DEVELOPMENT OF A QUALITY SYSTEM
Ulyahin T.M. (TSTU, Tambov, Russia)
Annotation: The most powerful justification for a formal quality system is managements belief that a quality system can improve the business and save money. The truth of this belief has been shown in many examples, but there are still many who do not believe the results. This is principally because the implementation of an effective quality system is difficult, and requires continued work. Many people simply do not do it right. However, if your company has the right reasons for the effort, and is willing to stay the course, the benefits will be worth it.
The development of a quality system takes the concentrated effort of many people.
This chapter discusses the necessary ingredients for this effort and how to obtain them. Figure 1 shows the recommended organization, consisting of a steering committee, a project coordinator, and quality teams.
1 Management Involvement.
The quality system is an important tool of any business that can either add or subtract to the business success. Since the quality system is so important to the operation, the management must be willing and involved participants to the process. Management involvement is through the steering committee.
2 Organization of the Effort.
As with any large task, organization is the key to success. The organization of the effort must begin early. It is also important to track and modify the organization of the task as circumstances change.
3 Document Generation Order.
Most of this task is the generation of documents. There are several different ways to order this writing. The best way generally is to write procedures first, followed by the Work Instructions and Quality Manual.
Steps to Develop a Quality System
There are three major steps in developing a quality system. These steps are:
identify the responsible individual;
establish the steering committee;
organize and conduct the effort.
The development of an improved quality system and registration to the IS standards requires an organized effort that involves the total company. Development of an improved quality system must begin with management commitment and support. This is generally best obtained using a steering committee. This steering committee is made personnel that are responsible for the general direction of the effort. The steering committee directs the quality system improvement effort through a quality system project manager (QSPM).
The QSPM establishes the project, assigns responsibilities, and schedules the program. This person must have a good understanding of the IS requirements, and how to organize the work that must be done.
A company employee generally fills the project manager person, although many companies use outside consultants.
Quality Team does the actual work. These teams establish the content of the procedures, the process steps, and help implement the procedures when completed.
Figure 1 Suggested Quality Development Organization
The first step of a quality system development effort is the selection of the responsible individual. Top management generally selects the QSPM. The quality system project manager is the most important person in the quality system development effort. This individual or a small group of individuals under his or her direction generates the actual documents. The QMPM should receive training before beginning the documentation development effort.
Outside consultants frequently fill this position in smaller companies.
Steering Committee
The steering committee directs, guides, reviews, and approves the documents generated by the QSPM. The steering committee constitutes "management review" as defined by Paragraph 4.1.3.of ISO 9001. All committee meetings have to be documented and recorded. These meeting minutes will be good evidence of management review of the system to present to the ISO auditor.
The function of the steering committee is to provide overall direction to the QSPM during the development of the quality system. This committee should meet regularly, preferably bi-weekly to review the status. As a minimum, the committee should meet at critical project points.
The members of the steering committee are responsible for directing the effort. Members of this committee do not have to be experts in a quality system, or even have a quality department background. However, they should be familiar with the general requirements so that they can supply effective leadership.
Training recommended for the steering committee is:
basic Quality System fundamentals;
IS standards;
IS registration;
Quality System Maintenance.
All trainings will go to the personnel records as partial fulfillment of the ISO training requirements.
Organize and Conduct the Efforts
There are five phases in the development of a quality system. These are:
Phase 1. Establish the current state of the quality system.
Phase 2. Quality system design.
Phase 3. Develop documentation.
Phase 4. Install and implement quality system.
Phase 5. Evaluate and revise quality system.
Phase 1. Establish the Current State of the Quality System
Each company that has been in business for any period has a quality system. The first step of the development is to find out WHAT is the status of the PRESENT quality system. It is important that the development team understand how the present quality system works. Then, the new system can use as much of the existing system as possible.
This phase consists of the following steps:
audit the present quality system;
establish present quality system status;
establish corrective actions.
Phase 2. Quality System Design
The new quality system is designed in this phase. This means that the number of documents, the organization of the documents, and the documentation system is established. Poor decisions can cause extra work.
The steps of Phase 2 are:
generate company quality policy;
determine the basic quality system outline;
determine which present documents are usable;
establish the titles and general content of all documents;
determine the membership of the quality teams;
establish who will review each document;
establish the schedule.
Phase 3. Develop Documentation
Creation of the documents occurs in Phase 3. This phase takes considerable time and effort. Good preparation in Phase 2 can hold the amount of work and confusion down to a minimum. The QSPM or the document writers assigned, under the direction of the quality teams, write each document. The steering committee maintains control of the development process.
The steps to accomplish during Phase 3 are:
generate quality system documents;
review and approve the documents;
train all company personnel in IS and quality system principles;
select and train internal auditors.
Phase 4. Install and Implement Quality System
Phase 4 is the implementation to introduce the new quality system into the company operation. This implementation is generally a slow and painful process since many of the ideas introduced are new and different. Phase 3 and Phase 4 are often performed in parallel to shorten the total time of the development.
The operations in Phase 4 must be done with care, and a sensitivity to the personnel involved. Frequently there will be considerable resistance to the new quality system. Surprisingly, this resistance is seldom from the first line workers. Generally, the resistance comes from middle management who sees the quality system controls as a threat and a restriction to their operations. It is important that the steering committee support Phase 4 actively, making sure that personnel at all levels understand the importance of the quality system.
The steps of Phase 4 are:
train personnel in applicable documents;
conduct frequent internal audits to encourage complains and answer operational questions;
record operational difficulties in the quality system for correction.
Phase 5. Evaluate and Revise Quality System
Phase 5 completes the development by evaluating the developed system and correcting the discovered deficiencies. The system errors or problems identified in Phase 4 are corrected. In this phase, the company also conducts a system audit to determine the general adequacy and compliance to the ISO standard. During Phase 5, the ISO registrar may also be selected and the audit scheduled.
The steps of Phase 5 are:
re-train personnel in changed documents;
correct identified system errors or problems from Phase 4;
select and schedule the IS registrar (if applicable).
References
1 Ulyahin, T.M. Quality Management System in then Russian industrial company: developing problems // European Journal of Natural History. London, 2007.
2 American National standard, ANSI/ASQ Q90-1987, American Society for Quality, Milwaukee, Wisconsin 53203.
3 Feigenbaum, A.V., Total Quality Control McGraw-Hill, new York, N.Y., Third Edition.