ISO 9002: ways to solve problem areas for foundries.Audits show that metalcasters often are deficient de·fi·cient adj. 1. Lacking an essential quality or element. 2. Inadequate in amount or degree; insufficient. deficient a state of being in deficit. in six areas. Using ISO's 18-point framework can help prevent these costly deficiencies. The 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 quality system standards have made a significant impact on the 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. industry in a very short time. For the first time in our industry, a majority of foundry management personnel--if for no other reason than fear of losing their markets--has been able to see a positive link between quality assurance and profits. Unfortunately, many foundrymen remain skeptical and believe that the ISO 9000 standards are nothing more than another window-dressing win·dow-dress·ing also win·dow dress·ing n. 1. a. Decorative exhibition of retail merchandise in store windows. b. Goods and trimmings used in such displays. 2. scheme being imposed on them by buyers and customer quality assurance people who are basically interested only in passing more of their costs over to the foundry. These foundrymen are destined des·tine tr.v. des·tined, des·tin·ing, des·tines 1. To determine beforehand; preordain: a foolish scheme destined to fail; a film destined to become a classic. 2. to have poor results with their ISO 9000 programs. They will not recoup recoup To sell an asset at a price sufficient to recover the original outlay or to offset a previous loss. the cost of compliance because they fail to see that an effective quality assurance program will reduce costs by preventing costly problems from ever occurring. Foundry management should not consider ISO certification on any basis other than reducing the cost of quality. The program shouldn't should·n't Contraction of should not. shouldn't should not shouldn't should be attempted if management can't justify the certification and upkeep costs by estimates showing lower scrap, rework re·work tr.v. re·worked, re·work·ing, re·works 1. To work over again; revise. 2. To subject to a repeated or new process. n. and returns. Basic Requirements By now, most foundrymen know ISO 9002 is the standard that applies to a manufacturer that makes a product to the customer's design. Thus, it is the applicable standard for the vast majority of foundries. Table 1 shows the basic 18-point framework of ISO 9002 and a brief statement of subjects covered under each section. ISO 9002 was not written specifically for foundries; rather, it is written in generic language that applies to the manufacturer of any product. A foundryman will find that it is difficult to read and understand how each section pertains to casting production. Since a universal interpretation is unlikely, Table 1 represents the author's interpretation of what ISO 9002 states in "foundry language." While there may be minor differences in interpretation, the 18 points of ISO 9002 do provide the framework for a thoroughly documented quality system. However, ISO 9002 is not a total quality management (TQM (Total Quality Management) An organizational undertaking to improve the quality of manufacturing and service. It focuses on obtaining continuous feedback for making improvements and refining existing processes over the long term. See ISO 9000. ) program--it's just part of such a program. ISO 9002 certification requires a foundry to have a documented quality system that produces written confirmation that procedures are followed, testing is done, training is adequate and records are kept. The foundryman will be required to have three basic levels of documentation. The first level requires that a quality assurance manual be written to describe the quality system. Usually referred to as Level 1 documentation, the manual should follow the 18-point outline. The second level--generally referred to as Level 2--requires written standard operating procedures standard operating procedure Medtalk A technique, method or therapy performed 'by the book,' using a standard protocol meeting internally or externally defined criteria; a formal, written procedure that describes how specific lab operations are to be performed. . They should cover the basic methods each department uses for doing everyday tasks involved in making a product. The procedures should be written and signed by the first-line supervisor and department head, or dictated dic·tate v. dic·tat·ed, dic·tat·ing, dic·tates v.tr. 1. To say or read aloud to be recorded or written by another: dictate a letter. 2. a. to a staff employee more adept at procedure writing. In any case, the written procedure should be signed by the supervisors responsible for its implementation so that "ownership" is established. Any time changes are made in a procedure, a new revision should he written along with a new revision number, date of revision and new signatures. Level 3 documentation covers the job-specific manufacturing details necessary to produce the individual casting. Information should include such items as pouring weight, metal type, pouring temperature, sleeve Ideally, this information should be collected and documented during production of the first article, placed into the data base for future use, and made available to any employee needing the information when the part is produced. The quality assurance manual will contain little or no proprietary information and may be given to customers and auditors AUDITORS, practice. Persons lawfully appointed to examine and digest accounts referred to them, take down the evidence in writing, which may be lawfully offered in relation to such accounts, and prepare materials on which a decree or judgment may be made; and to report the whole, together upon request. For this reason, the manual can serve as an important marketing tool. It should be clearly written and must address the subjects considered most important by the people who will read it. In many cases, the manual will be the first impression a prospective customer receives of your organization. It also will be the first part of your quality program that an ISO auditor auditor n. an accountant who conducts an audit to verify the accuracy of the financial records and accounting practices of a business or government. A proper audit will point out deficiencies in accounting and other financial operations. sees. Level 2 and 3 procedures are considered proprietary information that should not be given to customers or auditors so it won't won't Contraction of will not. won't will not won't will get into competitors' hands. Auditors should be permitted to see this information and to audit the procedures, but they should not be given copies. A foundry should begin the ISO 9002 certification process by first preparing the quality assurance manual according to according to prep. 1. As stated or indicated by; on the authority of: according to historians. 2. In keeping with: according to instructions. 3. the format in Table 1. Though it probably will be necessary to revise the manual once or twice before it is ready for the ISO auditor, the manual will define the responsibilities of all key employees, and set the framework for tasks that must be accomplished and documented. Most foundries already have good Level 3 job-specific written procedures. However, a majority of foundries are very weak in Level 2 standard operating procedures. In most cases, this is the area where foundries will have to spend the most time and effort in preparing for ISO 9002 certification. Level 2 procedures are a very important part of the quality program because they form the basis of a documented training program for hourly workers and newer supervisory employees. Problem Sections Quality system audits done over the past few years have revealed that foundries--even those that already have quality assurance manuals and basic quality programs--are consistently deficient in certain areas when audited for ISO 9002 standards. The most common deficiencies include: Section 3--Contract Review: The order entry procedure is generally lacking because customers often fail to send written confirmation and don't don't 1. Contraction of do not. 2. Nonstandard Contraction of does not. n. A statement of what should not be done: a list of the dos and don'ts. consistently put the drawing revision number on the purchase order. As a result, the foundry cannot always be certain that the casting was made to the proper revision. It is not uncommon for the customer to fail to send the latest drawing revision. Section 4--Document Control: Most foundries don't have the latest drawing of every active pattern. In many cases, they are making castings of parts which no drawing exists. How does the foundry propose to inspect a casting for which there is no drawing? Section 5--Purchasing: Few foundries have a written list of acceptable suppliers for each commodity or service purchased. And few have formal vendor rating programs backed up with documentation of vendor quality and services. Section 9--Inspection and Testing: Few foundries do anything more than look at vendor certifications when receiving materials. Nor can many foundries show evidence that all castings ready for shipment have been subjected to a final inspection. Section 11--Inspection and Test Status: Foundries that make large quantities of small castings will have a problem convincing an outside auditor that every box of castings has been through all required testing and inspection before reaching the shipping department. Section 17--Training: Since most foundries don't have sufficient Level 2 written operating procedures, it's difficult to prove that employees have received adequate training. Even in foundries that do a lot of training and regularly send management personnel to outside meetings, few records exist. Recommendations Foundries should attempt to have their quality program conform as close as possible to ISO 9002 standards before registration auditors arrive. Following are suggestions on how to structure a quality program in the six problem areas listed above: Section 3--Contract Review: The foundry will have to educate its customers about the importance--to both parties--of sending written confirmation of all telephone orders placed with the foundry. Also, all purchase orders must include the revision of the drawing referenced in the order. No order should be entered into the manufacturing schedule without the revision number. This revision number also should be checked to ensure that it has not changed since the last order. If a customer is remiss re·miss adj. 1. Lax in attending to duty; negligent. 2. Exhibiting carelessness or slackness. See Synonyms at negligent. in sending written confirmation, the foundry should send a written acknowledgment acknowledgment, in law, formal declaration or admission by a person who executed an instrument (e.g., a will or a deed) that the instrument is his. The acknowledgment is made before a court, a notary public, or any other authorized person. of the phone order before pouring the castings. Section 4--Document Control: If a customer can't provide a drawing for any active pattern, the foundry should inform the customer in writing that it will make "the product of the mold mold, name for certain multicellular organisms of the various classes of the kingdom Fungi, characteristically having bodies composed of a cottony mycelium. The colors of molds are caused by the spores, which are borne on the mycelium. " and won't accept responsibility for casting dimensions. A copy of this letter should be kept in the files in lieu of Instead of; in place of; in substitution of. It does not mean in addition to. the nonexistent non·ex·is·tence n. 1. The condition of not existing. 2. Something that does not exist. non drawing. When the drawing files are up to date, an employee should be given the responsibility for maintaining them. A sign-out system should be implemented for any employee taking a drawing from the files. Section 5--Purchasing: Almost all foundries have at least an informal list of suppliers that it regularly turns to for certain commodities or services. Unfortunately, very few have a written list of acceptable suppliers for the products they buy, as required in this section. A master list of acceptable suppliers should be compiled, even if most commodities only have one acceptable supplier (as will often be the case). Ground rules should outline the requirements and qualifications for a new supplier to be added to the list. Suppliers should be informed that they will be dropped from the list if their service and quality are not satisfactory. ISO 9002 also requires that a foundry adequately control its suppliers and subcontractors. This means that documentation of supplier quality and service is to be kept. Foundry management people should occasionally visit supplier facilities and have formal meetings with key vendors at least annually. Section 9--Inspection and Testing: In the foundry, this applies to purchased materials, castings in process and final inspection of castings before shipment. ISO 9002 doesn't specifically require that a foundry perform an incoming inspection of all materials received if it can be "otherwise 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. as conforming to specified requirements" (Paragraph 4.9.1.1). This paragraph also states "verification shall be in accordance Accordance is Bible Study Software for Macintosh developed by OakTree Software, Inc.[] As well as a standalone program, it is the base software packaged by Zondervan in their Bible Study suites for Macintosh. with the quality plan or documented procedures." For the foundry, this means that if sufficient data on the material and vendor has been collected to show high reliability, incoming inspection can be reduced. In effect, this constitutes an effective vendor certification program, which if properly instituted, can result in a minimum amount of incoming inspection by the foundry. Most foundries would have much difficulty in convincing an ISO auditor that all castings packaged for shipment on any given day have been inspected and approved for shipment by a final inspector. Foundries that make large castings don't have as much difficulty in complying with this section as do small casting producers. A paint mark, chalk mark or sticker applied to a casting surface properly identifies it as belonging on the shipping dock. However, this isn't easy for foundries that produce a lot of small castings. In this case, a sampling inspection plan such as Mil-Std-105 is very useful as a final audit of each box of castings just before shipping. Section 11--Inspection and Test Status: This section's requirements can be very difficult for producers of small castings who must handle them by the boxful. One practical method for properly identifying the status of small castings is to put removable metal identification tags An identification tag might be:
Section 17--Training: Most foundries keep no documentation of training, except in government-mandated areas to meet OSHA OSHA n. Occupational Safety and Health Administration, a branch of the US Department of Labor responsible for establishing and enforcing safety and health standards in the workplace. and EPA EPA eicosapentaenoic acid. EPA abbr. eicosapentaenoic acid EPA, n.pr See acid, eicosapentaenoic. EPA, n. rules and regulations. ISO 9002 compliance requires foundries to begin documenting training conducted in the quality sector--just as they do in government areas. Table 1. Quality Assurance Manual Outline in Accordance with 9002 Requirements Section 1: Management Responsibility a) Management quality policy b) Management organization and responsibilities c) Quality organization & authority d) Management review of quality system Section 2: Quality System a) Maintenance and updating of QA manual b) Manufacturing procedure documentation c) Standards of acceptability used to judge quality d) Value of first article production program e) Identification and preparation of quality records Section 3: Contract Review a) Order entry procedure b) Checking drawing revision c) Advance quality planning d) Sample casting production and evaluation Section 4: Document Control a) Maintenance of drawing files b) Data required on customer purchase order c) Control of proprietary procedure files Section 5: Purchasing a) Records of acceptable suppliers b) Control of suppliers and subcontractors c) Clarity of information on purchase orders d) Verification of purchased product quality Section 6: Purchaser Supplied Products a) Checking of incoming customer tooling b) Records of receipt and maintenance c) Pattern and gage storage Section 7: Product Identification and Traceability a) Casting identification b) Traceability methods used c) Record keeping Section 8: Process Control a) Instructions for making the casting b) Monitoring and control of casting during manufacture c) Criteria for workmanship d) Definition & control of special processes Section 9: Inspection & Testing a) Receiving inspection and testing Inspection and testing Industrial activities which ensure that manufactured products, individual components, and multicomponent systems are adequate for their intended purpose. b) In-process inspection and testing c) Final inspection and testing d) Identification and disposition of nonconforming castings e) Inspection and test records Section 10: Inspection, Measuring & Testing Equipment a) 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. of measuring equipment b) Checking of test hardware, gages Gages Devices for determining the relative size or shape of objects. The function of gages is to determine whether parts are within or outside of the specified tolerances, which are expressed in a linear unit of measurement. and fixtures c) Maintenance of equipment d) Documentation and record keeping Section 11: Inspection & Test Status a) Identification of methods used b) Records of responsible inspection authority Section 12: Control of Nonconforming Products a) Procedures used to identify nonconforming castings b) Identification and segregation segregation: see apartheid; integration. of defective defective adj. not being capable of fulfilling its function, ranging from a deed of land to a piece of equipment. (See: defect, defective title) castings c) Notification of concerned parties d) Responsibility for review and disposition of defects Section 13: Corrective Action 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 a) Procedures for investigating nonconforming products b) Initiation of preventive action A preventive action is a change implemented to address a weakness in a management system that is not yet responsible for causing nonconforming product or service. Candidates for preventive action generally result from suggestions from customers or participants in the process c) Documentation of change in procedures Section 14: Handling, Storage, Packing and Delivery a) Handling procedures to prevent damage b) Storage and packaging of casting prior to shipment c) Delivery methods and records Section 15: Quality Records a) Maintenance of quality records b) Storage of quality records c) Time of retention of records Section 16: Internal Quality Audits a) Frequency of quality audits b) Procedures for follow-up follow-up, n the process of monitoring the progress of a patient after a period of active treatment. follow-up subsequent. follow-up plan action c) Corrective action methods & responsibility Section 17: Training a) Identification of training needs b) Procedures for training employees c) Maintenance of training records Section 18: Statistical Techniques a) Statistical methods used b) Processes or characteristics evaluated c) Authority to make process changes Table 2. Do's and Dont's for Foundries Seeking ISO 9002 Certification Do: * Expect (demand) that this program reduce quality costs. * Show evidence to all employees that top management is involved and interested in the program. * Begin by writing your quality assurance manual to the ISO 9002 format. Remember that this manual is to be a marketing showpiece show·piece n. Something exhibited, especially as an outstanding example of its kind. showpiece Noun 1. anything displayed or exhibited 2. . * Expect to show evidence that all employees have received training in the quality area. * Expect it to take 18-24 months for certification, even if a quality program already is in place. * Select a quality system registrar See domain name registrar. with experience in auditing foundries. Don't: * Make this project more difficult than necessary. Preparing for ISO 9002 certification is not the same as preparing for a TQM program. * Waste time and money teaching everyone statistical process control, a very small part of ISO 9002. * Demand that all first-line supervisors write their own procedures. If they're not good writers, give them staff help. * Give out copies of the Level 2 or 3 procedures. These are proprietary to your operations. * Let this become a consultant's program. Most work should be done by the foundry's employees so that ownership is properly established. Clearing Up Some Confusion about ISO 9000 Every foundry in the U.S. needs to be busy building an appropriate quality philosophy into daily operations. The metalcasting industry has had enough casualties, and it is time to make the necessary positive changes in attitude toward the future. Foundrymen, however, are torn by several misconceptions Misconceptions is an American sitcom television series for The WB Network for the 2005-2006 season that never aired. It features Jane Leeves, formerly of Frasier, and French Stewart, formerly of 3rd Rock From the Sun. about ISO 9000 and its processes. Listed below are two items that may need clarification. Proving Quality--ISO 9000 does not prove quality; it proves that a system is in place that meets the requirements of ISO 9000. There is no provision to ensure that the product itself fully complies with the expectations of the customer. A foundry could produce 1000 identical castings that meet all written procedures yet fail to meet the actual requirements of the customer. Your ISO auditor might be very happy, but your customer might be unhappy. This is why ISO 9000 standards are not an acceptable substitute for the supplier quality assurance standards of companies like Motorola and Ford. And because the standards do not guarantee product quality, ISO explicitly refuses to allow registered companies to use their registration seal on their products. Writing Manuals--It is best for foundries to write their own manuals so they fully understand what is going on in the ISO 9000 process. For an effective quality system, everyone in the foundry must be active. The people who run machines and/or processes know more about their activities than anyone else and must be intimately involved. Otherwise, you risk making erroneous erroneous adj. 1) in error, wrong. 2) not according to established law, particularly in a legal decision or court ruling. assumptions that could be revealed during an audit. Following the path of Deming, the way to make a foundry profitable is to adopt a defect defect - bug prevention policy. This is achieved by recognizing that variation is the enemy of quality. Foundries must stabilize stabilize See peg. and control the variation in the process. Then, foundries can look for opportunities to improve the capability of each process, where cost effective. Most importantly Adv. 1. most importantly - above and beyond all other consideration; "above all, you must be independent" above all, most especially , before you embark on Verb 1. embark on - get off the ground; "Who started this company?"; "We embarked on an exciting enterprise"; "I start my day with a good breakfast"; "We began the new semester"; "The afternoon session begins at 4 PM"; "The blood shed started when the partisans such a project, take the time to fully understand what ISO 9000 will and will not do for your foundry. |
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