Documenti di Didattica
Documenti di Professioni
Documenti di Cultura
No:-4
CAP-412
Software
Project
Management
Submitted to: Submitted by:
Respected Ankur Singh
Sandeep Sharma Sir Roll no:-
Re3801a29
(b)Change control
Change control is a systematic approach to managing all changes made to a
product or system. The purpose is to ensure that no unnecessary changes are
made, that all changes are documented, that services are not unnecessarily
disrupted and that resources are used efficiently. Within information technology
(IT), change control is a component of change management.
Part B
Q 1: Compare and contrast the product and
process quality management?
Ans
Product Controls
Quality systems that focus on sorting and isolating defective product are
generally called product controls. Because the process generates defective
product, efforts are made to identify, sort, and segregate the defective product.
Often, the defects are made throughout the process but only culled at the end.
For example, a manufacturer sells a sterile original equipment manufacturer
(OEM) part. The part is made from a metal press, where it is etched with a lot
number, cleaned, packaged, and steam sterilized. Prior to shipment, samples of
the sealed product are inspected. If the metal press caused hairline cracks to
form in the part, then this may be detected only at the very end of the process.
All of the cleaning, labelling, packaging, and sterilization are wasted on
essentially defective product. Because defective product is definitely present,
product controls require 100% inspection or multiple 100% inspections to
guarantee product quality. Statistical sampling plans are not useful because they
presume an acceptable defect level of a few percent, which is generally not
acceptable for Food and Drug Administration (FDA) regulated products.
Process Controls
Process controls are quality systems based on preventing defects by controlling
and monitoring manufacturing processes. Because no defective product is
produced, these processes can achieve much higher quality levels than a system
based on product controls. Processes must be rigorously characterized,
understood, and controlled for this system to be effective. For example, a
pharmaceutical manufacturer typically combines a number of drug components
into a heated batch reactor, mixes them thoroughly, dries them in a granulator,
and compresses them into tablets. Process controls for this operation would
include specifications on batch size, mixing speed, drying temperature, mixing
temperature, drying time, mixing time, and speed at which pellets are
compressed. These are distinct from product specifications in that they will be
different depending on the equipment used.