Repetitive Deviation

GOOD DOCUMENTATION PRACTICE (GDocP) DEVIATION AND DISCREPANCY HANDLING
1

what to do in case of repetitive deviation?

2

Hello,

same question raised from everywhere today. There are lot of option to
minimize repetitive type of deviation

  1. Retraining to concern personal if in case of human error
  2. Change in work profile of concern personal
  3. Add provision of CAPA to terminate or transfer of concern personal in
    SOP or any document to take action
  4. Observed activity in presence of trained personal after deviation untill
    not found satisfactory result

If deviation occur due to machine any other reason please feel free to ask
me.

Thanks

3

The above reply item #3 is the correct answer. You need to have a CAPA in place which gets to the root of the problem.

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4

To identify repitative deviation, a trending of deviation should be recommended,
ADVANTAGES FOR TRENDING OF DEVIATIONS

To identify repetition of deviations.
To identify weak area of system.
To identify weak area of facility.
To identify poor investigation.
To identify poor maintenance / equipment defect
Effectiveness of CAPA.
ToList item identify training needs.
In business point of view; it is best to identify the weak area of system

To perform good trending deviation should categorizes as
Process –Yield.
Environment –Non conformity.
System error
People Mistake / Error
Process –material.
Documentation –lost.
Environment Monitoring-missing.
Equipment –Malfunction error.
Process-Design.
Documentation –reference support.

So deviation tending is useful to controls repitative deviation

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