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Risk analysis method in the establishment of quality management system

Most of the enterprises there is a confusion in the establishment of quality management system: how to make the system operate with good combination of procedures and work documents? How much is appropriate? How to improve the system suitability and effectiveness? This is also a consultant is difficult to grasp. I think this is the enterprise in the system failed to establish the survey on the status quo at the beginning of the grasp in the operation of the key risk points. Here I have a few years of consulting experience in the process of combination of several recent corporate coaching experience, for reference.

No matter what kind of management system (quality, environment, occupation health and safety) established, is a risk identification, risk process control. Every organization operates at least risk aspects: business risks and risk management. Including risk investment, financial risk and other aspects; the risk management includes human resource risk, quality, security and other aspects. We will discuss about the quality of the risk here.

The quality of the risk from the characteristics of the products / services or product / service in the process of the influence of these characteristics on man, machine, material, method, measurement, ring. Man: the quality of personnel, ability, consciousness; machine: equipment, tooling and other material procurement; supplier management; method: document control design, development; test: verification, testing, measuring equipment management; ring: working environment, external support. When the above factors cannot be controlled, will inevitably affect the characteristics of the products / services. It can not achieve the expected purpose of value-added operators, this is the risk. This is also the terms we describe the quality management system standards of management and control requirements.

The above mentioned aspects of the risk should be identified and controlled, we are very clear. The problem is that different enterprise of the same or of the same type standard system for the processes involved can do to control in the same way? The answer is negative. Because each process risk of different enterprises is different. Such as: the general manufacturing enterprises, is crucial to the product. Material procurement and supplier management process is the process of high risk control requirements, documents and the nature is relatively high. While the pure processing enterprises, processing materials supplied by the customer. Buy only auxiliary materials or equipment tooling. This kind of enterprise in the establishment of a system of procurement and supplier management process naturally without much attention.

To establish the system, the size of the risk basically determines the ability of the personnel training and process requirements, document number and detail level. Therefore, enterprises in the establishment of quality management system (including the quality management system standards such as ISO9001; special industry standards such as ISO22000/, AS9100/TS16949/ISO13485) to fully identify risks of each process, then according to the size of the establishment of the corresponding risk control methods, and establish the appropriate file system. To ensure the operation of the system and the enterprise conformity, suitability, effectiveness.

In view of different industries, such as manufacturing, sales, services and other aspects of the risk, will be followed in the article in the form of specific examples to analyze and explain

Identification and control of high risk process for quality management system in manufacturing enterprises

As mentioned above, different enterprises, the risk of different sizes. The process for the manufacturing process, how to identify high risk? No matter what kind of manufacturing enterprises, the key risk points are usually in production, warehousing, procurement process. We look at a few specific examples:

An injection molding enterprise. The shape and the size of customer care products, which mainly depends on the shape and size of die. So the key point of this kind of enterprise risk in the mold design and manufacturing process. So we should pay more attention to the process of establishing the system, deal with design, mold processing, acceptance, management form a detailed file to control.

An enterprise, by pultrusion processing of glass fiber profiles. Although the mold is also used in the forming process, but the mold design and the relatively simple, the product is relatively simple, it should not be mold management process for the key risk identification process, found in research, product quality is the main influence factor is the color, hardness and so on. These factors depends on the processing before the auxiliary materials such as paint, resin formulation deployment. So this kind of enterprise is similar to the processing of paint, ink and other products. The key process for the formulation design. So we should develop a detailed formulation design and verification work files and qualification formula design staff confirmed.

A cosmetics manufacturing enterprises, the production of washing and cream cosmetics, this kind of enterprise features: to formulation design requirements, health (low microbial content and low heavy metal content) requirements, procurement and storage of materials, testing personnel requirements. So the high risk process includes the formulation, disinfection and sterilization that store (FIFO) design, production license, qualification confirmation, inspection personnel, procurement and supplier management.

With the development of science and technology, more and more modern manufacturing, processing in the form of more and more. Several examples of high risk is not expressed in the process of enterprise. But more than a few examples, can basically reflect the key risk points existing a large part of manufacturing enterprises.

Identification and control of high risk process for quality management system in sales enterprises

Sales industry contains several situations: pure marketing; brand agent; sales and customer service service. The common local key risk points this several sales enterprise, the common risk points are generally in the service process, such as material verification, customer communication. Also have their own characteristics. The following three examples:

Shenzhen imported brand engine sales agents, sales agents and foreign enterprises in addition, engine manufacturers supply authorization service. Generally speaking, customers buy this kind of brand products of the brand based on trust, therefore, quality of products by the manufacturer to ensure customer requirements. The supplier is only limited to the authenticity of the product source. Native manufacturers authorized for the key risk points. Must provide written proof of authorization. This is one; and for maintenance services, the same licensing requirements, that is the service personnel authorization. This authorization is reflected in the staff training of qualified native manufacturers, and awarded a certificate. This is the second of our manufacturing enterprises; most major risk points in the production process, service process, service industry will also exist large risk points, that is the service quality. The quality of service The general will be reflected through customer feedback. So the investigation and analysis of customer satisfaction of each service should also become the third key risk points. More than three risk points should be in the file (file or file) in detail, and pay special attention to.

A civil aviation enterprise product sales, most of its products and the sales agent brand products. But its characteristics are: general chemicals; some products have special requirements such as low temperature storage; civil aviation authorities have special requirements on (the implementation of AS9120 quality management system). According to the above characteristics. We identify the key risk points a: chemical identification, transport, handling, storage process; the verification process feed (including the ability to verify the requirements of personnel); low temperature transportation and storage process (including the temperature records and temperature measuring equipment requirements); the origin of raw supply consistency for the product certification requirements, product identification (segmentation special requirements of AS9120); the retention period of records requirements. Naturally, these high risk control standards also require file support and high detail.

A gift sales enterprise, typical purchase and sale enterprises, for such enterprises, high-risk points are generally in supplier management and purchase verification (supplier on-site inspection); customer satisfaction evaluation analysis

Almost all sales oriented organizations are basically above these critical risk points. Once the key risk points are identified, the method of control is consistent with the previous statement, and is no longer repeated

Identification and control of high risk processes for quality management systems in other service industries

The identification and control of speaking in front of two key industry risk process. In addition to the various service industries, modern service industry category but also more than the manufacturing sector, not with examples. Here I choose some counseling examples introduced, as mentioned earlier, the key risk points of service industry are generally in the service process in close relationship between people:

A canteen contractor, general services to large enterprises canteen. Clearly, this kind of enterprises should pay attention to the diet service process: health permit organization; kitchen staff health certificate; dietary health assurance and inspection process; raw and cooked food procurement and storage management. The concentration of risk in security for the customer and employee health. These aspects need more detailed and effective job file support.

A electric power design organization, the operation is relatively simple, mainly to provide Substation Engineering (substation) design services. Even from the standard requirements, but also should pay more attention to the design of output, namely project (in various engineering drawings based). To ensure that the design output meets the requirements, must identify the following key points: design personnel qualifications, ability, training needs; the various stages of the design review.

A cleaning company, including disinfection service, termite prevention service. The key risk points of this kind of service companies the same services business license; personnel qualification confirmation certificate. Due to the risk of the use of its services in the drug substance itself, leading to high risk of its own: drug procurement, identification the storage, use and management; in the process of warning signs implementation of each project. Analysis service to customer satisfaction.

The key risk points of almost all construction and decoration companies in a construction company should be the progress and disclosure plan of each project, monitoring, acceptance and engineering supervision at all stages

All of the above risk analysis examples are from the company I have been consulting, for reference only, the content of the article will be insufficient or not the place, hope to correct



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