what is the diffirence between deviation and change control?
at what situations we can raise the deviation and change
control
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Answer / r. venugopala reddy
Deviation are two types. 1. Unplanned deviation and
2.Planned deviation. Deviation shall be raised to the
unplanned deviations and immediate action shall be taken to
the deviations but Planned deviations are temporary change
controls that means we can raise the temporary change
control instead of planned deviations.
Suppose we depatured the approved procedures or system, such
cases we can raise the deviation. In case we will departure
the approved procedures or systems as per our requirement
i.e. either customer requirements or yield/quality
requirements,such cases we can raise change control.
| Is This Answer Correct ? | 6 Yes | 1 No |
Answer / mahendra singh devda
Deviation means If we not follow established procedure or if
any change in written established process.
Change Control Proposal is a systematic procedure for any
change in established procedure, equipment,facility or documents
as per requirements & raise by concerned department with
proposal and justification and all relevant supporting
documents and approved by QA after evaluation.
| Is This Answer Correct ? | 5 Yes | 1 No |
Answer / bhopa lchandra jha
Very simple let us see our life full of deviation but after several deviations either it is planned or unplanned we think of something new and we want to chane our life and we wnt to controle through planning. Like this deviation and change controle applicable to all material, process and system.
| Is This Answer Correct ? | 2 Yes | 1 No |
Answer / vikash patel
aim of change control always to improve product quality
but deviation may or may not impact quality of product
| Is This Answer Correct ? | 4 Yes | 3 No |
Answer / rajesh kumar
Departure from the standards is called deviation and change
conrol defines the actions required to take a proposed
changes in specification, proceess/equipment or process.
Therefore,when u observe and deviation from estabilished
stds. you need to raise the deviation for the same.
When u need to change in any aspect like in specification,
process/equipment and systems same can be changed through
change conrol procedure.
| Is This Answer Correct ? | 3 Yes | 2 No |
Answer / gopala krishna gnanga
Deviation means when we have any written procedure like SOP,STP,BPR,protocol etc, and someone works against this,then it is called Deviation.It means Deviation from any written procedure that we have implemented.
Change Control means a document that control any change (new or up gradation) in your current quality and change control. If there is deviation happen and as CAPA of it one needs to upgrade the system then you need to file change control
| Is This Answer Correct ? | 2 Yes | 1 No |
Answer / nirav shah
Deviation means departure from any established procedure.
change control: procedure for control the changes of establises procedire
| Is This Answer Correct ? | 1 Yes | 0 No |
Answer / md. mosaruf hossan
Deviation is the temporarily reviewed effort to a change by
short listed concerned persons.
Change Control is the integreted effort of several
responsible department to make a change permenantly.
| Is This Answer Correct ? | 16 Yes | 16 No |
Answer / arvind mishra
A process that ensures that changes to materials, methods,
equipment and software are properly documented, validated,
approved and traceable.The process includes evaluation to
determine whether validation is required and the level of
validation required.
Deviation is a process in which we have to perform a task
that is not mentioned in the SOP,deviations are two types
one is planned deviation and
another is un planned deviation. Planned deviations are two
types one is tempery and another is permenent. tempery
deviations are approved by QA (for a limited period) then
proceed. permanent deviations are must be reviewed by
releated departments and approved by QA through change
control procedure.
Conclusion;- When deviation is permanent then approved by QA
through change control procedure.
| Is This Answer Correct ? | 0 Yes | 0 No |
Answer / ketan patel
When we change any process or any equipment the documentry evidence need to check it for proper work by raising changecimontrol.and if we deviat system by no changes only for temporary changes we have to fill deviation. It both are completely fill by all concern department.and close in 30 days.and if note done than close by raising in 60 days.
| Is This Answer Correct ? | 1 Yes | 1 No |
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what is the diffirence between deviation and change control? at what situations we can raise the deviation and change control
31 Answers Biocon, Cipla, DRL, Glenmark, Granules, Lupin, Micro Labs, Mylan, Natco, Ranbaxy, Swissmedic,
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