The link between FMEA & Control Plan
Common mistakes that impede performance
Are we conscientious users of the FMEA and the Control Plan and still have problems? Then we should be careful that:
1. The FMEA should be aligned with the Control Plan process steps.
The process steps must correspond to those defined in the Flowchart. Each line in the FMEA must have a corresponding line in the Control Plan, more precisely for each risk identified in the FMEA we must have a control for prevention or at least detection in the Control Plan.
2. The control frequency should be given to the real risk in the process
Consider a manual process with a major influence from the operator. If we work in 2 shifts, the breaks being taken without the actual stopping of the work means that we have 4 operators who can influence that process - two in each shift, one who performs the process normally and one who replaces it during the break. How effective would a control at the beginning and end of the exchange be? Or worse, at the beginning and end of the day?
3. The number of controlled parts to be correlated with the actual process
The smaller the change that may occur on the product, the more parts will need to be controlled in order to detect it. If we think about the risk of breaking a tool, it can be identified by a single controlled part. On the other hand, if we think about the risk posed by the continuous wear of a tool we will need a much larger number of controlled parts to be able to identify it.
4. Activities should be focused primarily on preventing the occurrence of risk
If we base our control only on detecting risk, there is a good chance we will not succeed. It is already known that, statistically speaking, a visual control at the end of the line, even performed on 100% of the products will detect 80% of the problems. What organizations should do is define and implement, in the earliest stages of a project, error prevention systems (POKA-YOKE) and statistical process control (SPC).
It's complicated ? We say no, it only requires good knowledge about the production process and the tools that can be used (FMEA, Control Plan).
Does it cost all these activities? Yes (people, training, maybe investments for programs and equipment), but it recovers tenfold. If they are made with the head.
Is the time to align the FMEA with the Control Plan worthwhile? It certainly gives the performance that can be achieved in series production ‘makes all the money’.
Are we conscientious users of the FMEA and the Control Plan and still have problems? Then we should be careful that:
1. The FMEA should be aligned with the Control Plan process steps.
The process steps must correspond to those defined in the Flowchart. Each line in the FMEA must have a corresponding line in the Control Plan, more precisely for each risk identified in the FMEA we must have a control for prevention or at least detection in the Control Plan.
2. The control frequency should be given to the real risk in the process
Consider a manual process with a major influence from the operator. If we work in 2 shifts, the breaks being taken without the actual stopping of the work means that we have 4 operators who can influence that process - two in each shift, one who performs the process normally and one who replaces it during the break. How effective would a control at the beginning and end of the exchange be? Or worse, at the beginning and end of the day?
3. The number of controlled parts to be correlated with the actual process
The smaller the change that may occur on the product, the more parts will need to be controlled in order to detect it. If we think about the risk of breaking a tool, it can be identified by a single controlled part. On the other hand, if we think about the risk posed by the continuous wear of a tool we will need a much larger number of controlled parts to be able to identify it.
4. Activities should be focused primarily on preventing the occurrence of risk
If we base our control only on detecting risk, there is a good chance we will not succeed. It is already known that, statistically speaking, a visual control at the end of the line, even performed on 100% of the products will detect 80% of the problems. What organizations should do is define and implement, in the earliest stages of a project, error prevention systems (POKA-YOKE) and statistical process control (SPC).
It's complicated ? We say no, it only requires good knowledge about the production process and the tools that can be used (FMEA, Control Plan).
Does it cost all these activities? Yes (people, training, maybe investments for programs and equipment), but it recovers tenfold. If they are made with the head.
Is the time to align the FMEA with the Control Plan worthwhile? It certainly gives the performance that can be achieved in series production ‘makes all the money’.
