askartsolutions logo- TS 16949

 

Understanding The ISO/TS 16949:2002 Standard 

8.4 Analysis of Data  

You shall: 

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: 

Þ           customer satisfaction 

Þ           conformity to product requirements 

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

Þ           suppliers 

8.4.1 Analysis and use of data 

You shall compare trends in quality & operational performance with progress towards objectives, leading to action that: 

Þ           Prioritizes and promptly solves customer-related problems 

Þ           Determines key customer related trends to support status review, decision making and longer term planning 

Þ           Enables an information system for timely reporting of product usage 

Note: Compare data with competitor and/or appropriate benchmarks 

Key Explanation Points and Tips: 

Þ      It 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.  

Þ      You 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. 

Þ      Your 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).  

Þ      Compare 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. 

Þ      Performance 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.  

 

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Preface - TS16949
◦ Introduction
◦ Major Clauses
◦ Process Approach -1
◦ Process Approach-2
◦ Plan/Do/Check/Act
◦ Cont Improve Model
◦ Compatibility
◦ TS 16949 Scope
◦ Application
◦ Normative References
◦ Terms And Definitions
◦ 4.1 General Reqmts
◦ 4.2.1 Documentation Reqmts
◦ 4.2.2 Quality Manual
◦ 4.2.3 Document Control
◦ 4.2.4 Control Of Records
◦ 5.1 Mgmt Commitment
◦ 5.2 Customer Focus
◦ 5.3 Quality Policy
◦ 5.4.1 Quality Objectives
◦ 5.4.2 QMS Planning
◦ 5.5.1 Quality Responsibility
◦ 5.5.2 Mgmtt Rep
◦ 5.5.3 Internal Communications
◦ 5.6 Mgmt Review
◦ 6.1 Resource Provision
◦ 6.2 Human Resources
◦ 6.3 Infrastructure
◦ 7.1 Planning Product Realization
◦ 7.2 Customer Processes
◦ 7.3.1 D & D Planning
◦ 7.3.2 D & D Inputs
◦ 7.3.2 D & D Outputs
◦ 7.3.4 To 7.3.6 - Review, Verification And Validation
◦ 7.3.6.2 Prototypes-PPAP-Changes
◦ 7.4.1 Supplier Mgmt
◦ 7.4.2 Purchasing Information And Supplier Performance Monitoring
◦ 7.5.1 Production Control-1
◦ 7.5.1 Production Control-2
◦ 7.5.2 Production Process Validation
◦ 7.5.3 to 7.5.5 Identification--Customer Property, etc
◦ 7.6 Monitoring And Measuring Devices
◦ 8.1 Measurement, Analysis & Improvement
◦ 8.2.1 Customer Satisfaction
◦ 8.2.2 Internal Audits
◦ 8.2.3 Monitoring Processes
◦ 8.2.4 Product Monitoring And Measurement
◦ 8.3 Control Of NC Product
◦ 8.4 Analysis Of Data
◦ 8.5.1 Continual Improvement
◦ 8.5.2 Corrective Action
◦ 8.5.3 Preventive Action
◦ TS 16949 Annex A - Control Plan