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.
