sop for Preventive Maintenance of Equipments and Machineries

1.0 OBJECTIVE :

1.1 To lay down the procedure for Preventive Maintenance of Equipment’s & Machineries.

2.0. SCOPE :
2.1 This procedure is applicable to all Equipments ,Machineries & Utility at Pharma Dekho

3.0. RESPONSIBILITY :

3.1 Technician / Operator / Supervisor of EM Department shall be responsible to carry out the Preventive
Maintenance of Equipments & Machineries as per schedule and maintaining the record.
3.2.1 Officer / Dy. Manager Engineering Department shall be responsible to Check Preventive Maintenance of
Equipments & Machineries and to take corrective action if any deviation.

4.0. ACCOUNTABILITY :

4.1 Head Engineering Department shall be accountable for compliance of SOP

5.0. PROCEDURE :
5.1. EM department person shall prepare Annual Preventive Maintenance Plan in respect of Monthly / Bi-
Monthly / Quarterly / Half yearly / Yearly as per Annex-I and send it to Head -EM for signature and final approval by Head QA.
5.2. All Equipments , Machineries and Utility shall be included in Annual PM planner.
5.3. After the approval of Head – QA , Department Executive / Dy- Manager shall prepare Preventive
Maintenance Month-wise schedule as per Annex- II.
5.4. Indicate the scheduled and execution status in Yearly and Monthly Planner.
5.5. The list of equipments which are scheduled for preventive maintenance in a particular month shall be
informed to the head of the concerned department through Annex-II.

5.6. Preventive Maintenance of all equipment shall be performed during no operation condition of that
equipment on “Weekly off” or no production activity or in standby condition (Utility case).
5.7. Ensure that the PM shall be carried out within the “ Planned month”.
5.8. The Engineering activity shall be allocated to the technicians / engineering personnel with the relevant
Preventive maintenance checklist.
5.9. Follow below mentioned general procedure for Preventive maintenance of Equipment & Machineries :
5.9.1 The preventive maintenance activity should be recorded in the Check List.
5.9.2 Before preventive maintenance activity :
5.9.2.1 Ensure that main switch of equipment is off and electric supply cord ( if applicable ) is detached.

5.9.2.2 Affix a label of “UNDER MAINTENANCE” on Machine, Equipment or Utility.
5.9.3 During Preventive maintenance activity :
5.9.3.1 Attend the machines as per the planner and record the activity in checklist as per Annex-III.
5.9.3.2 If the preventive maintenance of equipment could not be carried out as per scheduled date, the same shall be
carried out on subsequent suitable date. However such machines shall be attended within the prescribed
time limits from the due date as per Point No. 5.7.
5.9.3.3 In case of any abnormal observation, the technician/ engineering personnel shall immediately report it to the
Engineering Officer and take corrective action as per the directives
5.9.3.4 Preventive maintenance shall include the replacement of any parts required over and above servicing so that
the machine keeps giving satisfactory performance in day-to-day operations.
5.9.3.5 On completion, report (Annex-III) shall be filled. Such records shall be signed by the
concerned department head along with the engineer concerned.
5.9.4 After completion preventive maintenance activity :
5.9.4.1 Connect electric supply of equipment.
5.9.4.2 Remove the label of UNDER PREVENTIVE MAINTENANCE from equipment.
5.9.4.3 Clean surrounding area of machine and collect all scrap/waste /used items.
5.9.4.4 Hand-over the machine to concern department head.
5.10 If additional jobs other than those scheduled as per checked list are done, (e.g.:Major change or replacement of
machine parts) which may have impact on the validated system, intimate QA Manager / Head to Asses the
impact. If QA decides that there is no direct or indirect relationship between the change and the final quality
of the product, product safety, product efficacy or the compliance and regulatory status, no further action is
necessary and record of the same to be mentioned in Annex-III whenever applicable .

5.11 If QA decides that there is an impact of the change on the final quality of the product, product safety,
product efficacy or the compliance and regulatory status then change control procedure shall be followed as
per SOP No.: 1QA-007
5.12 At the end of the year or whenever deemed necessary, all the PM activities shall be reviewed and analyzed, i.e. planned vs. actual for any Improvement and if required the PM frequency shall be modified after following proper change control.
5.13 For any addition or Deletion of Equipment & Machineries, following correction shall be in Annex-I
and Annex-IV :
5.13.1 For Deletion – Draw a line in same Equipment row and write “DELETED” in Annex-I
5.13.2 For Addition – Enter new Equipment & Machineries in Annex-IV for its Preventive maintenance.
5.14 Symbol used for P.M. Planner Schedule :
M- Monthly , B- Bi Monthly , Q – Quarterly , H- Half Yearly , Y – Yearly
5.15 If Equipment & Machineries falls under more than 1 category as per planned, than all previous
category check points shall also cover in the Higher category P.M. schedule. For example M,Q,H comes in same month ,than M,Q check points shall cover with H check points

6.0. ABBREVIATION :

Sr. No.	Abbreviation used	Full form of abbreviation used
1.0	SOP	Standard Operating Procedure
2.0	EM	Engineering & Maintenance
3.0	QA	Quality Assurance
4.0	PM	Preventive Maintenance

7.0 ATTACHMENTS (ANNEXES) :
Annex-I : Preventive Maintenance Annual Planner for the Year
Annex-II : Preventive Maintenance Month Wise Plan
Annex-III : Preventive Maintenance Checklist & Report
Annex-IV : New Equipment & Machineries Preventive Maintenance Annual Planner

8.0 REFERENCE :
In House

Annex-II : Preventive Maintenance Month Wise Plan