QM: 8.4 Analysis of Data

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Introduction:

Effective data analysis is an essential part of the quality management system.

Entire Quality Management System will be inefficient if sources of data are not identified, data not collected, and analyzed to determine the suitability and effectiveness of the QMS and to evaluate where continual improvement can be implemented. Trend analysis ensures that the quality is built in rather than tested into the product.

8.4	ANALYSIS OF DATA

8.4 Analysis of Data

Determination, collection, and analysis of appropriate data is performed to demonstrate the suitability and effectiveness of the quality management system, and to evaluate where continual improvement of the quality management system can be made.

Data and information recorded in quality records are compiled and reviewed periodically to determine trends in the performance and effectiveness of the quality system and to identify the opportunities for improvement. Where appropriate, statistical techniques are utilized to monitor and improve product quality, process capability and market analysis.

Individual department is responsible for determining, collecting, evaluating and reviewing the information on an ongoing basis and presented to quality department for management review. Quality assurance is responsible for coordinating the activities, and for reporting conclusions and trends to the Management through management review meetings.

Information and source of information include:

Information for continual improvement (through Monitoring and measurement activities, audits)

Conformity to product and customer requirements (through nonconformance, customer feedback, customer complaints)

Characteristics and trends of processes and products (through Monitoring and measurement of product and process)

Characteristics and trends of environmental monitoring program (through Monitoring and measurement of controlled environments)

Corrective and preventive actions (through Non-conformance and reported deviations)

Supplier performance (through Inspection and testing of received products and services, delivery times)

Customer satisfaction (through customer complaints, customer feedback, customer recognitions and rewards)

Effectiveness of training (through monitoring and measurement of process and product, non conformance and reported deviations, audits).

The analysis of data provides information relating to characteristics and trends of processes and products including opportunities for preventive action.