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NCRs and issues happen in any company. The way the company handles these is what defines the culture of the organization. More often than not, the responsibility is simply dropped at the Quality/Safety department regardless of their knowledge of the matter. Yes, Quality/Safety should be informed about it, but they cannot and should not be responsible for everything that goes wrong. Check out how we believe NCRs should be handled.

Filing NCRs/Issues

The first step is getting employees to file NCRs/Issues. There should be hardly any boundaries for them to file one. (link to easily creating them). The creation form for an NCR/Issue should be no more than five input fields, including the options to add pictures and be mobile accessible. Keeping this step easy will allow for much more data from the field. The employees on the ground really know what is going on, so make sure you leverage their knowledge.

Responsibility

When the NCR has been filed, not all the information is known yet. The NCR owner has the responsibility to get the report fully filled in and to make sure all the data is collected properly. Quality/Safety shouldn’t be the owner of all the NCRs, however, they should be informed about the issue. Line managers should own the NCRs that have been reported in by someone in their department or team. These managers are close to the operations and therefore able to collect the required information. Also, most of the time they know much better what goes on at the operations level.

owner has the responsibility to get the report fully filled in and to make sure all the data is collected properly. Quality/Safety shouldn’t be the owner of all the NCRs, however, they should be informed about the issue. Line managers should own the NCRs that have been reported in by someone in their department or team. These managers are close to the operations and therefore able to collect the required information. Also, most of the time they know much better what goes on at the operations level.

CAPA Plan

Next to the data that needs to be collected, there will be specific actions. These actions can either be planned by the responsible manager or by the Quality/Safety department. These actions should help to solve the issue immediately or even prevent certain issues from happening in the future.

The actions should be distributed among the employees and no task should be owned by more than one person. This distribution of actions increases the engagement and allows for collecting data from the person that has the most knowledge of the matter.

Feedback

Provide feedback to the person that filed the issue. This feedback can be simply a summary of how the company handled it. The engagement will be so much higher when people get informed because they see that the company really cares and actually does something with their reports.

Next Steps

When all the NCRs are filled, it is up to Quality/Safety to make sense of it all.Analyze the results, find the common root cause, and analyze their financial impact. When the data is structured, you will see how impressive it can be and how much money the company leaves on the table by repeating errors.

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