Surviving ISO implementation.

This British foundry director who went through ISO 9000 shares his problems, concerns and advice...before and after certification.

Shortly after weathering the early 1980s recession, Cradley Castings, a gray iron and aluminum foundry, was advised by its largest customer that the supplier intended to introduce the British Standard BS5750, the British National equivalent of ISO 9000.

The customer also told us its future policy would be to do business only with foundries that were ISO 9000 registered.

It was clear the foundry needed to aim for ISO 9000 registration to maintain its customer base. Investigating the system further, the foundry realized there could also be long-term advantages through increased efficiency, a greater awareness of everyone's contribution to quality, and fewer internal rejects and customer complaints.

Consequently, we knew if we were to maintain our existing customers and gain new customers, we had no choice. We had to introduce ISO 9000.

Signing a Consultant

Being a relatively small company, it was obvious that Cradley needed assistance in implementing the system. Therefore, a consultant organization was appointed to do a preliminary survey of Cradley's existing system to assess the depth of the problem.

The consultants reported, "...There is no organized system, although there are some process control and quality documents. The development of the quality system and quality manual will involve starting from a low base line."

The consultants were encouraged, however, that six months earlier, Cradley had installed a computer with a software program capable of handling production and quality records. This provided potential for computerizing much of the quality data derived in the proposed quality system.

The computer software, Dewtec Production Control System, is now marketed in the U.S. by AFS. More than 1000 pattern numbers were registered in the pattern files and about 500 orders in the current order file. It was obvious the computer system could save the company from the potential avalanche of paperwork.

The consultants who carried out the preliminary survey were unable to give full backing to the implementation stage. After evaluating several consultants, a formal contract was signed with TEC (Consultants), Ltd., Birmingham, England, in November 1988. The terms were to identify and advise actions that Cradley Castings needed to obtain BS5750 Part 2/ISO 9002: 1987 registration.

The company's general quality manager was designated as the main contact between the company and the consultants, and it was agreed that there would be regular minuted review meetings chaired by the CEO, in addition to working meetings between the quality manager and the consultants.

The initial in-depth survey of the existing quality system showed there was a sound basis for the formal system. ISO 9000 is concerned only with commonsense principles that quality-conscious companies in any field should already be observing.

ISO 9002 Clauses

It was agreed that the draft manual prepared by the consultant should be discussed in detail on a clause-by-clause basis in meetings by the consultant, quality manager and CEO.

The initial reaction to the consultant's draft was one of horror.

Management felt the draft was too comprehensive for a company of Cradley's size and couldn't be operated with existing staff levels. Cradley officials stressed that their goal was to implement a system that could be operated by existing staff while still satisfying the requirements of ISO 9000.

The CEO intended to question every aspect of the system and the consultant would need to justify its inclusion.

The quality manager's job was to mediate between management and the consultant and approve the final system--knowing he was going to have to implement and operate it on a day-to-day basis.

This method was successful. Although it probably extended the implementation period, it was a major factor in the success of the project. Here, we concentrated on the requirements of ISO 9002 to show how each clause of the standard was introduced.

Management Responsibility--The company is required to issue and display a signed policy statement outlining its policy, objectives and commitment to quality.

All employees were required to attend a meeting at which ISO 9000 was briefly described. Management explained its implications for both the company and its employees, and emphasized how the successful application of the system relied on their full cooperation.

The duties of all personnel who manage, perform, verify or have any input to quality were defined, together with their responsibility, authority and interrelationship. Regular management review meetings would be held to determine the continued adequacy and effectiveness of the system.

Quality System--The quality system was defined and cross references were made between the quality manual, quality control procedures and work instructions. This clause is basically a statement of intent and doesn't require any practical application.

Contract Review--A main purpose of a quality system is to ensure that the customer receives exactly what was ordered. Cradley had been checking all orders on receipt, but no formal contract review procedures were documented.

Procedures were specified to ensure that:

* order requirements were adequately defined and documented;

* any requirements differing from those in the relevant quotation were resolved;

* the company had the capability to meet contractual requirements.

The computerized production control system was updated and additional accountancy software was added on a network basis.

The computerized system could hold the check information for the contract review in the pattern register file. The order would then be checked against the information held in the pattern register and the contract review document would be signed by the production manager.

The order would then be entered in the computer order file and an order acknowledgement would automatically confirm to the customer what would be supplied (in metal type), along with the price and delivery date. After being signed to verify the order entry on the computer, it would be filed.

In today's financially crippling liability actions, this aspect of the ISO 9002 system is vital, if only to confirm the company is supplying what the customer has specified and that any liability rests with him.

Document Control--Documents and data must be reviewed and approved for adequacy by authorized personnel before and when issued. All documents must be identified by a number and issue code to ensure the correct issues of all quality associated documents are available and being used.

In addition to the drawing and issue number recorded on the pattern register file, an engineering drawing register must be maintained within the computerized production control system. This information is checked during the contract review procedure.

Purchasing--Suppliers and subcontractors are assessed as to their capability to satisfy company's requirements. The quality system must continuously monitor both suppliers and subcontractors.

Cradley monitored suppliers by means of a single-page vendor survey form (although we have received documents up to 10 pages from our customers).

The quality manager must compile and maintain an approved suppliers list, giving each an annual performance rating.

Purchaser Supplied Product--Customer-supplied patterns are classified in this category, and on receipt, the pattern equipment must be inspected and reported on an incoming pattern check sheet. At the same time, any relevant information is recorded in the pattern register file of the production control system before the pattern is stored.

Product Identification and Traceability--ISO 9000 requires procedures to establish and maintain the identity of the product to drawings, specifications and work documents during production and dispatch. Full traceability to specific melts is not mandatory, but should be available if required.

The castings would be dated (if required) but under normal circumstances, the traceability requirements would be satisfied by referring to the computer production control system's historical traceability file.

Process Control--The standard's in-process requirements caused the most problems, and resulted in long and sometimes heated arguments among senior staff members in trying to determine the most suitable system for our operation.

It was originally proposed that a route card containing work instructions would be pulled for each order. It was to accompany the patterns and the castings throughout production.

This was impractical, however, since an order can be produced over a number of days and castings couldn't be maintained in individual order batches through the knockout and dressing operations.

Handwritten cards were previously issued to the foundry, listing the pattern number and the quantity required. The cards were returned to the office each day and production information was entered on the computer. The aim was to retain this basic card system with the route card replacing the work card.

After passing through pattern inspection, the route card would accompany the pattern to the foundry. It would record the production and be returned to the office each day as the original work cards system had operated. After all the castings were produced, the route card would then be passed to the inspection department and signed by the inspection staff to confirm all work instructions were carried out.

After the castings were cleaned and inspected, they would be conveyed to the dispatch department, where a yellow label would be attached to signify further work had to be carried out (such as machining, painting, heat treatment) or a green label if the castings were available for dispatch. Any reject castings would be segregated to a quarantine area for a second inspection prior to reworking or final rejection.

Since castings can work their way through the finishing shop in an ad-hoc manner rather than in complete batches, the quantities processed would be recorded on a daily inspection sheet rather than on an operation card. This sheet would also be returned daily to the office and the relevant information entered into the computer. All reject castings would be recorded on a daily reject report and entered into the computer with the reason for their rejection. Scrap analysis sheets must be printed and discussed at regular scrap meetings.

In addition to the work instructions in the form of the route card, other work instructions need to be drawn up and issued in respect to metal control, casting, sand control, cleaning, and the operation of the various test and inspection equipment. Other process controls within the foundry and by subcontractors (such as heat treatment and painting) must also be issued.

Inspection and Testing--Raw materials must be inspected or verified on receipt to ensure they comply with the purchase order requirements. The details of all incoming raw materials would be recorded on a good inwards inspection record and accompanied by a certificate of conformity where specified.

All incoming subcontracted work must also be recorded in the goods inward record.

Like most foundries in the U.K., Cradley Castings doesn't operate its own pattern shop. Consequently, all new patterns supplied by subcontract pattern shops would have to be accompanied by a certificate of conformity referring to the drawing number and issue number to which they had been manufactured.

All castings (acceptable or rejected) must be recorded in the historical file of the computer production control system. This information must be maintained for at least three years.

No dispatches can be made until all quality procedures have been satisfied and the route card signed. A certificate of conformity might be issued and signed by a designated staff member.

Inspection, Measuring and Test Equipment--A calibration chart is drawn up to detail instrument identification number, frequency of calibration and date of calibration. This information, with the date of the next calibration and other calibration data, is recorded for testing, weighing and laboratory equipment.

Inspection and Test Status--All raw materials must be identified with suppliers' identification labels, inspected and endorsed with a quality control "Passed" stamp upon satisfactory inspection and/or placed in approved areas.

The manufacturing and quality requirements for each casting are contained on the route card, which is issued for each work order. A member of the quality department is responsible for ensuring that the requirements are fulfilled.

Control of Nonconforming Product--Procedures must be established and maintained for controlling raw materials or castings that don't conform to the specified requirements. The nonconforming items are quarantined, and in the case of raw materials, returned to the supplier. Rejected castings are recorded on the computer. Regular scrap meetings are held when defective castings that continually show adverse trends or other problems are discussed.

The meetings are minuted and any corrective action recorded and followed up. If a particular problem gives cause for concern, the quality manager has the authority to stop production while an investigation into the problem is carried out.

Concessions to specified requirements must be justified and only applied for on the authority of the quality manager. They must never be used as a means of submitting low standards of quality for acceptance.

Corrective Action--When corrective action is required, it can only be authorized by the quality manager and must be fully documented. Where applicable, the customer's approval must be sought before undertaking the action. Customers' returns and complaints are also recorded, investigated and corrective action taken where necessary.

Handling, Storage, Packaging and Delivery--The quality system applies until the castings are delivered and procedures are documented. For example, any specific packaging requirement, such as shrink-wrapping, must be identified on the route card.

Quality Records--All quality verification records must be retained for at least three years. This was a major problem from the start and the decision was made to seek maximum use of the computerized production control system. As a consequence, all traceability and reject analysis records are held in the historical file.

Internal Quality Audits--A prerequisite of ISO 9000 is that the system be continually monitored by company personnel who are independent of the functions being audited. For example, the quality manager audits the contract review procedures, which are the responsibility of the production manager.

Audit sheets made up as a questionnaire are used as written summaries for each clause covered by the standard. An audit plan ensures each element of the quality system is subjected to a periodic audit, usually twice a year.

All nonconformances emerging from the audit must be recorded on the audit sheet and audit plan, and must be corrected within a stipulated time.

The audits are reviewed by the CEO and reported on at the annual management review.

Training--Training needs must be identified and provided for all activities affecting quality. A training record is maintained for each employee.

Statistical Techniques--It is company policy to carry out 100% visual inspection. As a consequence, statistical techniques such as SPC are not currently used. Where appropriate, graphical analysis of reject castings would be undertaken.

Implementing the System

After accepting the draft procedures in mid-1989, the company began implementing them. Some of the clauses were relatively easy to implement, but discipline is essential to ensure that implementation isn't delayed--which we found was another advantage to using consultants. An implementation plan was drawn up and the consultant made regular visits to the company to ensure it was being followed.

Contract review and process control gave us the most difficulties.

Contract Review--The first question on the contract review asks, "Is the pattern equipment to the latest drawing issue?" To ensure that the latest drawing issue was on file for each pattern, all existing drawings were destroyed and, on receipt of an order, a copy of the latest drawing was requested from the customer. Thereby, a new drawing file was built up for all current running patterns.

Process Control--As the system was implemented, it became apparent that the most practical advantages could be derived from the process control aspect.

But after implementing the route card system, it was clear it was not altogether satisfactory. The main problem was the route card had to be retained as evidence that the casting had been produced to specification.

The fact it was circulating in the foundry environment meant that, in many instances, it became illegible.

Consequently, separate operating cards were designed in liaison with Dewtec staff to cover the coremaking and molding functions.

Under the revised procedure, the route card is returned from the pattern stores to production control, having been endorsed that the pattern equipment is in satisfactory working condition, and the coremaking and molding operations raised. These cards contain the same basic information as the route card and the work instructions in respect to the operation to which they refer. They are issued with the appropriate coremaking and pattern equipment to the foundry operatives.

Foundry operators enter production quantities on the operation cards that are returned daily to the computer operator. This production data is transferred to the computer and retained in the historical file, thus satisfying the traceability requirement and allowing the operation cards to be destroyed when the order is completed.

In the meantime, the route card is transferred to the inspection department. The route card stays in the inspection department until the castings have been cleared through final inspection and subsequently dispatched. It is then returned to the office, attached to the order and filed.

While the consultant made regular visits to progress the implementation plan, the work instruction manual was being prepared. It contains work instructions for the foundry operators (such as sand, inoculation, melting) and instructions for subcontractors (such as painting and heat treatment).

The system was up and running in 1990 and the fine-tuning of the system was undertaken. The quality control procedures manual was completed and the quality assurance manual was written.

All this work, together with writing the work instruction manual, was undertaken by the consultants with their word-processing and desktop publishing facilities. This was certainly an area our company could not undertake, primarily because we didn't have the staff or sophisticated printing equipment.

In early 1991, the quality system had been in operation for nearly a year and was considered ready for assessment by an independent organization.

There are a number of accredited assessment organizations in the U.K., some covering specific trades, while others cover a range of both manufacturing and service industries. Three organizations were invited to submit quotes for carrying out the assessment.

B.S.I. Quality Assurance, a division of the British Standards Institution, was chosen to carry out the assessment. A draft scope of registration was developed that read: "Jobbing and batch production of gray iron castings up to 250 kg weight in BS1452 Grades 180, 220 and 260, also aluminum sand castings to BS1490 up to 25 kg weight."

The application for registration to ISO 9002 was made and a copy of the quality policy manual was forwarded to B.S.I. for assessment to ensure it complied with the requirements of ISO 9002 so that any significant omissions or deviations could be corrected prior to assessment.

The company was subsequently informed that the document didn't meet the intent of ISO 9002. B.S.I. said the on-site assessment visit would occur in August 1991 and two B.S.I. members would carry out the assessment.

The Assessment

A meeting of all employees was arranged prior to the assessment, when the procedure was described. The enthusiasm for the system and the forthcoming assessment were particularly welcomed by the management.

The "big day" finally arrived. An introductory meeting involving the production manager, quality manager and CEO representing the company and the two assessors from B.S.I. was convened. The assessors said if they found a major nonconformity at any point, they would suspend the assessment. It was determined the quality and production managers would accompany each assessor for the duration of the assessment.

The assessment took two days to complete. The assessors then retired to an office to make their deliberations and judgment.

It was a great relief when B.S.I. informed management that if the foundry satisfactorily cleared the nonconformities within 42 days, a recommendation would be made for Cradley Castings' registration to BS5750 Part 2: ISO 9002.

The corrective action was taken and confirmed to B.S.I. On Sept. 19, 1991, the company received its certificate of registration. The registration entitled the company to use the B.S.I. registered firm symbol on letterhead, in advertisements, on stationery and for any other promotional purposes other than product marking.

Obtaining ISO 9002 registration was looked upon as something of an achievement but the company could not rest on its laurels. Registration is only the start. The quality system has to be maintained and has to be seen.

Minor nonconformities will arise and will need to be corrected. Only if major nonconformities are found will the registration be suspended.

In the U.K., certification bodies must conduct routine surveillance and a full reassessment not exceeding every four years. B.S.I.'s policy is that it will reassess the entire quality system over a two-year period.

After several assessment visits, several amendments were made in June 1992 to the three manuals, as well as to the certificate of conformity document.

Worth of Consultants?

Consultants were the target of much criticism in a U.K. survey. Some consultants entered companies with preconceived ideas, replaced tried and tested procedures that worked with new ones that didn't, and often charged excessive fees for doing so.

It is doubtful if Cradley could've achieved registration without consultant assistance. It benefited from the fact its consultants were foundry-oriented and that it had a computer-aided production control system. Most importantly, each clause of the system was examined in great detail. Without this, Cradley might have suffocated under an avalanche of paperwork.

Many small companies express concern at being forced into the standard by their customers. The threat of losing business from the larger companies, where the takeup of the standard has been considerably higher, has been real. Many foundries are seeking registration as a means of maintaining business.

Undoubtedly, implementing ISO 9002 to Cradley Castings increased the amount of documentation, but it's also had advantages. There is no doubt Cradley has benefited from the introduction of BS5750/ISO 9000.

It gained new customers and increased its business with existing customers because it was registered and its competitors weren't. Every company will benefit from ISO 9000, if only as a result of the self-scrutiny it imposes.

Advantages of ISO 9000

* no longer rely on any one individual's memory;

* foundry officials gain perspective on colleagues' jobs and responsibilities;

* improved efficiency in quality administration;

* greater consistency from order to order;

* greater awareness of defects;

* more comprehensive mechanism for ensuring action is taken in reducing rejects;

* gain new customers;

* absorb business from competitors who aren't ISO 9000 registered.