Monitoring and Measurement

Let’s get straight into it; Your company applies suitable methods for monitoring and, where applicable, measurement of the quality management system processes.  These methods demonstrate the ability of the processes to achieve planned results.  When planned results are not achieved, correction and corrective action is taken, as appropriate, to ensure conformity of the product.

There are many ‘key’ words in the above; suitable, where applicable, as appropriate, planned and the biggy, ‘quality management system processes’.  Not machinery, not inventory management, not anything other than identified, within scope quality management systems activities.

Like, internal audits, like trend analyses, like planned maintenance scheduling, like, well you get the picture.  Some monitoring processes are a requirement of licence conditions, so you had best be monitoring them.  Others are defined KPIs or objectives through your quality policy.

No need to go big here.  No need to re-invent or develop tricky stuff.  Make sure you close loop such monitoring back to your own corrective action procedures.  Make sure that normal monitoring have fail-safes, hold points and the ability to concession.  And if you have adequately described this in your Control of Nonconforming Product Procedure and your Corrective Action Procedure and your Preventive Action Procedure, then all you need do is ‘road-map’ it and you’re done.