It is known that managing an organization in a systematic and transparent manner is the way to lead and operate the organization successfully. An effective QMS should be designed for continually improving performance and addressing the needs of all parties. Managing an organization encompasses quality management amongst other management disciplines, where a quality management system can assist organizations in enhancing customer satisfaction.
Generally speaking, an effective QMS encourages organizations to:
- analyse customer requirements;
- define the processes that contribute to the achievement of a product which is acceptable to the customer; and
- keep these processes under control.
A QMS provides the framework for continual improvement and aims to enhance satisfaction from customers and other interested parties. As we have discussed in the previous section, certification of the quality management system (which also applies to product certification) by a third party certification body provides confidence to the organization and its customers that it is able to provide products that consistently fulfill requirements.
The ISO 9000 series 9000 (including ISO 9001) for quality management systems is one of the ISO's (International Organization for Standardization) most well known standards ever. The series helps organizations to implement quality management systems. There are quite a lot of companies and organizations in Hong Kong that hold ISO 9001 certification. Can you identify some local companies that are ISO 9001 certified?
There are eight fundamental quality management principles in the ISO 9000 series that can be used by top management in order to lead the organization towards improved performance. They are:
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Customer focus
The success of all organizations depends very much on whether they understand their customers' current/future needs/requirements and whether they are willing to strive to exceed customer expectations. Customers' needs and expectations are usually reflected in product specifications and collectively referred to as customer requirements. Customer requirements may also be specified contractually by the customer or may be determined by the organization itself. Eventually, customers are the parties that ultimately determine the acceptability of the product. However, we should bear in mind that customer needs and expectations are not static; they are dynamic and change with time. Sometimes they change slowly, sometimes they change fast. Major reasons for the changes include competitive pressures and technical advances, and the organizations are driven to continually improve their products and processes. For example, a three mega-pixel digital camera was considered to be the state-of-the-art technology ten years ago. In 2011, an entry level digital camera can deliver photographs with ten mega pixels.
Monitoring customer perceptions can include obtaining input from sources such as customer satisfaction surveys, customer data on delivered product quality, user opinion surveys, lost business analysis, compliments, warranty claims and dealer reports. -
Leadership
Leaders take total control of resources and the direction of the organization. One of their major duties is to develop and maintain an internal environment in which all employees within the organization are fully involved in achieving the organization's objectives. -
Involvement of people
Employees are the asset and essence of all organizations. With the support from leaders, employees are expected to have full involvement (i.e. to put their abilities to use) for the organization's benefit. This can be achieved by effective internal communication within the organization and providing necessary training to employees. -
Process approach
Every organization is made up of a series of interacting processes. A process can be considered as a set of activities that uses resources (materials, manpower, machines, etc.) to transform inputs into outputs. The process approach emphasizes the interaction between different processes, and the inputs and outputs that link these processes together. The output of one process becomes the input of another.
To illustrate the process approach, you can think of the example of making a cake, which involves the following processes:
- purchasing of ingredients at specified grade
- measuring the weight of each ingredient
- mixing the ingredients homogeneously
- baking the mixed ingredients in an oven.
The product (e.g. the cake in our example) is the result of processes, and the ISO 9001 Standard is designed to manage and improve those processes. The key steps can be summarized as follows:
- Identify your key processes.
- Define quality standards for those processes.
- Decide how process quality will be measured.
- Document the approach to achieving the desired quality, as determined by your measurements.
- Evaluate the quality and continuously improve.
It can be seen from the above example that the effectiveness of the entire system depends very much on the effectiveness of individual processes.
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System approach to management
Identifying, understanding and managing interrelated processes as a system contributes to the organization's effectiveness and efficiency in achieving its objectives. The system approach can be summarized into the steps below:
- Determining the needs and expectations of customers and other interested parties (refer to the earlier section on 'Customer focus' for details).
- Establishing the quality policy and quality objectives of the organization.
The quality policy and quality objectives can provide a focus to the organization, which also determine the desired results in order to satisfy the customers. The quality policy shall:
- be established and maintained by the top management. The top management shall provide necessary resources and commit to comply with both regulatory and other requirements.
- provide a framework for establishing and reviewing quality objectives.
- be promoted throughout the organization to increase awareness, motivation and involvement.
- be reviewed periodically for suitability during management reviews and undergo continual improvement.
The quality objectives need to be consistent with the quality policy and commitment to continue improvement, and their achievement needs to be measurable.
Examples of quality objectives
Examples of some quality objectives are:
- product — reduction in defect rates to 50 ppm (defective parts per million)
- process — increase in the output rate to 10k per day by reducing the waste and cycle time of the processes
- customers — reduction in the number of complaints per month
- suppliers — rejection percentage of defective materials less than 5%
- resources — reduction in the number of incidents per year
- Determining the processes and responsibilities necessary to attain the quality objectives. (Refer to the earlier section on the process approach for details of process determination.)
- Establishing and implementing methods to measure the effectiveness and efficiency of each process.
Monitoring and measuring equipment (thermometer for temperature, timer for timing, etc.) shall be used. The equipment shall be calibrated or verified at specified intervals before use. Equipment shall be identifiable with the calibration/verification status, and shall be protected from damage and deterioration during handling, maintenance and storage. - Determining the means of preventing non-conformities and eliminating their causes. This can be achieved by monitoring customer satisfaction, internal audit, monitoring and
measurement of processes and product.
The product shall not be released to the customer until all the product requirements have been satisfactorily met. - Establishing and applying a process for continual improvement of the quality management system. The effectiveness of the quality management system can be evaluated through the use of the quality policy, quality objectives, internal and external audit results, analysis of production data, corrective and preventive actions and management review.
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Continual improvement
When planned process outcomes are being achieved and requirements fulfilled, the organization should focus its efforts on actions to improve process performance to higher levels on a continual basis. The following short description on continual improvement is extracted from SCI S319 Unit 5.
In a total quality management organization, internal and external customers define quality. With quality defined, the organization must then become obsessed with meeting or exceeding this definition. This means all personnel at all levels approach all aspects of the job from the perspective of 'how can we do this better?' When an organization is obsessed with quality, good enough is never good enough. There must be a continual striving to improve all business and production processes. Quality improvement projects, such as on-time delivery, order entry efficiency, billing error rate, customer satisfaction, scrap reduction and supplier management are good places to begin. Continuous quality improvement helps management to review and improve the quality of the company's products continuously by gradual changes as in below.
Figure 1.1 The never-ending process of continuous improvement
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Factual approach to decision making
Results from accurate data and information analysis form the basis of effective decisions. Statistical methods are commonly used to quantify process performance and assist in decision making. -
Mutually beneficial supplier relationships
A manufacturer (or an organization) and its suppliers are interdependent. A mutually beneficial relationship (or win-win situation) enhances the ability of both to create value. A manufacturer (or an organization) requires its suppliers to provide quality materials in order to produce quality goods. On the other hand, the suppliers of a quality manufacturer can also enhance its reputation and increase the business opportunities.
Having read the eight fundamental quality management principles, try the Activity 2.
We have discussed different conformity assessment activities and certification of QMS. Conformity assessment of products can be carried out in many ways (i.e. testing, certification and inspection) and by many different parties (i.e. first, second and third). Certification of QMS is one of the most popular approaches to provide products that consistently fulfill requirements and to enhance customer satisfaction. The International Standards ISO 9000 family describes the fundamentals of QMS for organizations. The requirements for QMS specified in ISO 9001 are generic and applicable to organizations in any industry or economic sector regardless of the offered product category. However, ISO 9001 itself does not establish requirements of products. Product certification was introduced to incorporate the requirements of a product or type of products into a certification scheme. A product certification scheme may also employ other different conformity assessment activities such as testing and inspection. We will discuss product certification in the next section of this module.
Before we discuss the product certification basics, have a go at the following activity, in which you will watch an eight-minute video from the International Organization for Standardization on ISO 9001.
We now move on to look at the process of product certification
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