Analysis of Data

Good old clause 8.4, analysis of data, probably the most ignored clause of the standard.  Why?  Well it is a bit squishy, a bit fluffy but mostly because the certifiers leave it alone but when they do give it some focus, they are like a dog with a bone.  But I digress.  Let us look at the requirements.

Your company determines, collects and analyses appropriate data to demonstrate the suitability and effectiveness of the quality management system and to evaluate where continual improvement of the effectiveness of the quality management system can be made.  This  includes data generated as a result of monitoring and measurement and from other relevant sources.  The analysis of data provides information relating to; customer satisfaction, conformity to product requirements, characteristics and trends of processes and products including opportunities for preventive action, and suppliers.

As always it has the very big caveat of ‘appropriate’ data and only to demonstrate suitability, effectiveness of the quality management system and to evaluate continuous improvement.  Sure they list a number of aspects of the business that contain ‘relevant’ data for analysis but nowhere does it prescribe what and how.  So don’t be bullied and don’t run amok.

Always start with data that is generated now, especially data that get the owners, shareholders, stakeholders excited.  So financial data is a good starting point.  Then look at what other data that is collected and reported on.  Next look at the fuzzy stuff.  I won’t define what is fuzz and what isn’t, just remember, if you have to invent gathering tools and data just for the sake of the quality management system, then it is probably fuzzy.

This doesn’t mean fuzz is bad.  Some companies need to redefine fuzz to core, because without it your probably cannot demonstrate appropriate, relevant, data and it’s analysis and if you can’t, then you probably cannot get certified either.

So define what data is core to the business, describe when it is gathered, when it is analysed, maybe even describe how it is analysed and demonstrate that you do it.  I would normally put this in both the quality manual and a management review procedure, because at the end of the day, it needs to have a quality focus to meet the requirements of a quality management system.