change control pdf2 for assignment topic

Change control

1. CHALLENGES IN CHANGE A
CONTROL
There are many factors, but the following are the most common issues:
Poor Communication -Lack of communication between departments, failure to
follow up or escalate change requests and delayed or inappropriate notification of
changes made by suppliers etc.
Poor Turnaround -Timeliness can make or break a product's chances of
succeeding in the market. Companies that rely on a manual system to generate
data and to route and track submissions and change orders are likely to have poor
turnaround for change implementation because the system requires more time
and effort. The problem becomes worse when there is an unexpected change-a
deviation-and supporting data not generated in a timely manner. Delays may
also result because of failure to recognize the urgency of a change and the
absence of a contingency plan for certain types of changes.
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2. DOCUMENTATION
Change control requires a written procedure to establish at least the following steps:
What type of changes does change control take into account?
What are the requirements or urgent changes?
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For which areas does this operating procedure apply?
Who can suggest changes?
How are changes requested (forms, method of communication)?
How are changes graded and who is responsible for the rating?
How are the measures for carrying out the change established?
Who is responsible for the implementation and monitoring of all measures?
Who is included in the change control team?
What are the duties of the change control team?
How is the change documented (format, content, storage)?
Who is responsible to authorize changes?
All quality-relevant changes should be documentcd
All actions to be taken, including the nced for and extent of qualification or validation, should be
described
The records can be archived in paper form or electronically
When storing documents, raw data and other relevant documents for change should be kept accessible
The documentation for the change procedure should show that the change was evaluated (risk analysis)
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