Understanding The ISO/TS 16949:2002 Standard 

8.2.3 Monitoring and Measurement of Processes  

You shall: 

Apply suitable methods for monitoring, and where applicable, measurement of QMS processes (see 4.1) 

These methods shall demonstrate the ability of QMS processes to achieve planned results (see 4.1) 

If planned results are not achieved, take correction and corrective action to ensure product conformity 

8.2.3.1 Monitoring and Measurement of Manufacturing Processes 

Perform process studies of all new manufacturing (including assembly and sequencing) processes) to verify process capability & to provide additional input for process control 

Document the  results of process studies with specifications (where applicable) for production, measurement, test & maintenance instructions 

These documents shall include objectives for manufacturing process capability, reliability, maintainability & availability, as well as acceptance criteria 

Maintain manufacturing process capability or performance as specified by the customer part approval requirements 

Implement Control Plans & process flow diagram to ensure conformity to specified: 

Þ            Measurement techniques, 

Þ            Sampling plans, 

Þ            Acceptance criteria and 

Þ            Reaction plans when criteria not met 

Keep a record of significant process events such as tool change, machine repair, etc. 

Initiate reaction plans from the Control Plan, for characteristics that are either unstable or not statistically capable. 

These reaction plans shall include containment of product and 100% inspection, as appropriate 

Then complete a corrective action plan indicating timing and assigned responsibilities to assure that the process becomes stable and capable. If required, review these plans with the customer and get their approval.  

Keep records of effective dates of process changes 

Key Explanation Points and Tips: 

Þ      You must establish methods and indicators to monitor and measure your QMS processes (see clause 4.1e and 5.4.1) to demonstrate process capability to achieve planned results and identify opportunities to improve the process. Use your organizations cross-functional knowledge of customer requirements; product; technology; manufacturing processes; etc, to determine process monitoring and measuring indicators and controls. Monitoring and measurement may be done manually or by automated means. 

Þ      One way to identify useful measuring and monitoring methods is to review what problems could occur or have occurred within a particular process. Monitor and measure these occurrences and develop process controls (methods) to reduce or eliminate them. Problems (risks) can occur with any of the variables in a process – e.g. – materials; equipment; facility; methods; technology; personnel; computer hardware or software; etc. By using fishbone analysis or similar tools, you can develop very useful monitoring and measuring methods and process performance indicators. 

Þ      Correction refers to action taken to eliminate a detected nonconformity (see clause 8.3). Correction involves the containment, evaluation of the nonconformity and action that may result in rework; regrade; scrap; return of nonconforming material/work to supplier or outsourcer; or acceptance through a customer concession or deviation permit. 

Þ      Correction differs from corrective action (clause 8.5.2). Corrective action is action taken to eliminate the cause of a detected nonconformity to prevent recurrence; whereas correction does not address cause. 

Þ      You must monitor your manufacturing QMS processes, first to determine and establish capability of new processes to conform to requirements 

Þ      And secondly, to monitor these processes over time to verify ongoing stability and capability to meet requirements 

Þ      And thirdly to determine and achieve levels of continual improvement 

Þ      Use your APQP, FMEA, MSA and PPAP reference manuals for guidance in determining process monitoring and measuring indicators and controls. Also review specific measurement and monitoring requirements at OEM customer or IATF websites. 

Þ      The output of your manufacturing process design process (clause 7.3.3.2 and 7.3.2.2) must specify the manufacturing process capability, reliability, maintainability & availability indicators, as well as process approval acceptance criteria 

Þ      Your manufacturing process capability performance must conform to the capability documented in your PPAP submission or agreed with your customer in writing. You must keep records of this ongoing conformance to your customer requirements and use this information to identify opportunities to improve the process.  

Þ      The measurement techniques, sampling plans, acceptance criteria and reaction plans must be documented or referenced in your control plan. Managers responsible for corrective action must be promptly informed of product and process nonconformities (see clause 5.5.1.1). Also review specific sampling plan requirements at OEM customer or IATF websites. 

Þ      Where the customer is significantly affected by a process nonconformity or change, they must be notified. Corrective action plans as well as resulting updated/changed PPAP’s must be reviewed and approved by the customer, when so required. If in doubt, get clarification from the customer. 

Þ      Use your manufacturing design process (clause 7.3) and change control process (clause 7.1.4) to manage manufacturing process changes. 

Þ      Performance indicators are not needed for this clause as it provides direction for the application of monitoring and measurement performance 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 effective implementation and maintenance of QMS processes. Review the performance indicators within each process covered this far.  

Þ      Performance indicators to measure process effectiveness and efficiency include - productivity; reduction of cycle time, waste, errors, omissions and failures; asset utilization rates (downtime, turnover), etc. 

Þ      Don’t overlook performance indicators to measure compliance with process related regulatory requirements – e.g., reduction in health and safety incident/violation rates; reduction in regulatory reporting violations, etc.