1. Modernidad y Educación
1.5. El proyecto educativo moderno
Define, describe, and interpret the basic elements of a quality system, including planning, control, and improvement, from product and process design through quality cost systems, audit programs, and so on.
(Evaluate)
Body of Knowledge II.A
Every system includes inputs, outputs, activities (processes), and relationships.
The elements of a quality system are the activities used to assure customer satis-faction. Typically, these activities depend on the type of organization, its structure, the market, and the particular type of product or service provided.
Quality-related activities start with identifying customer needs and extend throughout the lifecycle of the product, as depicted in Figure 10.1. The procedures and work instructions followed within each of these functional areas to achieve the stated quality objectives represent elements of the quality system. It is impor-tant to note that the suitability and effectiveness of the system as a whole is deter-mined by the attributes of these individual elements and their relationships. Top management must establish, document, and maintain such systems with overall objectives in mind.
System elements closely correspond to the various phases in the tradi-tional product lifecycle depicted in Figure 10.1. In other words, a quality system must cover all the activities that affect product or service quality. ISO 9004:1994 listed the following fourteen functional elements of a quality system. Although ISO 9004:1994 is obsolete, every element is still pertinent, and each of these ele-ments is discussed elsewhere in this book.
1. Quality in marketing. The marketing function is an important source of information regarding the implied and stated needs of the customer, actual field performance, and the degree of customers’ satisfaction with the product. Such information will help identify product problems relative to expectations and initi-ate corrective measures. Consequently, the marketing function is required to define
Pa rt I I. A
and document the requirements for a quality product, provide the organization with a formal statement or outline of product requirements, and establish an infor-mation feedback system for monitoring field performance on a continuous basis.
2. Quality in specification and design. With the customers’ needs clearly iden-tified, the design function provides the translation of these needs into technical specifications. Formal plans should be prepared and documented for identifying critical stages of the design process and assigning responsibility for each. Design reviews should be conducted at the end of each stage to identify problem areas and initiate corrective actions. All necessary measures should be taken to assure clear and definitive statements of the design requirements. Methods for evaluat-ing conformance durevaluat-ing production should also be specified. Design verification and validation through prototype testing or other techniques is required. Provi-sions should be made for periodic evaluation of the design in light of field perfor-mance data.
3. Quality in purchasing. The standard requires that all purchasing activities be planned and controlled by documented procedures. Successful purchase of supplies begins with clear definition of the requirements. A close working rela-tionship with vendors and subcontractors is required to facilitate and secure con-tinuous quality improvements. Procedures must be established for evaluating the capability of the vendors. In some cases the vendor is required to establish a dem-onstrated capability of meeting design requirements. If incoming inspection is to be performed, the costs involved should be considered and the vendor should be notified of the results.
Figure 10.1 Product lifecycle and quality system elements.
Adapted from ANSI/ISO/ASQC Q9004-1-1994. Used with permission.
Pa rt I I.A
4. Quality of processes. This element stipulates the requirements of operation under controlled conditions. The operation of processes and the operating condi-tions should be specified by documented work instruccondi-tions. Process capability studies are required to determine the effectiveness of the process and to identify the need for improvements.
5. Control of processes. This is a central element in achieving conformance to design requirements. The type and sensitivity of the control technique depends on the quality characteristic involved or generated, the nature and stability of the process, and its potential capability. Control should extend over the material and parts used, tooling and any shop aids utilized, and environmental conditions.
Proper identification of materials from the time of receipt to product delivery and installation is required. Statistical techniques for monitoring process variables are described in Chapter 37.
6. Product verification. This element addresses the allocation of test and inspec-tion points in the process for the purpose of verifying conformance. Verificainspec-tion of incoming materials and products at various stages of the process prevents the unnecessary cost of further processing nonconforming units. Final product verifi-cation is performed to prevent shipping nonconforming units to customers.
7. Control of inspection, measuring, and test equipment. All measuring systems used in the development, production, and installation of products should be con-trolled. Documented procedures should be established to maintain the measuring process in a state of statistical control. The procedure includes initial calibration against a reference standard as well as periodic recall for adjustment and recali-bration, and may be extended to all vendors.
8. Control of nonconforming product. Documented procedures for dealing with nonconforming units should be established and maintained. These procedures include steps for the identification, segregation, and review of the nonconformi-ties. The objective is to avoid the unintended use of such units and the consequent dissatisfaction of internal and external customers.
9. Corrective action. A quality system should define the responsibility and authority for instituting corrective actions. These actions should be planned after identifying the root causes of the problem. Actions to eliminate these causes may involve a variety of functions such as design, purchasing, production, and quality control. The objective should be to prevent the recurrence of these causes and improve quality. Corrective action is required to monitor the effect of such actions in order to ensure that the above objectives are met.
10. Postproduction activities. Included here are procedures for product storage, delivery, and installation activities. These activities should prevent deterioration of product quality, secure proper identification, and safeguard against improper installation. Also, the quality system should allow for a feedback of information regarding field performance, customer satisfaction, and the initiation of correc-tive actions.
Pa rt I I. A
11. Quality records. These are records indicating the results of implement-ing the system and providimplement-ing subjective means for evaluatimplement-ing its effectiveness.
An organization is required to establish and maintain documented procedures for identification, collection, storage, retrieval, and disposition of these records.
Analysis of the quality records can help identify trends in quality performance, as well as the need for and effectiveness of corrective actions. In addition, records should indicate authorized changes to the quality manual and any modifications made in the procedures or work instructions. Documentation systems are dis-cussed in the next chapter.
12. Personnel. Employee training, qualification, and motivation are key factors in developing the human resources of an organization and emphasizing quality awareness among them. Documented procedures for identifying and providing training programs at all levels should be established and maintained. Periodic assessment of personnel skills and capabilities should be considered. Recogni-tion of proper job performance and the use of motivaRecogni-tional programs are ways in which management can support quality improvement efforts.
13. Product safety. Procedures are needed for identifying the safety aspects of products and processes. These aspects are best identified and considered during the design phase of the product lifecycle. Further, the rule of strict liability has created a need to plan for field failures and their legal implications. These proce-dures may include documenting prototype and product design evaluation test-ing for safety, providtest-ing adequate operational instructions with warntest-ings against known hazards, and developing contingency plans for product recall. Failure mode and effects analysis, fault tree analysis, and hazard function analysis are all valuable tools.
14. Use of statistical methods. This element of the quality system is concerned with the analytical techniques used to measure, control, and improve quality throughout the product lifecycle. These include design of experiments, estimation and test of significance, control charts, and sampling inspection.