To describe a standard operating procedure (SOP) for critical parameter deviations.
1.0 PURPOSE:
To describe a standard operating procedure (SOP) for critical parameter deviations.
2.0 SCOPE:
The standard operating procedure describes in detail the method to be followed for critical parameter deviations.
3.0 RESPONSIBILITY:
The responsibility of reporting critical parameter deviations 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 Whenever there is a deviation in the critical parameter (listed stage-wise in annexure-I), the concerned operator shall bring to the notice of the Supervisor/Production In-charge. The Supervisor/Production In-charge shall review the deviation,correct the situation and instruct the operator to carry out the operation thereon with atmost care.
4. 2 The deviations shall be recorded by the operator in the batch manufacturing sheet and the Supervisor/Production In-charge shall record the same in shift log book. Production officer/plant manager shall fill failure investigation report xxxxx and send to Head of QAD. Production Officer/Plant Manager shall also intimate the deviation to Head of Produc tion.
4. 3 Depending on the nature of deviation Head of Production/Plant Manager shall contact Head of PID and Head of QCD in person or phone and request to monitor the batch closely and Manager (QC) shall carry out any additional testing if required.
4. 4 The deviated batch material shall be used in production, if it conforms to the approved specifications.
4.5 If the product is deviating from the specifications, the necessary corrective action shall be carried out as per the standard operating procedure for non-confirming product (SOP SIFTING.).
5.0 RECORDING:
Supervisor shall record the deviation in the shift log book, Production Officer/Plant Manager shall fill failure investigation report and send to the Head of QAD .
Critical parameter deviations, production
