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PROCEDURE FOR HANDLING OF ABNORMAL OBSERVATIONS AND SCADA ALARMS IN THE OPERATION OF PURIFIED WATER SYSTEM

OBJECTIVE:

To lay down a procedure for handling of abnormal observations and SCADA alarms in the operation of purified water system.

  • SCOPE:

This SOP is applicable for handling of abnormal observations and SCADA alarms in the operation of purified water system at {Company Name} {Company Location}.

  • RESPONSIBILITY:
  • Technical Assistant/Executive – Engineering is responsible to initiate abnormal observations.
  • Head- Engineering – is responsible for compliance SOP.
  • ACCOUNTABILITY:

Engineering Head

Head Quality Assurance

PROCEDURE:

Operate the purified water system as per SOPs.

During the system monitoring, if any mechanical snags are detected or any abnormal observations are made like failure of loop circulation pump, UV lamps, UF membranes etc., and then intimation shall be given to Head Engineering on priority basis.

The failure which may / may not have impact on product quality Process Non-Conformance (PNC) shall be initiated as per the SOP and investigated.

Head Engineering shall inform to Head production and Head QA regarding the abnormal Condition.

Head Engineering shall investigate the abnormal observation with the assistance of the related departments and / or manufacturer as per Annexure-I.

Based on the investigation, corrective and preventive action shall be proposed and executed as per the SOP.

Depending upon the nature of abnormality, if required sanitization cycle shall be performed.

After rectification, QC department shall be tested by water quality.

To meet the demand of abnormal condition requirements in terms of spare parts, Executive Engineering shall indent and maintain inventory of the same.

In case of emergency, spares shall be organized directly through the Purchase and Finance departments.

Any alarm appearing in “SCADA” Alarm report will be reported to QA along with the corrective action, QA shall evaluate the impact of the alarm and advise for necessary corrective actions if any, to engineering, production and QC departments.

REFERENCES:

  Not Applicable

Click the link to download word file copy of this document:
https://pharmaguidehub.com/product/procedure-for-handling-of-abnormal-observations/

ANNEXURES: 

    ANNEXURE No.TITLE OF ANNEXURE
    Annexure-IInvestigation report of abnormal observation.

    ENCLOSURES: SOP Training Record.

    DISTRIBUTION:

    Master Copy                           Quality Assurance Department

    Controlled Copy No. 01                     Head Quality Assurance

    Controlled Copy No. 02                 Head-Engineering

    ABBREVIATIONS:

    SOP       :          Standard Operating Procedure

    QA        :          Quality Assurance

    QC        :          Quality Control

    UV        :          Ultra-Violet

    UF         :          Ultra Filtration

    PNC      :          Process Non-Conformance

    REVISION HISTORY:

                                                                 CHANGE HISTORY LOG
    Revision No.Details of Changes Reason for ChangeEffective Date
    00New SOPNot ApplicableTo be written manual

    ANNEXURE-I
      INVESTIGATION REPORT OF ABNORMAL OBSERVATION

    Click the link to download word file copy of this document:
    https://pharmaguidehub.com/product/procedure-for-handling-of-abnormal-observations/

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