Understanding ISO 9000: using it painlessly day to day.
Earlier parts of this series answered basic questions about ISO 9000 and examined how it can be implemented beneficially in a foundry. This article expands on 18 key clauses and provides guidelines on how to conform to the program in your daily operations. It also shows how several foundries and diecasting shops have implemented this subset into daily activities.
There are 18 clauses within ISO 9002, the subset TABULAR DATA OMITTED of ISO 9000 that applies to foundries and other manufacturing operations, which apply to quality system requirements. The International Quality Assurance Standard ISO 9002, which is now becoming common among European foundries, requires the establishment of a documented quality system in the foundry, comprised of procedures for manufacturing each of the foundry's products.
The use of such procedures is intended to prevent nonconformance between specified and actual supplied cast products, and if any nonconformances arise, to facilitate their early detection and subsequent prevention.
While ISO 9002 Quality Assurance System operation can be, and often is at the outset, based on paperwork and keeping record cards, foundries can achieve dramatic savings in time and effort by the judicious use of computer systems to streamline record-keeping and speed up document preparation. Each clause should help the average U.S. foundryman better understand ISO 9002's impact on his own operations.
The 18 Clauses of the ISO 9002 Standard
4.1 Management Responsibility--This clause requires a foundry to state its policy on quality and define the responsibilities and authority of its people with regard to quality. In practice, firms are able to operate effectively only when managers are provided with information with enough time to correct any problems.
A good management reporting system is essential. It must deal with orders, production, scrap and many other areas. There also must be a record kept of what control action the manager took to rectify any problems in a given situation.
This clause also requires companies to establish a quality policy that should be signed by the CEO and posted. Suitably trained employees must undertake inspection, testing and process monitoring, and system audits must be completed by employees independent of those having responsibility for the work performed. A management representative will be responsible for maintaining the efficiency of the system, and it often is necessary to change the person's title to "technical/quality manager" to stress the importance of the quality role. Regular management reviews of the system must be maintained to ensure its continuing suitability and effectiveness.
4.2 Quality System--This clause insists that foundries define their quality system and how it operates, including provisions for quality planning. Documented quality systems are required to ensure that the product conforms to the customer's order requirements.
A quality policy manual should be written to outline the policy and the principles of the company's quality system. Quality control procedures should include the detailed operating instructions required to implement these policies.
It also is strongly recommended that foundries wishing to obtain ISO 9002: 1987 certification hold an in-house seminar to relate the requirements to all personnel.
4.3 Contract Review--The contract review clause states the need for a system to review orders and order amendments before acceptance, whether or not adequate information is available, whether the company can do the job and if the contract on offer is the same as what was quoted.
4.4 Document Control--This clause makes provisions for ensuring that only the correct versions of key documents are available for use. It may seem extremely simple to do, but it's frequently difficult.
For drawings, only the latest revision should be used, and a formal system, such as a card index system or computer data base is necessary. A formal system for withdrawing or destroying old documents is important to prevent others from using them in error.
Method or route cards outline the sequence of operations to be carried out on castings in production. Either manual or computerized document control is imperative so that details to be followed are correct.
A formal method of controlling all copies of quality and other standards to which the foundry manufactures its castings is needed. Not only is such a system required, but foundries must demonstrate that it is in use.
Documents and data must be reviewed before issuing and current issues of documents must be available at relevant locations.
Changes to these documents must be reviewed and agreed upon by the same people who originally approved them. A master list is required to establish current revisions of company documents.
4.5 Purchasing--When a foundry has selected its suppliers, it must continually monitor the performance of those suppliers--including subcontractors services. It is necessary to provide adequate and precise information on purchase orders.
The company must ensure that purchased products conform to specified requirements and that they are obtained from an approved source of supply. Suppliers and subcontractors must be selected on the basis of their ability to meet the company's requirements and records must be maintained to substantiate that this is true.
Purchase orders must contain detailed and clear descriptions of the product, including all quality assurance requirements. Specifications must be quoted in full, together with their appropriate issue numbers.
When specified by TABULAR DATA OMITTED the customer, suppliers must verify that the purchased items and materials conform to specified requirements.
4.6 Purchaser Supplied Product--The company must establish and maintain procedures for verification, storage and maintenance of all materials supplied to it. It is recommended that formal procedures be documented to define the company's method of controlling free issue items.
At any stage where free issue materials prove to be unsuitable, it should be formally reported to the customer and the product must not be processed or used until the customer provides disposition instructions.
4.7 Product Identification and Traceability--Procedures must be instituted to establish and maintain the identity of the product to drawings, specifications and work documents during production and dispatch.
When traceability is required by a customer, a unique identification system must be used and recorded for each batch. This can become very cumbersome if operated manually, and a computerized system is commonly used to maintain a set of historical traceability records.
Product identity must be maintained for all incoming raw materials, raw materials in storage, castings, work in progress and dispatch.
Part number identification should be clear and legibly applied to all castings, usually as part of the pattern detail. When applying part numbers is not practical, a label or batch card system should be considered.
4.8 Process Control--The production processes directly affecting quality must be properly planned and carried out under controlled conditions.
Foundries normally need to document their procedures for achieving required metal grades and must specify the process controls. This involves the control of raw material, melting practices with respect to composition charges, release of cast melt related to castings and relevant batch sizes. Attention should be given to work instructions, establishing workmanship criteria and approval processes and equipment.
Foundries often need to document process control procedures: core manufacturing; mold assemblies, including location and size of runners and risers; shotblasting procedure and control; fettling and viewing; and dimensional inspection.
Although they can't always be verified by subsequent inspection and may only become apparent after the product is in use, processes must be monitored continuously or compliance with documented procedures must be maintained in some other way.
4.9 Inspection and Testing--This clause covers receiving inspection and testing, in-process inspection and testing, final inspection, and inspection and test records.
Receiving inspection and testing requires a documented system for receiving products, inspecting and storing them. All products purchased by the foundry must be inspected on receipt to ensure that they comply with purchase order requirements. All must be identified and recorded to permit immediate recall TABULAR DATA OMITTED in the event of nonconformance.
In-process inspection and testing requirements state all cast products must be inspected, tested and identified, and process monitoring and control methods must be used to establish product conformance to specified requirements. All products must be held and identified as nonconforming until inspection procedures have been completed.
The clause's final inspection requirements state all final inspections and tests must be consistent with instructions and there must be evidence of nonconformance of the finished product. No dispatches can be made until the quality plan or procedures have been completed and authorized.
Inspection and test records must be established to provide evidence that the product has passed inspection or tests. Comprehensive records of inspection and testing are normally required, demonstrating objective evidence of acceptance or rejection at each stage.
4.10 Inspection, Measuring and Test Equipment--Suitable systems of control, calibration, maintenance and inspection of measuring equipment must be operated. In addition to documented procedures, appropriate records showing that the equipment is suitable for the purpose are required.
An equipment register assigns a unique number to all test and measuring equipment used by the company. Any personal equipment also must be registered. Calibration record cards normally are compiled and maintained to show the status of calibration and the results obtained.
4.11 Inspection and Test Status--Methods that allow for the identification of a product's inspection status at all stages of production must be employed. Information identifying the inspection authority responsible for the release of the conforming product must be available. A system must be introduced into the foundry to make provisions for evidencing the inspection status of goods incoming materials, in-process and finished castings awaiting dispatch.
The incoming inspection of the purchase order can be used to support completion of verification checks of raw material, which then can be placed in the material stores and identified by color code.
In-process identification status of castings can be achieved by using the batch card and/or labels. The inspection status of finished castings can be indicated by attaching a passed final inspection label to the products or container.
Rejected or suspect castings can be identified with a hold or reject label endorsed with the reason for nonconformance.
Inspection stamps also can be used to endorse labels or documents to indicate the inspection status as well as the person responsible for carrying out the verification release.
4.12 Control of Nonconforming Product--Procedures must be established and maintained for controlling products that do not conform to specified requirements.
Documented procedures are required for the control of nonconforming castings in all areas of manufacture. Identification labels should be used and a suitable quarantine area should be identified.
The responsibility for review and authority for the disposition of nonconforming product must be defined. It is recommended that procedures be written detailing how rejected work is reviewed and who has the authority to issue disposition instructions for nonconforming items.
4.13 Corrective Action--Documented procedures must be maintained to:
* investigate the cause of nonconforming product and the corrective action needed to prevent recurrence;
* analyze processes, concessions, quality records and customer complaints to eliminate potential causes of nonconformances;
* initiate preventive actions to deal with possible risks of nonconformity;
* apply controls to ensure that corrective actions are taken,
* implement and record changes in procedures resulting from corrective action.
4.14 Handling, Storage, Packaging and Delivery--Procedures must be documented and maintained for handling, storage, packaging and delivery of product.
Handling and secure storage areas must be provided to prevent damage or deterioration. Suitable controls must be used for receiving and issuing products and regular assessments of products in stock are necessary to ensure they remain in suitable condition.
Packaging and marking must be controlled to ensure specified requirements are met. Protection of product quality must be arranged after final inspection and, where specified, extended to include delivery to its destination.
4.15 Quality Records--Procedures must be maintained to identify, index, file, store and dispose of records to demonstrate achievement of the quality system's effectiveness.
Foundries need to establish systems for retaining and filing all quality verification records. These records must be retained for a minimum period of three years. Included among the 19 verification records required are calibration records, goods receiving records, audit sheets, customer orders and amendments, certificates of conformity, and reject notes and analysis.
4.16 Internal Quality Audits--Quality system audits and follow-up actions must be carried out according to documented procedures and must be scheduled on priority basis. Foundries need to raise an audit plan to organize the auditing reviews of the quality system on a controlled basis.
Such plans should provide for the review of each of the company's procedures at least twice each year, depending on the nature of the procedure, and the review should be completed by employees who are independent of the functions being audited.
4.17 Training--Needs must be identified and then provided for all activities affecting quality. Employees performing specifically assigned tasks must be qualified on the basis of appropriate education, training or experience and records should be established documenting their training.
Training of company personnel in the requirements of ISO 9002 and auditing techniques also is recommended so that the different sections of the international standard are understood and a collective attitude on quality is adopted.
4.18 Statistical Techniques--Where appropriate, procedures for identifying adequate statistical techniques required for verifying acceptability of process capability or product characteristics must be applied.
Procedures should be established for the introduction of sampling techniques to be used for goods receiving and final inspection release and it is suggested that a suitable sampling plan be used for the work.
Covering All Bases
Regardless of the mechanism used to maintain the Quality Assurance System, it is clear that foundries registered under ISO 9002 have realized considerable benefits.
Showing that each of the clauses is used, and not bypassed, is at the heart of all ISO 9002 system stipulations. Personnel in all ISO 9002 certified businesses must be seen to be "singing from the same songbook."
Mr. Law will discuss ISO 9000 and foundries at the AFS Foundry Executive Management Conference on September 13-16, 1992 in Colorado Springs, Colorado. He also will be a primary instructor at "Implementing ISO 9000," a CMI seminar scheduled for November 18-20, 1992. This seminar is designed specifically for the metalcasting industry. Presentations will include an introduction to ISO 9000, how to write procedures, audit planning and follow-up. For more information on these events, phone AFS headquarters at 708/824-0181 or 800/537-4237.
How Foundries Measure up to ISO 9002 and Improve
In order to show the relationship between the standard and its practical interpretations, two examples of contract review and document control are cited.
Clause 4.3 (contract review) requires the review of orders and order amendments before acceptance, whether or not adequate information is available, whether the company can do the job and if the contract on offer is the same as what was quoted. Looking at how current foundries handle this matter, one foundryman said, "Although all incoming customers' inquiries and orders are reviewed by the company, there are no documented procedures which detail the checks that are made and there are no records to evidence these checks."
Here is a recommendation on how foundries can conform to this requirement.
A formal review will be necessary for all future inquiries, orders or order amendments. The inquiry, order drawings or product samples have to be checked to establish the manufacturing processes required, to ensure that the company fully understands the requirements and that it has the resources to undertake and inspect the work.
It is normal to arrange that verbal orders should be entered onto a verbal order sheet and, after completion of a satisfactory review, clearly identified with a stamp or signature. Finally, it usually is recommended that detailed procedures are written to explain how the company's contract review system is operated and that particular attention is given to the means of identifying and controlling changes and/or additions to customer requirements.
This requires that the incoming order is formally logged onto an orders received system--preferably onto a computer data base. A number of items must then be checked, such as:
* Is the casting referred to in the order the same one quoted?
* Is the alloy ordered the one quoted?
* Can all of the quality requirements be satisfied?
* Do we have the pattern/die equipment on-site?
* Can we make the job in the lead time available?
Clearly, these questions will need to be answered by more than one person, but each needs to be answered before accepting the job. The acceptance must be formal and able to demonstrate that the job was formally accepted by the foundry.
While a manual clerical system can easily handle such needs, there will be an extra clerical workload generated by these procedures. A computerized system that can store orders in a computer file can more quickly and cost-effectively handle this task. When every question in the contract review procedure is complete, it will print a customer order acknowledgement letter.
For clause 4.4, which deals with document control, it is required that documents and data must be reviewed and approved for adequacy by authorized personnel, and that appropriate documents are available at relevant locations.
Typically, foundries have no sufficient formal system in operation to approve and control the issue of customer drawings and specifications.
Generally, foundries aren't using an issue number system for controlling internal documents. The issues of ISO or other standard specifications are not controlled effectively.
It usually is recommended that the technical/quality manager controls quality
documentation, preferably using a computerized system.
A master register system should be used to identify the receipt and issue of all drawings, customer specifications, national/ISO specifications and company documentation.
In-house documentation also will need to be uniquely identified with serial numbers and issue numbers so that a control system can be established.
It should be noted that drawings should be registered immediately after receipt of an order.
This clause also requires that all changes to documents be reviewed and agreed upon by the same people that originally approved them.
In general, foundries deal with document changes on an informal basis. It is not considered to be comprehensive enough, however, to meet the requirements of the standard.
No formal procedure exists for controlling changes to internal quality related documents, forms, national specifications and standards and customer specifications.
It normally is recommended that formal documented procedures are issued in respect to changes and amendments to drawing, specifications, forms, etc. The company documents should be reviewed each year to ensure that they continue to be used for the purpose for which they were designed.
Finally, changes to the Quality Policy Manuals and the Quality Control Procedures will need to be formally controlled and documented.
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|Title Annotation:||Quality in the 90s; includes related article; following quality system requirements for foundries|
|Article Type:||Industry Overview|
|Date:||Aug 1, 1992|
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