Understanding The ISO/TS 16949:2002 Standard 

8   MEASUREMENT, ANALYSIS & IMPROVEMENT  

8.1 General 

You shall 

l        Plan & implement monitoring, measurement, analysis, and improvement processes to: 

a)    demonstrate conformity of product 

b)    ensure conformity of the QMS 

c)    continually improve the effectiveness of the QMS 

Determine applicable methods, including statistical techniques, and the extent of their use 

8.1.1 Identification of Statistical Tools 

Determine appropriate statistical tools for each process during advance quality planning and include these in the Control Plan

8.1.2 Knowledge of basic statistical concepts 

Your shall understand & use basic statistical concepts such as variation, control (stability), process capability and over-adjustment, throughout the organization. 

Key Explanation Points and Tips: 

Þ      You must plan and implement processes that measure, analyze and improve the health of your QMS. The focus of these processes must be on product and process conformity and improving QMS effectiveness. Consider using a variety of methods including statistical techniques.  

Þ      In planning what to track and measure, we should review the quality objectives we established in clause 5.4.1 and the performance indicators we established for our QMS processes and activities. You have to be careful not to overwhelm your organization with objectives as this may cause more frustration than positive results. Prioritize objectives and performance indicators to focus on meeting customer requirements and key or risk prone processes.  

Þ      Planning of measurement and data analyses processes must consider the methods and resources (time, manpower, computer, software, statistical tool, etc) needed to collect, organize and analyze product and QMS performance data. 

Þ      Use your APQP reference manual to determine what statistical methods to use for products and QMS processes and to what extent to use them. Include these methods in your control plan. Also review specific statistical concepts and tools required at OEM customer or IATF websites. 

Þ      Statistical methods for product development may include – variation analysis; regression analysis; dependability analysis; and prediction. 

Þ      Statistical methods for purchased product may include – histograms and stratification; Pareto fault analysis; sampling plans; criteria for acceptance statistics. 

Þ      Statistical methods to verify product characteristics and process parameters include – process capability studies; control charts; Pareto analysis; variation analysis (special cause, common cause). 

Þ      Statistical methods for field analysis include – dependability assessment; Pareto analysis; traceability analysis; Shainin techniques. 

Þ      Statistical methods for monitoring and measuring devices – refer to various techniques in your customer reference manuals – e.g. Measurement Systems Analysis (MSA) reference manual.  

Þ      Over-adjustment in clause 8.1.2 refers to making process adjustments that are not statistically appropriate i.e. tampering.  

Þ      Define and implement appropriate training and competency requirements for all personnel using statistical methods, tools and analysis. 

Þ      Where the any of the monitoring, measurement and analysis processes are done off-site (e.g. in large organizations, customer satisfaction feedback may be done at head-office), your QMS must include the off-site processes within your QMS and ensure that such processes comply with ISO 9001 requirements. Evidence of the off-site facility’s compliance may include - a copy of their ISO 9001 certification; results of their internal audits to ISO 9001; auditing the outsourced facility; etc. The expectation is to flow down to the off-site facility, the relevant ISO 9001requirements  

Þ      Clause 8.1 does not require a ‘documented’ procedure. However, you must identify and document all processes addressing this clause as part of your QMS (see clause 4.1). For these processes, you must also identify what specific documents, controls and resources are needed (see clause 4.2.1d. and 7.1b.). You could use a product quality plan; documented procedure or other combination of specific practices, procedures, documents and methods. Look at the risks related to your product, processes and resources in determining the extent of documented controls you need to have (also see clause 4.2.1 notes).  

Þ      Performance indicators are not needed for this clause as it provides direction for the application of monitoring and measurement methods and tools indicators for all QMS processes. However the output of monitoring and measurement methods used within each QMS process provides useful performance indicators for determining the degree of conformity of product and QMS to requirements and whether the QMS has been effectively implemented and maintained.