Striving for win : wins in the QMS

So, when is a corrective and preventive action (CAPA), not a CAPA ??

I don’t ask this in a philosophical, beard-scratching way, but in order to share an example that sheds some light on a theme you will see runs through many of the editions of this newsletter: the often-competing positions of Compliance and Quality.

Only a few days ago I ran a poll on LinkedIn where I asked the question: Do all CAPAs need documenting in the CAPA system ? For example, minor clarifications to a procedure.

And boy, did it generate some interest ! It was posted in a group specifically interested in CAPA – so I presume most voters were somewhat knowledgeable about the matter, or were simply hanging around the wrong people.?

Within a few days over 560 people voted, such was the raw nerve it maybe touched.?

The vast majority felt if it walked like a CAPA and talked like a CAPA , then well, it was a CAPA and should be documented in the CAPA system.?

But at what cost ?

As all seasoned quality professionals know all this comes with a degree of rigour and expectations around the planning, implementation, training, and effectivity checking of a CAPA event – as nothing in life or business is truly free.?

CAPAs come at a cost, aside from crossing the t's and dotting the i's in other QMS subsystems. Generally it costs resources getting a CAPA event kicking and screaming over the line.

Whilst there were some beacons of light who felt this was perhaps over-kill and responded likewise in the comments of the poll, there were also an equal number who voiced that a CAPA was a CAPA was a CAPA, and documentation in the CAPA system of the QMS was a must. Some may have even fainted at the very thought of such non-compliance and heresy.??

So why does this matter ?

Well, if you have never rolled up your sleeves and had to operate a QMS this may be just look like an intellectual question.??If the standards or regulations say something must be done in a certain way, then I’m afraid it just must happen.

Now we all know auditors and inspectors who have never had to operate in the messy real world of a live QMS in a moving breathing business. But it is the real world we live in and one where we need to make pragmatic, risk-based decisions to survive and serve our customers and shareholders.

This conundrum – one of how to balance compliance with practicalities - was driven home to me recently whilst working with a client who appeared caught in this Compliance v Quality trap, and was effectively being punished for doing the right thing.?

The client in question is a large multinational medical device company with over 30 years of experience. They had embraced some of the best current thinking around taking a risk-based approach. They had?stratified their non-conformance system; bucketing issues into High, Medium and Low risk events. High risk events mandated CAPA. For events in the middle zone it was to be considered. Whilst for Low risk events no action was needed, other than record the event and look for repeats. In essence, document the issue, close it out and move on. Overall, it was a highly laudable approach.

Well, until human nature got involved.?

Peering into their CAPA data-base showed around 1/3?of?CAPA events were from low-risk issues, where though not mandated individuals felt the right thing to do was to clarify the procedure, tweak training etc to prevent the event happening again.?ie: going beyond what was needed.

Even though the system allowed them to do absolutely nothing, at times it is hard to hold people back from making improvements.

They were caught between either doing the right thing ie: continuously improving but creating a system that becomes unworkable, as it becomes clogged with low-risk events technically not required. Or doing nothing and though compliant it stifles an individual's desire to make improvements.?Now, which one is really better ? That's a rhetorical question by the way.

The question is not around whether such improvement events help or even whether they are recorded in the QMS.??It is more a question how much rigour is enough ??

Can other systems??- ie: non-conformance / change control??- handle them with a lighter touch ??

This is a valid question even before we talk about CAPA for truly preventive actions - preventing issues that have yet to happen. As an aside most companies struggle to demonstrate preventive CAPA during regulatory inspection, not surprising when the system sometimes punishes you for doing the right thing.?

However, based on the feedback from the poll - and the view of many auditors - the majority of opinion was: No. If it looks like CAPA then it goes in the CAPA system. No ifs, no buts.

And this is dilemma we face. Not so much, comply or die but comply and die as the QMS is forced to behave in a disproportionate way and at times act as a drag anchor on the business.

So, what is the answer ?

Well one approach is to just rigorously enforce procedures. If you don’t need to do something then don’t do it, or face the resource penalty if you must act.

And alternative approach is taking a more pragmatic, risk-based approach with actions that are proportionate, with documentation that reflects this proportionality. Deliver a response that is still compliant with the overall expectations of the regulators ie: organisations fix and ideally prevent problems and improve. But not be pedantic on how it is documented. Horses for courses as it were.

And in the regulators defence, the regulations generally state what you must do not necessarily how you must do it.?

This is really important. Many peer functions often look on the Quality organisation - and the QMS - as hamstringing the overall business and unable to think pragmatically for the greater good, and in truth much of these knots are self-inflicted and created by us in Quality.?And yes it is safer and easier to put everything in the CAPA system, as explaining a different though equally compliant approach takes some effort. But I'd say that is our job.

The role of the modern quality professional is not to see Compliance and Quality as being in conflict. More specifically our role is to find creative win : wins for both Compliance and Quality. They are just different sides of the same coin.

So, the next time somebody says it must be done in a certain way, no ifs – no buts, ask yourself: Really ? Stress-test their reasoning with your customers' needs central to your questioning.

Because at times for the good of the overall business and to satisfy all the customers of the QMS (patients, regulators and shareholders) sometimes it is better to ask forgiveness than ask permission. A pedantic approach is often just the lazy option.

All the best

matt

Available to pre-order on Amazon now: Transforming Quality Organizations: A Practical Guide (Wictome & Wells, Business Expert Press, New York).