not the task is performed as ------------.
defined
80
To better understand the principle of independence, consider?
the role of a proofreader.
81
An author has read their writing so many times that they might not see obvious errors; it is more?
efficient to ask someone who is uninvolved to check the document.
82
Additionally, there are different types of audits depending on the subject under consideration:
--Process audits are typically internal audits. They check the functionality or processes, e.g., of an assembly line. The goal is to evaluate to what extent the process delivers the required results.
--Product audits typically check products, e.g., the product material. The goal is to evaluate the product quality.
--System audits evaluate systems, e.g., the functionality of a complete or parts of a quality management system.
83
When a firm has implemented a QMS, it is natural that it be checked in terms of?
efficiency and conformance to the desired norm.
84
Often, an internal quality audit of the quality management system is:
planned before, and during, its operation.
85
A quality audit is a structured evaluation or inspection by an independent body to check?
whether the quality requirements are met and procedures are followed as specified in the defined standard.
86
These quality checks on procedures are:
laid out in the quality plan and should be administered periodically.
87
A quality audit is not something employees should fear.
A quality audit not only points toward problems, but also?
acknowledges areas where performance is already very good.
88
In a company culture in which errors are accepted as part of ?
a continuous improvement process, a quality audit can also be seen as a check or an assessment of good work.
89
Indeed, quality audits can be very useful. In particular, a quality audit has the following goals and ensures that:
===the planned quality is achieved, and problems are detected.
===the products or services and work procedures are safe.
===all relevant laws and guidelines are followed.
the IT system provides sufficient, adequate, and accurate data.
===appropriate action after error detection takes place when required.
===opportunities for improvement are identified.
90
Firms should have a formal process that specifies how audits are conducted, determines whether?
the QMS confirms to the established standard and assesses its effectiveness.
91
The result and the date of the audit should be ------------------------.
documented
92
Overall, it is essential that firms maintain a positive view of the process, so that?
they can learn from mistakes.
93
If quality goals are set too high, employees might not reach them or distort the data or system to fit the goal.Thus,?
setting realistic goals and defining clear processes for the audit protects against these problems.
94
Conducting an audit requires a lot of planning, both by?
in the QMS planning stage, the firm needs to carefully decide how processes are structured, which checklist to develop, or which errors to monitor.
the firm and the auditor, if no internal audit is done.
95
The firm must prepare for the audit well in advance. For example,?
in the QMS planning stage, the firm needs to carefully decide how processes are structured, which checklist to develop, or which errors to monitor.
96
The auditor also needs to plan the audit well in
----------------. They require three basic ingredients to conduct an audit.
First, the auditor is typically guided by --------------------------------. A principle is a rule or basic doctrine of conducting audits that develops from accepted practice in an ----------------over time.
Second, an auditing standard is required so that the audit is conducted by a -----------------------------------------------------that measures performance objectively according to criteria.
advance
auditing principles
industry
professional authority
97
The auditor needs to be knowledgeable to conduct the audit, must be independent from?
the performer, and needs to have a professional attitude when writing the report afterward.
98
Third, an auditing procedure is necessary so that the conclusions drawn from?
the process are not arbitrary, but based on scientific methods.
99
image
100
image
101
image
102
The audit process always follows a typical structure as?
outlined in DIN ISO 19011:2011
103
The process of a quality audit is initiated by a firm’s -----------------------------. The table above shows an example of a --------------------------------, in which an external auditing team checks the documents before assessing the firm in person or conducts the interviews and walk-through with the firm’s audit team online.
management
third-party audit
104
This online alternative was implemented in many firms during?
the COVID-19 pandemic.
105
It is yet unclear whether online audits will be kept to reduce costs when?
possible in the future.
106
Once the process is completed, the audit cycle is --------------until either the firm starts a new audit cycle or seeks --------------------------------.
closed
certification
107
Once the internal audit and management review are completed, ?
many firms want to have their QMS audited for certification.
108
A certification audit is completed to receive a certificate, like -----------------------. These audits assess and document whether a ----------- adheres to the standards.
ISO 9000
QMS
109
Benes and Groh note two reasons why firms may want to receive a certificate for their QMS:
1) because it is an accepted independent verification of a third party (like a certification company) and
2) because it might be an explicit requirement of one or more customers.
110
Similar to an audit, the goal of a certification is to?
determine the conformity of the QM system with the standard requirements.
111
If conformity is verified, the certification issuers will?
issue a certificate
112
Many international manufacturers (and some authorities) require?
proof of a general or industry-specific quality norm.
113
Here, trust is created that the firm is improving continuously and that the firm’s quality is?
according to standards.
114
The certificates are often displayed in ?
the firm’s entrance or on the internet
for the public to see.
115
Auditors are approved within industry branches where they have work experience for?
If a certification audit is conducted, at least one of the auditors needs to have a scope of the same industry branch as the firm that wants to receive the certificate
at least three to five years.
116
This approval is called -----------------and the industry branches are listed in an international list called the ----------------- (the branch code of the European Co-operation for Accreditation ------------).
“scope,”
EAC Code
EA
117
If a certification audit is conducted, at least one of the auditors needs to have?
a scope of the same industry branch as the firm that wants to receive the certificate.
118
The certificate is usually valid for three years. Before the firm conducts the audit, it often conducts an internal audit first to?
Whereas many certification auditors can attest to the firm’s adherence to a standardized norm, the certificate gains expressive power and is more meaningful if it is done by auditors of an accredited certification body
check the processes or products before hiring a third party.
119
After the certificate is issued, there are several internal and external review audits to check that?
the necessary changes were implemented during the lifespan of the certificate until a recertification takes place once the certificate expires.
120
For audits in private areas, a certification is often
--------------------. This certification can be provided by any person or body that feels-------------------------------------------------------------------.
sufficient
competent to validate the conformity of a QMS
121
A certification is conducted by qualified auditors. If they pass an exam with a conformity assessment body, they are?
qualified to conduct audits for three years. Afterward, an auditor must sit the exam again.
122
Auditors often work as freelancers?
Because this certificate is not necessarily trustworthy and of little value, most firms seek accreditation from accredited conformity assessment bodies.
123
In the public sphere, e.g., hospitals, medical products, or education, the audit must be?
certified by accredited conformity assessment bodies.
124
The accreditation thus ensures that there is?
a standard quality level among all accreditation bodies and that they can be trusted.
125
Hermann and Fritz explain that an accreditation is a?
confirmation by a third party that formally states that a conformity assessment body has the competence to perform certain conformity assessment tasks.
126
In Germany, whether a certification is accredited is stated on?
the printed label of the national accreditation body of the Federal Republic of Germany
127
The DAkkS aims to establish confidence in testing because?
certification is required in many industry sectors.
128
By accrediting auditors, they assure that they work according to?
the required international standards,
rules,
and laws
129
For international recognition, there need to be?
universal rules for all accreditation-based certifications.
130
The International Accreditation Forum (IAF) coordinates uniform accreditation and certification rules for :
systems, products, services, and personnel and works closely with the ISO
131
In August 2021, the IAF had 87 accreditation body memberships, of which?
DAkks is a member
132
A QMS is a methodology for ensuring that?
a manufacturer produces to the required specifications.
133
The intention of setting up a QMS is to?
assure the planned quality standard in a transparent and systematic way.
134
A firm’s QMS is embedded in their management system and is influenced by?
international norms, ideas of TQM, and business excellence.
135
A QMS is usually implemented in the form of a project, which takes about?
one to two years, during which several audits monitor the implementation progress.
136
An audit is a systematic, documented objective check to assess whether?
the desired norms are fulfilled.
137
Internal audits are administered by?
independent employees within the firm.
138
Second- and third-party (by external firm stakeholders) audits are?
external audits are done by specialized external parties. Process, product, and system audits also exist.
139
A quality audit is typically a --------------------------. These audits should be seen positively, so that areas for improvement can be ------------------ and learning can take place. Audits follow a typical ---------------- structure, which is standardized in ---------------------------------------.
system audit
identified
six-step
DIN ISO 19011
140
A certification is an audit that results in a document that?
attests the firm’s conformity to the required standard, e.g., that the QMS adheres to ISO 9000.
141
Firms seek certification to have ?
an accepted independent verification from a third party,
but this process is often not standardized.
142
For public services, like hospitals and universities, a certification must be ?
from an accredited certification body.
143
Accreditation means that a third party formally attests that the auditor is?
coordinates uniform accreditation and certification rules and works closely with the ISO.
competent to perform the assessment.
144
The International Accreditation Forum (IAF)?
coordinates uniform accreditation and certification rules and works closely with the ISO.
