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Fitter Mechanical-Life Sciences APPRENTICESHIP CURRICULUM FOR FITTER MECHANICAL-LIFE SCIENCES Program SECTOR: Life Sciences BLOCK I (Basic Training): COURSE NAME: Fitter Mechanical-Life Sciences QP Name, QP Code and Version No., and NSQF Level: Fitter Mechanical, LFS/Q0213 V1.0, NSQF Level 3 Training Duration: 260 Hrs (1.4 months) BLOCK II (Training at Employer Location): COURSE NAME: Fitter Mechanical-Life Sciences QP Name, QP Code and Version No., NSQF Level: Fitter Mechanical, LFS/Q0213 V1.0, NSQF Level 3 Training Duration: 2044 Hrs (10.6 months) TOTAL PROGRAM DURATION: 2304 Hrs (12 months)

FOR FITTER MECHANICAL-LIFE SCIENCES Program

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Page 1: FOR FITTER MECHANICAL-LIFE SCIENCES Program

Fitter Mechanical-Life Sciences

APPRENTICESHIP CURRICULUM

FOR

FITTER MECHANICAL-LIFE SCIENCES

Program

SECTOR: Life Sciences

BLOCK I (Basic Training):

COURSE NAME: Fitter Mechanical-Life Sciences

QP Name, QP Code and Version No., and NSQF Level: Fitter

Mechanical, LFS/Q0213 V1.0, NSQF

Level 3

Training Duration: 260 Hrs (1.4 months)

BLOCK II (Training at Employer Location):

COURSE NAME: Fitter Mechanical-Life Sciences

QP Name, QP Code and Version No., NSQF Level: Fitter

Mechanical, LFS/Q0213 V1.0, NSQF

Level 3

Training Duration: 2044 Hrs (10.6 months)

TOTAL PROGRAM DURATION: 2304 Hrs (12 months)

Page 2: FOR FITTER MECHANICAL-LIFE SCIENCES Program

Fitter Mechanical-Life Sciences 2

Table of Contents

PROGRAM CURRICULUM .................................................................................................. 3

Basic Training (Block I) ...................................................................................................... 5

General Information ........................................................................................................ 5

Curriculum ....................................................................................................................... 7

Hands-On at Employer Location (Block II) ...................................................................... 15

General Information ...................................................................................................... 15

Curriculum ..................................................................................................................... 17

Assessment Criteria ...................................................................................................... 24

Annexure I: Tools and Equipment for Basic Training (Block I) ..................................... 30

Annexure II: Tools and Equipment for Hands-On at Employer Location (Block II) ...... 35

Further Learning ............................................................................................................... 40

Learning Pathways ........................................................................................................ 40

Employment Opportunities ........................................................................................... 40

Page 3: FOR FITTER MECHANICAL-LIFE SCIENCES Program

Fitter Mechanical-Life Sciences 3

PROGRAM CURRICULUM

Program Name Fitter Mechanical-Life Sciences

Program Duration 2304 Hrs (12 months)

Version No. 1.0 Version Update Date 04/12/18

Entry Qualification Educational and/or Technical Qualification Required

Minimum qualification – 10+2 Maximum qualification – Diploma/ ITI Experience – 0-2 years

Block 1 Training Outcomes for Fitter Mechanical-Life Sciences

After completing this programme, participants will be able to:

• Outline Fitter Mechanical / helper job description and responsibilities.

• Support supervisors in the mechanical job work of maintenance process, in carrying out maintenance activities for various utilities and production equipment.

• Assemble and install infrastructure according to the specifications as per SOPs and manuals

• Carry out proper reporting and documentation

• Maintain a healthy, safe, and secure working environment in the life sciences facility by learning managing emergency situations and their results.

• Practice professional skills at work

Block II Training Outcomes for Fitter Mechanical-Life Sciences

After completing this programme, participants will be able to:

• Explain the salient aspects of the life sciences industry and its pertinent regulations in order to demonstrate performance that is in line with industry standards.

• Support supervisors in the mechanical job work of maintenance process, in carrying out maintenance activities for various utilities and production equipment.

• Assemble and install infrastructure according to the specifications as per SOPs and manuals

• Recall detailed norms pertaining to GMP, good documentation practices, and 5S guidelines. and perform documentation to receive and store goods in a store/ warehouse.

• Maintain a healthy, safe and secure working environment in the life sciences facility by learning managing emergency situations and their results.

• Practice core communication skills and professional skills at the workplace such as planning and organizing, problem-solving, decision-making, using analytical and critical skills, and demonstrating a customer-centric approach.

Note: 1 week has 48 hours of learning (8 hrs a day x 6 days a week). For example:

S. No.

QP2 Durations (in hrs) Weeks Months

1 1152 24 6

2 1728 36 9

3 2304 48 12

Page 4: FOR FITTER MECHANICAL-LIFE SCIENCES Program

Fitter Mechanical-Life Sciences 4

Block I: This is a training block done in the Instructor-Led training approach, with theory and

practical sessions. The training sessions may be held at training provider’s premises.

Block II: This is a training block done at the Employer location. This is largely hands-on with

inputs/ guidance provided by the on-site mentors and supervisors. The employer may conduct

instructor-led sessions in classrooms/ workshops and may also look at new age – technology-

based performance support tools for additional support.

Page 5: FOR FITTER MECHANICAL-LIFE SCIENCES Program

Fitter Mechanical-Life Sciences 5

Basic Training (Block I)

General Information

1. Course Name: Fitter Mechanical-Life Sciences

2. QP Code with Version No. and QP Name: LFS/Q0213, V1.0, Fitter Mechanical

3. NSQF Level: 3

4. Theory hours: 120 Hrs

5. Practical hours: 140 Hrs

6. Batch Size: 30

7. Power Norms: 6 KW for Workshop

8. Space Norms: 10 (x20=200sq) feet

9. Assessment: QP based assessment is conducted by an Assessment Agency as deputed by

the Life Sciences Sector Skill Development Council.

10. Tools, Equipment, and Machinery required: As per Annexure I

11. Trainer Qualification: Trainer Prerequisites for Course: Fitter Mechanical-Life Sciences

Sr. No.

Area Details

1 Job Description

To deliver accredited training service, mapping to the curriculum detailed above, in accordance with the Qualification Pack “LFS/Q0213, V1.0”.

2 Personal Attributes

Aptitude for conducting training, and pre/ post work to ensure competent, employable candidates at the end of the training. Strong communication skills, interpersonal skills, ability to work as part of a team; a passion for quality and for developing others; well-organised and focused, eager to learn and keep oneself updated with the latest in the mentioned field.

3 Minimum Educational Qualifications

12th Pass/ ITI

4a Domain Certification

Certified for Job Role: “Fitter Mechanical - Life Sciences” mapped to QP: “LFS/Q0213, V1.0”. Minimum accepted score is 80% as per LSSSDC guidelines.

4b Platform Certification

Recommended that the Trainer is certified for the Job Role: “Trainer”, mapped to the Qualification Pack: “MEP/Q0102”. Minimum accepted score is 80% as per LSSSDC guidelines.

5 Experience Minimum Four (4) years’ experience in life sciences Fitting/ Maintenance/ Engineering department (Manufacturing occupation) out of total Min. Six (6) years’ experience for non-trained and non-qualified talent with 12th Class pass education qualification Or Minimum Three (3) years’ experience in life sciences Fitting/ Maintenance/ Engineering department (Manufacturing occupation) out of total Min. Six

Page 6: FOR FITTER MECHANICAL-LIFE SCIENCES Program

Fitter Mechanical-Life Sciences 6

(6) years’ experience for non-trained and non-qualified talent with ITI Fitter qualification Or Minimum Two (2) years’ experience in life sciences Fitting/ Maintenance/ Engineering department (Manufacturing occupation) out of total Min. Four (4) years’ experience for non-trained and non-qualified talent with Polytechnic Diploma/ Graduation education qualification Or Minimum One (1) years’ experience in life sciences Fitting/ Maintenance/ Engineering department (Manufacturing occupation) out of total Min. Two (2) years’ experience for non-trained and non-qualified talent with M. Tech (Mechanical Engineering) education qualification Or Minimum Three (3) years’ experience in life sciences Fitting/ Maintenance/ Engineering department (Manufacturing occupation) with Fitter Mechanical -Life Sciences Level-3 qualification

Page 7: FOR FITTER MECHANICAL-LIFE SCIENCES Program

Fitter Mechanical-Life Sciences 7

Curriculum Block I is aimed at training candidates for the course of a “Fitter Mechanical-Life Sciences”, in the

“Life Sciences” Sector/Industry and aims at building the following key competencies amongst the

learner.

S.

No.

Module Name Key Learning Outcomes Equipment Required

1. Orientation Theory Duration (hh:mm) 10:00 Practical Duration (hh:mm) 00:00 Corresponding NOS Code Bridge Module

• Explain the overview of Life Sciences Industry in Indian and Global context

• Explain the opportunities in pharmaceutical & biopharmaceutical sub-sector of Life Sciences Industry

• Explain the manufacturing basics in life sciences sector and good manufacturing practices

• Recall the organization structure and employment benefits in Life Sciences organizations.

• Identify typical mechanical maintenance activities of a manufacturing function in a Life Sciences organization.

• Outline the role of a Fitter Mechanical, required skills and knowledge (as per Qualification Pack) including its career path

• Follow legislation, GxP standards, policies, regulations and procedures used in the life sciences organization relevant to fitter mechanical job role

GMP Guideline Book, White Board, White Board Duster, White Board Marker, White Screen, Flip Charts, Laser Pointer, Permanent Markers, MS Office, Projector, Sound System with Mike

2. Ensure Healthy, Safe and Secure Workplace Theory Duration (hh:mm) 10:00 Practical Duration (hh:mm) 10:00 Corresponding NOS Code LFS/N0101

• Identify relevant health and safety requirements applicable in the work place

• Identify importance of working in clean and safe environment in life sciences Industry

• Recall the basic concepts of safety including hazards, accidents, safety signs and signals and Heinrich pyramid and practice same at shop floor

• Outline functioning of utility systems at plant

• Use engineering related tools and techniques to operate the machine safely

• Follow the clean room practices

• Use material safety data sheet and follow the process of safety analysis

• Follow the fire safety concepts and prepare oneself to act in case of fire emergency at shop floor.

ABC Type Fire Extinguisher, Chemical Absorbent Roll, Face Mask (Full Face), Face Mask (Half Face), Gloves({Heat, Acid, Chemical} Resistant), Gloves(Nitrile), Gum Boots, Helmet, Lab Coat, Manual Bottle Eye Washer, PVC Apron, Safety Goggles, Safety Shoes, Self-Contained Breathing Apparatus, Various Mask Cartridges, GMP Guideline Book, White Board, White Board Duster, White Board Marker, White Screen, Flip Charts, Laser Pointer, Permanent Markers, MS Office, Projector

Page 8: FOR FITTER MECHANICAL-LIFE SCIENCES Program

Fitter Mechanical-Life Sciences 8

• Provide the critical information to concerned team members and supervisor

• Comply with health and safety, environmental and other relevant regulations and guidelines at work

• Follow procedures and guidelines for personal protective equipment (PPE) and other relevant safety regulations while performing maintenance activities

• Ensure that work area is clean and safe from hazards

• Follow the emergency procedures and perform first aid in case of accident

• Practice professional skills

3. Perform Fitting and Assembly operations on Metal Components Theory Duration (hh:mm) 40:00 Practical Duration (hh:mm) 56:00 Corresponding NOS Code LFS/N0260

• Perform basic steps of measurement, mathematical calculations and understand engineering terminology

• Extract and use information from engineering drawings and related specifications in relation to work undertaken

• Interpret first and third angle drawings, imperial and metric systems of measurement, workpiece reference points and system of tolerancing (geometric dimensioning and tolerancing -- GD&T)

• Use the basic marking devices and prepare suitable datum using basic marking devices

• Follow mark-out conventions when marking out the workpiece

• Calibrate the basic marking devices

• Use tools for proper assembly of infrastructure by adjusting their parts in proper order for installation

• Follow standard steps while performing different fitting operations

• Identify the requirement of assembly or maintenance of manufacturing parts and processing in life sciences sector

• Prepare materials for the marking out activities, in order to enhance clarity, accuracy and safety

• Perform various fitting activities as per SOP

• Use right method of holding the workpiece for hand fitting, drilling, threading activities

• Use correct method of mounting the workpiece

ABC Type Fire Extinguisher, Assembling Operations Tools: Bolts, Assembling Operations Tools: Cap Screws, Assembling Operations Tools: External Circlips, Assembling Operations Tools: Internal Circlips, Assembling Operations Tools: Nuts, Assembling Operations Tools: Nuts, Bolts, Machine Screws, Cap Screws ; External Circlips, Internal Circlips, Special Clips; Tab Washers, Locking Nuts, Wire Locks, Shimming And Packing, Assembling Operations Tools:Foiler, Assembling Operations Tools: Hammer, Assembling Operations Tools: Locking Nuts, Assembling Operations Tools: Machine Screws, Assembling Operations Tools:Plier, Assembling Operations Tools: Shimming And Packing, Assembling Operations Tools: Special Clips, Assembling Operations Tools: Tab Washers, Assembling Operations Tools: Wire Locks, Chemical Absorbent Roll, Conventional Lathe Machine, Conventional Milling Machine, Drilling Machine: Pedestal Drilling Machine, Drilling Machine: Portable, Eye Washer With Sprinkler, Face Mask (Full Face), Face Mask (Half

Page 9: FOR FITTER MECHANICAL-LIFE SCIENCES Program

Fitter Mechanical-Life Sciences 9

• Use appropriate methods of aligning, adjusting and positioning components before securing them

• Make use of application of cutting fluids and compounds with regards to range of different materials

• Use the measuring equipment for mechanical assembly and maintenance work

• Explain job requirements as per the job work card

• Select appropriate equipment, parts and accessories for general machining and fitting or assembling operations

• Obtain and use calibrated measuring equipment

• Mark out range of features on the components

• Cut and shape material to required specifications using hand fitting methods

• Assemble and secure the components and sub-assemblies in their correct positions using correct and appropriate methods as per SOP

• Fasten components permanently using engineering fasteners, adhesives, soldering and brazing.

• Dismantle mechanical assemblies without damaging components or sub-assemblies using procedures for isolation and locking off a device / system

• Check dimensional accuracy by measuring linear dimensions, diameters, flatness, squareness, angles, profiles, hole size and position, thread size and fit

Face), Flexible Shaft Grinding Machine, Flexible Shaft Grinding Machine, Forklift, Generator, Geometric Dimensioning Tool, Gloves({Heat, Acid, Chemical} Resistant), Gloves(Nitrile), Grinding Machine: Ag4 Grinder, Gum Boots, Helmet, Lab Coat, Manual Bottle Eye Washer, Marking Equipments: Permanent Markers, Marking Equipments: Protractor, Marking Equipments: Punches, Marking Equipment: Scribers, Marking Equipments: Scribers, Punches, Scribing Blocks, Squares, Protractor, Marking Equipments: Scribing Blocks, Marking Equipments: Squares, Material Safety Data Sheet, Measuring Equipment : External Micrometres, Measuring Equipment : Vernier/Digital/Dial Calliper, PVC Apron, Safety Goggles, Safety Shoes, Sample Job Card, Sample Log Books, Sample Machine History Record, Sample Machine Inspection Record, Sample Maintenance Schedule, Sample Shift Schedule, Self-Contained Breathing Apparatus, Surface Finish Equipment ;Bore Gauges, Surface Finish Equipment ;Depth Micrometres, Surface Finish Equipment ;Depth Verniers, Surface Finish Equipment ;Feeler Gauges, Surface Finish Equipment ;Height Gauge, Surface Finish Equipment ;Hole Gauges, Surface Finish Equipment ;Profile Gauges, Surface Finish Equipment ;Protractors, Surface Finish Equipment ;Radius Gauges, Surface Finish Equipment ;Rules, Surface Finish Equipment ;Slip Gauges, Surface Finish Equipment ;Thread Gauges, Surface Finish

Page 10: FOR FITTER MECHANICAL-LIFE SCIENCES Program

Fitter Mechanical-Life Sciences 10

Equipment ;Try Squares, Tolerancing Tool, Trolly, Various Mask Cartridges, Vice Mounted Tables, Computer, Computer Work desk, GMP Guideline Book, White Board, White Board Duster, White Board Marker, White Screen, Flip Charts, Laser Pointer, Permanent Markers, MS Office, Projector, Sound System With Mike

4 Perform maintenance activities on mechanical equipment/ machinery Theory Duration (hh:mm) 40:00 Practical Duration (hh:mm) 56:00 Corresponding NOS Code LFS/N0261

• Follow the safety procedures and protocols for use of equipment

• Adhere to procedures and guidelines for personal protective equipment (PPE) and other relevant safety regulations while performing mechanical fitting and maintenance operations

• Keep work area clean and safe from hazards

• Follow procedures to keep all tools, equipment, power tool cables, extension leads in a safe and usable condition

• Prepare machine for maintenance operation

• Interpret the job requirements, required instruments and tools from the job card

• Identify the interdependencies of the machine under maintenance and estimate the timelines

• Perform fault diagnosis using the different tools and diagnostic techniques

• Carry out test procedures using correct testing equipment as per SOP

• Carry out fault diagnostic analysis and risk analysis of fault and complete documentation as per SOP

• Carry out maintenance activities on utilities; machine tool; lifting and handling equipment; processing plant; production plant; engines; pumps; process control valves; compressors; transfer equipment; mechanical structures; work-holding devices

• Perform dismantling processes as per laid out procedure in manuals and SOP

• Reassemble the components using correct methods

ABC Type Fire Extinguisher, Assembling Operations Tools: Bolts, Assembling Operations Tools: Cap Screws, Assembling Operations Tools: External Circlips, Assembling Operations Tools: Internal Circlips, Assembling Operations Tools: Nuts, Assembling Operations Tools: Nuts, Bolts, Machine Screws, Cap Screws ; External Circlips, Internal Circlips, Special Clips; Tab Washers, Locking Nuts, Wire Locks, Shimming And Packing, Assembling Operations Tools: Foiler, Assembling Operations Tools: Hammer, Assembling Operations Tools: Locking Nuts, Assembling Operations Tools: Machine Screws, Assembling Operations Tools: Plier, Assembling Operations Tools: Shimming And Packing, Assembling Operations Tools: Special Clips, Assembling Operations Tools: Tab Washers, Assembling Operations Tools: Wire Locks, Chemical Absorbent Roll, Conventional Lathe Machine, Conventional Milling Machine, Drilling Machine: Pedestal Drilling Machine, Drilling Machine: Portable, Eye Washer With Sprinkler, Face Mask (Full Face), Face Mask (Half Face), Flexible Shaft Grinding Machine, Flexible Shaft Grinding Machine, Forklift, Generator,

Page 11: FOR FITTER MECHANICAL-LIFE SCIENCES Program

Fitter Mechanical-Life Sciences 11

• Document the change request as per SOP

• Perform replacement or refitting of basic hydraulic and pneumatic components like valves; seals; buckets; solenoid operated cylinders; clamping and positioning components; other basic components

• Perform trial run post maintenance activity to conform the job specification

• Record the observation and entire maintenance activity in the prescribed formats as per SOP and GMP

Geometric Dimensioning Tool, Gloves({Heat, Acid, Chemical} Resistant), Gloves(Nitrile), Grinding Machine: Ag4 Grinder, Gum Boots, Helmet, Lab Coat, Manual Bottle Eye Washer, Marking Equipments: Permanent Markers, Marking Equipments: Protractor, Marking Equipments: Punches, Marking Equipments: Scribers, Marking Equipments: Scribers, Punches, Scribing Blocks, Squares, Protractor, Marking Equipments: Scribing Blocks, Marking Equipments: Squares, Material Safety Data Sheet, Measuring Equipment : External Micrometres, Measuring Equipment : Vernier/Digital/Dial Calliper, PVC Apron, Safety Goggles, Safety Shoes, Sample Job Card, Sample Log Books, Sample Machine History Record, Sample Machine Inspection Record, Sample Maintenance Schedule, Sample Shift Schedule, Self-Contained Breathing Apparatus, Surface Finish Equipment ;Bore Gauges, Surface Finish Equipment ;Depth Micrometres, Surface Finish Equipment ;Depth Verniers, Surface Finish Equipment ;Feeler Gauges, Surface Finish Equipment ;Height Gauge, Surface Finish Equipment ;Hole Gauges, Surface Finish Equipment ;Profile Gauges, Surface Finish Equipment ;Protractors, Surface Finish Equipment ;Radius Gauges, Surface Finish Equipment ;Rules, Surface Finish Equipment ;Slip Gauges, Surface Finish Equipment ;Thread Gauges, Surface Finish Equipment ;Try Squares, Tolerancing Tool, Trolly, Various Mask Cartridges, Vice Mounted Tables,

Page 12: FOR FITTER MECHANICAL-LIFE SCIENCES Program

Fitter Mechanical-Life Sciences 12

Computer, Computer Work desk, GMP Guideline Book, White Board, White Board Duster, White Board Marker, White Screen, Flip Charts, Laser Pointer, Permanent Markers, MS Office, Projector, Sound System With Mike

5 Coordinate with Shift Supervisor, cross functional teams and within the team Theory Duration (hh:mm) 08:00 Practical Duration (hh:mm) 06:00 Corresponding NOS Code LFS/N0204

• Follow general reporting process, protocol and escalation policy.

• Submit the reports and other GMP and engineering related documents as per SOP

• Complete the shift handover documents as per SOP

• Use techniques for collaborating with other groups and divisions in order to achieve organizational goals

• Explain the importance of cGMP/QMS/ SOP related documentation

• Use the appropriate method for responding to audit queries

• Face internal audit interactions in English or local language

• Use IT tools in communication and coordination

• Practice core communication skills and professional skills to meet the work output requirements

• Maintain the quality standards in communication both written in verbal

• Proactively inform supervisor on issues requiring intervention

• Deliver quality work on time and report any anticipated reasons for delays resolve conflicts

• Interact with immediate supervisor and colleagues within the cross functional teams

Computer, Computer Work desk, GMP Guideline Book, White Board, White Board Duster, White Board Marker, White Screen, Flip Charts, Laser Pointer, Permanent Markers, MS Office, Projector, Sound System with Mike, Sample Job Card, Sample Log Books, Sample Machine History Record, Sample Machine Inspection Record, Sample Maintenance Schedule, Sample Shift Schedule

6 Transportation of Material and tools Theory Duration (hh:mm) 08:00 Practical Duration (hh:mm) 04:00 Corresponding NOS Code Bridge Module

• Follow correct methods of handling and moving of material, tools, machine and parts

• Perform basic physical activities as needed during assembly and maintenance operations

• Use the methods of driving, transport machineries and its maintenance

• Load & stack the stock and tools & transport them safely using trolley, forklift etc

• Inspect the obstructions in the path of transportation and remove them in safe conditions

Assembling Operations Tools: Bolts, Assembling Operations Tools: Cap Screws, Assembling Operations Tools: External Circlips, Assembling Operations Tools: Internal Circlips, Assembling Operations Tools: Nuts, Assembling Operations Tools: Nuts, Bolts, Machine Screws, Cap Screws ; External Circlips, Internal Circlips, Special Clips; Tab Washers, Locking Nuts,

Page 13: FOR FITTER MECHANICAL-LIFE SCIENCES Program

Fitter Mechanical-Life Sciences 13

Wire Locks, Shimming And Packing, Assembling Operations Tools: Foiler, Assembling Operations Tools: Hammer, Assembling Operations Tools: Locking Nuts, Assembling Operations Tools: Machine Screws, Assembling Operations Tools: Plier, Assembling Operations Tools: Shimming And Packing, Assembling Operations Tools: Special Clips, Assembling Operations Tools: Tab Washers, Assembling Operations Tools: Wire Locks, Chemical Absorbent Roll, Conventional Lathe Machine, Conventional Milling Machine, Drilling Machine: Pedestal Drilling Machine, Drilling Machine, Forklift, Grinding Machine: Ag4 Grinder, Gum Boots, Helmet

7 Information Security and IT Skills for Fitter Mechanical Theory Duration (hh:mm) 04:00 Practical Duration (hh:mm) 08:00 Corresponding NOS Code Bridge Module

• Maintain the confidentiality of the data and internal processes

• Use IT tools for data entry in e-documents wherever needed

• Maintain information security while using e-mail and other official communication channels

• Maintain online records

Computer, Computer Work desk, GMP Guideline Book, White Board, White Board Duster, White Board Marker, White Screen, Flip Charts, Laser Pointer, Permanent Markers, MS Office, Projector, Sound System with Mike, IT lab

Total Duration Theory Duration 120:00 Practical Duration 140:00

Unique Equipment Required: ABC Type Fire Extinguisher, Assembling Operations Tools: Bolts, Assembling Operations Tools: Cap Screws, Assembling Operations Tools: External Circlips, Assembling Operations Tools: Internal Circlips, Assembling Operations Tools: Nuts, Assembling Operations Tools: Nuts, Bolts, Machine Screws, Cap Screws ; External Circlips, Internal Circlips, Special Clips; Tab Washers, Locking Nuts, Wire Locks, Shimming And Packing, Assembling Operations Tools: Foiler, Assembling Operations Tools: Hammer, Assembling Operations Tools: Locking Nuts, Assembling Operations Tools: Machine Screws, Assembling Operations Tools: Plier, Assembling Operations Tools: Shimming And Packing, Assembling Operations Tools: Special Clips, Assembling Operations Tools: Tab Washers, Assembling Operations Tools: Wire Locks, Chemical Absorbent Roll, Conventional Lathe Machine, Conventional Milling Machine, Drilling Machine: Pedestal

Page 14: FOR FITTER MECHANICAL-LIFE SCIENCES Program

Fitter Mechanical-Life Sciences 14

Drilling Machine, Drilling Machine: Portable, Eye Washer With Sprinkler, Face Mask (Full Face), Face Mask (Half Face), Flexible Shaft Grinding Machine, Flexible Shaft Grinding Machine, Forklift, Generator, Geometric Dimensioning Tool, Gloves({Heat, Acid, Chemical} Resistant), Gloves(Nitrile), Grinding Machine: Ag4 Grinder, Gum Boots, Helmet, Lab Coat, Manual Bottle Eye Washer, Marking Equipments: Permanent Markers, Marking Equipments: Protractor, Marking Equipments: Punches, Marking Equipments: Scribers, Marking Equipments: Scribers, Punches, Scribing Blocks, Squares, Protractor, Marking Equipments: Scribing Blocks, Marking Equipments: Squares, Material Safety Data Sheet, Measuring Equipment : External Micrometres, Measuring Equipment : Vernier/Digital/Dial Calliper, PVC Apron, Safety Goggles, Safety Shoes, Sample Job Card, Sample Log Books, Sample Machine history Record, Sample Machine Inspection Record, Sample Maintenance Schedule, Sample Shift Schedule, Self-Contained Breathing Apparatus, Surface Finish Equipment ;Bore Gauges, Surface Finish Equipment ;Depth Micrometres, Surface Finish Equipment ;Depth Verniers, Surface Finish Equipment ;Feeler Gauges, Surface Finish Equipment ;Height Gauge, Surface Finish Equipment ;Hole Gauges, Surface Finish Equipment ;Profile Gauges, Surface Finish Equipment ;Protractors, Surface Finish Equipment ;Radius Gauges, Surface Finish Equipment ;Rules, Surface Finish Equipment ;Slip Gauges, Surface Finish Equipment ;Thread Gauges, Surface Finish Equipment ;Try Squares, Tolerancing Tool, Trolly, Various Mask Cartridges, Vice Mounted Tables, Computer, Computer Work desk, GMP Guideline Book, White Board, White Board Duster, White Board Marker, White Screen, Flip Charts, Laser Pointer, Permanent Markers, MS Office, Projector, Sound System with Mike

Grand Total Course Duration: 260 Hours, 0 Minutes

(This syllabus/ curriculum has been approved by Life Sciences Sector Skill Development

Council.)

Page 15: FOR FITTER MECHANICAL-LIFE SCIENCES Program

Fitter Mechanical-Life Sciences 15

Hands-On at Employer Location (Block II)

General Information

1. Name of the Course: Fitter Mechanical-Life Sciences

2. QP Code with Version No. and QP Name: LFS/Q0213, V1.0, Fitter Mechanical- Life

Sciences

3. NSQF Level: 3

4. Training Duration: 2044 Hrs

5. Batch Size: 30

6. Assessment: The Life Sciences Sector Skill Development Council (LSSSDC) will conduct

the assessment at the end of Block II.

7. Tools, Equipment, and Machinery required: As per Annexure I

8. Trainer Qualification: Trainer Prerequisites for course: Fitter Mechanical- Life Sciences

Sr. No.

Area Details

1 Job Description

To deliver accredited training service, mapping to the curriculum detailed above, in accordance with the Qualification Pack “LFS/Q0213, V1.0”.

2 Personal Attributes

Aptitude for conducting training, and pre/ post work to ensure competent, employable candidates at the end of the training. Strong communication skills, interpersonal skills, ability to work as part of a team; a passion for quality and for developing others; well-organised and focused, eager to learn and keep oneself updated with the latest in the mentioned field.

3 Minimum Educational Qualifications

12th Pass/ ITI

4a Domain Certification

Certified for Job Role: “Fitter Mechanical - Life Sciences” mapped to QP: “LFS/Q0213, V1.0”. Minimum accepted score is 80% as per LSSSDC guidelines.

4b Platform Certification

Recommended that the Trainer is certified for the Job Role: “Trainer”, mapped to the Qualification Pack: “MEP/Q0102”. Minimum accepted score is 80% as per LSSSDC guidelines.

5 Experience Minimum Four (4) years’ experience in life sciences Fitting/ Maintenance/ Engineering department (Manufacturing occupation) out of total Min. Six (6) years’ experience for non-trained and non-qualified talent with 12th Class pass education qualification Or Minimum Three (3) years’ experience in life sciences Fitting/ Maintenance/ Engineering department (Manufacturing occupation) out of total Min. Six (6) years’ experience for non-trained and non-qualified talent with ITI Fitter qualification Or Minimum Two (2) years’ experience in life sciences Fitting/ Maintenance/ Engineering department (Manufacturing occupation) out of total Min. Four

Page 16: FOR FITTER MECHANICAL-LIFE SCIENCES Program

Fitter Mechanical-Life Sciences 16

(4) years’ experience for non-trained and non-qualified talent with Polytechnic Diploma/ Graduation education qualification Or Minimum One (1) years’ experience in life sciences Fitting/ Maintenance/ Engineering department (Manufacturing occupation) out of total Min. Two (2) years’ experience for non-trained and non-qualified talent with M. Tech (Mechanical Engineering) education qualification Or Minimum Three (3) years’ experience in life sciences Fitting/ Maintenance/ Engineering department (Manufacturing occupation) with Fitter Mechanical -Life Sciences Level-3 qualification

Page 17: FOR FITTER MECHANICAL-LIFE SCIENCES Program

Fitter Mechanical-Life Sciences 17

Curriculum

Block II is aimed at training candidates for the course of a “Fitter Mechanical-Life Sciences”, in the

“Life Sciences” Sector/Industry and aims at building the following key competencies amongst the

learner.

S.

No.

Module Name Key Learning Outcomes Equipment Required

1 Safety and Hygiene Theory Duration (hh:mm)

08:00

Duration (hh:mm)

16:00

Corresponding NOS Code LFS/N0101

• Practice safety while assembling machines in manufacturing area by following gowning procedures as per SOP

• Follow movement of man and material SOP

• Follow SOPs pertaining to machine handling.

• Use personal protective equipment while assembling and fitting machines

• Apply fire safety concepts and prepare oneself to act in case of fire emergencies in the manufacturing area.

• Perform fire extinguisher operations in case of an accident

• Use materialsafety data sheets to conduct safety analysis for every process.

• Follow organizational guidelines pertaining to spillage and waste management.

• Follow the proper escalation matrix .

ABC Type fire extinguisher, chemical absorbent roll, Face mask (full face), face mask (Half Face), gloves ({Heat, Acid, Chemical} Resistant), gloves(Nitrile), gum boots, helmet, lab coat, manual bottle eye washer, PVC apron, safety goggles, safety shoes, self-contained breathing apparatus, various mask cartridges, GMP guideline

2 Good Manufacturing Practice (GMP) Theory Duration (hh:mm)

08:00

OJT Duration (hh:mm)

32:00

Corresponding NOS Code LFS/N0101

LFS/N0260

LFS/N0261

• Perform the role of a fitter mechanical by following good manufacturing practices (GMP).

• Explain the importance of GMP in life sciences manufacturing.

• Practice deviation management

• Follow Corrective Action Preventive Action CAPA and change control procedure.

• Use the knowledge of equipment qualification after assembling or fitting the machine.

• Follow the ten principles of GMP

• Follow the steps of quality risk management.

• Perform documentation conforming

data integrity aligned to cGMP

Computer, computer work desk, conveyers, cutting tools, formats for logbooks, GMP Guidelines and 5S guidelines

3 Waste disposal and Management Theory Duration (hh:mm) 16:00 OJT Duration

• Explain categories for pharmaceutical and bio-pharmaceutical industrial waste

• Follow the material segregation rules as per the SOP

• Follow 5S principles for material handling

ABC type fire extinguisher,

bins and shelve , bins,

chemical absorbent roll,

CO2 type fire extinguisher,

face Mask (Full Face), face

mask (Half Face), formats

for log books, gloves({Heat,

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(hh:mm) 64:00 Corresponding NOS Code LFS/N0101 LFS/N0261

• Decontaminate toxic waste before disposal

• Dispose of waste, discarded or rejected equipments and tools as per the SOP, GMP, and EHS guidelines

• Implement waste management technologies used in life sciences manufacturing facilities

Acid, chemical Resistant ),

gloves(Nitrile ),

gloves(Sterile Surgical ),

gloves(Washing ), GMP

guideline book, gum boots,

helmets, industrial ladders,

printer, PVC apron, racks/

shelves, refrigerator,

4 5S and Housekeeping Theory Duration (hh:mm) 08:00 OJT Duration (hh:mm) 32:00 Corresponding NOS Code LFS/N0101 LFS/N0261

• Maintain hygiene in storage/ working area as per SOP and WHO requirements.

• Recall basic instructions and use tools used for housekeeping.

• Recall methodology and materials required for cleaning variety of surfaces and equipment.

• Recall all types of stains and cleaning material required to remove the specific stain.

• Check all types of working environment conditions (ventilation, temperature)

• Check required personal protective equipment at the time of cleaning method and material usage

• Follow theGMP, EHS guidelines and WHO rules for cleaning of soiling & surfaces of different types.

• Examine the floor post cleaning activity for the presence of oily substances and scrap material around the work area.

• Evaluate accidental damage and reinforce the GMP protocol and workplace SOPs

• Escalate to supervisor as per SOP in case of uncontrolled situations and deviations.

Cleaning material (Soap, detergent, chemical etc), safety boards, half face mask, full face mask, safety goggles, safety shoes, gum boots, chemical absorbent, self-contained breathing apparatus, PVC apron, gloves(Nitrile, {Heat, acid, chemical} resistant, washing etc..), lab coat, eye washer with sprinkler/ Manual bottle eye washer, Co2 type fire extinguisher, ABC type fire extinguisher, cleaning equipment

5 Fitting and Assembly operations Theory Duration (hh:mm)

42:00

OJT Duration (hh:mm)

500:00

Corresponding NOS Code LFS/N0260 LFS/N0204 LFS/N0101

• Identify tools, instruments, equipment and materials for marking and fitting

• Demonstrate marking

• Perform basic fitting operations like hack sawing, filing, drilling, tapping, grinding, riveting and sheet Metalwork

• Identify the tools, tool holders and work holding devices for operation of lathe

• Identify the tools, tool holders and work holding devices for operation of lathe

• Demonstrate lathe work and drilling work in the pharmaceutical manufacturing industry

ABC type fire extinguisher, assembling operations tools: bolts, assembling operations tools: cap screws, assembling operations tools: external circlips, assembling operations tools: internal circlips, assembling operations tools: nuts, assembling operations tools: nuts, bolts, machine screws, cap screws ; external circlips, internal circlips, special clips; tab washers, locking nuts, wire locks, shimming and packing, assembling operations

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• Demonstrate pipe fitting, assembly and dismantling of valves

• Identify the fixtures and explain their function

• Identify the material handling devices and explain their function

• Demonstrate dismantling of transmission and machine sub-assemblies and transmission assemblies

• Inspect and replace the damaged parts

• Test the assemblies for proper functioning

Tools: foiler, assembling operations tools: hammer, assembling operations tools: locking nuts, assembling operations tools: machine screws, assembling operations oools :plier, assembling operations tools: shimming and packing, assembling operations tools: special clips, assembling operations tools: tab washers, assembling operations tools: wire locks, chemical absorbent roll, conventional lathe machine, conventional milling machine, drilling machine: pedestal drilling machine, drilling machine: portable, eye washer with sprinkler, face mask (full face), face mask (Half Face), flexible shaft grinding machine, flexible shaft grinding machine, forklift, generator, geometric dimensioning tool, gloves({Heat, Acid, Chemical} Resistant), gloves(Nitrile), grinding machine: Ag4 grinder, gum boots, helmet, lab coat, manual bottle eye washer, marking equipments: permanent markers, marking equipments: protractor, marking equipments: punches, marking equipment: scribers, marking equipments: scribers, punches, scribing blocks, squares, protractor, marking equipments: scribing blocks, marking equipment: squares, material safety data sheet, measuring equipments : external micrometers, measuring equipment : vernier/digital/dial calliper, PVC apron, safety goggles, safety shoes, organization job card, organization log books, organization machine history record, organization machine inspection record, organization maintenance schedule, organization shift schedule, self-contained breathing apparatus, surface

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finish equipment ;bore gauges, surface finish equipment ;depth micrometers, surface finish equipment ;depth verniers, surface finish equipment ;feeler gauges, surface finish equipment ;height gauge, surface finish equipment ;hole gauges, surface finish equipment ;profile gauges, surface finish equipment ;protractors, surface finish equipment ;radius gauges, surface finish equipment ;rules, surface finish equipment ;slip gauges, surface finish equipment ;thread gauges, surface finish equipment ;try squares, tolerancing tool, trolly, various mask cartridges

6 Drilling, Welding and Brazing Practices Theory Duration (hh:mm)

42:00

OJT Duration (hh:mm)

300:00

Corresponding NOS Code LFS/N0260 LFS/N0261

• Demonstrate precision drilling

• Identify the jigs and fixtures

• Practice reaming, tapping, countersinking and counter boring

• Identify and explain the major parts of the welding and brazing equipment

• Demonstrate setting up of welding and brazing equipment

• Perform the process of gas welding, arc welding, brazing and gas cutting

• Follow guidelines for equipment

handing

Drilling machine: portable, eye washer with sprinkler, face mask (full face), face mask (Half Face), flexible shaft grinding machine, flexible shaft grinding machine, forklift, generator, geometric dimensioning tool, gloves({Heat, Acid, Chemical} Resistant), gloves(Nitrile), grinding machine: Ag4 grinder, gum boots, helmet, lab coat, manual bottle eye washer, marking equipments: permanent markers, marking equipments: protractor, marking equipments: punches, marking equipment: scribers, marking equipments: scribers, punches, scribing blocks, squares, protractor, marking equipments: scribing blocks, marking equipment: squares, material safety data sheet, measuring equipments : external micrometers, measuring equipment : vernier/digital/dial calliper, PVC apron, safety goggles, safety shoes, organization job card, organization log books, organization machine history record, organization machine inspection record,

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organization maintenance schedule, organization shift schedule, self-contained breathing apparatus, surface finish equipment ;bore gauges, surface finish equipment ;depth micrometers, surface finish equipment ;depth verniers, surface finish equipment ;feeler gauges, surface finish equipment ;height gauge, surface finish equipment ;hole gauges, surface finish equipment ;profile gauges, surface finish equipment ;protractors, surface finish equipment ;radius gauges, surface finish equipment ;rules, surface finish equipment ;slip gauges, surface finish equipment ;thread gauges, surface finish equipment ;try squares, tolerancing tool, trolly, various mask cartridges

7 Maintenance activities on various machinery and equipments Theory Duration (hh:mm)

16:00

OJT Duration (hh:mm)

960:00

Corresponding NOS Code LFS/N0261 LFS/N0101

• Inspect drilling machine and lathe as per test chart

• Practice preventive maintenance of drilling machine and lathe

• Ensure that the tools, equipment and devices used in assembly are in a good condition

• Follow the quality working Instructions /SOP

• Report the defects occurring frequently and preventive actions to avoid them

• Carry out basic inspection after each step of maintenance activity

• Report to the supervisor any activity leading to delay in completing the work in time

ABC type fire extinguisher, assembling operations tools: bolts, assembling operations tools: cap screws, assembling operations tools: external circlips, assembling operations tools: internal circlips, assembling operations tools: nuts, assembling Operations tools: nuts, bolts, machine screws, cap screws ; external circlips, internal circlips, special clips; tab washers, locking nuts, wire locks, shimming and packing, assembling operations Tools: foiler, assembling operations tools: hammer, assembling operations tools: locking nuts, assembling operations tools: machine screws, assembling operations oools :plier, assembling operations tools: shimming and packing, assembling operations tools: special clips, assembling operations tools: tab washers, assembling operations tools: wire locks, chemical absorbent roll, conventional

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lathe machine, conventional milling machine, drilling machine: pedestal drilling machine, drilling machine: portable, eye washer with sprinkler, face mask (full face), face mask (Half Face), flexible shaft grinding machine, flexible shaft grinding machine, forklift, generator, geometric dimensioning tool, gloves({Heat, Acid, Chemical} Resistant), gloves(Nitrile), grinding machine: Ag4 grinder, gum boots, helmet, lab coat, manual bottle eye washer, marking equipments: permanent markers, marking equipments: protractor, marking equipments: punches, marking equipment: scribers, marking equipments: scribers, punches, scribing blocks, squares, protractor, marking equipments: scribing blocks, marking equipment: squares, material safety data sheet, measuring equipments : external micrometers, measuring equipment : vernier/digital/dial calliper, PVC apron, safety goggles, safety shoes, organization job card, organization log books, organization machine history record, organization machine inspection record, organization maintenance schedule, organization shift schedule, self-contained breathing apparatus, surface finish equipment ;bore gauges, surface finish equipment ;depth micrometers, surface finish equipment ;depth verniers, surface finish equipment ;feeler gauges, surface finish equipment ;height gauge, surface finish equipment ;hole gauges, surface finish equipment ;profile gauges, surface finish equipment ;protractors, surface finish equipment ;radius gauges, surface finish equipment

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;rules, surface finish equipment ;slip gauges, surface finish equipment ;thread gauges, surface finish equipment ;try squares, tolerancing tool, trolly, various mask cartridges

Grand Total Course Duration: 2044 Hours, 0 Minutes

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Assessment Criteria

Job Role Fitter Mechanical – Life Sciences

Qualification Pack LFS/Q0213, V1.0

Sector Skill Council Life Sciences Sector Skill Development Council

S. No. Guidelines for Assessment

1. Criteria for assessment for each Qualification Pack will be created by the Sector Skill

Council. Each Performance Criteria (PC) will be assigned marks proportional to its

importance in NOS. SSC will also lay down proportion of marks for Theory and Skills

Practical for each PC.

2. The assessment for the theory part will be based on knowledge bank of questions created

by the SSC

3. Individual assessment agencies will create unique question papers for theory part for each

candidate at each examination/training center (as per assessment criteria below)

4. Individual assessment agencies will create unique evaluations for skill practical for every

student at each examination/training center based on the assessment criteria below

5. To pass the Qualification Pack , every trainee should score a minimum of 70% aggregate

in all NOS

6. In case of successfully passing only certain number of NOS's, the trainee is eligible to take

subsequent assessment on the balance NOS's to pass the Qualification Pack

Marks

Allocation

Assessment

Outcome

Assessment Criteria of Outcomes Total

Marks

(400)

Out

Of Theo

ry

Skills

Practi

cal

1. LFS/N0260

Perform fitting

and assembly

operations on

metal

components

PC1. comply with health and safety, environmental and other relevant regulations and guidelines at work

100

3 1 2

PC2. adhere to procedures and guidelines for personal protective equipment (PPE) and other relevant safety regulations while performing broaching operations

4 1 3

PC3. ensure work area is clean and safe from hazards

2 0 2

PC4. ensure that all tools, equipment, power tool cables, extension leads are in a safe and usable condition

2 0 2

PC5. ensure that all machines and machine tools are secured at all times

2 0 2

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PC6. determine job requirement from job specification documents obtained from valid sources

3 0 3

PC7. establish the procedures to complete the general machining, fitting or assembling operations

3 0 3

PC8. obtain the appropriate equipment, parts and accessories for the general machining, fitting or assembling operation

2 0 2

PC9. check that all measuring equipment is within calibration date

3 0 3

PC10. prepare/determine suitable datums from which to mark out (e.g. choosing a machine face or filing a flat face as a datum)

3 0 3

PC11. apply a marking medium to enhance clarity of the marking out

3 0 3

PC12. use an appropriate method of marking out (e.g. direct marking using instruments, use of templates or tracing/transfer methods)

4 0 4

PC13. use a range of marking out equipment (e.g. rules, squares, scribers, Vernier instruments)

3 0 3

PC14. mark out a range of features 3 0 3

PC15. cut and shape the materials to the required specification, using appropriate tools and techniques

6 2 4

PC16. use a range of hand fitting methods for fitting operations

4 0 4

PC17. Use a range of manually operated machines for performing machining operations

3 0 3

PC18. use appropriate methods and techniques to assemble and secure the components and sub-assemblies in their correct positions

6 2 4

PC19. drill, tap and ream locating holes as required to permanently locate components

4 0 4

PC20. fasten components permanently using methods such as using engineered fasteners, applying adhesives, soldering and brazing

3 0 3

PC21. produce mechanical assemblies as per job specifications

6 2 4

PC22. dismantle mechanical assemblies without damage to components and/or subassemblies

4 0 4

PC23. deal promptly and effectively with problems within their control, and seek help and guidance from the relevant people if they have problems that they cannot resolve

3 0 3

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PC24. keep the work area in a safe and tidy condition during and on completion of the manufacturing activities

2 0 2

PC25. return all tools and equipment to the correct location on completion of the fitting activities support the customer remotely over the internet to test potential solutions

3 0 3

PC26. perform the necessary checks for dimensional accuracy

5 1 4

PC27. use the appropriate measuring equipment for checking activities

3 0 3

PC28. produce components within all of the applying standards

5 1 4

PC29. generate stage inspection reports 3 0 3

Total 100 10 90

2. LFS/N0261

Perform

maintenance

activities on

mechanical

equipment/

machinery

PC1. comply with health and safety, environmental and other relevant regulations and guidelines at work

100

3 1 2

PC2. adhere to procedures and guidelines for personal protective equipment (PPE) and other relevant safety regulations while performing fabrication and fitting operations

4 1 3

PC3. work following laid down procedures and instructions

3 1 2

PC4. ensure work area is clean and safe from hazards

2 0 2

PC5. ensure that all tools, equipment, power tool cables, extension leads are in a safe and usable condition

2 0 2

PC6. follow all relevant setting up and operating specifications for the products or mechanical equipment being commissioned

3 1 2

PC7. follow the defined procedures and set up the equipment correctly ensuring that all operating parameters are achieved

3 1 2

PC8. obtain job specifications and requirements from valid sources and find out the fault

2 0 2

PC9. obtain and interpret drawings, specifications, manufacturers' manuals and other documents needed in the maintenance process

3 1 2

PC10. follow the procedure to be adopted to establish the background of the fault and the tools to be used

3 1 2

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PC11. evaluate various types of information available for fault diagnosis

3 0 3

PC12. evaluate sensory information to assess likely faults e.g. sound, visual

3 0 3

PC13. collect evidence regarding the fault from the sources using a range of diagnostic equipment and techniques

3 0 3

PC14. apply monitoring or testing procedures to help in the fault diagnosis using a range of test equipment

4 1 3

PC15. relate previous reports/records of similar fault conditions

2 0 2

PC16. evaluate the likely risk of running the equipment with the displayed fault, and the effects the fault could have on health and safety, and on the overall process or system

3 0 3

PC17. carry out the maintenance activities in the specified sequence and in an agreed timescale

5 1 4

PC18. carry out maintenance activities on various equipment

4 0 4

PC19. perform dismantling processes mechanical equipment using appropriate method or technique in order to replace defective components

4 0 4

PC20. re-assemble the components using appropriate methods, and adjust them to meet the operating specification

5 1 4

PC21. carry out servicing and maintenance techniques as applicable

5 1 4

PC22. replace or refit basic hydraulic and pneumatic components

4 0 4

PC23. identify requirements for welding, machining, electric or electronic repair and handover to the relevant personal after following due process

3 0 3

PC24. conduct a trial run of the equipment at full power/speed/flow

3 0 3

PC25. confirm that the produced component/process outcomes meet specifications

3 0 3

PC26. monitor and record measurements and observations

3 0 3

PC27. review and update maintenance procedures and plans

3 0 3

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PC28. deal with equipment malfunction and rectify faults during the breakdown servicing process as appropriate

4 1 3

PC29. identify areas of improvements in the various maintenance services and implement the improvement activities agreed upon by the relevant authorities

3 0 3

PC30. deal promptly and effectively with problems within their control, and seek help and guidance from the relevant people if they have problems that they cannot resolve to ensure zero idle time of machine/ equipment

3 0 3

PC31. leave the work area in a safe and tidy condition on completion of the manufacturing activities

2 0 2

Total 100 12 88

3. LFS/N0204

Coordinate with

Shift

Supervisor,

cross functional

teams and

within the team

PC1. understand the work output requirements

100

12 6 6

PC2. understand the quality standards to be maintained

12 6 6

PC3. proactively inform supervisor on issues requiring intervention

12 6 6

PC4. comply with company policy and rule

13 6 7

PC5. deliver quality work on time and report any anticipated reasons for delay

13 6 7

PC6. be able to resolve conflicts 12 6 6

PC7. multi-task relevant activities to align with team goals

12 6 6

PC8. put team over individual goals 14 6 8

Total 100 48 52

4. LFS/N0101

Maintain a

healthy, safe

and secure

working

environment in

the life sciences

facility

PC1. observe and comply with the company’s current health, safety and security policies and procedures

100

10 5 5

PC2. while carrying out work, use appropriate safety gears like head gear, masks, gloves and other accessories as mentioned in the guidelines

10 5 5

PC3. report any identified breaches in health, safety, and security policies and procedures to the designated person

10 5 5

PC4. responsible for maintaining discipline at the shop-floor/ production area

10 5 5

PC5. identify and correct any hazards that the individual can deal with

10 5 5

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safely, competently and within the limits of their authority

PC6. adhere and comply to storage and handling guidelines for hazardous material

10 5 5

PC7. identify and recommend opportunities for improving health, safety, and security to the designated person

10 5 5

PC8. complete any health, safety and security activities like safety drills and prepare records legibly and accurately

10 4 6

PC9. report any hazards that the individual is not competent to deal with to the relevant person in line with organizational procedures and warn other people who may be affected

10 4 6

PC10. follow the company’s emergency procedures promptly, calmly, and efficiently

10 5 5

Total 100 48 52

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Annexure I: Tools and Equipment for Basic Training (Block

I)

Sector: Life Sciences

Block I QP Code with Version No. or Course Code: LFS/Q0213, V1.0

Block I QP Name or Course Name: Fitter Mechanical-Life Sciences

Block I NSQF Level: 3

S.

No.

Equipment Name

Minimum number of Equipment required (per batch of 30 trainees)

Unit Type

Is this a mandatory Equipment to be available at the Training Center (Yes/No)

Dimension/Specification /Description of the Equipment/ ANY OTHER REMARK

1 ABC Type Fire Extinguisher

2 No. Yes

2 Assembling Operations Tools:

Bolts

10 Packet Yes Unit= Packet of 100

3 Assembling Operations Tools:

Cap Screws

10 Packet Yes Unit= Packet of 100

4 Assembling Operations Tools: External Circlips

10 Packet Yes Unit= Packet of 100

5 Assembling Operations Tools: Internal Circlips

10 Packet Yes Unit= Packet of 100

6 Assembling Operations Tools:

Nuts

10 Packet Yes Unit= Packet of 100

7 Assembling Operations Tools:

Nuts, Bolts, Machine Screws,

Cap Screws; External Circlips, Internal Circlips,

Special Clips; Tab Washers, Locking Nuts, Wire Locks,

Shimming And Packing

10 Packet Yes Unit= Packet of 100

8 Assembling Operations Tools:Foiler

10 No. Yes Unit= Pc

9 Assembling Operations Tools:

Hammer

10 No. Yes Unit= Pc

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10 Assembling Operations Tools:

Locking Nuts

10 Packet Yes Unit= Packet of 100

11 Assembling Operations Tools: Machine Screws

10 Packet Yes Unit= Packet of 100

12 Assembling Operations Tools:

Plier

10 No. Yes Unit= Pc

13 Assembling Operations Tools:

Shimming and Packing

10 Packet Yes Unit= Packet of 100

14 Assembling Operations Tools:

Special Clips

10 Packet Yes Unit= Packet of 100

15 Assembling Operations Tools:

Tab Washers

10 Packet Yes Unit= Packet of 100

16 Assembling Operations Tools:

Wire Locks

10 Packet Yes Unit= Packet of 100

17 Chemical Absorbent Roll

2 No. Yes

18 Computer 5 No. Yes (including Monitor, CPU, Keyboard, typewriter, UPS)

19 Computer Work desk

5 No. Yes with Internet connectivity through LAN/ Wifi

20 Conventional Lathe Machine

1 No. Yes

21 Conventional Milling Machine

1 No. Yes

22 Drilling Machine: Pedestal Drilling

Machine

2 No. Yes

23 Drilling Machine: Portable

2 No. Yes

24 Eye Washer with Sprinkler

2 No. No

25 Face Mask (Full Face)

4 No. Yes 4 each type

26 Face Mask (Half Face)

4 No. Yes 4 each type

27 Flexible Shaft Grinding Machine

4 No. Yes minimum two each

28 Flexible Shaft Grinding Machine

2 No. Yes

29 Flip Charts 5 No. Yes

30 Forklift 1 No. No

31 Generator 1 No. Yes 1.25 time to the capacity of total consumption of the lab

equipments

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32 Geometric Dimensioning Tool

1 No. Yes

33 Gloves ({Heat, Acid, Chemical}

Resistant)

2 Box Yes Unit= Box; 2 boxes

34 Gloves (Nitrile) 2 Box Yes Unit= Box; 2 boxes

35 GMP Guideline Book

2 No. Yes Unit= Pc

36 Grinding Machine: Ag4 Grinder

2 No. Yes

37 Gum Boots 1 No. Yes

38 Helmet 30 No. Yes One for each student

39 Lab Coat 30 No. Yes One for each student

40 Laser Pointer 1 No. No

41 Manual Bottle Eye Washer

2 No. Yes

42 Marking Equipments:

Permanent Markers

5 No. Yes

43 Marking Equipments:

Protractor

5 No. Yes

44 Marking Equipments:

Punches

5 No. Yes

45 Marking Equipments:

Scribers

5 No. Yes

46 Marking Equipments:

Scribers, Punches, Scribing Blocks,

Squares, Protractor,

Permanent Markers

5 No. Yes

47 Marking Equipments:

Scribing Blocks

5 No. Yes

48 Marking Equipments:

Squares

5 No. Yes

49 Material Safety Data Sheet

1 No. Yes For all materials & solvents in Lab

50 Measuring Equipments:

External Micrometers

5 No. Yes

51 Measuring Equipments:

Vernier/Digital/Dial Caliper

5 No. Yes

52 MS Office 5 No. Yes Version 2007 or above (including Ms. Word, Ms

Excel, Ms Powerpoint, Ms Outlook)

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53 Projector 1 No. Yes any make (DLP or LCD) Projector

54 Pvc Apron 2 No. Yes

55 Safety Goggles 30 No. Yes One for each student

56 Safety Shoes 4 No. Yes

57 Sample Job Card 1 No. Yes Unit= Pc

58 Sample Log Books 1 No. Yes Unit= Pc

59 Sample Machine History Record

1 No. Yes Unit= Pc

60 Sample Machine Inspection Record

1 No. Yes Unit= Pc

61 Sample Maintenance

Schedule

1 No. Yes Unit= Pc

62 Sample Shift Schedule

1 No. Yes Unit= Pc

63 Self-Contained Breathing Apparatus

2 No. Yes

64 Sound System with Mike

1 No. No

65 Surface Finish Equipment; Bore

Gauges

5 No. Yes

66 Surface Finish Equipment; Depth

Micrometres

5 No. Yes

67 Surface Finish Equipment; Depth

Verniers

5 No. Yes

68 Surface Finish Equipment; Feeler

Gauges

5 No. Yes

69 Surface Finish Equipment; Height

Gauge

5 No. Yes

70 Surface Finish Equipment; Hole

Gauges

5 No. Yes

71 Surface Finish Equipment; Profile

Gauges

5 No. Yes

72 Surface Finish Equipment; Protractors

5 No. Yes

73 Surface Finish Equipment; Radius

Gauges

5 No. Yes

74 Surface Finish Equipment; Rules

5 No. Yes

75 Surface Finish Equipment; Slip

Gauges

5 No. Yes

76 Surface Finish Equipment; Thread

Gauges

5 No. Yes

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77 Surface Finish Equipment; Try

Squares

5 No. Yes

78 Tolerancing Tool 1 No. Yes

79 Trolly 2 No. Yes

80 Various Mask Cartridges

4 No. Yes one each type

81 Vice Mounted Tables

10 No. Yes ( 6Ft X 2.5Ft X 3Ft(H)) Bench Vices -5 No. , Pipe

Vices- 5No.

82 White Board 1 No. Yes 35 Sq Ft Preferred

83 White Board Duster 1 No. Yes Any

84 White Board Marker

2 No. Yes Any Color

85 White Screen 1 No. No 35 Sq Ft preferred

86 Machine Valves 4 No. No 1 Each Type used in machines in Pharma/

Biopharma equipments

87 Utility Valves 4 No. No 1 Each Type used in Utilities for Pharma/ Biopharma plants

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Annexure II: Tools and Equipment for Hands-On at

Employer Location (Block II)

Sector: Life Sciences

Block II QP Code with Version No. or Course Code: LFS/Q0213, V1.0

Block II QP Name or Course Name: Fitter Mechanical – Life Sciences

Block II NSQF Level: 3

S.

No.

Equipment Name

Minimum number of Equipment required (per batch of 30 trainees)

Unit Type

Is this a mandatory Equipment to be available at the Training Centre (Yes/No)

Dimension/Specification /Description of the Equipment/ ANY OTHER REMARK

1 ABC Type Fire Extinguisher

2 No. Yes

2 Assembling Operations Tools:

Bolts

10 Packet Yes Unit= Packet of 100

3 Assembling Operations Tools:

Cap Screws

10 Packet Yes Unit= Packet of 100

4 Assembling Operations Tools: External Circlips

10 Packet Yes Unit= Packet of 100

5 Assembling Operations Tools: Internal Circlips

10 Packet Yes Unit= Packet of 100

6 Assembling Operations Tools:

Nuts

10 Packet Yes Unit= Packet of 100

7 Assembling Operations Tools:

Nuts, Bolts, Machine Screws,

Cap Screws ; External Circlips, Internal Circlips,

Special Clips; Tab Washers, Locking Nuts, Wire Locks,

Shimming And Packing

10 Packet Yes Unit= Packet of 100

8 Assembling Operations Tools:

Foiler

10 No. Yes Unit= Pc

9 Assembling Operations Tools:

Hammer

10 No. Yes Unit= Pc

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10 Assembling Operations Tools:

Locking Nuts

10 Packet Yes Unit= Packet of 100

11 Assembling Operations Tools: Machine Screws

10 Packet Yes Unit= Packet of 100

12 Assembling Operations Tools:

Plier

10 No. Yes Unit= Pc

13 Assembling Operations Tools:

Shimming and Packing

10 Packet Yes Unit= Packet of 100

14 Assembling Operations Tools:

Special Clips

10 Packet Yes Unit= Packet of 100

15 Assembling Operations Tools:

Tab Washers

10 Packet Yes Unit= Packet of 100

16 Assembling Operations Tools:

Wire Locks

10 Packet Yes Unit= Packet of 100

17 Chemical Absorbent Roll

2 No. Yes

18 Computer 5 No. Yes (including Monitor, CPU, Keyboard, typewriter, UPS)

19 Computer Work desk

5 No. Yes with Internet connectivity through LAN/ Wifi

20 Conventional Lathe Machine

1 No. Yes

21 Conventional Milling Machine

1 No. Yes

22 Drilling Machine: Pedestal Drilling

Machine

2 No. Yes

23 Drilling Machine: Portable

2 No. Yes

24 Eye Washer with Sprinkler

2 No. No

25 Face Mask (Full Face)

4 No. Yes 4 each type

26 Face Mask (Half Face)

4 No. Yes 4 each type

27 Flexible Shaft Grinding Machine

4 No. Yes minimum two each

28 Flexible Shaft Grinding Machine

2 No. Yes

29 Flip Charts 5 No. Yes

30 Forklift 1 No. No

31 Generator 1 No. Yes 1.25 time to the capacity of total consumption of the lab

equipments

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Fitter Mechanical-Life Sciences 37

32 Geometric Dimensioning Tool

1 No. Yes

33 Gloves ({Heat, Acid, Chemical}

Resistant)

2 Box Yes Unit= Box; 2 box

34 Gloves (Nitrile) 2 Box Yes Unit= Box; 2 box

35 GMP Guideline Book

2 No. Yes Unit= Pc

36 Grinding Machine: Ag4 Grinder

2 No. Yes

37 Gum Boots 1 No. Yes

38 Helmet 30 No. Yes One for each student

39 Lab Coat 30 No. Yes One for each student

40 Laser Pointer 1 No. No

41 Manual Bottle Eye Washer

2 No. Yes

42 Marking Equipments:

Permanent Markers

5 No. Yes

43 Marking Equipments:

Protractor

5 No. Yes

44 Marking Equipments:

Punches

5 No. Yes

45 Marking Equipments:

Scribers

5 No. Yes

46 Marking Equipments:

Scribers, Punches, Scribing Blocks,

Squares, Protractor,

Permanent Markers

5 No. Yes

47 Marking Equipments:

Scribing Blocks

5 No. Yes

48 Marking Equipments:

Squares

5 No. Yes

49 Material Safety Data Sheet

1 No. Yes For all materials & solvents in Lab

50 Measuring Equipment:

External Micrometres

5 No. Yes

51 Measuring Equipments:

Vernier/Digital/Dial Caliper

5 No. Yes

52 MS Office 5 No. Yes Version 2007 or above (including MS. Word, MS

Excel, MS Power point, MS Outlook)

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53 Projector 1 No. Yes any make (DLP or LCD) Projector

54 PVC Apron 2 No. Yes

55 Safety Goggles 30 No. Yes One for each student

56 Safety Shoes 4 No. Yes

57 Organizational Job Card

1 No. Yes Unit= Pc

58 Log Books 1 No. Yes Unit= Pc

59 Organization Machine History

Record

1 No. Yes Unit= Pc

60 Organization Machine Inspection

Record

1 No. Yes Unit= Pc

61 Organization Maintenance

Schedule

1 No. Yes Unit= Pc

62 Organization Shift Schedule

1 No. Yes Unit= Pc

63 Self-Contained Breathing Apparatus

2 No. Yes

64 Surface Finish Equipment; Bore

Gauges

5 No. Yes

65 Surface Finish Equipment; Depth

Micrometres

5 No. Yes

66 Surface Finish Equipment; Depth

Verniers

5 No. Yes

67 Surface Finish Equipment; Feeler

Gauges

5 No. Yes

68 Surface Finish Equipment; Height

Gauge

5 No. Yes

69 Surface Finish Equipment; Hole

Gauges

5 No. Yes

70 Surface Finish Equipment; Profile

Gauges

5 No. Yes

71 Surface Finish Equipment; Protractors

5 No. Yes

72 Surface Finish Equipment; Radius

Gauges

5 No. Yes

73 Surface Finish Equipment; Rules

5 No. Yes

74 Surface Finish Equipment; Slip

Gauges

5 No. Yes

75 Surface Finish Equipment; Thread

Gauges

5 No. Yes

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76 Surface Finish Equipment; Try

Squares

5 No. Yes

77 Tolerancing Tool 1 No. Yes

78 Trolly 2 No. Yes

79 Various Mask Cartridges

4 No. Yes one each type

80 Machine Valves 4 No. No 1 Each Type used in machines in organization

equipments

81 Utility Valves 4 No. No 1 Each Type used in Utilities for organization

plants

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Fitter Mechanical-Life Sciences 40

Further Learning

Learning Pathways

After completion of apprenticeship training the candidates will have wide career choices available with

them in the life sciences industry. A candidate after completing apprenticeship can be skilled

horizontally in various segments such as fitting, assembling, drilling, welding & brazing, and can finally

be vertically moved to heading the production unit.

The candidates after their tenure as apprentice may do any of the following:

a. Fitter Mechanical (Immediately)

b. Manufacturing Assistant / Helper- Life Sciences (Level 3) (LFS/Q0216)

c. Supervisor Mechanical and Calibration – Life Sciences (Level 5)

Employment Opportunities

Apart from above mentioned avenues, the apprentice can always aspire to be one of the following:

1. After 6-7 years of Industry work experience as Fitter Mechanical- Life Sciences post qualifying

the certification of Fitter Mechanical- Life Sciences, candidate has an option to qualify for

Supervisor Mechanical and Calibration Job role for a vertical progression.

2. Fitter Mechanical – Life Sciences also has an option to qualify for Maintenance Assistant- Life

Sciences as a lateral progression.