preventive maintenance

• Objective:To lay down a procedure for preparing preventive maintenance procedures or programs for equipment or system and their component(s).

• Scope:This standard operating procedure is applicable for preparation of Preventive Maintenance procedure or programs for all equipments or systems installed in the formulation plant.

• Responsibility
  • Officer/ Executive- Engineering shall be responsible for the preparation of Preventive Maintenance procedure or programs as per the concept laid in this SOP.
• Accountability:Head of Engineering/ designee shall be responsible for implementation and compliance of this SOP.
• Abbreviations and Definitions:
• Preventive Maintenance: Maintenance of equipments/instruments/ systems at pre-determined frequency to ensure optimum functioning and to minimize breakdown.
• Breakdown Maintenance -Maintenance of equipments and instruments in event of their breakdown.
• Preventive Maintenance-  A schedule which gives frequency in terms of dates or Schedule days or period at which the preventive maintenance shall be undertaken

• Procedure
• Each equipment or Instrument or a system shall have Preventive Maintenance Procedure in the shape of a Standard Operating Procedure (SOP).
• Each preventive maintenance SOP can be equipment/ instrument/ component specific or depending upon its application, it can be a single or common SOP for carrying preventive maintenance of different equipment/ instrument/ component e.g. there can be a  common  SOP on   preventive  maintenance of  Gear  Boxes  or  motors   of    the concerned equipment.

• The scope of preventive maintenance SOP of each machine shall include: Machine Name, Name of Manufacturer/Supplier, Model of machine and Equipment Identification No.
• The procedure of preventive maintenance shall be written considering the frequency of usage, handling and operation of machine, Internal cleaning and lubrication.
• Annual Preventive Maintenance Planner shall be prepared for the complete year by Engineering Department and approved by Head of Engineering, Concerned department and Quality Assurance. Controlled copies of planner shall be given to concerned department and original copy shall be retained with Quality Assurance Department (Annexure-I).
• A Monthly Preventive Maintenance Planner shall be developed by incorporating planned date, as approved on Annual Preventive Maintenance Planner in last week of every month. Concerned Department shall approve the same Monthly Preventive Maintenance Planner on the basis of availability of equipment for Preventive Maintenance for respective dates and same shall be approved by Head of Engineering Department (Annexure-II).
• Engineering personnel shall mark upper half box in red colour  for planned date and Production Personnel shall mark lower half box in green colour for agreed date within the acceptable tolerance as mentioned which that machine shall be free for maintenance.
• The preventive maintenance schedules shall have ±7 days acceptable tolerance and maintenance shall be done within this period.
• Preventive Maintenance procedure for each machine shall have a preventive maintenance checklist and Spare Part Used. Preventive Maintenance Checklist shall be made as per recommendations of the manufacturer, operation and maintenance manual and operational experience mentioned in this SOP.
• Preventive maintenance check as per Annexure-III shall be sign on “Done by” a technician and “Approved by” the Officer / Executive of Engineering Department and Concerned Department. Spare part used during maintenance shall be recorded on spare part used format as per Annexure-IV.
• If for any machine, Preventive Maintenance Schedule is given in cumulative operating hours, then it shall be performed within ± 5 % of that time period. In such case Preventive Maintenance Checklist (Annexure-III) shall be used for recording and maintenance shall be done as per Master Preventive Maintenance Planner for hour basis (Annexure-V), spare part used during maintenance shall be recorded on Spare Part Used format as per Annexure-IV.
• The preventive maintenance check as per Annexure-IV shall be filled.
• The Master `Preventive Maintenance Planner for Running Hours Basis, shall be “Prepared By” Engineering Department and “Approved By” Head of Engineering, Concerned and Quality Assurance (Annexure-V).
• Controlled copies of planner shall be given to concerned department and original copy shall be retained with Quality Assurance Department.
• A History Card shall be prepared by Engineering Department for each machine, which contains all information related to that machine. ie: Machine Name, I D No., Capacity, Model, Make, Motors, belt, other consumables details, utility services required. Preventive Maintenance and Breakdown Maintenance History will be recorded at the back side of History Card along with spare part used, same shall be signed by Technician on ‘Done By’ and checked by Officer / Executive of Engg. Dept.
• Any major repair or replacement of any critical part, which affects the performance of the machine, shall be undertaken through change control procedure.
• Engineering person shall prepare the critical Equipment list and critical spare part list and submit the list to QA Department.
• QA person shall review the list and make it master by stamping “MASTER COPY” and prepare controlled copy of the master copy for distribution to separate departments
• QA person shall issue the controlled copy of critical Equipment list and critical spare part list to different department as per the requirement
• Review of the preventive maintenance schedules shall be done annually to evaluate the frequency of the maintenance.
• All preventive maintenance records shall be retained for a period of at least 5 years from the date of generation of that record.

• Forms and Annexure
  • Annual Master Preventive Maintenance Planner –  Annexure-I
  • Monthly Preventive Maintenance Planner – Annexure-II
  • Preventive Maintenance Checklist – Annexure-III
  • Spare parts Used –  Annexure-IV
  • Preventive Maintenance Planner for Hour Basis – Annexure-V
  • History Card – Annexure-VI.

• Distribution:
  • Master Copy – Documentation Cell
  • Controlled Copies -Engineering, Production, Quality Control, and Quality Assurance,Warehouse.
• History

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