FREE online courses on Quality Management System - Quality Management Process Model

 

The final product and/or service quality is the net result of the output of all functional processes. Each functional department has responsibility to do its work correctly to ensure that its output is fit for use by the next process. In this way, each department has to carry out certain quality related activities along with its main function.

 

For example, management defines requirements under Management responsibility, necessary resources are determined and deployed under Resource management, processes are established and implemented under Product and/or Service realization, results are measured, analyzed and improved through Measurement analysis and improvement. Outcomes are regularly reviewed and the management takes appropriate actions to meet the requirements of customers to their satisfaction.

 

Structure of Quality Management System: Functions related to quality system should be clearly established within the overall organizational structure. The lines of authority and communication should be defined, documented and made known to every concerned employee of the organization.

 

Responsibility and authority: Activities contributing to quality, whether directly or indirectly should be defined and documented. General and specific responsibility related to quality should be clearly defined and established.

 

Interface controls and coordination measures between different activities should be identified and defined.

 

Resources and personnel: For effective implementation of quality policy and achievement of quality objectives, management should identify the required resources and provide them with competent personnel.

 

Resources include human resources, design and development equipment, manufacturing facilities, inspection and testing equipment, inspection and computer software.

 

Quality System Documentation: In order to design, develop, produce and deliver quality product or service by an organization, there are several individual activities performed by the personnel deployed in various functional departments of a company.  All these activities are directed towards getting the desired quality in the outputs of various processes, which can meet the customer requirements.  These numerous individual tasks are interrelated to each other.  For accomplishment of the quality objective, it is essential that there must not be any task left undone and at the same time, there should not be any duplication of efforts.  All the tasks must be performed in a proper sequence and with right procedures.

 

In other words, the quality objectives, task sequence, task procedures and other interrelated quality assurance activities must be clearly identified, defined, documented and performed in a planned and regulated manner.

 

There are several ways of documenting a quality system.  As per the ISO 9000 standards, “the quality system should be documented and demonstrable in a manner consistent with the requirement of the selected model”.

 

Demonstration means that the elements of quality system are not only adequate but also ensure that product or service conformity complies to specified requirements.

 

Documentation means that written procedures for all aspects of company's operations will be established and maintained.  Records of all relevant dates will be kept and used to meet the objective of quality policy.

 

To meet the requirements of ISO 9000 quality system, all the elements and provisions adopted by the organization for its quality management should be documented in a systematic and orderly manner in the form of written policies and procedures.

 

The quality management system is normally documented by means of a Quality Manual.  The quality manual states the quality policy and describes the quality management system of an organization and may relate to an organization's total activities or selected part of it.

 

The quality manual could be supported by several tiers of documents, each tier giving progressively more details. Together, these documents define the complete quality management system.

 

Development of quality system documentation is one of the most important and major activities for any organization.  The quality management system document is generally prepared in 4 levels or tiers (it may be three levels or more also as per the need of the organization).  The four levels of documents are:

 

Level 1.         Quality Manual

Level 2.         Quality Procedures

Level 3.         Work Instructions and

Level 4.         Quality Records

 

Quality Manual

 

The purpose of quality manual is to inform the employees and customers about the management policy and objectives for quality.  Broadly, it states what is being done to assure the quality of the product or service to meet the customer requirements. The quality manual must address how each element of ISO 9001/ ISO 9002 or ISO 9003 will be applied in quality management activities of the organization. The purpose is to assure the customer, user or assessor that the organization has taken care to incorporate all aspects of ISO 9000 standard.

 

Quality Procedures

 

The purpose of quality procedures is to instruct the work force in broad terms, how the policies and objectives expressed in the quality system manual are to be implemented and achieved at each functional department or division level. This is a confidential document for internal use of company. Quality procedures can be developed separately for each department.

 

Procedures relevant to all departments and activities addressed in quality manual are prepared, describing how groups of people in the same or various departments will integrate their efforts to meet the management stated quality objectives. Generally, the procedures are documented for all activities right from receipt of an enquiry, till the delivery of the product or service to the customers.

 

Work Instructions

 

These are level three documents, prepared to describe in detail, how a specific activity is to be performed and define the quality standards of acceptability for the product or service. These are used by front line operators and working staff.

 

These documents are released in the form of drawings, pictures, operation sheets, inspections and test schedules, flow charts, etc.

 

Quality Records

 

The purpose of quality records is to ensure and demonstrate that the product or service provided has been developed and produced in accordance with the requirements specified in quality procedures and work instructions and proves the effective functioning of quality system.

 

Quality records are to be generated by operating people who are involved in design, development, production, inspection, delivery, servicing or other operations and activities.  Various types of forms and record sheets can be designed to meet the production recording, auditing, inspection recording, procurement activities and specific ISO 9000 requirements.

 

Quality audit

 

Quality audit is a systematic and independent examination to determine whether quality activities and related results comply with planned arrangements, whether these arrangements are implemented effectively and whether they are suitable to achieve quality objectives.

 

Quality audits are conducted by qualified and trained auditors in a planned manner. Audit findings in the form of non-conformance are reported to top management for initiating appropriate corrective and preventive actions. Implementation of corrective action is verified on the basis of follow up audits by the auditor.

 

Review and evaluation of quality system: Organization's management should provide for independent review and evaluation of quality system at defined intervals, to ensure its continuing suitability and effectiveness for implementation of quality policy and achievement of quality objectives.

 

Review should consist of structured evaluation based on audit findings, customer complaints, market feedback, process performance, quality records and the overall performance of the quality system.

 

Based on management review, appropriate action should be taken to improve the quality of products, processes, facilities, systems and people.

 

Quality improvement: Continuous quality improvement is one of the most important guiding principle of quality system. Management must ensure that the system will facilitate and promote continuous improvement in quality of its products through improvements in its processes and systems.