【正文】 facturing process [] ? Include in internal audits all quality management related processes, activities and shifts [] 3/15/2023 42 Pro Enviro Ltd Wayside House Wilson39。s Lane Coventry CV6 6NY Comparing ISO/TS 16949 with ISO 9001 Additional Requirements of ISO/TS 16949:2023 vs ISO 9001:2023 Measurement, Analysis and Improvement (cont’d) ? Internal auditors shall be suitable qualified [] ? Perform process capability studies and include the conclusions in the quality or control plan. Studies shall include the。 ? stability of the process ? capability of the inspection and test process ? capability of the reaction plans to contain the effect of any nonconformity [] 3/15/2023 43 Pro Enviro Ltd Wayside House Wilson39。s Lane Coventry CV6 6NY Comparing ISO/TS 16949 with ISO 9001 Additional Requirements of ISO/TS 16949:2023 vs ISO 9001:2023 Measurement, Analysis and Improvement (cont’d) ? Conduct product audits [] and ?layout inspections? . checking every measurement and parameter shown on the approved design drawings. [] ? Conduct appearance inspections on items for which customer specifies this . checking every aspect of the appearance of the finished product as perceived by the end user. Maintain master samples and means of making parisons. [] ? Class product with unidentified status as nonconforming. Make instructions for rework available. [(.1), ] ? Inform customers promptly if nonconforming product is shipped [] 3/15/2023 44 Pro Enviro Ltd Wayside House Wilson39。s Lane Coventry CV6 6NY Comparing ISO/TS 16949 with ISO 9001 Additional Requirements of ISO/TS 16949:2023 vs ISO 9001:2023 Measurement, Analysis and Improvement (cont’d) ? Obtain a customer concession before proceeding with any further processing if any part or material is not fully in accordance with approved requirements. This shall apply to product or material still being processes by a supplier. [] ? Analyse trends in quality operational performance。 use data to: ? manage progress towards overall objectives ? identify priorities ? provide a factual basis for decision making ? anticipate and predict problems arising from the end users. Establish benchmarks to measure performance against petitors or other appropriate recognised criteria.[] 3/15/2023 45 Pro Enviro Ltd Wayside House Wilson39。s Lane Coventry CV6 6NY Comparing ISO/TS 16949 with ISO 9001 Additional Requirements of ISO/TS 16949:2023 vs ISO 9001:2023 Measurement, Analysis and Improvement (cont’d) ? Define a programme for continual improvement [] ? Focus manufacturing improvement on reducing variation [] ? Define a process for problem solving [] ? Use error proofing methods in the corrective action process [] ? Apply corrective action to other similar processes and products [] ? Minimise the time for corrective action [] 3/15/2023 46 Pro Enviro Ltd Wayside House Wilson39。s Lane Coventry CV6 6NY Assessing where you are now 3/15/2023 47 Pro Enviro Ltd Wayside House Wilson39。s Lane Coventry CV6 6NY Techniques to support ISO/TS 16949 Statistical Analysis Statistical Process Control (SPC) Measurement Systems Analysis (MSA) 3/15/2023 48 Pro Enviro Ltd Wayside House Wilson39。s Lane Coventry CV6 6NY Statistical Analysis SPC Statistical Process Control (SPC) “ The use of statistical techniques such as control charts to analyse a process or its outputs so as to take appropriate actions to achieve and maintain a state of statistical control and to improve process capability.” ? Detects variation in process measures to enable。 ? reduction of variation, and, ? prevention of defects / waste. ? Applied to all processes whose output measures offer ? Variable data . part dimensions ? Attribute data – conforming。 yes/no that can be counted . parts received ontime 3/15/2023 49 Pro Enviro Ltd Wayside House Wilson39。s Lane Coventry CV6 6NY Statistical Analysis ISO/TS 16949:2023 requirement for Statistical Analysis ? Measurement, analysis and improvement ? Identification of statistical tools ? Knowledge of basic statistical concepts ? Monitoring and measurement of manufacturing process ? Manufacturing process improvement 3/15/2023 50 Pro Enviro Ltd Wayside House Wilson39。s Lane Coventry CV6 6NY Statistical Analysis SPC ? Variable data forms a pattern that, if stable, can be described as a distribution. Distributions, differ in ? Location ? Spread ? Shape …or any bination of these. ? If the shape of variable data is ?normal? (typical)。 ? location is measured by the mean [ X ] ? spread is measured by the range [R] or standard deviation [sd] ? SPC can be applied to see if variation is unacceptable 3/15/2023 51 Pro Enviro Ltd Wayside House Wilson39。s Lane Coventry CV6 6NY Statistical Analysis SPC ? Variation in variable data can e from ? Common causes – natural random events – which affect all values of process output ? Special causes – intermittent, often unpredictable causes making the process output unstable ? Control charts help identify special causes by showing ? Values beyond control limits ? Non–random patterns or trends . 7 points increasing/decreasing, 7 points one side of the average 3/15/2023 52 Pro Enviro Ltd Wayside House Wilson39。s Lane Coventry CV6 6NY Statistical Analysis SPC ? Before assessing process capability, special causes must be removed ? Process Capability then measures ? How variable the process is [ Pp, Cp ] ? How process variation fits within the specified limits [Ppk, Cpk] how well it meets a customer requirement Cpk Approx parts per million out of specification 66,000