effective and efficient quality managements-1

175
11-03-2015 Compiled by M.Karikalan, [email protected] 1 ISO 9000 ISO 9001 Management

Upload: karikalan-murugasen

Post on 17-Jul-2015

293 views

Category:

Leadership & Management


0 download

TRANSCRIPT

Page 1: Effective And Efficient Quality Managements-1

11-03-2015

Compiled by

M.Karikalan, [email protected] 1

ISO 9000

ISO 9001

Management

Page 2: Effective And Efficient Quality Managements-1

11-03-2015 2

TIME IS MONEY

Page 3: Effective And Efficient Quality Managements-1

11-03-2015 3

OUR TIMEs are ?

Page 4: Effective And Efficient Quality Managements-1

11-03-2015 4

Contents:

1.WHAT IS A PROJECT?2.Coordinated Undertaking of Interrelated Activities3.PROJECT MANAGEMENT4.Managing Quality and Safety 5.Attitude Is Everything 6.Developing the Quality Management Plan7.INTERNAL COMMUNICATION8.Cultural best practices9.Factors affecting project success10.A model of how the learning organisation can be encouraged11.Workforce behaviours12.Communication challenges for the construction project manager13.The characteristics of construction projects, people and processes14.Contract Organization15.SPECIFICATION

16.STANDARD17.CODE

Page 5: Effective And Efficient Quality Managements-1

11-03-2015 5

Contents:18.IntroductionEmergence of Quality Management ConceptIn-Process-Inspection19.The Need for Quality Management System20.ISO 9000 Series of Standards21.Crises of Credibility 22.Specifies quality management system 23.The aim of certification 24.Quality System Standards25.Documentation26.Procedures27.Records28.What is ISO? 29.What is ISO 9000?30.Examples 31.customer complaints32.Customer satisfaction33.Cognitive probe

Page 6: Effective And Efficient Quality Managements-1

11-03-2015 6

34.Maintaining Standards (Auditing)35.What to audit? 36.Differences between Training and Education37.Types of Sample38.Sample Handling39.Sample Preparation40.Fitness for Purpose41.What is an NCR?42.Stakeholder (Interested Party) 43.IS ;1570044.Complaints Handling 45.Findings include46.Nonconformance

47.MAJOR NONCONFORMITY48MINOR NONCONFORMITY49.Dispositions50.Customer Satisfaction 51.Reviewing and closing nonconformities

Page 7: Effective And Efficient Quality Managements-1

11-03-2015 7

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 OrientationProjects are directed at achieving specific results—that is, they are goaloriented. These goals drive the project, and all planning and implementationefforts are undertaken so as to achieve them.

Coordinated Undertaking of Interrelated ActivitiesProjects 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.

Page 8: Effective And Efficient Quality Managements-1

11-03-2015

Source: Managing Projects in Organizations J. Davidson Frame

How to Make the Best Use of Time, Techniques, and PeopleThird Edition 8

“My most basic objective is to get the job done—on time, within budget, and accordingto specifications.”

PROJECT MANAGEMENT

Page 9: Effective And Efficient Quality Managements-1

11-03-2015 9

Beginning in the 1990s, project management became a hot managementapproach. As the U.S. economy entered a post-industrial phase,American managers discovered that many of the management guidelinesestablished for a manufacturing economy no longer served themwell in an information economy. In a manufacturing environment, emphasisis placed on predictability and repetitive activities, and to a largeextent, management is concerned with standardization and rationalizationof production processes. With an information economy, uniquenessof events has replaced repetition. Information itself is dynamic andever changing. Flexibility is the watchword of the new order, and projectmanagement is a key to this flexibility.

Continue……

Page 10: Effective And Efficient Quality Managements-1

11-03-2015 10

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.

Page 11: Effective And Efficient Quality Managements-1

11-03-2015 11

Attitude Is EverythingGood 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 isthe goal of the construction manager.

Page 12: Effective And Efficient Quality Managements-1

11-03-2015

Construction ManagementJumpStart

Second Edition12

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 finalproduct — 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.

Page 13: Effective And Efficient Quality Managements-1

11-03-2015 13

Page 14: Effective And Efficient Quality Managements-1

11-03-2015 14

Quality Those attributes of a product or service that meet the needs andexpectations 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.

Page 15: Effective And Efficient Quality Managements-1

11-03-2015What does “Product Quality” Really mean?-David A. Garvin, Harvard University,1984

15

Page 16: Effective And Efficient Quality Managements-1

11-03-2015 16

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

Page 17: Effective And Efficient Quality Managements-1

11-03-2015designed by the Budapest Univerity of Economic Sciences and MUCIA business schools, supported by the

United States Agency for International Development. 17

Page 18: Effective And Efficient Quality Managements-1

11-03-2015 18

Page 19: Effective And Efficient Quality Managements-1

11-03-2015 19

Page 20: Effective And Efficient Quality Managements-1

11-03-2015 20

Page 21: Effective And Efficient Quality Managements-1

11-03-2015 21

Page 22: Effective And Efficient Quality Managements-1

11-03-2015 22

Project Participant Relationships

Page 23: Effective And Efficient Quality Managements-1

11-03-2015 23

Traditional Construction Project Organization

Page 24: Effective And Efficient Quality Managements-1

11-03-2015 [1A] 24

Construction is a people-intensive, highly social industry where peopleinteract regularly in support of the production effort. The face-to-face channelsused 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.

Page 25: Effective And Efficient Quality Managements-1

11-03-2015[1A] Communication in Construction, Theory and practice

Andrew Dainty, David Moore and Michael Murray25

Professional and process discontinuitiesConstruction projects comprise a rich network of different types of people(from unskilled labourers to highly skilled professionals) who are situatedwithin different parts of the supply chain (from client advisors to facilitiesmanagers). Between them lie many interfaces defined by project position,contractual roles and obligations, societal expectations and stereotypes andindividual nuances and traits. In many respects it is the multitude of peopleinvolved and the richness of communication that stems from this mix, asthey interact within the project delivery process, that make it such an interestingindustry to study from a communication perspective. However, suchinterfaces and differences in perspective can also lead to misunderstandingsand/or barriers to communication which have to be overcome if projects areto be successful.

Page 26: Effective And Efficient Quality Managements-1

11-03-2015Quality Management Systems for Assisted Reproductive Technology—ISO 9001: 2000

Bryce E Carson Sr Michael M Alper, MD Christoph Keck, MD26

INTERNAL COMMUNICATIONAs 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.

Page 27: Effective And Efficient Quality Managements-1

11-03-2015 27

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. 1998American Society of Civil Engineers

Page 28: Effective And Efficient Quality Managements-1

11-03-2015 28

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 ofchange(s);

Page 29: Effective And Efficient Quality Managements-1

11-03-2015 29

● pragmatic:● normative;● concerns how to relate to the environment, notably customer’s pragmatismencourages 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, thedevelopment of theory Z (Ouchi 1981) provides a further perspective on the relationshipof managerial style, organisational culture and performance (together withconsequences). Such compatibility is reflected in Wallach’s (1983) typologies oforganisational culture—bureaucratic, innovative and supportive—complimenting theorganisational 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 ofthe overarching top management (analogous to a Greek temple);● task, in which jobs or projects are a primary focus yielding an organisational net (as ina matrix organisation);

Page 30: Effective And Efficient Quality Managements-1

11-03-2015 Procurement SystemsA 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.

Page 31: Effective And Efficient Quality Managements-1

11-03-2015Procurement 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

Page 32: Effective And Efficient Quality Managements-1

11-03-2015Source: Morris 1989

International Journal of Project Management, an imprint of Elsevier Science Ltd32

Factors affecting project success

Page 33: Effective And Efficient Quality Managements-1

11-03-2015 33

Figure 5.3 illustrates one model for encouraging the learning organisation. Thecompany’s external environment has its part to play in encouraging the learningorganisation. The procurement system could provide a useful driver for change towardsthe learning organisation becoming the norm. Stakeholders and clients are presentlyloosely integrated in terms of reflective learning.

Interorganisational relationships vary from co-producing subcontractors or consultantson a project through to more formal partnering or strategic alliance arrangements. Thelink between successful strategic direction, communication and monitoring for controlhas been well established for a long time; however, more recent questioning of how thisis effectively achieved brings in interesting issues of stability and turbulence. Part of theperceived failure of strategic management has been attributed to an overreliance uponstability 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 withcommunication technologies that support rapid information and data exchange. This hascaused turbulence which planners could neither anticipate nor perceive. The effectiveresponse is to maintain a clear vision of the strategic goals and use organisationallearning to experiment and fine-tune plans or substantially to replan, depending uponwhat has been learned from experience (Mintzberg 1994:209). Thus organisationallearning is extremely important to the strategic planning process for all projectparticipants.

Page 34: Effective And Efficient Quality Managements-1

11-03-2015Procurement Systems

A guide to best practice in construction Edited by Steve Rowlinson and Peter McDermott34

figure 5.3 A model of how the learning organisation can be encouraged

Page 35: Effective And Efficient Quality Managements-1

11-03-2015 [1A] 35

Workforce behavioursOrganisational 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 andsupporting people in improving their communication skills is central to the improved performance of the sector in the future.

Page 36: Effective And Efficient Quality Managements-1

11-03-2015 [1A] 36

Communication challenges for theconstruction 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.

Page 37: Effective And Efficient Quality Managements-1

11-03-2015 37

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.

Page 38: Effective And Efficient Quality Managements-1

11-03-2015 [1A] 38

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 communicationproblems (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 constructionthis 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.

Page 39: Effective And Efficient Quality Managements-1

11-03-2015Contracting for Engineering and Construction Projects-Fifth Edition-PETER MARSH Gower

39

Duties of Architect /Engineer under Client‘s instruction1 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 orprices 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

Page 40: Effective And Efficient Quality Managements-1

11-03-2015 40

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.

[Ref. : Code Clinic For Study of API Standard II04, Eighteenth Edition, Welding of Pipelines

and Related Facilities]

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.

[Ref. : Code Clinic For Study of API Standard II04, Eighteenth Edition, Welding of Pipelines

and Related Facilities]

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 ]

Page 41: Effective And Efficient Quality Managements-1

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

Page 42: Effective And Efficient Quality Managements-1

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

42

Page 43: Effective And Efficient Quality Managements-1

11-03-2015 43

Page 44: Effective And Efficient Quality Managements-1

11-03-2015 44

Page 45: Effective And Efficient Quality Managements-1

11-03-2015

Contracting for Engineering and Construction Projects-Fifth Edition-PETER MARSH Gower

45

PROJECT MANAGERSUnder some forms of contract the controland administration of the contract on behalfof the purchaser is given to an individual orfirm named the project manager.

Page 46: Effective And Efficient Quality Managements-1

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 theowner, one or more contractors, and various professional entities that providefinance, design, construction, and operation services. These entities work as partieswithin a contract framework with mutual relationships.

At a glance, owners may be subsumed into three broad areas.

Page 47: Effective And Efficient Quality Managements-1

11-03-2015 47

Service owners include public and private entities that build an infrastructure, afacility 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 ownerare: a municipality to build a new school or a road, an electric utility company toerect a new power station, and a hotel company to run its own accommodationfacilities.

Service owners

Real estate developers and property managers do business within the constructionindustry, while service owners are usually industrial players in a specific consumeror business-to-business market.Owners usually go into an agreement with contractors that have specializationto 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.

Page 48: Effective And Efficient Quality Managements-1

11-03-2015 48

• Property or asset managers act as landlords that develop building investmentsto get long-term return from rental fees and facility management services. Anexample is an insurance company or a private-equity real estate investor.

• Real estate developers aim at selling constructed facilities to the market with ashort-term return on investment. Typically, real estate developers have residentialhousing and office building programs.

Page 49: Effective And Efficient Quality Managements-1

11-03-2015Contracting for Engineering and Construction Projects-Fifth Edition-PETER MARSH Gower

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.

Page 50: Effective And Efficient Quality Managements-1

11-03-2015 50

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 allocationbetween the parties.

Page 51: Effective And Efficient Quality Managements-1

11-03-2015 51

When the owner uses a time and material or a unit price payment scheme, heshoulders 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 paymentscheme, the contractor bears most of the financial risk.

Page 52: Effective And Efficient Quality Managements-1

11-03-2015 52

Page 53: Effective And Efficient Quality Managements-1

11-03-2015

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

Page 54: Effective And Efficient Quality Managements-1

11-03-2015Alberto De Marco,Project Management for Facility Constructions-A Guide for Engineers and Archite

54

Page 55: Effective And Efficient Quality Managements-1

11-03-2015 55

The emphasis of this PPT is on helping people help their companiestoward 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.

Page 56: Effective And Efficient Quality Managements-1

11-03-2015 56

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.)PeopleA product embodied in design drawings and specs

Page 57: Effective And Efficient Quality Managements-1

11-03-2015 57

Manufacturing says: I don’t understand what I’m supposed to buildWhat criteria do we test toWhere is the change I need to:Reduce costsAvoid making scrapAvoid making parts that will have to be reworkedWill this change increase the “bone pile” of down-level material

Page 58: Effective And Efficient Quality Managements-1

11-03-2015 58

Sales says:You mean the product isn’t ready for the market windowWhere is that promised new featureWhy didn’t we deliver a product with the options the customer asked for

Customer says: I didn’t get what I orderedWhere is the fix you promised meWhere is that new feature or option

Repair says: I could fix it easier if I knew what is in this productW hat changes should be and shouldn’t be incorporated upon repair

Page 59: Effective And Efficient Quality Managements-1

11-03-2015 59

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 standardsWe can’t meet International and US standards

Employee says: I asked them to do something about this a long time ago

Good design documentationand its control is the solution for the root cause of these symptoms.

Page 60: Effective And Efficient Quality Managements-1

11-03-2015

Watts, Frank B. ISBN 978-0-8155-1595-1Engineering 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.

Page 61: Effective And Efficient Quality Managements-1

11-03-2015 61

•Reduces field maintenance, retrofit, and repair cost.• Knows exactly what is non interchangeable in each product.•Improves the understanding and communication betweenDesign 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…)

Page 62: Effective And Efficient Quality Managements-1

11-03-2015 62

File Management ProceduresA 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.

Page 63: Effective And Efficient Quality Managements-1

11-03-2015 63

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.

Page 64: Effective And Efficient Quality Managements-1

11-03-2015 64

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).

Page 65: Effective And Efficient Quality Managements-1

11-03-2015 65

.......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.

Page 66: Effective And Efficient Quality Managements-1

11-03-2015 66

Owner ResponsibilitiesThe 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).

Page 67: Effective And Efficient Quality Managements-1

11-03-2015

Source ASCE MANUALS AND REPORTS ON ENGINEERING PRACTICE NO. 73

QUALITY IN THE CONSTRUCTED PROJECT A GUIDE FOR OWNERS, DESIGNERS, AND CONSTRUCTORSTHIRD EDITION

Constructor ResponsibilitiesAs 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.

Page 68: Effective And Efficient Quality Managements-1

11-03-2015Concurrent Engineering in Construction Projects Edited by

Chimay J. Anumba, John M. Kamara and Anne-Francoise Cutting-Decelle68

Documents as the industry’s knowledge base

Page 69: Effective And Efficient Quality Managements-1

11-03-2015

http://www.qcin.org/articles/downloadpdf.php?downloaded=Effectiveness_of_QMS.pdf

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

Page 70: Effective And Efficient Quality Managements-1

11-03-2015

http://www.qcin.org/articles/downloadpdf.php?downloaded=Effectiveness_of_QMS.pdf

70

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. Thisconcept was largely based on “process compliance”, where the process was viewed to be comprising of 7 Ms i.e.

“In-Process-Inspection”

Page 71: Effective And Efficient Quality Managements-1

11-03-2015 71

1. Man2. Material3. Machine4. Method5. Milieu (Environment)6. Measurement7. 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”

Page 72: Effective And Efficient Quality Managements-1

11-03-2015 72

The Need for Quality Management SystemIn 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 riskconsiderations 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.

Page 73: Effective And Efficient Quality Managements-1

11-03-2015 73

Page 74: Effective And Efficient Quality Managements-1

11-03-2015 74

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

Page 75: Effective And Efficient Quality Managements-1

11-03-2015 75

Page 76: Effective And Efficient Quality Managements-1

11-03-2015 76

Crises of CredibilityThe ISO 9000 series of quality standards work on the premises that Customersrequire products with characteristics that satisfy their needs and expectations,collectively referred to as customer requirements or product specifications. The qualitymanagement system (QMS) approach encourages organizations to analyze thecustomer requirements, define a process that contributes to the achievement of aproduct, which is acceptable to the customer, and keep these processes under control. Some organizations have used the ISO 9000 series of standards to developquality management systems that are integrated into the way they do business areuseful in helping them to achieve their strategic business objectives and add value forthe organization. On the other hand, many other organizations have simply created aset of bureaucratic procedures and records that do not reflect the way the organizationactually works. Setting up such elaborate procedures simply adds costs, withoutproviding any value additions to the product or process.

Page 77: Effective And Efficient Quality Managements-1

11-03-2015http://accab.org/images/publication/16102014071346.pdf

77

ISO 9001 (Clause 1.1)• “Specifies quality management systemrequirements for organization to:– demonstrate its ability to consistentlyprovide product that meets customer andapplicable statutory & regulatoryrequirements– enhance customer satisfaction………”NOTE: “Services” are a specific kind of product, and are also covered by ISO 9001

Specifies quality management system

Page 78: Effective And Efficient Quality Managements-1

11-03-2015http://accab.org/images/publication/1610

2014071346.pdf78

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

Page 79: Effective And Efficient Quality Managements-1

11-03-2015 79

Quality System StandardsAccreditationAccreditation bodyAccreditation standardCertificate of accreditationCertificationCertification bodyComplianceCPA (Clinical PathologyAccreditation)GLP (Good Laboratory Practice)GMP (Good Manufacturing Practice)IS0 17025 standardIS0 9000 seriesNAMAS MlO/MllSurveillanceUKAS (United Kingdom Accreditation Service)Terminology to indicate that the laboratory meets the requirements of astandard is used rather loosely. The preferred usage is:

Page 80: Effective And Efficient Quality Managements-1

11-03-2015 80

meeting the requirements of IS09000 series is Certification;satisfying IS0 17025 (a standard that specifically addresses technicalcompetence) 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.

Page 81: Effective And Efficient Quality Managements-1

11-03-2015 81

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.

Page 82: Effective And Efficient Quality Managements-1

11-03-2015 82

DocumentationThere are several reasons why a quality system must be fully documented.Firstly it is a pre-requisite of most quality standards. Secondly, in mostlaboratories it would be impossible to accurately remember and hence communicateall of the analytical methodology and quality management procedure tostaff. This would lead to the quality system becoming compromised due to staffturnover. Thirdly the process of audit (see Section 5.1) requires a precisedefinition of the planned quality system. This is provided by the documentation.There are several terms used to describe the types of documentation used in aquality system in addition to the quality manual itself (see Section 5.1).Archives RecordsCalibration schedule Sample registerChain of custody Standard operating procedureControlled documents Study planMethods documentation Test sheetProcedure Training recordProtocol Unique sample identifierTerms for the different types and levels of documentation below the qualitymanual may vary. The terms in common use are described.

Page 83: Effective And Efficient Quality Managements-1

11-03-2015

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

83

Page 84: Effective And Efficient Quality Managements-1

11-03-2015 84

The term procedure is generally applied to the documentation describingactivities to be carried out in the laboratory. Some laboratories inay make adistinction between procedures, which describe activities other than the test methods themselves, and methods documentation; others will regard everythingbelow 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

Page 85: Effective And Efficient Quality Managements-1

11-03-2015 85

For all quality standards, staff working in a laboratory must be suitablytrained. For laboratory workers a training record is a document used to recordeach 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 identifytraining needs and skills that the analyst will require in the future.In addition to descriptions of procedures to be followed, the quality systemmust provide for the creation and maintenance of records which show what hasbeen done. This is necessary to enable the laboratory to replicate, if required, theanalytical process that was performed for a particular sample. The process ofaudit is only possible if adequate records are maintained and the absence ofadequate records will constitute a non-compliance with most quality managementstandards

Page 86: Effective And Efficient Quality Managements-1

11-03-2015 86

Example: 5.4RecordsThe 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

Page 87: Effective And Efficient Quality Managements-1

11-03-2015http://www.performance.gov.in/sites/all/document/files/iso9001/ISO-9001-Guidelines.pdf

87

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.

Page 88: Effective And Efficient Quality Managements-1

11-03-2015 88

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 demonstrateThat 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.

Page 89: Effective And Efficient Quality Managements-1

11-03-2015 89

The ISO 9000 standard provides thefundamentals and vocabulary used in

the entire ISO 9000 family of standards.It sets the stage for understanding thebasic elements of quality managementas described in the ISO standards. ISO

9000 introduces users to the eight QualityManagement Principles as well as the

use of the process approach to achievecontinual improvement. (See Figure 1).

ISO 9000

Page 90: Effective And Efficient Quality Managements-1

11-03-2015 90

Page 91: Effective And Efficient Quality Managements-1

11-03-2015 91

ISO 9004 is[1] used to extend the benefitsobtained from ISO 9001 to all parties

that are interested in or affected by youroperations. Interested parties include your

employees, owners, suppliers, partnersand society in general.

ISO 9004 gives guidance on awider 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 isrecommended as a guide for organizationswhose top management wishes to extend

the benefits of ISO 9001 in pursuit ofsystematic and continual improvement of

the organization’s overall performance.However, it is not intended for certification

or contractual purposes.

Page 92: Effective And Efficient Quality Managements-1

11-03-2015 92

Page 93: Effective And Efficient Quality Managements-1

11-03-2015 93

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.

Page 94: Effective And Efficient Quality Managements-1

11-03-2015 94

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 contractualpurposes by organizations seeking recognition of their quality managementsystem. 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 systemmore 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 orregional award programmes.

Page 95: Effective And Efficient Quality Managements-1

11-03-2015 95

Page 96: Effective And Efficient Quality Managements-1

11-03-2015 96

Page 97: Effective And Efficient Quality Managements-1

11-03-2015 97

Page 98: Effective And Efficient Quality Managements-1

11-03-2015 98

Page 99: Effective And Efficient Quality Managements-1

11-03-2015 99

Page 100: Effective And Efficient Quality Managements-1

11-03-2015Web www.iso.org

[1] ISBN 978-92-67-10494-2b100

Example 1A metal parts fabricating[1] companyrecognized the need to demonstrate theircapability to produce consistent qualityproduct. They first used ISO 9000 todevelop a plan to create an acceptableQMS. Next, they prepared the qualitymanual and quality system proceduresas required by ISO 9001, excluding therequirements covering product designand development because their productsare made to designs prepared by theircustomers. They implemented the QMSdescribed in their manual and proceduresand ensured the system functioned asplanned. Later, in order to bid on the supplyof parts to a major automotive company,they upgraded their quality system tomeet the automotive sector specificrequirements of ISO/TS 16949.

Page 101: Effective And Efficient Quality Managements-1

11-03-2015 101

Example 2A welfare agency decided to improvethe quality of the services it provided toclients. It adopted ISO 9004 as the basisfor implementing its system and planningfor improvements. The agency recognizedthat ISO 9000 provided very usefuladditional guidance in terminology andunderstanding and applying QMS conceptsto their system. They mapped the resultingsystem processes to requirementsidentified in ISO 9001. They planned to seekcertification to ISO 9001 to gain recognitionand credibility from clients and supporters.

Page 102: Effective And Efficient Quality Managements-1

11-03-2015 102

Example 3An electrical appliance manufacturerhad a well-established company cultureof continual improvement and effectiveproduction control. The managementdecided to improve the company’sdevelopment processes and to implementISO 9001 to obtain certification forcommercial purposes. The companyused ISO 9004 to guide its improvementprocesses and ISO 10006 to develop aproject management plan. Regulatoryagencies demanded products be designedand packaged recognizing the end of lifedisposition of products and packaging.The company was able to use the designand document control requirements inISO 9001 to satisfy regulators ofcompliance to new requirements

Page 103: Effective And Efficient Quality Managements-1

11-03-2015 103

Example 4A 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 businessprocesses 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 EMSstandard. 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 andISO 9004.

Page 104: Effective And Efficient Quality Managements-1

11-03-2015 104

Example 5A firm of international lawyers wantedto improve their client managementprocesses using the systematic approachfound in ISO 9001, but did not intend togain certification. Their QMS providesfor the design and development ofnew services such as internationaltax planning and modifying traditionalservices to meet the requirements of newor amended legislation. They includedpurchasing control to cover the selectionof computer hardware and software, aswell as purchasing the services of specialistlawyers as needed. After successfullyimplementing ISO 9001, they used theself-assessment guidelines of ISO 9004 tomonitor their progress as they improvedtheir QMS to achieve greater clientsatisfaction.

Page 105: Effective And Efficient Quality Managements-1

11-03-2015 105

Example 6A computer software developer serving a niche market recognizedthat 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 theintegration of the acquisition into their own structure very quickly with a minimum of disruption to customers.

Page 106: Effective And Efficient Quality Managements-1

11-03-2015 106

Example 7A 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), recognizingthat design and development is an important part of creating new serviceprocesses. 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.

Page 107: Effective And Efficient Quality Managements-1

11-03-2015 107

Example 8A franchise organization had difficultymaintaining consistent operation byfranchisees and determined that anenhanced management system wasrequired. They learned that ISO 9001included the tools they needed and withthe help of ISO/TR 10013 they developedthe quality manual and quality systemprocedures to be used throughout thefranchise network. To ensure a consistentapproach in managing customersatisfaction, they used guidance found inISO 10001, ISO 10002 and ISO 10003.When the system was implemented, thefranchise organization used ISO 19011 toestablish an audit programme to confirmthat the ISO 9001-based QMS continued tofunction as required and was improved ona continual basis.

Page 108: Effective And Efficient Quality Managements-1

11-03-2015 108

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".

Page 109: Effective And Efficient Quality Managements-1

11-03-2015 109

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 “customerfeedback” (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

Page 110: Effective And Efficient Quality Managements-1

11-03-2015 110

• 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 customersatisfaction - again, this should actually be more demanding than justresponding 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.

Page 111: Effective And Efficient Quality Managements-1

11-03-2015 111

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 andimplementation of an effective and efficient complaints-handling process for alltypes of commercial or non-commercial activities, including those related toelectronic commerce.”The process for complaints handling described in ISO10002 can be used as anelement of a quality management system.

Customer satisfaction

Page 112: Effective And Efficient Quality Managements-1

11-03-2015 112

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 aconsistent, systematic and responsive manner, to the satisfaction of thecomplainant and the organization,• enhance the ability of an organization to identify trends and eliminatecauses of complaints, and improve the organization's operations,• help an organization create a customer-focused approach to resolvingcomplaints, and encourage personnel to improve their skills in working withcustomers, and • provide a basis for continual review and analysis of the complaints handlingprocess, the resolution of complaints, and process improvementsmade”

Page 113: Effective And Efficient Quality Managements-1

11-03-2015 113

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.

Page 114: Effective And Efficient Quality Managements-1

11-03-2015 114

ISO 9001 "4.2.1 GeneralThe quality management system documentation shall include:….d) documents, including records, determined by the organization to be necessary to ensure theeffective 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 toa) the size of organization and type of activities,b) the complexity of processes and their interactions, andc) the competence of personnel."The auditor should requests information on the auditee's operating processes andsubsequently ask questions, record answers and observe staff at all levels (includingadministrative 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 theobserved need for consistency, and the role that any documentation could play in avoiding any significant, identified risks.

Page 115: Effective And Efficient Quality Managements-1

11-03-2015 115

Introduction

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

Page 116: Effective And Efficient Quality Managements-1

11-03-2015 116

Page 117: Effective And Efficient Quality Managements-1

11-03-2015 117

Maintaining Standards (Auditing)-page 1422A 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.

Page 118: Effective And Efficient Quality Managements-1

11-03-2015 118

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 thetwo.

Differences between Training and Education

Page 119: Effective And Efficient Quality Managements-1

11-03-2015 119

Page 120: Effective And Efficient Quality Managements-1

11-03-2015 120

Types of Sample

Aggregate sampleBatchBulk sampleComposite sampleGross sampleHeterogeneous sampleHomogeneous sampleJudgmental sampleLotRandom sampleRepresentative sampleRetained sampleSelective sample

Page 121: Effective And Efficient Quality Managements-1

11-03-2015 121

Page 122: Effective And Efficient Quality Managements-1

11-03-2015 122

A homogeneous sample is one for which there is no evidence of variationthroughout its extent.

Example: 1.1Homogeneous sampleA 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 .2Heterogeneous sampleA soil sample made up of stones, clay, organic matter, etc. would be heterogeneous for iron(II) ions.

Page 123: Effective And Efficient Quality Managements-1

11-03-2015 123

A composite sample, sometimes referred to as an aggregate sample, is one thatis 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 compositionto 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 particularaspect of the material from which it is taken, e.g. a sample of water taken fromimmediately downstream of an industrial outfall to assess the worst possiblesituation with regard to potential pollution. Some analysts refer to judgmentalsamples as those chosen to illustrate a particular property of the material underconsideration.A random sample is chosen from a bulk material at random, i.e. so that anypart of the bulk has an equal chance of selection, and without any particularreference to the properties of the bulk.A retained sample is a sample taken for future reference purposes, e.g. for usein analysis where the result is the subject of a dispute.

Page 124: Effective And Efficient Quality Managements-1

11-03-2015 124

Sample HandlingAliquot

IntegrityLaboratory sample

Primary sampleSample accountability

Sub-sampleTest portionTest sample

An aliquot in this context is a part of a laboratory sample used in theanalytical determination: the term is used commonly for the individual portionstaken to repeat a single analysis.

Page 125: Effective And Efficient Quality Managements-1

11-03-2015 125

A primary sample is the sample taken from the lot or batch; in most cases aportion of this sample will be taken and known as a sub-sample. The sub-sampleor part of the sub-sample is used to provide the laboratory sample.

Sample PreparationClean-upDigestion

DissolutionExtraction

Pre-concentrationPre-treatment

Page 126: Effective And Efficient Quality Managements-1

11-03-2015 126

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

Page 127: Effective And Efficient Quality Managements-1

11-03-2015 127

Principle Characteristics Key Tasks

Process definition ISO 9000 type of qualitymanagement.

Ensuring effectiveness and efficiency of processes by use of performancemeasures

Page 128: Effective And Efficient Quality Managements-1

11-03-2015 128

Principle Characteristics Characteristics

Quantitativemanagement

Feedback loops and performancemeasures are established.

Refining of feedback loops,ensuring the participationof each employee

Continuousimprovement

All members of the company are involved in improvementactions.

Continuous review of measures and feedback loops

Page 129: Effective And Efficient Quality Managements-1

• 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 teamBefore 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

Page 130: Effective And Efficient Quality Managements-1

(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 thecommitment 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.

11-03-2015 130

Page 131: Effective And Efficient Quality Managements-1

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’srequirements have been fulfilled.NOTES1. Customer complaints are a common indicator of low customer satisfaction but their absence does not necessarily imply high customersatisfaction.2. Even when customer requirements have been agreed with the customer and fulfilled, this does not necessarily ensure high customersatisfaction.3.7 Feedback - Opinions, comments, suggestions and expressions of satisfaction/ dissatisfaction.

11-03-2015 131

Page 132: Effective And Efficient Quality Managements-1

3.8 Non-conformity - Non fulfilment of a requirement.3.9 Public Service Organization - An organization which provides service(s) to public at largeand/or whose activities influence public interest.Example : Government ministries and departments, Regulatory bodies, Public utility serviceproviders, 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.NOTES1. 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 andthe 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 regardsservice quality, as formally expressed by top management.

11-03-2015 132

Page 133: Effective And Efficient Quality Managements-1

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.

11-03-2015 133

Page 134: Effective And Efficient Quality Managements-1

Complaints HandlingThe 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 timenorms 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, andiii) time limits within which the complaint will be closed.

11-03-2015 134

Page 135: Effective And Efficient Quality Managements-1

11-03-2015 135

Page 136: Effective And Efficient Quality Managements-1

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; andj) Nominating `Ombudsman’ who could be approached if normal service delivery mechanism does not respond.

11-03-2015 136

Page 137: Effective And Efficient Quality Managements-1

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;

11-03-2015 137

Page 138: Effective And Efficient Quality Managements-1

Findings include –

1. Major Nonconformity 2. Minor Nonconformity 3. Opportunities for Improvement

11-03-2015 138

Page 139: Effective And Efficient Quality Managements-1

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

11-03-2015 139

Page 140: Effective And Efficient Quality Managements-1

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:

11-03-2015 140

Page 141: Effective And Efficient Quality Managements-1

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

Page 142: Effective And Efficient Quality Managements-1

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

11-03-2015 142

Page 143: Effective And Efficient Quality Managements-1

DispositionsReworkAn action of correction that renders the nonconforming or suspect material to a status that said material will meet all specified requirements.RepairAn 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.ScrapAn 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).SalvageAn 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

Page 144: Effective And Efficient Quality Managements-1

11-03-2015 144

Page 145: Effective And Efficient Quality Managements-1

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 andempowered. 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 facingorganizations 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

Page 146: Effective And Efficient Quality Managements-1

11-03-2015 146

Page 147: Effective And Efficient Quality Managements-1

Not all non-conformities require CAPA- high risk or out of control

11-03-2015 147

Page 148: Effective And Efficient Quality Managements-1

Correction

or

Analysis of cause

Analysis of cause Correction

Corrective action Corrective action

Review of actions in response to a nonconformityManagement 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

Page 149: Effective And Efficient Quality Managements-1

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 inCorrective Actions. Fishbone analysis is also agood tool.

11-03-2015 149

Page 150: Effective And Efficient Quality Managements-1

EXAMPLE 1• CAPA # :Example 1• Problem: “Loose bolts found 3 different times on line 1.”• Cause: “ Human error- Maintenance personnel are nottightening bolts correctly.”• Corrective Action: “Train personnel”• Preventive Action: “Use Lock tight on bolts.”

11-03-2015 150

Page 151: Effective And Efficient Quality Managements-1

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

Page 152: Effective And Efficient Quality Managements-1

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

Page 153: Effective And Efficient Quality Managements-1

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

Page 154: Effective And Efficient Quality Managements-1

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

Page 155: Effective And Efficient Quality Managements-1

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.

11-03-2015 155

Page 156: Effective And Efficient Quality Managements-1

11-03-2015 156

Page 157: Effective And Efficient Quality Managements-1

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.

Page 158: Effective And Efficient Quality Managements-1

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.

Page 159: Effective And Efficient Quality Managements-1

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 METAL ARC/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

AL'S WELDING & STEEL FABRICATION, INC.

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.

Page 160: Effective And Efficient Quality Managements-1

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

Page 161: Effective And Efficient Quality Managements-1

11-03-2015 161

Page 162: Effective And Efficient Quality Managements-1

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

AL'S WELDING & STEEL FABRICATION, INC.

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".

Page 163: Effective And Efficient Quality Managements-1

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.

Page 164: Effective And Efficient Quality Managements-1

11-03-2015 164

Non-Conformance RegisterNCR register.· This opens the Non conformance Corrective and Preventive Action Form at the form entry screen.· Enter date in Registration Date (dd/mm/yyyy).· Customer / Supplier Reference (if any)· Notified By· Customer / Supplier / Internal:· Always ensure that the Customer/Supplier Company's name is written briefly and the same each time for the purpose of searching in this database. Using initials can be helpful.· If the company’s name is entered in two or more different ways, then only some or none of required reports will be found upon searching and report generation.· Notified (within your company)· Problem and Investigation of Problem· Investigator's Name. Investigator may be assigned here by Manager· Date of Investigation· Problem Caused by Customer / Supplier? Note: Authorisation required if problem caused by customer/supplier.· Customer / Supplier Informed of Costs?

Page 165: Effective And Efficient Quality Managements-1

11-03-2015 165

· Authorised Signature. Note: If cause of problem is assigned to the customer/supplier, an authorised Manager signs here and in the final authorisation box. No further action is necessary.· Corrective action required? If problem is not assigned to the customer, then some corrective action is usually required.· Corrective Action: Summary of actions proposed or undertaken. Note closeout of NCR/CAR is not possible until all actions finalised.· Corrective Actioner· Completion Date· Fate of Product: 1 - Rework, 2 - Return to Supplier, 3 - Scrapped, 4 - Use as is, 5 –Other..· Preventive Action Required: Used to determine root cause of problems to prevent potential future nonconformities. May be assigned or determined by a Manager.· Preventive Action· Preventive Actioner· Completion Date· Completed - Authorised Signature: Note: Mandatory field for close out of the NCR.· Note: Not all data needs to be entered at one time. Data can be added to successively during the investigation.

Page 166: Effective And Efficient Quality Managements-1

11-03-2015 166

The Manager or designate shall signify completion of the Corrective and Preventive action by signing off the NCR completed.

A large list of reports appears as follows. (Note: CPA stands for correctivepreventive action). · Select appropriate report and enter desired data. Note: The summary reports are very brief and largely serve to identify reports for print out in full form through the Registered no. Query.· The summary have counters for the number of entries to facilitate generation of other reports (e.g. % not closed out).· Other reports can be generated by the QA Administrator upon request. Example -Report to Supplier of faulty parts· To generate a report to send to a faulty supplier, fill in the form. Check the box “Corrective ActionRequired” and leave Corrective Action section blank.· Identify by the summary reports the correct NCR number. Type that number in the Report - CPARegistered Number Query section and print out the report.

Page 167: Effective And Efficient Quality Managements-1

11-03-2015 167

Review:· Incomplete NCRs and other NCRs and the quality system in general are reviewed by Management at Management Review Meeting. This review shall be conducted to identify and eliminate any potential non-conformances. Management reviews shall be conducted in accordance with Management Responsibility Procedure.· Note: Efforts should be made to ensure that all completed NCRs have been signed off in the Completed - Authorised Signature box. Otherwise it will appear as an incomplete NCR which will require management review.· Closing off an NCR means all possible information has been obtained from it and no further discussion is required at management review.

Page 168: Effective And Efficient Quality Managements-1

11-03-2015 M.Karikalan 168

Using the Four YardsticksAll performance challenges are measurable by some combination of the following:• Speed/ time• Cost• On-spec/ expected quality• Positive yieldsThe first two are quantitative and objective and the second two a blend of objective / subjective and quantitative / qualitative. Becoming adept at the use of these yardsticks will take you a long way toward overcoming the anxieties and obstacles inherent in performance outcome-based goals.

Conclusion

Page 169: Effective And Efficient Quality Managements-1

11-03-2015 169

There are six choices you need to make when applying a speed / time metric:1. What is the process or series of work steps you wish to measure?2. What step starts the clock?3. What step stops the clock?4. What unit of time makes the most sense?5. What number and frequency of items going through the process must meet your speed requirements?6. What adjustments to roles and resources (e.g., systems) are needed to do the work of measurementand achieve the goals?

Some of the more fundamental processes in organizations in addition to order fulfillment include new product / service development and introduction, customer service, integrated supply chain, and the hiring /development / retention of people.

Page 170: Effective And Efficient Quality Managements-1

11-03-2015 170

………….the first two yardsticks (speed / time and cost) measure the effort or investment put into organizational action, while the second two (on-spec / expected quality and positive yields) measure benefits you get out of that effort or investment. The best goals typically have at least one performanceoutcome related to effort put in and at least one outcome related to the benefits produced by that effort.

Page 171: Effective And Efficient Quality Managements-1

11-03-2015

Quality Engineering Handbook, Second Edition , Thomas Pyzdek edited by Paul A. Keller,MARCELDEKKER,

171

The flowchart will show how the process elementsrelate to one another and it will help in the selection of control points. It will alsoshow the point of delivery to the customer, which is usually an important control point.Note that the customer may be an internal customer.

Page 172: Effective And Efficient Quality Managements-1

11-03-2015 172

internal customers may usually not useoutside providers, but after that they may seek better services and/orbetter prices from other vendors.

Page 173: Effective And Efficient Quality Managements-1

11-03-2015 173

internal customers and specialists within the requesting departments oftenhave strong relationships with their service providers in which they do not accept purchasingto interfere (Van Weele, 2005).

Page 174: Effective And Efficient Quality Managements-1

11-03-2015 174

A second group of internal customers, according to Juran (1988), are all the internal units who must depend on output of another internal unit to achieve their goals and who must satisfy other units with their own output (pp. 24-27).

Page 175: Effective And Efficient Quality Managements-1

11-03-2015 J. M. Juran 175

In one company, once the team had gotten under way, it was realized that the internal customer—a “sister facility”—was not represented. Steps were taken to invite the facility in, to avoid an “usversus them” relationship (Black and Stump 1987).