Let’s start with monitoring, measurement and evaluation. The company determines: a) what needs to be monitored and measured; b) the methods for monitoring, measurement, analysis and evaluation needed to ensure valid results; c) when the monitoring and measuring are performed; d) when the results from monitoring and measurement are analysed and evaluated. The company evaluates the performance and the effectiveness of the Quality Management System. The company retains appropriate documented information as evidence of the results.
Another ‘general’ clause heading, another yawn. But……wait, this is pretty good stuff. We get to pick what we monitor and measure. Just make sure it meets your customer needs and your stakeholder needs. Notice I said needs. NOT wants or should. However, customer don’t necessarily know what they need and often look at what they want. So educate them, negotiate with them and make sure we all know the what.
Next up is the how and what we need to do to validate the measurements. Some of this stuff is really easy. Cross checks, calibrations, steel rulers, etc. Others are stupidly complex with non-destructive testing, atomic absorption mass spectrometry and so forth. Once again a negotiated level of awareness and expertise which quite often has commercial impacts.
The when is next. Frequencies, times, triggers, etc. Heck, there is even a very little used but oh so important standards around sampling that can help with this. Risk mitigation and commercial obligations will help her too.
And finally, once the what how when is finalised determining analysis and evaluation around specifications and thresholds need to be defined.
And why do all this? It helps with product and service expectations. It helps with determining the effectiveness of the actual quality management system. It requires us to keep appropriate records (retained documented information) to assure we are doing the right thing at the right time to meet the implied and actual expectations.