TITLE

PREVENTIVE &
BREAKDOWN
MAINTENANCE OF EQUIPMENTS AND
INSTRUMENTS

DEPTT/
SECTION

TECHNICAL
SERVICES &
MAINTENANCE

RELATED ISO 9001 CLAUSE

4.9

PREPARED BY

REVIEW & OPERATIONAL

APPROVAL BY

DOCUMENT #.
RP-SP/F-06

ISSUE DATE

ISSUE #.
01

PAGE #.
1 of 3

ADMINISTRATIVE
APPROVAL BY

PURPOSE
1.1 The purpose of this procedure is to device a system, establish a procedure, provide instructions and assign
responsibilities for preventive and breakdown maintenance of production equipments and laboratory
instruments to ensure the continuing production and testing capability.
2.0 SCOPE
2.1.1
2.1.2
2.1.3

This procedure is applicable for preventive and breakdown maintenance of all equipments and
instruments engaged in the manufacturing and testing of products at Ray Pharmaceutical.
The procedure also covers supporting equipments like boilers, compressors, generators, air
conditioning and air handling units engaged in maintaining the suitable working condition of areas.
This procedure also covers the maintenance work (preventive and breakdown) done by external
bodies.

3.0 ABBREVIATIONS
3.1
3.2
3.3
3.4
3.5
3.6

FM
REA
QAM
PM
ME
WO

=
=
=
=
=
=

Factory Manager
Request for Engineering Action
Quality Assurance Manager [ Management Representative ]
Production Manager
Maintenance Engineer
Warehouse Officer

4.0. RESPONSIBILITIES
4.1 The following designations are responsible to comply with this procedure for the areas mentioned below
4.1.1 ME is responsible to ensure implementation of this procedure for manufacturing and packaging
areas besides supporting equipments as identified in 2.1.2.
4.1.2 PM is responsible to provide equipments to engineering as per the equipments maintenance
frequency. Also where specified in the maintenance schedule, they are responsible to ensure
through operators, daily oiling, / greasing and cleaning of the machines before the machine startup.
4.1.3 QAM is responsible to ensure preventive maintenance of laboratory instruments as per their
maintenance schedule / frequency.

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4.1.4

PM, WO and QAM are responsible to ensure that concerned section incharges initiate REA in case
of breakdown maintenance or any work required from the workshop. (i.e. used as a work order also).

5.0 PROCEDURE
5.2

PREPARATION AND EXECUTION OF MAINTENANCE SCHEDULE

5.2.1 ME prepares the equipments preventive maintenance schedule on the basis of following
5.2.1.1 Equipment status i.e. new or old.
5.2.1.2 Equipments working condition.
5.2.1.3 Equipments utilization frequency.
5.2.1.4 Previous experience with the equipment and the reoccurring problems.
5.2.1.5 Manufacturers recommended frequency.
5.2.1.6 Others.
5.3 ME ensures that each equipment is planned for preventive maintenance according to the Preventive
Maintenance Schedule.
5.3.1 ME ensures that designated persons are following the maintenance schedule.
5.3.2 Designated person(s) performs the preventive maintenance as per the respective equipment
maintenance schedule.
5.3.3 Designated persons report / record the activity performed i.e. part inspected, repaired, replaced, bypassed & adjusted etc on the machine maintenance card available with the machine.
5.3.4 Designated persons or area incharge signs and write remark, if required on the form.
5.3.5 In case of any potential problem observed by maintenance or respective dept. It is noted on the
maintenance card.
5.4 AVAILABILITY OF EQUIPMENTS
5.4.1 The respective section incharges ensures the availability of machines for preventive maintenance.
5.5 MACHINE BREAKDOWN / PART REPAIR
5.5.1 In case of machine breakdown the respective machine operator /
area incharge initiates the REA (Job Order), however in case of
small routine breakdown of

emergency the respective area

incharge can call the maintenance staff for corrective action

without raising a job order.
5.5.2
5.5.3
5.5.4
5.5.5

The request initiator fills the originator section of the form.

The concerned engineering / maintenance staff acknowledges the form.
The concerned engineering / maintenance staff writes the action taken on the form along with the
request status i.e. whether open or closed.
In case of non-availability of the part required or any other reason, the request may remain open.

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5.5.6
5.5.7

The ME is responsible for the closure of all the open requests.

The concerned engineering / maintenance staff takes the acknowledgement of the originator after the
request has been closed.
5.6 LABORATORY INSTRUMENTS
5.6.1 The QAM schedule the preventive maintenance schedule of the instruments on the basis of following
5.6.1.1 Service contract with the supplier / manufacturer.
5.6.1.2 Frequency specified in the manual.
5.6.1.3 Frequency of utilization.
5.6.2 The QAM ensures that the schedule identifies all the parameters to be checked / inspected which are
critical for continual and accurate functioning of the instrument.
5.7 MACHINE BREAKDOWN HISTORY
5.7.1 ME are responsible to maintain the Machine Breakdown Maintenance form for the plant equipments
respectively.
5.7.2 Breakdown Maintenance form & Preventive Maintenance Checklist identifies the location of the
machine and all the major works /changes done on the machine.
6.0 RELATED DOCUMENTS
6.1 Annual Maintenance Schedule
(RP-F/F-23)
6.2 Preventive Maintenance Check List (RP-F/F-24)
6.3 Breakdown Maintenance (RP-F/F-25)

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