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Deviation management

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All ISO standards have in common that they are intended to create continuous improvement within various focus areas through non-conformance management.

Process descriptions and management documents describe the business as it should work, but the world is not perfect - everyone makes mistakes and constant improvements are needed. In order to catch mistakes and make improvements, these events must be continuously recorded and acted upon.

To get there, the reporting of cases and incidents as well as their processing must be systematized. It is also important that the person reporting the incident receives feedback on the reported case. The illustration to the right shows a basic sketch of non-conformity management/case management.

Depending on the business, it will vary in complexity and number of levels. All experience shows that it must be easy to report a case: Be it an improvement proposal, incident, deviation, etc. It must also be easy for managers to process incoming cases.

Many businesses therefore choose to purchase a deviation system. According to ISO, a deviation is an event where something in the system deviates from something – for example a procedure or an instruction. In practice, many incidents will therefore not be deviations, but pure incidents. We at 4human QM365 therefore prefers not to call this a deviation system, but rather to use the term improvement system.

The procedure in the deviation system we offer.

Deviation processing with 4human QM365

1. Registration

A situation may arise, a near-miss, or an employee may want to report an improvement suggestion. We have created a system that makes it easy for the user to report this right away.

To make the system even more accessible, you can also connect to the App for field reporting. This is especially true for professional groups that do not normally have access to a PC when a discrepancy occurs.

Today, just about everyone has a smartphone. This, together with a user-friendly app, means that the threshold for enrollment is low. On a PC, the employee is greeted with an enrollment form where some of the fields are predefined. This also makes it easy for the employee in the office to know what to fill in, and ensures that enrollment does not take unnecessarily long.

2. Case processing

As soon as a message has been sent, the right case manager receives a notification by email. One click and the case manager can read the message that has been entered.

The case manager's task is to fill in more detailed information about the incident. This can include elements such as root cause analysis, the case manager can determine whether the case is a non-conformity or not, determine whether the incident is related to quality, environment and/or HSE, material damage, operational loss, severity, etc.

Another important task for the case manager is to create any measures. The measures ensure that the case can later be closed. It is also the case manager's task to give the right people responsibility for the measures. These people responsible for the measures in turn receive a notification by email about the task they must complete and the deadline set for completing the task. The system also includes automatic reminders if they extend this deadline. When all measures have been completed, the case manager can close the case. (The complexity of the non-conformance processing can vary depending on the type of business.)

3. Post-control and verification of measures

To ensure that important measures have had an effect, this must be verified. Our tool will therefore give the case manager the opportunity to create a reminder on a suitable date in the future. A notification is then sent and the case manager checks and can confirm or deny whether the measure has had the desired effect. This may, for example, apply to cases that end with a routine having to be changed to improve quality. Then you have to check after a while whether it has had the desired effect. If it has not had the desired effect, you can continue working on the case.

4. Implementation

4human QM365 has over many years gained solid experience in non-conformance management and in implementing a user-friendly and useful non-conformance and improvement system. Our customers have everything from a handful to hundreds of employees. We have specialized in listening and seeing the different organizations so that each customer can do this in a way that they can identify with and benefit from the data.

Our improvement/deviation system Better basically has a setup that suits most businesses, but where adaptations and adjustments are needed, this is usually a simple job. The reason is that it is built in SharePoint and all adaptations are done at a high level, which makes it quick and easy.