ISO9000 Quality Management System Basics

Author: Yu Jinping, Que Shipeng
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4.1 Procurement Control
Procurement products refer to those purchased to be used as part of the product or in subcontracted activities during the product realization and service process. Procurement products can be tangible or intangible, such as:
- The iron alloys and refractory materials purchased by an iron and steel plant;
- The silica, clay, and high-alumina bauxite purchased by a refractory materials plant;
- The coking coal, manganese ore, silica, and chromium ore purchased by an iron alloy plant;
- The general or application software for computers in various enterprises;
- Transportation or packaging subcontract projects; and so on.
The procurement process includes:
(1) Identifying the extent to which procurement products affect subsequent realization processes and their products;
(2) Evaluating and selecting suppliers;
(3) Ordering;
(4) Regularly evaluating suppliers;
(5) Procurement documentation;
(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 the supplier's 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) Examining 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 controlling suppliers based on their impact on the product realization process.
4.2 Procurement Information
Procurement documentation 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. These activities can be conducted either by the organization or by the supplier. Verification of procurement products can be performed in various ways, 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 method of verification and release should be determined based on the specific product and its impact on the product realization process and should be specified in the procurement documentation.
5.1 Operation Control
The operation of production and services refers to the process 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 instructions should be available, such as process technical procedures or production operation procedures.
Second, use equipment correctly and maintain it on a planned basis to ensure that the equipment's operational capabilities are continuously maintained 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.
Last, clearly define the release, delivery, and applicable post-delivery activities for the product. For example:
- Products that have not been inspected or verified to meet requirements shall not be released or delivered;
- Products should be delivered to customers according to the specified time and method;
- 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. Identified products 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.
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 labeled 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.