Deviation and incident

Quality Assurance
1

What is the main difference between deviation and incident?
Please give some examples…
Plz clear me whether these are incident or deviation?

  1. Temperature excursion occurs during manufacturing.
  2. One step skipped during process as per batch record.
  3. Personal working in the area is handling the product without wearing hand gloves .
  4. During transfer of material from one area to another,it’s spillaged.
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2

Case 1,2,3, are deviations, those may have impact on the quality of the product.
Case 4 is the incident.

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3

Case 1 & 2 are non-compliance from the Approved procedure so it can be treated as Deviation.
Case 3 & 4 are treated as Incidents.
If, Case-3 was defined in Approved procedure, it will be treated as Deviation.

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4

When an event don’t have direct impact on product quality it may be treated as incident. but when it is directly impact product quality it is considered as deviation.

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5

Case:3-Personal handling the material without hand gloves means there is a chance of product contamination with hands sweating and it may leads to microbiology growth. Hence it impact on the quality of the product, so it has to consider as the deviation.
In general for production personnel there have been some instructions were defined in SOP, while handling the products.
If it is defined in your inhouse SOP, but not followed means deviation.

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