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Presentation on theme: “Quality Management System”— Presentation transcript:

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Quality Management System
Large organizations, or ones with complicated processes, could not function well without management systems – although they may have been called by some other name. Companies in such fields as aerospace, automobiles, defence, or health products have been operating management systems for years. ISO’s management system standards now make these successful practices available for all organizations. Generic management system standards The vast majority of ISO standards are highly specific to a particular product, material, or process. However, both ISO 9000 and ISO are known as generic management system standards. Generic means that the same standards can be applied to any organization, large or small, whatever its product – including whether its “product” is actually a service – in any sector of activity, and whether it is a business enterprise, a public administration, or a government department. Management system refers to what the organization does to manage its processes, or activities. In a very small organization, there is probably no “system”, as such, just “our way of doing things”, and “our way” is probably not written down, but all in the manager’s or owner’s head. The larger the organization, and the more people involved, the more the likelihood that there are some written procedures, instructions, forms or records. These help ensure that everyone is not just “doing his or her thing”, and that there is a minimum of order in the way the organization goes about its business, so that time, money and other resources are utilized efficiently. To be really efficient and effective, the organization can manage its way of doing things by systemizing it. This ensures that nothing important is left out and that everyone is clear about who is responsible for doing what, when, how, why and where. Management system standards provide the organization with a model to follow in setting up and operating the management system. This model incorporates the features which experts in the field have agreed upon as representing the state of the art. A management system which follows the model – or “conforms to the standard” – is built on a firm foundation of state-of-the-art practices. 11 Quality Management System Understanding our QMS for the achievement of organization and business success.

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Objectives of the Orientation
To learn the benefits of implementing the requirements of the quality management system The effect of not following the requirements. 2

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Course Outline What is ISO and Quality Management System
Clauses and Benefits of ISO 9001:2008

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ISO 9001:2008 So what about it? ISO has thousands of standards. They number them to keep track, and the series is all Quality Management is the standard with the requirements that you must meet to become registered ISO 9001 is the quality management standard that gives the requirements for building and maintaining an effective quality management system. ISO Registration shows your customers and potential customers that you have a good quality management system in place. ISO 9001 is a standard for QUALITY MANAGEMENT SYSTEM 4

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Quality Management Systems
55 How? At this point, you may be wondering whether, and how, you can help shape the ISO 9000 standards. In the past, you may have been under the misapprehension that ISO standards were developed by full-time standardization experts in an ivory tower who then threw them over the wall and expected users to get on with them. You will now have understood that the business sectors most interested in implementing the eventual standards are the ones who provide experts to develop the standards. Your own interest may be such that you would like to provide input, or even participate in the work. In fact, there are channels and opportunities for you have a say in the future development of ISO 9000. What? When ISO/TC 176 embarked on the development of generic quality management standards for worldwide application, it was able to take advantage of a substantial base of national experience, notably in the United Kingdom and in Canada. In the United Kingdom, the BS 5750 standards were well on their way to broad acceptance and, in Canada, a series of national standards known as CSA Z299 were also widely used. Other countries with well developed quality management practices, such as Japan, also took a keen interest in the work of the new committee. In addition, experience of military quality assurance specifications, such as the NATO AQAP series, enriched the sources from which TC 176 was able to draw. What does ISO stand for? “International Organization of Standardization” Instead of using an acronym (IOS) they used the Greek word for equal, which is ISO. What does ISO do? ISO is an international group that develops standards of all types. ISO 9001 is the quality management standard that gives the requirements for building and maintaining an effective quality management system. ISO Registration shows your customers and potential customers that you have a good quality management system in place. What is ISO 9000? ISO is the International Organization for Standardization. It is located in Switzerland and was established in 1947 to develop common international standards in many areas. Its members come from over 120 national standards bodies. What’s the full title of ISO ? ISO 9001 Quality Management Systems- Requirements Why did they named ISO standards as ISO 9001 and what does 9001 stand for? ISO has thousands of standards. They number them to keep track, and the 9000 series is all Quality Management is the standard with the requirements that you must meet to become registered NEW STANDARD ISO 9001:2000 The term ISO 9000 refers to a set of quality management standards. ISO 9000 currently includes three quality standards: ISO 9000:2000, ISO 9001:2000, and ISO 9004:2000.  ISO 9001:2008 presents requirements, while ISO 9000:2000 and ISO 9004:2000 present guidelines.  All of these are process standards (not product standards). ISO first published its quality standards in 1987, revised them in 1994, and then republished an updated version in These new standards are referred to as the “ISO 9000 2000 Standards”. How was ISO developed? The ISO 9000 Series was developed by an ISO technical committee. TC 176 is responsible for the ISO 9000 series. Technical committees are made up of industry professionals from member countries. They set up working groups to draft the standard. The standards are circulated and reviewed until there is consensus. Members then vote on adoption of the document as an international standard The ISO Standards apply to all kinds of organizations in all kinds of areas. Some of these areas include manufacturing, processing, servicing, printing, forestry, electronics, steel, computing, legal services, financial services, accounting, trucking, banking, retailing, drilling, recycling, aerospace, construction, exploration, textiles, pharmaceuticals, oil and gas, pulp and paper, petrochemicals, publishing, shipping, energy, telecommunications, plastics, metals, research, health care, hospitality, utilities, pest control, aviation, machine tools, food processing, agriculture, government, education, recreation, fabrication, sanitation, software development, consumer products, transportation, design, instrumentation, tourism, communications, biotechnology, chemicals, engineering, farming, entertainment, horticulture, consulting, insurance, and so on. Where ISO 9000 came from and who is behind it Who? In the ISO system, standards are developed by national delegations of experts from business, government and other relevant organizations. They are chosen by the national standards institutes participating in the technical committee concerned and are required to present a consensus position based on the views of stakeholders in their country. In 1979, a new ISO technical committee was approved: ISO/TC 176, Quality management and quality assurance. Initially, 20 member countries decided to become active participants (P-members) in the work of this new committee and another 14 countries opted to follow the work as observers (O-members). Today, the number of countries participating in ISO/TC 176 is more than 50, with around another 20 as observers. The new committee set to work and, in 1986, had completed its first standards. Published in the early part of 1987, these standards were known as the ISO 9000 series. ISO 9001:2008 Quality Management Systems – a web of interconnected processes that are used to manage a business.

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International Organization for Standardization
ISO is not an acronym for International Organization for Standardization What is ISO? The ISO 9000 family of standards represents an international consensus on good management practices with the aim of ensuring that the organization can time and time again deliver the product or services that meet the client’s quality requirements. These good practices have been distilled into a set of standardized requirements for a quality management system, regardless of what your organization does, its size, or whether it’s in the private, or public sector. What is ISO 9000? ISO is the International Organization for Standardization. It is located in Switzerland and was established in 1947 to develop common international standards in many areas. Its members come from over 120 national standards bodies. NEW STANDARD ISO 9001:2000 The term ISO 9000 refers to a set of quality management standards. ISO 9000 currently includes three quality standards: ISO 9000:2000, ISO 9001:2000, and ISO 9004:2000.  ISO 9001:2008 presents requirements, while ISO 9000:2000 and ISO 9004:2000 present guidelines.  All of these are process standards (not product standards). ISO first published its quality standards in 1987, revised them in 1994, and then republished an updated version in These new standards are referred to as the “ISO 9000 2000 Standards”. What is the definition of ISO 9002? ISO 9002 is no longer in use. It was the standard that applied to organizations that did not do design or development. It was made obsolete with the 2000 year revisions. Now companies that do not do design are registered to ISO 9001; they include a “Permissible Exclusion” in the Quality Manual stating that design and development do not apply and are not included in the Quality System What is ISO 9003? ISO 9003 is an obsolete version of ISO The current version is ISO 9001:2000, and it does not have a document numbered 9003. What is ISO 9004 ISO 9004 is a guidance document that gives you more detailed guidance on quality management systems, useful when implementing ISO It is “QMS-Guidelines for performance improvements”. What are the roles of ISO 9000 and 9004? ISO 9000 and 9004 have further guidance on Quality Management Systems. ISO 9000 has definitions and general guidance, and ISO 9004 provides guidance for performance management. They are not “Normative Standards”, that is they do not provide requirements for your quality management system, but more information and guidance for you to use to develop your QMS. The organization’s short name was taken from the Greek word “isos”, meaning “equal”. 6

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8 MANAGEMENT PRINCIPLES
77 8 MANAGEMENT PRINCIPLES 1. CUSTOMER FOCUS 2. LEADERSHIP ISO 9001 3. INVOLVEMENT OF PEOPLE 4. PROCESS APPROACH 5. SYSTEM APPROACH 6. CONTINUAL IMPROVEMENT 7. FACTUAL APPROACH 8. MUTUAL BENEFICIAL SUPPLIER RELATIONSHIPS

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New Emphasis In general, the new standard is more customer-oriented than the old standard. While the old standard was also oriented towards meeting customer requirements and achieving customer satisfaction, the new standard addresses this in much greater detail.  In addition, it expects you to communicate with customers and to measure and monitor customer satisfaction. The new standard also emphasizes the need to make improvements. While the old standard did implicitly expect organizations to make improvements, the new standard makes this explicit. Specifically, ISO 9001 now wants you to evaluate the effectiveness and suitability of your quality management system, and to identify and implement systemic improvements. 88 When ISO updated the 9000 series from 1994 to 2000 they decided to focus on a process approach to the QMS versus the old functional approach. All work is a process. This means that in everything we do there are inputs and outputs, suppliers and customers, and means to get the work done. When ISO updated the 9000 series from 1994 to 2000 they decided to focus on a process approach to the QMS versus the old functional approach. All work is a process. This means that in everything we do there are inputs and outputs, suppliers and customers, and means to get the work done.

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Model of Process Based QMS
99 Model of Process Based QMS

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The Customer-Supplier Chain
The Customer-Supplier Chain Customer Requirements Output Input Work team Customer Feedback

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Elements of a Typical Quality Management System Manual
Elements of a Typical Quality Management System Manual What is a quality manual? A Quality Manual describes your company’s overall Quality Management System. It states, in a general way, how your company meets the requirements of ISO 9001:2000. A Quality Manual is required by the standard and must include a reference to the procedures of the Quality Management System, and identify the interrelation of the Quality Management System Processes (often handled in a flow chart). Describe the structure of a quality manual. Quality Manuals are typically structured similar to the ISO 9001 Standard, this is not a requirement, but is a common effective approach. Each section briefly describes how your organization meets the requirements of the standard, and references the quality system procedures related to that section. The quality manual will also describe the interrelation of the quality system processes. This is often done in a flow chart.

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Contents 1 2 3 4 Scope Normative Reference Terms and Definitions
1.1 General 1.2 Application 1 Normative Reference 2 Terms and Definitions 3 Quality Management System 4.1 General Requirements 4.2 Documentation Requirements 4

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Contents (cont.) 5 6 Management Responsibility Resource Management
5.1 Management Commitment 5.2 Customer focus 5.3 Quality Policy 5.4 Planning 5.5 Responsibility, authority and communication 5.6 Management Review 5 Resource Management 6.1 Provision of resources 6.2 Human resources 6.3 Infrastructure 6.4 Work environment 6

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Contents (cont.) 7 8 Product Realization
7.1 Planning of product realization 7.2 Customer-related processes 7.3 Design and development 7.4 Purchasing 7.5 Production and service provision 7.6 Control of monitoring and measuring devices 7 8 Measurement, Analysis and Improvement 8.1 General 8.2 Monitoring and measurement 8.3 Control of nonconforming product 8.4 Analysis of data 8.5 Improvement

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Quality Manual (ISO 9001:2008) 15151515 What is ISO 9000?
ISO is the International Organization for Standardization. It is located in Switzerland and was established in 1947 to develop common international standards in many areas. Its members come from over 120 national standards bodies. NEW STANDARD ISO 9001:2000 The term ISO 9000 refers to a set of quality management standards. ISO 9000 currently includes three quality standards: ISO 9000:2000, ISO 9001:2000, and ISO 9004:2000.  ISO 9001:2008 presents requirements, while ISO 9000:2000 and ISO 9004:2000 present guidelines.  All of these are process standards (not product standards). ISO first published its quality standards in 1987, revised them in 1994, and then republished an updated version in These new standards are referred to as the “ISO 9000 2000 Standards”.

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Design and development validation …
Section 1: Scope Includes the design and construction of cleanroom, ventilation and air conditioning system, metal finishing system, environmental control system for automotive and other industrial or commercial applications. Exclusion Design and development validation …

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Section 2: Normative References
Section 2: Normative References ISO 9000:2005 ISO 9001: 2008 QMS ISO 9001:2000 QMS ISO 9002:1994

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ISO 9002:1994 Section 2: Normative References 18181818
ISO 9001:2000 Elements 1. Scope 2. Normative Reference 3. Terms and Definitions 4. Quality Management System 5. Management Responsibility 6. Resource Management 7. Product Realization 8. Measurement, Analysis and Improvement 1. Scope 2. Normative Reference 3. Definitions 4.1 Management responsibility 4.1.1 Quality Policy 4.1.2 Organization Responsibility and authority Resources Management representative 4.1.3 Management review 4.2 Quality System 4.2.1 general 4.2.2 quality system procedures 4.2.3 quality planning 4.3 contract review 4.4 design control 4.5 document and data control 4.6 purchasing 4.7 control of customer-supplied product 4.8 product identification and traceability 4.9 process control 4.10 inspection and testing 4.11 Control of inspection, measuring and test equipment 4.12 Inspection and test status 4.13 Control of nonconforming product 4.14 Corrective and preventive action 4.15 Handling, storage, packaging, preservation and delivery 4.16 Control of quality records 4.17 Internal quality audits 4.18 Training 4.19 Servicing 4.20 Statistical techniques ISO 9002:1994

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Section 3: Terms and Definition
Section 3: Terms and Definition Definitions Terms used by an organization:

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Section 4: General requirements
Section 4: General requirements Processes, interaction, improvement The focus is on looking at: What we do. Who we are doing it for. Improving how we provide service.

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Section 4: General requirements
Section 4: General requirements Documentation requirements Control of document Documents must show a control number, adoption and revision dates, in order to ensure use of the most recent information. Control of records Each record must be controlled in order to ensure uniform quality.

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Section 4: General requirements
Section 4: General requirements LEVEL 1 – QUALITY MANUAL Quality Policy Quality Objectives Requirement Standard Other Statutory and Regulatory Requirements 2222

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Section 4: General requirements
Section 4: General requirements Documentation requirements Quality manual The quality manual describes our intent to establish a quality management system with an emphasis on continual improvement.

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Quality Policy Section 4: General requirements
Section 4: General requirements Quality Policy The staff and management of ___ are committed to consistent provision of quality products and services that will satisfy the demands and expectations of customers Quality Policy The staff and management of __ are committed to consistent provision of quality products and services that will satisfy the demands and expectations of customers by continual improvement of the QMS and conforming to local standards and prevailing codes of practice. The policies and objectives so designed must be streamlined to all directions in an organization, otherwise no one will be clear where to go. In this regard communication acts as the central nerve system be educating every member of the organization about the quality system. by continual improvement of the QMS and conforming to local standards and prevailing codes of practice.

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For revision Section 4: General requirements Current Objectives
Section 4: General requirements Current Objectives Maintain good business relationship with the clients. Deliver quality products and services to the satisfaction of the clients Effect efficiency in operations by continual improvement of the Quality Management System. Improve employee’s competence through periodic evaluation and development of skills, knowledge and abilities by providing appropriate training. For revision Objectives Reply to customer’s needs and inquiries as required by customer. Complete and deliver quality projects to the satisfaction of the client within schedule and budget while conforming to local standards and prevailing codes of practice. Effect efficiency in operations by continual improvement of the QMS. Improve employee’s competence through periodic evaluation and development of skills, knowledge and abilities by providing appropriate training education.

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Section 4: General requirements
Section 4: General requirements LEVEL 2 – QUALITY PROCEDURES Control of Documents Control of Records Internal Quality Audits Control of Non-conforming Products Corrective Action Preventive Action 2626

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Section 4: General requirements
Section 4: General requirements LEVEL 3 – QUALITY PLAN Incoming Inspection Plan In-Process Inspection Plan Final Test Report/ Inspection Plan Work Instruction 2727

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Section 4: General requirements
Section 4: General requirements LEVEL 4 – FORMS / FORMATS/RECORDS Testing Report forms Commissioning Report Forms Inspection forms Check Sheets/Check List Miscellaneous Documentation Forms 2828

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Section 4: General requirements
Section 4: General requirements 23 MANDATORY RECORDS Management Review Competence, Training and Awareness Planning and Production Review of Requirement Related to Product Design and Development Input 2929

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Section 4: General requirements
Section 4: General requirements 23 MANDATORY RECORDS (cont’n) Design and Development Output Design and Development Review Design and Development Verification Design and Development Validation Control of Design and Development Changes 3030

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Section 4: General requirements
Section 4: General requirements 23 MANDATORY RECORDS (cont’n) Purchasing Process Availability of Monitoring and Measuring Equipment Preservation of Product Customer Property Control of Monitoring and Measuring Equipment Standards used for Calibrating Monitoring and Measuring Equipment 3131

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Section 4: General requirements
Section 4: General requirements 23 MANDATORY RECORDS (cont’n) Identify and Enable Calibration Result of Calibration and Verification Internal Audit Monitoring and Measurement of Product Control of Non-conforming Product Corrective Action Preventive Action 3232

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Section 5: Management Responsibility

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Summary of Section 5 Management Responsibility Commitment Focus Policy
T o i n f o r m e m p l o y e e s a b o u t t h e e f f e c t i v e n e s s o f t h e s y s t e m a n d t o e n s u r e t h e y h a v e r e l e v a n t i n f o r m a t i o n t o e n a b l e t h e m t o p e r f o r m t h e i r a c t i v i t i e s e f f e c t i v e l y . T o d e f i n e e f f e c t i v e m e t h o d s o f c o m m u n i c a t i o n w i t h c u s t o m e r s o n m a t t e r s s u c h a s p r o d u c t i n f o r m a t i o n , e n q u i r y a n d o r d e r h a n d l i n g , c o m p l a i n t s , e t c . Summary of Section 5 Management Responsibility Commitment Focus Policy Objectives Planning These correspond to the following principles: Customer focus Leadership

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Section 6: Resource Management

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Summary of Section 6 Resource Management Provide quality resources
Summary of Section 6 Resource Management Provide quality resources Provide quality personnel Provide quality infrastructure Provide quality environment This corresponds to the following principle: Involvement of People

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Section 7: Product Realization
Product /Service Realization

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Section 7: Product Realization
Section 7: Product Realization 7.1 Plan and develop the processes Include product objectives, relevant processes and resource, appropriate test and validation 7.2 Customer related processes Customer requirement – stated and implied Statutory and regulatory Product requirements and changes Organization ability Communication with customers

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Section 7: Product Realization
Section 7: Product Realization 7.3 Design and development Planning, inputs, outputs, systematic reviews, verification and validation, control of changes 7.4 Purchasing Supplier evaluation and selection Relevant purchasing information Verification of purchased product

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Section 7: Product Realization
Section 7: Product Realization 7.5 Production and service provision Controlled conditions including product characteristics, work instructions, suitable equipment, measuring devices, and system Release, delivery and post delivery activities Validation of processes when no other method Identification and traceability of product and it’s status Care of customer property Preservation of product Includes constituent parts

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Section 7: Product Realization
Section 7: Product Realization 7.6 Control of monitoring and measuring devices Calibrated where necessary Adjusted and readjusted Identifies status Safeguarded from invalid adjustment Protected from damage or deterioration

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Control of the following process
Summary of Section 7 Control of the following process realization planning customer communication product development purchasing function operation monitoring These correspond to: Get the facts before you decide Focus on customers Use a process approach Work with your suppliers

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Section 8: Measurement, Analysis & Improvement
CONTINUAL IMPROVEMENT OF THE QUALITY MANGEMENT SYSTEM

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General Section 8: Measurement, Analysis & Improvement
Section 8: Measurement, Analysis & Improvement General Measurement and monitoring processes To demonstrate product conformity, system conformity and continually improve the Quality Management System. Customer satisfaction Perception of fulfillment.

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Section 8: Measurement, Analysis & Improvement
Section 8: Measurement, Analysis & Improvement Monitoring and Measurement Internal planned audit, etc. Process Auditors, independent of their own work will audit department process. Processes Demonstrate achievement of planned results.

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Section 8: Measurement, Analysis & Improvement
Section 8: Measurement, Analysis & Improvement Monitoring and Measurement Product Monitor and measure characteristics. Conformity with acceptance criteria. Waivers / concessions. Nonconforming process/product Elimination or correction of nonconforming processes.

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Section 8: Measurement, Analysis & Improvement
Section 8: Measurement, Analysis & Improvement Analysis of data Customer satisfaction Product and process requirements and trends Suppliers

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Section 8: Measurement, Analysis & Improvement
Section 8: Measurement, Analysis & Improvement Improvement Continually improve effectiveness of the system Corrective action Preventive action

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Measurement, Analysis and Improvement
Summary of Section 8 Measurement, Analysis and Improvement Perform remedial processes Monitor and  measure quality Control nonconforming products Analyze quality information Make quality improvements 8.0 Remedial Requirements 8.1 Perform remedial processes 8.2 Monitor and  measure quality 8.3 Control nonconforming products 8.4 Analyze quality information 8.5 Make quality improvements Auditing Continual Improvement How much improvement is “enough”? It should be emphasised that the requirement in ISO 9001:2008 is for continual improvement of the effectiveness of the QMS. Continual improvement emanates from the objectives set by top management, which should (at least) address: the improvement of internal efficiency (for the organization to remain economically competitive), individual customer needs, and the level of performance that the market normally expects. For example, in the aeronautical sector, the “acceptable rate” of non-conforming delivered product is zero percent, so it would not be useful for the organization to set objectives for an “improvement“ in this rate. However, it would be useful for the organization to have objectives aimed in improving its internal efficiency and its competitiveness (e.g. through innovation). The auditor should seek to determine if the auditee has attempted to set objectives that establish the correlation between the 3 factors of: corporate objectives, customer needs, and market expectations. Thereafter, it is up to the organization to balance the need for improving internal efficiency and the need to progress with external performance (although the two are very often closely related). No one in isolation can ever be considered as being “enough” or “not enough”. One area which can be problematic for the auditor is to know what is a reasonable market benchmark. Continuing the above aeronautical example, if the organization announced that it had improved from a level of 50% non-conforming product delivered to 40%, this would demonstrate continual improvement, but would hardly be acceptable, given the industry sector’s zero percent normal rate. However, if it announced that it had set an objective to improve its performance from 0,50% to 0,40%, this would be much nearer the market norm. The only real solution for the auditor is to verify how the organization has determined this proposed rate of improvement, how it has evaluated the associated risks, and how this relates to customer requirements and the monitoring of feedback on customer satisfaction This corresponds to: Get the facts before you decide Encourage continual improvement 49

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End of Presentation

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A SHORT QUIZ

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What do you do when accepting a task? (Answerable by Yes or No)
What do you do when accepting a task? (Answerable by Yes or No) Before accepting an assignment, do you make sure you understand completely what you are supposed to do? Are the deadlines clear? Is it clear how much responsibility and authority you have in the project? Do you know which tasks you can perform on your own. Without reporting back to your boss? Do you let your boss know if a new assignment makes it difficult for you to do your other jobs? This quiz can set you on the right track. Write Yes or No after each question, then score yourself below. “When I sat down and analyzed the reasons for my mistakes and errors, I realized that most of my problems occur because I jump into projects without being fully prepared. I miss a deadline because I didn’t fully understand the amount of work that would be involved, or some part of the project would need to be done because I did not listen carefully to instructions. What can I do to prevent such occurrences in the future.” – K.W., Antioch, Illinois Your ability to carry tasks properly is a crucial element of your personal quality. Your chances for exciting, stimulating and challenging new assignments and your opportunities for promotion largely depend on your ability to perform delegated tasks satisfactorily. You’ve made great progress by narrowing done where problems occur for you. Now begin taking the necessary steps to successfully launch your next new project. How did you score? If you answered nine or ten questions as Yes, you are doing an excellent job of getting new projects off the right start. Keep that up and you’ll significantly lower the possibility for errors and mistake. If you scored any lower, take the corrective action explained in the questions you missed the next time you accept a project, and you’ll be well on your way to performing your tasks more effectively.

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What do you do when accepting a task (Continuation)
What do you do when accepting a task (Continuation) Do you make suggestions to make priorities on how much time you will allow the project? Do you get the information and background material you need to do the job properly? Do you try to imagine all the problems and obstacles that could arise while you are doing the job – then plan accordingly? Is it clear who makes decisions when your boss is not available? If a problem arises that you can’t handle, do you talk to your boss about the situation? This quiz can set you on the right track. Write Yes or No after each question, then score yourself below. “When I sat down and analyzed the reasons for my mistakes and errors, I realized that most of my problems occur because I jump into projects without being fully prepared. I miss a deadline because I didn’t fully understand the amount of work that would be involved, or some part of the project would need to be done because I did not listen carefully to instructions. What can I do to prevent such occurrences in the future.” – K.W., Antioch, Illinois Your ability to carry tasks properly is a crucial element of your personal quality. Your chances for exciting, stimulating and challenging new assignments and your opportunities for promotion largely depend on your ability to perform delegated tasks satisfactorily. You’ve made great progress by narrowing done where problems occur for you. Now begin taking the necessary steps to successfully launch your next new project. How did you score? If you answered nine or ten questions as Yes, you are doing an excellent job of getting new projects off the right start. Keep that up and you’ll significantly lower the possibility for errors and mistake. If you scored any lower, take the corrective action explained in the questions you missed the next time you accept a project, and you’ll be well on your way to performing your tasks more effectively.

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Are You Quality-Conscious? (Answerable by True or False)
Are You Quality-Conscious? (Answerable by True or False) When it comes to quality, there’s always room for improvement. Nobody can be aware of quality needs all the time. Customers pay little attention to quality. A quality program must mesh with the organization’s goals and profit plans. Quality means conformance to standards. This quiz can help you evaluate where you stand today. Have each member read each statement and respond by agreeing or disagreeing. Then check you scores and review your answers together “We’ve had a quality-improvement program going in our company for two years, and our senior managers soon are going to give every team an appraisal. Before they do, we as a team want to evaluate our own awareness of what goes into a successful quality program.” – J.J.H., Henderson, Kentucky The Proper Answer: 1. True; 2. False. Quality doesn’t evolve by itself. It requires the constant attention of everyone in the organization; 3. False. Customers today are sophisticated and demanding. They pay as much attention to quality as to price; 4, 5 & 6. True; 7. False. Personal and business quality standards will be the ones to lead business quality programs. 8 & 9. True; and 10, false. People who talk about quality are realists. The only way to compete successfully today is to continually improve quality. The passing grade for this test is 10. If you missed just one answer, your team is failing in at least one key quality area. Concentrate on those statements that you evaluated incorrectly and try to turn your attitude around.

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Are You Quality-Conscious? (Continuation)
Are You Quality-Conscious? (Continuation) Quality should operate in all parts of a business Personal quality standards and business quality standards have little in common. Quality requires commitment. Quality relates to the process as much as to the goal. People who talk about quality are mostly idealists. This quiz can help you evaluate where you stand today. Have each member read each statement and respond by agreeing or disagreeing. Then check you scores and review your answers together “We’ve had a quality-improvement program going in our company for two years, and our senior managers soon are going to give every team an appraisal. Before they do, we as a team want to evaluate our own awareness of what goes into a successful quality program.” – J.J.H., Henderson, Kentucky The Proper Answer: 1. True; 2. False. Quality doesn’t evolve by itself. It requires the constant attention of everyone in the organization; 3. False. Customers today are sophisticated and demanding. They pay as much attention to quality as to price; 4, 5 & 6. True; 7. False. Personal and business quality standards will be the ones to lead business quality programs. 8 & 9. True; and 10, false. People who talk about quality are realists. The only way to compete successfully today is to continually improve quality. The passing grade for this test is 10. If you missed just one answer, your team is failing in at least one key quality area. Concentrate on those statements that you evaluated incorrectly and try to turn your attitude around.

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Reflection Now . . . TELL me what’s is going on !!! 56565656
One word of warning: There is no requirement that the organization should set objectives for improvement of all its processes at any one time. As in the above example on reducing customer complaints, some processes may not be deemed by top management to contribute significantly to the reduction of delays, and it is only normal therefore, that the organization would not concentrate on these areas. What is Quality Auditing? If the top management has set a (realistic) objective for a process, and there is no evidence of improvement, this information must be fed back into the management review so that top management can decide what type of action is appropriate – for example, re-adjusting the objective or providing other means to impact on the process. “Systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled.” Audit criteria is a “set of policies, procedures, or other requirements against which collected audit evidence is compared.” Audit evidence consists of “records, statements of fact or other information, relevant to the audit and which are verified.” [i] ISO CD2/ISO and ISO 9000 – 2000, ASQ Quality Press, Ten Essential Audit Questions All experienced auditors accumulate favorite audit questions, and I’m no exception. I have a short, punchy list of queries I invariably ask while evaluating a management system. Favorites aside, though, what are truly the most important audit questions? What questions will reveal a system’s effectiveness and an organization’s overall performance? I compiled a list of the top 10. 1. How do you contribute to achieving your organization’s objectives? ISO 9001:2008 requires that organizations establish measurable objectives at relevant functions and levels. Perhaps an even more significant requirement is that personnel understand how they contribute to these objectives. This requirement doesn’t apply only to some employees; it applies to everyone. All personnel must be able to communicate, in their own words, how they help move objectives in the right direction. It’s conceivable that not all objectives apply to everyone in the company, and in those cases auditors would only expect that personnel understand the objectives that apply to them. This question directly reflects on an organization’s ability to communicate what matters most to its success. Truly comprehending objectives means that people understand specifically what they can do to improve the organization. They appreciate the significance of their roles and are prepared to carry them out. This knowledge creates strategic focus throughout the organization. Instead of having a limited view of activities and tasks, personnel begin to understand how their jobs link to the organization’s larger mission. Closely related questions include: How are objectives determined? How are employees trained on objectives? How is progress against objectives communicated to the organization? What processes and/or tools are in place to help achieve objectives? Is there evidence of progress? 2. What happens if your product, materials or supplies are nonconforming? This question reflects on the organization’s ability to deal with product problems in a systematic way. Controlling nonconforming products is a basic discipline and one that Getting more value from it…  Here are some ways that I’ve seen organizations obtain more value from ISO Clause Internal Audit:The biggest advantage companies are getting from this Clause is by using their internal audit personnel to assess process performance (which is over and above procedure compliance). This is leading them to uncover bottlenecks (and waste) hidden within the processes. Organizations are also using a “process audit” approach to emphasize the “internal customer” concept with employees in all areas, and to actively engage them in identifying ways to improve or streamline their jobs. As well, internal audit personnel are achieving a broader knowledge and understanding of the business (as a result of their preparation for conducting “process” audits), which they are taking back to their respective work areas. Finally, some companies are now starting to look at also using internal audits as a “risk assessment” tool, by alerting management to potential risks to the business, and as “peace of mind” regarding safety issues, good corporate governance practices and privacy legislation. Q&A Q: For Clause Internal Audit, how do we get our current auditors to switch over to a “process” approach? A: With “process” auditing, you need to first understand that this represents a “change”, which initially appears to be a harder audit to conduct… so don’t be surprised if you meet some resistance. You need to help them make this switch by first explaining what “process” auditing means and then in specific terms, explain how it will change the current way they perform their audits. You may want to carry out a mock or practice audit, so each auditor gets a chance to try this new approach and ask questions. My experience has been that most auditors take to “process” auditing quickly because they see a flow and sequence to the questions, as they “walk” along the links in the chain. Auditors will also need more time to prepare for a process audit since it requires a more thorough understanding of the chain of events that take place in a department or function. I would also make sure the Management Team is made aware of this new approach and let them know that auditors will be trying to uncover ways to de-bottleneck or streamline existing processes, and that this will require their full support. Improvement of the process or improvement of the QMS? An auditor should remember that it would be unrealistic to expect an organization to make progress all potential improvements simultaneously. Each improvement will require the commitment of resources, which may need prioritisation by top management, especially where investments are needed. Instead, the auditor should seek to ensure that the improvement objectives are consistent overall, and are coherent with the trilogy of factors mentioned above. However, an organization that does not have a policy and objectives relating to continual improvement is clearly not complying with the standard. Similarly, the absence of any evidence of improvement on at least one of these aspects would have to be considered as indicating that an organization’s quality policy is not in line with ISO 9001: 2000. Reflection Now TELL me what’s is going on !!!