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8.2 Monitoring and Measurement
8.2.3 Monitoring and Measurement of Processes
Apply suitable methods for monitoring, and where applicable, measurement of QMS processes (see 4.1)
These methods must 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
Key Explanation Points and Tips:
ÞYou 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.
ÞAnother way to identify useful methods and indicators is to review what problems could occur or have occurred within a particular process. Monitor and measure these occurrences and develop process controls 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.
ÞCorrection refers to action taken to eliminate a detected nonconformity, i.e. the symptom. (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.
ÞCorrection 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. Managers or personnel responsible for corrective action must be promptly informed of product and process nonconformities.
ÞYou must monitor your manufacturing QMS processes:
ÞFirst to determine and establish capability of new processes to conform to requirements
ÞAnd secondly, to monitor these processes over time to verify ongoing stability and capability to meet requirements
ÞAnd thirdly to determine and achieve levels of continual improvement
ÞTo achieve planned results, control methods used for monitoring and measurement should focus on achieving the performance indicators we have identified for each QMS process. The monitoring and measurement techniques, sampling plans, acceptance criteria may be documented or referenced in your quality plan; or you could use a combination of specific practices, procedures, documents and methods. Look at the risks and benefits in determining the extent of documented controls you need to have (also see clause 4.2.1 notes).
ÞPerformance 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.
