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8.4 Analysis of Data
Determine, collect, and analyze appropriate data (from monitoring and measuring activities as well as other relevant sources) to:

Demonstrate the suitability and effectiveness of your QMS and to identify opportunities to continually improve its effectiveness

Analyze data to provide information relating to:

Þcustomer satisfaction

Þconformity to product requirements

Þcharacteristics and trends of processes and product (including opportunities for preventive action)

ÞSuppliers

Key Explanation Points and Tips:

ÞIt is amazing how many organizations have wonderful systems for collecting data, but do a poor job in sorting, summarizing and presenting this data for decision-making. You must sort and summarize the data you collect into TGR and TGW (things gone right and things gone wrong) and present them separately. Management can then focus on continual improvement of TGR and take corrective action on TGW.

ÞYou must collect and analyze QMS data that relate to the effectiveness and efficiency of products; services; QMS processes; production output; supplier performance; use of resources; cost of poor quality; customer satisfaction; etc. Do year over year trend analysis to determine longer-term progress, identify opportunities for further improvement or prioritize correction action for negative trends.

ÞYour process for data collection and analysis must address the type of data to be collected; how it should be sorted and classified (remember TGR and TGW); use of appropriate information systems and data gathering tools and techniques; assignment of responsibility and authority to review and act; competency and training in use of tools and data analysis; that the data is gathered, analyzed and acted upon on a timely basis.
A summary of QMS performance data must be included in your periodic management review (see clause 5.6).

ÞCompare trends in quality and operational performance against your business plans; competitors and industry benchmarks, where practical. Focus on key customer-related trends to prioritize prompt solutions to problems; to determine longer-term planning for performance improvement; and to enhance customer satisfaction.

ÞPerformance indicators to measure the effectiveness of processes for data collection and analysis may include - reduction in cycle time to gather and evaluate data; reduction in inaccurate and incomplete data; increase in improvement opportunities obtained from data analysis; etc.