Deviation and it's manangement in manufacturing industry

Definition

Deviations are defined as measured differences between observed value and expected value or normal value for a condition of product or any process. It is also defined as a standard documented value or procedure as well.

Occurrence

A deviation can be occurred by sampling and testing of the raw materials and also the finished products and manufacturing.

Industrial Level

There are four types of deviation which are:

1.   Machine

2.   Material

3.   Man

4.   Method

Other types of Deviation:

1.   Location deviation.

2.   Supplier deviation.

3.   Quality deviation.

4.   Quantity deviation.

5.   Delivery Time deviation.

IMPORTANCE OF DEVIATION IN MANUFACTURING INDUSTRY

1. Quality is considered as the number one priority in manufacturing industry and without the standard quality no other processes will be carried out or made to the mark because compromising in quality stands for compromising with the standards of manufacturing and to do that falls under risk and deviations.

2. Before starting the topic all the manufacturers and constructors starts managing their deviations in the same manner or do a slight change to the construction management process or production. This is how it leads to the deviations and those deviations cannot be reconstructed or managed as the suppliers got big problems in demands and the purchase orders leads to nothing but to a drastic drama before making any marketing.

3. Managing deviations is very important for every aspect of manufacturing and customer and to do that different remarkable stoppable came into line up that causes cost effective to the customers and manufacturers. There are several ways through which deviations can be managed among which falls documentations but making sure from the customer is important in that manner. It can be possible if you stand down and make changes to the standard materials and manufacturing drawings because that will be only cost effective for the customer and it will be failed to mention the approval from the customer. The material becomes rusted and ends up become useless as the customer wanted was rust free. In case if the customer does not approve manufacturing procedures or liability of the product than in that case the customer’s approval for the change can be acceptable. This will cause liability to the manufacturer, makes acceptable for the product quality to the customer’s own product approve and change and most importantly maintains the overall quality of the product.

4. Deviations do not always fall under changes of the material. Deviations can be any change of in the procedures, devices, locations, suppliers and the delivery times, colors in paint, hardware, method of manufacturing design changes and the so on; as forever possibilities of the changes. Under all categories the most important of all is to get approval, document and manage the changes. If we take example without FDA quality standards, the used medical devices during surgery will get failed in surgery if we do not follow the rules. The car will not be opened to cooperate that it should be. Another rules and standards that is FAA quality standards without them, airplanes will be unsafe and unreliable to fly.

5. Here in Pharmaceutical manufacturing, we change from customer’s manufacturing drawings, clauses in the quality standards; and other manufacturing specifications. It is usually such times when we get to know we would like to make changes or not. When we start writing up the notes we makes all necessary changes and differences like costing, pricing, quotes from their specifications. This will allow the customers to review pricing and all the lists for what will we plan to do for the fabrication process and it differs at all what they had requested.

6. The customer starts producing purchase order and from there we have to make changes and bring the line into one platform by understanding the customer’s point of view before accepting the purchasing order. Why are we doing that? We are doing that because in this way we can build the trust of the customer and the customer will become fully aware of what changes had been made before purchasing the order. This process seems pretty easy but once when we start making all the necessity changes it will get tricky and then we get to know that why it is so important in tracking the changes and managing the deviations as per the requirements of the customers. Nobody wants to fabricate the process and make revisions and carry out changes or make it a second attempt for their approval.

7. The easiest way to manage the deviation is to do the implementations by the customers on first hand according to their requirements as they will be doing to add their drawings and quotes and all you will be needing to do get approval and add the purchase order since it will be already implemented according to the specifications of the customer.