PROCESS DEVIATIONS (NON CRITICAL PARAMETERS)

1.0    PURPOSE:
    
    To describe a  standard operating procedure (SOP) for process  deviations (non-critical parameters).
    
2.0    SCOPE:
    
    The  SOP describes   in  detail  the method to be followed in case of process deviations (non-critical parameters).
    
3.0    RESPONSIBILITY:
    
    The  responsibility of reporting the process  deviations  (non-critical  parameters) to Head of Production  as per the SOP lies with the staff of the rank not lower than operator of the production department.
    
    The responsibility of preparing, reviewing and approving the SOP lies with the Officer (Production), Head of Production and Head of QAD  respectively.
    
4.0    METHOD:
    
4.1    The operator records the deviations during his shift  in  the batch  manufacturing sheet and the supervisor records the  same in the log book.  The Block Incharge reports deviations  to  the Head of production, if the deviation is more  than 8  hours at any particular step.
    
4. 2    The Block Incharge will investigate the problem and take  necessary steps to rectify the same in future.
    
4. 3    The Head of Production  will report the deviations  to  the  Head of QAD once in a month.  The Head of  Production will carryout the trend analysis once in 6  months  and prepares a report.   
    
    
5.0    RECORDING:
    
    The responsibility of recording deviations in the batch  manufacturing sheet and log book lies with staff of rank not  lower than operator and supervisor respectively. Head of  Production will give a report to  Head of QAD once in a month and the report  will be  kept  on record.
    
    

Process deviations,