Seven Steps for Corrective and Preventive Actions to support Continual Improvement
Do you think that corrective and preventive actions are a waste of time, or something that is only useful as a showcase for the registrar? I have found that many companies struggle with implementing effective corrective action systems, but here are some ideas on how you can use these tools more effectively in your company.
Correction vs. corrective action in ISO 9001
One of the biggest difficulties is in understanding the difference between “correction” and “corrective action.” Correction is when you find a problem and fix the immediate problem, such as changing the oil in a machine that has run out and is making bad parts, while corrective action goes deeper and finds the underlying root cause of the problem (in this case, waiting too long to change oil) and fixes that root cause (implementing a preventive maintenance program to change the oil on a schedule before bad parts are made).
While every problem needs a correction, the best bang for the buck is to use corrective actions on bigger problems that are repetitive and recurring. If a problem has only surfaced once, then performing and documenting a seven-step corrective action process may be too expensive, but if it occurs several times a month an investigation and corrective action will likely save money in the long run, since time will be saved when fewer problems occur.
Remember, ISO 9001 does not require that the documented corrective action system be used on every little problem that arises, but that the system is documented and in use for addressing problems to support continual improvement.
Process for ISO corrective action
I have found that there are a few simple steps that we all go through, subconsciously, when we are trying to solve a difficult problem, and these work well when properly documented as a Corrective Action system in an ISO9001 company (and it works with any other ISO management system as well). There are many ways to document these, from fancy computer programs to simple paper or PDF forms, but the steps all seem to follow the same flow.
1) Define the problem. First, make sure the problem is, in fact, a real problem, and not a perceived problem. A good test is if you can write the problem with a requirement to compare, what is often called a “Should Be” and “Is” statement (e.g. Parts should be nickel plated, parts were received painted black). If you can’t say what the outcome should be (or is expected to be), then you may not have identified a real problem.
2) Define the scope. Make sure you understand how big the problem to be addressed is. Is it just today’s product, or was yesterday’s product affected too? Is it just this one product, or is it on more than one product? Make sure you know what the problem is, and more importantly, what it is not. If the problem only happens on Wednesday, this may be important information.
3) Containment Actions. Make a correction to stop the problem for right now while you look for the ultimate cause and fix that. Basically, what immediate checks or stop gap measures are you putting in place to make sure that we will definitely catch the problem again if it recurs while you are fixing it.
4) Find the Root Cause. This is the trickiest part. How do you make sure you have found the underlying issue? There are many different ways to do this, from asking “Why” five times until you find the ultimate cause, to more difficult methods like a classic Ishikawa (or Fishbone) Diagram. Whole training courses have been dedicated to this topic, but suffice it to say that you want to try to identify the underlying problem, not just a surface problem. After this step, it is wise to make sure that your scope has not become bigger, making further containment actions necessary.
5) Plan a Corrective Action. Decide what steps are needed to eliminate the root cause of the problem. Here, depending on the problem, you will need to identify the cost and return on investment. How will it be funded (if it is a complicated and expensive fix), and who needs to approve the expense?
6) Implement the Corrective Action. This is as simple as following through on your plan and making it happen. It could be as simple as implementing the preventive maintenance program already described, or buying and installing a new piece of equipment because the old one could no longer keep the accuracy you need.
7) Follow up to make sure the Plan worked. Simply put, after you have made your updates, wait a suitable amount of time and make sure the problem doesn’t recur. If it does, you need to question if you got the actual root cause. This is the most important step, but also the step that most companies have trouble with. Often, people want to close out the paperwork quickly, or think the registrar requires closure early to demonstrate timeliness, but proper follow-up is essential.
And that is it.
One further note is that corrective action is used when you are reacting to a problem that has already happened, while preventive action follows the same seven-step process except that it is applied to a problem that is found before something bad happens. A corrective action would be rounding the corners of a table after someone gets hurt, but a preventive action would be rounding the corners before someone is hurt because you noticed they were sharp and might cause an accident.
Corrective & Preventive Actions – the best way to save money
It may seem redundant, but the biggest benefits can be realized by properly fixing the biggest problems. Wisely using corrective actions for the biggest problems is the most effective way to save money by driving continual improvement, and saving money through improvement is the best reason to implement an ISO9001 Quality Management System.
Click here to see a free sample of Procedure for Corrective and Preventive Action.