Quality Consciousness, Habits and Processes CIT - College of Computer Studies Page 1 Introduction Our forefathers knew – as we know – that quality is important. Metrology, specifications, inspection – all goes back many centuries before the Christian era. Then came the twentieth century. The pace quickened with a lengthy procession of “new activities” and ideas launched under a bewildering array of names: quality control, quality planning, continuous quality improvement, defect prevention, statistical process control, reliability engineering, quality cost analysis, zero defects, total quality control, supplier certification, quality circles, quality audit, quality assurance, quality function deployment, Taguchi methods, competitive benchmarking. Following World War II, two major forces emerged that have had a profound impact on quality. The first force was the Japanese revolution in quality. Prior to World War II, many Japanese products were perceived, throughout the world, to be poor in quality. To help sell their products in international markets, the Japanese took some revolutionary steps to improve quality: 1. The upper managers personally took charge of leading the revolution. 2. All levels and functions received training in the quality disciplines. 3. Quality improvement projects were undertaken on a continuing basis – at a revolutionary pace. The Japanese success has been almost legendary. The second major force was the prominence of product quality in the public mind. Several trends converged to highlight this prominence: product liability cases, concern about the environment, some major disasters and near disasters, pressure by consumer organizations, and the awareness of the rule of quality in trade, weapons, and other areas of international competition. These two major forces, combined with others, have resulted (for many companies) in the changing set of business conditions that are enmeshed with the quality parameter.
Transcript
Quality Consciousness, Habits and Processes CIT - College of Computer Studies
Page 1
Introduction Our forefathers knew – as we know – that quality is important. Metrology,
specifications, inspection – all goes back many centuries before the Christian era. Then came the twentieth century. The pace quickened with a lengthy
procession of “new activities” and ideas launched under a bewildering array of names: quality control, quality planning, continuous quality improvement, defect prevention, statistical process control, reliability engineering, quality cost
analysis, zero defects, total quality control, supplier certification, quality circles, quality audit, quality assurance, quality function deployment, Taguchi methods, competitive benchmarking.
Following World War II, two major forces emerged that have had a
profound impact on quality. The first force was the Japanese revolution in quality. Prior to World War
II, many Japanese products were perceived, throughout the world, to be poor in quality. To help sell their products in international markets, the Japanese took some revolutionary steps to improve quality:
1. The upper managers personally took charge of leading the revolution. 2. All levels and functions received training in the quality disciplines.
3. Quality improvement projects were undertaken on a continuing basis – at a revolutionary pace.
The Japanese success has been almost legendary.
The second major force was the prominence of product quality in the
public mind. Several trends converged to highlight this prominence: product liability cases, concern about the environment, some major disasters and near disasters, pressure by consumer organizations, and the awareness of the rule of
quality in trade, weapons, and other areas of international competition.
These two major forces, combined with others, have resulted (for many companies) in the changing set of business conditions that are enmeshed with the quality parameter.
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Module 1 Introduction to Quality System
What is Standard?
According to the dictionary, standard is an object considered by an authority or by general consent as a basis of comparison. It is also an approved model, anything, as a rule or principle that is used as a basis for judgment. Standard is an authoritative principle or rule that usually implies a model or pattern for guidance, by comparison, with which the quantity, excellence, correctness, of other things may be determined. What is Quality?
The dictionary has many definitions of “quality”. A short definition that has achieved acceptance is: Quality is customer satisfaction. “Fitness for use” is an alternative short definition.
Although such a brief definition has a focus, it must be developed further to provide a
basis for action. According to the International Organization for Standardization (ISO), quality is “the
totality of features and characteristics of a product or service that bear on its ability to satisfy stated or implied needs”. However, there are problems with this definition. Whose needs does the service or product or address? Who are its customers? Customers for a product or service produced by a company can be located within or outside the company or both, depending on the product or service. A product or service may be provided by one company unit to another solely for the latter’s use, or for subsequent delivery to a customer outside the organization. It has been said that most product or service defects (no matter where they occur in the service or manufacturing process) usually find their way to the point of interface between a company and its outside customers.
In an attempt to address this problem, ISO has added seven footnotes to its definition,
including that: “in a contractual environment, needs are specified, whereas in other environments, implied needs should be identified and defined” and that “needs can change with time.” Needs can be defined in terms of safety; usability; availability; versatility; compatibility with other products; reliability; maintainability; overall cost (including purchase price, maintenance costs, and product life); environmental impact; or other desired characteristics.
A manufacturer’s production system may be considered by his customer’s to produce
“quality” product if the AQL (acceptable quality level) is 0.1, that is only one in 1,000 products contains defects.
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What is quality all about? PROCESS Doing the right thing Doing it the right way Doing it right the first time Doing it on time CUSTOMER Meeting all clientele expectations and needs on time Delivering the right service on time Treating each clientele with integrity, respect and courtesy PEOPLE Trained to do the right jobs right the first time and all the time Have proper attitude towards work Empowered to improve his work processes/systems What is Quality System? Product quality depends on the following variables: 1. Caliber of the components or materials used 2. Type of equipment used in design, production, handling, installation, testing and shipping 3. The equipment calibration and maintenance procedures employed 4. The training and experience of production and supervisory personnel 5. The level of “workmanship” 6. Sometimes the environmental conditions in the area where the product is produced. Thus, quality system is the process, organizational structure, procedures, and resources that manufacturers and suppliers use to control these variables to produce a product of consistent quality, which meets defined specifications. ISO 9000 standards are the standards that are being adopted globally for quality systems. Why does quality important? In defining quality for goods and services, two components have been identified: product features and freedom from deficiencies. Although both of these components are essential to generating sales, in general the product features component is more dominant. For profit-making organizations, the contribution of quality to sales income occurs through several means: Increasing market share Securing premium prices Achieving economics of scale through increased production Achieving unique competitive advantages that cement brand loyalties
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For both profit and nonprofit organizations, quality is synonymous with providing satisfaction to customers, both internal and external. For most organizations, satisfaction must be viewed relative to the competitions and thus goes far beyond the document called a “specification”.
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Module 2
Total Quality Management (TQM) “Customer satisfaction” is achieved through two components: product features and freedom from deficiencies. A closer examination of the two components reveals further insights: 1. Product features have a major effect on sales income (through market share, premium
prices, etc.). In any industries, the total external customer population can be segmented by the level or “grade” of quality desired. Thus the spectrum of customers leads to a demand for luxury hotels and budget hotels; to a demand for refrigerators with many special features as well as for those with basic cooling capabilities. Product features refer to the quality of design. Increasing the quality of the design generally leads to higher costs.
2. Freedom from deficiencies has a major effect on costs through reduction in scrap, rework,
complaints, and other results of deficiencies. “Deficiencies” are stated in different units, e.g., errors, defects, failures, off-specification. Freedom from deficiencies refers to quality of conformance. Increasing the quality of conformance usually results in lower costs. In addition, higher conformance means fewer complaints and therefore increased customer satisfaction.
The recent emphasis on customer satisfaction, broad application of quality concepts, and participation of all employees has given rise to a new title – Total Quality Management (TQM). TQM is the system of activities directed at achieving delighted customers, empowered employees, higher revenues, and lower costs. Importance for Implementing Quality Improvements On the trilogy of quality processes (e.g. planning, control, and improvement), the process of quality improvement plays a dominant role in reducing costs. The costs associated with poor quality are due to both sporadic and chronic quality problems. A sporadic problem is a sudden, adverse change in the status quo, which requires remedy through restoring the status quo (e.g., changing a depleted reagent chemical). A chronic problem is a long-standing adverse situation, which requires remedy through changing the status quo (e.g., revising an unrealistic specification). “Continuous improvement” (called Kaizen by the Japanese) has acquired a broad meaning, i.e., enduring efforts to act upon both chronic and sporadic problems and to make refinements to processes. For chronic problems, it means achieving better and better levels of performance each year; for sporadic problems, it means taking corrective action on periodic problems; for process refinements, it means taking such action as reducing variation around a target value.
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The distinction between chronic and sporadic problems is important for two reasons: 1. The approach to solving sporadic problems differs from that to solving chronic problems.
Sporadic problems are attacked by the control process. Chronic problems use the improvement process.
2. Sporadic problems are dramatic (e.g., an irate customer reacting to a shipment of bad parts)
and must receive immediate attention. Chronic problems are not dramatic because they occur for a long time (e.g., 2 percent scrap has been typical for the past five years), are often difficult to solve, and are accepted as inevitable. The danger is that the fire fighting on sporadic problems may take continuing priority over efforts to achieve the larger savings that are possible, i.e., on chronic problems.
Techniques for Building Employee Improvement The most effective approach to improvement is “project by project”. Here, a project is a chronic, quality-related problem, which has been chosen for solution. Setting up the approach comprises three main steps: Proving the need Identifying projects Organizing project teams Carrying each project involves: Verifying the project need and mission Diagnosing the causes Providing a remedy and providing its effectiveness Dealing with resistance to change Instituting controls to hold gains ORGANIZING PROJECT TEAMS A project team usually consists of about six to eight persons who are drawn from multiple departments and assigned to address the selected problem. Their job is to bring the project to a successful conclusion as defined in the mission statement for the project. The team meets periodically and members serve part time in addition to performing their regular functional responsibilities. When the project is finished, the team disbands. The project team consists of a leader, a secretary, and other team members. (Consulting specialists from disciplines such as accounting, software, metallurgy, etc., are invited to meetings when needed.) Project Team Leader. The project team leader steers the team in its responsibility of carrying out the project. Successful leadership requires knowledge of the project area and skills in getting members from several functional areas to work as a team. It is often useful for the team leader to come from the organizational unit most impacted by the problem. Project Secretary. Each team requires a project secretary to handle documentation: agendas, minutes, reports, etc. The secretary should be a member of the project team.
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Project Team Members. Team membership draws upon all of the skills and knowledge necessary for the project. For chronic problems, the teams are usually cross-functional and consist of middle management, professional, and work force personnel. Surprisingly, some projects are relatively easy and can be handled with a minimum of skills and knowledge. (Such projects are often the result of a previous lack of a project approach.) Other projects are complex and require more depth in team membership, perhaps even including consulting specialists from within the company. Supplementing the formal team membership is a “facilitator”. Many companies have adopted the concept of using a facilitator to help project teams carry out their first project. Although not member of the team, the facilitator can play an important role. The role of the facilitator consists of any or all of the following:
Explaining the company’s approach to quality improvement and how it differs from prior efforts at quality improvement Providing assistance in team building Assisting in the training of project teams Assisting the project team leader to solve human relations problems among team members Helping the team avoid a poor choice of project Reporting progress on projects to management Revitalizing a stalled project
PROJECT TEAMS: INTRADEPARTMENTAL AND INTERDEPARTMENTAL The vital few chronic problems usually cut across department lines and require cross-functional “project teams”. Other chronic problems are centered within one department. Some of these problems can be solved by individuals, but many call for departmental teams called “Quality Circles” or “employee involvement groups”. While both types of teams are essential, there are important differences between the two. A company-wide effort on improvement involves many teams (and other individual activities). This, in turn, requires setting up the machinery to select problems and then form, train, monitor and provide time and recognition for these teams. A company-wide Quality Council usually has this responsibility. Concepts of Benchmarking A benchmark is a point of reference by which performance is judged or measured. For quality, possible benchmarks go from the traditional to the unusual: The specification
Customer desires Competition Best in our industry Best in any industry
For survival in the marketplace, the traditional benchmark (the product specification) must be supplemented by measuring quality relative to competition; for quality leadership the
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benchmark must be the “best”. Xerox, for example, defines competitive benchmarking as “the continuous process of measuring our products, services and practices against our toughest competitors or those companies renowned as leaders.” Thus a benchmark for a photocopier product would be the best competitor in the photocopier industry; a benchmark for the Xerox system of packing warehouse orders might be the performance of a company in any industry, e.g., a mail order firm selling consumer products. The initial benchmarking steps are:
1. Determining the characteristics to be benchmarked 2. Determining the organizations from which data will be collected 3. Collecting and analyzing the data 4. Determining the “best in class”
Strategic plans are then developed to develop or adapt the “best practices”. Such strategies are, of course, directed at both retaining present customers and generating new ones. Usage of Quality Function Development
Attainment of quality requires the performance of a wide variety of identifiable activities or quality tasks. In a tiny enterprise, these tasks, (sometimes called work elements) may all be performed by a few persons. As the enterprise grows, however, specific tasks may become so time-consuming that we must create specialized departments to perform them. Corporations have created departments such as product design, manufacture, inspection and testing, etc., which are essential to launching any new or changed product. These functions follow a relatively unvarying sequence of events (see figure on spiral). In addition to the main “line” activities in the spiral, we need many administrative and support activities such as finance, human resources, warehousing, and data processing.
It is evident from the spiral that many activities and tasks must be performed to attain
fitness for use. Some of these are performed within manufacturing or service companies. Others are performed elsewhere, e.g., by suppliers, merchants, regulators, etc. It is convenient to have a shorthand name for this collection of activities, and the term “quality function” is used for this purpose. Quality function is the entire collection of activities through which we achieve fitness for use, no matter where these activities are performed.
Some practitioners look upon the spiral or the quality function as a system, i.e., a
network of activities or subsystems. Some of these subsystems correspond to segments of the spiral. Others, although not shown on the spiral, are nevertheless present and active, e.g., data processing, and standardization. These subsystems, when well designed and coordinated, become a unified system, which carries out the intended quality objectives.
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Spiral of Progress in quality.
Role of Inspection Inspection is performed for a wide variety of purposes. 1. Distinguishing between good and bad product 2. Determining if a process is changing 3. Measuring process capability 4. Rating product quality 5. Securing product design information 6. Rating the inspectors accuracy 7. Determining the precision of measuring instruments Each of these purposes has its special influence on the nature of the inspection and on the manner of doing it. Inspection, typically performed under static conditions on items such as components, can vary from simple visual examination to a series of complex measurements. The emphasis on inspection is to determine conformance to a standard. Usage of Pokayoke An important element of prevention is the concept of designing the process to error free through “error proofing” (the Japanese call it pokayoke or bakayoke ). A widely used form of error proofing is the design (or redesign) of the machines and tools (the “hardware”) so as to make human error improbable or even impossible. For example, components and tools may be designed with lugs and notches to achieve a lock-and-key effect,
Feedback
Market research
Use
Retailing
Specification
Wholesaling Customer Service
Marketing, administrative,
support
Production; process control
Inspection test
Manufacturing planning Purchasing
Suppliers
Market Research Product
development and design
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which makes it impossible to misassemble them. Tools may be designed to sense the presence and correctness of prior operations automatically or to stop the process on sensing depletion of the material supply. For example, in the textile industry a break in a thread releases a spring-loaded device, which stops the machine. Protective systems, e.g., fire detection, can be designed to be “fail-safe” and to sound alarms as well as all-clear signals. The second major form of error proofing is redundancy – requiring multiple improbable events to occur simultaneously before a defect can be created or can escape. Important process setups typically require multiple approvals. For example, the weighing out of the ingredients for a pharmaceutical batch must be done independently by each of two registered pharmacists. Look alike products may bear multiple identity codes (numbers, colors, shapes, etc.). Automated 100 percent testing may be superimposed on the process controls. The “countdown” so well dramatized during the pre-launch phases of a space vehicle is also form of redundancy.
A third approach helps human beings to reduce their own fallibility. Some of this involves magnifying normal human muscle strength and senses through programmed indexing of fixtures, optical magnification, viewing through closed-circuit television, simultaneous signals to multiple senses, etc. For example, ampoules of medicine may be dumped into a dye bath and left there overnight to simplify the discovery of cracks in the glass. Even in the review of documents there has recently emerged awareness that there are two kinds of review – active and passive. The former requires so positive a participation, e.g., reading a number out loud, that full attention is indispensable. The passive review, e.g., silently looking or listening, does not make full attention indispensable.
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Module 3
Introduction to ISO 9000 Series What is ISO?
The ISO 9000 Standard was developed in Geneva, Switzerland by the International Organization for Standardization (ISO) and is an internationally recognized quality benchmark that can be applied to any business in any environment. It was founded in 1946 to promote the development of international standard and related activities, including conformity assessment, to facilitate the exchange of goods, services, and to develop cooperation in intellectual, scientific, technological, and economic activity worldwide. ISO’s work covers all areas except those related to electrical and electronic engineering, which are covered by the International Electrotechnical Commission (IEC). The results of ISO’s technical work are published as International standards or Guides.
At present, it comprises the national standard bodies of 91 countries. The American
National Standards Institute (ANSI) is the member body representing the United States. ISO is made up of approximately 180 Technical Committees. Each technical committee is
responsible for one o many areas of specialization ranging from asbestos to zinc. There are two main variations of the Standard:
ISO 9001 – for businesses which design their own products/services ISO 9002 – for all other businesses
Applying the ISO 9000 Standard promotes a focus on the quality of an organization’s business and management processes, with the result that improved consistency of product/service delivery is achieved.
What is ISO 9000?
ISO 9000 is a series of Standards (published ISO) which define a framework of minimum requirements for the implementation of quality systems to be used in contractual situations identical to the EN series of standards (EN29000) and other national series. It has been adopted worldwide as suitable criteria for assessment and registration of companies of independent accredited third-party organizations (Registrars).
ISO 9000 standards provide a systematic approach to process management, requiring a
detailed account of procedures and operation. This system includes documentation of the processes of how a company designs, produces, inspects and packages, and installs its products. Its structure focuses on the management of all processes that affect quality.
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The ISO 9000 Standard Series is generic in scope. Each Standard addresses a different aspect of quality assurance, depending on the needs of the user. Who developed the ISO 9000 Series Standards?
ISO Technical Committee 176 (ISO/TC176) was formed in 1979 to harmonize the increasing international activity in quality management and quality assurance standards. Subcommittee 1 was established to determine common terminology. Subcommittee 2 was established to develop quality systems standards – the result being the ISO 9000 series, published in 1987 (revised 1994).
The United States had input into this development process through membership in ISO
via ANSI. This input was channeled through a Technical Advisory Group (TAG). The ISO 9000 standards were intended to be advisory in nature and were developed
primarily for use in two-party contractual situations for internal auditing. The ISO 9000 Standard Series has been adopted in the United States as the
ANSI/American Society for Quality Control (ASQC) Q90 Series (Soon to be changed to the ANSI/ASQC Q9000 series).
Statistics show that returns from ISO 9000 registration are both real and long lasting.
ISO Benefits
It will guide you to build quality into your product or service and avoid costly after-the-fact inspections, warranty costs, and rework. It will also reduce the number of audits customers perform on your operation.
Benefits of Implementing the ISO 9000 Standard
Improved management efficiency, internal communications and problems solving abilities
Less duplication and waste
Improved product/service quality, customer satisfaction and customer focus
Enhanced company image
Provides a framework for other improvement initiatives such as TQM and Benchmarking
Cost Vs Benefits
Companies paid $245,000 on average for costs associated with registration, including
auditing fees and internal expenses. Remember the costs are much lower for companies that
have some form of quality system in place.
Companies saved an average of $179,000 annually after registration.
Eighty percent of the registered companies say ISO 9000 registration influences their choice
of supplier.
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Almost 83% of the registered companies say they encourage some supplier to seek
registration and 34% encourage all suppliers to seek registration.
More than 80% of the registered companies say they use ISO 9000 registration as a criterion
for selecting suppliers.
ISO Sections
ISO 9000, ISO 9004 – statements of purpose and guidelines ISO 9001, 9002, 9003 – provide detailed requirements for quality assurance procedures.
ISO 9000 Series Breakout ISO 9000-1 (ANSI/ASQC Q90), Quality Management and Quality Assurance Standards – Guidelines for Selection and Use.
- This standard explains fundamental quality concepts; defines key terms; and provides guidance on selecting, using, and tailoring series and helps in the selection and use of the standards in the ISO 9000 family.
ISO 9001-1 (ANSI/ASQC Q91), Quality Systems – Model for Quality Assurance in Design/Development, Production, Installation and Servicing.
- This is the most comprehensive standard. It addresses all elements in the including design. The 1994 edition of the standard improved the consistency of the terminology and clarified or expanded the meaning of some of the standard’s clauses. Several new requirements, such as that for the quality planning, were also added.
ISO 9002 (ANSI/ASQC Q92), Quality Systems – Model for Quality Assurance in Production and Installation, and Servicing.
- Model for quality assurance in production, installation, addresses the prevention, detection and correction of the problems during production and installation. It is identical with ISO 9001, except that it does not include design requirements. The 1994 edition added servicing requirements to the 1987 edition.
ISO 9003 (ANSI/ASQC Q93), Quality Systems – Model for Quality Assurance in Final Inspection and Test.
- This is the least comprehensive standard. It addresses the detection and control of problems during final inspection and testing. The 1994 edition added additional requirements including: contract review; control of customer supplied product; corrective action; and internal quality audits.
ISO 9004-1 (ANSI/ASQC Q94), Quality Management and Quality System Elements – Guidelines.
- This standard provides guidance in developing and implementing an internal quality system and in determining the extent each quality system element is applicable. It is intended to assist a supplier in improving internal quality management procedures and practices – it is not intended for use in contractual, regulatory or registration applications. The 1994 edition contains new guidance and clarification of the guidance contained in the 1987 edition.
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Module 4 20 Elements of the ISO 9000 Series 1. Management Responsibility
Three important aspects: 1. Quality Policy
It is setting the goal. 2. Organization
a. Responsibility and Authority b. Verification Resources and Personnel c. Management Representative – liaison officer
3. Management Review Organizational Chart
An organization chart defines clear responsibilities for all people whose mark affects product quality. This include people who:
a. take action to prevent product effects, or b. identify and record any product quality problems, or c. recommend or provide solutions to product problems, or d. verify that quality problems have been solved, or e. control further work on a product until quality problems are solved.
The management representative typically carries out the following steps to gain and maintain compliance:
1. Write a quality manual and other documents necessary to a quality system. 2. Oversees conduct of internal audits, in compliance with the “Internal Audits” and
“Management Review” requirements of ISO 9001. 3. Request a “third party audit” from a recognized assessment agency when the
results of the internal audits are satisfactory, in order to gain ISO 9001 and registration.
4. Carries out periodic internal audits and management review even after registration is obtained.
2. Quality System GENERAL POLICY It is the network of processes that leads to the transformation of inputs (information, materials, energy, etc.) into products or services. A structure is required to manage processes, procedure to guide and resources required to implement these procedures.
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supplier – establish, document, and maintain a quality system. - prepare a quality manual covering ISO requirements. Steps for determining the necessary processes for the quality system: Step 1: Identification to core processes Methodology for core processes Mission -> Goals -> Plan -> Program -> Quality (Strategies, Projects and Objectives) Clients Charter Measurement <- Output <- Core processes Step 2: Outlining the work flow process
- steps and sequential activities
Procedure describes how many organizations manage its daily operations. It is the main document that controls the operations of quality system. It also gives clear guidelines and direction on the nature of activity. 3. Contract Review
GENERAL POLICY
In this element, supplier shall establish and maintain procedures for contract review and for the coordination of these activities. Each tender, contract, and order (statement of requirement) shall be reviewed by the supplier to ensure that: a) the requirements are adequately defined and documented. b) Any contract or accepted order requirements differing from those in their tender are
resolved. c) The suppliers can meet contracted or accepted order requirements.
In the amendment to contract, the supplier shall identify how amendment to a contract is made and correctly transferred to functions concerned within the supplier’s organization. Records of such contract reviews shall be maintained. 4. Design Control
Design Control is the fourth element of ISO 9000. Phases of Design Control: 1. Design and Development Planning 2. Organizational and Technical Interface
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2 Processes in Planning the Design: a. Project Proposal b. Project Plan
3. Design Input It is the most important in product development process.
Considerations in Developing Project Proposal: a. User performance expectations b. Technological viability c. Safety d. Reliability
4. Design Review 5. Design Output
It is the creation and transformation of product into a developed model that can be tested against specification.
Characteristics of an Outputted Products: a. Performance Characteristics b. Safety Characteristic
6. Design Verification Process: a. Performing alternative calculations b. Comparing the new design with the similar proven design, if available c. Undertaking test and demonstration. d. Reviewing the design stage demonstration before release.
7. Design changes 5. Document Control
GENERAL POLICY Document Control refers to the set of documents management features required to
control the access and use of electronic documents, as well as maintain a history of documents creation, distribution and usage.
Electronic Document Control has the ability to control the electronic document file in a computer network environment.
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4 key elements of EDC: 1. Access control – software has the ability to control the electronic file of the document at the operating system level and therefore can control who can or cannot access a file. 2. Function Control – provides the ability to define on a user by user basis what function can be performed. 3. Revision Control – prevents the accidental overwriting and loss of prior document revisions. 4. Discipline Control – sets the document rules to ensure that all users abide the rules with minimal supervision. These rules are: a. Allowing only one person to check-out a document at a time.
b. Prevent new document revisions from overwriting the original document. c. Assure that only authorized personnel may view critical documents.
Document Control System has a main group of people, namely:
1. End-users 2. Management 3. Regulators
END-USERS
The people who use the system on day to day basis. MANAGEMENT
They are the managers and they are not using the system regularly, but have real interest in its success.
REGULATORS
One who will be certifying the system that has a certain set of requirements that must be met. Controls are also ensured that: 1. The pertinent issues of appropriate documents are available wherever essentials to the effective functioning of the quality systems are performed. 2. Invalid and/or obsolete documents are promptly removed from all points of issue or use, are otherwise assured against unintended use. 3. Any obsolete documents retained for legal and/or knowledge preservation purposes are suitably identified. Document – life-blood of the business requirement. Forms: form, slip, report, control, receipt
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The document changes have the following feature: a. Document integrity b. Access control c. Audit trail d. Master list e. Sign-off information 6. Purchasing
The following are the requirements of purchasing: a. Evaluation of Subcontractors b. Purchasing data c. Verification of purchased product 1. Supplier verification of subcontractors 2. Customer verification of subcontracted products.
PURCHASING DATA
Purchasing documents shall contain data clearly describing the product order, including, where applicable:
a. the type, class, grade or other precise identification. b. the title or other positive identification and applicable issue of specification, drawing, process requirements, inspection instructions, and other relevant technical data, including requirements for approval or qualification of product, procedures, process equipment, and personnel. c. the title, number and issue of the quality system standard to be applied. The supplier shall review and approve purchasing documents for adequacy of supplied requirements prior to release. 7 Purchaser-Supplied Product Purchaser-supplied product includes: a. Verification of customer-supplied product b. Storage of customer-supplied product c. Maintenance of customer-supplied product 1. Preventive 2. Corrective
Customer
equipment
Supplier A Supplier B
Equipment &
Equipment
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8. Product Identification and Traceability GENERAL POLICY
A part number correlated to corresponding drawings, specifications and technical
documents identifies materials, components, subassemblies and products. Serial numbers, or lot numbers, or date of manufacture, as applicable uniquely identifies finished products. KEY COMPONENTS
a. a process/method for identification of products. b. a process to allow traceability of unique product or batch where required. c. procedure to ensure the use of the system agreed, and how this will relate to nonconformance reporting, inspection, and testing.
PROCEDURAL POLICIES
1. Responsibility
1.1 Production and Inventory Control department (PIC) is responsible for assigning serial nos. Document Control is responsible for assigning parts numbers.
1.2 Receiving and Production are responsible for making purchased product and manufactured parts/subassemblies, respectively. All personnel handling products and responsible for maintaining the identification.
1.3 Packaging personnel are responsible for labeling finished product with their identification
labels; including serial nos., lot nos., or date codes, where applicable. 2. Materials, Part and Product Identification
3. Records
Document Control department maintains the part number and associated technical documentation. Serial number, lot number, or date code of a product is a key to correlation with its part list, technical documentation and quality records.
9. Process Control
GENERAL POLICY
Process Control is the development of documented work instructions for all process that
affect the quality of the product. It is the general term applied to describe the many methods of regulating the variables
involved in industrial operations.
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Process Control Loops:
1. measurement 2. evaluation 3. adjustments
PROCESSES
The results of which cannot be fully verified by subsequent inspection and testing of product. It denotes all activities connected with production (manufacturing). It also includes all steps necessary to perform a service Process control includes:
1. control of the working environment
a. temperature – affects spin coating processes, painting and other b. humidity c. particulate contamination d. noise and vibration e. elastic discharge f. bacterial contamination
2. Control of the manufacturing process
- Statistical process control - Automatic feedback process control 3. Preventive Maintenance Production planning is the key requirement of this standard. Control of a process involves: 1. work instructions 2. process monitoring approval 3. the use of workmanship standards
TWO WAYS 1. Process Control is controlling the processes through which the product passes. 2. Product Control is controlling the product of the elements that drive the process.
A. Planning Production, Installation and Servicing processes
1. Production Requirement – needed to identify the production processes required to produce a particular product.
2. Implementation Plan – route
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3. Installation Plan
B. Ensuring that the work is carried out under controlled conditions.
1. Production Plans
2. Installation Plans – site surveys, site preparation, transport and delivery of equipment, inspection of equipment entering the site.
C. Documented Procedures Control procedure to prevent problems. D. Suitable production, installation and servicing equipment
E. Suitable working environments
F. Compliance with government safety and environmental regulations applicable government
G. Compliance with reference documents
H. Controlling process and product characteristics
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Establish and maintain documented procedures for inspection and testing activities in
order to verify that the specified requirements for the product are met. 11. Inspection, Measuring and Test Equipment GENERAL POLICY
Inspection, measuring and test equipment shall be controlled in a manner which ensures that the measurement uncertainty is known and is consistent with the required measurement capability.
Requirement: To prepare and document procedures to control, calibrate and maintain equipment used
for inspection, measurement and product testing.
Calibration is the process of periodically comparing the equipment against reference standards to determine how accurate it is and whether or not, it is still capable of meeting the precision requirement.
Equipment is to be calibrated once every six months.
2 Systems: 1. In-house Measurement and Calibration System 2. External Calibration Laboratory UKAS (United Kingdom Accreditation Service) is recognized by the DTI as the sole national body responsible for assessing and accrediting organization performing calibration, testing and sampling. 12. Inspection and Test Status GENERAL POLICY
It requires a company or a supplier to develop and implement procedures to identify a product.
Scope of Requirements: 1. Identification Requirements 2. Verification Status Maintenance of Inspection and Test Status Do’s and Don’ts: 1. Don’t reassign inspection stamps to another individual 2. Do secure stamps for unauthorized use. 3. Don’t leave stamps unattended. 4. Don’t lend your stamps to another person 5. Don’t stamp any document unless you have personally inspected an item. 6. Don’t stamp any document unless there is a proper location to place the stamp because it
could mean anything.
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Note: A stamp has to indicate that the specified requirements have been met. 13. Control of Nonconforming Product GENERAL POLICY
The supplier shall establish and maintain procedures to ensure that the product that does not conform to specified requirements prevented from unintended use or installation. Control shall provide for identification, documentation, evaluation, segregation, and disposition of non-conforming products and notifications to the functions concerned.
IDENTIFICATION AND DOCUMENTATION
When a non-conformance is noted, it is documented on the non-conformance form (NCF). The top half of the form is designated for describing the specific details of non-conformity. The bottom half of the form is filled out by the Quality Assurance Manager.
NON-CONFORMITY DISPOSITION
It states that the following have to be accounted for in your system:
Define responsibility for review and disposition Written procedure has to be in place Identify, document evaluation, disposition non-conforming goods Segregate where possible Notify the appropriate people Notify customers when “ use as is”, repair or rework is conducted Re-inspect repaired or reworked material according to your quality control plan Rework instructions shall be readily available The network material will be analyzed to determine prevention methods in the future. Visually critical rework needs a customer sign-off Written authorization is needed from the customer before shipping goods that deviate from
the established quality area The options are that it may be: - reworked to meet the specified requirement - accepted as is with or without repair by 14. Corrective Action Your company must have a system and written procedure for: 1. Investigating the cause of a problem (including nonconforming goods) 2. Investigating the action needed to prevent reoccurrence 3. Actively look for potential cause of problems 4. Respond to problem in proportion to the situation 5. Make certain that corrective action are taken effectively 6. Make change in your system as needed 7. Give appropriate records of corrective actions and their effect.
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Level 1: Document Begin by identifying the authority for the corrective action system.
Level 2: Document You need to plan a corrective action that makes sense for your company.
Level 3: Document
CAR is one opportunity to let ISO 9000 make your company more efficient. CORRECTIVE ACTIONS
These are the actions that an organization takes in order to fix the immediate problem.
Key actions that must be described in procedures and must be recorded when they occur: customer complaints must be processed non-conformities of goods or services, processes and the quality system must be processed determination of actions to eliminate the cause of the nonconformance system to ensure the action has actually been taken and it was effective PREVENTIVE ACTIONS
The actions that an organization takes in order to prevent recurrence of the problem 15. Handling, Storage, Packaging and Delivery GENERAL POLICY
It deals with product after its final inspection
HANDLING Handling Methods: 1. handling and lifting mechanism 2. training of personnel STORAGE 3 Basic Requirements: 1. Storage areas are adequate and secure 2. Movement of goods in and out of storage areas is controlled 3. Condition of goods is assessed regularly PRESERVATION
Appropriate methods for preservation and segregation of product shall be applied when such product is under the suppliers’ control.
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HANDLING PROVISIONS Lifting equipment Pallets and container Conveyors and stackers Design features for enabling handling of the product Handling of electrostatic sensitive devices Handling of hazardous materials Handling of fragile materials PACKAGING 2 Levels: 1. defining general requirements, authority and responsibility 2. other specifications and instructions established and maintained by packing or shipping
department. DELIVERY 100% on-time shipments 16. Quality Records GENERAL POLICY
Documented procedures for identification, collection, indexing, access, filing, storage, maintenance and disposition of quality records. 17. Internal Quality Audits WHAT IS QUALITY AUDIT?
“ A systematic and independent examination to determine whether quality activities and related results comply with planned arrangements and whether these arrangements are implemented efficiently and are suitable to achieve objectives.”
Internal audit, corrective action and follow-up are the mechanisms essential to the improvement of the quality system. Authority and Responsibility of Auditor AUTHORITY 1. Authorized to examine any office, department, political or subdivision or organization. 2. Have access to all of the record properties, and personnel relevant to the subject under
review.
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3. Internal auditor will provide assistance as necessary, towards implementation of the recommendations.
RESPONSIBILITIES 1. To appraise the adequacy and completeness of internal controls. 2. To confirm compliance with the will of the board of county commissions. 3. To discuss findings and recommendations. 4. To conduct an “exit interview”. 5. To submit an official audit report AUDIT OBJECTIVES 1. To determine the conformity and non-conformity of the system 2. To determine the effectiveness of the implemented quality system 3. To provide auditee with an opportunity to improve the system 4. To meet regulatory requirements
Auditee is the organization being audited.
Auditor is an external public accountant hired by a company to independently examine the company’s financial records and quality system.
Client is the organization that asked for the audit. It could be an auditee, customer, regulatory body and registrar. A client may initiate an audit because:
a. A regulatory agency requires the audit b. A previous audit indicated that a follow-up audit was needed c. An auditee has made important changes.
BENEFITS Increased management confidence Identify system deficiencies Interchange ideas Increased commitment and motivation 2 Auditors: 1. external auditor – independent 2. internal auditors – dependent Starting the IQA: 1. Start the quality audit 2. Prepare the checklist working papers 3. Collect evidence 4. Confirm investigation evidence 5. Investigate dues 6. Document observations 7. List non-conformities 8. Draw conclusions
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9. Discuss reports 10. Prepare audit reports 11. Submit the report 12. Take remedial actions 18. Training
GENERAL POLICY
Identifying training needs and provide for the training of all personnel performing
activities affecting quality. 19. Servicing It is an activity that primarily applies to manufactured products. It means to replenish consumables needed to keep on item in operating condition. Servicing includes: after sales service product support help lines customer service inquiry desks others 20. Statistical Procedures/Techniques Statistical Techniques includes: - identification of needs - procedures ISO 9000 Series Compliance Checklist
Elements ISO 9002 ISO 9003
1. Management Responsibility √ √
2. Quality System √ √
3. Contract Review √ X
4. Design Control X X
5. Document Control √ √
6. Purchasing √ X
7. Purchaser - Supplied Product √ X
8. Product Identification and Traceability √ √
9. Process Control √ X
10. Inspection and Testing √ √
11. Inspection, Measuring and Test Equipment √ √
12. Inspection and Test Status √ √
13. Control of Nonconforming Product √ √
14. Corrective Action √ X
15. Handling, Storage, Packaging and Delivery √ √
16. Quality Records √ √
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17. Internal Quality Audit √ X
18. Training √ √
19. Servicing X X
20. Statistical Techniques √ √
Module 5 On the Road to Certification Span of Time in Undertaking Certification
The amount of time it takes you to certify to one of the ISO standards depends on the current state of your quality system and documentation:
If your company uses a quality system framework such as Category 5 of the Baldrige Criteria
(Management of Process Quality) or MIL-Q-9858A, you may search ISO 9000 series conformance in less than 12 months with a minimum of consulting help.
If your company has sketchy procedures or is relatively unsophisticated in the application of
the quality methods and procedures you might reach ISO 9000 series conformance from 12
to 15 months. If your company is starting a quality system from scratch and you have less than a full
commitment from your senior leadership, it will take you up to and beyond 24 months to reach ISO 9000 level quality.
Another rate of criterion: Research on certification shows an initial ISO 9000 series failure rate
about 60% for companies that try to prepare without outside consulting help. My advice is that the more sophisticated your company is on ISO 9000, the more need you have for outside help. Cost of Certification
First think of ISO 9000 series certificate of registration in terms of the benefits. The
benefits you get depend on your industry and your particular business but they can’t be sizable. Some facilities recoup the cost associated with ISO 9000 in as little as 9 months.
Total costs do vary on the size of your plant and your industry but there are some
ballpark figures for a company of modest size:
Total consulting fees, based on fees of $1,000 per day, might fall between $25,000 to
$80,000 The fees to the registrar you select are $1,000 per day plus travel and expenses for a
minimum of 10 days. At very least, a registrar will bill you for one or two days for the initial visit, a two or three preliminary audit and a three to five day registration audit. Thus total registrar fees may range from $10,000 to $30,000.
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Your total cost (consulting and registrar) will range anywhere from $35,000 to $11,000 plus. The smaller the firm, normally the lower the total cost.
Remember, certification to an ISO 9000 series standard requires your firm to undergo surveillance audit about every six months and an entire re-audit every three years. Steps of Certification
Corrective Action
Consult National Register of
Certification Bodies
Select a Certification Body
Initial Site Visit
Initial Site Visit Report Submitted
Submit Quality System
Documentation
Quality System Documentation Audit
Initial Implementation
Audit
Report Submitted Corrective Action
Major Nonconformit
y?
Withdraw Certification
Periodic
Documentation & Implementation Audit
Recommendation
Corrective Action
Conformity?
Suspension Criteria met?
Issue/Renewal of
Certificate
Noncorformity follow-
up Action
yes
yes
yes
no
no
no
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Registration Process
Registration can take between 6 to 18 months depending on company size, commitment, human resources, existing systems and customer demands and pressures. There are 4 distinct phases:
PREPARATION
Employees are briefed, existing processes examined. DEVELOPMENT
ISO 9000 quality requirements are compared to your current processes and reviewed to determine required modifications.
IMPLEMENTATION
The new procedures are formalized in a quality manual. The employees are educated and trained to follows the manuals procedures.
CERTIFICATION
Your manual is submitted to third party Registrar. Upon approval, as well as successful completion of an on-site audit, registration certificate is awarded.
