Understanding ISO 9000: its implementation in American foundries and diecasting shops.Having previously answered basic questions about ISO (1) See ISO speed. (2) (International Organization for Standardization, Geneva, Switzerland, www.iso.ch) An organization that sets international standards, founded in 1946. The U.S. member body is ANSI. 9000, this article shows that it can be implemented successfully in a foundry A semiconductor manufacturer that makes chips for third parties. It may be a large chip maker that sells its excess manufacturing capacity or one that makes chips exclusively for other companies. . ISO 9000 is not the mysterious subject that many of its so-called "gurus" would have you believe. It is little more than a codification The collection and systematic arrangement, usually by subject, of the laws of a state or country, or the statutory provisions, rules, and regulations that govern a specific area or subject of law or practice. of sensible ways of doing things--an attempt to put your foundry's operations into a simple and logical format to promote the smooth running of the company and help guarantee consistency of output. ISO 9000 refers to your foundry's systems, not its products! Here's a rather exaggerated example. If your quality policy states that you will consistently produce porous porous /por·ous/ (por´us) penetrated by pores and open spaces. po·rous adj. 1. Full of or having pores. 2. Admitting the passage of gas or liquid through pores. castings with sand burned onto the surface and your customers would accept them in such a condition--you would satisfy ISO 9000, as long as you could demonstrate an ability to produce such (low-grade low-grade Of or relating to debt that has a credit rating of B or below. Low-grade debt offers an above-average yield but entails substantial risk because promised payments may not be made in a timely manner. ) castings consistently. In fact, you can view ISO 9000 as a management tool that will ensure good practice becomes custom and practice. While the first article in this series defined ISO 9000, this article looks at how you can implement it. The next article will show how it works on a day-to-day basis. The fourth part will analyze the costs and benefits of ISO 9000 systems in many European foundries. Principles & Objectives The principal objective of the ISO 9000 standard is to establish "control" in key areas of a company in order to guarantee a "consistent" product. This involves independent assessment of a company's systems that is comparable to taking a driving test and then receiving a license confirming that the individual is capable of driving safely. As outlined in the first part of this series, there are 20 clauses in the full ISO 9001 standard, but ISO 9002 (the subset A group of commands or functions that do not include all the capabilities of the original specification. Software or hardware components designed for the subset will also work with the original. of ISO 9000 that applies to foundries and other manufacturing operations Manufacturing operations concern the operation of a facility, as opposed to maintenance, supply and distribution, health, and safety, emergency response, human resources, security, information technology and other infrastructural support organizations. ) contains only 18. This list of action points is given in Table 1. The 18 clauses of ISO 9002 (Sections 4.1 to 4.18) cover the ground rules by which a company operates, sets out how to do a job and ensures that it is done correctly. 4.1--Management Responsibility: Requires the foundry to state its policy on quality, define the responsibilities and authority of its people with regard to quality, allocate To reserve a resource such as memory or disk. See memory allocation. adequate resources to operating the system and provide a mechanism to review its effectiveness. 4.2--Quality System: Insists the foundry define its quality system and how it operates, and must include a provision for quality planning. 4.3--Contract Review: States the foundry must have a system to review all orders and order amendments before acceptance to ensure there is adequate information, the company can do the job and the contract is the same as that quoted (if applicable). 4.4--Document Control: Necessitates making provision for ensuring that only the correct versions of key documents are available for use. This is a seemingly seem·ing adj. Apparent; ostensible. n. Outward appearance; semblance. seem ing·ly adv. simple thing to do, but is frequently difficult in practice. 4.5--Purchasing: When a foundry decides who will be its suppliers, it must continually con·tin·u·al adj. 1. Recurring regularly or frequently: the continual need to pay the mortgage. 2. monitor the performance of those suppliers, including suppliers of subcontracted sub·con·tract n. A contract that assigns some of the obligations of a prior contract to another party. intr. & tr.v. sub·con·tract·ed, sub·con·tract·ing, sub·con·tracts services. It is necessary to provide adequate and precise information on purchase orders. 4.6--Purchaser Supplied Product: These items (commonly known as Free Issue Items) must be verified ver·i·fy tr.v. ver·i·fied, ver·i·fy·ing, ver·i·fies 1. To prove the truth of by presentation of evidence or testimony; substantiate. 2. and controlled, with provision for any damage or loss. 4.7--Product Identification and Traceability: All materials, all semi-finished and finished products must be adequately identified at all times. This can be a real headache headache Pain in the upper portion of the head. Episodic tension headaches are the most common, usually causing mild to moderate pain on both sides. They result from sustained contraction of face and neck muscles, often due to fatigue, stress, or frustration. in foundries because of the processes used. (Note here that traceability is not a mandatory requirement.) 4.8--Process Control: This clause states that you must identify, plan and control the process or service. Documented procedures and other instructions are needed to define how this is to be achieved, including how workmanship criteria are decided. 4.9--Inspection and Testing: Requires the existence of a system for inspecting and testing on receipt of goods, during processing and upon completion. In the case of services, this would involve monitoring the quality of service offered. 4.10--Inspection, Measuring and Test Equipment: Requires that the method for controlling calibration calibration /cal·i·bra·tion/ (kal?i-bra´shun) determination of the accuracy of an instrument, usually by measurement of its variation from a standard, to ascertain necessary correction factors. and maintenance of test equipment or other items be defined. 4.11--Inspection and Test Status: This clause requires the foundry to define the stage that each product has reached in the manufacturing process. 4.12--Control of Nonconforming Product: Rejected castings must be identified and recorded before a decision is made on the next action (rectify rec·ti·fy v. 1. To set right; correct. 2. To refine or purify, especially by distillation. , scrap, remanufacture, etc.). The system should prevent such items from being shipped in error. 4.13--Corrective Action: This provides for investigating and rectifying the cause of problems to prevent their recurrence recurrence /re·cur·rence/ (-ker´ens) the return of symptoms after a remission.recur´rent re·cur·rence n. 1. . It also requires evaluating processes, service reports and records to prevent the initial occurrence of problems. 4.14--Handling, Storage, Packaging and Delivery: This deals with preserving quality after castings are shipped, and can involve any post-shipment activities on treatments. 4.15--Quality Records: The foundry must have a system for identifying, collecting, indexing, filing, storing, maintaining and disposing of quality records (inspection records, complaint reports, etc.). 4.16--Internal Quality Audits: Is a requirement that the quality assurance system itself will be monitored continually so that it is up to date and in-line with changing circumstances CIRCUMSTANCES, evidence. The particulars which accompany a fact. 2. The facts proved are either possible or impossible, ordinary and probable, or extraordinary and improbable, recent or ancient; they may have happened near us, or afar off; they are public or . 4.17--Training: A foundry must identify the training needs of personnel who affect quality and make the provisions to ensure that they are adequately trained to do their job. 4.18--Statistical Techniques: Where such techniques (sampling, SPC 1. (business) SPC - Statistical Process Control. Something to do with quality management. 2. (body) SPC - Software Productivity Centre. 3. (company) SPC - Software Publishing Corporation. 4. , etc.) are applicable, the foundry must lay down detailed instructions that define how they are used. Satisfying ISO 9000 The ISO 9000 standard itself is very bland. While each clause is carefully worded to convey a specific meaning, with rare exceptions (e.g. Contract Review) it does not state what is to be done. The company has to decide this. In some cases, there are guidelines guidelines, n.pl a set of standards, criteria, or specifications to be used or followed in the performance of certain tasks. , separate from the standard, published by the Assessing Bodies (Bureau Veritas an institution, in the interest of maritime underwriters, for the survey and rating of vessels all over the world. It was founded in Belgium in 1828, removed to Paris in 1830, and reëstablished in Brussels in 1870. See also: Bureau , British Standards British Standards are the national standards of the UK. The standards body which produces them is BSI British Standards, a division of BSI Group. It is incorporated under a Royal Charter and is formally designated as the National Standards Body (NSB) for the UK. Institution, Lloyds Register of Quality Assurance, Yarsley Quality Assured Firms, etc.) in conjunction with representatives of the industry or service sector and other organizations. These indicate good practice but do not form part of the standard. All assessments are carried out against ISO 9000 itself, but any guidance notes will be considered by the assessor when judging the adequacy of the company's systems. In the case of foundries, the guidelines have been well defined by the many foundries that have already been assessed to ISO 9000. Many clients ask, "How far do we have to go?" The answer is, "Far enough to ensure that you have adequate control all of the time." It is only by experience and in-depth understanding of the standard (and the assessors) that one is able to make such judgments. There is no safe rule of thumb. There is a danger that companies (particularly foundries) go over the top in preparing procedures, tying themselves to an unnecessary degree when allocating responsibilities or defining process checks. If so, the outcome will be a system that is restrictive, unwieldy and expensive to operate. A good consultant will help avoid this danger, giving guidance on the necessary contents of the quality system. The first task is to decide how the foundry will address each clause. Frequently, foundries are routinely doing a large portion of what will eventually form the ISO 9000 system. However, it is rare for there to be evidence or adequate records to prove that it has been done. Obviously, this is an area in which a good consultant can help. It is no good having a comprehensive quality system if the foundry does not follow it all of the time. You should be aware that the objective of the system is to "give confidence that a given level of quality is being achieved." To do this, you need to provide an outside observer with evidence that the system is adequate and is being followed. Implementing ISO 9000 Successful implementation of ISO 9000 is best achieved by a combination of consulting, project management, and a training and coaching program to prepare the foundry for assessment and subsequent registration to ISO 9002. A quality consultant with experience in successfully preparing foundries for assessment to ISO 9000 is almost a pre-requisite for a successful approach to assessment. A few foundries in Europe have been successful in piloting themselves through the difficult waters of the ISO 9000 registration. But it has almost always been at the expense of hitting the rocks once or twice usually resulting in needing several (expensive) attempts at registration before meeting with success. Assuming a consultant is used, the following procedure is suggested: * Initially a survey of existing practices should be undertaken. * Once this has been completed, the consultant should suggest a realistic implementation timetable for assessment. * A Quality System should be designed in consultation with management in the foundry, but starting from the ISO 9000 standard itself, not from existing documentation that may have been created for an entirely different set of criteria. * Quality Policy Manuals and Quality Control Procedures should be written by the consultant. The Manual and Procedures should always be in separate volumes: a "slim" manual and a "fat" set of procedures is one sign of a well-designed system. The reason for this is that simple amendments to operating procedures should not cause alterations to the manual. Otherwise, a reassessment Reassessment The process of re-determining the value of property or land for tax purposes. Notes: Property is usually reassessed on an annual basis. You may request a "reassessment" if you disagree with your assessment. might be necessitated by relatively trivial TRIVIAL. Of small importance. It is a rule in equity that a demurrer will lie to a bill on the ground of the triviality of the matter in dispute, as being below the dignity of the court. 4 Bouv. Inst. n. 4237. See Hopk. R. 112; 4 John. Ch. 183; 4 Paige, 364. changes in the detailed operating procedures. * Work Instructions (sometimes called Job Guides) should be created when necessary. * Working closely with management, the consultant should hold regular review discussions to assess progress and highlight problems. Revisions to the implementation timetable should be by mutual agreement. * Personnel training should be coordinated with implementation to ensure that key staff fully understand all important areas and are able to use their newly acquired skills immediately. Training sessions involving all staff are sometimes a valuable way of getting everyone's cooperation. * Advice and support should be an integral part of the project and should occur throughout all phases. Program at Work It is normal in foundry-based ISO 9000 projects for work to fall into four logical phases, some parts of which must be carried out with the consultant on-site, others of which can be accomplished without the consultant on the premises. There is usually the need for the consultant to spend two intensive, on-site working sessions of between one and three weeks with a period of eight to 10 weeks intervening in·ter·vene intr.v. in·ter·vened, in·ter·ven·ing, in·ter·venes 1. To come, appear, or lie between two things: You can't see the lake from there because the house intervenes. 2. . During this time, a considerable amount of fax and telephone contact will be needed between the foundry and consultant. The four phases are outlined below. Phase 1--This step should be conducted mainly on-site. Initially, the consultant should survey all relevant organizational, processing and manufacturing practices in current use. In addition, subcontractors, suppliers and the foundry's customer base should be examined. The foundry should cooperate in providing all information as it is requested. Next, an investigation of any existing quality assurance systems should be undertaken. This is followed by an assessment of quality assurance practices (formal and informal) in relation to the ISO 9000 standard. All deficiencies found during the audit should be reported formally to foundry management for discussion at a review meeting. The report should list all "nonconformances" in the system and advise how they can be overcome. Phase 2--This part of the program is to be conducted on-site. The consultant should design a quality assurance system that is consistent with the ISO 9002 standard as soon as recommendations in the report have been accepted by management. This should be compiled in a draft Quality Policy Manual to include the quality policy statement, management responsibility on quality and an organization chart. The manual should cover each clause of the International Standard in sequence and outline the company's policy in meeting the requirements of each relevant section. Phase 3--This part can be conducted on-site and off-site. When the quality assurance system outlined in the Quality Policy Manual has been agreed upon Adj. 1. agreed upon - constituted or contracted by stipulation or agreement; "stipulatory obligations" stipulatory noncontroversial, uncontroversial - not likely to arouse controversy , work should start on the Quality Control Procedures and (where required) detailed Work Instructions or Job Guides. Quality control procedures for individual operations should be devised, using where possible existing established procedures and working practices. Writing of the Quality Policy Manual, the Quality Control Procedures and the Work Instructions (as required) should then be completed. Procedures should include examples of essential records, labels, documents, stamps, forms, etc. Following this, an implementation timetable should be agreed upon and a target date should be set for assessment. Phase 4--The final phase should be conducted mainly on-site. The various documents Quality Policy Manual, Quality Control Procedures and any Work Instructions should be prepared on a word processor so that amendments can be incorporated easily. Formal briefing sessions would normally be held for individual departments in conjunction with the foundry's quality representative to ensure that people in each department are fully conversant CONVERSANT. One who is in the habit of being in a particular place, is said to be conversant there. Barnes, 162. with the International Standard and the Quality Control Procedures for their area of responsibility. Training courses should be conducted for selected staff members to provide them with a knowledge of various critically important topics, including ISO 9000 implementation, procedure writing and (internal) quality system auditing. The consultant should provide continuous help in solving problems that may occur during implementation. Advice should be given as to the most appropriate Assessment Body to use and how to prepare for the all-important assessment visit. Before the actual assessment, the consultant should conduct an independent formal audit (acting as agent provocateur a·gent pro·vo·ca·teur n. pl. a·gents pro·vo·ca·teurs A person employed to associate with suspected individuals or groups with the purpose of inciting them to commit acts that will make them liable to punishment. ) to identify outstanding problems and suggest corrective actions A corrective action is a change implemented to address a weakness identified in a management system. Normally corrective actions are instigated in response to a customer complaint, abnormal levels if internal nonconformity, nonconformities identified during an internal audit or . The principal requirement is that the consultant be even more critical than the eventual assessor will be so that the assessment itself seems anticlimactic an·ti·cli·max n. 1. A decline viewed in disappointing contrast with a previous rise: the anticlimax of a brilliant career. 2. after the consultant's criticisms. Obtaining ISO 9000 registration for a foundry is never likely to be an easy task. The reason for this lies more in the inherently unsystematic nature of most foundry management systems than in any innate difficulty in achieving high-quality products. European experience has shown that many foundries have poorly defined management systems and can obtain only sketchy data. These factors, however, make an even stronger case for foundries achieving ISO 9000 as they have more potential improvements to make than other, more tightly managed businesses. As will become apparent from the case studies of European foundries in the third part of this series, whatever the reason that those foundries initially decided to implement ISO 9000 registration, when questioned subsequently all stated that improvements in internal efficiency were the greater single benefit arising from their ISO 9000 projects. Mr. Law will be a featured speaker on the subject of ISO 9000 and foundries at the AFS A distributed file system for large, widely dispersed Unix and Windows networks from Transarc Corporation, now part of IBM. It is noted for its ease of administration and expandability and stems from Carnegie-Mellon's Andrew File System. AFS - Andrew File System Foundry Executive Management Conference on September 13-16, 1992 in Colorado Springs, Colorado The City of Colorado Springs is the second most populous city (after Denver) in the state of Colorado and the 48th most populous city in the United States.[4] The city is the county seat of El Paso County. . Table 1. The ISO 9000 Credo Credo A Latin word which means "a set of fundamental beliefs or a guiding principle.” For a company, a credo is like a mission statement. Notes: For example, Sam Walton, founder of Wal-Mart, established the "Three Basic Beliefs” as his company's credo. * Clearly state the Foundry's Quality Message. * Specify who is responsible for particular tasks. * Verify (1) To prove the correctness of data. (2) In data entry operations, to compare the keystrokes of a second operator with the data entered by the first operator to ensure that the data were typed in accurately. See validate. the customers' exact requirements and the foundry's ability to meet them. * Make certain everybody sings to the same "Song Sheet." * Ensure that materials and services purchased are to the correct specification and supplied from a reliable supplier (preferably pref·er·a·ble adj. More desirable or worthy than another; preferred: Coffee is preferable to tea, I think. pref ISO 9000 registered). * Exercise care in handling customers' goods. * Properly identify all materials and products. * Maintain product quality. * Maintain accurate records. * Develop and enforce the quality system through audits and reviews. * Provide adequate training for all employees. * Apply statistical techniques to ensure quality where appropriate. * Monitor and control all activities and processes. * Carry out periodic checks on all work. * Use only calibrated cal·i·brate tr.v. cal·i·brat·ed, cal·i·brat·ing, cal·i·brates 1. To check, adjust, or determine by comparison with a standard (the graduations of a quantitative measuring instrument): equipment. * Indicate when products will move to the next process step. * Identify, control and segregate seg·re·gate v. seg·re·gat·ed, seg·re·gat·ing, seg·re·gates v.tr. 1. To separate or isolate from others or from a main body or group. See Synonyms at isolate. 2. all rejects and scrap. * Recognize and diagnose diagnose /di·ag·nose/ (di´ag-nos) to identify or recognize a disease. di·ag·nose v. 1. To distinguish or identify a disease by diagnosis. 2. errors and prevent their recurrence. |
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