What sells in the market? PRODUCT
What is Product? Product is defined as below:
Webster Dictionary:
Something that is made or grown to be
sold or used
Something that is the result of a process
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Business Dictionary:
A good,
idea, method, information, object or service created
as a result of process and serves a need or
satisfies a want. It has combination of tangible and intangible
attributes (benefits, features, functions, uses) that
a seller offers a buyer for purchase.
Law: A commercially distributed good
that is (1) tangible personal property, (2) output or
result of
a fabrication, manufacturing, or production process, and
(3) passes through a distribution channel before being consumed or used.
Marketing: A good or service that
most closely meets the requirements of a
particular market and yields enough profit to
justify its continued existence.
http://www.businessdictionary.com/definition/product.html |
ISO
9000: 2005
product
(3.4.2) is defined as “result of a
process (3.4.1)”;
process is
defined as “set of interrelated or interacting activities which transforms
inputs into outputs”.
If the term “process” is replaced by
its definition, as follows:
product then
becomes “result of a set of interrelated or interacting activities which
transforms inputs into outputs”.
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Quality attributes of the product are directly related to a process used to
create it. The process is defined in a set of procedures which when
followed as intended results in a product of consistent quality. Thus, a procedure directly affects the quality of the product.
In
technical writing these procedures
are called as Standard Operating Procedures or SOPs. SOP can be administrative or technical (manufacturing,
cleaning, testing, equipment operating, instructions etc). A format, structure,
sequence, record forms shall be defined and shall be consistent in all the standard operating procedures for consistency
and traceability. This starts with first procedure that is ‘Writing a Standard Operating Procedure’.
The
primary purpose of an SOP is to standardize working procedures to ensure
control. An SOP takes guesswork and uncertainty out of process equation.
Every
good quality system is based on its SOPs.
A
good documentation system shall
ensure that a laid down procedures
are elaborate, systematic and unambiguous so that the created product is of
consistent quality. Records provide
evidence that the procedure was executed as intended.
Quality Product is created by following quality procedures.
Your
favorite dish has a recipe which
when followed impart flavor (quality attributes) to a dish. These attributes
are result of ingredients added in specific quantity in a defined sequence at
different stage during dish preparation. For someone else to prepare the same
dish with same quality attributes a recipe is not enough. A demonstration is
required along with a recipe, in other words trained to cook your favorite dish. Training is required to execute
a perfect procedure. Training becomes much more important when a critical task
is being performed or complex equipments/machines are handled.
Thus
a good documentation system shall
ensure that the personnel shall be trained
in established procedure to create product of desired quality.
Lay down the procedures and provide
training.
However
in Quality System the buck doesn’t stop at preparing SOP, training and
implementation. Next step is improvement. SOP needs continual review and
development to ensure that they integrate new aspects. The aspects related to
changing regulatory, technical & organizational requirements and experience
gained.
When
the cycle of creation, training and improvement is followed SOP becomes a High Level View of the
Process.
Remember,
the most frequent reported deficiency, during the inspection are the lack of
written SOPs and /or failure to adhere to them.
WHO,
EU, FDA and other countries make references to written procedures throughout
the documents. Nevertheless, SOPs do not have to ‘’fit into a box’’. Formats can vary. An attempt is made to
provide an acceptable format with content in this post and following posts.
SOP has 3 parts:
- Approval Page
- Contents
- Record Forms (has different formats as per requirement)
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