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.


Quality Audits


Any organization needs a mechanism by which it can check whether or not its operations are complying with all standards defined to meet its charter and objectives.  This is the purpose of quality audits: to ensure that the company has documented standards or specifications on how to do things and that these standards are complied with at all times. 


Simply put, a quality audit consists of  preparing a list of items (procedures, equipment set-ups, quality records, measurements, etc.)  to check and going to the areas responsible for these items for an actual check or audit of these items. The audit may be performed by a person (the auditor) or a group of persons (the audit team). 


Using the audit plan or checklist as basis, the auditor proceeds by asking questions, reviewing documents, checking records against specs, making measurements,  etc. to ensure that all the audit items have adequate documentation and are implemented in accordance with the documentation. There are three types of audits: 1) first-party or self audits; 2) second-party audits; and 3) third-party audits. 


First-party audits, also known as internal or self audits, pertain to audits wherein the auditors themselves are employees of the company being audited.  Some companies let people directly audit the areas they are responsible for, while some companies ask people to audit areas that are not under their jurisdiction. Self-audit teams are usually composed of three or four people.


Second-party audits involve a direct customer of the company being audited as the auditor. Needless to say, a second-party auditor has a direct interest in how well the auditee adheres to the standard, even if he or she is not an employee of the auditee.


Third-party audits pertain to audits wherein the auditor is an independent, third-party entity not related in any way to the company and the company's customers.  Third-party auditors are usually hired by the company to conduct audits that will help the company get certified to a certain quality standard, such as the ISO 9000.  


Gap Analysis and Corrective Action System


The world is not perfect, so there will always be room for improvement within the company.  Gap analysis is the comparison of what actually goes on within a company to what is required of the company. At a high level, it pertains to the comparison of the existing quality system and its current implementation to the requirements of external standards.  At a different albeit equally important level, gap analysis is the comparison of the company's actual practices with its quality system requirements.  The objective of gap analysis is to identify as many discrepancies as possible in order to systematically address them through a corrective action system.


Gap analysis and corrective action pertaining to quality system conformance to external requirements are often addressed by a special team composed of personnel who have the expertise and authority on the element being analyzed. Simply put, this team will review the company's quality system against the conformance model it was or will be certified to, as well as applicable government regulatory and statutory requirements.  Any gaps will then be addressed by instituting process changes and making the necessary documentation revisions.


Just as there is a need to do gap analysis at quality system level, there is a need to do gap analysis at product/process conformance level.  Thus, a company's quality system must include a gap analysis (GA) mechanism and corrective action (CA) system for product/process conformance discrepancies. No matter how mature a company's operations are, there will be glitches along the way.  An effective corrective action system will minimize, if not preclude, the recurrence of such glitches in the future.


At a minimum, the GA/CA system of the company must have a standard procedure for: 1) highlighting detected discrepancies and initiating a GA/CA request; 2) documenting the gap analysis results; 3) identifying and documenting containment and corrective actions; 4) proper disposition of affected products, if any.


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

The ISO9000 Standard; Metrology and Calibration




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