There are three steps to an effective Total Quality System: capture data and to process it in a way which identifies wasteful processes; use this data to drive efficient changes in procedures which will benefit the organisation; and use the Quality Audit System to ensure that the organisation is following correctly all processes and procedures. This includes manpower that is sufficient, trained and has its competencies managed; processes and procedures that are documented, effective and relevant; and all supporting facilities equipment or infrastructure are appropriately controlled and managed.
For an efficient Quality Audit System (QAS), six small audits in a year will yield far better results than one big audit that might satisfy a regulator. Quality findings are reported to the responsible person or post holder. This is necessary for the accomplishment of corrective action and to close the loop but equally important is the measurement of the data to generate a corporate understanding of status and trends: without such data it is very difficult for an organisation to develop effective change strategies. This can be accomplished through a monthly presentation of the Quality status of the major findings from the preceding month, the current outstanding issues, and the planned audits for next month and forming the essential elements of such a briefing should take no more than 20 minutes.
The development of an effective QAS should look at and ensure compliance with regulatory requirements; look at and ensure the effective delivery of in company processes; and frequently sample the product to ensure it meets the company as well as regulatory standards. In addition, an effective QAS will carry out a significant proportion of surveillance to validate the quality system.
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