Quality management system

All organizations function by having employees follow defined processes to achieve outcomes perceived as the organization’s objectives. The degree to which processes are documented varies greatly from organization to organization as does the degree to which employees of the organization work to meet the organization’s primary goals. The management of an organization can be aided by following the requirements of the ISO 9000 series of standards. Currently there are three main standards in these series: ISO 9001, ISO 9002 and ISO 9003 — all issued in 1994. These are to be replaced by ISO 9001: 2000, scheduled for release in the second part of 2000. The application of this International Standard can be used by an organization to demonstrate its capability to meet customer requirements for products and/or services, and for assessment of that capability by internal and external parties. The standard does not cover the technical requirements for an organization it merely provides guidelines on a method of managing the various interlinked functions of an organization. The standard is based on the concept that any activity or operation, which receives inputs and converts them to outputs, can be considered as a process. Almost all product and/or service activities and operations are processes. Fig. 1.7 is a conceptual presentation of the generic quality management system requirements of a ‘process model’.

FIG. 1.7. Quality management process model.

1.5.5.1. Quality management system requirements

An organization needs to prepare procedures that describe the processes required to implement the quality management system. The range and extent of the system procedures depends upon such factors as the size and type of the organization, complexity and interaction of the processes, methods used and skills and training of personnel involved in performing the work. The procedures are typically at three levels:

(1) System level procedures that describe the activities required to implement the quality management system

(2) Process level procedures that describe the sequence and interactive nature of the processes necessary to ensure the conformity of the product and/or service

(3) Work instructions or operation level procedures that describe the operating practice and control of process activities.

1.5.5.2. Management responsibility

To implement a successful management system, top management needs to:

 create and maintain an awareness in the organization of the importance of fulfilling customer requirements

 establish quality policy and measurable quality objectives which lead to continual improvement and customer satisfaction

 establish a quality management system

 perform management reviews

 ensure availability of trained personnel and resources

 ensure customer needs and expectations are determined and converted into requirements with the aim of achieving customer confidence

 ensure customer requirements are fully understood and met

 ensure the organization identifies and has access to the legal requirements that are applicable to quality aspects of its products and/or services.

1.5.5.3. Quality manual

A requirement of the quality management system is for the organization to prepare a quality manual containing descriptions of the elements of the quality management system and their interaction, system level and process level procedures, or a reference to them if they are stand-alone documents. Often the quality manual also contains the organization structure and an overview of personnel responsibilities.

1.5.5.4. System level procedures These procedures need to cover:

 document and data control including approval, review and distribution

 control of records including their identification, storage, retrieval, protection, retention time, and disposition.

 the management review process to ensure the system’s continuing suitability, adequacy and effectiveness. The review needs to evaluate the need for changes to the organization’s quality management system, including policy and objectives. The periodic

review process needs to consider current performance and improvement opportunities caused by:

 the result of audits

 customer feedback

 process performance and product conformance analyses

 status of preventive and corrective actions

 follow-up actions from earlier management reviews

 changing circumstances.

 human resource management.

1.5.5.5. Process level procedures and instructions

Processes that are necessary to manufacture, fabricate or construct the required product or provide the necessary service need to be determined, planned, documented and implemented so that the processes are carried out under controlled conditions and produce outputs that meet customer requirements. The organization needs to:

 determine and implement arrangements for measurement, monitoring and follow-up actions to ensure processes continue to operate to achieve planned results and outputs;

 ensure the availability of the information and data necessary to support the effective operation and monitoring of the processes;

 maintain as quality records the results of process control measures, to provide evidence of effective operation and monitoring of the processes;

 establish a process for identifying customer requirements and to ensure that no changes are necessary before supplying a product or service;

 capture customer complaints and any organizational actions relating to nonconforming product and/or service customer responses relating to performance of product and/or service;

 plan and control design and/or development of the product and/or service;

 control its purchasing processes to ensure purchased product and/or service conforms to the organization’s requirements. This requires the evaluation and selection of suppliers based on their ability to supply product and/or service in accordance with the organization’s requirements;

 ensure the availability and use of suitable measuring and monitoring equipment;

 ensure the implementation of suitable monitoring or verification activities suitable methods for release and delivery and/or installation of product and/or service;

 make arrangements for identifying the status of a product and/or service with respect to required measurement and verification activities and, where applicable, needs to identify the product and/or service by suitable means throughout all processes.

 where traceability is a requirement, control and record the unique identification of product and/or service;

 if at any time the organization has under its control any property of a customer, exercise care so that the property is identified, verified, stored and maintained; any customer property that is lost, damaged or otherwise found to be unsuitable for use needs to be recorded and reported to the customer;

 ensure that during internal processing and final delivery of product and/or service to the intended destination that the identification, packaging, storage, preservation, and handling do not affect conformity with product and/or service requirements; it is important that product release and/or service delivery does not proceed until all the specified activities have been satisfactorily completed and the related documentation is available and authorized;

 determine any production and/or service processes where the resulting output is not able to be readily or economically verified by subsequent monitoring, inspection and/or testing; these processes need to be validated to demonstrate their effectiveness and acceptability;

 control, calibrate and maintain those measuring and monitoring devices used to demonstrate conformance of product and/or service to specified requirements.

1.5.5.6. Measurement, analysis and improvement

An important requirement of the quality management system is that the organization implementing the system needs to define, plan and implement measurement, monitoring, analysis and improvement processes to ensure that the quality management system, processes and products and/or services conform to requirements. The type, location, timing and frequency of measurements and the requirements for records need to be defined and the effectiveness of measures implemented need to be periodically evaluated. This may require the use of appropriate statistical tools. Areas needing to be measured and monitored include:

 customer satisfaction or dissatisfaction

 internal audit of all processes including the identification of opportunities for improvement

 process monitoring to demonstrate the continuing ability of the process to satisfy its intended purpose

 monitoring and control of non-conformity to prevent unintended use or delivery

 review and disposition of non-conformities

 analysis of data for improvement

 use of corrective action to reduce or eliminate the causes of non-conformity in order to prevent recurrence

 establishment of preventive action to establish a process for eliminating the causes of potential non-conformities to prevent occurrence.

2. VISUAL INSPECTION