Houston… We Have a Problem…
Auditing corrective actions can be difficult. Often, on the first pass most corrective actions seem OK. The difficult part is scrutinizing them and evaluating them for their potential to prevent the problem from happening again.
- Has the problem been well defined?
A lot of the issues with resolving a problem stem from a poorly written problem statement or from nonconformity. A nonconformity is the non-fulfillment of a requirement, according to the ISO standards. Which means you essentially need to identify the gap – the difference between the expected requirement and what was actually observed.
- Requirement: all employees must have chemical hazards training.
- Observation: only 5 of 10 employees have received the required chemical hazards training.
- Nonconformity/problem statement: not all employees have received the required chemical hazard training.
The problem statement does not include:
- The solution
- The cause of the problem
- Any other problems
- Has the root cause been identified?
Has the investigator identified the true root cause along with all of the contributing factors? The majority of findings do not relate to human behavior factors. There is usually additional contributing factors, such as:
As an auditor, if you can still ask “Why?”, then they may not have fully explored the issue.
- Have the identified corrective actions addressed the root causes?
There are two types of actions that need to be taken, immediate corrections and long term corrective actions. See my previous blog post for the difference. The long term actions should address the root causes and contributing factors. This is how the problem will be prevented from recurring.
- Have the actions been verified for effectiveness?
The actions have to be verified for effectiveness. This goes beyond just verifying that the actions were completed.
To be verified for effectiveness, a number of questions should be asked:
- Were the actions completed?
- Did the actions address the root cause?
- Will the actions prevent the problem from happening again?
The last question may take a while to answer, sometimes even up to 6 months after the implementation of the actions.
The goal of a solid corrective action process is to drive continual improvement, not just fix things. As auditors we need to push companies forward. It’s a waste of money and resources repeatedly repairing the same problem.
As Einstein said, doing the same thing over and over again, but expecting a different result is the definition of insanity.