FDA inspections are always a very interesting experience: on one hand very stressful, of course, but on the other hand they always leave that magical feeling of having learned something more, not only on your job, but also a little about life. For example, last year one of the many inspectors I came across impressed me with a simple statement: “If there is no CAPA (Corrective Actions Preventive Actions) management, it means that the system is dead.”

If you think about it, it is rather true: only correcting and preventing problems you can improve the effectiveness of the system and the organization evolves. If nothing is done, the system is still, fictitious and, of course, dead. As regards CAPA then, let’s refer, for example, to chapters 8.5.2 and 8.5.3 of EN ISO 13485:2016 but also to 21 CFR 820.100 Corrective and preventive action.

First of all, a Corrective Action is not the action that solves a non-compliance: this is one of the most widespread misunderstandings. “I detected this non-compliance and I solved it with this corrective action” is one of the most wrong statements. The action taken to solve a non-compliance is the Correction. The Corrective Action is the action implemented simultaneously with the non-compliance or once it is solved, to avoid the non-compliance recurrence in the future. While the Preventive Action prevents the occurrence of any non-compliance that has not yet occurred (or to manage an improvement).

The other aspect that really challenges organizations is applying a method, as effective as possible, to investigate the causes. Far too little attention is given to causes investigation in the CAPA form or the text included is rather short. Often the field has not been completed. Terms such as “Provider error”, “Return”, “Repaired” or others that either have nothing to do with the Root Cause Analysis or are so vague and hastily written that you cannot understand what actually caused the problem. Incidentally, “supplier error” is not enough for an investigation of the causes, it is necessary to go further and directly contact the supplier to find out why he was wrong.

So let’s see how to facilitate effective causes investigation in 5 steps.

  • Analyze the problem, define the impact this has had on the product quality and on the process effectiveness as well as estimating it in terms of gravity and probability of occurrence (or re-occurrence). Apply a risk management process;
  • Define a method to identify the root cause or, at least, the most probable one. With the 5 whys rule, for example: a succession of five questions allowing to tackle the root of the problem.  For example:

Why the equipment x in the line y in production does not work (first why)

Why the component z of the equipment x is broken (second why)

Why the component z has not been replaced for two years, although the need for an annual replacement was indicated by the manufacturer (third why)

Why no scheduled maintenance was performed (fourth why)

Why the maintenance personnel has resigned and has not yet been replaced (fifth why, the problem root).

  • Simply identify the root cause. FDA inspectors, and Americans in general, have always preferred the check list. The bible in this case is The Checklist Manifesto: How to Get Things Right by Atul Gawande, a collection of precious tips, so banal that it is rather good to apply them;
  • Describe in detail the investigation, so that whoever is not inside my head can reconstruct the reasoning you have done in points 1 and 2;
  • If you do not carry out an investigation, you shall explain why, providing a justification on the basis of objective criteria (the investigation has already been performed in the non-compliance/linked complaint No. x, it is within a historically accepted and documented defect percentage, etc.).

CAPAs are essential for the evolution of the organization and, as already mentioned, if they are not enough or they are not properly managed, if they are neglected or misdirected, the system is dead or is dying.
Yet, this is a basic principle that perhaps it is usually forgotten in its essence and that sometimes FDA inspectors tend to remind. A principle that goes beyond the technicalities of Quality and that brings us back to life, to childhood. In order to grow it is necessary to learn from our mistakes like children.


THEMA - Logo TRASPARENTE_smallMarisa Testa
QA/RA Manager

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