The 4-O System: What Is It?
The idea behind the 4-O approach is to identify the cause of the detected nonconformity(ies), ensure a complete correction is carried out, and structure the organization in such a way that the nonconformity(ies) will not occur again in the future. An improvement has thus been implemented that reduces the likelihood of recurrence. This makes the corrective action structural and, in the inspector’s view, “sufficient,” allowing the certification to be issued after all.
The 4-O system consists of four steps: Cause, Scope, Solution, and Operationality. Using a separate audit form, the inspector will assess whether the corrective action is sufficient for each nonconformity using this system.
Step 1: Cause
In this first step, the inspector will inquire about the cause of the identified nonconformity. Only when the cause of the nonconformity is known can you take targeted measures for the future.
To take targeted measures to prevent the error from occurring in the future, it is important that you understand how the nonconformity arose. Consider, for example, the following questions:
- Is there an error in the software that caused the deviation?
- Was the deviation caused by an incorrect software setting?
- Did the deviation result from incorrect data entry (human error)?
Step 2: Scope
In the second step, you determine the scope: how significant is the deviation or problem? For the inspector, a deviation often comes to light during a random audit. The inspector does not know at that point whether it is an isolated incident or whether the non-compliance has occurred more frequently. The company must demonstrate this itself. The inspector must be informed which other employees were involved in the non-compliance and the amount involved.
Step 3: Solution
Now that you know the cause and scope of the identified non-compliance, you can address it more effectively. The solution must address both past and future issues. A retroactive solution could be, for example, paying the correct wages retroactively. A forward-looking solution involves implementing measures to reduce the likelihood of recurrence.
Step 4: Implementation
In this final step, it is important to verify whether the chosen solution will actually work going forward. If, for example, the error occurs again afterward, then the solution has not worked. At that point, the goal is to go through the 4-O framework again until the solution is effective and sustainable. Here, too, the inspector may request supporting documentation.