Quality Management Systems

The quality management system of an organization is the collective body of processes, operating procedures, objectives,  responsibilities, resources and infrastructure needed to implement effective management of quality.  The first step in setting up a quality management system within a company is to generate a quality manual. This should be done even before any quality procedures or specifications are written. 

The quality manual is the company's quality bible or constitution. It is a document that states in a concise and brief format the high-level policies and objectives of the company required to achieve its desired level of quality. It should also show how the company's over-all documentation of specifications is structured.

It is good practice for a company to choose an international quality standard as basis of its quality management philosophy before it writes up its quality manual. One such standard that semiconductor companies have embraced over the years is the ISO 9000 series of standards. As such, most semiconductor companies base their quality manual on the ISO 9000 standards. An ISO 9000-based quality manual must address every ISO element or section of the ISO 9000 standard that the company wants to be certified to.

Each ISO quality section or element addressed by the quality manual should be written with at least three parts, i.e., Scope, Policy and Responsibilities. The Scope portion should simply state the purpose of the covered area. The Policy portion should state the company policy regarding the applicable ISO clause. The Responsibility portion should state who, in generic titles or positions, is responsible for the policy.

Quality attainment and maintenance need money (referred to as the cost of quality) so the quality system of the organization should not exceed what's needed to meet the organization's quality objectives. It is therefore essential for a company to clearly document its quality objectives, and the processes by which it will achieve these objectives.  The embodiment of these quality objectives is the company's quality standard, and it is up to the quality system to ensure that the company's documented procedures, actual operation, and quality records all conform to this standard.  

A quality system should encompass not only the quality of the finished product of a company, but should cover the quality of operational processes as well.  In fact, it not only must cover the over-all in-process quality of the company, but should also consider the quality systems of its suppliers and subcontractors, as well as those of the customers. 

In the semiconductor industry, the quality system of a company is the backbone of how it does its business. A company that has a great product can fail if the quality of its operations is inferior. Even the basic task of getting customers relies greatly on the quality system of the company.  For instance, a semiconductor company needs ISO certification before it can attract customers, and ISO certification revolves around an extensive audit of the quality system of the company.  

I. Quality System Planning 

Quality system planning is the first stage in setting up a quality management system within the company.  This pertains to the identification and acquisition of resources, logistics, and manpower needed to define and achieve the required quality of the company.  If the company is to be certified to ISO 9000, then quality planning should ensure that the company's quality system will eventually conform to all the requirements of the ISO9000 elements. 

Quality planning should include compatibility among the various aspects of the company's operations from start to finish: product design, production, and product inspection/testing. It should also include definition of product and process specifications. Identification of the necessary monitors as well as inspection/verification stations at suitable points along the production process should also be addressed as early as quality planning.  Measurement capability requirements must likewise be defined during quality planning.

II. Quality System Documentation

Once the quality system plan of the company has been completed, the quality system must undergo full documentation that comprehends the complexity of the production process, the manpower skills required for production, and the training requirements to achieve these manpower skills. At the minimum, quality system documentation should include the company's quality manual and specifications showing the company processes, work instructions in support of these processes, and production/quality records required by these work instructions.

III. Quality System Implementation

The last stage of setting up a quality system is, well, its implementation. By the time this stage is reached, the over-all quality system should have been defined and documented, and supported by product- or process-specific quality plans. Implementation should involve everybody in the company - the management for enforcing, reviewing, and continuously improving the quality system, and the personnel to comply with the quality system to achieve the company's quality objectives.  Quality audits must be conducted regularly to ensure that the actual implementation of the quality system is in full conformance with the quality system documentation.

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See Also:  Quality Audits;  Corrective Action System; Monitors and Controls; Document Control;

The ISO9000 Standard; Metrology and Calibration