For a medical device company regulatory requirements can be burdensome. This burden can multiply if regulatory requirements are followed obstinately. This little story shows - with a twinkle in your eye - how this could look like.
The company is producing medical devices. At there location they have two buildings. The buildings are separated by a public street. The street is a dead end with no traffic. To keep the production ongoing, parts must be transported between the two buildings. This is done by a production guy using a cart.
One day the CEO asks the Quality Manager: From time to time we do have quality issues with our parts. We can rule out suppliers, it must be within our production. Please go and investigate. The Quality Manager does as he was asked for. Looking at the process did bring no news. Finally, he was talking to the production guy who transports the parts between the buildings. The production guy tells him: “Of course I know about that. It is not safe to use the street when it is raining. Everything is getting wet. I asked for some protections, but that was not approved.”
The Quality Manager is happy that he got to the bottom of that. He went back to his office and started to think about a solution. They are based on his notes: 1) Street is not safe and 2) protection required. First thing he was doing is to look in the quality management standard for guidance. The standard offered a section that wrote: “The manufacturer shall implement and evaluate measures for safe transport.” The Quality Manager is shocked that he missed this requirement until now. This would be a non-conformance in the next audit.
He researches further and finds out that a possible protection, when crossing a street, is to build a zebra crossing. The Quality Manager sets us a presentation for the CEO to inform him about his findings and to request the budget. The CEO agrees as he wants this quality issue solved and he also does not want to receive a non-conformance in an audit.
The zebra crossing is built and included in the quality management system. However, the quality issue remains. The next day the notified body comes for an audit. The auditor - without surprise - investigates the zebra crossing. He tells the quality manager: “I’m an expert with safe street crossing. While zebra crossings are ok, they do not represent state of the art anymore. State of the art is traffic lights. Only that will help you to remedy your quality issues.” The auditor leaves with a recommendation to build a traffic light.
The CEO and the Quality Manager discuss the matter. To avoid a non-conformance and to solve this quality issue they install a traffic light. Of course, they consider applicable standards for traffic light, especially they took attention to not disturb the other traffic with their traffic light. The traffic lights were installed. Surprisingly the quality issue remained, and the company had a new issue. Production did not receive the parts in time anymore and production would stop due to missing parts.
Again, the CEO and the Quality Manager discussed. The Quality Manger, obviously also not happy about the outcome, said, that he did hire a Lean Six Sigma Master Black Belt. He will assign him the project and this guy will for sure find the solution. The CEO agrees with that.
The Lean Six Sigma Master Black Belt takes up his office and starts to analyze the issue. Soon he has the solution: The production guy spends too much time at the red light of the traffic light. That disrupts the process flow and causes this poor performance of the process. Obviously, the traffic light is no good solution. Luckily the Lean Six Sigma Master Black Belt has a better solution. He suggests building a bridge over the street to connect the two buildings. The crossing is still safe, and the unproductive waiting time will be eliminated. The CEO agrees again having no solution of his own. The loss of performance with the traffic light is by far bigger than the original quality issue. So, the traffic light is replaced by a big, solid bridge. Unfortunately, the cart can only be loaded with half of the load, otherwise it would not make it over the bridge, as it is rather steep.
But the bridge solved the problem. A short while later the performance was back at the level before the start of the quality actions. And the quality issue was gone, too. Everybody should be happy, but the CEO, the Quality Manager and the production guy do not to speak to each other anymore.
The CEO thinks, quality management can solve problems, however it is very expensive and requires too many resources. I’ll try other ways first, which might prove less costly. It is better to keep quality management short and keep them out of daily business.
The Quality Manager thinks that it’s proven again, that only a good quality management can solve problems. However, the system must be much tighter, so issues like the street crossing can be solved much faster. Quality Management must be involved much deeper in operations.
The production guy thinks that quality management might be capable of finding solutions for a problem. But it is too complicated to work with them, as quality management does not really understand the problems and their solutions are quixotic. It will be better to solve problems without involving them.
Now, if anybody is wondering how it worked with the bridge and the performance and quality. The solution is obvious: the production guy did not cross over the bridge but went under the bridge. This way he could still carry full load and when it was raining, the load keeps dry.
This situation sounds familiar? You can change it. We know how. Qserve – the practical approach.