ISO 9000 Quality Management System Basics

Author: Yu Jinping et al. / Country:
Publisher:
Publish Date: 2003-07-01
Features:
4.1 Procurement Control
Procurement products refer to products purchased to be used as part of the product or in subcontracting activities during product realization and service processes. Procurement products can be tangible or intangible, such as:
- The iron and steel plant purchasing ferroalloys and refractory materials;
- The refractory materials plant purchasing silica, clay, and high-alumina bauxite;
- The ferroalloy plant purchasing coke, manganese ore, silica, and chromium ore;
- The general or application software for computers in various enterprises;
- Subcontracting projects for transportation or packaging; and so on.
The procurement process includes:
(1) Identifying the impact of procurement products on subsequent realization processes and their products;
(2) Evaluating and selecting suppliers;
(3) Ordering;
(4) Regularly evaluating suppliers;
(5) Procurement documents;
(6) Verification of procurement products;
(7) Control of nonconforming procurement products.
Organizations should control the procurement process for externally supplied products that constitute part of the organization and for procurement products affecting the quality of externally supplied products (including hardware, software, process materials, and services). They should specify criteria for supplier selection and regular evaluation to assess the supplier's ability to provide products according to the organization's requirements. The criteria for evaluation, selection, and re-evaluation generally include:
- Product quality, price, and delivery time;
- Post-delivery service and support capabilities;
- The establishment and implementation of the quality management system.
Different evaluation criteria may be applied to different procurement products. Evaluation methods can include one or more of the following:
(1) Assessing the supplier's relevant experience;
(2) Reviewing the quality, price, delivery, and problem-handling of supplier products;
(3) Auditing the supplier's quality management system and evaluating their ability to provide required products as planned;
(4) Investigating the supplier's customer satisfaction levels;
(5) Investigating the supplier's financial status, service and support capabilities, and logistics capabilities.
Additionally, organizations should record evaluation results and tracking information and use them as a basis for supplier control based on their impact on the product realization process.
4.2 Procurement Information
Procurement documents should include procurement information used to describe the product, including the following:
(1) Quality requirements for the product;
(2) Requirements for procedures;
(3) Requirements for processes;
(4) Requirements for equipment;
(5) Requirements for personnel;
(6) Requirements for the quality management system.
4.3 Verification of Procurement Products
Before procuring products, organizations should investigate the procurement information (i.e., the products to be procured), which includes approval requirements for products, procedures, processes, and equipment; qualification requirements for personnel; and requirements for the quality management system. Before communicating with suppliers, organizations should ensure that the specified procurement requirements are sufficient and appropriate.
To ensure the conformity of procurement products, organizations should implement verification activities. Verification can be conducted either by the organization or by the supplier. There are various ways to verify procurement products, such as:
- Inspecting or testing at the supplier's location;
- Inspecting or testing upon receipt by the organization;
- Verifying supplier-provided quality certificates or other qualified documents.
The specific verification and release methods to be used should be determined based on the product and its impact on the product realization process and should be specified in the procurement documents.
5.1 Operation Control
The operation control of production and services refers to the processes of product formation, release, delivery, and post-delivery services. Since it directly affects the quality of products provided to customers, it must be controlled.
When implementing operation control, the following steps should be taken:
First, obtain information on product characteristics, such as the chemical composition, mechanical properties, and process performance of the product. Generally, product characteristic information is expressed through product standards or technical specifications. When necessary, operation guidance documents, such as process technical procedures or production operation procedures, should be available.
Second, use equipment correctly and maintain it on a planned basis to ensure the continuous operational capability of equipment to meet the needs of the product realization process.
Third, to control products and processes during operation, necessary measurement and monitoring equipment should be provided and used.
Finally, clear specifications should be made for product release, delivery, and applicable post-delivery activities. For example:
- Products that have not been inspected or verified to meet requirements should not be released or delivered;
- Products should be delivered to customers according to specified timeframes and methods;
- Appropriate post-delivery activities should be defined based on the characteristics of the organization's products and services. Post-delivery activities generally include providing product user manuals, supplying spare parts, offering training, and providing maintenance services.
5.2 Identification and Traceability
To prevent confusion, misuse, or unintended use of products during the realization process, and to enable necessary product traceability, organizations should define and control identification methods for products. The products to be identified include procurement products, intermediate products, and finished products throughout the production and service operation process. Identification is divided into two types:
- Identification to prevent confusion and misuse of products with different characteristics;
- Identification to prevent unintended use of nonconforming products, such as inspection and test status identification.
During production and service operations, appropriate methods should be used to identify products to distinguish their different characteristics and states, such as labeling, hanging signs, coloring, or designating specific areas.
When traceability requirements exist, unique identification should be used. For example, steel products for critical applications should not only be marked with furnace numbers and batch numbers but also indicate whether they are the head or tail of a billet, with each batch or individual product identified.