QMS Data Management- Series 1

Data management includes the following

·         Identification of opportunities for data identification

·         Prioritization/classification of data in each of those opportunities

·         Identification of data to be managed

·         Planning for data management

·         Systematic arrangement for data collection

·         Data collation

·         Analysis

·         Identification and implementation of corrective and preventive actions

QMS clause No. 8, identifies Measurement, Analysis and Improvement and focuses on measurement of QMS and calls for determination of applicable methods, including statistical techniques. Data planning however starts from Cl. No. 4.1, when there is a need to monitor, measure, and analyze QMS processes. In addition, clause number 8.2.1, 8.2.2, 8.2.3, and 8.2.4 also need to be managed.

Records form a major chunk of data management. Records requirement are specified and needs to be addressed. Records provide evidence that the realization processes meet the QMS requirements. Hence, management of data from those records forms the basis of the improvements. Records could be in the form of sheer information and measurable data. Such measureable data management is what is needed in the Clause No. 8.

Data measurement

Records form the basis for data identification.

Below given are some of the areas of data measurement:

·         Process related- 5.6, 6.2.2, 6.3, 7.2, 7.3, 7.4.1, 7.4.2,7.4.3, 7.5.1,7.5.2, 7.5.3, 7.5.4,7.5.5, 7.6, 8.2.1, 8.2,2,8.2.3

·         Product/service related- 7.2, 7.3,7.4.3,7.5.1, 7.5.3, 8.2.4,

The first step is to segregate information and monitorable and measurable data from the records.

Data management includes systematic collection of data from the processes and product/service realization

Data collection is done in such a manner, that they can be collated and analysed

Designing of various formats/templates/checklists/control charts to be used for data collection play an important role. Frequency of collection and method of recording data is planned to provide adequate information on the effectiveness of the control of the process/product/service.

A poorly designed format/template can defeat the purpose of data measurement, without providing required information. Once the data is collected, a collation matrix would help in consolidating them and help in prioritizing for subsequent analysis.

A collation Matrix would typically contain data on various parameters of each process being monitored, frequency of data collection, and the source of data collected.

Data analysis would be discussed in the next article. Meanwhile, initiate data collection and collation. Any help, do not hesitate to contact. Good luck