Categories
HR SOP

SOP Title: Plant Security Procedure

SOP Title: Plant Security Procedure

 

  1. Objective:

To lay down procedure for security system at the site.

  1. Scope:

This procedure is applicable to security of the facility assets and personnel working at the site from any unwanted incidents and indiscipline.

  1. Responsibility:

All Personnel: To follow the plant security procedure.

HR/Administration Department: To ensure compliance of the procedure.

  1. Accountability:

Head HR/Administration

  1. Procedure:

5.1  Definitions:

Plant Security: Means system deployed to protect factory assets and personnel from any incident, mishaps, misuse, theft and hazard and monitor the facility to remain in the compliance state of the procedure.

5.2  Procedure:

5.2.1 Trained personnel (Security Guards) shall be deputed at the site for conducting the security in the plant.  
5.2.2 Plant shall be monitored 24 hours for security concern by the security guards.  
5.2.3 If any observation of non compliance or incident is detected, it shall be communicated to HR Department and Plant Head.  
5.2.4 Details of location of guards  
5.2.4.1 Day Shift: security officer and  guard shall stand at Main Gate as per requirement.  One guard and one Lady Security Guard take round around the boundary wall of the factory.  
5.2.4.2 Night Shift: One guard shall be at Main Gate and one guard shall stand at the back side wall. One guard shall keep continuous vigil around the boundary wall of the factory.  
5.2.5 Details of the duty schedule  
5.2.5.1 The duty schedules shall be of 12 hours for each security person except the lady guard.  
5.2.6 Nature of Duties  
5.2.6.1 To check and notify the entry and exit of factory personnel and visitors and maintain the records of the same.  
5.2.6.2 To provide the visitors slip and to collect the same and keep in the records.  
5.2.6.3 To inspect the incoming and outgoing personnel for anything carrying inside and outside the factory which is not suppose to be.  
5.2.6.4 To check the incoming goods as per the challan or bills and putting the stamp of gate entries along with the entry in the log book.  
5.2.6.5 Inspection of the outgoing goods from the factory as per the invoice quantity and certifying the same.  
5.2.6.6 Checking of the scraps going out of the factory for sale to avoid anything which not a part of the scrap sold.  
5.2.6.7 To check workers movement and other activities so as to maintain the discipline.  
5.2.6.8 Daily inspection of the surrounding of the factory premises to ensure that the security measures taken are in perfect condition.  
5.2.6.9 To check that smoking is avoided in the factory premises and to ensure the compliance of the same.  
5.2.6.10 To check and ensure that the water tanks are filled and all the lines are working perfectly.  
5.2.6.11 To check that the compound lights and other lights are working perfectly and to inform the same in case of non-compliance.  
5.2.6.12 To check the offices as well as plant lights and fans are switched off, when work is completed and the rooms are locked.  
5.2.6.13 To check and ensure that the water tanks are filled and all the lines are working perfectly.  
5.2.7 Training  
5.2.7.1 Training on the security procedure, discipline, duties and responsibilities, safety and emergency system shall be given to the security personnel before assigning responsibilities.  
5.2.7.2 The security procedure shall be available with the security personnel in the security room.  

 

  1. Abbreviation:
QA Quality Assurance
SOP Standard Operating Procedure
HR Human Resource Department

 

*Note – Ready to use SOP available in “DOWNLOAD” Section.

 

Categories
HR SOP

SOP Title: Waste Management

SOP Title: Waste Management

 

  1. Objective:

To lay down procedure for waste management i.e. collection, labelling, storage disposal or destruction of all type of waste generated in the premise.

  1. Scope:

This procedure is applicable to general waste, hazardous waste, non hazardous waste produced in the departments during handling, storage, manufacturing, packing, testing etc of materials and products and other operations in the premise.

  1. Responsibility:

All departments: To collect, label, transfer of the waste generated in their department to the scrap yard for disposal as per procedure.

QA department: To prepare, review and approve the procedure and ensure compliance of the procedure.

Administration departments: To review the procedure and ensure that the waste material is disposed of in accordance with the SOP.

  1. Accountability:

Head administration/ Head Quality Assurance department.

  1. Procedure:

5.1  Definitions:

General Waste or Non Hazardous Waste or Scrap: Any waste which does not contain any hazardous constituents that could adversely impact public health or the environment if mismanaged. It includes rejected packing materials, labels, container, used poly bags, papers, used gloves, clothes, masks, cupboard, plastics, glass etc.

Hazardous Waste: Any waste which by reason of any of its physical, chemical, reactive, toxic, flammable, explosive or corrosive characteristics causes danger or is likely to cause danger to health or environment.

Concerned department: Department to which the scope of given document lies with respect to preparation, review or execution responsibility of particular steps as mentioned in procedure.

5.2  Procedure:

5.2.1 Collection of waste  
General waste or scrap or non hazardous waste
5.2.1.1 General waste or scrap from different shall be collected and transferred to the scrap yard by the housekeeping personnel in regular basis.  
5.2.1.2 Any waste or scrap generated during activity, operation, storage and handling, processing shall be promptly collected and kept in the waste bin provided in sections/departments in the supervision of staff.  
5.2.1.3 Housekeeping personnel shall collect the scrap in the poly bags from the waste bin provided in the section/department and transfer it to the scrap yard.  
5.2.1.4 During collection and transfer of scrap from the department or sections special supervision shall be taken to ensure procedure is properly followed.  
5.2.1.5 Waste like papers, rejected printed foils, labels, cartons or other printed material shall be destroyed by tearing or shredding before putting in the waste bin or transferring to the scrap yard.  
Hazardous waste or chemical waste
5.2.1.6 Spilled material, in process rejects (powder, tablets, capsule etc) shall be collected from the designated ‘REJECTED’ container and slurry shall be made by adding water to it in a HDPE container labelled with ‘Hazardous Waste’ in the department in supervision of staff.  
5.2.1.7 Hazardous waste shall be removed regularly from concerned departments and special precaution shall be taken during transfer to scrap yard for disposal.  
5.2.1.8 During handling hazardous waste personnel protective equipment i. e. face mask, gloves, shoes, goggle, apron etc (as applicable) shall be worn by the person who is handling the waste.  
5.2.2 Labelling and storage of waste  
5.2.2.1 Non hazardous waste shall be labelled with ‘Non Hazardous Waste’ before transferred or collected from the concerned department.  
5.2.2.2 Hazardous waste, if it is solid or powder pharmaceutical waste shall be removed from concerned department after making it unusable by adding water and keeping in a well closed HDPE container.

If the hazardous waste is consist of liquid/semisolid then it shall be removed as such or by diluting it with water.

 
5.2.2.3 Hazardous waste shall be labelled as ‘Hazardous Waste’ before transferring from the concerned department.  
5.2.2.4 Hazardous and Non hazardous waste shall be stored in well closed and labelled container in designated area in the scrap yard under the safe custody of responsible person.  
5.2.2.5 During storage the waste material shall be monitored physically to ensure that there is no leakage or production of harmful substance in the container.  
5.2.2.6 Any type of waste shall not be stored more than 60 days in the premise i.e. it should be dispose of within this period.  
5.2.3 Disposal/destruction of waste  
5.2.3.1 Any waste material that require disposal shall be handled in conformance with the respective state or central legislation i.e. Waste Management Act, Water (Prevention and Control of Pollution) Act, Air (Prevention and Control of Pollution) Act, Bio-Medical Wastes (Management and Handling) Rules etc and other applicable legislation  
5.2.3.2 Non hazardous waste or scrap that can be shredded shall be destroyed by tearing or shredding through shredding machine in departments or scrap yard as applicable.  
5.2.3.3 Hazardous waste and Non hazardous waste shall be dispose of to the consent approved contractor as mentioned below on regular basis to render it non-infectious in contractor facility.  
5.2.4 Certified contractors
5.2.4.1 Certified contractor shall be contracted for general waste or non-hazardous waste disposal. After compliance of required certification, the contract shall be made with written consent letter.
5.2.4.2 Certified contractor shall be contracted for hazardous waste disposal waste disposal. After compliance of required certification, the contract shall be made with written consent letter.
5.2.5 Documentation and Records :-  
5.2.5.1 Consent letter of the certified contractor for hazardous waste shall be kept along with the copy of certificate from authorized board or agency.  
5.2.5.2 A record of waste disposal shall be maintained (as applicable) for hazardous waste and non hazardous waste.  
5.2.5.3 For hazardous waste original copy or photocopy (as applicable) of waste disposal shall be kept as specified under state pollution control board.  
5.2.5.4 All waste disposal/destruction records shall be retained for at least 3 years from its collection and disposal.  

 

  1. Abbreviation:
Abbreviation Expansion
SOP Standard Operating Procedure
HDPE High Density Poly Ethylene

 

*Note – Ready to use SOP available in “DOWNLOAD” Section.

 

Categories
HR SOP

Title: Cleaning of General Areas in the Premise

Title: Cleaning of General Areas in the Premise

  1. Objective:

To lay down procedure for cleaning of general areas in the premise.

  1. Scope:

This procedure is applicable to the general areas i.e. general or primary change rooms, outer corridors and other entrances to the general change rooms.

  1. Responsibility:

HR/Administration Department: To ensure that the cleaning procedure is followed meticulously and provide necessary arrangements for cleaning.

QA Department: To set the procedure and ensure compliance of the procedure in the site.

  1. Accountability:

Head HR/Administration and QA Department

  1. Procedure:

5.1  Definitions:

General Areas: Includes areas which lead directly or facilitate entry to the Production, QC and Warehouse area/corridor; other surrounding areas of critical areas and needed to be maintained in good state of cleanliness and sanitation.

Critical areas: Includes areas where the product or material is stored, processed or tested and the area is needed to be maintained at controlled environmental conditions to avoid any contamination and cross contaminations.

5.2  Procedure:

5.2.1 Cleaning Policy  
5.2.1.1 All the general areas which lead to the critical areas or corridor of critical area or surrounds the Production, QC, QA and Warehouse area shall be maintained in sanitary condition to avoid any risk of ingress of contaminants.  
5.2.1.2 The housekeeping personnel shall be trained in the cleaning procedure.  
5.2.1.3 Avoid creating large wet area during cleaning.  
5.2.1.4 All cleaning aids shall be cleaned after each cleaning and at the end of the shift.  
5.2.1.5 Cleaner room or genitor room shall be maintained at sanitary condition at all time.  
5.2.1.6 Rubbish should be collected in either bins or bags and disposed of properly to avoid any risk of contamination.  
5.2.1.7 Cleaning shall be done as per current approved procedure by workman and he/she shall be monitored by the Housekeeping supervisor or administration personnel.  
5.2.1.8 All problems related to the implementation of cleaning procedure shall be reported to the housekeeping supervisor or HR personnel who shall then mediate with the QA Head to sort out the problem.  
5.2.2 Cleaning aids  
5.2.2.1 Following types of cleaning aids shall be used for cleaning in the general areas in the premise:

·        Buckets

·        Mops

·        Squeegees

·        Chemicals/disinfectants

·        Dustpans and waste bins

·        Nylon brush

 
5.2.3 Cleaning solution preparation  
5.2.3.1 Following types of disinfectants and cleaning solution shall be used for cleaning with the specified concentration and frequency of the general areas:

Frequency Name of disinfectant Concentration of disinfectant Cleaning solution preparation
 

 

Weekly

Dettol 2.5% v/v 125 ml of Dettol in 5.0 litres of potable water
Savlon 2.5% v/v 125 ml of Savlon  in 5.0 litres of potable water
 Eteol – H 2.5% v/v 125 ml of Eteol – H  in 5.0 litres of potable water
Whenever required Detergent 0.1 % w/v 1 gram dissolve in 1 litre of potable water

 

NOTE: Dettol and Savlon shall be changed every week. If either one is not available Eteol shall be used.

5.2.4 Cleaning surfaces and frequency of cleaning  
5.2.4.1 Following are the cleaning surfaces which shall be cleaned as per frequency mentioned below:

Cleaning surfaces Frequency
Floor Twice daily
Doors & Windows Once daily
Ceiling Weekly
Light fixtures Weekly
Walls Weekly
Supply air and return air grills Weekly
Fans Weekly
Cross over benches, Cupboard/Garment cabinet Weekly
Fire Extinguisher Weekly
Tacky mats Twice daily
Sinks and drains Once Daily

 

NOTE: Above mentioned frequency can be increased as per requirement.

5.2.5 Cleaning Procedure  
5.2.5.1 Cleaning of the general area/room shall be started from upward to downward (ceiling to floor) to avoid contamination to the cleaned surfaces.  
5.2.5.2 Ceiling, light fixtures and air grills  
5.2.5.2.1 Clean the ceiling, light fixtures and air grills by moping with dry lint free cloth followed by moping with moist cloth dipped in 0.1 % soap solution.  
5.2.5.3 Fans  
5.2.5.3.1 Switch OFF the mains before cleaning.

Remove dust with a dry cotton cloth. Wipe the surface using a clean moist cloth.

 
5.2.5.4 Walls  
5.2.5.4.1 Clean the walls by moping with dry lint free cloth then by moping with moist cloth dipped in 0.1 % soap solution working from ceiling line down to the floor.  
5.2.5.5 Doors & Windows  
5.2.5.5.1 Clean the doors and windows by moping with the dry lint free cloth followed by moping with moist cloth dipped in 0.1 % soap solution.  
5.2.5.6 Cross over benches and Cupboard/garment cabinet  
5.2.5.6.1 Clean the cross over bench and garment cabinets by moping with the dry lint free cloth then by moping with moist cloth dipped in 0.1 % soap solution.  
5.2.5.7 Floor  
5.2.5.7.1 Remove all the debris from the surface and collect in the waste bin or poly bags for disposal.  
5.2.5.7.2 Clean floor by rubbing with the help of mope dipped in the 2.5 % disinfectant solution and allow sufficient time for cleaning.
5.2.5.7.3 Wipe the floor with the help of wiper/squeegees and collect in the bucket and drain in the washing area.
5.2.5.8 Cleaning of outside corridor  
5.2.5.8.1 Remove all the debris from corridor.  
5.2.5.8.2 Clean the tacky mats by knocking over to remove the dust trapped.
5.2.5.8.3 Clean the floor by sweeping with the help of broom to remove soil from the surface.
5.2.5.8.4 Clean the floor using 2.5 % disinfectant solution as per schedule.
5.2.5.8.5 Clean the fire extinguisher with moist cloth.
5.2.5.9 Cleaning of washing area, sinks and drain points  
5.2.5.9.1 First clean the sink and drains by scrubbing with a nylon brush dipped in 0.1% v/v liquid soap.  

 

5.2.5.9.2 Wash it with sufficient quantity of tap water.
5.2.5.9.3 Then put about 150 ml of 5 % v/v disinfectant solution and allow remaining wet for sufficient time.
5.2.5.9.4 Clean the washing area floor as mentioned in the step no. 5.2.5.8.1 to 5.2.5.8.4
5.2.5.9.5 Finally wash the sink, floor and drain with tap water and wipe properly.
5.2.5.10 Cleaning aids  
5.2.5.10.1 After completion of cleaning process take all the cleaning aids to the wash area for cleaning.  
5.2.5.10.2 Clean the mop by dipping and squeezing in tap water then clean by dipping in soap solution finally wash with tap water.
5.2.5.10.3 Clean wiper/squeegees by rubbing with soap solution.
5.2.5.10.4 Keep the cleaning aids for drying.
5.2.5.10.5 The empty containers of disinfectants should be transferred to scrap yard after   defacing the label and rinsing with tap water.
5.2.5.11 Documentation and records  
5.2.5.11.1 Records of cleaning of general areas shall be maintained as specified in Annexure.  
5.2.5.11.2 Cleaning records shall be retrieved periodically to the QA Department.

 

  1. Abbreviation:
Abbreviation Expansion
SOP Standard Operating Procedure
QA Quality Assurance
QC Quality Control
ml Millilitre
%                         Percent
v/v Volume by volume
w/v Weight by volume

*Note – Ready to use SOP available in “DOWNLOAD” Section.

Categories
HR SOP

SOP Title: Medical Examination of Personnel

SOP Title: Medical Examination of Personnel

 

  1. Objective:

To lay down procedure for ensuring health and medical fitness of every personnel working in the premise

  1. Scope:

This SOP is applicable to all personnel working in Production, Quality Control, Quality Assurance, Warehouse, Engineering, Purchase/Account and HR/Administration department.

  1. Responsibility:

*HOD Administration/HR departments is responsible for arranging the medical check-up of new recruit before joining the duties and at periodical interval.

*All Department Heads are responsible to ensure that all personnel working in the departments have undergone health check up and medical examination

  1. Accountability:

Head HR/Administration and all departments’ heads

  1. Procedure:

5.1  Definitions:

Medical examination and Health Checkups: An examination carried out to determine the physical fitness of applicant/personnel to perform the respective job prior to or during employment.

5.2  Procedure:

5.2.1 All personnel who will supposed to work in Production, Quality Control, Quality Assurance, Warehouse, Engineering, Purchase/Account and HR/Administration department shall undergo medical examination prior to employment  
5.2.2 Medical examination  
5.2.2.1 Medical examination shall include-

1- Physical examination, (weight height, pulse rate, Blood Pressure., distant vision, near vision, colour vision test, respiratory test, heart rate, mouth checks, hearing etc).

2- Pathological investigation which includes blood test and urine test are to be performed.

3- If the age of the personnel is more than 40 years he/she has to undergo for Electrocardiogram (ECG) test

 
5.2.3 Procedure of medical examination  
5.2.3.1 For new employee, he/she shall be sent to the authorized medical centre as mentioned below for medical examination prior to assign duties  
5.2.3.2 For periodical medical examination the qualified physician from the certified centre as mentioned below shall be called for the examination.  
5.2.3.3 All departments’ heads and personnel shall be informed to undergo medical examination so that presence of all personnel can be ensured.

All medical examinations shall be carried out in the premises of the company.

 
5.2.3.4 Proper arrangement for effective medical examination and presence of personnel shall be ensured during examination.  
5.2.3.5 After obtaining reports of medical examination it shall be ensured that all reports are filled, and duly signed with a remark by the Physician.  
5.2.3.6 In case, if any pathological tests shall be recommended by the physician it shall be done under the observation of the physician and a clear remark shall be given whether he can be absorbed in working till the report comes.  
5.2.3.7 In case a person found unfit for the job or affected by any contagious disease he/she shall not be employed or allowed to perform the respective job and shall be advised for further necessary treatment.  
5.2.3.8 After completion of the treatment the employee shall be allowed to resume his/her duties after obtaining medical fitness certified by qualified physician.  
5.2.4 Schedule of medical examination  
5.2.4.1 1- Initial medical examination prior to assigning job

2- Periodical medical examination once in a year

3- As and when any health illness is noticed 

 
5.2.5 Documentation and records  
5.2.5.1 After completion of the medical examination a record of examination of all personnel shall be maintained in a file.  
5.2.5.2 A consent letter of the Physician shall be kept that he is certified and responsible for the medical examination of the personnel.  

 

  1. Abbreviation:
Abbreviation Expansion
SOP Standard Operating Procedure
QAP Quality Assurance Procedure
AMD Administration Department
HR Human Resource

*Note – Ready to use SOP available in “DOWNLOAD” Section.

 

Categories
HR SOP

SOP Title: Laundering of Garments

SOP Title: Laundering of Garments

 

  1. Objective:

To lay down procedure for laundering of garments used by the personnel for working in the departments at the site.

  1. Scope:

This procedure is applicable to all garments used by personnel working at the site and visitors visiting the facility.

  1. Responsibility:

All Departments: To follow the procedure in the facility and cooperate in maintaining cleanliness hygiene and compliance with GMP gowning system.

HR/Administration Department: To ensure that the laundering procedure is followed meticulously and provide necessary arrangements.

QA Department: To set the procedure and ensure compliance of the procedure in the site.

  1. Accountability:

Head HR/Administration and QA Department

  1. Procedure:

5.1  Definitions:

Laundering: Include organized system for cleaning of garments used by the personnel to ensure that the cleaned garments free from any contaminants/residue are available for use in the facility.

 

5.2  Procedure:

5.2.1 Collection of used garments  
5.2.1.1 Garments used in the departments or any operation by the personnel shall be put in the dedicated ‘Used Garment Bin’ provided in respective departments change rooms.  
5.2.1.2 The used garments shall be collected into poly bags, closed with cable tie and transferred to the Garment rooms.  
5.2.1.3 Used garments shall be kept separately in the garment room and counted for total number for each type of piece.  
5.2.1.4 Total count of individual type of piece shall be recorded in Annexure and a copy of the same shall be sent to the contractor each time for his reference.  
5.2.2 Sending garments for outside cleaning and receiving cleaned garments  
5.2.2.1 After counting, these garments shall be packed in the poly bags, tied with cable tie and send to the outside contractor for cleaning along with the copy of filled ‘Garment Cleaning Slip’ and returnable gate pass.  
5.2.2.2 The garments shall be sent to the contractor through company vehicle or outside service vehicle in safe manner.  
5.2.2.3 After cleaning garments shall be received along with the Garment Cleaning Slip and verified against the sent quantity.  
5.2.2.4 If any garments are found to be short (less), it shall be brought to the notice of the laundry man and recorded on the challan and Garment Cleaning Slip.  
5.2.2.5 The record of the receiving of shortcoming garment shall be updated after receiving the same.  
5.2.2.6 The above record of garment cleaning shall be filed and maintained.  
5.2.3 Garment cleaning procedure  
5.2.3.1 Count and verify the garments quantity with the slip received along with the garments and make ready for clean.  
5.2.3.2 Observe the garments carefully for any oil spot, chemicals or other sticky spots if observed, remove it with solvents prior to washing.  
5.2.3.3 Dip the above treated garments in a soap solution (50 gm detergent in 10 litres of water i.e. 0.5 %) at a temperature between 40 to 450C and centrifuge for 15 to 20 minutes.  
5.2.3.4 Squeeze the above treated garments and dip in a drum of fresh water then again rotated for 10 minutes and with another change of fresh water these are placed for drying.  
5.2.3.5 Dry the cleaned garments either by centrifugal method or by drying in blowing warm air.  Drying in direct sunlight shall be always avoided.  
5.2.3.6 Iron or press the dried garments.  
5.2.3.7 Count the cleaned ironed garments, pack in the clean poly bag and tie to close properly.  
5.2.3.8 Fill and sign the Garment Cleaning Slip.  
5.2.3.9 Send the cleaned garments to the manufacturer along with the Garment Cleaning Slip and challan.  
5.2.4 Storage and maintenance of garments  
5.2.4.1 Cleaned garments shall be stored in dedicated garment room with separate area/racks clean and unclean garments.  
5.2.4.2 The garment room shall be maintained in cleaned and sanitary state at all time.  
5.2.4.3 Cleaned Garments shall be issued to the departments as per the requirement and kept in the respective change room.  
5.2.5 Laundry facility inspection and contract  
5.2.5.1 The facility for laundry of garments shall be inspected initially before contract agreement and thereafter annually.  
5.2.5.2 Inspection shall be carried out with the objective to evaluate and assess the capability of the laundry facility/service with respect to implementation of cleaning procedure and hygienic practices.  
5.2.5.3 After compliance of the inspection objectives, the contract shall be made with written consent letter.  

 

  1. Abbreviation:
Abbreviation Expansion
 SOP Standard Operating Procedure
QA Quality Assurance
GMP Good Manufacturing Practice

 

*Note – Ready to use SOP available in “DOWNLOAD” Section.

 

Categories
HR SOP

SOP Title: Clothing, Hygiene and Entry of Personnel

SOP Title: Clothing, Hygiene and Entry of Personnel

  1. Objective:

To lay down formal guideline for clothing, hygiene and entry of personnel at the site.

  1. Scope:

This procedure is applicable to all personnel working at the site and visitors visiting the facility.

  1. Responsibility:

All Departments: To follow the procedure in the facility and cooperate in maintaining cleanliness and hygiene.

HR/Administration Department: To ensure that the procedure is followed meticulously and provide necessary arrangements.

QA Department: To set the procedure and ensure compliance of the procedure in the site.

  1. Accountability:

Head HR/ Administration and QA Department

  1. Procedure:

5.1  Definitions:

Clothing: Includes all sorts of apparel worn or to be worn by personnel working in the site as per the requirements of the activity/department for GMP compliance.

Hygiene: Includes health maintenance or system of principles for preservation of health, prevention of disease, sanitary practices and thereby prevention of contamination in the site.

 

5.2  Procedure:

5.2.1 All personnel entering the site shall be guided and trained to follow the clothing practice to maintain hygiene.  
5.2.2 The following basic requirements shall be provided necessarily to follow the procedure:

·         Clean dresses and foot wear (area specific).

·         Facilities to keep their belongings (lockers).

·         Facilities for washing and drying.

·         Facilities for disinfection of hands.

·         Facility for keeping food material in the canteen.

·         Facilities for wearing specific equipment (PPE) wherever required.

 
5.2.3 Personnel Hygiene  
5.2.3.1 Following instructions shall be followed strictly in the site as prime responsibility:

·         Keep hairs short and clean.

·         Keep their nails trimmed.

·         Keep beard shaved.

·         In case of disease or illness inform the Concern Head and resume duty after medical fitness certification.

·         Do not spread the things at working area; use waste bin provided.

·         Drinking, chewing, smoking and eating inside facility are strictly. prohibited.

·         Don’t use any cosmetics while working in the Production, QC and Warehouse area.

 

 

 

 

 

5.2.4 Clothing and Entry

Following clothing system shall be followed for clothing inside the premise:

5.2.4.1 Primary Gowning  
5.2.4.1.1 White colour lab coat, trouser shall be worn for QC personnel.  
5.2.4.1.2 White colour lab coat, trouser, cap and mask shall be worn by Production, QA and Warehouse personnel.  
5.2.4.1.3  Blue colour lab coat, trouser, cap and mask shall be worn by Engineering personnel.  
5.2.4.1.4 White colour lab coat, trouser, cap and mask shall be worn by Visitors or Disposable Gowning may be provided.  
5.2.4.1.5 Green colour lab coat, trouser, cap and mask shall be worn by Housekeeping personnel.  
5.2.4.1.6 All the primary gowning shall be provided in the respective general change rooms.  
5.2.4.1.7 Procedure for entry and exit shall be followed as per QA SOP.  
5.2.4.2 Foot wares  
5.2.4.2.1 Black colour safety shoes shall be used by all QC and Engineering personnel. White colour rubber shoes shall be used by all Production and Warehouse personnel in core area. Street shoes shall be used outside the general/primary change room during tea time, lunch time or other departmental work movements. The shoes shall be provided in the respective general change rooms.  
5.2.4.2.2 Visitor shall be guided to wear specified shoe covers while entering QC, Production or Warehouse Departments through general change rooms.  
5.2.4.3 Entry  
5.2.4.3.1 All the critical areas in the site shall be provided with restricted entry (access to authorised personnel only).  
5.2.4.3.2 Current approved procedure shall be followed for entry/exit to these areas.  
5.2.4.3.3 Visitors shall be accompanied and guided by the Concerned Department Head or QA Head for entry to the critical areas.  

 

  1. Abbreviation:
SOP Standard Operating Procedure
PPE Personnel Protective Equipment
i.e. Id Est (that is)
QA Quality Assurance
QC Quality Control

 

*Note – Ready to use SOP available in “DOWNLOAD” Section.

 

Categories
HR SOP

SOP Title: Pests Control

SOP Title: Pests Control

  1. Objective:

To lay down procedure for pests and rodents control in the site to prevent entry of pests, rodents, vermin etc and maintain cleanliness and hygiene.

  1. Scope:

This procedure is applicable to entrance of critical areas i.e. Production, Quality Control, Warehouse, periphery of the building and other vulnerable areas where the risk of pest and rodent entry/harbouring exists.

  1. Responsibility:

Administration Departments: To follow the procedure and ensure that corrective and preventive measures for control of pest and rodents, if ineffectiveness of procedure or service is noticed.

Concerned Department: To ensure that the pests and rodents control service is provided in their respective department and to inspect that the procedure is being followed.

QA Departments: To prepare and approve the procedure and to ensure compliance of the procedure.

  1. Accountability:

Head, Administration and QA Department

  1. Procedure:

5.1  Definitions:

Pests: Includes birds, bats, rodents and insects whose uncontrolled presence affects hygiene and cleanliness.

Rodents: Includes rats, mice, squirrel, and other animals belonging to the class rodent. 

5.2  Procedure:

5.2.1 All the areas and entrances to the critical areas i.e. production, QC, warehouse HVAC service floor shall be identified and facilitated with the effective pest control system.  
5.2.2 Following areas shall be covered under the pest and rodent control system:  
5.2.2.1 Critical areas: Manufacturing, packaging, QC Laboratory, Warehouses, and Critical Utility.  
5.2.2.1 Non critical areas: Offices, Canteen, Boiler House, Generator Room,  Maintenance Store, Flammable Store, Utility Areas, Periphery of the building etc.
5.2.3 Equipment/Chemical Used  
5.2.3.1 .     Fly control units

·         Rodent trap

·         Rodent toxic

·         Rodent Non-toxic

·         Pesticides

 
5.2.4 Physical Barrier  
5.2.4.1 All the doors to the critical areas shall be kept closed at all time.  
5.2.4.2 Air curtains or physical barrier shall be provided and kept in operation at entry gate to the critical areas where applicable.
5.2.4.3 All the windows or open ventilation facility to critical or non critical areas (if

any) shall be provided with physical barrier like filters or louver etc to protect from external environment.

5.2.5 Control of Pests  
5.2.5.1 The pest control treatment is given to protect from flies i.e. house flies, flesh flies, other insects like cockroaches, ants etc.  
5.2.5.2 The treatments include placing insect light trap or fly control units at the strategic locations and keep it in operation every time.  
5.2.5.3 Treatment by space spray of insecticide shall also be given in all the susceptible nooks and corners to control other insects.

 

Note: Pest and rodent control treatment shall be done in such a way that shall not adversely affect the cleanliness and hygiene of the area. The treatment process to control pests and rodents shall be carried out outside the general change room or main entry.

 
5.2.6 Control of Rodents  
5.2.6.1 The pest control treatment is given to protect from rodents i.e. rats, mice or other crawling rodents.  
5.2.6.2 The treatments include placing rodent trap at the strategic locations in the site and keeping it in operation in all time.
5.2.6.3 The traps are provided with bait and replaced after use.
5.2.7 Routine Inspection/Monitoring  
5.2.7.1 All the services and facility provided for the pest and rodent control shall be monitored routinely for their correct working and observation of pests /rodents.  
5.2.7.2 Pest control units and Rodent traps shall be cleaned as and when required to maintain hygiene and working operation.  
5.2.7.3 For pesticide spray external agency personnel shall be monitored during spraying of pesticide.  
5.2.7.4 After an infestation has been reported or found on routine inspections, it shall be reported and analysed for associated risk and cause.  
5.2.7.5 Adequate preventive measures shall be taken when there is frequent infestation or observance of pest or rodents.  
5.2.7.6 External services for identification of cause and necessary preventive measure shall be granted, if required.  
5.2.8 Annual Report  
5.2.8.1 A report shall be prepared annually and record shall be maintained including details like observance of infestation, risk assessment, preventive measures taken and product/material/system/activity affected.  
5.2.8.2 Reports requiring urgent attention and remedial actions involving extra expenditure shall be brought to the notice of management.  
5.2.9 Pesticides MSDS  
5.2.9.1 MSDS for pesticides used shall be obtained and referred during use. This must be approved under Pesticides Regulation. Pesticide shall be verified and approved by QA Head before use in the site.  
5.2.10 Contractor (External Agency)  
5.2.10.1 External Pest Control agency services shall be hired for pest and rodent control at site.  
5.2.10.2 Pest Control Frequency:- Weekly Basis  

 

  1. Abbreviation:
SOP Standard Operating Procedure
MSDS Material Safety Data Sheet
i.e. Id Est (that is)
HVAC Heating Ventilation and Air Conditioning

 

*Note – Ready to use SOP available in “DOWNLOAD” Section.

 

Categories
HR SOP

SOP Title: Administration/HR Procedure

SOP Title: Administration/HR Procedure

  1. Objective:

To lay down procedure for administrative instructions at the site.

  1. Scope:

This procedure is applicable to all personnel working at the site.

  1. Responsibility:

All Personnel: To follow the administrative procedure and rules.

Administration Department: To ensure proper communication and compliance of the instructions and rules.

  1. Accountability:

Head Administration

  1. Procedure:
1 All personnel should enter the gate well before the time and be present on time in their respective departments.  
2 All personnel should make their check in and checkout entry into the fingerprint punching machine (Biometric System) provided at the reception.  
3 Attendance should also be made into the Attendance Register for reference purpose.  
4 Personnel should wear formal dresses only.  
5 Personnel should keep their lunch box in the respective lockers provided in the canteen.  
6 Personnel should maintain cleanliness and neatness in the respective departments.  
7 Personnel should keep gentle and soft voice in the premise.  
8 Before leaving for lunch and tea ensure that light and machines in the working area are put off.  
9 Before winding up the day ensure that the doors, windows are closed and lights, computers and other electronic gadgets are put off.  
10 Ensure that the water is not wasted in any department and any leakage is to be reported immediately to the Engineering Department.  
11 Ensure that papers, stationeries and other consumables are not misused or wasted in the premise.  
12 Ensure that telephones and other electronic media are utilized for office purpose only.  
13 Ensure that the leaves are taken as per leave policy only.  
14 Ensure that Gate Pass is done while going for official work.  
  1. Abbreviation:
SOP Standard Operating Procedure
AMD Administration Department
QA Quality Assurance

 

 

*Note – Ready to use SOP available in “DOWNLOAD” Section.

 

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