Data, data everywhere..

..but to mangle the words of Coleridge’s epic poem, data with sometimes ‘ not a drop of use.’.

Today in our organisations we are drowning in a sea of data, and this is a short article about it.? But before you sigh - not another piece on Big Data, AI and Quality 4.0 - be reassured it is not. That discussion – on the ballyhoo that is Quality 4.0 - is for another time.?

This is a discussion on what data is, or what it isn't and how it is misused by virtually all Quality organisations.??Including probably yours.?

The important thing about data – and most Quality professionals get this - is not so much the data itself, but how it is used. How it is turned into wisdom and to use that tired and rather hackneyed phrase ‘actionable intelligence. ‘

And there’s the rub. We don’t use data in this way and generally don’t use it in that most important of our meetings, one to determine whether the Quality System is doing its job: Quality System Management Review (QSMR).?

If you are a Quality professional, you have certainly had to sit through one of these sessions.??You may even be to blame for subjecting them on your business peers. Shame on you.?

As an example on how data can be misused, let's look at the top 5 mistakes during Quality System Management Review meetings.?

1??????????All talk and no action

Or as they say in Texas, ' all hat and no cattle.' A lot is discussed, and everybody voices their opinion, but nothing is decided, or documented and eventually even remembered.?

QSMR should drive a data driven discussion and a conclusion. And yes, deciding to do nothing is often a valid a decision as any. But decide something. It you going to have data, use it. Leaving a presentation deck open-ended is both a waste of resources and effort. It also opens you up to a painful discussion at your next regulatory inspection.?

2??????????You don’t have the correct people at the meeting

You cannot measure the effectiveness, suitability and adequateness – blame ISO for these clunky words - of your Quality System unless you involve the right people.?

This essentially depends on what you consider it to be for. If you feel the Quality System is there simply for regulatory compliance, then your attendance list will be very small ie: just you and your other colleague working in Quality.??If you recognise that the QMS impacts the whole of your business – essentially a blueprint around how you run it - then you will almost certainly have to broaden your invite list to discuss the data.

Remember, any Quality System costs money to run. So, you will need to invite a representative from Finance. It also involves people. Remember them - those other guys in the factory ? Therefore, you will need somebody from Human Resources, and also that guy from R&D who designs your products.??And finally, if you don’t already have a representative from Manufacturing - the people that actually make all the stuff - then shame on you again.

3??????????Death by PowerPoint

Today PowerPoint is hard to escape from. Some companies have reverted back to a more document / narrative style presentation. However, few companies are brave enough to execute the QSMR review through the medium of contemporary dance, so some form of PowerPoint presentation will probably be needed.

But do you really think you were going to have a constructive and focused discussion after reviewing a deck of over 120 slides on a Friday afternoon ? The regulatory changes that are happening in the Middle East may be important to your business, but are they going to get the needed attention at the end of that humongous deck ? And whose bright idea was it to put the regulatory update at the very end ?

Consider splitting your session into bite-size chunks or drastically cutting down the content along the lines coming next.

4??????????Don’t measure the system. Measure its output.?

Many QSMR reviews are focused sadly on the mechanics of the Quality System. For example, the number of nonconformances opened, the number of open change orders, the number of CAPAs closed on time etc, etc.

Whilst this is extremely interesting, customers do not care a jot.?

There obviously needs to be some review of the transactional steps in the Quality System??- external auditors expect to see it.?But such content does?not?measure the output of the system in terms of making sure its customers i.e. regulators, your end customer and your shareholders are getting the outputs they are expecting from your Quality System.

Focus on data that is indicative of whether your Quality System is doing its job. Do not review data that is in control and requires no discussion. Focus on aspects that are atypical or moving in an uncomfortable direction linked to customer expectation. Leadership discussion time is valuable. Use it wisely.

Also QSMR is not opportunity for individuals presenting to the leadership team to justify their existence or reassure them everything is fine-and-dandy in their area. It is a chance to ask for resources, extra capability and help from senior management when they are struggling to satisfy customers because of an issue with the Quality System.?

This does require a high degree of management openness and ability to see through the charade and political nature that many QSMR sessions often become. It should be there to help you.

5??????????Lagging rather than leading indicators

This is a difficult one. Most of the QSMR is generally reactive and based on lagging indicators of quality. But try and consider what would be the leading indicators that would be more predictive of quality issues and challenges down the line.

The single question that underlies all these mistakes is:??Are we reviewing the correct data to decide on whether the QMS is performing effectively for its customers ??

This brings us to a more basic question.

So, what is data ??

The nature of the Quality professional is that we are generally more comfortable with quantitative data. The sort you can build a graph with and wave in front of someone's face. Data that is verifiable and unemotional. Facts are generally viewed as more important than opinions.?

However, there is no rationale to treat qualitative data – ie: views, feelings and opinions, as the poor cousins of numeric data. Opinions are extremely important. Most democracies are based on no more than an opinion-poll at intervals to decide who gets to be in charge.

Opinions matter.??Your customer’s opinions on the quality of your products will certainly make or break your business. Sadly some individuals working in Quality organisations today will know the exact percentage of non-conformances that we closed on time in last month, but will be oblivious to the main reason that customers were complaining about their products.

Feelings are powerful.?

This applies to the Quality System. People’s opinions on how difficult it is to use really matter. Your change control system may be very compliant and the shiniest available, but if nobody wants to use it, it is useless and a significant compliance risk.??Few Quality organisations use narrative / qualitative data as well as they could or should to better understand how their Quality System is performing.?

So, broaden your approach, and yes, it is more difficult. Opinions are harder to handle and shoe-horn into a smart table. But unless you widen your ways to understand data in all its forms, it may be only telling you half the story you need to be successful.?

It’s not so much the volume of data that’s surrounding you that’s the challenge, it's probably just the wrong stuff.