- Objective:To lay down the procedure for Handling of PLC System Failure.
- Scope:This standard operating procedure is applicable for all PLC system’s installed in formulation plant of Pharmaceutical company name with location.
- Production Supervisor / Officer shall be responsible for implementation of this SOP.
- Engineering personnel shall be responsible for handling and repairing the PLC system hardware
- Head-Production/ Designee shall be responsible for compliance of this SOP.
- Abbreviations and Definitions
SOP – Standard Operating Procedure
QA – Quality Assurance
S.S.- Stainless steel
PLC – Programmable logical controller
HDPE – High density polyethylene
MMI – Man Machine Interface
- In case of PLC/MMI Software/Hardware failure condition, production department shall intimate to Engineering department for the corrective action through Maintenance work order.
- After receiving the Maintenance work order, Production shall handover the equipment for further action.
- Engineering Department shall take following action.
- Engineering department shall have PLC hardware system in spare or purchase new as per specification
- Keep application software / source code backup for all PLC system with application name, software version and store in control area in two different locations.
- Restore by either external agency or vendor service engineer.
- Production, Engineering and QA person shall take the trial for the operation of the equipment and revalidate the equipment and control system.
- If operation of equipment found satisfactory, then engineering department shall hand over the equipment to production department.
Precaution:-During the maintenance work all the material shall be taken out and covered properly in HDPE or S.S container with a “CONTAINER LABEL” affixed on it.
- Forms and Records
- Master Copy – Documentation Cell (QA)
- Controlled Copies – Production, Engineering and Quality Assurance
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