Purpose: product Impurities
Check if physical hazards like product impurities (foreign material) can get into the products.
Definition: product Impurities
- Hard plastic;
- Machine parts.
Foreign material can enter the product in a variety of ways. To prevent this, it is important to examine the objects and assess if there is a possible risk of contamination for the product. For example, through a break or loose-fitting parts.
The chance of possible contamination is assessed via the iMIS Audit rounds.
Actions by abnormalities:
When an object is not good, direct action should be taken to prevent product contamination.
- The first step is always blocking the object
- Review if the object can be made, and if so, carry out the repair immediately.
- If repair is not possible, the object should be removed / replaced.
- Make any necessary repairs. And in such a way that contamination of the product can no longer occur.
- Reduce the cause so that, depending on the cause, measures can be taken.
- Instruct personnel.
- Change maintenance frequency.
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