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Tuesday, August 26, 2008

COLLECTION OF SWAB FOR CLEANING VALIDATION - SOP

1.0 PURPOSE:
To provide a written procedure for collection of swab for cleaning validation.
2.0 SCOPE:
Applicable to sample from hard to clean area of cleaned equipments.
3.0 RESPONSIBILITY:
Executive Manufacturing, Executive QA, Assistant Manager QA.
4.0 ACCOUNTABILITY:
Manager Quality Assurance.
5.0 DEFINITIONS:
Nil
6.0 PROCEDURE:
6.1 Check the area / part of the equipment which is hard to clean.
6.2 Select 4 x 4 square inch area of the hard surface to clean.
6.3 Swab the marked area using Readymade Swab in four direction as shown below


6.4 Collect the swab sample as per the sampling plan.
6.5 Collect the swab in clean glass bottle labeled properly.
7.0 REFERENCES:
Nil
8.0 ENCLOSURES:
Nil
9.0 ABBREVIATION:
9.1 QA : Quality Assurance

DETERMINATION OF AVERAGE WEIGHT OF TABLETS - SOP

1.0 PURPOSE:
To provide a written procedure for determination of average weight of tablets and checking of individual weight variation.
2.0 SCOPE:
Applicable to determination of average weight of a tablet during in process checking.
3.0 RESPONSIBILITY:
Operator Manufacturing, Executive Manufacturing and Executive QA.
4.0 ACCOUNTABILITY:
Assistant Manager Manufacturing.
5.0 DEFINITIONS:
Nil
6.0 PROCEDURE:
6.1 AVERAGE WEIGHT OF A TABLET:
6.1.1 Check the cleanliness of the balance.
6.1.2 Collect Sample of 20 tablets.
6.1.3 Weigh the tablets, record the weight in BMR.
6.1.4 Calculate the average weight of tablet.
6.1.5 Calculate the mean (average weight of tablets) of average weight of each in Process check.
6.2 CHECKING OF INDIVIDUAL WEIGHT VARIATION:
6.2.1
Collect sample of 20 tablets.
6.2.2 Weigh the tablets, record the weight in BMR.
6.2.3 Calculate the average weight of tablet.
6.2.4 Weigh 20 individual tablets one by one and record the observations in the BMR individually.
6.2.5 Check the lower weight and upper weight for determination of lower and upper percentage deviation.
6.7 Upper % deviation = ( Average weight of 20 tablets – Upper weight)x100/Average weight of 20 tablets
6.8 Lower % deviation = (Average weight of 20 tablets – Lower weight) x 100/Average weight of 20 tablets
6.9 After checking initial parameters, if it is with in the limit, compression machine can be started.
6.10 Fill weight should be checked as per the BMR instructions.
7.0 REFERENCES:
Nil.
8.0 ENCLOSURES:
Nil.
9.0 ABBREVIATIONS:
9.1 BMR : Batch Manufacturing Record.

ENTRY OF TIME IN DOCUMENTS -SOP

1.0 PURPOSE:
To provide a written procedure for entry of time in documents.
2.0 SCOPE:
This procedure is applicable to all documents.
3.0 RESPONSIBILITY:
Executives – All concerned departments
4.0 ACCOUTNABILITY:
Manager Quality Assurance
5.0 DEFINITIONS:
Nil
6.0 PROCEDURE:
6.1
Mention time in hours in documents.
e.g., Morning 8.00 AM : write as 8:00 Hrs.
Afternoon 2:45 PM: write as 14:45 Hrs.
Evening 6:00 PM: write as 18:00 Hrs.
6.2 Change the date after 24:00 Hrs.
7.0 REFERENCES:
Nil
8.0 ENCLOSURES:
Nil
9.0 ABBREVIATIONS:
9.1 Hrs.: Hours

USAGE OF PURIFIED WATER -SOP

1.0 PURPOSE:
To provide a written procedure to describe the steps to be followed for using purified water.
2.0 SCOPE:
This procedure is applicable for usage of Purified water from all user point.
3.0 RESPONSIBILITY:
Executive Manufacturing
4.0 ACCOUNTABILITY:
Plant Manager
5.0 DEFINITIONS:
Nil
6.0 PROCEDURE:
6.1 For usage of Purified water, open the valve of user point at maximum flow and allow the water to run for about one minute before taking it for use.
6.2 In the locations where hosepipes are connected to user point, use water from the end of hosepipe and allow the water to run for about one minute before taking it for usage.
6.3 Connect the hosepipe before usage and disconnect after operation.
6.4 Use separate hosepipes for potable water and purified water.
6.5 Drain the hosepipe and dry after the usage.
6.6 After ensuring the inner wall of the hosepipe is dry, close both the ends with aluminum foil and preserve until next use.
7.0 REFERENCES:
Nil
8.0 ENCLOSURES:
Nil
9.0 ABBREVIATIONS:
Nil

SCREENING OF RAW MATERIALS FOR TSE/BSE RISK

1.0 PURPOSE:
To provide a written procedure for screening and control of raw materials (API & Excipients) for TSE/ BSE risk.
2.0 SCOPE:
This procedure covers screening and control of raw materials (API & Excipients) for TSE/ BSE risk.
3.0 RESPONSIBILITY:
Plant Head, Manager Quality Control and Manager Quality Assurance.
4.0 ACCOUNTABILITY:
Manager Quality Assurance
5.0 DEFINITIONS:
Nil.
6.0 PROCEDURE:
6.1 The QA Department shall prepare a questionnaire to qualify suppliers with respect to BSE/TSE risk.
6.2 This questionnaire shall be approved by Manager QA.
6.3 This procedure shall include the screening and controls that are required in qualifying supplier to assure that raw materials procured are free from BSE / TSE risk.
6.4 The QA Department shall require the material Purchase department to purchase only from such manufactures who have fulfilled criteria described in this document.
6.5 QA shall provide the questionnaire to Purchase department for distribution to the manufacturers of raw materials.
6.6 Material Purchase department shall intimate to suppliers to send filled BSE / TSE Questionnaire or BSE / TSE risk certificate before sending material to XXXXXX company.
6.7 The materials Purchase department shall return the filled questionnaire / BSE / TSE risk free certificate to QA for evaluation.
6.8 The Manager Quality Assurance shall review the filled questionnaire or BSE /TSE risk free certificate received from the suppliers.
6.9 QA recommends to purchase the material from the supplier who satisfactorily filled questionnaire and meet all criteria. If not found satisfactory, QA shall send queries to the manufacturer for further clarification. Material shall not be purchased until the filled questionnaire found satisfactory.
6.10 QA shall approve the supplier based on the minimum requirement:
6.10.1 BSE /TSE risk certification or comments of BSE /TSE evaluation questionnaire.
6.10.2 By considering other criteria (Audit for all API and Primary Packing material supplier).
6.11 Supplier BSE / TSE risk shall be evaluated every year by reconfirming the above procedure.
6.12 To minimize the risk of TSE / BSE contamination the following measures shall be taken:
• Proper segregation of material between TSE / BSE free and non TSE free material (All capsules procured are certified to be BSE free)
• Difference in the color of capsules between TSE / BSE free and non TSE free shall be maintained.
• If same color of capsule have to be produced, difference in the printing on the capsules shall be maintained for easy identification.
• As an Additional Measure cleaning validation shall be done for presence of gelatin with the acceptance criteria of a maximum of 10 PPM.
• As a worst case in future, dedicated machine will be provided to minimize the risk.
7.0
REFERENCES:
Nil
8.0
ENCLOSURE:
8.1 Questionnaire for screening of supplier for TSE /BSE risk : QAGN: xxxxxx
9.0
ABBREVIATIONS:
9.1 TSE : Transmissible Spongiform Encephalopathy.
9.2 BSE : Bovine Spongiform Encephalopathy
9.3 API : Active Pharmaceutical Ingredient
9.4 QA : Quality Assurance

QUESTIONNAIRE FOR SCREENING OF SUPPLIER FOR TSE/BSE RISK

Name of the Supplier : ___________________________________

Address : ___________________________________

___________________________________

____________________________________

Telephone No. : ____________________________________

Contact Person : ____________________________________


Material Supplied : ____________________________________

1. Does the material to be supplied have any animal derived ingredients?  YES  NO
2. If yes, which animal species it is derived from?

3. Is the animal a ruminant?
(Refer to Note 1 below for a definition and list of ruminant animals)
 YES  NO
a) If the animal is ruminant , answer to the following:

From which tissue of the animal, the ingredient is derived?
(Examples: Lungs , Intestines , Brain, Liver ,Spine , Skin , Bones , Blood , Serum , etc)

b) Is the animal from which the material is derived born/brought up / slaughtered in a BSE /TSE risk country as listed by logriatory antharhes USFDA/MHRA/ Canadian

c) Is the material manufactured in a BSE / TSE risk country?
(Refer Note 2 below for list of BSE / TSE risk countries as published by USFDA.
 YES  NO

d) Do you have documentation or access to documentation tracing the animals used in the production of the material to its source country, farm, and individual animal identification tag?

e) Do you have a certificate of animal origin issued by your country’s responsible Government Agency?

If Yes attach a copy
 YES  NO

4. Is the material to be supplied manufactured in a facility where BSE/TSE risk materials are also processed?

If yes, how would you ensure there is no risk of cross –contamination?
 YES  NO

5. During manufacturing of supplied material, have any material of animal origin /TSE non complaint been used as a processing aid?
 YES  NO

6. XXXXXX company require to advice immediately in witnessing, if any of the above circumstances change?
 YES  NO

7. You are committing to re-affirm on at least annual basis that the above conditions will not change?
 YES  NO

8. You will provide a statement of compliance to TSE / BSE on with every delivery (COA)?
 YES  NO

Note 1:
Section 589.2000(a) (7) of the Federal Register defines “ruminant” as including “any member of the order of animals which has a stomach with four chambers (rumen, reticulum, omasum and abomasums) through which feed passes in digestion. The order includes, but is not limited to cattle , buffalo , sheep , goats, deer , elk and antelopes”

Note 2:
Countries / areas affected with BOVINE SPONGIFORM ENCEPHALOPATHY (BSE):
- 9 CFR 94.18

Austria
Japan
Belgium
Liechtenstein
Czech Republic
Luxembourg
Finland
Netherlands
France
Oman
Germany
Poland
Greece
Portugal
Ireland,
Republic of Slovakia/ Slovenia
Israel
Spain
Italy
Switzerland
United Kingdom (UK) [includes Great Britain (England , Scotland , Wales and isle of man ],Ireland, Northern Ireland and the Falkland islands]

#3. Countries that are considered to have a substantial risk associated with BSE due to:

Lack of implementation of an adequate surveillance program, or

Potential of disease exposure/ introduction , or

Uncertainty of status because insufficient information is available to conduct a full risk assessment

Andorra
Former Yugoslav Republic of Macedonia
Albania
Monaco
Austria
Republic of San Marine
Bosnia –Herzegovina
Norway
Bulgaria
Poland
Croatia
Romania
Federal Republic of Yugoslavia
Slovak republc
Finland
Slovania
Hungary
Swaden

Signed , for and on behalf of :

Company Name :
Name :
Signature :
Designation : Date :

OFFICE STAMP


(To be filled by XXXXX company)

Review & Comments by QA:
Name , Signature & Date

SAMPLING OF BLEND AND BULK FINISHED PRODUCT -SOP

1.0 PURPOSE:
To provide a written procedure for sampling of Blend and Bulk finished product.
2.0 SCOPE:
Applicable to In process sampling.
3.0 RESPONSIBILITY:
Executive Manufacturing , Executive QA and Assistant Manager QA.
4.0 ACCOUNTABILITY:
Manager Quality Assurance
5.0 DEFINITIONS:
Nil
6.0 PROCEDURE:
6.1 SAMPLING OF BLEND:
6.1.1 Sampling of Blend is done after unloading the blend in to IPC, Sample is collected from all IPC, Composite sample is made by mixing samples collected from all IPC in sample bag, Label the sample with proper information.
6.2 SAMPLING OF BULK FINISHED TABLET / CAPSULE:
6.2.1 Collect about 10 tablet / capsule in a sample bag at each time during individual weight variation checking. At the end of batch pooled composite sample from the same is sent to Quality control analysis.
6.3 PROCESS VALIDATION SAMPLING:
6.3.1
During Process validation, sampling is done as per the protocol
6.3.2
In process validation samples are collected in triplicate from each point as per protocol
• First sample for analysis
• Second sample for conformation / repetition if any disturbance occurs in first sample analysis.
• Third sample should be kept until analysis report is completed.
7.0
REFERENCES:
Nil
8.0 ENCLOSURES:
Nil
9.0 ABBREVIATION:
9.1 IPC: Intermediate Product Container
9.2 QA : Quality Assurance

OPERATION AND CLEANING OF HARDNESS TESTER (MONSANTO TYPE)

1.0 PURPOSE:
To provide a written procedure for the Operation and Cleaning of Hardness Tester (Monsanto Type).
2.0 SCOPE:
Applicable to Hardness Tester (Monsanto Type ) used for checking Tablet Hardness
in production.
3.0 RESPONSIBILITY:
Executive Manufacturing and Executive QA, Assistant Manager QA.
4.0 ACCOUNTABILITY:
Manager Quality Assurance
5.0 DEFINITIONS:
Nil
6.0 PROCEDURE:
6.1
OPERATION:
6.1.1 Hold one tablet between the two faces provided by pushing forward the movable face inside by turning the plunger clockwise. Coincide the `Zero'
in the scale with the pointer.
6.1.2 Enclose front part where tablet is held in a sample polybag.
6.1.3 Start applying pressure on the tablet by gently rotating the plunger
6.1.4 When the tablet breaks, note the hardness (in kg/sqcm) directly from the scale. In case, if the pointer is in between the two divisions of scale, read the hardness as 0.5 kg / sq.cm.
6.1.5 Discard the broken tablets in water and sample polybag in waste bin.
6.2
CLEANING:
6.2.1 After use, clean the hardness Tester with clean lint free cloth and keep in its box. This procedure is to be followed during product change over and at the end of shift.
6.2.2 After batch is completed dismantle the hardness tester and clean with potable water followed by 0.1% SLS solution followed by potable water to remove the SLS solution and finally rinse with purified water, and clean with lint free cloth and keep in its box.
7.0 REFERENCES:
Nil
8.0 ENCLOSURES:
Nil
9.0 ABBREVIATIONS:
9.1 SLS : Sodium lauryl Sulphate (0.1%)
9.2 Kg / sq.cm : Kilogram / Square Centimeter.

OPERATION AND CLEANING OF AUTOMATED FRIABILATOR (EF-2)

1.0 PURPOSE:
To provide a written procedure for operation and cleaning of the Automated Friabilator EF-2 (USP) .
2.0 SCOPE:
Applicable to determine Friability of tablets in Manufacturing.
3.0 RESPONSIBILITY:
Executive Manufacturing,Executive QA and Assistant Manager QA.
4.0 ACCOUNTABILITY:
Manager Quality Assurance
5.0 DEFINITIONS:
Nil
6.0 PROCEDURE:
6.1
OPERATION:
6.1.1
Check cleanliness of the equipment.
6.1.2 Switch ON the instrument, drum will initialize itself to the loading position, the display will now show START.
6.1.3 Weigh and record the weight of the tablets.
A. For the tablets having individual weight up to 0.650 g take 20 tablets.
B. For the tablets having individual weight above 0.650 g take 10 tablets.
6.1.4 Adjust the counts to 100 by pressing the COUNT key followed by ‘1’, ‘0’, ‘0’ keys. (Count range 1 to 99999).
6.1.5 Press ENTER to confirm the reading.
6.1.6 To see and confirm the number of counts press COUNT key.
6.1.7 On confirming the number of counts press RUN/HALT key to start, the display shows the elapsed count.
6.1.8 NOTE: Test can be performed by adjusting ‘TIME’ similarly as ‘COUNT’.
6.1.9 When test is over drum rotates in reverse direction discharging the tablets in the tray.
6.1.10 The test over is indicated by an audible beep and display shows END
6.1.11 The drum initializes itself to loading position and display shows START indicating the instrument is ready for the next run.
6.1.12 Remove the tablets from the tray.
6.1.13 De- dust and weigh the tablets and note down the weight of the tablets.
Calculate the percentage loss in the weight by using the formula


Percentage Loss =Initial Wt – Final Wt/Initial Wt X 100

Notes :
• Do not hold the drums while rotating.
• After testing destroy the tablets.
6.2
CLEANING:
6.2.1 Remove the knob on the shaft by pressing the button.
6.2.2 Pull the outside drum out from the shaft carefully. Similarly remove the inside drum by pulling it outside.
6.2.3 Remove the detachable disc from the drum by pulling it outside of both the drums.
6.2.4 Clean both the drums with clean cloth.
6.2.5 Remove both the trays.
6.2.6 Clean the trays with clean cloth.
6.2.7 After cleaning, put the drums and trays back on its position.
7.0
REFERENCES:
Nil
8.0
ENCLOSURES:
Nil
9.0 ABBREVIATION:
9.1 Wt: Weight.

DIFFERENTIAL PRESSURE MONITORING - SOP

1.0 PURPOSE
To provide a written procedure for the Differential Pressure Monitoring.
2.0 SCOPE:
This procedure is applicable to all Magnehelic gauges in shop floor.
3.0 RESPONSIBILITY:
Concerned Departmental Executives and Departmental Heads.
4.0 ACCOUNTABILITY:
Plant Manager
Manager Quality Assurance
5.0 DEFINITIONS:
Nil
6.0 PROCEDURE:
6.1 Ensure that all the doors are closed before noting the differential pressure.
6.2 Record the differential pressure in ‘Differential Pressure Recording Format’ Refer
QAGN:xxxxx Note readings at about 10.00 hrs.  30 mins., 14.00 hrs  30 mins, and 16.30 hrs. 30 mins.
6.3 If the differential pressure is not complying with the acceptance criteria do not proceed for activity in that particular area. Inform QA and Maintenance through the format ‘Intimation Note for Differential Pressure Correction’ Refer format No. QAGN:xxxxxx, send an intimation note to Maintenance department for corrective action.
6.4 After the differential pressure is achieved, recheck the reading, record in the format as Specified in point 6.2.
7.0 REFERENCES:
Nil
8.0 ENCLOSURES:
8.1 Differential Pressure Recording Format No. QAGN:xxxxxxx
8.2 Intimation Note for Differential Pressure Correction’ Format No. QAGN:xxxxxxx
9.0 ABBREVIATIONS:
Nil

Sunday, August 24, 2008

SAFE HANDLING, USE AND STORAGE OF COMPRESSED GASES

1.0 DISTRIBUTION
All Departments.
2.0 APPLICABLE DOCUMENTS
INA-03-001 Environment, Health and Safety Policy
INA-03-003 General Plant Health and Safety
3.0 APPLICABLE FORMS
Nil
4.0 APPLICABILITY
This procedure applicable to Xxx India Pvt Ltd, Xxx Plant only
5.0 PURPOSE
To provide guidelines for safe handling, usage and storage of compressed gases.
6.0 RESPONSIBLE DEPARTMENTS
QA, Production, and Engineering
7.0 RESPONSIBILITY
EHS Coordinator
8.0 PROCEDURE
8.1 General
8.1.1 Only experienced and properly trained persons are to handle compressed gases.
8.1.2 Do not remove or deface labels provided by the supplier for the identification of the cylinder contents.
8.1.3 Ascertain the identity of the gas (by carefully seeing the tag, mark or label on it) before using it. Know and understand the properties and hazards associated with each gas before using it. The Material Safety Data Sheet (MSDS) for the gases being used must be available in the vicinity and a copy of the MSDS must be submitted to Environment, Health, and Safety section.
8.1.4 All compressed gases cylinders are required to have a safety cap, at the time they are received. Any cylinder that does not have a safety cap should be returned to vendor.
8.2 Handling and use
8.2.1 Wear stout gloves.
8.2.2 Use a cylinder trolley or other suitable device for transporting cylinders, even for a short distance. The cylinder will have to be properly secured to the trolley during transportation.
8.2.3 Leave valve protection caps/guards in place until the cylinder is ready for use.
8.2.4 Wear suitable eye protection. The choice is between safety glasses/ goggles for chemicals fumes, vapors, dust etc. and full-face shield. The PPE will depend on the pressure, the nature of the gas / chemical and work conditions to which the concerned person is exposed.
8.2.5 Do not use cylinders as rollers or supports, or for any other purpose other than to contain the gas as supplied.
8.2.6 Keep cylinder valve outlets clean and free from contaminants, particularly oil and water.
8.2.7 Never attempt to repair or modify cylinder valves or safety relief devices. Damaged valves should be reported immediately to the suppliers.
8.2.8 Close the cylinder valve whenever gas is not required, even if cylinder is still connected to equipment.
8.2.9 Replace outlet caps or plug and cylinder caps, as soon as cylinder is disconnected from equipment.
8.2 Storage
8.2.1 Store cylinder in location free from fire risk and away from sources of heat and ignition. They should be restrained vertically using a chain.
8.2.2 The cylinder storage compound should be kept clear and access should be restricted to authorized personnel only. The compound should be clearly marked as 'cylinder store’ and appropriate hazard warning sign must be displayed (e.g. flammable, toxic, radioactive, etc.).
8.2.3 Store full and empty cylinders separately and arrange full cylinders so that the oldest stock is used first.
8.2.4 The cylinder should also be kept to a minimum number.
8.2.5 Oxidizers shall be stored away from flammable.
8.2.6 Smoking, use of flames, and hot works, in the vicinity of cylinder storage area should be prohibited.
8.2.7 Every container, vessel, tank, cylinder or store room used for storing highly flammable liquid / compressed gas shall be clearly marked “Danger Flamable Liquid” or “Danger Flamable Gas”
8.2.8 All electrical apparatus shall either be excluded from the area of risk or they shall be of such construction so installed, maintained as to prevent danger of being the source of ignition.
8.2.9 Effective measures shall be taken to prevent accumulation of static charges to dangerous extent. High or low voltage electrical wirings should be avoided up to the maximum extent near such area. Flameproof lights should be used in the area having flammable gas or liquid.
8.2.10 No person is allowed to put on iron nailed shoes or do chipping / hammering in the vicinity having flammable liquid or gas without isolation of the particular equipment or line (permit to work only through GWP & HWP), they have the potential to be the source of static charge.
8.2.11 Filled and empty cylinders are tagged as FILLED and EMPTY, along with their respective names to know their status.
8.2.12 Marking of safe working pressure and date of last examination on every pressure vessel in the plant
9.0 REFERENCES
9.1 The Factory Act 1948: Section 31, Clause 2: Rule 61

CONTRACTOR COMPLIANCE

1.0 DISTRIBUTION
All Departments
1.0 APPLICABLE DOCUMENTS
INA-03-001 Environment, Health and Safety Policy
INA-03-003 General Plant Safety
3.0 APPLICABLE FORMS
INA-03-003-01 Avoid Verbal Instruction Slip
INA-03-007-01 Hot Work Permit
INA-03-007-02 General Work Permit
INA-03-017-01 Confined Space Entry Permit
INA-03-008-01 Accident / Injury Report
INA-03-008-02 Learning Incident Report
4.0 APPLICABILITY
This procedure applicable to Xxx India Pvt Ltd, Xxx Plant
5.0 PURPOSE
To establish procedures to be complied by contractors.
6.0 SCOPE
To ensure that outside contractors follow all the statutes of the Indian Government and Xxx’s Environment, Health and Safety requirements when executing work on company premises.
7.0 RESPONSIBLE DEPARTMENTS
QA, Production and Engineering
8.0 RESPONSIBILITY
EHS Coordinator
9.0 DEFINITION
A contractor is defined as any person or firm who performs work or provides services and does not receive direct supervision by an employee of Xxx India. A person or persons visiting the facility to view the operations is not considered to be a contractor. Examples of contractors are building contractors, service contractors, electrical contractors, etc. The definition will cover both short term and long-term contractors.
7.0 PROCEDURE
7.1 Duties and Responsibilities of Xxx's Staff Engaging Contact Services
7.1.1 The department and or individuals engaging the service of outside contractors are responsible for strict compliance of this policy and ensuring comprehensive communication to the contractors.
10.1.2 The department and or the individual engaging the services of the contractor shall make available to the contractor the set of rules to be followed in Xxx's premises. The set of rules is attached in Appendix 1.
10.1.3 All contractors' activities on Xxx's premises shall be performed under the supervision of the hiring Xxx person. The department engaging the services of the contractor will ensure that he/she understands and follows the EHS regulation of Xxx (India), Xxx Plant and same shall be documented in HR Training form(INA-56-005-03,as attachment). The Xxx personnel responsible for the contractor shall submit a copy of Contractor entry request through AVI (Form #INA-03-003-01) to the Security Department upon arrival or prior to the contractor’s arrival.
10.1.4 The Xxx staff responsible for hiring the contractor shall ensure that the contractor signs the Non-Disclosure Agreement. The signed Non-Disclosure Agreement shall be submitted to the manager of the department concerned.
10.1.5 Follow Xxx requirements outlined in section 10.3 of this procedure.
10.2 Duties and Responsibilities of the Contractor
10.2.1 The contractor shall ensure that there will be an onsite supervision while the work is being conducted on site. The contractor supervisor shall supervise the contractor employees and enforce all Xxx requirements along with country, state and local regulation.
10.2.2 The contractor has the responsibility and obligation to know and comply with all Indian regulations and Xxx's rules. The contractor shall make safety and environmental considerations an integral part of the daily work habits within the facility.
10.2.1 The contractor is responsible for protecting the health and safety of his/her employees, Xxx employees and property and maintaining a clean environment.
10.2.2 The contractor shall provide the workers with the required personal protective equipment (PPE) and shall ensure that workers use PPE properly. Personal protective equipment may include, but not limited to: helmets, safety shoes, goggles/safety glasses, gloves, shields, aprons, respirators, and earplugs and safety harness.
10.2.3 Contractors can be terminated immediately if they do not follow the applicable rules and regulations.
10.2.4 The contractor shall remove any worker violating any Environment, Health and Safety regulations immediately and inform the EHS Coordinator, Security and the concerned department.
10.2.5 Contractors are responsible for disposing of any hazardous & non hazardous waste that they generate when executing their work.
10.2.6 The contractor shall obtain the necessary instructions in AVI Slip (INA-03-003-01) for disposing off any waste that they may generate when executing the work.
10.2.7 The contractor will bring and submit to the Xxx EHS Coordinator, the MSDS of the material used by him / his company at least 02 days prior to the job starting.
10.3 Procedures for Establishing Contracts
10.3.1 Written contracts between Xxx and any outside contractor shall contain the following statement or equivalent thereof, owning environment, health and safety responsibility:
- Contractors and their representatives shall observe all the Statutes of Indian Government and Xxx Environment, Health and Safety requirements, when executing work on Xxx premises.
10.3.2 Contract agreement shall also include all the points mentioned in section 10.2. Examples of such contracts are building contracts, monthly, yearly service contracts, etc.
10.3.3 The department/individual engaging the services of the contractor shall communicate the Environment, Health and Safety rules to the contractor and his representatives.
10.2.1 The department/individual engaging the services of the contractor should see that the contractor or his companion following various procedures but not limited to the following:
- Safe handling use and storage of compressed air/gas (INA-03-006)
- Lock Out and Tag Out Procedures (INA-03-019)
- Confined space entry(INA-03-017)
- Welding and cutting Safety- Hot work permit requirements (INA-03-007)
- Hazardous Communication (INA-03-010)
- Personal protective equipment (INA-03-012)
- Fall protection (INA-03-014)
- GMP requirements.
10.2.2 The department and or the individual engaging the services of the contractor
must ensure that contractor obtains a hot work permit approved from the EHS Coordinator, before the commencement of any hot works. The hot works permit must be displayed prominently at the locations of the works.
10.2.3 The department and or the individual engaging the services of the contractor
must ensure that contractors legally dispose off any waste arising from his operation. Contractors are not allowed to dispose their waste in Xxx's waste stream.
10.2.4 The department and or the individual engaging the services of the contractor
must ensure that contractors comply with Xxx's GMP requirements when executing their work.
7.0 ATTACHMENTS
Appendix 1: EHS Guidelines for Contractors

Appendix 1
SET OF RULES FOR CONTRACTORS
1.0 Duties and Responsibilities of the Contractor
A. The contractor shall ensure that there will be an onsite supervisor while work is being conducted on site. The contractor supervisor shall supervise contractor employees and enforce all the applicable regulations and Xxx's requirements.
B. The contractor has the responsibility and obligation to know and comply with the country, state & local regulations of India and Xxx's rules. The contractor shall make safety and environment an integral part of the daily work habits within the facility.
C. The contractor is responsible for protecting the health and safety of his/her employees, Xxx employees and properties and maintaining a clean environment.
D. The contractor shall provide the workers with the required personal protective equipment and shall ensure that workers use them properly. Personal protective equipment may include, but not limited to: helmets, safety shoes, goggles/safety glasses, gloves, shields, aprons, respirators, and earplugs, safetyharness.
E. Contractors shall maintain good housekeeping standards always:
i. The contractor shall remove any worker violating any Environment, Health and Safety regulations immediately and inform the EHS Coordinator, Security and the concerned department.
ii. Contractors are responsible for disposing off any waste that they may generate when executing their work.
iii. The contractor shall obtain the necessary instructions in AVI Slip (INA-03-003-01) for disposing off any waste that they may generate when executing the work.
iv. The contractor will bring and submit to the Xxx EHS Coordinator, the MSDS of the material used by him / his company at least 02 days prior to the job starting.
Note: The contracters can be terminated immediately if they do not follow the applicable rules and regulations
2.0 Rules and Regulations for Contractors
A. Access
- Employees of contractors and their nominated sub-contractors who need to enter Xxx premises must first obtain a Visitor Pass from the Security.
- Visitors or relatives of contractor’s employees, who are not employed by the contractor, will not be allowed on Xxx’s premises.
- The Visitor Pass must be visibly worn above the waistline at all times.
- Term passes for contractors and his representatives must be returned to Security, when expired or when the contract is completed.
- No one is allowed to enter Xxx plant without prior approval by authorized Xxx representative.
- Xxx staff must escort contractor’s personnel who have been granted permission to enter the plant.
- Contractor’s personnel who have been issued a term Contractor Pass is allowed to enter the Plant unescorted, e.g. cleaners, shipping contractors, suppliers, etc.
- Entry to and exit from Xxx plant is allowed only through the employee entrance guard lobby. All the contractor’s personnel will have to sign the logbook both while entering the plant and while exiting from the plant.
B. Parking
Vehicles may be temporarily parked near the building to unload tools and materials. Once this is completed, the vehicles must be removed. The vehicles must be parked at the designated area.
C. Restrictions
- Contractor personnel are not allowed to use Xxx's staff canteen without prior approval or bring food into any part of the premises.
- All keys issued to contractors must be returned prior to leaving the premises.
- Smoking - Xxx (India) is a designated non-smoking site. However, smoking is permitted outside the building.
D. Conduct
- All contractor personnel are expected to conduct themselves in a business like manner while on site.
- All contractors shall wear appropriate attire and footwear at all times.
- No loud or abusive language is allowed.
- No unauthorized radios, cameras are permitted in Xxx plant premises.
- The possession of intoxicants or illegal drugs on Xxx grounds is not permitted.
E Material Safety Data Sheets
- On site Material Safety Data Sheets for Xxx materials are available in the Environment, Health and Safety Department. These must be given to the contractor supervisor during training.
- The Xxx contact person or department responsible for the contractor must provide the Environmental, Health and Safety Department with the Material Safety Data Sheets for hazardous materials which will be brought into the premises, such as cleaning solvents, paints, adhesives, etc. This is required prior to commencement of any operation.
F. Safety
- The contractor or his personnel shall comply with all current regulations/codes while working at Xxx premises. Xxx will reserve the right to halt any work where good safety habits are not observed. Any delay incurred as a consequence of non-compliance will be the contractor's liability.
- The contractor will be responsible for the following:
o Report immediately any unsafe conditions.
o All tools and equipment must be maintained in good condition and used only as intended.
o Safety glasses must be worn when needed for eye protection.
o Hearing protection is required in posted areas.
o Protective equipment (goggles/face shields, glove) must be worn when working around or handling dangerous chemicals.
o Respiratory and/or hearing protection must be used as needed or where required.
o Hard hats are required once he/she is present in the plant / working area.
o Suitable signs or barricades must be set up to clearly identify hazards caused by the contractors when applicable.
o All construction areas will be barricaded so that persons cannot walk into the worksite.
- No horseplay or practical jokes are permitted.
- All machines, equipment, electrical circuits, pipelines, etc., which will be repaired must first be tagged out of service with a 'Danger, Do Not Operate' tag. This tag shall have the date and contractor's name. In addition, the disconnect or supply valve must be physically locked to prevent the inadvertent operation, which could expose any person to possible injury. For electrical equipments its current or rpm and other capacities that may cause risk should be displayed properly.
- Fire exits and passageways must not be blocked at all times.
- All the activities at Xxx (India), Xxx are performed in such a fashion to achieve world class levels of least environmental impact. Keeping the above in mind, misuse or mismanagement of hazardous chemicals by contractor personnel while conducting work on site will not be tolerated. If the need arises, contractor personnel may request assistance from the Environment, Health and Safety Department, when dealing with chemicals or materials that are likely to have Environmental Impact.
G. Emergencies
- Chemical Spills:
Should a chemical spill occur which involves release of hazardous material to a drain, threatens life or property, immediately call EHS Coordinator and notify with the following information:
o Your name
o Specific location
o Materials and/or areas involved
- Fire Emergency:
Should a fire emergency occur, immediately activate the fire alarm and immediately call EHS Coordinator and notify with the following information:
o Your name
o Specific location
o The nature of emergency such as burning/smoldering electrical equipment, etc.
H. Waste Disposal
- The contractor is responsible for disposing off any waste that is generated when executing their work. The necessary permits for disposing off the wastes shall also be obtained by the contractor INA-03-003-01 ( on Avoid verbal instruction Slip).
- If at any time during the contractual work, should the need to impact building materials arise, please contact Environment, Health and Safety Department, prior to any work.
I. Cutting and Welding
- The contractor shall inspect the work site before beginning work and shall perform all works in a safe manner. A Xxx hot works permit, issued by the EHS Department is required for all operations involving cutting and welding.
J. Company Equipment
- All site tools and equipment, including pallet jacks, pallet stackers, fork lifts and trained operators should only use carts.
- Contractors must provide all tools, equipment, and materials necessary to complete their contracted work.
- The contractor at his or her own risk will use any Xxx tools, equipment and material that are loaned to the contractor.
K. Good Manufacturing Practices
- Nature of operations in some areas requires the use of hair and/or mustache covers. All contractor personnel must wear these covers while working in these designated areas.
- Additionally, other areas may require special gowning. Also wrist watches, jewellery and make-up may not be allowed in certain areas. All contractor personnel must review procedures for any area that they plan to enter or work in with the Xxx contact person responsible for them being on site.
L. Housekeeping
- Good housekeeping is a major concern to Xxx in the daily operation. Contractors and their employees shall leave their work areas clean and in an orderly condition on a daily basis. This shall also include a general clean up of trash. Materials, tools and/or equipment shall be arranged in an orderly manner. At the completion of work, materials, tools and equipment must be promptly removed from the work site.
- Special care must be taken not to block walkways, roadways or fire extinguishing and safety equipment (safety showers, eye wash stations and spill kits).
- In certain areas, dust blocking enclosures or walls may be required to limit the amount of disruption to adjacent areas.
M. Clean Rooms
- Entry to clean rooms is restricted. Prior permission is required for entrance. Departmental management will provide specific instructions on environmental requirements while working in these areas and obtain necessary clearances.
N. Confidentiality
- All manufacturing processes and company operations are considered confidential.The contractor will have to sign a Non-Disclosure Agreement
- Contractors and their employees are expected not to discuss anything observed in our facilities with anyone outside of Xxx.
- Additionally, no video, photographic or reproduction equipment of any kind may be used within the facility unless prior approval has been granted.

Saturday, August 23, 2008

EMERGENCY RESPONSE AND CONTINGENCY PLAN

1.0 DISTRIBUTION
All Departments
2.0 APPLICABLE DOCUMENTS
INM-03-001 Environment, Health and Safety Policy
3.0 APPLICABLE FORM
INM-03-008-01 Accident / Injury Report
INM-03-008-02 Learning Incident Report
INM-03-008-03 Spill Report Form
4.0 APPLICABILITY
This process is applicable to Xxx (India) Pvt. Ltd. Xxx plant only.
Note: This plan will be reviewed and updated at least annually by end of Q1.
5.0 PURPOSE
To outlay procedures to ensure minimum or no injury/loss of life and property during emergencies. The guidelines for emergency situation includes- Natural disasters, Bomb and telephone threats, Fire incidents, Spill occurrences.
6.0 SCOPE
This procedure defines the individual responsibilities and procedures for anticipated crisis
situations with attitude, logical approach and without panic.
7.0 RESPONSIBLE DEPARTMENT
EHS Department
QA Department
Production Department
Engineering Department
Logistics Department
Service Center
IT Department
8.0 RESPONSIBILITY
All employees
9.0 DEFINITIONS
9.1 Disaster is an emergency that is not adequately anticipated and controlled.
9.2 Emergency: A condition that is out of the normal operating conditions and which cannot be controlled by normal operating procedures and which has detrimental effects on the health and safety of personnel, and which endangers life and property.
9.3 Emergency readiness means that you are prepared to react promptly to save lives and protect property if your plant is threatened by an emergency of any type.
9.4 Emergency Response Operation Center: A location where a control station will be established and response actions will be directed during a crisis. The guardroom at the entrance gate will be the emergency response-operating center during crises/emergency situation. The control desk will be established under the direction of the Emergency Coordinator. The guardroom will have the following:
9.4.1 Facility layout drawings
9.4.2 Heavy-duty flashlights
9.4.3 Battery powered megaphones
9.4.4 Emergency lighting
9.4.5 Personal Protective Equipment-gumboot, cotton gloves, helmets, eye goggles and respiratory mask
9.4.6 First aid supplies
9.4.7 Updated list of telephone contacts
9.5 First Aid Stations: Designated locations stocked with first aid materials at which First -Aiders are to approach for first aid requirements during a crisis. Refer to Section 10.13 Facility Site Plans, Appendix VIII, ‘Locations of First Aid Kit.’
9.6 Reporting and Information Center: An area established remote of the Emergency Response Center from where news will be released to media, governmental agencies, and families. The EHS and HR departments, depending on the prevailing site conditions will decide the location of the Reporting and Information Center.
9.7 Designated Assembly Areas: Areas are pre-established and marked to where employees are to proceed after a building evacuation. Refer to Section10.13, Facility Site Plans, Appendix III, ‘List of locations of hazard and fire fighting equipments with plant drawing showing emergency exits and designated assembly area for evacuation’.
9.8 Emergency Phone List: A list of emergency contacts including management personnel. The list is updated yearly and distributed to the key personnel and the emergency responders within Xxx India. The HR function is responsible for updating existing list of emergency contact numbers. Refer Section 10.13, Facility Site Plans, ‘Appendix-I, Emergency Organizational Contact List’.
10.0 PROCEDURE
The emergency response and contingency plan covers following aspects:
10.1 Emergency Organization and Contacts
10.2 Emergency response team and their functions
10.3 Emergency Responsibility by Title
10.4 Plant warning system
10.5 Emergency Equipment
10.6 Emergency Evacuation Plan
10.7 Drills & Exercise
10.8 Fire / Explosion Response Plan
10.9 Spill Response Plan (Control and Countermeasures)
10.10 Bomb Threat Plan
10.11 Written and Telephone Threat
10.12 Power failure
10.13 Facility Site Plans
10.14 Emergency reporting system
10.1 Emergency Organization and Contacts
10.1.1 The emergency organization and contacts list will include the names and telephone numbers (office and residence) of the following list. The names and telephone numbers will be updated on a yearly basis .The HR function is responsible for updating existing list of emergency contact numbers. It will be posted at the security post. Also all the emergency personnel listed in item 10.1.2 in their offices and home will maintain the updated list.
10.1.2 Xxx India Management:
a. Director – Manufacturing
b. Works Manager
c. Quality Assurance Head
d. Human Resource Head
e. Logistic Head
f. Executive Engineer
g. IT Personnel.
10.1.3 Community Response Centers:
a. Fire
b. Hospital
c. Police
10.1.4 Insurance Company - United India assurance Company
10.1.5 Neighboring factory contacts
10.2 Emergency Response Team and their functions:
The emergency response team will consist of three sub teams:
a. Emergency Coordinator b. Backup Emergency Coordinator
c. Evacuation team
a. Emergency Coordinator (EC) –
For directing the Shift Emergency Responder for plant emergency operations like shut down and lock out procedures (partial or complete as necessary to prevent loss of man and material). Interface with Backup Emergency Coordinators. Activate Reporting and Information.
b. Backup Emergency Coordinators (BEC)-
i) EHS Coordinators - For emergency response, Safety and First-aid
ii)Plant Engineer - He will coordinate with Emergency Coordinator for providing technical assistance during any emergency situation.
iii)Human Resource & Security - For Facility Coordination, Telecommunications, Security, Public Communications, and External Assistance.
iv)Shift Emergency Responder (SER) - The area in charge at that particular shift / time of work for the coordination with the Manager Operation and plant engineer.
c. Evacuation Team-
Members of the Safety Committee (Possibly 02 persons from each department)
To facilitate evacuation during emergency situations.
10.3 Emergency Responsibility by Title
10.3.1 Emergency Coordinator (EC)- -(Shift superindant)
a. Pre-Emergency Responsibilities: Co-ordinate drills, ensures the testing of emergency equipments in his area. Ensure adequate staffing and safety training of each employee.
b. Emergency Responsibilities: Assumes charge and directs remedial measures. Designate a responsible person of his team for correct and quick communication with Back-up Emergency team. Assess nature of emergency and coordinate with the EHS department. Help the evacuation team (Safety Committee members). Direct the Shift emergency responder for plant emergency operations like lock out procedures (partial or complete as necessary to prevent loss of man and material). Interface with Backup Emergency Coordinators. Activate Reporting and Information. He along with Plant Engineer is responsible for providing technical advice and assist the emergency coordinator during emergencies. His duty is to provide plant drawing for fire protection system and utilities.
b. Post Emergency Responsibilities: Determine extent of damage; assess the nature of loss and arrange for the resources required for restoration of normal operating conditions. Co-ordinate review meetings to critique emergency response action. Handle the regulatory, and Division notifications. Conduct an investigation of the accident and revise plant operations to prevent a repeat occurrence. Inventorise and replace all used emergency equipment with the help of EHS personnel.
10.3.2 Backup Emergency Co-ordinator (BEC)-
The backup emergency coordinator team will consist of:
a. EHS Manager & Coordinator
b. Shift Engineer
c. HR & Security personnel
d. Shift Emergency Responder(security guard on duty at main gate)
10.3.3 EHS Manager & Coordinator-
a. Pre-Emergency Responsibilities: Co-ordinate drills and exercises on an annual basis. Conducts debrief and discuss improvement opportunities. Ensures the testing of emergency equipments in the plant. Ensure safety and emergency training of the employees and record them. Report any unsafe activity that may result in damage to men, materials and environment to the manager responsible for the area. Aid EHS Manager in handling the regulatory affairs and division notifications related to matters of environment, health and safety.
b. Emergency Responsibilities: Should assist the emergency coordinator in his responsibilities during emergency. In the absence of emergency coordinator, takes charge. First responder assumes charge and directs remedial measures. Assist the emergency coordinator, evacuation team in his responsibilities, coordinate with the HR and Security personnel.
c. Post Emergency Responsibilities: Assist the emergency coordinator in his responsibilities. In the absence of the emergency coordinator, take charge.
10.3.4 Human Resource & Security –
a. HR personnel are responsible for facility coordination, security, telecommunications, and public communications. Arrange for external assistance like fire, police, or medical etc. coordinate with emergency coordinator and EHS coordinator.
b. Shall ensure that a copy of the emergency response plan, emergency contact numbers is maintained with security personnel.
c. Maintain contact with the press and civil authorities (government, police, etc.) and ensure that accurate information concerning the incident is given to the media. Obtain approval of the Plant Manager or their representative for release of any information requiring security clearance.
a. Keep (designated) company representatives informed of the incident.
b. Maintain necessary communication with employees.
c. The security guard shall be responsible for providing security during an emergency to prevent unauthorized access. He shall follow the instructions and respond efficiently. If fire is reported to the Security Guard Station, Security personnel shall immediately contact the EHS Personnel or HR Department. Upon direction , Security Personnel shall call Police, Contact Fire Station and confirm that the Police Force is notified and that a fire engine is on the way and provide the following information:
-- Name of the organization
-- Address
-- Location of fire within the building
-- Size and extent of fire
-- Number of injured persons
-- Name of the hazardous material involved
d. Whenever the alarm is noticed, the security guard shall:
- Check the physical location of the fire
- Inform the Emergency Coordinator, Backup Emergency Coordinator, or EHS Department about the location of the fire.
10.3.5 Shift Emergency Responders(SER)
a. Responsibility: First responders during the respective shift.
b. Pre-Emergency Duties: Attend annually the training on emergency response. Aid the emergency coordinator.
c. Emergency Duties: Upon receiving the call from Security or as soon as he comes to know about the emergency, notify emergency coordinator, back-up emergency coordinator or EHS coordinator, in the same order of priority as directed in Appendix- IV, Emergency event reporting system. Participate in plant emergency response actions until relieved by the emergency coordinator or backup. Assure that the emergency area is secured.
d. Post emergency duties: Report to and assist the emergency coordinator or backup in their post-emergency duties.
10.3.6 Shift Engineer
a. Pre-Emergency Responsibilities: Co-ordinate drills, ensures the testing of emergency and all other equipments in his area. Ensure safety training of each employee in his department. Aid the working of the emergency coordinator. Provide procedures for plant emergency operations like shut down and lock out procedures (partial or complete as necessary to prevent loss of man and material).
b. Emergency Responsibilities: In absence of the emergency coordinator, assumes charge and directs remedial measures along with the EHS personnel. Ensure correct and quick communication with Back-up Emergency Coordinators. Assess nature of emergency and coordinate with the EHS department. Help the evacuation team (Safety Committee members). Ensures that the shift emergency responder follows the instructions of the emergency coordinator correctly and also the procedure provided for shut down, startup and lock out are correctly followed. Interface with Backup Emergency Coordinators. Assists to activate reporting and information. He along with emergency coordinator (Manager Operations) is responsible for providing technical advice and assists him during emergencies. His duty is to provide plant drawing for fire protection system and utilities.
c. Post Emergency Responsibilities: Determine extent of damage; assess the nature of loss and arrange for the resources required for restoration of normal operating conditions. Co-ordinate review meetings to critique emergency response action. Follow the regulatory and Division notifications. Conduct an investigation of the accident and revise plant operations to prevent a repeat occurrence. Inventorise and replace all used emergency equipment with the help of EHS personnel
10.4 Plant Warning System
During emergency plant warning system will activate. The plant will be warned through the alarm. Refer Facility Site Plan Section 10.13, Appendix-III-‘List of locations of hazard and fire fighting equipments with plant drawing showing emergency exits and designated assembly area for evacuation’.
10.4.1 The alarm will warn each employee and guest against the emergency. The employees (non-emergency response team) and guests are to follow the nearest escape root and collect at the assembly point. While the Emergency Responding Team will actively start functioning.
10.4.2 It is the responsibility of the host to ensure that his/her guests follow the instructions and ensure their safe evacuation, if required during emergency.
10.5 Emergency Equipment:
Emergency equipment is tested and maintained on a regular basis as indicated below. The maintenance department updates emergency evacuation routes that are posted.
EQUIPMENT FREQUENCY OF TEST DEPT IN CHARGE
Fire hoses and sprinklers Semi annual Maintenance
Fire extinguishers Monthly H R
Alarms Semi annual Maintenance
First Aid Kits Upon use H R
Personal Protective Equipment Quarterly/upon use EHS Department
10.4 Emergency Evacuation Plan
Emergency response and evacuation drills are conducted once annually. Every exit and the doors leading to it are numbered. If possible each department or area has a minimum of two routes for evacuation. Designated assembly areas are identified and marked on the schematics. Refer to Section 10.11 Facility Site Plans, Appendix III - ‘List of locations of hazard and fire fighting equipments with plant drawing showing emergency exits and designated assembly area for evacuation’.
10.4.1 Conduct debriefs and discusses plant personnel improvement activities.
10.4.2 The Emergency Evacuation Team (Safety Committee Members) has the following responsibilities during an emergency:
a. Upon hearing the fire alarm, ask the employees to evacuate; instruct employees and guests to calmly walk to the designated assembly area. The evacuation team will aid in the evacuation in the areas.
b. Ensures employees not to go to the lockers or return to the building for personal items during the emergency until the ‘all clear’ order is given.
c. Upon meeting at the designated area, instruct employees not to leave the premises. Take a head count to ensure that no employees are missing. Report missing employees to the emergency coordinator or EHS coordinator and wait for further instructions from the EHS coordinator or backup emergency coordinator.
d. Once the 'ALL CLEAR’ order is given by the emergency coordinator and EHS Manager, the EHS coordinator and the backup emergency coordinators will jointly assist employees and guests to reenter the building and maintain order.
10.6.3 Employees have the following responsibilities during a crisis:
a. Upon hearing the fire alarm or the paging system instructing to evacuate, calmly evacuate through the nearest exit in an orderly fashion and as per the instruction of the EHS coordinator and emergency evacuation team.
a. Assemble at the designated area and report to the emergency coordinator or EHS manager.
b. Remain in the designated area until instructed by the EHS coordinator and backup emergency coordinator.
10.6.4 Emergency Evacuation
It will be executed with the help of the evacuation team(members of the safety committee) and assisted by emergency coordinator, backup emergency coordinators. A decision on evacuation (complete or partial) must be made after all information has been gathered by four or at least any two of the following:
a. Work's Manager
b. Director Manufacturing
c. QA Head
10.6.5 Elements to be considered are:
a. Evaluation of data collected (all information available on threat).
b. Cause of evacuation- Big Fire, local bomb threat, natural disaster (climatic conditions, earthquake etc.)
c. Date of week
d. Total employee number
e. Time of shift
f. If an evacuation is to take place, Head of the department or his designee must ensure that all employees leave quickly and safely by the available emergency exits.
g. Police, fire, or other available bomb experts must be utilized for any search activities.
h. In the event an emergency when arises to such magnitude that an immediate evacuation of the plant is warranted, the Facility Alarm System should be used to notify all persons in the Plant to make other employees aware/convey the news of emergency situation evacuate immediately.
i. Reporting will be done as early as possible, after normalization of the operations/functions through the related form.
Note: The assembly points and emergency exits are marked in the lay out drawing attached with Appendix –III ‘List of locations of hazard and fire fighting equipments with plant drawing showing emergency exits and designated assembly area for evacuation’.
10.7 Drills & Exercises
10.7.1 Purpose
Drill and exercise are conducted annually. The primary function is to provide the means of testing the adequacy of the emergency response plan and the level of readiness of response personnel and to learn improvement opportunities.
10.7.2 Responsibility
a. The EHS Manager with assistance from the various response coordinators is responsible for coordinating the development of and assisting in the conducting of drill and exercise.
b. Respective Employees are the responsibility to escort the Visitors and Contractors to calmly walk to the nearest exit.
10.7.3 Types of Exercise/Training:
The following types of drills and exercises are to be used:
a. Full Scale Training
This level of exercise requires the coordination of EHS Coordinator and the members of safety committee. The intent is to evaluate the operational capability of the Plant Emergency Organization and the adequacy of this Plan.
Frequency: Conducted annually involving all emergency response personnel and in cooperation with the community.
Respective department manager will review the emergency response and contingency, six months after full-scale training
b. Preparations
i) Preparation for a drill or exercise will vary depending on the type and scope involved. However, preparation and planning should include:
- Plan review and identification of possible problem areas
- Establishing objectives
- Identifying resources and personnel involved
- Assigning and training controllers and evaluators
- The scenario used will be realistic and based upon current operating conditions. The primary event (fire, spill, etc.) to be determined will be based on the objective of the exercise.
ii) A sequence of major events list will be developed to help stimulate an actual emergency incident. Expected responses for each major event are to be determined. Conditions are simulated as closely as possible to the actual emergency situations.
c. Follow up
i) Results of drills and exercises are to be reviewed by all participants. The management team and the involved emergency response coordinators will identify the areas such as deficiencies, in the plan, training, personnel or equipment.
ii) The EHS manager is required to prepare a final report and submit it to the Management for corrective actions.
d. Fire Drills:
- EHS Coordinator shall conduct a fire drill annually.
- Designated associate to ensure that their employees move in an orderly fashion to the designated exits
- Do not break the seals and open the doors
- Departmental head/designated representatives are to ensure that all their employees are accounted for.
- Drills are to be taken seriously, as it is a practice, which will save people during a crisis.
- Do not panic and run as such acts can kill/injure more people than an actual fire.
- A team will be asked to evaluate the drill. EHS coordinator will determine when the drill is over and will direct the employees to return to the building.
10.8 Fire / Explosion Response Plan
10.8.1 Purpose:
Guidelines for reporting and responding to a facility fire.
10.8.2 Fire Incident:
The primary role is to – Sound the nearest fire alarm (if the smoke detectors did not detect and the hooters do not blow automatically). Evacuate people from the building as per the instructions of the Evacuation team and follow the nearest emergency root / exit Refer Appendix- IV, Plant lay out drawing showing emergency escape doors and assembly point. However if a small fire is present and can be safely extinguished by a trained employee using a portable, hand fire extinguisher then to do so:
a. Identify the type of fire; locate and use the nearest appropriate/suitable fire extinguisher before the emergency. Refer to Section 10.13 Facility Site Plans and Appendix III – ‘List of locations of hazard and fire fighting equipments with plant drawing showing emergency exits and designated assembly area for Evacuation’.
b. Notify Section Head, EHS department, and the security guard. Report location, size and extent of fire, and whether any hazardous materials were involved.
c. Notify Facilities/Maintenance and related emergency organization and contact person, Refer Section 10.12, Appendix –I, II, &V
d. After the fire is out, ventilate smoke from the area.
e. The head (or designee) of the department involved with fire shall:
- Ensure a calm and orderly evacuation out of the building and to the designated assembly area. He may take help form Evacuation team (Safety Committee members) also.
- Take a head count to ensure that all the department employees have evacuated.
f. Ensure that the employee(s) involved with the fire report the following information to Security Guard:
- Name
- Location of fire, size and extent of fire
- Any injured or missing persons
- Any hazardous materials involved
- If reporting by phone, do not hang up until told to do so.
- If there is time and if there is no danger, close all the windows and doors.
- Stop any machinery or motors
- Disconnect electrical equipment
- Shut off fuel supply to any open flames, if safe to do so.
- Check if the fire hoses at the zone have been tampered. If so, report and close nozzle.
- Submit an accident, injury or incident report to the EHS Department.
10.8.3 The emergency coordinates and/or his backup or the emergency responders will meet the Fire Department, relay the information and direct them to the place of accident; will implement emergency response duties as described in Section 10.3 "Emergency Responsibilities by Title".
10.8.4 The emergency coordinator and the backup emergency coordinator will assist when hazardous materials are involved and will also make the necessary corporate and regulatory notifications and reports.
10.8.5 The fire protection equipment/system available at the facility and their locations are as per – Appendix III-‘ list of location of hazard and fire fighting equipments with plant drawing showing emergency exits and designated assembly area for evacuation’ and Appendix-VI’ List of fire protection and fire fighting equipments.
10.8.6 Shift, Weekend and Holiday Fire Emergency: In the event of a fire emergency, associate will call the Security Guard and provide the information. The security guard shall then call the emergency coordinator, the member from the emergency backup team or the EHS coordinator (whoever is present or can be contacted easily). Upon direction from the emergency coordinator the member of the emergency backup team or EHS Coordinator (whoever is informed by the security guard), the security guard shall call Fire Station / Police Force / medical assistance (do as directed as directed). The emergency coordinator shall then call the EHS manager or coordinator and provide the same information. Refer to Section 10.13, Appendix-I ‘Emergency Organizationtional Contact list’.
10.8 Spill Response Plan
10.9.1 Purpose:
The purpose of this plan is to outline the Facility's response to Hazardous Materials Spill and the minimum requirements that must be considered when dealing with responses. A complete list of chemicals used in the facility, the maximum quantity stored on site and location of storage is kept available with the EHS Manager.
10.9.2 Definitions:
a. Hazardous Materials: Substances, which are classifiable under the classification system as specified in THE FACTORY ACT SEC. 2 (cb). Hazardous substances also include empty receptacles or packages, which have contained hazardous substances, unless such receptacles or packages have been decontaminated.
b. Hazardous Materials Incident: A hazardous materials spill in quantities typically used in operations.
c. Hazardous Materials Emergency: A material spill greater than the quantity typically used in operations or a smaller spill which is not easily controlled by a department hazardous material spill responder, given the materials and training provided.
10.9.3 Hazardous Material Spill Responders:
Employees should be trained to respond to spills in their own areas. These employees shall be given the basic training on handling and dispensing of solvents and waste solvents. They are trained to handle only lab quantity levels of solvent spills.
10.9.4 Hazardous Materials Incident:
a. Employees Responsibility: Any employee having information regarding an actual, or suspected non-routine release of hazardous material into air, sewer, storm water, ground water or ground shall immediately contact the supervisor or designee.
b. Head of the Department’s Responsibilities: The HOD shall ensure that at least 2 department employees are fully trained at all times to respond to accidental releases in their departments.
i) Ensure that spill kits are provided where hazardous chemicals are used. The kit will contain absorbers, neutralizers, pillows, dikes, chemical resistant gloves & clothing, goggles, respirators, waste collection cans/bags; spill report form.
 The emergency coordinator or backup and the security officer Stationed at employee entrance lobby shall be contacted immediately.
 If the condition creates a hazard to employees or others working in the area, the supervisor will instruct the employees to evacuate the area as outlined in Section 10.6" Emergency Evacuation Plan".
ii) Responders Responsibilities:
 If necessary, advise the supervisor to isolate and evacuate the immediate spill area and surrounding area.
 Notify EHS manager.
 Determine the identity of the hazardous substance and assess the materials hazard as per the material safety data sheet (MSDS) and other pertinent data available. MSDS are available in each department.
 Warning signs will be posted at the site/location of spill – ‘Spillage here-Do not come near’ to avoid any accident due to spill that has occurred.
 If any person(s) is injured or overcome by exposure, the supervisor shall arrange for emergency medical help. Refer to Section 10.1, "Emergency Organization and Contacts" and Appendix I-‘ Emergency Organizational Contact List’ for telephone number.
 Wear personal protective equipment as advised by MSDS.
 Never clean up a spill alone. Ensure that another spill responder is nearby.
 Use pads, dikes, pillows and absorbent to absorb hazardous material.
 Once absorbed, place the material in the waste bags.
 Clean up the residue on surface with soap and water. Place all the cleaning material in the waste bags.
 Fill up the Spill Report (Form # INM-03-004-01) and send it to EHS coordinator.
 Request for replacement spill kit contents.
 If the situation becomes an Emergency/Crisis, i.e. the spill cannot be contained, evacuate the immediate and surrounding areas and contact Security.
 The Security guard shall immediately contact the Emergency Co-ordinator or backup (shift responders during shift) immediately and relay the message.
 The emergency coordinator or back up or the emergency responders shall assess the type of chemical spilled and extent of spill.
 The emergency coordinator or backup or the shift responders shall ensure that area is properly isolated, demarcated and affected employees are evacuated. Evacuate the area or building as outlined in Section10.6, "Evacuation Plan". Then call the outside responders for assistance.
 Work with the outside response team to ensure clean up.
iii) EHS Co-ordinator's Responsibilities:
 Upon learning of an incident/emergency, the emergency coordinator will obtain the basic facts and make an initial assessment of the situation.
 If the released material is spreading or is in danger of spreading to a larger area and poses a threat to the health and safety of persons outside the facility, the Police Force shall be contacted immediately. The
 Checklist of Xxx Emergency Response Resources in the Xxx Environmental Manual shall be reviewed to determine any division or corporate personnel should be notified.
 Once the safety and health of personnel is assured and the emergency has been brought under control, the licensing officer as defined in THE FACTORY ACT, 1948, SECTION 2 (c, b) shall be furnished with a detailed report in writing as to the circumstances of the accidental release of the hazardous substance and the subsequent action taken in relation thereto. If there are any injured persons then the Department of Industrial Safety shall also be notified of the accident. The Division Environmental Manager will also be furnished with a detailed report.
iv) To prevent or minimize the effect of spills:
 Keep containers closed when not in use.
 Do not store materials together where it is incompatible and store it in the appropriate storage areas.
 Practice good house keeping
 Know your responsibilities in the event of an emergency.
 Emergency Coordinator shall conduct a hazardous material spill response drill annually to determine the effectiveness of the response plan.
 A weekly inspection of the hazardous materials and waste storage areas will be undertaken by the EHS coordinator and documented to ensure that everything is in order.
v) Techniques that can be used to detect presence of Hazardous Concentrations of Chemicals:
 Observations of visible fumes for chemicals which exhibit this property.
 Knowledge of the odor threshold of the chemical.
 Observance of liquid pools of the chemicals.
 Air monitoring results from direct reading of the monitors.
 Results from automatic continuous monitors
10.9.5 Specific Spill Prevention, Control and Counter- Measure Plan
a. Purpose:
This Spill Prevention, Control and Counter measure Plan (SPCCP) is prepared for the prevention and containment of oil, IPA, spills. The oil spill referred to herein in the plan refers only to the Furnase.Oil meant for the Boiler. The lubricating oils, hydraulic oils etc., will be handled as per Section 10.8, Hazardous Material Spill Response.
b. Tank and Spill handling equipments Location:
The tank location and the nearby spill handling equipment are listed in the Appendix- VI, “Facility Site Plans”, Section 10.11.
c. Spill Protection Provisions:
The fuel oil tank is placed inside a dike area that has concrete floors and walls that are sufficiently impervious to contain spilled oil. The capacity of the secondary containment is 20% more than the capacity of the tank. In addition brooms and absorbents will be kept to nearest approach for controlling any spills/leaks.
10.8.6 Procedures for Checking and Receiving Bulk Fuel:
a. A facilities associate shall be present for the entire duration of the filling.
b. Upon the tanker arrival, the associate shall check that all the seals at the discharge valves and hatch covers are intact. The seal number must tally with the number stated in our delivery order.
c. The facilities associate, prior to filling, shall ensure that adequate spill response material is available.
d. The facilities associate shall visually check the transfer equipment for integrity and ensure that it is properly connected to the tank.
e. If everything is in order, the facilities associate shall start pumping.
10.8.7 Dike Drainage:
Dikes and other containment areas are designed to contain spills. However, they also collect storm water that needs to be drained. The following precautions shall be taken for dike drainage:
a. The dike valve shall be locked when dike is not being drained.
b. Prior to draining the dike, the associate shall visually inspect for any oil in the water. If there is oil in the water, the technician shall use the oil adsorbent from the spill kit to adsorb the soil prior to draining the dike. The adsorbent shall be disposed off as hazardous waste.
c. A written note should be sent to EHS Department before disposal of the waste.
10.8.8 In the event of an oil spill:
a. The security guard shall activate the emergency contact list, Section 10.1- Emergency Organization and Contacts.
b. The oil spill will be handled as per Section 10.7, Hazardous Material Spill Response and refer Appendix VII- ‘Location of spill controlling equipments’.
c. Training: All persons involved in the oil filling operation and responders shall undergo annual SPCC training plan as outlined.
d. Security: In case of a shut down of the facility, all outlet and drain valves on the bulk storage tank shall be locked in the closed position and capped.
10.10 Bomb Threat Plan
10.10.1 Purpose:
To provide a plan of organized action to be taken upon receipt of a bomb threat during and after normal working hours. Consequently, prior planning to meet the threat must include contact with the local police department.
10.10.2 Specific Guidelines
This procedure is to be used in the event of bombs or bomb threats. Threats or calls relating to bombs should not be disregarded.
a. In the event of a bomb threat, the determination whether to evacuate or not to evacuate the facility is a managerial decision. The source of the threat, the frequency of threats, effectiveness of search procedures, occupancy of building, and weather conditions, are factors that should be considered in this determination.
b. In case of evacuation, the evacuation procedure as per -10.6 Emergency Evacuation Plan will be followed.
10.10.3 Authority for decision of evacuation
A decision on evacuation (complete or partial), Order and direct search, facility shutdown re-entry or re-occupancy after evacuation must be made after all information has been gathered by four or at least any two of the following:
a. Manager Operations
b. Plant Manager
c. Director Manufacturing
d. QA & RA Manager
10.10.4 If suspected device is found:
i. If not already done, evacuate the area as per Section 10.6, Evacuation Plan.
ii. Anything done to minimize damage from explosion (Examples: Shut down nearby operating machinery. Remove sources of combustion and combustibles, shut all interior fire doors) will be done as per the instructions given by Emergency Coordinator, EHS Personnel and the plant Engineer.
iii. If not already done, call the Xxx Police Department when a suspicious item is found. DO NOT TOUCH ANY SUSPICIOUS ITEM. The police department will contact the Bomb Disposal Squad to handle the disposal of bomb.
10.11 Written and Telephone threats
10.11.1 Purpose:
The purpose is to define specific procedure of responding to any threat -written or telephone
a. Written Threats:
i) The person receiving a written threat should:
 Handle the envelope or package as little as possible since examination by trained investigators may reveal fingerprints or provide clues as to the identity of the sender. Preserve the entire message, including the envelope, until released to the investigator.
 Contact the Security Officer at employee entrance lobby immediately.
10.11.2 Telephone Threats:
a. Telecommunications Operator (8.00 a.m. - 5.00 p.m.)
i) As soon as it is clear that the caller is making a bomb threat, LET HIM FINISH HIS MESSAGE WITHOUT INTERRUPTION. If any response is essential, keep it to one or two words. The following should be observed:
- Background noise
- Caller’s voice: Male/Female, Soft/Loud/Course, etc.
- Caller’s attitude: Vulgar, passive, normal, calm
- Noticeable speech defect
i) These observations may be helpful to the police department.
i) After the caller has finished giving his message, record all the information. Note whether the caller repeated his message or any part of it. Note the exact time of its receipt. Write the message down immediately after the call, EXACTLY AS YOU RECEIVED IT; then fill in the other details you were able to get.
 Contact the security officer and inform about the bomb threat.
 The Security officer shall immediately contact the EHS coordinator or backup and give information about the bomb threat.
a. Telephone Threats during Shift, Off Hours and Weekends:
i) Person receiving the telephone threat should:
 Contact the Security Officer. The security officer shall immediately contact the emergency coordinator, EHS coordinator or emergency shift responder of that shift and back up emergency coordinators and give information about the bomb threat.
ii) Shift Emergency responder, responding to the call from the telecommunications operator, talk to Plant Manager or emergency coordinator on phone. Strictly, follow the instructions received by them for:
 Deciding whether to contact Police force and other community responders.
 Deciding whether to implement evacuation. If evacuation is necessary, employees will be notified by:
-- Telephone by security personnel
-- Sounding the fire alarm
-- Activate Section10.6” Evacuation Plan”
 Deciding whether to form search teams. The search team shall consist of employees familiar with the area(s) to be searched.
10.12 Power Failure
At the time of power failure, the procedure mentioned below is to be followed:
POWER FAILURE RESPONSE PROCEDURE
Power Failure
Activate the back up power generators.
Plant electrical staff to identify / rectify the cause of failure
a) Main incoming power supply failure
b) High tension electrical supply failure
c) Low tension electrical supply failure
Follow Plant Evacuation Procedure if a major fault has been detected that may result in risk to man and material.
Main Incoming Failure
Inform Plant Engineer
Xxx Power Sub Stattion
Xxx Power supply person will detect, rectify fault and resume power supply.
High Tension
(H T) failure
Inform Plant Engineer
Plant Engineer will identify cause of H T failure
If unable to reset, Plant Engineer will isolate faulty circuit.
Low Tension
(L T) Failure
Plant Electrical personnel to identify cause of failure
Reset breaker immediately
If unable to reset, isolate faulty circuit and turn on unaffected system
Upon L T reset: - Check & identify facility
Emergency Power Supply
Check emergency supply to essential equipment
P A system, Fire Pump.
Isolate all power supply to chillers, pumps, to prevent power surge when supply resume.
Power Supply Restored
Staggered power turn on for facility systems
Check all Facility system back to normal
Evacuated staffs return to production / office upon safety clearance
Incident Report Form
Facility to submit incident report to Safety Specialist.
Corrective action must be included in report
Follow up TNEB or Plant Engineer. Report in case of Main Incoming or H T failure.
10.13 Facility Site Plan
10.13.1 Purpose:
To identify facility sites and respective buildings including emergency contingency requirements
10.13.2 The lists / drawing of the following are as below:
a. Appendix I Emergency Organizational contact list
b. Appendix II Accident/injury and first-aid Reporting System
c. Appendix III List of locations of hazard and fire fighting equipments with plant drawing showing emergency exits and designated assembly area for Evacuation
d. Appendix iV Emergency event reporting system
e. Appendix V List of fire protection/fire fighting equipments
f. Appendix VI Location For Spill Controlling Equipments
g. Appendix VII Location for First – aid Kit
h. Appendix Viii List of telephone contacts of Neighboring Factories, Hospitals/Nursing Homes, Fire station and Police Station

GENERAL PLANT SAFETY

1.0 DISTRIBUTION
All Departments.
2.0 APPLICABLE DOCUMENTS
INA-03-001 Environment Health and Safety Policy
3.0 APPLICABLE FORMS
INA-03-003-01 Avoid Verbal Instruction Slip.
INA-03-007-01 Hot Work Permit
INA-03-007-02 General Work Permit
INA-03-008-01 Accident & Injury Report
INA-03-008-02 Learning incident Report
4.0 APPLICABILITY
This procedure applicable to Xxx India Pvt Ltd, Xxx Plant
5.0 PURPOSE
To establish a procedure for Safe work conditions in Plant
6.0 SCOPE
This procedure has been developed for the protection of everyone in Xxx Plant premises. For effective implementation, it applies to every employee / visitor / Contractor etc. in Xxx Plant premises.
7.0 RESPONSIBLE DEPARTMENTS
QA, Production and Engineering
8.0 RESPONSIBILITY
EHS Coordinator
9.0 DEFINITION
Learning incident: Any incidence / occurrence that could result in an accident.
10.0 PROCEDURE
10.1 To ensure high safety standards all employees shall strictly follow the below rules:
10.1.1 No work should be done without written communication. All works other than Hot work permit and General work permit systems should be permitted through Avoid Verbal Instruction Slip (Form # INA-03-003-01)
10.1.2 Designated personal protective equipment must be worn in required areas.
10.1.3 No one is allowed to operate electrical hoist of INDEF system except those authorised for the purpose.
10.1.4 No one is allowed to stand on or work under elevated forklifts.
10.1.5 Loose clothing such as untucked shirts; neckties and others such loose fitting clothes, which may get caught in machines, must not be worn while working near machines.
10.1.6 Necklaces, chains or jewellery must not be worn while working around a mobile machine.
10.1.7 Any equipment believed to be unsafe must be reported to your supervisor.
10.1.8 Do not stack pallets on end, or over 1.5m high and do not leave pallets in the aisle.
10.1.9 Keep desk and file drawers closed except when removing or replacing material.
10.1.10 Do not stack heavy objects on top of shelves.
10.1.11 Running, fighting or playing in or around all areas in the plant are prohibited.
10.1.12 Departmental safety records will be used as a measure of performance for respective managers and supervisory personnel.
10.1.13 Safety shoes are to be worn, while performing the job at INDEF and Utility.
10.1 House Keeping
10.1.1 Housekeeping standards must be maintained throughout the plant and work areas.
10.1.2 Access to fire extinguishers, hoses, stretchers, eyewash and shower stations and other safety equipment should never be blocked.
10.1.3 Fire exits and passages must be kept unhindered / clear at all times.
10.1.4 The First-aid and fire fighting equipments should be so distributed over the entire plant area that a person has to travel not more than 15 mts to reach the nearest equipment. The buckets for fire fighting should hang approximately 750 mm above the floor level.
10.2 Safety Training and Orientation
10.2.1 Each new employee will receive an initial safety orientation conducted by EHS and should cover: Safety Policy and Safety Goal.
10.2.2 Each employee will ensure that safety is made part of his department’s safety orientation.
10.2.3 Specialized safety training will be developed and conducted on as needed basis.
10.1 Accident, Injury and Learning Incident Reporting
10.1.1 Any accident, injury or learning incident must be reported to the Supervisor-in-charge immediately.
10.1.2 Head of the department or his designee must contact EHS Manager or his designee within two hours of learning the accident occurrence.
10.1.3 When an accident/injury occurs in which an outside medical consultation is required, the supervisor must submit an Accident Report to Human Resource/Environment, Health & Safety department within 24 hours of its occurrence.
10.1.4 When an accident occurs after office hours, refer to SOP # INM -03-004 emergency organization and contacts list. The list is available at security counter at the entrance and also posted on the bulletin board.
10.1.5 Any learning incident should also be reported to your supervisor.
10.1.6 Head (s) of the of department(s) or his designee concerned must report any accident / injury to the EHS Manager within one week through the form (Form # INA-03-008-01). Reporting of learning incident through the form to EHS Manager within two days of its occurrence (Form # INA-03-008-02).
10.2 RESPONSIBILITIES AND ACCOUNTABILITY
10.2.1 Management Responsibility
- Assume overall responsibility for work safety.
- Review all accident investigation reports.
- Lead and motivate employees to achieve good standard of safety.
10.1.1 All employees with supervisory responsibilities (this shall include any employee who is deemed as responsible for any visitors, contractors etc. while they are in Xxx’s premises) are responsible to:
- Conduct departmental safety orientations for new and transferred employees.
- Prepare and review annually departmental safety rules.
- Inform employees under his or her charge the departmental safety rules.
- Prepare departmental machinery/equipment job instruction breakdown (JIB) and job safety analysis (JSA).
- Train, certify and maintain training records of new and transferred employees on machinery/equipment JIB and JSA.
- Conduct annual JIB refreshers.
- Conduct annual JSA review for submission to the EHS Manager for review by end of January on the following year.
- Prepare and display departmental machinery/equipment lockout/ tag out procedures and ensure compliance with procedures.
- Ensure that all employees under supervision wear the necessary personal protective equipment for that particular job.
- Enforce all safety rules.
- Conduct periodical safety inspection of his/her department (at least quarterly) and recommend improvement actions.
- Assist in safety inspections conducted by the Safety Committee
- Report and investigate for cause and correction of all accidents / injuries (Form # INA-03-008-01) and Learning incidents (Form # INA-03-008-02).
- Ensure injured employee(s) receive first- aid or medical attention.
- Take prompt actions to prevent accidents recurrence.
10.1.1 All employees are responsible for:
- Observe and abide by all established policies rules, procedures and practices.
- Operate only those machines as certified by their respective supervisors.
- Not to tamper with safety guards and devices.
- Wear, use and maintain in good working order all safety equipment issued to him/her.
- Find out what certification to work, safe operating procedures and instructions apply in the job he/she is assigned to.
- Follow proper procedures and not improvise by using methods, tools or equipment that may compromise safety.
- Maintain good housekeeping.
- Report any unsafe machinery, equipment, practice and other unsafe condition or unsafe act.
- Assist in accident investigation when required.
APPROVAL SIGNATURE ON FILE

HEALTH AND SAFETY COMMITTEE

1.0 DISTRIBUTION
All Departments.
2.0 APPLICABLE DOCUMENTS
INA-03-001 Environment Health and Safety Policy
3.0 APPLICABLE FORMS
INA-03-009-01 Safety Inspection Form
4.0 APPLICABILITY
This procedure applicable to Xxx India Pvt. Ltd., Xxx Plant
5.0 PURPOSE
To establish EHS Committee to implement the team’s EHS Commitments
6.0 SCOPE
This procedure describes EHS committee, its duties and responsibilities and rules of operation.
7.0 RESPONSIBLE DEPARTMENTS
QA, Production and Engineering
8.0 RESPONSIBILITY
EHS Coordinator
9.0 PROCEDURE
9.1 Committee is established to:
9.1.1 Establish and cultivate active participation in maintaining a safe and healthy working environment.
9.1.2 Provide an effective Health and Safety Communication channel.
9.1.3 Promote health and safety awareness, safe work practices and maintain safe working conditions

9.2 Committees Organization
There shall be a plant health and safety committee consisting of representatives from each department.
9.2.1 Safety Committee
a. The Safety Committee shall be formed at the beginning of each year.
b. The Safety Committee shall consist of at least one representative from each department. Wherever possible give equal representation of executive and staff cadres. Ideally all major work areas are represented in the committee.
c. The EHS Manager or his representative shall be Safety Committee Chairman.
d. Member's contributions and participation shall be recognized and given due considerations during performance appraisal.
9.3 Duties and Responsibilities
9.3.1 To review annually the Plant Safety Management System.
9.3.2 To perform annual Health and Safety reviews of all departments.
9.3.3 To coordinate efforts in health and safety.
9.3.4 To inculcate the habit of safe work practice and create a healthy environment for work.
9.3.5 To plan, publicize and organize the Committee's safety activities.
9.3.6 To assess the effectiveness of the campaigns and promotion activities.
9.3.7 To assist in the achieving of Plant safety goals.
9.3.8 Health and safety policies, auditing and accident investigations.
9.3.9 To review and recommend health and safety rules, procedures and policies to management for adoption and implementation.
9.3.3 To conduct safety audit jointly with the respective supervisors monthly and immediately after any accident.
9.3.4 To investigate and record accidents, learning incidents, unsafe acts and conditions with a view of prevention and elimination.
9.3.5 To develop and implement an effective employee health and safety training program.
9.3.13 To review annual accident statistics and authorize the implementation of appropriate counter measures.
9.3.14 To review accident investigation report.
10.0 RULES
10.1 The Committee shall meet at least once a quarter.
10.2 All members must attend at least 75% of the Committee meetings.
10.3 All members shall undergo appropriate training as arranged by the Plant.
10.3 Only matters relating to Health & Safety in the plant shall be discussed at any meeting of a Safety Committee.
11.0 REFRENCES
-The Factories Act 1948 &
-The TamilNadu Factories rules 1950

ENVIRONMENT HEALTH AND SAFETY POLICY

1.0 DISTRIBUTION
All Departments.

2.0 APPLICABLE DOCUMENTS
Xxx Corporate Policy

3.0 APPLICABLE FORMS
Nil

4.0 APPLICABILITY
This procedure is applicable to Xxx (India) Pvt. Ltd., plant only.

5.0 PURPOSE
To describe Xxx Plant Team’s commitment towards Environment, Health and Safety of employees and customers

6.0 SCOPE
To state the Environmental, Health and Safety Policy of the Plant.

7.0 RESPONSIBLE DEPARTMENTS
All

8.0 RESPONSIBILITY
All
9.0 PROCEDURE

9.1 The Team’s EHS Mission:
9.1.1 To be a LEADER in Environmental, Health and Safety (EHS) management and performance.
9.1.2 To produce Xxx products, services, and technologies in workplaces free from environmental and workplace hazards.
9.1.3 To promote culture that recognizes company’s shared values and integrates leading Environmental, Health and Safety principles and practices into business operations.
9.2 The MISSION is achieved through:
9.2.1 Sustainable Development: All employees must conserve our resources, both human and natural, and will minimize or eliminate adverse Environmental, Health and Safety effects and risks associated with our products, services and operations. Focus will be on pollution prevention and incidence avoidance.
9.2.2 Compliance: All should be committed to meeting or exceeding government regulations and complying with company Environmental, Health and Safety management standards.
9.2.3 Resources: All will ensure that our operations have adequate resources to provide coordinated and effective Environmental, Health and Safety programs through awareness, training, technologies and continuous improvement evaluations.
9.2.4 Customers: All employees will work with customers to help them address our mutual Environmental, Health and Safety issues.
9.2.5 Employees: Employees have opportunities to participate in Environmental, Health and Safety activities to gain the awareness, skills, and knowledge to carry out this policy. We will provide workplaces free from recognized hazards and promote healthy lifestyles.
9.2.6 Suppliers and Contractors: By working with our suppliers and contractors enhance mutual Environmental, Health and Safety performance.
9.2.7 Community and Government: Participating in community and government Environmental, Health and Safety initiatives. We will make relevant EHS information available to the public.
9.2.1 Business Integration:
a. Environmental, Health and Safety considerations will be integrated into our business.
b. The team commits to continuous improvement in Environmental, Health and Safety performance. Goals will be set on the basis on significant Environmental, Health and Safety aspects, progress is measured and results are communicated. All outside inquiries from our stakeholders will be responded immediately.
c. Conformance with this policy is the responsibility of every employee.
10.0 REFERENCES
-The Factories Act 1948 &
-The TamilNadu Factories rules 1950: