SOP for Execution of Preventive Maintenance EN-69

• OBJECTIVE:
  • To lay down the procedure for Execution of Preventive Maintenance.

• SCOPE:
  • This SOP is applicable for the Execution of Preventive Maintenance for all the equipments, facilities, utilities and devices installed at Pharma plant.

• RESPONSIBILITY:
  • Technician/ Operator of Engineering Department shall be responsible for proper execution of Preventive Maintenance as per SOP.
  • Officer-Engineering or above shall be responsible for preparation of preventive maintenance schedule and ensuring proper execution of preventive maintenance as per schedule.
  • Engineering – Head or designee shall be responsible for reviewing the SOP and for ensuring proper execution of preventive maintenance as per SOP.
  • User Department – Head shall be responsible for ensuring that the preventive maintenance of equipments is done as per schedule.
  • The PM activity shall be checked by user department as per check points of respective check list.
• ACCOUNTABILITY:
  • Engineering – Head shall be accountable for compliance of this SOP.
• DEFINITIONS:
  • Preventive Maintenance: The preventive maintenance describes all scheduled work done on a routine, predefined basis to maintain facilities, equipment, utilities and devices in good status in order to ensure reliable performance.
• PROCEDURE:
  • Precaution
  • Technician shall have to wear the proper PPE equipment during Preventive Maintenance activity.
  • Ensure that equipment power supply must in OFF condition.
  • Use proper tools for particular operation.
  • Take care while using sharp tools.
• Planning of Preventive Maintenance
  • Executive / Head – Engineering shall prepare the annual schedule for Preventive Maintenance of all equipments as per the Format No. SOP/EN/XXXYYY.
  • The Preventive Maintenance frequency shall be as per OEM recommendation, usage of equipment, past experience as defined in the individual equipment preventive maintenance SOP’s.
  • The annual schedule shall be updated by attaching Addendum if any new equipment is installed.
  • Head – Engineering reviews the updated annual schedule.
• Execution
  • On the basis of Annual Preventive Maintenance Planner, Engineering department shall prepare Monthly Preventive Maintenance Intimation Slip as per Format No. SOP/EN/XXXYYYat the last week of preceding month.
  • User department shall give date and clearance for preventive maintenance of equipment in Monthly Preventive Maintenance Intimation Slip on the basis of availability of the equipment for Preventive Maintenance for respective preventive maintenance dates.
  • Concerned Department will hand over the equipment to Engineering Department to carry out the preventive maintenance.
  • Engineering Head or designee shall allot the maintenance job to Executive / Technician as per approved planner.
  • The Executive / Assistant / technician will carry out the preventive maintenance works under supervision of Executive – Engineering as per the instructions given in the respective SOP of the equipment.
  • After completion of preventive maintenance work, Executive / Assistant / technician will record the details as per the respective Preventive Maintenance Checklist & Record Format.
  • Preventive Maintenance shall be carried out as per the planner with a grace period as given below:
  • Monthly Preventive Maintenance                             :   ±  5 days
  • Quarterly Preventive Maintenance                            :   ±  7 days
  • Half Yearly Preventive Maintenance                        :   ± 15 days
  • Yearly Preventive Maintenance                                :  ± 30 days
  • For production block, if production campaign is under progress during scheduled preventive maintenance period, the same shall be performed immediately after completion of the campaign.
  • In case the next preventive maintenance activity (i.e. Yearly, Half yearly, Quarterly, Monthly) gets  preponed, the next preventive maintenance activity shall be as per the original schedule and it shall not be altered.
  • The annual schedule shall be reviewed and revised if necessary, based on the availability of spares and external services required.
  • Head – Engineering shall circulate the monthly schedule to user departments through mail and provide reference copy of approved monthly preventive maintenance schedule to concerned department.
  • The revised schedule shall be forwarded to user departments for allocation and planning of equipment.
  • If preventive maintenance of the particular equipment shall not be done within the grace period then deviation shall be raised by user department as per SOP/QA/XXXYYY – Deviation management.
  • In emergencies wherein preventive maintenance cannot be carried out due to Non availability of spares, technical personnel (internal & external), reasons beyond control of organization, the Engineering department shall raise a deviation as per SOP/QA/XXXYYY – Deviation management.
  • The cause for differing the schedule shall be reviewed by Head – Engineering, Head – User department and then it shall be forwarded to QA for approval.
  • Based on the QA approval, the Preventive Maintenance of the said equipment shall be differed to the proposed time or to the next scheduled preventive maintenance.
  • If the equipment is not available due to any of the above said reasons for the next frequency also, then the equipment shall be stopped for performing preventive maintenance.
  • If any non critical part / spare which are identical to the earlier part / spare are replaced, the details shall be recorded in the Equipment History Card as per Format No. SOP/EN/XXXYYY
  • Any major repair or replacement of any critical part, which affects the performance of the equipment, shall be undertaken through change control procedure.
  • After completion of preventive maintenance, the status label shall be displayed on the equipment as necessary as per Format No. SOP/EN/XXXYYY
  • Old and removed status labels shall be shredded.
  • Any modification or breakdown maintenance apart from above shall be recorded into the equipment History card as per the – Format No. SOP/EN/XXXYYY
  • All entries in equipment History cards shall be reviewed by Head – Engineering and informed to Head – User Department.
  • Critical equipments like Refrigeration plants, Boiler, Elevators, Air compressors are covered under annual maintenance contract to the OEM / Expertise which is awarded by the Management in consultation with Engineering Head, however preventive maintenance activities are carried out by the department technicians with the help of expertise wherever required.
• Records
  • Preventive maintenance yearly planner will be preparing on yearly bases for individual department as per Format No. SOP/EN/XXXYYY
  • New equipment will be added as perFormat No. SOP/EN/XXXYYY and it will be incorporated into the yearly planner at the end of year.
  • The Preventive Maintenance Frequency for the Equipment installed in water system will be matched to the nearest Sanitization schedule of the respective system.
  • Those AHU runs in weekly OFF or unable to take filter cleaning during production will be matched to the nearest Sanitization schedule of the respective system.
  • These shall be preserved for a period of 3 years.
  • The defects of Preventive Maintenance, if any are analyzed annually and accordingly Preventive Maintenance schedules shall be revised.
  • An Excel soft copy shall be maintained for review of annual breakdown analysis along with history card.
  • Based on annual breakdown analysis, the schedules shall be reviewed.
• Instructions
  • External vendor/party for AMC/service shall be handled by SOP/QA/XXXYYY and SOP/QA/XXXYYY
  • Entry and Exit procedure for external party  into the company premises as per following:
  • Entry & Exit procedure for respective area shall be done as per respective SOP.
• ABBREVIATIONS
  • CRF No.   :     Change Request Form number
  • QA            :     Quality Assurance
  • PM            :     Preventive Maintenance
  • OEM         :     Original Equipment Manufacturer
  • EN             :     Engineering
• REFERENCES
  • Deviation Management                                                                      :  SOP/QA/XXXYYY
  • Personnel Qualification of Aseptic Processing Area                          :  SOP/QA/XXXYYY
  • and Sterility Testing Area.
  • Management of External Agencies for Outsourcing                          :  SOP/QA/XXXYYY
  • Services.
• DISTRIBUTION LIST
  •   SOP shall be distributed to following departments Quality Assurance, Engineering as per user request.
• ANNEXURES
  • Equipment History Card                                                                     :    SOP/EN/XXXYYY
  • Preventive Maintenance Program                                                       :    SOP/EN/XXXYYY
  • Preventive Maintenance Checklist & record                                      :    SOP/EN/XXXYYY
  • Preventive Maintenance Status Label                                                 :    SOP/EN/XXXYYY
  • Addendum for new equipment                                                          :    SOP/EN/XXXYYY
  • Monthly Preventive Maintenance Intimation Slip                              :   SOP/EN/XXXYYY

EQUIPMENT HISTORY CARD

Name of Equipment   :                                                                                                                            Equipment ID             :

Make                           :                                                                                                                            Model                         :

Serial  No.                   :                                                                                                                            Date of Installation                                  :

Location                      :