Effective And Efficient Quality Managements-1

11-03-2015
Compiled by
M.Karikalan,
karikalan@y7mail.com 1
ISO
9000
ISO
9001
Management

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Contents:
1.WHAT IS A PROJECT?
2.Coordinated Undertaking of Interrelated Activities
3.PROJECT MANAGEMENT
4.Managing Quality and Safety
5.Attitude Is Everything
6.Developing the Quality Management Plan
7.INTERNAL COMMUNICATION
8.Cultural best practices
9.Factors affecting project success
10.A model of how the learning organisation can be encouraged
11.Workforce behaviours
12.Communication challenges for the construction project manager
13.The characteristics of construction projects, people and processes
14.Contract Organization
15.SPECIFICATION
16.STANDARD
17.CODE

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Contents:
18.Introduction
Emergence of Quality Management Concept
In-Process-Inspection
19.The Need for Quality Management
System
20.ISO 9000 Series of Standards
21.Crises of Credibility
22.Specifies quality management system
23.The aim of certification
24.Quality System Standards
25.Documentation
26.Procedures
27.Records
28.What is ISO?
29.What is ISO 9000?
30.Examples
31.customer complaints
32.Customer satisfaction
33.Cognitive probe

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34.Maintaining Standards (Auditing)
35.What to audit?
36.Differences between Training and Education
37.Types of Sample
38.Sample Handling
39.Sample Preparation
40.Fitness for Purpose
41.What is an NCR?
42.Stakeholder (Interested Party)
43.IS ;15700
44.Complaints Handling
45.Findings include
46.Nonconformance
47.MAJOR NONCONFORMITY
48MINOR NONCONFORMITY
49.Dispositions
50.Customer Satisfaction
51.Reviewing and closing nonconformities

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WHAT IS A PROJECT?
• They are goal oriented.
• They involve the coordinated undertaking of interrelated activities.
• They are of finite duration, with beginnings and ends.
• They are all, to a degree, unique.
Goal Orientation
Projects are directed at achieving specific results—that is, they are goal
oriented. These goals drive the project, and all planning and implementation
efforts are undertaken so as to achieve them.
Coordinated Undertaking of Interrelated Activities
Projects are inherently complex. They entail carrying out multiple activities that are
related to each other in both obvious and subtle ways.
Some tasks cannot be executed until other tasks have been completed, some must be
carried out in parallel, and so on. Should the tasks get out of sync with each other, the
whole project may be jeopardized.

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Source: Managing Projects in Organizations
J. Davidson Frame
How to Make the Best Use of Time, Techniques, and People
Third Edition 8
“My most basic objective is to get the job done—on time, within budget, and according
to specifications.”
PROJECT MANAGEMENT

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Beginning in the 1990s, project management became a hot management
approach. As the U.S. economy entered a post-industrial phase,
American managers discovered that many of the management guidelines
established for a manufacturing economy no longer served them
well in an information economy. In a manufacturing environment, emphasis
is placed on predictability and repetitive activities, and to a large
extent, management is concerned with standardization and rationalization
of production processes. With an information economy, uniqueness
of events has replaced repetition. Information itself is dynamic and
ever changing. Flexibility is the watchword of the new order, and project
management is a key to this flexibility.
Continue……

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Managing Quality and Safety
“What Is Construction Management?” You will recall that the three-legged stool
represents the three primary elements of construction management: cost, time, and
quality. You may also recall that safety makes up the foundation of that stool and that
without safety, the effectiveness of our management efforts is really in question.
Quality not only impacts aesthetics, appearance, and durability — it also impacts
performance. And poor performance can lead to failures in everything from an
improperly installed section of roof flashing resulting in a leak to the deflection of a
structural steel beam resulting in a roof collapse. There is no question that failures
due to poor quality cost dollars and time, but in some instances, poor quality can even
cost lives or serious injury.
The characteristics of a good quality management plan and a good safety
management plan are quite similar. Although each is defined by distinct concepts and
specific mechanisms of control, which I will explain, it makes sense to administer
quality and safety plans as one integrated management function.

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Attitude Is Everything
Good contractors stake their reputations on quality and safety. You can write all of the policies, procedures,
and rules that you want, but the truth is, if the leadership of the company has not established a
foundational attitude of superior workmanship and an immovable stance on safety, it will all be for naught.
When it comes to quality and safety, attitude is everything. And this attitude must emanate from the
highest levels of leadership and management down to every single worker and subcontractor in the field.
Successful construction managers are well aware of what they must do to achieve quality results and
maintain high safety performance. They must do the following:
Insist upon good quality plans and specifications
◆◆ Whenever possible
◆◆ Provide experienced and adequate supervision on all jobs
◆◆ Provide thorough and adequate inspections
◆◆ Make sure that all workers are qualified to do the job they are hired to do
◆◆ Never accept inferior work
◆◆ Above all else, in still an attitude toward high quality and safety throughout the company
However, sometimes even these are not enough. Although the project manager and superintendent are
accountable for developing and implementing the quality and safety plans on the job, they must have
support and participation from the field: quality and safety are ultimately achieved at the labor force level.
Employees and subcontractors alike must embrace the plans and be encouraged in and recognized for their
efforts to produce high-quality work and a safe work environment. And when they are, it sends a loud
message, not only to other workers on the job but also to the project owner and the public at large. This is
the goal of the construction manager.

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Construction Management
JumpStart
Second Edition
12
Developing the Quality Management Plan High quality on the job
site, or anyplace else, does not just happen automatically.
There must be an intention about it. In other words, quality
happens on purpose.
The construction manager must have a quality management plan
in place long before the first shovel of dirt is turned on the job.
Achieving high quality in construction requires a comprehensive,
systematic approach that looks at every detail involved with
moving the project from an idea on paper to the final
product — a building, a bridge, or a highway.
Developing the Quality Management Plan
In construction, quality is defined as meeting or exceeding the requirements established in
the design documents. Fundamentally, the quality of the construction project is set through
the plans and specifications provided by the architects and engineers. There are various
levels of quality that can be specified for any given project. The design team works with the
owner to determine exactly what their expectations for quality are.

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Quality
Those attributes of a product or service that meet the needs and
expectations of the user, as perceived by the user. .
Quality Control
The regulatory process through which we measure actual quality,
performance, compare it with standards, and act on the difference.
Quality Assurance
The activity of providing to all concerned, the evidence needed to establish
confidence that the quality function is being performed adequately.
Quality Function
The Entire Collection of activities through which an organization achieves
quality.
Quality System
The specifically designed plans, tasks, and programs within an organization
to achieve quality.

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What does “Product Quality” Really mean?-David A. Garvin, Harvard University,1984
15

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MANAGING ATTITUDES TOWARD QUALITY
DEFECTS ARE NOT THE CAUSE FOR BLAME BUT A CALL TO ELIMINATE
CAUSES
 QUALITY WILL NOT BE SACRIFICED TO ACHIEVE COST OR DELIVERY GOALS
 IDENTIFY AND REPORT COST OF QUALITY (AS A PERCENTAGE OF SALES OR
COST OF GOODS SOLD)
 EVALUATE MANAGEMENT ON COST-OF-QUALITY PERFORMANCE
 CHANGE ORGANIZATIONAL STRUCTURE -GIVE QUALITY ASSURANCE
PROMINENCE

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designed by the Budapest Univerity of Economic Sciences and MUCIA business schools, supported by the
United States Agency for International Development. 17

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Project Participant Relationships

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Traditional Construction Project Organization

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Construction is a people-intensive, highly social industry where people
interact regularly in support of the production effort. The face-to-face channels
used to exchange information throughout the project lifecycle is known as
interpersonal communication, the efficacy of which to some extent defines the
success or otherwise of construction projects.

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[1A] Communication in Construction, Theory and practice
Andrew Dainty, David Moore and Michael Murray
25
Professional and process discontinuities
Construction projects comprise a rich network of different types of people
(from unskilled labourers to highly skilled professionals) who are situated
within different parts of the supply chain (from client advisors to facilities
managers). Between them lie many interfaces defined by project position,
contractual roles and obligations, societal expectations and stereotypes and
individual nuances and traits. In many respects it is the multitude of people
involved and the richness of communication that stems from this mix, as
they interact within the project delivery process, that make it such an interesting
industry to study from a communication perspective. However, such
interfaces and differences in perspective can also lead to misunderstandings
and/or barriers to communication which have to be overcome if projects are
to be successful.

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Quality Management Systems for Assisted Reproductive Technology—ISO 9001: 2000
Bryce E Carson Sr Michael M Alper, MD Christoph Keck, MD
26
INTERNAL COMMUNICATION
As with all practices, communication is the greatest weakness. In implementing an
effective quality management system, an effective communication methodology must
be implemented. Maintain an internal communication system that enhances service
delivery processes as well as the effectiveness of the quality management system.
Electronic communication via Intranets, Internets and email provides an effective and
flexible approach. This form of communication allows for communication both
upwards through the practice, as well as downwards. Other methods such as
memoranda, postings on bulletin boards, staff meetings, either formal or informal
methods, also have a place in this process.

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Critical communications variables
•Accuracy:
The accuracy of information received, as indicated by the frequency of conflicting instructions,
poor communications and lack of coordination
•Procedure:
The existence, use and effectiveness of formally defined procedures outlining scope, methods,
etc.
•Barriers:
The presence of barriers (interpersonal accessibility logistic/or other) interfering with
communications between supervisors or other groups
•Understanding:
An understanding of information expectations with supervisors and other groups
•Timeliness:
The timeliness of information received, including design and schedule changes
•Completeness:
The amount of relevant information received
Source: Thomas et al. 1998
American Society of Civil Engineers

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In analysing organisational cultures, Hofstede (1994) employed six dimensions:
● Process:
● result orientations;
● technical and bureaucratic routines (can be diverse);
● outcomes (tend to be homogeneous);
● Job:
● employee orientation;
● derives from societal culture as well as influences of founders and managers;
● Professional:
● parochial;
● educated personnel identify with profession(s);
● people identify with employing organisation;
● open:
● closed system;
● ease of admitting new people, styles of internal and external communications;
● tight:
● loose control;
● degrees of formality, punctuality, etc. may depend on technology and rate of
change(s);

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● pragmatic:
● normative;
● concerns how to relate to the environment, notably customer’s pragmatism
encourages flexibility.
The alignment of Hofstede’s dimensions or organisational culture with the managerial
‘schools’ of human-task (theory Y, theory X) orientation is quite clear; however, the
development of theory Z (Ouchi 1981) provides a further perspective on the relationship
of managerial style, organisational culture and performance (together with
consequences). Such compatibility is reflected in Wallach’s (1983) typologies of
organisational culture—bureaucratic, innovative and supportive—complimenting the
organisational types noted by Weber (1964).
Schein (1984) suggested two primary types of organisational culture:
● free-flowing—an unbounded, egalitarian organisation without (much) formal structure,
thereby encouraging debate and (some) internal competition;
● structured—a bounded, rigid organisation with clear rules and requirements
(analogous to the organic-mechanistic analysis of Burns and Stalker 1961).
Handy (1985) suggests that there are four primary forms of organisational culture:
● power, which is configured as a web with the primary power at the centre;
● role in which functions and professions provide the structural pillars for the support of
the overarching top management (analogous to a Greek temple);
● task, in which jobs or projects are a primary focus yielding an organisational net (as in
a matrix organisation);

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A guide to best practice in construction Edited by Steve Rowlinson and Peter McDermott
30
● person, in which people interact and cluster relatively freely.
Handy suggests that the main factors which influence organisational culture are:
● history and ownership;
● size;
● technology;
● goals and objectives;
● environment;
● people.
Given her focus upon effecting change, Kanter (1984) suggested that organisational cultures
could be examined along the dimensions of inferiority-success (as for followers and leaders
amongst firms in a market) and age-youth (concerning both the individual firm and the industry:
youth involves new industries, new firms, rapid and extensive innovation; age involves
established, staid organisations which envisage little need for change where problems need not
be confronted as they will resolve themselves). From a distillation of literature on organisational
culture, Liu and Lee (1998) identify the main orientations to be:
● power;
● rule and procedure;
● people;
● results;
● innovation;
● internal-external focus;
● team;
● customer;
● communication.

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Procurement Systems
A guide to best practice in construction Edited by Steve Rowlinson and Peter McDermott 31
Cultural best practices
Figure A.6 Project cultural (‘onion’) layers

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Source: Morris 1989
International Journal of Project Management, an imprint of Elsevier Science Ltd
32
Factors affecting project success

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Figure 5.3 illustrates one model for encouraging the learning organisation. The
company’s external environment has its part to play in encouraging the learning
organisation. The procurement system could provide a useful driver for change towards
the learning organisation becoming the norm. Stakeholders and clients are presently
loosely integrated in terms of reflective learning.
Interorganisational relationships vary from co-producing subcontractors or consultants
on a project through to more formal partnering or strategic alliance arrangements. The
link between successful strategic direction, communication and monitoring for control
has been well established for a long time; however, more recent questioning of how this
is effectively achieved brings in interesting issues of stability and turbulence. Part of the
perceived failure of strategic management has been attributed to an overreliance upon
stability both in the internal and in the external environments that companies confront.
This is generally not the case in real life, particularly in a global economy with
communication technologies that support rapid information and data exchange. This has
caused turbulence which planners could neither anticipate nor perceive. The effective
response is to maintain a clear vision of the strategic goals and use organisational
learning to experiment and fine-tune plans or substantially to replan, depending upon
what has been learned from experience (Mintzberg 1994:209). Thus organisational
learning is extremely important to the strategic planning process for all project
participants.

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Procurement Systems
A guide to best practice in construction Edited by Steve Rowlinson and Peter McDermott
34
figure 5.3 A model of how the learning organisation can be encouraged

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Workforce behaviours
Organisational communication is arguably a key factor in embedding new ways of
working necessary for change within construction organisations.
Communication is not merely a mechanism to convey or transmit information,
but is a tool by which workforce attitudes and behaviours can be challenged,
manipulated and changed (see Townly, 1994). In recent years, some construction
companies have begun to recognise the power of ‘softer’ behavioural competencies in
defining the success of an organisation (Moore et al., 2002). This acknowledgement
stems from the realisation that it is the behavioural input to a project’s development
that determines its success. Such behaviours are manifested and conveyed to others in
the ways in which project participants communicate. Thus, training, developing and
supporting people in improving their communication skills is central to the improved
performance of the sector in the future.

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Communication challenges for the
construction project manager
................................construction industry relies on the abilities and skills of line
managers to a greater extent than do most other sectors. Pinto and Pinto (1991)
showed that managers’ efforts to clarify and establish shared agreement for
deliverables had a positive influence on team member satisfaction. Other
research has demonstrated the important role of managers’ communication in
ensuring job satisfaction (Henderson, 1987; Pettit et al., 1997) and positive
relations between co-workers and managers (Klauss and Bass, 1982). This
presents a significant leadership and communication challenge for project
managers who must ensure that their teams are motivated and working towards
a successful outcome for the endeavour with which they are engaged. However,
construction companies also require their managers of projects to make
decisions that align with the overall strategic philosophy of the organisation.
Moreover, they are expected to communicate the organisational vision in such a
way that the remainder of the team collectively direct their efforts around them.

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The characteristics of construction projects, people and processes
These features are summarised by Loosemore et al. (2003) as:
● Their unique, one-off nature – unlike other project-based sectors, where prototypes can be tested before
production gets underway, construction projects tend to be one-off, unique undertakings that are designed and
constructed to meet a particular client’s product and service needs.
● Their tendency to be awarded at short notice – many construction projects are awarded following a period of
competitive tendering, where possibilities for thorough planning are often limited.
● The labour intensiveness of construction activity – the construction industry remains one of the most people-
reliant industrial sectors; staffing costs represent the majority of costs on most projects. The industry employs an
extremely diverse range of people from a wide range of occupational cultures and backgrounds, including people
in unskilled, craft, managerial, professional and administrative positions, and these diverse groups of employees
operate as an it inerrant labour force, working in teams to complete short-term project objectives in a variety of
workplace settings. Hence, the industry is made up of many disparate organisations which come together in
pursuit of shared project objectives, but also individual organisational goals. These are not necessarily
compatible or mutually supportive and they might not align with peoples’ personal objectives, which can lead to
competing demands on those working within project-based environments. These features make construction
one of the most challenging environments in which to manage people effectively, and thereby ensure that they
contribute to organisational success.

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Continue…….
• Jargon, semantics and the potential for misunderstandings – the industry’s fragmented
structure and culture and its technical nature have led to the creation of both formal and
informal languages developing around its processes and people. For example, the vocabulary
and glossaries used by project management practitioners can lead to communication
problems (Delisle and Oslon, 2004). A lack of standardisation in size, quality and
commonality of meaning in glossaries that are targeted at project management practitioners
mean that individuals define similar processes differently. The use of technical language and
jargon (written and spoken) are common within many occupations. In construction
this may be evident in drawings, specifications, method statements and other project
documentation. Verbal communication may also be ineffective and time wasting when noise
occurs in a transfer due to the use of overly complex language.

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Contracting for Engineering and Construction Projects-Fifth Edition-PETER MARSH Gower
39
Duties of Architect /Engineer under Client‘s instruction
1 Furnishing the contractor with drawings and information.
2 Issue of variation orders altering extent, nature or quantity of the works.
3 Suspension of the works.
4 Nomination of sub-contractors and suppliers.
5 Approval of the work and inspection.
6 Pricing of variation orders where new rates or
prices must be established.
7 Pricing of additional sums which may be due to the contractor for
suspension, unforeseen circumstances, and so on.
8 Adjudicating on the validity of claims presented by the contract.
9 Granting of extensions of time.
10 Issue of certificates.
Contract Organization

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SPECIFICATION
A SPECIFICATION is “a detailed description of parts of a whole; a statement or enumeration
of parts of a whole; a statement or enumeration of particulars as to actual or required quality,
size, etc.”
[Ref. : Code Clinic For Study of API Standard II04, Eighteenth Edition, Welding of Pipelines
and Related Facilities]
STANDARD
A STANDARD is “established for use as a ‘rule’ or basis of comparison in measuring quality,
quantity, content, relative value, ets.” ASTM Standards for various products such as ASTM A36
for weldable structural steels are examples.
CODE
A CODE is “a body of laws; as of a nation, state or industry group; arranged systematically
for ease of use and reference”. Examples include AWS D1.1, API 1104 and ASME Section VI I I.
NOTE: As originally published, many documents have printing errors. Codes are no
exception. Always check for and mark in the code any changes that are given on any applicable
‘Errata Sheets’.
[Ref. : Code Clinic For Study of API 1104 Welding of Pipelines and Related Facilities -
Nineteenth Edition ]

11-03-2015 [Basic concept of Quality Assurance module-14,Canadian Welding Bureau] 41

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[Basic concept of Quality Assurance module-14,Canadian Welding Bureau]
42

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45
PROJECT MANAGERS
Under some forms of contract the control
and administration of the contract on behalf
of the purchaser is given to an individual or
firm named the project manager.

11-03-2015 Contracting for Engineering and Construction Projects-Fifth Edition-PETER MARSH Gower 46
Roles in Construction Projects
In principles, a construction project is the outcome of a joint effort between the
owner, one or more contractors, and various professional entities that provide
finance, design, construction, and operation services. These entities work as parties
within a contract framework with mutual relationships.
At a glance, owners may be subsumed into three broad areas.

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Service owners include public and private entities that build an infrastructure, a
facility or a utility project with the purpose of running the business with a long-term
social or economic return on investment. Examples of this kind of owner
are: a municipality to build a new school or a road, an electric utility company to
erect a new power station, and a hotel company to run its own accommodation
facilities.
Service owners
Real estate developers and property managers do business within the construction
industry, while service owners are usually industrial players in a specific consumer
or business-to-business market.
Owners usually go into an agreement with contractors that have specialization
to construct the product required by the project, such as building, infrastructure
and civil works, or plant engineering. In the previous examples, the municipality
will look for a building contractor; the electric utility company will select a
specialist engineering and contracting firm; the real estate developer will join a
residential housing constructor.

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• Property or asset managers act as landlords that develop building investments
to get long-term return from rental fees and facility management services. An
example is an insurance company or a private-equity real estate investor.
• Real estate developers aim at selling constructed facilities to the market with a
short-term return on investment. Typically, real estate developers have residential
housing and office building programs.

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49
Roles in Construction Projects
Most general contractors are responsible for the construction job based on
design specifications and drawings produced by owner’s architects and
engineers. Yet, some contractors are able to supply both design and
construction, thus acting as design-build firms, or engineering-procurement-
construction (EPC) contractors.
Engineering-procurement-construction (EPC) contractors.

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Payment Schemes
‘..................A successful agreement divides risks to save money on contract
price and provides incentive to contractors to have them finish early, in
budget, and with good quality. Such incentives are strongly influenced by the
mechanism used by the owner to pay the contractor for work performed.
Thus, a correct payment scheme has to go with the choice of the appropriate
delivery system to enable the participants’ commitment in cost savings.
Figure 1.1 depicts various possible payment schemes depending on risk allocation
between the parties.

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When the owner uses a time and material or a unit price payment scheme, he
shoulders most of the financial risk associated with the project.
Negotiated cost-plus-fee contracts may have different provisions regarding
compensation of the contractor, usually based on risk sharing policies between
the contract parties.
When the owner uses a firm-fixed-price or guaranteed-maximum-price payment
scheme, the contractor bears most of the financial risk.

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Alberto De Marco, Project Management for Facility Constructions-A Guide for Engineers
and Archite
53
Unit Prices
Cost Plus Fixed Percentage Fee
Cost Plus Incentive Fee
Cost Plus Fixed Fee
Target Cost Plus Incentive Fixed Fee
Cost Plus an Award Fee
Guaranteed Maximum Price (GMP)
Firm Fixed Price

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Alberto De Marco,Project Management for Facility Constructions-A Guide for Engineers and Archite
54

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The emphasis of this PPT is on helping people help their companies
toward exceptional Configuration Management processes.
Engineering Documentation Control is a significant business strategy and an absolute
foundation block for: TQM (Total Quality Management), JIT (Just In Time), Cross-
Functional Teams (Concurrent Engineering), Engineering/Manufacturing/Supply
Chain software systems, Lean Manufacturing, meeting domestic or international
standards, and efficient manufacturing. In fact, it must be a significant company
strategy if best in class or world-class manufacturing is to be achieved.

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Why do we need Engineering Documentation at all? Why control that documentation?
The mere use of the word “control” puts most engineers into a very defensive mode.
Are we trying to stifle the engineer’s creativity? What is there to “manage” about the
configuration of a product? Let us first identify the basic “raw materials” of Product
Manufacturing— the very essence of product manufacturing. There are three primary
elements:
Tools (machine, mold, software, etc.)
People
A product embodied in design drawings and specs

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Manufacturing says:
 I don’t understand what I’m supposed to build
 What criteria do we test to
 Where is the change I need to:
Reduce costs
Avoid making scrap
Avoid making parts that will have to be reworked
 Will this change increase the “bone pile” of down-level material

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Sales says:
You mean the product isn’t ready for the market window
Where is that promised new feature
Why didn’t we deliver a product with the options the customer asked for
Customer says:
 I didn’t get what I ordered
 Where is the fix you promised me
 Where is that new feature or option
Repair says:
 I could fix it easier if I knew what is in this product
 W hat changes should be and shouldn’t be incorporated upon repair

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Quality says:
 Is this cost in our Cost of Quality
 Should we treat ourselves, our suppliers, or our customers this way
 How can we meet our customer’s standards
 We can’t meet International and US standards
Employee says:
 I asked them to do something about this a long time ago
Good design documentation
and its control is the solution for the root cause of these symptoms.

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Watts, Frank B. ISBN 978-0-8155-1595-1
Engineering documentation control handbook : configuration management in industry. -- 3rd ed. 60
Benefits :
•Helps to get new products to the market faster and reduce delivery time for a customized
product.
•Happier customers because they see the new option, change, or feature they had requested,
much quicker.
•The customers get what they ordered with fewer missed delivery commitments.
•Reduces the “bone piles” of down-level material.
•Gets real cost reductions implemented quicker.
•Reduces the manufacturing rework and scrap costs significantly.
• Improves Bill of Material (BOM) accuracy and saves the corresponding material waste and
correction time, resulting in corresponding improvement in product quality and inventory
accuracy.
•Eliminates multiple BOM and saves the costs of maintaining the bills, not to mention
eliminating the risks associated with multiple bills.
•Evolution of BOM in lead-time to produce the product.

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•Reduces field maintenance, retrofit, and repair cost.
• Knows exactly what is non interchangeable in each product.
•Improves the understanding and communication between
Design Engineering and the rest of the world.
•Clarifies the responsibilities and thus eliminates finger pointing.
•Saves wear and tear on Configuration Managers, Master Schedulers, and
all types of engineers.
•Complies with applicable customer or agency standards.
•Sorts out changes that are not needed or aren’t cost-effective.
•Saves many dollars/money a year in paper and copying costs alone.
•Significant reduction in the cost of quality.
•Allow the company to qualify as a best in class producer.
•Set the stage for innovation in engineering and manufacturing
Benefits (cont…)

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File Management Procedures
A document filing system for both paper and electronic products greatly increases efficiency. Effective filing systems focus on enhancing
the speed and accuracy of document retrieval, not just storage. Filing systems typically use standard designations, classifications, and dates
so that documents can be indexed correctly and located quickly. Examples of documents to be filed include the following:
• Project development materials,
• Correspondence and reports,
• Telephone and conversation logs,
• E-mails,
• Design calculations,
• Project drawings and project specifications,
• Quality control forms,
• Cost estimates,
• Schedules,
• Time sheets,
• Project costs,
• Value engineering or life-cycle cost information,
• Shop drawings and manufacturer’s submittals,
• Construction reports to the owner or regulatory agencies, and
• Project close-out documents.
Large or complex projects may require separate files for each of the categories mentioned, while a single file may be sufficient for small
projects. Files may also be arranged by project phase.

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The following is a general checklist of pre-qualification information that may be requested by the owner:
The Associated General Contractors of America (AGC) has prepared a pre-printed form, “Construction Contractor’s Qualification Statement for
Engineered Construction” (AGC Doc. 220), for use as a suggested generic pre-qualification statement or a contract-specific qualification statement.
Guidance for the presentation of design-builder qualifications may be found in the Design-Build Institute of America’s “Design-Build Contracting Guide”
(Doc. 2215). The American Institute of Architects (AIA) has prepared a helpful document titled “Contractor’s Qualification Statement” (AIA document
A305). Another example is a form developed by the California Department of Industrial Relations in response to California law. This was developed as a
guidance document, including model questionnaire, titled “Pre-Qualification of Contractors Seeking to Bid on Public Works Projects.”
• Constructor name, location, license, and corporate structure, if applicable.
• Commitment of constructor to not change key personnel.
• Business data: financial information, bonding capacity, bank references.
• Construction experience: projects constructed or under construction, size, type, performance on schedule, and budget.
• Workforce on constructor payroll versus subcontracting.
• Equipment owned versus rentals.
• Safety records: written program, actual experience.
• Quality control: written program.
• Resumes of key executive and supervisory staff.
• Current workload: remaining bonding capacity.
• Personnel to be assigned to key positions of management and field supervision.
• Performance of completed projects, specifically including information on project cost and completion relative to terms of the contract and references for
each project’s owner.
• Record of litigation, including arbitration, mediation, mini-trials, and other proceedings, i.e., with ILRB, EEOC, OSHA, IRS, etc.

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Construction contract documents generally include the following:
• The agreement (the document signed by the parties, which customarily identifies the parties; states the contract price,
payment terms, and contract time; and lists the contract documents);
• General conditions;
• Supplementary conditions;
• Lien waivers;
• Confidentiality agreements;
• Project drawings;
• Project specifications;
• Addenda (if any) issued before bid submittal;
• Bid instructions;
• Bid forms;
• Contractor’s bid;
• Notice to proceed;
• Performance and payment bonds (if any);
• Change orders or contract modifications (post-execution).

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.......Regardless of who prepares the construction contract documents, the owner must make decisions on many subjects, such
as insurance requirements, bonds, and bidding requirements.
Because the contract documents are the key to defining quality requirements, it is important to denote the preparation effort
necessary to produce quality contract documents both individually and as an integrated “package.” Quality contract documents
help provide quality in constructed projects. It is essential that attention be given to a careful review of all of the documents to
help ensure coordination and consistency, i.e., avoid gaps and conflicts, the source of many misunderstandings and disputes.

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Owner Responsibilities
The primary responsibilities of the owner during construction generally include
• Providing clear expectations for the project;
• Providing quality assurance oversight for the duration of the project;
• Administering contracts and coordinating the activities of participants;
• Making prompt decisions on construction matters;
• Responding in a timely manner to documents and materials submitted for review;
• Making payment according to contract terms;
• Enforcing contracts;
• Performing other duties and responsibilities assigned by the contract and governing statutes;
• Maintaining communication with the public and/or affected parties.
While the following activities may occur during the early phases of construction, they are most
effective if implemented during pre-construction:
• Establishing responsibilities for quality assurance. This may be either in-house staff or
contracted third party.
• Establishing value engineering responsibilities;
• Assigning overall responsibility for construction site safety (usually to the constructor).

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Source
ASCE MANUALS AND REPORTS ON ENGINEERING PRACTICE NO. 73
QUALITY IN THE CONSTRUCTED PROJECT A GUIDE FOR OWNERS, DESIGNERS, AND CONSTRUCTORS
THIRD EDITION
Constructor Responsibilities
As the team member performing work at the project site, the constructor’s principal responsibilities include the following:
• Planning construction-related activities, including coordinating and sequencing of construction activities;
• Constructing the facility in accordance with the project drawings, project specifications, and approved change orders of the construction contract;
• Providing or causing others to provide the selection, planning, and implementation of the actual means and methods of construction;
• Notifying the owner and design professional of possible design problems during the construction process;
• Notifying the owner and design professional of unforeseen site conditions;
• Establishing and maintaining the project construction schedule and budget;
• Performing quality control for construction activities, with deficiencies tracked on a rolling completion list maintained by the constructor and shared with all
parties;
• Developing and implementing the construction site safety plan (if delegated by the woner);
• Preparing (or causing to be prepared) and reviewing the required shop drawings and other submittals and monitoring the completion of the various
necessary shop drawings throughout the project using a submittal schedule created prior to the start of a project;
• Managing and paying construction suppliers and subcontractors;
• Fulfilling the provisions of the owner-constructor contract;
• Complying with applicable laws and regulatory guidelines. Variations in the contractual arrangements and participation of other project related organizations
(such as program, project, and construction managers) may involve modifications to the constructor’s responsibilities as described above.

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Concurrent Engineering in Construction Projects Edited by
Chimay J. Anumba, John M. Kamara and Anne-Francoise Cutting-Decelle
68
Documents as the industry’s knowledge base

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69
Emergence of Quality Management Concept:
During World War–II, the European and American industry was faced
with the burden of producing enormous quantities of military
products meeting their stringent requirements of time and quality. It
saw emergence of new concepts in organizational management,
including “Quality Management”. Some of the pioneering works done
in “Statistical Quality Control” in 1920s by Bell Telephone Laboratories
(Dr. Shewart) and Hawthorn Works of Western Electric Company (Dr.
Deming and Dr. Juran) got immense boost during and after World War
II, and this led to the formation of American Society for Quality
Control (ASQC).
INTRODUCTION

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The post-World War II period witnessed dramatic developments of
Quality Management Tools and their applications in different
organizations. Most of the companies converted their Inspection
Departments to the Departments of “Quality Control”, or “Quality
Engineering”, or “Quality Assurance”. As the things settled down,
the manufacturing organizations adapted the concept of “Quality
Assurance”, which contained planned and systematic actions
required to provide adequate confidence to a customer that a
product or service would satisfy the given quality requirements. This
concept was largely based on “process compliance”, where the
process was viewed to be comprising of 7 Ms i.e.
“In-Process-Inspection”

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1. Man
2. Material
3. Machine
4. Method
5. Milieu (Environment)
6. Measurement
7. Money (Resources)
The manufacturing processes were designed around these
seven Ms. The inspection activity was limited to the monitoring
(measurement) of process at certain vital points, which later
came to be known as “In-Process-Inspection”. This era of
“Quality Assurance” also made use of Statistical Process Control
(FORD –1965) and Reliability Engineering (Dr. Shewart)
“In-Process-Inspection”

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The Need for Quality Management System
In the present globally competitive environment, it is not just
sufficient to achieve quality at any cost; it is necessary to achieve
quality at a competitive cost to sustain the market forces. In this
context, establishment of Quality Management System
(QMS) provides a right framework for the organizations to harness
their capabilities, direct their efforts to achieve the intended
business results, and provide a basis for long-term growth and
survival. QMS is commensurate with the benefit, cost, and risk
considerations of an organization. The key objectives of QMS are to
have effective management of internal processes to:
• Enhance customer / stakeholder satisfaction,
• Sustain business competitiveness, and
• Increase bottom line results and profitability with optimum use of
resources.

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ISO 9000 Series of Standards:
Following the lead taken by the UK, many national
quality system standards were introduced in various
parts of the world. Many of these Standards were copies
of the British Standards, with certain modifications or a
few additions. Increase in the global interest in Quality
Management Systems resulted in the International
Organization for Standardization (ISO) developing and
publishing the ISO 9000 - Series of International
Standards on Quality Management System in 1987.
ISO 9000 Series of Standards

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Crises of Credibility
The ISO 9000 series of quality standards work on the premises that Customers
require products with characteristics that satisfy their needs and expectations,
collectively referred to as customer requirements or product specifications. The quality
management system (QMS) approach encourages organizations to analyze the
customer requirements, define a process that contributes to the achievement of a
product, which is acceptable to the customer, and keep these processes under control.
Some organizations have used the ISO 9000 series of standards to develop
quality management systems that are integrated into the way they do business are
useful in helping them to achieve their strategic business objectives and add value for
the organization. On the other hand, many other organizations have simply created a
set of bureaucratic procedures and records that do not reflect the way the organization
actually works. Setting up such elaborate procedures simply adds costs, without
providing any value additions to the product or process.

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77
ISO 9001 (Clause 1.1)
• “Specifies quality management system
requirements for organization to:
– demonstrate its ability to consistently
provide product that meets customer and
applicable statutory & regulatory
requirements
– enhance customer satisfaction………”
NOTE: “Services” are a specific kind of
product, and are also covered by ISO 9001
Specifies quality management system

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What is the aim of certification?
• TO PROVIDE CONFIDENCE
– By demonstrating that the organization does
have a management system conforming to the
requirements of ISO 9001
– By showing that the system is effective in
achieving the desired outputs
• “Consistent conforming products”
• “Enhanced customer satisfaction”

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Quality System Standards
Accreditation
Accreditation body
Accreditation standard
Certificate of accreditation
Certification
Certification body
Compliance
CPA (Clinical Pathology
Accreditation)
GLP (Good Laboratory Practice)
GMP (Good Manufacturing Practice)
IS0 17025 standard
IS0 9000 series
NAMAS MlO/Mll
Surveillance
UKAS (United Kingdom Accreditation Service)
Terminology to indicate that the laboratory meets the requirements of a
standard is used rather loosely. The preferred usage is:

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meeting the requirements of IS09000 series is Certification;
satisfying IS0 17025 (a standard that specifically addresses technical
competence) is Accreditation; strictly, compliance is only applied to
GLP but tends to be used as a generic term.
An organisation may work to a number of different quality system
standards. These standards are described in documents, which define
the requirements that must be met.

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The IS0 9000 series (International Organization for Standardization) are
the quality management standards most commonly used by organisations
manufacturing or supplying products or services in the UK and across the
world. Laboratories may be certified against these standards but it is
more usual, because of the additional scrutiny and hence additional
credibility arising, for laboratories to seek accreditation against one of the
standards specifically designed for laboratories. Laboratory accreditation
is the “formal recognition” that a testing laboratory is competent to carry
out specific tests or specific types Of tests.

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Documentation
There are several reasons why a quality system must be fully documented.
Firstly it is a pre-requisite of most quality standards. Secondly, in most
laboratories it would be impossible to accurately remember and hence communicate
all of the analytical methodology and quality management procedure to
staff. This would lead to the quality system becoming compromised due to staff
turnover. Thirdly the process of audit (see Section 5.1) requires a precise
definition of the planned quality system. This is provided by the documentation.
There are several terms used to describe the types of documentation used in a
quality system in addition to the quality manual itself (see Section 5.1).
Archives Records
Calibration schedule Sample register
Chain of custody Standard operating procedure
Controlled documents Study plan
Methods documentation Test sheet
Procedure Training record
Protocol Unique sample identifier
Terms for the different types and levels of documentation below the quality
manual may vary. The terms in common use are described.

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A GUIDE TO WRITING AS AN ENGINEER by David Beer, David
McMurrey
83

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The term procedure is generally applied to the documentation describing
activities to be carried out in the laboratory. Some laboratories inay make a
distinction between procedures, which describe activities other than the test
methods themselves, and methods documentation; others will regard everything
below the quality manual as a procedure.
Example: 5.3
Procedures
•how to record all samples coming into the laboratory;
•how test reports and certificates are to be issued;
•how to conduct internal audits and reviews;
•how to deal with complaints from customers;
•methods for calibration and performance checks on equipment;
•instructions for preparing, labeling and storing reagents;
•standardisation of titrimetric solutions;
•safe disposal of unwanted chemicals and samples;
• analytical methods.
Procedures

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For all quality standards, staff working in a laboratory must be suitably
trained. For laboratory workers a training record is a document used to record
each analyst’s training and the date when the analyst is deemed competent to
carry out a particular task. It should be reviewed on a regular basis to identify
training needs and skills that the analyst will require in the future.
In addition to descriptions of procedures to be followed, the quality system
must provide for the creation and maintenance of records which show what has
been done. This is necessary to enable the laboratory to replicate, if required, the
analytical process that was performed for a particular sample. The process of
audit is only possible if adequate records are maintained and the absence of
adequate records will constitute a non-compliance with most quality management
standards

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Example: 5.4
Records
The types of records relating to the analysis include:
the client’s requirements;
the methods used;
analytical raw data, including all charts, spectra, print-outs,
work sheets and note books;
calibration and audit records;
quality control checks including any proficiency testing;
reference items employed;
the identities of the equipment used and analysts;
analytical reported results;
interpretation and conclusions;
correspondence;
client report.
Records

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What is ISO?
ISO (International Organization for Standardization) is the world's largest developer
and publisher of International Standards.
ISO is a network of the national standards institutes of 161 countries, one member per
country, with a Central Secretariat in Geneva, Switzerland, that coordinates the
system.
ISO is a non-governmental organization that forms a bridge between the public and
private sectors. On the one hand, many of its member institutes are part of the
governmental structure of their countries, or are mandated by their government. On
the other hand, other members have their roots uniquely in the private sector, having
been set up by national partnerships of industry associations.
Therefore, ISO enables a consensus to be reached on solutions that meet both the
requirements of business and the broader needs of society.
Because "International Organization for Standardization" would have different
acronyms in different languages ("IOS" in English, "OIN" in French for Organisation
internationale de normalisation), its founders decided to give it also a short, all-
purpose name. They chose "ISO", derived from the Greek isos, meaning "equal".
Whatever the country, whatever the language, the short form of the organization's
name is always ISO.

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What is ISO 9000?
The International Organization for Standardization
(ISO) currently has a portfolio of over 18,500
standards, of which the ISO 9000 series relating to
quality management is undoubtedly the best known.
Within this series, ISO 9001:2008 [1] (“Quality
management systems — Requirements”), is Widely
used by organization around the world demonstrate
That they have a clearly defined and well managed
set of processes that enable them to consistently
provide products (including services) that meet
customer and applicable statutory and regulatory
requirements.

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The ISO 9000 standard provides the
fundamentals and vocabulary used in
the entire ISO 9000 family of standards.
It sets the stage for understanding the
basic elements of quality management
as described in the ISO standards. ISO
9000 introduces users to the eight Quality
Management Principles as well as the
use of the process approach to achieve
continual improvement. (See Figure 1).
ISO 9000

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ISO 9004 is[1] used to extend the benefits
obtained from ISO 9001 to all parties
that are interested in or affected by your
operations. Interested parties include your
employees, owners, suppliers, partners
and society in general.
ISO 9004 gives guidance on a
wider range of objectives of a quality
management system than does ISO 9001,
particularly in managing for the long-term
success of an organization. ISO 9004 is
recommended as a guide for organizations
whose top management wishes to extend
the benefits of ISO 9001 in pursuit of
systematic and continual improvement of
the organization’s overall performance.
However, it is not intended for certification
or contractual purposes.

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ISO 9001 and ISO 9004 [1]are compatible and can be used separately or in
combination to meet or exceed expectations of customers and interested
parties. Both standards apply a process approach. Processes are
recognized as consisting of one or more linked activities that require
resources and must be managed to achieve predetermined output. The
output of one process may directly form the input to the next process and
the final product is often the result of a network or system of processes.
The eight Quality Management Principles provide the basis for the
performance improvement.

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ISO 9001 specifies[1] the basic requirements for a quality management system
(QMS) that an organization must fulfil to demonstrate its ability to consistently
provide products (which include services) that enhance customer satisfaction
and meet applicable statutory and regulatory requirements.
The standard can be used for certification/registration and contractual
purposes by organizations seeking recognition of their quality management
system. ISO 9001 has been organized in a user-friendly format with terms that
are easily recognized by all business sectors.
You will obtain the greatest value by using the entire family of standards in an
integrated manner. It is highly recommended that you use ISO 9000 to become
familiar with the basic concepts and the language used before you adopt ISO
9001 to achieve a first level of performance. The practices described in ISO
9004 may then be implemented to make your quality management system
more effective and efficient in achieving your business goals and objectives.
The ISO 9001 and ISO 9004 standards have been written to enable you to relate
them to other management systems (e.g. environmental), or to sector specific
requirements (such as ISO/TS 16949 in the automotive industry) and to assist
you in gaining recognition through national or
regional award programmes.

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[1] ISBN 978-92-67-10494-2b
100
Example 1
A metal parts fabricating[1] company
recognized the need to demonstrate their
capability to produce consistent quality
product. They first used ISO 9000 to
develop a plan to create an acceptable
QMS. Next, they prepared the quality
manual and quality system procedures
as required by ISO 9001, excluding the
requirements covering product design
and development because their products
are made to designs prepared by their
customers. They implemented the QMS
described in their manual and procedures
and ensured the system functioned as
planned. Later, in order to bid on the supply
of parts to a major automotive company,
they upgraded their quality system to
meet the automotive sector specific
requirements of ISO/TS 16949.

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Example 2
A welfare agency decided to improve
the quality of the services it provided to
clients. It adopted ISO 9004 as the basis
for implementing its system and planning
for improvements. The agency recognized
that ISO 9000 provided very useful
additional guidance in terminology and
understanding and applying QMS concepts
to their system. They mapped the resulting
system processes to requirements
identified in ISO 9001. They planned to seek
certification to ISO 9001 to gain recognition
and credibility from clients and supporters.

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Example 3
An electrical appliance manufacturer
had a well-established company culture
of continual improvement and effective
production control. The management
decided to improve the company’s
development processes and to implement
ISO 9001 to obtain certification for
commercial purposes. The company
used ISO 9004 to guide its improvement
processes and ISO 10006 to develop a
project management plan. Regulatory
agencies demanded products be designed
and packaged recognizing the end of life
disposition of products and packaging.
The company was able to use the design
and document control requirements in
ISO 9001 to satisfy regulators of
compliance to new requirements

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Example 4
A large chemical processing company was required by its major customers
to gain certification to ISO 9001 and to be environmentally friendly. To
address these issues, the company leadership planned a comprehensive
management strategy linking their QMS and an environmental
management system (EMS). A thorough review of their business
processes indicated that all elements of ISO 9001 were applicable to their
quality management system and the Annex in ISO 9001 provided the
information needed to effectively link it to the ISO 14001 EMS
standard. The company used ISO/TR 10013 to guide the development of
the required documentation in its various production divisions, ISO 10015
for guidance in the preparation of training plans for their employees and
ISO 19011 for auditing both the QMS and EMS. Management achieved
additional benefits and continual improvements using ISO 9000 and
ISO 9004.

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Example 5
A firm of international lawyers wanted
to improve their client management
processes using the systematic approach
found in ISO 9001, but did not intend to
gain certification. Their QMS provides
for the design and development of
new services such as international
tax planning and modifying traditional
services to meet the requirements of new
or amended legislation. They included
purchasing control to cover the selection
of computer hardware and software, as
well as purchasing the services of specialist
lawyers as needed. After successfully
implementing ISO 9001, they used the
self-assessment guidelines of ISO 9004 to
monitor their progress as they improved
their QMS to achieve greater client
satisfaction.

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Example 6
A computer software developer serving a niche market recognized
that as their user base expanded they would be faced with issues
concerning product management including new product
development and configuration control. Changes to base
products, user hardware and regulatory requirements were
compounding customer service issues. The company used ISO/IEC
90003 (QMS for software) when developing new software and
incorporating new features in existing product lines. ISO 9004
provided the guidance they needed to establish documented
procedures to implement change control and software
improvement. ISO 10006 and ISO 10007 provided additional
assistance as they managed the project and prepared procedures
for configuration management. They later acquired another
software developer and were able to use their QMS to guide the
integration of the acquisition into their own structure very quickly
with a minimum of disruption to customers.

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Example 7
A bank decided to implement a quality management system for its on-line
Internet banking services. They used ISO 10019 in the selection of a consultant to
guide them in their QMS implementation. They ensured that their quality
manual made clear that their other conventional banking services were not
included in their quality management system. While adopting the requirements
of ISO 9001, the bank obtained guidance from ISO 9000 to interpret words and
phrases used in the standard for their application. They applied all the
requirements of the product realization section (Clause 7), recognizing
that design and development is an important part of creating new service
processes. The bank used ISO/TR 10013 to prepare their documentation, which
they posted on their internal computer network to ensure current procedures
are available to their staff.

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Example 8
A franchise organization had difficulty
maintaining consistent operation by
franchisees and determined that an
enhanced management system was
required. They learned that ISO 9001
included the tools they needed and with
the help of ISO/TR 10013 they developed
the quality manual and quality system
procedures to be used throughout the
franchise network. To ensure a consistent
approach in managing customer
satisfaction, they used guidance found in
ISO 10001, ISO 10002 and ISO 10003.
When the system was implemented, the
franchise organization used ISO 19011 to
establish an audit programme to confirm
that the ISO 9001-based QMS continued to
function as required and was improved on
a continual basis.

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Customer complaints is an essential part of a quality management system, in order to provide feedback
when the outputs of a QMS have not achieved the objective of providing ”consistently conforming
products".

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While there is no single clause in ISO 9001 that is dedicated to customer complaints
handling, it is important for auditors to be aware of the various clauses of the standard
which relate to this topic and which enable them to evaluate an organization’s
complaints handling process.
The ISO 9001 clauses which directly or indirectly require the effective management of
customer complaints (often as part of the requirements on “customer feedback”),
include:
• Clause 5.2 requires top management to ensure that “customer requirements are
determined and are met”
• Clause 5.6 requires management review inputs to include “customer
feedback” (which necessarily includes customer complaints)
• Clause 7.2.3 requires the organization to “determine and implement effective
arrangements for communicating with customers in relation to…………customer
feedback, including customer complaints”
customer complaints

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• Clause 8.2.1 requires the organization to “monitor information relating
to customer perception as to whether the organization has met customer
requirements” - actually more demanding than just responding to customer
complaints, if properly implemented – it requires the organization to
proactively seek customer feedback rather than just sitting back and
reacting to “formal complaints” which are often few and far between
because the “customer” can’t be bothered or feels they are wasting their
time.
• Clause 8.4 requires the organization to analyse data relating to customer
satisfaction - again, this should actually be more demanding than just
responding to complaints.
• Clause 8.5.2 requires a documented procedure that defines
requirements for reviewing nonconformities (including customer
complaints) and subsequently acting on those NC’s to determine cause,
implement corrections and corrective actions, and verify effectiveness etc.

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ISO 10002:2004 Quality management - Customer satisfaction - Guidelines for
complaints handling in organizations and to encourage their clients to make use of
this guidance in developing their complaints handling process.
The Introduction to ISO 10002 states:
“This International Standard provides guidance for the design and
implementation of an effective and efficient complaints-handling process for all
types of commercial or non-commercial activities, including those related to
electronic commerce.”
The process for complaints handling described in ISO10002 can be used as an
element of a quality management system.
Customer satisfaction

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The Introduction to ISO 10002 further states:
“Implementation of the process described in this International Standard can
• provide a complainant with access to an open and responsive complaints
handling process,
• enhance the ability of the organization to resolve complaints in a
consistent, systematic and responsive manner, to the satisfaction of the
complainant and the organization,
• enhance the ability of an organization to identify trends and eliminate
causes of complaints, and improve the organization's operations,
• help an organization create a customer-focused approach to resolving
complaints, and encourage personnel to improve their skills in working with
customers, and
• provide a basis for continual review and analysis of the complaints handling
process, the resolution of complaints, and process improvements
made”

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It is very important that auditors have
knowledge of ISO 10002 and its guidelines,
and that they use that knowledge during audits.
However, ISO 10002 does not
specify any requirements, but just gives
guidelines; consequently it is not possible for
an auditor to raise any nonconformities against
its recommendations.

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ISO 9001 "4.2.1 General
The quality management system documentation shall include:
….
d) documents, including records, determined by the organization to be necessary to
ensure the
effective planning, operation and control of its processes.
NOTE 2 The extent of the quality management system documentation can differ from
one organization to another due to
a) the size of organization and type of activities,
b) the complexity of processes and their interactions, and
c) the competence of personnel."
The auditor should requests information on the auditee's operating processes and
subsequently ask questions, record answers and observe staff at all levels (including
administrative personnel, process owners and operators), to confirm that the actual
working status conforms to the descriptions given.
Thereafter, the necessity for any documentation should be evaluated in the light of the
observed need for consistency, and the role that any documentation could play in
avoiding any significant, identified risks.

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Introduction
Source : HANDBOOK OF INDUSTRIAL ENGINEERING, Technology and Operations Management
Third Edition, Edited by GAVRIEL SALVENDY, Purdue University

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Maintaining Standards (Auditing)-page 1422
A standard can restrict productivity if it has not been updated because workers will
produce only to the obsolete standard and not to their capabilities.
What to audit? To keep the work-measurement system up to date, accurate, and useful,
MILSTD-1567A says the audit should determine (1) the validity of the prescribed
coverage, (2) the percentage of type I and II coverage, (3) use of labor standards, (4)
accuracy of reporting, (5) attainment of goals, and (6) results of corrective actions
regarding variance analysis. How often to audit? Auditing should be on a periodic
schedule. A good procedure is to set an expiration date on each standard at the time it is
set; MIL-STD-1567 says annually. A rule of thumb is to have it expire at 24 months if the
application is 50 hr / year, at 12 months if between 50 and 600 hr / year, and at 6 months
if over 600 hr / year. Then, when the standard expires, and if it is still an active job, an
audit is made. If it is not active, the standard will be converted from permanent to
temporary. Then, if the job is resumed, the temporary can be used for a short period
(e.g., 30 days) until a new permanent standard is set. An advantage of a known expiration
date is that if a standard is audited (and perhaps tightened), the operator will not feel
picked on. If the resources for auditing are not sufficient for doing all the audits required,
use the Pareto principle. Audit the ‘‘mighty few’’ and don’t audit the ‘‘insignificant
many.’’ However, when the standard on one of the insignificant many passes the
expiration date, convert the permanent standard to temporary.

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Differences between Training and Education
‘‘Training’’ (the systematic, structured development of specific skills required to perform
job tasks) differs from ‘‘education’’ (development of broad-based informational
background and general skills). Most people are more familiar with education than
training because (a) their experiences from elementary school through college usually fall
within an educational model, and (b) much of what is called training in business and
industry is actually more akin to education than training.
Education is important, even essential, for building broad skill areas, but training is the
approach of preference for preparing people to perform specific tasks or jobs. Table 1
shows differences between education and training and between educators and trainers.
Not all differences apply to any specific instance of training or education, but as a whole
they illustrate the distinction between the
two.
Differences between Training and Education

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Types of Sample
Aggregate sample
Batch
Bulk sample
Composite sample
Gross sample
Heterogeneous sample
Homogeneous sample
Judgmental sample
Lot
Random sample
Representative sample
Retained sample
Selective sample

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A homogeneous sample is one for which there is no evidence of variation
throughout its extent.
Example: 1.1
Homogeneous sample
A drinking water sample would be homogenous for sodium ions.
The Sample Conversely, a heterogeneous sample is one that varies throughout its
extent; any sub-samples taken from it may be expected to vary in composition.
Example: I .2
Heterogeneous sample
A soil sample made up of stones, clay, organic matter, etc. would be heterogeneous for
iron(II) ions.

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A composite sample, sometimes referred to as an aggregate sample, is one that
is made up of several individual samples. Thus, a heterogeneous material may be sampled
several times and these samples combined to produce a composite sample that is aimed
to have the overall properties of the material.
A representative sample is one that is regarded as having identical composition
to the larger bulk or batch from which it has been taken. Results obtained from a
representative sample can thus be regarded as also applying to the bulk of material from
which the representative sample was taken.
A selective sample is one which has been chosen to demonstrate a particular
aspect of the material from which it is taken, e.g. a sample of water taken from
immediately downstream of an industrial outfall to assess the worst possible
situation with regard to potential pollution. Some analysts refer to judgmental
samples as those chosen to illustrate a particular property of the material under
consideration.
A random sample is chosen from a bulk material at random, i.e. so that any
part of the bulk has an equal chance of selection, and without any particular
reference to the properties of the bulk.
A retained sample is a sample taken for future reference purposes, e.g. for use
in analysis where the result is the subject of a dispute.

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Sample Handling
Aliquot
Integrity
Laboratory sample
Primary sample
Sample accountability
Sub-sample
Test portion
Test sample
An aliquot in this context is a part of a
laboratory sample used in the
analytical determination: the term is used
commonly for the individual portions
taken to repeat a single analysis.

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A primary sample is the sample taken from the lot or batch; in most cases a
portion of this sample will be taken and known as a sub-sample. The sub-sample
or part of the sub-sample is used to provide the laboratory sample.
Sample Preparation
Clean-up
Digestion
Dissolution
Extraction
Pre-concentration
Pre-treatment

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Fitness for Purpose
An analyst needs to select a suitable method
for carrying out an analysis. The
method needs to be validated and its
measurement uncertainty determined.

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Principle Characteristics Key Tasks
Process definition ISO 9000 type of quality
management.
Ensuring effectiveness and
efficiency of processes by
use of performance
measures

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Principle Characteristics Characteristics
Quantitative
management
Feedback loops
and performance
measures are
established.
Refining of
feedback loops,
ensuring the
participation
of each employee
Continuous
improvement
All members of
the company are
involved in
improvement
actions.
Continuous review
of measures and
feedback loops

• A report issued when a product, process or procedure does not comply with the set
standards for a product, process or procedure under inspection
• An NCR is any significant deficiency
• A means of tracking actions
• A tool to put right things that are going wrong
• A means of stopping repeated errors
• NCR’s are used to record findings from internal and external audits that require
addressing
• NCR’s are usually raised from within a process team relating to their inputs received
as outputs
• Accumulating data from across the organisation and reporting in a consistent way
will enable you to identify non-conformance trends before they seriously affect the
business.
(NCR's usually related to their inputs, outputs, and was raised from a process team
Before they seriously affect the business of the organization in a balanced way, and
reporting of non-compliance with the collection of data to identify trends from all
over to help you.)
11-03-2015 129

(IS ;15700)
For the purpose of this standard, the following terms and definitions, in addition to
that given in IS/ISO 9000 shall apply.
3.1 Citizens’ Charter - Citizens’ charter is a document declaring the intentions and the
commitment of an organization for providing effective and efficient service, taking into
account customer’s expectations and minimum acceptable levels of service, thereby
providing assurance that the organization complies with the service quality standards.
3.2 Complaint (Grievance) - Expression of dissatisfaction made to an organization
related to its products, services and/or process(es), where a response or resolution is
explicitly or implicitly expected.
3.3 Complainant - Person, organization, or its representative, making a complaint.
3.4 Complaints Handling Objective - Something sought, or aimed for, related to
complaints.
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3.5 Customer - Organization or person that receives a product and/or service.
Example : Consumer, client, citizen, end-user, beneficiary and purchaser.
3.6 Customer Satisfaction - Customer’s perception of the degree to which the customer’s
requirements have been fulfilled.
NOTES
1. Customer complaints are a common indicator of low customer satisfaction but their
absence does not necessarily imply high customer
satisfaction.
2. Even when customer requirements have been agreed with the customer and fulfilled,
this does not necessarily ensure high customer
satisfaction.
3.7 Feedback - Opinions, comments, suggestions and expressions of satisfaction/
dissatisfaction.
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3.8 Non-conformity - Non fulfilment of a requirement.
3.9 Public Service Organization - An organization which provides service(s) to public at large
and/or whose activities influence public interest.
Example : Government ministries and departments, Regulatory bodies, Public utility service
providers, etc.
NOTE - Wherever the term `organization’ has been used in this standard, it means ‘public
service organization’.
3.10 Quality - Degree to which a set of inherent characteristics fulfils requirements.
NOTES
1. The `requirements’ include product and/or service requirements.
2. “Inherent”, as opposed to “assigned”, means existing in something, especially as a
permanent characteristic.
3.11 Service - The results generated, by activities at the interface between the organization
and
the customer and by organization’s internal activities, to meet customer requirements.
3.12 Service Delivery - The organization’s activities, including those at the customer
interface,
necessary to provide the service.
3.13 Service Quality Objectives - Something sought, or aimed for, related to service quality.
3.14 Service Quality Policy - The overall intentions and direction of an organization as
regards
service quality, as formally expressed by top management.
11-03-2015 132

3.15 Stakeholder (Interested Party) - Person or group having an interest in
the performance or success of an organization.
Example: Customers, owners, people in an organization, suppliers, bankers,
unions, partners or society.
NOTE - A group can comprise an organization, a part thereof, or more than
one organization.
3.16 Top Management - Person or group of people, who directs and
controls an organization at the highest level.
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Complaints Handling
The organization shall establish a documented procedure for complaint
handling process. Various steps in the complaints handling process shall
include the following:
a) Identification of complaint prone areas in a systematic manner and
determine the time
norms for their redress;
b) Providing information concerning complaints handling process in clear
language and formats accessible to all. Such information shall include:
i) where and how the complaints can be made,
ii) minimum information to be provided by complainant, and
iii) time limits within which the complaint will be closed.
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g) Investigation of relevant circumstances and information relating to the
complaint. The level of investigation shall be commensurate with the
seriousness and severity of the complaint. If the complaint cannot be
immediately resolved, it shall be dealt in a manner which would lead to its
effective redress as soon as possible and the complainant shall be intimated;
h) Communication of the decision to the complainant regarding his complaint
immediately after the decision is taken and getting his feedback. In case the
decision is not in line with the remedy requested by the complainant, the
justification for the decision taken along with alternative internal and external
recourse available for appeal shall also be intimated, after which the
complaint shall be closed; and
j) Nominating `Ombudsman’ who could be approached if normal service
delivery mechanism does not respond.
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c) Widely publicizing the information about complaints handling process through
print, web and other media. The name, address, telephone number and other
contact details of the public grievance officer of the organization shall also be
displayed prominently at the reception and other convenient places in the
organization;
d) Unique identification of the complaint and recording necessary information
including relevant details of complaint, remedy requested, due date of redress,
relevant data related to the complaint and immediate action to be taken (if any);
e) Scrutiny of the complaint and its categorization as critical, major or minor
depending upon its seriousness and severity;
f) Acknowledgement of each complaint promptly giving the complaint number along
with an indication of the redress time and the name, designation and telephone
number of the employee to be contacted for all future correspondence;
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Findings include –
1. Major Nonconformity
2. Minor Nonconformity
3. Opportunities for Improvement
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Nonconformance
=
An observation that indicates policy or practice contrary to
the requirements of applicable standard or documented
procedures.
http://elsmar.com/level2/m-vs-m.html
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The absence or total breakdown of a system to meet the ISO 9000
requirement.
A number of minor nonconformities against one requirement can represent
a total breakdown of the system and thus be considered a major
nonconformity.
Any noncompliance that would result in the probable shipment of
nonconforming product.
A condition that may result in the failure or materially reduce the
usability of the products or services for their intended purpose.
MAJOR NONCONFORMITY
A Major Nonconformity is either:
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May be a long-standing minor nonconformance from
previous assessments, or a collection of similar minor non-
conformances indicating a widespread problem;
Established as detrimental to quality delivered to customers;
or
A failure or significant deficiency in a significant part of the
quality system governed by applicable standards.
A nonconformance which is of a serious nature.:
11-03-2015 141

An ISO 9000 nonconformance to that judgment and
experience indicate is not likely to result in the failure of the
quality system or reduce its ability to assure controlled
processes or products.
A failure in some part of the supplier's documented quality
system relative to ISO 9000, or
A single observed lapse in following one item of the
company's quality system.
MINOR NONCONFORMITY
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Dispositions
Rework
An action of correction that renders the nonconforming or suspect material to a status that said material will meet
all specified requirements.
Repair
An action of correction that renders the nonconforming or suspect material to a status that the material fulfills the
intend use or purpose but may not meet the specified requirements. The repair action may require additional input
from the intended customer regarding the permissibility of this action.
Scrap
An action that renders the nonconforming or suspect material to a condition which prevents usability of the product
in any manner. (Does not meet form-fit-function).
Salvage
An action that regrades the product for alternative applications or an action that removes usable components,
individual parts or subassemblies, from a completed product or larger subassembly for use in product.
Return to Vendor (RTV) or Return to Supplier (RTS)
An action that returns the nonconforming or suspect material to a sub-tier supplier for further disposition and/or
correction.
Note: Supplier is commonly used instead of Vendor, however they are synonymous.
Use As Is (UAI)
Acceptance of nonconforming or suspect material for use with or without repair or rework. A UAI action normally
requires additional input from the intended customer regarding the permissibility of this action.
11-03-2015 143

11-03-2015 145
Customer satisfaction, as measured by product delivery due date
performance, accurate order fill rate, response to quotes, and response to
changes in orders, can be significantly enhanced by creating an empowered
customer facing organization that is enabled and
empowered. It should be noted that this issue is one of the most critical
determinants of success for today’s e-commerce businesses. With the
iCollaboration tools, an organization can create customer facing
organizations that may be aligned with full customer responsibility, product
responsibility, order responsibility, or any combination of those. These
organizations or individuals are independent, do not have to call someone,
and yet are in synch with all other supporting organizations.
Customer Satisfaction

Not all non-conformities require CAPA
- high risk or out of control
11-03-2015 147

Correction
or
Analysis of cause
Analysis of cause Correction
Corrective action Corrective action
Review of actions in response to a nonconformity
Management system auditors are responsible for reviewing an
organization's response to a nonconformity and verifying the
effectiveness of actions taken. There should be three parts to the
response, depending on the product type or the situation of the
nonconformity (see table 1):
Table 1. Response to nonconformity
http://irca.org/en-gb/resources/Auditing-papers/Management-systems-the-missing-competence2/
11-03-2015 148

For example, for software it is inadvisable to implement a correction
until the cause is known. Alternatively, if a ‘low brake-pad’ warning light
goes on in a vehicle and you correct it by replacing the brake pads
before examining if the sensor was faulty, you might fail to resolve the
problem.
“Why analysis” very often works well in
Corrective Actions. Fishbone analysis is also a
good tool.
11-03-2015 149

EXAMPLE 1
• CAPA # :Example 1
• Problem: “Loose bolts found 3 different times on line 1.”
• Cause: “ Human error- Maintenance personnel are not
tightening bolts correctly.”
• Corrective Action: “Train personnel”
• Preventive Action: “Use Lock tight on bolts.”
11-03-2015 150

There are many methods and tools available to an organization for
determining the cause of nonconformity, from simple brainstorming to
more complex problem-solving techniques. The extent and
effectiveness of the corrective actions depends on identifying the true
cause. In some cases this will assist an organization to identify and
minimize similar nonconformities in other areas.
11-03-2015 151

In reviewing the response of an organization to a nonconformity, the auditor should
confirm that documentation and evidence for all three parts are provided by the
organization, and are appropriate, before accepting the response. Important
elements to verify in the review process include:
•Statements of actions – are they clear and concise?
•Descriptions of actions – are they thorough and accurate?
•The use of the past tense, as an indicator that the actions taken have been
completed.
•The dates of completion of corrective actions (dates indicating future action are
not good practice)
•Evidence supporting the claim that a corrective action has been fully and
effectively implemented in the way that it was described.
11-03-2015 152

In addition, the auditor should verify that the organization has ensured that the
corrective action taken does not create further problems. It should also be noted
that completing both correction and corrective action is not always appropriate
and that either correction or corrective action may be sufficient. This may happen,
for example, in cases where the nonconformity was absolutely accidental and the
probability of reoccurrence is very low.
11-03-2015 153

Effective corrective action should prevent the recurrence of the nonconformity,
by eliminating the cause. However, corrective action should not be confused
with preventive action. It should be noted that preventive action is not
applicable to already detected nonconformities. However, an analysis of the
causes of nonconformities may identify potential nonconformities on a wider
scale in other areas of the organization and provide input for preventive action.
•Require each non-compliance with a Corrective action?
• Require each non-compliance with a Correction?
* Note - Complaints always get a CA
11-03-2015 154

As nonconformities tend to be individual in their nature, a variety of methods or
activities may be used to close them off. For example, some will require direct
examination on site, while others may be closed-off remotely.
Before deciding to close-off a nonconformity, an auditor should review what the
organization did in respect of analysing the cause and the results it achieved
through corrective action. The auditor needs to ensure there is evidence
(including supporting documentation) to demonstrate that the described
corrective action has been fully implemented and is effective in preventing the
nonconformity from re-occurring. Only once the situation is satisfactory, should
the nonconformity be closed-off.
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11-03-2015 157
NON-CONFORMING MATERIAL CONTROL
Materials, details, sub-assemblies or assemblies that do not comply with customer
contracted requirements will be identified as "discrepant" by notation on the part,
and when physical size allows, segregated from the production list.
Specified instructions for the documentation and control of nonconforming
material control are in accordance with contract requirements and/or as specified
in the following:
A. When obvious rework (i.e., undersize or missing holes) Disposition:
"Drill per print", or oversize condition: plate is 2x2x1-1/2, SB 1x2x1-1/2 Disposition: "cut to 1"
length". Inspector will disposition as required.
B. When rework can be accomplished per a customer approved rework procedure, rework in
accordance with the applicable approved procedure.
C. When rework is required, and no customer approved standard rework procedure exists, and
controlled and inspected operations are required,
submit for Project Manager rework disposition, using Al's Welding Fax
Memo form, and label: "Non-Conformance Report".
Rework shall be controlled per contract requirements as flowed down by the
Project Manager.
When the determination has been made that rework is not possible. Al's Welding
nonconformance report may be sent to the customer for disposition, or if it is felt
by Project Management that a deviation from the contract could suffice, submit
the Memo form labeled: "Request for Assistance". In either case, customer
disposition is required.

11-03-2015 158
NON-CONFORMANCE DEFINITIONS
Repair: Customer authorized documented deviation from design, shop drawing and/or procedure
or specification.
Rework: Documented, unplanned activity to bring an item into compliance without deviation
from design, shop drawing and/or specification or procedure.
AL'S WELDING & STEEL FABRICATION, INC.
Scrap: The physical removal or alteration and special identification of non-conforming items from
production, to discard or prevent use in production lots.
WELDING CONSUMABLES CONTROL
SHIELDED METAL ARC WELDING (SMAW)
SMAW COATED ELECTRODES
Electrodes for SMAW processes will conform to:
a) ANSI/AWS A5.1, Specification for Mild Steel Covered Arc Welding Electrodes, or
b) ANSI/AWS A5.5, Specification for Low Alloy Steel Covered Arc Welding Electrodes
ANSI/AWS A5.1 Electrodes - Must be purchased in hermetically sealed containers. If or when the
seal is broken, the rods must be oven dried for a minimum of two (2) hours at 475 degrees F. +/-
25 degrees F. prior to use.
ANSI/AWS A5.5 Electrodes - Must be purchased in hermetically sealed containers. If or when the
seal is broken, the rods must be oven dried at 750 degrees F. +/- 50 degrees F. for a minimum of
one (1) hour.

11-03-2015 159
COATED ELECTRODES ATMOSPHERIC EXPOSURE REQUIREMENTS
After the container seal is broken, or after electrodes have been removed from the drying oven in
accordance with the above paragraphs, the electrode exposure to atmosphere shall not exceed the values
shown in AWS D1.1 for the specific electrode classification listed.
GAS METALARC/FLUX CORED ARC WELDING (GMAW & FCAW)
GMAW/FCAW ELECTRODES AND SHIELDING
Electrodes and shielding for GMAW and FCAW for producing welds with minimum specified yield of
60,000 PSI or less shall conform to the following:
ANSI/AWS A5.18, Specification for Carbon Steel Filler Metals for Gas Shielded Arc Welding, or
ANSI/AWS A5.20, Specification for Carbon Steel Electrodes for Flux Cored Arc Welding
MINIMUM YIELD STRENGTH REQUIREMENT
Weld metal having a minimum specified yield strength greater than 60,000 PSI
shall conform to the following:
Electrodes and shielding for GMAW shall meet ANSI/AWS A5.28, Specification for Low Alloy Steel
Filler Metals for Gas Shielded Arc Welding.
Electrodes and shielding gas for FCAW shall meet ANSI/AWS A5.29, Specification for Low Alloy Steel
Electrodes for Flux Cored Arc Welding.
GMAW/FCAW ELECTRODE/SHIELDING MINIMUM CERTIFICATIONS
Al's Welding will purchase GMAW/FCAW electrodes and shielding material with Certifications of
Conformance certifying that the electrodes will meet the requirements of classification or grade per the
requirements above of this procedure and include typical chemical and physical test
results.

11-03-2015 160
SHIELDING GAS
Gasses or gas mixture(s) for shielding in GMAW or FCAW shall be of a
welding grade having a dew point of minus forty degrees (-40 degrees F.)
or lower.
When requested by customer contract, engineering or
specification, Al's Welding will furnish proof of compliance by:
a) Gas manufacturer's Dew Point Certification
b) Independent laboratory test results traceable to the gas intended for use
in contract deliverable items.
SHOP CONTROLS
- Welders shall use only those consumables which they have personally
obtained
- All stubs or remnants of electrodes will be discarded
- Electrodes found to be uncontrolled will be discarded

11-03-2015 162
COATING INSPECTION
PURPOSE: To ensure that the required coating specifications are met.
TOOLS: Calibrated dry film thickness meter.
Calibrated dry film thickness shims
INSPECTION SEQUENCE:
Inspection often begins with a pre-job conference at which the ground rules are set. The inspector is
responsible for witnessing, verifying, inspecting and documenting the work at various points. The
following points will be reviewed along with the appropriate instruments used for each.
1. Pre-Surface Preparation Inspection
2. Measurement of Ambient Conditions
3. Evaluation of Compressor (Air Cleanliness) and Surface Preparation Equipment
4. Determination of Surface Preparation Cleanliness and Profile
5. Inspection of Application Equipment
6. Witnessing Coating Mixing
7. Inspecting Coating Application
8. Determination of Wet Film Thickness
9. Determination of Dry Film Thickness
10. Evaluating Cleanliness Between Coats
11. Pinhole and Holiday Testing
12. Adhesion Testing
13. Evaluating Cure
NOTE: Each of the above steps are explained in detail and are contained in the Steel
Structures Painting Councils, Volumes 1 & 2: "Good Painting Practices" and "Systems
and Specifications".

11-03-2015 163
RESPONSIBILITIES: A pre-coating review of the contract specifications using
the above sequence shall be conducted.
All results of any inspection shall be thoroughly documented in writing to verify
that the specified requirements have been met. Future maintenance or the
removal of a failed coating system may be dependent on the factual reporting of
every phase of the work.

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