SOP on Handling of PLC System Failure

April 6, 2016September 12, 2024 Pharmaceutical Guidanace

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.

Responsibility
- 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

Procedure
- 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

Not Applicable

Distributions
- Master Copy – Documentation Cell (QA)
- Controlled Copies – Production, Engineering and Quality Assurance
History

Date

Revision

Number

Reason for revision

–

New SOP

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