Welcome to my blog for all things related to business quality (processes, systems and ways of working), products and product quality, manufacturing and operations management.

This blog is a mixture of real-world experience, ideas, comments and observations that I hope you'll find interesting.



Corrective Actions

One of the best ways of solving systematic problems and improving the way you work is via a Corrective Action system, often known as CAPA – Corrective Actions and Preventive Actions. And, as with all the best processes, the trick is to keep it simple.

To solve a problem, or improve something that isn’t as good as it should be, you need some facts:

  • What are the symptoms or shortcomings?
  • Who is responsible for solving the problem?
  • Do you need any urgent, temporary ‘sticking plaster’ fixes?
  • What is the ‘root cause’ of the problem or shortcoming? (i.e. the real fundamental reason that it happened, not merely the symptomatic cause; for instance, if your Heathrow flight is delayed the root cause is never “the late arrival of the inbound aircraft” – that’s just another symptom – it is, for instance, that the airline’s schedules don’t allow sufficient time for unexpected repair work and there was a mechanical failure earlier in the day which had a knock-on effect)
  • What Corrective Actions, i.e. permanent long-term fixes, are needed to make sure the problem or shortcoming cannot ever occur again, and who is responsible for taking these actions?
  • Have each of the Corrective Actions been completed? When? How do you know they have been effective?

Powerful CAPA management tools are built into many integrated Quality Management systems, and a number of good stand-alone systems also exist (for instance, Everest by Lynk Software). However, for many companies CAPA is so simple that an home-brewed Excel spreadsheet or Access Database or other simple system is more than sufficient to list all the required information against each problem; for the last CAPA system I put in, I just produced some custom Wiki pages for the client’s Intranet.

My suggestion for a simple Corrective Action process is:

  • A group of senior staff – let’s call them the Quality Management Group (‘QMG’) –meets regularly to review Corrective Actions
  • Anyone in the company can draw attention to a problem or shortcoming by briefly describing the symptoms in the company’s CAPA system
  • For each problem that is identified, the QMG agrees on any urgent sticking-plaster fixes, often referred to as ‘Containment’, decides on the timescales, and assigns a senior member of staff to be responsible for identifying and managing Corrective Actions
  • The assigned member of staff investigates the real root cause and identifies and manages the required Corrective Actions to a conclusion to prevent the problem from happening again; this often involves getting assistance from other staff. Most importantly, they also produce evidence that the Corrective Actions that were taken have been effective.
  • The QMG regularly meets to review the Corrective Actions undertaken, and the evidence for their effectiveness in addressing the Root Causes of the problem. If they are satisfied they Close the Corrective Actions; if not, they keep them Open and ask for further work to be done.

Preventive Actions (some people say ‘Preventative’) are similar but different. In this case, rather than react to problems that have already been seen, the company attempts to predict problems and take action before they occur. This is preferable, as it should stop the problems occurring in the first place, but is considerably more difficult!

Techniques such as Failure Mode and Effects Analysis (FMEA), Process Failure Mode and Effects Analysis (PFMEA), Risk Analysis, and many others, can be used for Preventive Actions, but in the end a similar process can be used to manage them to a conclusion.

If you don’t have a Corrective Action process in place, why not try putting one in? It may all seem very obvious, but you would be amazed how effective it can be to take a simple, easy, structured approach like this and use it to solve problems and achieve Continuous Improvement in any organisation.

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