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sop for Breakdown Maintenance

 

sop for Breakdown Maintenance

 

1.0 PURPOSE
To define a procedure for handling of breakdown maintenance of equipment/ instrument.

2.0 SCOPE
2.1 This procedure applies to all the equipments instruments and utility equipments
3.0  REFERENCE
3.1 References
3.1.1 In-House

3.2 ANNEXURE
3.2.1 Annexure-I        : Breakdown maintenance intimation slip.
3.2.2 Annexure-II      : Log for issuance of Breakdown maintenance serial number.

4.0 ABBREVIATION 

4.1  Breakdown Maintenance
Breakdown Maintenance is a set of measures taken to rectify faults that result in the failure of
equipment /instrument and restore it to normal functioning.

4.2 Abbreviations
4.2.1 CAPA: Corrective and Preventive Action
4.2.2 PMF: Planned Modification form
4.2.3 QA: Quality Assurance
4.2.4 SIP: Sterilization In Place

5.0 RESPONSIBILITY
5.1 Corporate Quality Assurance



5.1.1 To ensure the implementation of the procedure.
5.2 Concerned department:

5.2.1    To report the breakdown and label “under breakdown maintenance”.
5.2.2  To intimate the breakdown.
5.2.3   To verify the maintenance status.
5.3      Engineering department
5.3.1   To receive the intimation of breakdown.
5.3.2   To evaluate the reason for breakdown and rectify the problem
5.3.3   To investigate impact analysis of the breakdown, if required.
5.3.4   To maintain the equipment/ instrument history card of respective equipment/ instrument.
5.4     Quality Assurance
5.4.1    To ensure the proper documentation of the breakdown.
5.4.2   To allocate incident number, if required
5.4.3   To allocate the planned modification number, if required.
5.5     QA Head
5.5.1   To investigate impact analysis of the breakdown, if required.
5.5.2   To ensure implementation of defined procedure.
5.6    Plant Head
5.5.1  To investigate impact analysis of the breakdown, if required.
5.5.2  To ensure implementation of defined procedure.

6.0 Distribution:
I. Quality Assurance
II. Quality Control
III. Production
IV. Ware house
V. Engineering
VI. Environment, Health and safety

7.0 PROCEDURE:
7.1 Part-1 (For concerned department)
7.1.1 In case of equipment/instrument breakdown, the concerned department shall label it

with “Under Breakdown Maintenance” status label as per SOP
7.1.2 The concerned department shall fill the Following details in the breakdown maintenance

intimation slip and shall send to QA for evaluation as per Attachment-I (Break down Maintenance slip).
• Sr. No. of breakdown maintenance (Shall be allocated by QA).
• Name, code and location of equipment /instrument which has failed to work/ function.
• Nature of problem.
• Product and batch(s) number under impact.
• Remarks of department head.
• Intimated to QA by and date.
7.1.3 Reference of breakdown maintenance intimation slip serial number shall be entered in

sequential log of equipment / instrument.
7.2 Part-2 (For Quality Assurance)
7.2.1 QA shall allocate the Serial Number as per below system and record in log as per Attachment-II:
BM/YY/B-NNN
Where,
BM stands for Breakdown Maintenance:
YY stands for last two digits of current year, i.e. 20 for year 2020.
B stands for Block i.e.- B1 for Block 1
B2 for Block 2
U for Utility block
Q for Quality control/ Quality Assurance
A for Admin block
7.2.2 Breakdown maintenance serial number shall be maintained block wise at Quality Assurance.
7.2.3 QA shall ensure that proper documentation for the breakdown is done in sequential log of

the equipment /instrument which has failed to work and in relevant batch records.
7.2.4 QA shall allot deviation/incident number and mention in break down intimation slip (Attachment-I).
7.2.5 If required, QA shall give further remarks regarding impact evaluation or any other in addition

to remarks of concerned department head.
7.2.6 QA may hold the product batches if any under impact till further investigation.
7.2.7 After filling of all the details QA shall forward the breakdown maintenance intimation slip to concerned department.
7.3 Part-3 (For concerned department)
7.3.1 Concerned department shall acknowledge the comments of QA and initiate for the further

actions required which may be preparation of incident investigation report with impact analysis.
7.3.2 Concerned department shall forward the break down maintenance intimation slip to engineering department.
7.4 Part-4 (For Engineering)
7.4.1 Engineering department shall acknowledge the breakdown intimation details and impact evaluation



filled by concerned department and QA.
7.4.2 Based on the trend of breakdown/maintenance history and condition evaluation of the equipment
/instrument, renewal/replacement decision shall be triggered by Engineering department in

consultation with concerned department and QA.
7.4.3 Engineering department shall evaluate the need of filing planned modification in consultation with

QA and QA shall allot planned modification number (if required) and include in break down maintenance intimation slip.
7.4.4 Engineering department shall evaluate the reason for break down and rectify the problem.
7.4.5 After maintenance, if required machine trials shall be given to the concerned department while handing it over.
7.4.6 Engineering department shall evaluate the need for the passivation and sanitization of the

rectified equipment / instrument and perform the same.
7.4.7 Engineering department shall evaluate the need for recalibration or requalification in consultation

with QA and document the same in breakdown maintenance intimation slip. QA shall inform to concerned

department and qualification team for requalification or recalibration of that equipment / instrument.
7.4.8 Equipment /instrument history card shall be updated by the engineering department and necessary

parts checked while preventive maintenance and shall be updated in the preventive maintenance checklist.
7.4.9 In case of repetitive breakdowns, the preventive maintenance frequency /schedule may be revised.
Note: All the change (modifications/ part replacements) shall be recorded in equipment
/instrument history card.
7.4.10 Engineering department shall fill the following details in the breakdown maintenance intimation

slip and shall be forwarded to concerned department along with necessary attachments like,
planned modification form, copy of updated equipment / instrument history card, passivation record,

sanitization record, machine trial report, etc., if required.
• Reason for breakdown.
• Planned modification required / not required. If required PMF (Planned modification form) no.
• Corrective action taken.
• Passivation required / not required. If required, report no.
• Sanitization required / not required. If required, report no.
• Recalibration /calibration required / not required.
• Requalification / qualification required / not required.
• SIP qualification required / not required.
• History card updated by / date.
• Maintenance report (MR) checked and forwarded to concerned department by date and time.
• Maintenance report (MR) received by concerned department, date and time.

7.5 Part-5 (For Concerned department)
7.5.1 After maintenance, the concerned department shall verify the recalibration/calibration,

SIP qualification,  requalification/qualification, Passivation, sanitization status in consultation

with QA and shall include reference document number for the same.
7.5.2 The concerned department shall include closing remarks if any and shall forward the breakdown

maintenance intimation slip to QA for evaluation along with necessary attachments like, copy

of sequential log, incident investigation report etc.

7.6 Part-6 (For Quality Assurance)
7.6.1 QA shall ensure that all actions suggested in the different parts of the breakdown maintenance

intimation slip are completed and wherever not completed, shall issue CAPA and monitor the same.
7.6.2 QA shall include but not limited to following status.
• Incident investigation status.
• Planned modification status.

• Recalibration /calibration, Requalification/qualification status.
• Impact evaluation status.
• Remarks on batch(s) disposition under impact of the breakdown.
• CAPA No.

8.0 REVISION HISTORY

 

Version No. 00 Effective Date
Details of revision: New SOP Prepared

 

Annexure-I 

BREAKDOWN MAINTENANCE INTIMATION SLIP

Serial No.:                                    
Part- 1 (For concerned department)

To : Engineering

From (Department) : Date :
Equipment /instrument name : Code : Location :
Nature of problem :
Product under impact :
Batch(s) under impact :
Intimated to QA by : Date : Remarks of department head : Sign/ Date:
Part- 2 (For quality assurance)

Deviation/ Incident no.:

Remarks for impact analysis / any other :

Evaluated by :                                                                                   Date:

Part- 3 (For concerned department)

Given for maintenance by :                                          Date :                         Time :

Received by (engineering) :                                        Date:                          Time :

Part- 5 (For concerned department)

Passivation report No.(If required) : Sanitization report No.(If required) :

Recalibration / calibration record no. (if required): Requalification / qualification record no. (if required) : SIP qualification record no. (if required):

Closing remark by department head:

Sign :                                    Date :

Part- 6 (For quality assurance) Incident investigation status : Planned modification status : Recalibration / calibration status : Requalification / qualification status: Impact evaluation status :

Batch disposition status :

CAPA no.

Note: For more details provide attachments.

 

Annexure-II 

 

LOG FOR ISSUANCE OF BREAKDOWN MAINTENANCE SERIAL NUMBER

 BLOCK:-

 

Date Breakdown Maintenance Serial No. Department Equipment/ Instrument Name Equipment/ Instrument Code Location Nature of Problem/ Breakdown Serial Number Allocated by QA (Sign/Date) Reference Deviation/ incident No.

(if any)

Reference CAPA No. (if any) Closure Status/ Remarks
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Preparation of Sodium Hydroxide Solution

sop for Breakdown Maintenance

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sop for water cooled chiller operation

cleaning and preventive maintenance of LAF and RLAF

sop for replacement of water system filters

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sop for Preventive maintenance of bottle washing machine

sop for Replacement of Battery of Electronic Devices

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sop for Preventive Maintenance of Dust Collector

sop for Replacement of HVAC filters

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sop for Replacement of Tube lights

sop for Replacement of UV light of purified water plant

sop for Cleaning of soft water storage tank and RO feed tank

sop for Preparation of Sodium hydroxide Solution

sop for Operation and regeneration of softener plant

Procedure Of Issuance Of material from Engineering Store

sop for Preventive Maintenance of Filter Press

sop for Preventive Maintenance of Sugar Transfer System

sop for Preventive Maintenance of Shrink Sleeve Machine

sop for Preventive Maintenance of ROPP Cap Elevator

sop for Preventive Maintenance of Liquid Transfer Pumps

sop for Preventive Maintenance of Liquid Tanks

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sop for Preventive Maintenance of Colloidal Mill

sop for Preventive Maintenance of Packing Collator Belt

sop for Checking light intensity

sop for Operation of Fire- Extinguisher

sop for Passivation of WFI Distribution Loop

sop for Analysis of Effluent Treatment Plant Water

sop for Methodology to Dispose ETP Sludge

sop for Action Plan In Case Of Electrical Power Failure

sop for Colour Coding of Piping and Accessories of Utilities

sop for Replacement Policy

sop for Disposal of Engineering Waste

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Procedure for Calibration of Magnehelic Gauge

Procedure for Calibration of Vacuum Gauge

Procedure for Calibration of Pressure Gauge

sop for Procedure for Calibration of Temperature Controller

sop for Area Validation

sop for Preventive Maintenance of Infrared Dryer Umbrella Type

sop for Preventive Maintenance of Battery stacker

sop for Preventive Maintenance of Lift

sop for Preventive Maintenance of Vacuum Cleaner

sop for Preventive Maintenance of laminar air flow unit

sop for Preventive Maintenance of Lozenges Manufacturing Line

sop for Preventive Maintenance of Garment Washing Machine

sop for Preventive Maintenance of Multi Column Distillation Plant

sop for Preventive Maintenance of Steam Sterilizer Autoclave

sop for Preventive Maintenance of Pure steam Generator

sop for Preventive maintenance of Depyrogenating Tunnel

sop for Preventive Maintenance of vial sealing machine

sop for preventive maintenance of Powder Filling and Rubber Stoppering machine

sop for Preventive Maintenance of Vial Washing Machine

sop for Preventive Maintenance of Inspection Table

sop for Preventive Maintenance of Hi-Cart

sop for Preventive Maintenance of Turn table

sop for Preventive Maintenance of sticker labeling machine

sop for Preventive Maintenance of Liquid Filling and Sealing Machine

sop for Preventive Maintenance of Linear Bottle Washing Machine

sop for Preventive Maintenance of De-Foiling Machine

sop for Preventive Maintenance of Strip Packing Machine

sop for Preventive Maintenance of Blister Packing Machine

sop for Preventive Maintenance of Capsule Polishing and Sorting Machine

sop for Preventive Maintenance of Capsule Filling Machine 

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sop for Preventive Maintenance of Chilling Plant

sop for Preventive Maintenance of Transformers

sop for Preventive maintenance of Purified Water System

sop for Break Down maintenance of Machine and Work Requisition

sop for Building Maintenance

sop for Operation of Lift

sop for Operation of Dust Extraction System

sop for Operation Of Effluent Treatment Plant

sop for Operation Of Diesel Generator

sop for Operation of Multi Column Distillation Plant

sop for Operation of Pure Steam Generator

sop for Operation of Air Handling Unit

sop for Operation of Cooling Tower

sop for Operation of Air Compressor

sop for Operation of Water Chilling Plant

sop for Operation of Boiler

sop for Cleaning of Pure Steam Generator

Cleaning of Over Head Water Tanks HDPE

sop for Cleaning of Water tanks

sop for Sanitization of multi column plant

sop for Sanitization of Ultrafiltration System

Sop for Chemical Sanitization of Reverse Osmosis

Sop for Sanitization of Hot Sanitization & Electro Deionization unit

sop for Sanitization of Purified Water Loop

sop for preparation of sodium meta bisulphate solution

sop for Testing of Hardness of Soft Water

sop for Operation & back wash of multi grade filter

sop for testing of chlorine contents in water

 

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