quality management system
Content
UNIT IV QUALITY SYSTEMS CHAPTER 8 INTRODUCTION
LESSON 40: QUALITY MANAGEMENT SYSTEMS
Introduction The central need for for reliable reliable products in tthe he Second World World War defence procurement focused focused on tight tight specificati cifications ons and consistency in product. This This was essential if the operationa tional researchers were to see the efficiency iciency of their models converted converted into military victory. victory. The The responsibility sponsibility was seen quite naturally to rest with the the suppliers because checks could not not reasonably onably or effectively effectively be carried out on the battle-ground. ttle-ground. Not surprisingly, therefore, postpost-wa war developments saw the quality lity drive being governed by diff different industries industries with dif different systems of standards. The The Internationa tionall Organ rganization ization for Standardization rdization (IS (I SO) was founde founded in 1946.It 6.It is is headquartered in Gene G eneva, Switzer itzerland. land. Its Its manda mandate te is to to promote the development of iinterna nternational tional standards to facili facilitate tate the exchange of goods and standards worldwide. T The he purpose of ISO is to to facilitate facilitate global co conse nsensus agreements on international international quality lity standards. It It has resulted in a systemfor certifying certifying suppliers suppliers to make sure they meet internationally internationally accepted standards for for quality lity management. It is a non-governm non- government organization. nization. ISO has as its members the national standa standards organizatio nizations ns for for more than 130 countries.
In the United United States the national standa standards arepublished published by the American National Ins Institute/ American Society for for Quality (ANSI/ ASQ) as as the the ANSI/ ASQ Q9000 Q9000series. The ISO 9000 Series of Standards is generic in in scope. By design, the the series can be tailored tailored to fit fit any organization’s needs, whether it is large or small, ll, a manufacturer or a service organization. Its purpose is to unify quality terms and definitions used by industrializ industrialized ed nations tions and usethose those terms to demonstrate onstrate a supplier’s capability pability of controll controlling ing its processes processes. In very simplif simplified terms, the the standards require an organization nization to say what it is is doing doing to ensurequality, lity, then then do what it it says, and, finally, finally, docume document or prove prove that it has done what it said. The objective objective of quality lity management is to quickly produce safe products, with lo low w costs, and to customer customer satisfacti tisfaction. on. Eg: In In the agri- food ood sector, quality management is especially important, and for the following reasons: •
•
During the 1970s it was generally acknowledged that the word quality lity had diff dif ferent meanings within and among industries and countries countries and around the world. orld. In 1979 the British Standards Instit Institute ute (BSI) in in the United Kingdom, ingdom, utili utilizing zing the quality lity standards of the U.S. Depa D epartment of of Defense standards MILMIL-Q9858 of the 1950s as the basis, published published the first first general standa standards BS 5750 that applied applied to a broad range of businesses and organizations. nizations. In the same year, BS BSI, recognizing recognizing the need for for standardization rdization for quality quality management and assurance, submitted submitted a forma formal proposal to ISO to develop international standards for quality assurance techniques techniques and practices. Using standard that already existed in the United Kingdom K ingdom and Canada as a basis, ISO established generic quality lity standards, primarily for manufacturing firms, that could be used worldwide. The The ISO 9000 series of qualityquality-ma management standards, guidelines, idelines, and technical technical reports, was first first published published in 1987, and it is review reviewed at least every fi five ve years. The IS ISO 9000 series was heavily avily based on on BS 5750, but reflected reflected interna international tional requirements and lessons lea learnt from from eight years use of BS 5750. In the meantime, other other standards were developed loped for for the the European Community (EN (EN 29000).Now, 00).Now, IS ISO 9000, BS 5750 and EN 29000 have been harmonized rmonized and are equivalent. quivalent. Most member countries countries of ISO have adopted dopted the ISO ISO 9000 series as their national standards.Likewise, thousands of organizations throughout the the world orld have quality lity systems registered to one one of the standards.
•
Agricultural products ofte ften perish because of physiological processes and microbiolo microbiologica gical contamination, tion, Agricultural products are very heterogeneous and the quality parameters for for components like like sugar, size and colour, colour, which are very important for for proces processing, have to be controlled, A large number of farms produce agricultural products on a small scale (LUNING (LUNING et al., 2002).
Many diff different quality lity systems have been developed veloped in the agrifood ood sector during thepast ten years and will ill continue continue to be developed. Reasons are, in particular ticular, numerous food food scandals and globalizati lobalization. on. These quality lity systems are organised in diff different ways. There Therearecontractually lly coordinated coordinated chain organisations, tions, and chain organisations nisations with “reg “regulated” or “participativ participative” e” quality management. The The consequencesinclude include e.g., diff different informa information tion flows flows in these quality lity systems (HELBIG, 2002). ISO 9000 ISO 9000 is a generic system that specifies, specifies, in in very broad terms, the necessary components components of a quality lity management system. Rather than being specific cific to any one industry, it it details the basic requirements of the quality lity function function for for all industries. Certificatio Certification n IS ISO 9000 was originally published in 1987by the Interna nternatio tiona nall Organizatio anization n for for Standa Standardization, rdization, a worldwide federation of of national standards bodies, bodies, headquartered in in Geneva, Switzerlan itzerland. The The organization nization was founde founded in 1946 to develop a comm common set of of standards for for manufacturing, trade and communications. unications. Today Today more than90 countries are members, each with a representative. The representative for for the the United States is the the American Natio National nal Standards Instit Institute ute (ANSI).
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The concept of Certification ISO 9000 was developed in part becauseof the European push toward afully integrated common market. It was recognized that for the common market to exist, there would have to be assurance of quality across borders. The European Economic Community, (now the European Union, or EU), adopted Certification ISO 9000 as the basic minimal quality management system for selling certain products (electronic components and construction equipment) within the European Union ISO 9000 Series of Standards:
regulatory requirements in order to achieve customer satisfaction. ιιι
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The five standards of the series are described briefly below:
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ISO 9000, “Quality Management and Quality Assurance Standards Guidelines for selection and use,” explains fundamental quality concepts, defines key terms, and provides guidelines for selecting, using, and tailoring the ISO 9001, 9002, and 9003standards. IT is the roadmap for the use of the entire series. ISO 9001, “Quality Systems-Model for Quality Assurance in Design, Development, Production, Installation, and Servicing,” is the most comprehensive standard in the series. It contains 20 elements covering the need for an effective quality system, from the receipt of a contract through the design/ development stage, and finally the service required after delivery. ISO 9002, “Quality Systems-Model for Quality Assurance in Production, Installation, and Servicing,” addresses the prevention, detection, and correction of problems during production and installation. It is for the use of those organizations that arenot involved in design. This standard addresses 19 of the 20 elements covered in the 9001 standard. ISO 9003, “Quality Systems-Model for Quality Assurance in Final Inspection and Test,” is the least comprehensive of the standards, covering 16of the 20 elements in 9001. It is not a quality control system. ISO 9003 addresses only those requirements for the detection and control of problems found during final inspection and testing. ISO 9004-1, “Quality Management and Quality System Elements-Guidelines,” provides guidance for a supplier to use in developing and implementing a quality system and in determining the extent to which each quality system element is applicable. It examines each of the elements in greater detail. In this respect it is useful for internal auditing purposes.
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ISO 9001:2000, Quality Management SystemsRequirements, is the requirement standard a company uses to assess its ability to meet customer and applicable
The ISO 9001:2000 standard replaces the ISO 9001:1994, ISO 9002:1994 and ISO 9003:1994 standards. Although an organization can continue to be certified to thesestandards until December 2003, if they so choose. Many companiesaround the world require that companies they do business with (e.g., suppliers) have ISO 9000 certification. In that way, despite possible language, technology, and cultural differences, a company can be sure that the company it’s doing business with meets uniform standards. If a manufacturer wants to purchasefrom a non-certified supplier, the manufacturer should visit the supplier and examine its processes, past performances, workers’ credentials, and so on to verify that the supplier can meet the required quality levels and performance schedule. It is easier, cheaper, quicker, and legally safer to select an already certified supplier. Therearethree forms of certification:
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First party: A firm audits itself against ISO 9000standards.
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Second party: A customeraudits its supplier.
iii Third party: A “qualified” national or international standards or certifying agency serves as auditor. •
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The ISO 9000 series was most recently revised and updated in 2000. ISO 9000:2000, Quality Management SystemsFundamentals and Vocabulary, is the starting point for understanding the standards. It defines the fundamental terms and definitions used in the ISO 9000 family of standards, guidelines, and technical reports.
ISO 9001, 9002 and 9003 standards have been consolidated into the single revised ISO 9001:2000standard.
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Other Quality Systems: •
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ISO 9004:2000, Quality Management Systems-Guidelines for performanceimprovements, providesdetailedguidance to a company for the continual improvement of its qualitymanagement system in order to achieve and sustain customer satisfaction.
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Certification involves getting theproper documents, initiating the required procedures and practices, and conducting internal audits (first party certification). This can befollowed by a second- or third-party audit as desired. In a two-party system, a customer would audit the quality system of a supplier for acceptability resulting in costly multiple audits. The best certification of a firm is through athird party. A third-party company called a registrar is the only authorized entity that canawardISO 9000 certification. Registrars are accredited by an authoritative national body and are contracted by companies for a fee to evaluate their quality-management system to see if it meets the ISO 9000 standards. A quality system certification involves the assessment and periodic surveillance audit of the adequacy of a supplier’s quality system by a registrar. When asupplier’s systemconforms to the registrar’s interpretation of the standard, the registrar issues a certification to that effect to the supplier.
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This certification ensures customers or potential customers that a supplier has a quality system in placeand it is being monitored. Once passed by the third-party audit, a firm is certified and maybe registered and recorded as having achieved ISO 9000 status, and it becomes part of a registry of certified companies recognized throughout the world. Therearevarious reasons for implementing a quality system that conforms to an ISO standard:
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Customer or marketing are suggesting or demanding compliance to a quality system. ii Need for improvements in processes or systems. iii Desirefor global deployment of products and services. iv As more and more organizations become registered, they arerequiring their subcontractors or suppliers to be registered, creating a snowball effect. •
Most organizations have found that implementing ISO 9000 systems have benefited them in the following ways:
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Fewer on-siteaudits by customers.
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Increased market share.
iii Improved quality, both internally and externally (fewer complaints). iv Improved product and service quality levels from suppliers. v Greater awareness of quality by employees. vi A documented formal system. vii Reduced operating costs. AS9000:The Aerospace Standards The aerospace industry requires that all elements of production and supply chain operate to levels of quality and performance that assure safe and reliable products. The Americas Aerospace Quality Group (AAQG) in cooperation with many aerospace companies developed specific requirements for quality systems that are to be implemented and maintained by the complete production and supply chain in the manufacture of products used in aviation and space applications. AS9000/AS9100 AS9100 includes ASQ9001:2000 quality system requirements and specifies additional requirements for the quality system of the aerospace industry. Examples of common and unique aerospace requirements found in AS9000/ AS9100 are: •
Identification and Control of Key Characteristics
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Stamp Control
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Foreign Object Detection (FOD)
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Requirements Flow Down
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Tooling Control
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AS9103 Variation Management of Key Characteristics: Established variation management requirements for Key Characteristics. This standard also specifies general requirements and provides aprocess to achieve those requirements. AS9120: This standard includes ISO 9001:2000 quality management system requirements and specifies additional requirements for a quality management system for the aerospace industry applicable to stockist distributors. AS9131 Quality Systems Non-Conformance Documentation: This document defines to supplier/ subcontractor common information and documentation required to inform customers, when applicable about nonconformity (Customer-provider use). Tooling & Equipment (TE 9000) The industries tooling and equipment supplement to QS9000
The tooling and equipment (TE) is an addition to the QS-9000, a requirement by most tooling and equipment suppliers within the automotive industry. The Standards Council of Canada (SCC) accredits registration bodies to register organizations to the requirements of TE9000 as part of its qualification programfor QS-9000 (automotive). TE-9000 outlines the fundamental quality management system expectations of automotive companies for their tooling and equipment suppliers QS 9000 Purpose Improving relationships to improve quality
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“The goal of developing your suppliers is based on the need to provide high quality to the customer.” Enhance quality systems for suppliers
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Eliminate redundant requirements
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Reducecosts
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Fundamentally different from ISO 9000.
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Customer and Regulatory Agency Involvement and Approval
AS9101A Quality System Assessment: The checklist corresponding to AS9100 Revision A.
AS9102 Aerospace First Article Inspection Requirement: Established the requirements for First Article Inspection. The purpose of First Article Inspection is to provide objective evidence that all engineering design and specification requirements are properly understood, accounted for, verified, and documented.
Designed to help suppliers to automakers provide evidence of standardized processes for dealing with customers. Major automobile manufacturer’s setup teams with suppliers to help in development.
Advantages •
Organization for International Standards
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European standards for quality
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Standards are broad and vague to adapt to different cultures
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Does NOT provide framework for organizational improvement and change Companies document quality systems in manuals to facilitate trade through supplier conformance
Quality Perspective
Success has created various other standards such as QS 9000
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What is your definition / perception of quality?
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Were your expectations met? Why? Why not?
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What are some of your suggestions for improvement (documentation and presentation)?
Disadvantages
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Not all countries accept ISO registrars
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Mainly for exporting firms
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Barrier to trade
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Time consuming
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Costly
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Difficult for small firms to afford Discourages free thinking and employeeempowerment
Exercise Q1.What is ISO ? Q2.Briefly explain the Objectives of each of the five ISO 9000 standards? Q3.Which are the five ISO 9000 series of standards? Q4.Write in brief about The ISO 9000 series which was most recently revised and updated in 2000. Q5.Explain QS 9000& TE 9000? Q6.What are the advantages and disadvantages of ISO?
QS 9000
QS 9000
o o o o o o o o o o
Introduction Purpose ISO 9000 Background Requirements Real World Examples Interactive Exercise Conclusion Suggested Readings References
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QS 9000 Purpose
What is ISO 9000?
Improving relationships to improve quality
Advantages o Organization for International Standards o European standards for quality o Standards are broad and vague to adapt to different cultures o Companies document quality systems in manuals to facilitate trade through supplier conformance o Success has created various other standards such as QS 9000
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“The goal of developing your suppliers is based on the need to provide high quality to the customer.”
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Enhance quality systems for suppliers
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Eliminate redundant requirements
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Reduce costs
QS 9000 Purpose
What is ISO 9000?
(continued)
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Fundamentally different from ISO 9000.
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Designed to help suppliers to automakers provide evidence of standardized processes for dealing with customers.
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Major automobile manufacturers setup teams with suppliers to help in development.
(continued)
Disadvantages o Not all countries accept ISO registrars o Mainly for exporting firms o Barrier to trade o Time consuming o Costly o Difficult for small firms to afford o Discourages free thinking and employee empowerment
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Background Information What is the me aning of Q S-9000? o Quality System Requirements o Common supplier quality standard (Big Three): n n n
o o
Chrysler Corporation Ford Motor Company General Motors Corporation
Applies to suppliers of: n n n
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production materials production and service parts heat treating painting and plating other finishing services
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Q. Does QS-9000 apply to external suppliers only, or do the Big Three also have to comply with it? A. QS- 9000 applies to external and internal suppliers of the products and services explained above. An external supplier is a company not owned by the Big Three. This includes most of what is thought of when considering the "supply base." However, many divisions of Big Three companies supply their competitors as well as their own pl ants. For example, it is not unusual for a Ford plant to sell component products to Ford, Chrysler, and General Motors divisions. In all such cases, these Big Three plants are external suppliers to the other companies and QS-9000 applies to them. In addition, within the Big Three companies, QS-9000 is being required of many of the internal supplying divisions. The timing requirements for internal divisions are the same as for external suppliers.
Does NOT apply to all suppliers of Big Three
Background Information o
What is QS -9000?
o
QS-9000 is the shorthand name for "Quality System Requirements QS-9000." It is the common supplier quality standard for Chrysler Corporation, Ford Motor Company, and General Motors Corporation. QS-9000 is based on the 1994 edition of ISO 9001, but it contains additional requirements that are particular to the automotive industry. These additions are considered automotive "interpretations" by the ISO community of accreditation bodies and registrars. QS -9000 applies to suppliers of production materials, production and service parts, heat treating, painting and plating and other finishing services. It does not, t herefor e, apply to all suppliers of the Big Three. QS - 9000 applies to external and internal suppliers of the products and services explained above. An external supplier is a company not owned by the Big Three. This includes most of what is thought of when considering the "supply base." However, many divisions of Big Three companies supply their competitors as well as their own plants. For exampl e, it is not unusual for a Ford plant to sell component products to Ford, Chrysler, and General Motors divisions. In all such cases, these Big Three plants are external suppliers to the other companies and QS-9000 applies to them. In addition, within the Big Three companies, QS-9000 is being required of many of the internal supplying divisions. The timing requirements for internal divisions are th e same as for external suppliers.
o o
(continued)
TE-9000 n n
Tooling and Equipment Supplement Internal shorthand as supplement to QS 9000
Worldwide Commitment n
Released throughout North America, several countries of South America, Europe, Australia and Asia
Compliance audits by qualified ISO 9001 registrars: n n n
Internal Customer (second-party) Third-party
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QS 9000 Requirements
QS 9000 Requirements
Management responsibility
Management Responsibility
o
“defining and documenting its policies for quality along with its objectives and its level of commitment. Clear lines of authority are drawn, assigning responsibility for managing, performing and verifying all work affecting quality.” “should be viewed as a strategic imperative for all of a supplier’s personnel. A supplier firm must have documented procedures for assessing training needs and for training all personnel who might impact a company’s quality. Records of past training must also be kept.”
QS 9000 Requirements 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20.
Design input
Quality policy
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Design output
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Organization
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Design review
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Resources
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Design verification
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Management representative
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Design validation
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Organizational interface
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Design changes
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Business plan
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Training o
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(continued)
Management responsibility Quality system Contract review Design control Document and data control Purchasing Control of customer -supplied product Product identification and traceability Process control Inspection and testing Control of inspection, measuring and test equipment Inspection and test status Control of nonconforming product Corrective and preventive action Handling, storage, packaging, preservation and delivery Control of quality records Internal quality audits Training Servicing Statistical techniques
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Analysis and use of company -level data Customer satisfaction
Quality System Requirements o
General
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Quality system procedures
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Quality planning
Design Control Requirements o
General Information
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Design and development planning n
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(continued)
Required skills
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Special characteristics
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Use of cross-functional teams
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Feasibility reviews The control plan
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Organizational, technical interfaces
Name some common requirement processes o
Common processes n n n
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Documentation Testing Implementation
Processes used to enhance supplier quality systems, eliminate redundant requirements and reduce costs.
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Points to Ponder
What are some supply chain priorities? o
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Supply Chain Priorities by auto assemblers, direct suppliers and indirect suppliers order of importance. 1.
Consistency
2.
Reliability
3. 4.
Relationship Technological capability
5.
Flexibility
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Price
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Service Finances
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Real World Example II “Few businesses survive their first 6 months, much less earn their QS 9000 and ISO 9002 certifications in the first half of the year. Nu Tech Plastics Engineering, a Tier One and Two automotive supplier, not only did both, but it also fulfilled its founder's goal of creating a business niche in taking on so-called problem jobs. Barely three years old, the company has built a $20 million a year business on solving other people's problems. Elektra all-electric molding machines and the company's process tuning shaved 12 seconds from the tool's cycle time.”
Tooling & Equipment (TE 9000)
Real World Example I
o
“Supplier Services Inc. (SSI)’s stated goal is to work with small and medium-sized manufacturers to achieve compliance with ISO 9000, QS 9000 and other industryspecific quality system requirements. Their message to those manufacturers or their suppliers is that while it is extremely difficult to manage quality and manufacturing standards when everyone expects fewer people to do the job, SSI is available to fill that organizational void with their own brand of expertise.”
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The tooling and equipment (TE) is an addition to the QS-9000, a requirement by most tooling and equipment suppliers within the automotive industry. The Standards Council of Canada (SCC) accredits registration bodies to register organizations to the requirements of TE-9000 as part of its qualification program for QS-9000 (automotive). TE-9000 outlines the fundamental quality management system expectations of automotive companies for their tooling and equipment suppliers It applies QS-9000 to suppliers of tooling, equipment, and related products.
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The Aerospace Standards o
The aerospace industry requires that all elements of production and supply chain operate to levels of quality and performance that assure safe and reliable products. The Americas Aerospace Quality Group (AAQG) in cooperation with many aerospace companies developed specific requirements for quality systems that are to be implemented and maintained by the complete production and supply chain in the manufacture of products used in aviation and space applications.
How does AS9100 differ from ISO 9001? As with other sector-specific standards, AS9100, Revision A, includes all the existing elements of ISO 9001 (both the 1994 and 2000 versions), and a variety of aerospace-sector -specific requirements. ISO/TS 16949 and TL 9000 follow a similar approach in the automotive and telecommunications industries respectively. o Who controls the requirements of AS9100? o As with other sector-specific standards, AS9100, Revision A, includes all the existing elements of ISO 9001 (both the 1994 and 2000 versions), and a variety of aerospace-sector -specific requirements. ISO/TS 16949 and TL 9000 follow a similar approach in the automotive and telecommunications industries respectively. o o
AS9000/AS9100: AS9100 includes ASQ9001:2000 quality system requirements and specifies additional requirements for the quality system of the aerospace industry. o Examples of common and unique aerospace requirements found in AS9000/AS9100 are: o Identification and Control of Key Characteristics o Stamp Control o Foreign Object Detection (FOD) o Requirements Flow Down o Tooling Control o Customer and Regulatory Agency Involvement and Approval
Conclusion
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Why should companies become QS 9000 certified? o
Enhance quality systems for suppliers
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Eliminate redundant requirements
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Reduce costs
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Points to Ponder ISO 14000 - A set of international standards for assessing a company’s environmental performance
Quality Certification
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ISO 9000
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Set of international standards on quality management and Quality assurance, critical to international Business
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ISO 9000 series standards, briefly, require firms to document their quality-control systems at every step (incoming raw materials, product design, in -process monitoring and so forth) so that they’ll be able to identify those areas that are causing quality problems and correct them.
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Management systems n
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Operations n
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Systems development and integration of environmental responsibilities into business planning Consumption of natural resources and energy
Environmental systems n
Measuring, assessing and managing emissions, effluents, and other waste
ISO 9000 Series ISO 9000
Helps companies determine which standard of ISO 9001, 9002, and 9003 applies
ISO 9001
Outlines guidelines for companies that engaged in design, development, production, installation, and servicing of products or service Similar to 9001, but excludes companies engaged in design and development
ISO 9002 ISO 9003
Covers companies engaged in final inspection and testing
ISO 9004
The guidelines for applying the elements of the Quality Management System
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LESSON 40: QUALITY MANAGEMENT SYSTEMS
Introduction The central need for for reliable reliable products in tthe he Second World World War defence procurement focused focused on tight tight specificati cifications ons and consistency in product. This This was essential if the operationa tional researchers were to see the efficiency iciency of their models converted converted into military victory. victory. The The responsibility sponsibility was seen quite naturally to rest with the the suppliers because checks could not not reasonably onably or effectively effectively be carried out on the battle-ground. ttle-ground. Not surprisingly, therefore, postpost-wa war developments saw the quality lity drive being governed by diff different industries industries with dif different systems of standards. The The Internationa tionall Organ rganization ization for Standardization rdization (IS (I SO) was founde founded in 1946.It 6.It is is headquartered in Gene G eneva, Switzer itzerland. land. Its Its manda mandate te is to to promote the development of iinterna nternational tional standards to facili facilitate tate the exchange of goods and standards worldwide. T The he purpose of ISO is to to facilitate facilitate global co conse nsensus agreements on international international quality lity standards. It It has resulted in a systemfor certifying certifying suppliers suppliers to make sure they meet internationally internationally accepted standards for for quality lity management. It is a non-governm non- government organization. nization. ISO has as its members the national standa standards organizatio nizations ns for for more than 130 countries.
In the United United States the national standa standards arepublished published by the American National Ins Institute/ American Society for for Quality (ANSI/ ASQ) as as the the ANSI/ ASQ Q9000 Q9000series. The ISO 9000 Series of Standards is generic in in scope. By design, the the series can be tailored tailored to fit fit any organization’s needs, whether it is large or small, ll, a manufacturer or a service organization. Its purpose is to unify quality terms and definitions used by industrializ industrialized ed nations tions and usethose those terms to demonstrate onstrate a supplier’s capability pability of controll controlling ing its processes processes. In very simplif simplified terms, the the standards require an organization nization to say what it is is doing doing to ensurequality, lity, then then do what it it says, and, finally, finally, docume document or prove prove that it has done what it said. The objective objective of quality lity management is to quickly produce safe products, with lo low w costs, and to customer customer satisfacti tisfaction. on. Eg: In In the agri- food ood sector, quality management is especially important, and for the following reasons: •
•
During the 1970s it was generally acknowledged that the word quality lity had diff dif ferent meanings within and among industries and countries countries and around the world. orld. In 1979 the British Standards Instit Institute ute (BSI) in in the United Kingdom, ingdom, utili utilizing zing the quality lity standards of the U.S. Depa D epartment of of Defense standards MILMIL-Q9858 of the 1950s as the basis, published published the first first general standa standards BS 5750 that applied applied to a broad range of businesses and organizations. nizations. In the same year, BS BSI, recognizing recognizing the need for for standardization rdization for quality quality management and assurance, submitted submitted a forma formal proposal to ISO to develop international standards for quality assurance techniques techniques and practices. Using standard that already existed in the United Kingdom K ingdom and Canada as a basis, ISO established generic quality lity standards, primarily for manufacturing firms, that could be used worldwide. The The ISO 9000 series of qualityquality-ma management standards, guidelines, idelines, and technical technical reports, was first first published published in 1987, and it is review reviewed at least every fi five ve years. The IS ISO 9000 series was heavily avily based on on BS 5750, but reflected reflected interna international tional requirements and lessons lea learnt from from eight years use of BS 5750. In the meantime, other other standards were developed loped for for the the European Community (EN (EN 29000).Now, 00).Now, IS ISO 9000, BS 5750 and EN 29000 have been harmonized rmonized and are equivalent. quivalent. Most member countries countries of ISO have adopted dopted the ISO ISO 9000 series as their national standards.Likewise, thousands of organizations throughout the the world orld have quality lity systems registered to one one of the standards.
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Agricultural products ofte ften perish because of physiological processes and microbiolo microbiologica gical contamination, tion, Agricultural products are very heterogeneous and the quality parameters for for components like like sugar, size and colour, colour, which are very important for for proces processing, have to be controlled, A large number of farms produce agricultural products on a small scale (LUNING (LUNING et al., 2002).
Many diff different quality lity systems have been developed veloped in the agrifood ood sector during thepast ten years and will ill continue continue to be developed. Reasons are, in particular ticular, numerous food food scandals and globalizati lobalization. on. These quality lity systems are organised in diff different ways. There Therearecontractually lly coordinated coordinated chain organisations, tions, and chain organisations nisations with “reg “regulated” or “participativ participative” e” quality management. The The consequencesinclude include e.g., diff different informa information tion flows flows in these quality lity systems (HELBIG, 2002). ISO 9000 ISO 9000 is a generic system that specifies, specifies, in in very broad terms, the necessary components components of a quality lity management system. Rather than being specific cific to any one industry, it it details the basic requirements of the quality lity function function for for all industries. Certificatio Certification n IS ISO 9000 was originally published in 1987by the Interna nternatio tiona nall Organizatio anization n for for Standa Standardization, rdization, a worldwide federation of of national standards bodies, bodies, headquartered in in Geneva, Switzerlan itzerland. The The organization nization was founde founded in 1946 to develop a comm common set of of standards for for manufacturing, trade and communications. unications. Today Today more than90 countries are members, each with a representative. The representative for for the the United States is the the American Natio National nal Standards Instit Institute ute (ANSI).
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The concept of Certification ISO 9000 was developed in part becauseof the European push toward afully integrated common market. It was recognized that for the common market to exist, there would have to be assurance of quality across borders. The European Economic Community, (now the European Union, or EU), adopted Certification ISO 9000 as the basic minimal quality management system for selling certain products (electronic components and construction equipment) within the European Union ISO 9000 Series of Standards:
regulatory requirements in order to achieve customer satisfaction. ιιι
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The five standards of the series are described briefly below:
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ISO 9000, “Quality Management and Quality Assurance Standards Guidelines for selection and use,” explains fundamental quality concepts, defines key terms, and provides guidelines for selecting, using, and tailoring the ISO 9001, 9002, and 9003standards. IT is the roadmap for the use of the entire series. ISO 9001, “Quality Systems-Model for Quality Assurance in Design, Development, Production, Installation, and Servicing,” is the most comprehensive standard in the series. It contains 20 elements covering the need for an effective quality system, from the receipt of a contract through the design/ development stage, and finally the service required after delivery. ISO 9002, “Quality Systems-Model for Quality Assurance in Production, Installation, and Servicing,” addresses the prevention, detection, and correction of problems during production and installation. It is for the use of those organizations that arenot involved in design. This standard addresses 19 of the 20 elements covered in the 9001 standard. ISO 9003, “Quality Systems-Model for Quality Assurance in Final Inspection and Test,” is the least comprehensive of the standards, covering 16of the 20 elements in 9001. It is not a quality control system. ISO 9003 addresses only those requirements for the detection and control of problems found during final inspection and testing. ISO 9004-1, “Quality Management and Quality System Elements-Guidelines,” provides guidance for a supplier to use in developing and implementing a quality system and in determining the extent to which each quality system element is applicable. It examines each of the elements in greater detail. In this respect it is useful for internal auditing purposes.
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ISO 9001:2000, Quality Management SystemsRequirements, is the requirement standard a company uses to assess its ability to meet customer and applicable
The ISO 9001:2000 standard replaces the ISO 9001:1994, ISO 9002:1994 and ISO 9003:1994 standards. Although an organization can continue to be certified to thesestandards until December 2003, if they so choose. Many companiesaround the world require that companies they do business with (e.g., suppliers) have ISO 9000 certification. In that way, despite possible language, technology, and cultural differences, a company can be sure that the company it’s doing business with meets uniform standards. If a manufacturer wants to purchasefrom a non-certified supplier, the manufacturer should visit the supplier and examine its processes, past performances, workers’ credentials, and so on to verify that the supplier can meet the required quality levels and performance schedule. It is easier, cheaper, quicker, and legally safer to select an already certified supplier. Therearethree forms of certification:
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First party: A firm audits itself against ISO 9000standards.
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Second party: A customeraudits its supplier.
iii Third party: A “qualified” national or international standards or certifying agency serves as auditor. •
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The ISO 9000 series was most recently revised and updated in 2000. ISO 9000:2000, Quality Management SystemsFundamentals and Vocabulary, is the starting point for understanding the standards. It defines the fundamental terms and definitions used in the ISO 9000 family of standards, guidelines, and technical reports.
ISO 9001, 9002 and 9003 standards have been consolidated into the single revised ISO 9001:2000standard.
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Other Quality Systems: •
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ISO 9004:2000, Quality Management Systems-Guidelines for performanceimprovements, providesdetailedguidance to a company for the continual improvement of its qualitymanagement system in order to achieve and sustain customer satisfaction.
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Certification involves getting theproper documents, initiating the required procedures and practices, and conducting internal audits (first party certification). This can befollowed by a second- or third-party audit as desired. In a two-party system, a customer would audit the quality system of a supplier for acceptability resulting in costly multiple audits. The best certification of a firm is through athird party. A third-party company called a registrar is the only authorized entity that canawardISO 9000 certification. Registrars are accredited by an authoritative national body and are contracted by companies for a fee to evaluate their quality-management system to see if it meets the ISO 9000 standards. A quality system certification involves the assessment and periodic surveillance audit of the adequacy of a supplier’s quality system by a registrar. When asupplier’s systemconforms to the registrar’s interpretation of the standard, the registrar issues a certification to that effect to the supplier.
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This certification ensures customers or potential customers that a supplier has a quality system in placeand it is being monitored. Once passed by the third-party audit, a firm is certified and maybe registered and recorded as having achieved ISO 9000 status, and it becomes part of a registry of certified companies recognized throughout the world. Therearevarious reasons for implementing a quality system that conforms to an ISO standard:
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Customer or marketing are suggesting or demanding compliance to a quality system. ii Need for improvements in processes or systems. iii Desirefor global deployment of products and services. iv As more and more organizations become registered, they arerequiring their subcontractors or suppliers to be registered, creating a snowball effect. •
Most organizations have found that implementing ISO 9000 systems have benefited them in the following ways:
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Fewer on-siteaudits by customers.
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Increased market share.
iii Improved quality, both internally and externally (fewer complaints). iv Improved product and service quality levels from suppliers. v Greater awareness of quality by employees. vi A documented formal system. vii Reduced operating costs. AS9000:The Aerospace Standards The aerospace industry requires that all elements of production and supply chain operate to levels of quality and performance that assure safe and reliable products. The Americas Aerospace Quality Group (AAQG) in cooperation with many aerospace companies developed specific requirements for quality systems that are to be implemented and maintained by the complete production and supply chain in the manufacture of products used in aviation and space applications. AS9000/AS9100 AS9100 includes ASQ9001:2000 quality system requirements and specifies additional requirements for the quality system of the aerospace industry. Examples of common and unique aerospace requirements found in AS9000/ AS9100 are: •
Identification and Control of Key Characteristics
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Stamp Control
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Foreign Object Detection (FOD)
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Requirements Flow Down
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Tooling Control
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AS9103 Variation Management of Key Characteristics: Established variation management requirements for Key Characteristics. This standard also specifies general requirements and provides aprocess to achieve those requirements. AS9120: This standard includes ISO 9001:2000 quality management system requirements and specifies additional requirements for a quality management system for the aerospace industry applicable to stockist distributors. AS9131 Quality Systems Non-Conformance Documentation: This document defines to supplier/ subcontractor common information and documentation required to inform customers, when applicable about nonconformity (Customer-provider use). Tooling & Equipment (TE 9000) The industries tooling and equipment supplement to QS9000
The tooling and equipment (TE) is an addition to the QS-9000, a requirement by most tooling and equipment suppliers within the automotive industry. The Standards Council of Canada (SCC) accredits registration bodies to register organizations to the requirements of TE9000 as part of its qualification programfor QS-9000 (automotive). TE-9000 outlines the fundamental quality management system expectations of automotive companies for their tooling and equipment suppliers QS 9000 Purpose Improving relationships to improve quality
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“The goal of developing your suppliers is based on the need to provide high quality to the customer.” Enhance quality systems for suppliers
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Eliminate redundant requirements
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Reducecosts
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Fundamentally different from ISO 9000.
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Customer and Regulatory Agency Involvement and Approval
AS9101A Quality System Assessment: The checklist corresponding to AS9100 Revision A.
AS9102 Aerospace First Article Inspection Requirement: Established the requirements for First Article Inspection. The purpose of First Article Inspection is to provide objective evidence that all engineering design and specification requirements are properly understood, accounted for, verified, and documented.
Designed to help suppliers to automakers provide evidence of standardized processes for dealing with customers. Major automobile manufacturer’s setup teams with suppliers to help in development.
Advantages •
Organization for International Standards
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European standards for quality
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Standards are broad and vague to adapt to different cultures
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Does NOT provide framework for organizational improvement and change Companies document quality systems in manuals to facilitate trade through supplier conformance
Quality Perspective
Success has created various other standards such as QS 9000
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What is your definition / perception of quality?
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Were your expectations met? Why? Why not?
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What are some of your suggestions for improvement (documentation and presentation)?
Disadvantages
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Not all countries accept ISO registrars
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Mainly for exporting firms
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Barrier to trade
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Time consuming
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Costly
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Difficult for small firms to afford Discourages free thinking and employeeempowerment
Exercise Q1.What is ISO ? Q2.Briefly explain the Objectives of each of the five ISO 9000 standards? Q3.Which are the five ISO 9000 series of standards? Q4.Write in brief about The ISO 9000 series which was most recently revised and updated in 2000. Q5.Explain QS 9000& TE 9000? Q6.What are the advantages and disadvantages of ISO?
QS 9000
QS 9000
o o o o o o o o o o
Introduction Purpose ISO 9000 Background Requirements Real World Examples Interactive Exercise Conclusion Suggested Readings References
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QS 9000 Purpose
What is ISO 9000?
Improving relationships to improve quality
Advantages o Organization for International Standards o European standards for quality o Standards are broad and vague to adapt to different cultures o Companies document quality systems in manuals to facilitate trade through supplier conformance o Success has created various other standards such as QS 9000
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“The goal of developing your suppliers is based on the need to provide high quality to the customer.”
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Enhance quality systems for suppliers
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Eliminate redundant requirements
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Reduce costs
QS 9000 Purpose
What is ISO 9000?
(continued)
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Fundamentally different from ISO 9000.
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Designed to help suppliers to automakers provide evidence of standardized processes for dealing with customers.
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Major automobile manufacturers setup teams with suppliers to help in development.
(continued)
Disadvantages o Not all countries accept ISO registrars o Mainly for exporting firms o Barrier to trade o Time consuming o Costly o Difficult for small firms to afford o Discourages free thinking and employee empowerment
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Background Information What is the me aning of Q S-9000? o Quality System Requirements o Common supplier quality standard (Big Three): n n n
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Chrysler Corporation Ford Motor Company General Motors Corporation
Applies to suppliers of: n n n
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production materials production and service parts heat treating painting and plating other finishing services
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Q. Does QS-9000 apply to external suppliers only, or do the Big Three also have to comply with it? A. QS- 9000 applies to external and internal suppliers of the products and services explained above. An external supplier is a company not owned by the Big Three. This includes most of what is thought of when considering the "supply base." However, many divisions of Big Three companies supply their competitors as well as their own pl ants. For example, it is not unusual for a Ford plant to sell component products to Ford, Chrysler, and General Motors divisions. In all such cases, these Big Three plants are external suppliers to the other companies and QS-9000 applies to them. In addition, within the Big Three companies, QS-9000 is being required of many of the internal supplying divisions. The timing requirements for internal divisions are the same as for external suppliers.
Does NOT apply to all suppliers of Big Three
Background Information o
What is QS -9000?
o
QS-9000 is the shorthand name for "Quality System Requirements QS-9000." It is the common supplier quality standard for Chrysler Corporation, Ford Motor Company, and General Motors Corporation. QS-9000 is based on the 1994 edition of ISO 9001, but it contains additional requirements that are particular to the automotive industry. These additions are considered automotive "interpretations" by the ISO community of accreditation bodies and registrars. QS -9000 applies to suppliers of production materials, production and service parts, heat treating, painting and plating and other finishing services. It does not, t herefor e, apply to all suppliers of the Big Three. QS - 9000 applies to external and internal suppliers of the products and services explained above. An external supplier is a company not owned by the Big Three. This includes most of what is thought of when considering the "supply base." However, many divisions of Big Three companies supply their competitors as well as their own plants. For exampl e, it is not unusual for a Ford plant to sell component products to Ford, Chrysler, and General Motors divisions. In all such cases, these Big Three plants are external suppliers to the other companies and QS-9000 applies to them. In addition, within the Big Three companies, QS-9000 is being required of many of the internal supplying divisions. The timing requirements for internal divisions are th e same as for external suppliers.
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(continued)
TE-9000 n n
Tooling and Equipment Supplement Internal shorthand as supplement to QS 9000
Worldwide Commitment n
Released throughout North America, several countries of South America, Europe, Australia and Asia
Compliance audits by qualified ISO 9001 registrars: n n n
Internal Customer (second-party) Third-party
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QS 9000 Requirements
QS 9000 Requirements
Management responsibility
Management Responsibility
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“defining and documenting its policies for quality along with its objectives and its level of commitment. Clear lines of authority are drawn, assigning responsibility for managing, performing and verifying all work affecting quality.” “should be viewed as a strategic imperative for all of a supplier’s personnel. A supplier firm must have documented procedures for assessing training needs and for training all personnel who might impact a company’s quality. Records of past training must also be kept.”
QS 9000 Requirements 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20.
Design input
Quality policy
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Design output
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Organization
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Design review
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Resources
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Design verification
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Management representative
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Design validation
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Organizational interface
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Design changes
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Business plan
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Training o
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(continued)
Management responsibility Quality system Contract review Design control Document and data control Purchasing Control of customer -supplied product Product identification and traceability Process control Inspection and testing Control of inspection, measuring and test equipment Inspection and test status Control of nonconforming product Corrective and preventive action Handling, storage, packaging, preservation and delivery Control of quality records Internal quality audits Training Servicing Statistical techniques
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Analysis and use of company -level data Customer satisfaction
Quality System Requirements o
General
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Quality system procedures
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Quality planning
Design Control Requirements o
General Information
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Design and development planning n
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(continued)
Required skills
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Special characteristics
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Use of cross-functional teams
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Feasibility reviews The control plan
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Organizational, technical interfaces
Name some common requirement processes o
Common processes n n n
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Documentation Testing Implementation
Processes used to enhance supplier quality systems, eliminate redundant requirements and reduce costs.
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Points to Ponder
What are some supply chain priorities? o
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Supply Chain Priorities by auto assemblers, direct suppliers and indirect suppliers order of importance. 1.
Consistency
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Reliability
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Relationship Technological capability
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Flexibility
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Price
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Service Finances
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Real World Example II “Few businesses survive their first 6 months, much less earn their QS 9000 and ISO 9002 certifications in the first half of the year. Nu Tech Plastics Engineering, a Tier One and Two automotive supplier, not only did both, but it also fulfilled its founder's goal of creating a business niche in taking on so-called problem jobs. Barely three years old, the company has built a $20 million a year business on solving other people's problems. Elektra all-electric molding machines and the company's process tuning shaved 12 seconds from the tool's cycle time.”
Tooling & Equipment (TE 9000)
Real World Example I
o
“Supplier Services Inc. (SSI)’s stated goal is to work with small and medium-sized manufacturers to achieve compliance with ISO 9000, QS 9000 and other industryspecific quality system requirements. Their message to those manufacturers or their suppliers is that while it is extremely difficult to manage quality and manufacturing standards when everyone expects fewer people to do the job, SSI is available to fill that organizational void with their own brand of expertise.”
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The tooling and equipment (TE) is an addition to the QS-9000, a requirement by most tooling and equipment suppliers within the automotive industry. The Standards Council of Canada (SCC) accredits registration bodies to register organizations to the requirements of TE-9000 as part of its qualification program for QS-9000 (automotive). TE-9000 outlines the fundamental quality management system expectations of automotive companies for their tooling and equipment suppliers It applies QS-9000 to suppliers of tooling, equipment, and related products.
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The Aerospace Standards o
The aerospace industry requires that all elements of production and supply chain operate to levels of quality and performance that assure safe and reliable products. The Americas Aerospace Quality Group (AAQG) in cooperation with many aerospace companies developed specific requirements for quality systems that are to be implemented and maintained by the complete production and supply chain in the manufacture of products used in aviation and space applications.
How does AS9100 differ from ISO 9001? As with other sector-specific standards, AS9100, Revision A, includes all the existing elements of ISO 9001 (both the 1994 and 2000 versions), and a variety of aerospace-sector -specific requirements. ISO/TS 16949 and TL 9000 follow a similar approach in the automotive and telecommunications industries respectively. o Who controls the requirements of AS9100? o As with other sector-specific standards, AS9100, Revision A, includes all the existing elements of ISO 9001 (both the 1994 and 2000 versions), and a variety of aerospace-sector -specific requirements. ISO/TS 16949 and TL 9000 follow a similar approach in the automotive and telecommunications industries respectively. o o
AS9000/AS9100: AS9100 includes ASQ9001:2000 quality system requirements and specifies additional requirements for the quality system of the aerospace industry. o Examples of common and unique aerospace requirements found in AS9000/AS9100 are: o Identification and Control of Key Characteristics o Stamp Control o Foreign Object Detection (FOD) o Requirements Flow Down o Tooling Control o Customer and Regulatory Agency Involvement and Approval
Conclusion
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Why should companies become QS 9000 certified? o
Enhance quality systems for suppliers
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Eliminate redundant requirements
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Reduce costs
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Points to Ponder ISO 14000 - A set of international standards for assessing a company’s environmental performance
Quality Certification
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ISO 9000
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Set of international standards on quality management and Quality assurance, critical to international Business
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ISO 9000 series standards, briefly, require firms to document their quality-control systems at every step (incoming raw materials, product design, in -process monitoring and so forth) so that they’ll be able to identify those areas that are causing quality problems and correct them.
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Management systems n
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Operations n
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Systems development and integration of environmental responsibilities into business planning Consumption of natural resources and energy
Environmental systems n
Measuring, assessing and managing emissions, effluents, and other waste
ISO 9000 Series ISO 9000
Helps companies determine which standard of ISO 9001, 9002, and 9003 applies
ISO 9001
Outlines guidelines for companies that engaged in design, development, production, installation, and servicing of products or service Similar to 9001, but excludes companies engaged in design and development
ISO 9002 ISO 9003
Covers companies engaged in final inspection and testing
ISO 9004
The guidelines for applying the elements of the Quality Management System
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