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QUALIFICATIONS PACK - OCCUPATIONAL STANDARDS FOR LIFE SCIENCES INDUSTRY

➢ OS describe what individuals need to do, know and understand in order to carry out a particular job role or function

➢ OS are performance standards that individuals must achieve when carrying out functions in the workplace, together with specifications of the underpinning knowledge and understanding

Life Sciences Sector Skill Development Council 14, Palam Marg, 2nd Floor, Vasant Vihar, New Delhi, 110057 Phone No.: +91 11 41042407/408 E-mail: [email protected]

Contents

1. Introduction and Contacts..….……….…….P.1

2. Qualifications Pack……….………………........P.2

3. Glossary of Key Terms ….……………..........P.4

4. NOS Units………………………..….……..………..P.6

5. Annexure: Nomenclature for QP & OS…P.34

6. Assessment Criteria………………………………P.36

Introduction

Qualifications Pack-Maintenance Supervisor/In Charge - HVAC – Life Sciences

SECTOR: LIFE SCIENCES

SUB-SECTOR: PHARMACEUTICAL AND BIOPHARMACEUTICAL

OCCUPATION: MANUFACTURING

REFERENCE ID: LFS/Q0209

ALIGNED TO: NCO-2004/ NIL

Maintenance supervisor also known as Maintenance In charge is responsible for monitoring the service, assembly and installation of HVAC at all locations in the life sciences facility, including supervision of helpers.

Brief Job Description: Maintenance Supervisor is responsible for monitoring assembly, installation, operation and maintenance of HVAC as per SOP, preparing effective maintenance schedules and ensuring smooth flow of work, carrying out reporting and documentation for maintenance activities, identifying and resolving any issues related to installation, operation or maintenance of HVAC and maintaining a healthy, safe and secure working environment.

Personal Attributes: The individual should have good writing and reading skills, should be able to comprehend situations and be effective in communication. He/she should be reliable, motivated and must have integrity.

Qualifications Pack For Maintenance Supervisor/

In Charge - HVAC – Life Sciences

Qualifications Pack Code LFS/Q0209

Job

Det

ail

Job Role Maintenance Supervisor/In Charge – HVAC – Life Sciences

Credits(NSQF) TBD Version number 1.0

Industry Life Sciences Drafted on 15/12/14

Sub-sector

Pharmaceutical and Last reviewed on

25/02/15

Biopharmaceutical

Occupation Manufacturing Next review date 01/06/17

NSQC Clearance on 20/07/2015

Job Role Maintenance Supervisor/In Charge – HVAC – Life Sciences

Responsible for monitoring the service, assembly and Role Description installation of HVAC at all locations, including supervision of

helpers.

NSQF level 5

Minimum Educational Qualifications Diploma in Mechanical Engineering/ITI/B.Sc

Maximum Educational Qualifications

B.Tech in Mechanical preferable/ M.Sc

Training On the job training

(Suggested but not mandatory)

Minimum Job Entry Age 18 Years

Experience 0-2 years

Compulsory:

Applicable National Occupational Standards (NOS)

1. LFS/N0219: Monitor assembly, installation, operation and maintenance of HVAC as per SOP

2. LFS/N0220: Prepare effective maintenance schedules

and ensure smooth flow of work

3. LFS/N0221: Carry out reporting and documentation for

maintenance activities

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Qualifications Pack For Maintenance Supervisor/ In Charge - HVAC – Life Sciences

4. LFS/N0222: Identify and resolve any issues related to

installation, operation or maintenance of HVAC

5. LFS/N0101: Maintain a healthy, safe and secure

working environment in the life sciences facility

Optional:

N.A.

Performance Criteria As described in the relevant NOS units

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Keywords /Terms Description

Defin

ition

s

Core Skills/Generic Skills

Core Skills or Generic Skills are a group of skills that are key to learning and working in today's world. These skills are typically needed in any

work environment. In the context of the NOS, these include

communication related skills that are applicable to most job roles.

Description helpful to anyone searching on a database to verify that this is the

appropriate NOS they are looking for.

Function Function is an activity necessary for achieving the key purpose of the sector, occupation, or area of work, which can be carried out by a person

or a group of persons. Functions are identified through functional

analysis and form the basis of NOS.

Job role Job role defines a unique set of functions that together form a unique employment opportunity in an organisation.

Knowledge and Knowledge and Understanding are statements which together specify the Understanding technical, generic, professional and organisational specific knowledge

that an individual needs in order to perform to the required standard.

National Occupational NOS are Occupational Standards which apply uniquely in the Indian Standards (NOS) context.

Occupation Occupation is a set of job roles, which perform similar/related set of functions in an industry.

Organisational Context Organisational Context includes the way the organisation is structured and how it operates, including the extent of operative knowledge

managers have of their relevant areas of responsibility.

Performance Criteria Performance Criteria are statements that together specify the standard of performance required when carrying out a task.

Qualifications Pack(QP) Qualifications Pack comprises the set of NOS, together with the educational, training and other criteria required to perform a job role. A

Qualifications Pack is assigned a unique qualification pack code.

Qualifications Pack Qualifications Pack Code is a unique reference code that identifies a Code qualifications pack.

Scope Scope is the set of statements specifying the range of variables that an individual may have to deal with in carrying out the function which have

a critical impact on the quality of performance required.

Sector Sector is a conglomeration of different business operations having similar businesses and interests. It may also be defined as a distinct subset of the

economy whose components share similar characteristics and interests.

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Def

init

ion

s


Sub-Sector Sub-sector is derived from a further breakdown based on the

characteristics and interests of its components.

Sub-functions Sub-functions are sub-activities essential to fulfil the achieving the objectives of the function.

Technical Knowledge Technical Knowledge is the specific knowledge needed to accomplish specific designated responsibilities.

Unit Code Unit Code is a unique identifier for an NOS unit, which can be denoted with an ‘N’.

Unit Title Unit Title gives a clear overall statement about what the incumbent should be able to do.

Acro

nym

s

Keywords /Terms Description

NOS National Occupational Standard(s)

NSQF National Skill Qualifications Framework

NCO-2004 National Classification of Occupations-2004

OS Occupational Standard(s)

QP Qualifications Pack

SOP Standard operating Procedure

HVAC Heating, Ventilation and Air Conditioning

GMP Good Manufacturing Practices

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Acr

on

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LFS/N0219: Monitor assembly, installation, operation and maintenance of HVAC as per SOP

National

Occupational

Standard

Overview

This NOS is about the knowledge, understanding and skills required by a Maintenance Supervisor – HVAC for monitoring the assembly and installation of HVAC, ensuring that the operation is as per SOP, monitoring the purchase of HVAC, taking care of day to day engineering activities and carrying out tests as per specifications. 6 | P a g e

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LFS/N0219 : Monitor assembly, installation, operation and maintenance of HVAC as per SOP

Unit Code LFS/N0219

Unit Title Monitor assembly, installation, operation and maintenance of HVAC as per SOP

(Task)

Description This NOS is about a Maintenance Supervisor monitoring the assembly and installation of HVAC according to requirements, ensuring that the operation of HVAC is as per

SOP, taking care of routine maintenance, preventive maintenance, breakdown

maintenance and modification and carrying out tests as per specification.

Scope

The unit/ task covers the following:

• Assembly and Installation

• Safety Checks

• Maintenance

• Material Disposal

Performance Criteria (PC) w.r.t. the Scope

Element Performance Criteria

Assembly and To be competent, the user/individual on the job must be able to:

Installation

PC1. coordinate with stores to determine which parts should be ordered for

installation or as spare parts of HVAC equipment, air filters, centrifuges, dryers,

etc

PC2. assist in maintaining proper levels of materials/supplies to ensure timely and

efficient completion of necessary task

PC3. assist in purchase of materials and ensure prevention of defects and

maintenance of quality as per requirement

PC4. identify the areas where new installations are required in coordination with the

manufacturing and quality teams

PC5. assist in approving purchases of materials and equipment

PC6. identify defect/problem in inappropriate sample

Safety Checks

PC7. start, operate, monitor and adjust HVAC equipment to ensure proper working

(such as air flow and turbulence, pressure differentiations, filter efficiencies)

PC8. ensure compliance with all regulations and company policies, including

qualification and requalification as per GMP standards

PC9. review all work orders before and after completion

PC10. take corrective action in response to typical faults and inconsistencies

PC11. set up appropriate equipment or apparatus for testing correctly

PC12. calibrate the equipment periodically as per the SOP

PC13. identify defective equipment/apparatus and steps to be taken like support preventive maintenance activities

PC14. verify the equipment accuracy by comparing with the standard reference

PC15. respond to emergency calls for system and equipment failure

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Maintenance PC16. set and adjust controls PC17. cover technical support desk during absence of Technical Support team

PC18. assist relevant stakeholders of HVAC with technical support; technical data,

development and maintenance of user manuals, FAQ’s, technical support

phone calls and warehouse tasks PC19. ensure that maintenance helper is working as per the SOP

PC20. take up the results of the findings with the appropriate authority

Material Disposal PC21. carry out disposal of waste and leftover tested material safety as per the SOP PC22. dispose all materials used in the experiment safely as per health and safety management system of the company

Knowledge and Understanding (K)

A. Organisational The user/individual on the job needs to know and understand:

Context

(Knowledge of the KA1. organizational coding system of HVAC and company manual

Company/ KA2. chemicals used in the process and their function

Organisation and KA3. different quality management systems (ISO-9000, TS16949, ISO-14001, OHSAS- its processes) 18000) KA4. methods of disposing of materials, importance of appropriate disposal and

implications of not following the material disposal procedure

KA5. importance of identifying non-conforming products and dealing of the same

KA6. which protective equipment to be used and how

KA7. impact of various practices on cost, quality, productivity, delivery and safety

KA8. characteristics of the material and equipment required in setting up HVAC and

its maintenance

KA9. use of monitoring and measuring devices

KA10. implications of using inaccurate measuring and testing equipment KA11. the reason and impact of the occurrence of problems KA12. measures, steps and possible solutions that have been taken/identified to

address problems

KA13. the appropriate authority for reporting any imbalances

KA14. the correct method for carrying out corrective actions outlined for each

problem

B. Technical The user/individual on the job needs to know and understand: Knowledge

KB1. working and installation of HVAC equipment, air filters, centrifuges, dryers, etc KB2. methods, materials and equipment used in installing, repairing and

maintaining heating, refrigeration and air handling equipment

KB3. different standard reference materials KB4. occupational hazards and safety precautions of the work

KB5. use of data analytics tools and methods to analyze and interpret the

data/information captured KB6. energy management systems

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LFS/N0219 : Monitor assembly, installation, operation and maintenance of HVAC as per SOP KB7. methods of using test and diagnostic equipment used in the calibration and

repair of chillers, boilers, control systems, refrigeration system, air quality and electrical systems

KB8. methods of using testing equipment, related test methods and purpose of

tests

KB9. quality requirements of materials and equipment

KB10. operating requirements, parameters and corrective action required where operation is outside specified operating parameters

KB11. common causes of variation and corrective action required

KB12. operational health and safety (OHS) hazards and controls, including limitations

of protective clothing and equipment relevant to the work process

KB13. requirements of different shutdowns as appropriate to the process and

workplace production requirements, including emergency and routine

shutdowns and procedures to follow in the event of a power outage

KB14. environmental issues and controls relevant to the process, including waste/rework collection and handling procedures related to the process

Skills (S)

A. Core Skills/ Reading Skills Generic Skills

The user/ individual on the job needs to know and understand how to:

SA1. read and understand manuals, SOPs, health and safety instructions, memos, reports, job cards etc.

SA2. read and interpret images, graphs, diagrams for typical product specifications,

job sheets, procedures, basic machine control panels, material labels and

safety information as provided

SA3. read various coding systems as per company norms

Writing skills


SA4. do legible entries with permanent ink SA5. write detailed reports for investigation SA6. pay attention to detail while recording maintenance parameters

Oral Communication (Listening and Speaking skills)

The user/individual on the job needs to know and understand how to:

SA11. communicate with upstream and downstream teams

SA12. communicate with people in a proper form and manner and use language that is open and respectful

SA13. resolve any difficulties in relationships with colleagues, or get help from an

appropriate person, in a way that preserves goodwill and trust

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LFS/N0219: Monitor assembly, installation, operation and maintenance of HVAC as per SOP B.

Professional Skills Plan & Organize


SB1. plan and organize resources to ensure assembly, installation and maintenance activities adhere to schedule

SB2. multi-task and adapt to meet work timelines

SB3. effectively delegate and lead to plan, lay out, supervise and inspect the work of subordinates

Decision Making


SB4. evaluate multiple options on defined, objective parameters when taking assembly, installation and maintenance decisions

SB5. collaborate with the team for identifying appropriate decisions SB6. apply commercial awareness as a decision parameter Critical Thinking


SB5. apply balanced judgement to different situations SB6. apply basic mathematical and statistical knowledge

Problem solving


SB7. solve conflicts and negotiate on behalf of the team and within the team SB8. explore new ways of doing things

SB9. identify and objectively evaluate both temporary/short-term and

permanent/long-term solutions Analytical Thinking The user/individual on the job needs to know and understand how to:

SB10. analyse operations data and information to identify assembly, installation and maintenance needs

SB11. pay attention to detail for identifying faults and anomalies

SB12. spot process disruptions and delays and report and communicate these to the manager with solutions

Customer Centricity Not Applicable

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NOS Version Control

NOS Code LFS/N0219



Industry Sub-sector

Pharmaceuticals, Last reviewed on

25/02/15 Biopharmaceuticals


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LFS/N0220: Prepare effective maintenance schedules and ensure smooth flow of work

National

Occupational

Standard

Overview

This NOS is about the knowledge, understanding and skills required by a Maintenance Supervisor for developing and communicating maintenance schedules, ensuring availability of material and manpower required for maintenance activities and data logging.

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LFS/N0220 : Prepare effective maintenance schedules and ensure smooth flow of work

Unit Code LFS/N0220

Unit Title Prepare effective maintenance schedules and ensure smooth flow of work

(Task)

Description This NOS unit is about a Maintenance Supervisor HVAC developing and

communicating maintenance schedules, ensuring availability of material and

manpower required for maintenance activities and data logging.

Scope The unit/ task covers the following:

• Maintenance Schedules

• Operations

Performance Criteria (PC) w.r.t the Scope


Maintenance To be competent, the user/individual on the job must be able to:

Schedules

PC1. inspect the manpower requirement based on maintenance required PC2. identify the material requirements for carrying maintenance

PC3. plan schedule for maintenance activities (including preventive maintenance)

while ensuring that work is not hindered

PC4. select the suitable alternatives in case the appropriate equipment and

materials are not available for maintenance and inform the appropriate person

PC5. plan the schedule of workmen for maintenance process

PC6. inform the workmen of the maintenance schedules

PC7. display the appropriate signage for the work being conducted

PC8. assign and distribute work orders and work requests

PC9. prepare vacation schedule for all employees and ensure that work is not

affected adversely

Operations

PC10. ensure that there is adequate ventilation for the work being carried out

PC11. ensure that work is carried out on time

PC12. ensure that the workmen are on time as per the schedule

PC13. ensure that they are carrying out their work without disturbing others

PC14. provide technical assistance when requested

PC15. deal with accidental damage, if any, caused while carrying out the work

PC16. report to the appropriate person any disturbances in material flow or

equipment

PC17. identify and report to the appropriate person any additional work required

that is outside one’s responsibility or skill

PC18. follow workplace procedures to deal with any accidental damage caused

during the installation and maintenance process and adhere to 5S and TPM

guidelines

PC19. ensure that, on completion of the work, the area is left clean and dry and

meets requirements

PC20. ensure that the equipment, materials and personal protective equipment that

were used are returned to the right places making sure they are clean, safe

and securely stored

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PC21. train staff in safety procedures and maintain safety data sheets for crews PC22. ensure that the waste garnered from the activity is disposed in an appropriate

manner

PC23. determine time and cost estimates for installation and maintenance PC24. replenish any necessary supplies or consumables


A. Organisational The user/individual on the job needs to know and understand: Context (Knowledge of the KA1. material and equipment used in the production process and their function

Company/ KA2. different quality management systems (ISO-9000, ISO-14001, OHSAS-18000) Organisation and KA3. importance of identifying non-conforming products and dealing of the same

its processes)

KA4. impact of various practices on cost, quality, productivity, delivery and safety


KA6. the reason and impact of the occurrence of problems

KA7. measures, steps and possible solutions that have been taken/identified to

address the previous problems

KA8. the appropriate authority for reporting any imbalances

KA9. the correct method for carrying out corrective actions outlined for each

problem

B Technical The user/individual on the job needs to know and understand: Knowledge

KB1. method of preparation of estimates and materials order for maintenance and

repair jobs

KB2. typical equipment faults and related causes, including recognition of signs and

symptoms of faulty equipment and early warning signs of potential problems

KB3. operating requirements, parameters and corrective action required where

operation is outside specified operating parameters

KB4. the occupational hazards and safety precautions of the work


KB6. operational health and safety (OHS) hazards and controls, including limitations

of protective clothing and equipment relevant to the work process



shutdowns and procedures to follow in the event of a power outage

KB8. environmental issues and controls relevant to the process, including

waste/rework collection and handling procedures related to the process

Skills (S)

Reading Skills

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A. Core Skills/ The user/ individual on the job needs to know and understand how to: Generic Skills

SA1. read and understand manuals, SOPs, health and safety instructions, memos,

reports, job cards etc.

SA2. read and interpret images, graphs, diagrams for typical product specifications, job sheets, procedures, basic machine control panels, material labels and safety information as provided

SA3. read various coding systems as per company norms SA4. use basic computer applications/software

Writing skills


SA5. do legible entries with permanent ink SA6. write detailed reports for investigation SA7. pay attention to detail while recording maintenance parameters

SA8. work on basic computer applications/software



SA9. communicate with upstream and downstream teams SA10. communicate work schedules clearly and precisely SA11. communicate with people in a proper form and manner and use language that

is open and respectful

SA12. resolve any difficulties in relationships with colleagues , or get help from an appropriate person, in a way that preserves goodwill and trust

B. Professional Skills Plan & Organize


SB1. study past data to identify resource needs for maintenance activities

SB2. plan and organize resources to ensure that maintenance activities cater to production efficiency needs

SB3. supervise and inspect the work of the technicians Decision Making The user/individual on the job needs to know and understand how to:

SB4. collaborate within the team and with other production teams for identifying appropriate maintenance schedules

SB5. apply technical know-how and commercial awareness as a scheduling decision parameter

Problem solving The user/individual on the job needs to know and understand how to:

SB6. solve conflicts within the team on work schedules and adherence

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SB7. identify alternate approaches/resource deployment/equipment utilization to ensure schedule adherence


permanent/long-term solutions Analytical Thinking The user/individual on the job needs to know and understand how to:

SB9. analyse operations data and information to identify assembly, installation and maintenance needs

SB10. pay attention to detail for identifying faults and anomalies for maintenance SB11. spot process disruptions and delays and report and communicate these to the

manager with solutions Critical Thinking

Not Applicable

Customer Centricity

Not Applicable

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NOS Version Control

NOS Code LFS/N0220



Industry Sub-sector




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LFS/N0221 : Carry out reporting and documentation for maintenance activities

National

Occupational

Standard

Overview

This NOS is about the knowledge, understanding and skills required by a Maintenance Supervisor for reporting data/problem/incidents etc. recording and documenting and ensuring information security.

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Unit Code LFS/N0221

Unit Title Carry out reporting and documentation for maintenance activities

(Task)

Description This NOS unit is about the Maintenance Supervisor HVAC reporting

data/problem/incidents etc. recording and documenting and ensuring information

security.


• Reporting

• Recording and Documentation

• Information Security



Reporting To be competent, the user/individual on the job must be able to:

PC1. report data/problems/incidents as applicable in a timely manner PC2. report to the appropriate authority as laid down by the company

PC3. follow reporting procedures as prescribed by the company

PC4. inform supervisors of completed and outstanding work orders

Recording and PC5. identify documentation to be completed relating to one’s role

Documentation PC6. record details accurately in the appropriate format

PC7. prepare complete job documentation including site assessments, daily status

reporting, assessment reports, post installation reporting, lessons learned,

opportunity for improvement, serial number and other relevant information

PC8. maintain time, materials and equipment use reports

PC9. maintain records of all data attendance and provide effective training to all

staff members

PC10. complete all documentation within stipulated time according to company

procedure

PC11. ensure that the final document meets the requirements of the individuals who

requested it or make any amendments accordingly

PC12. make sure documents are available to all appropriate authorities for inspection

Information Security

PC13. respond to requests for information in an appropriate manner while following

organizational procedures

PC14. inform the appropriate authority of requests for information received



Context

(Knowledge of the KA1. risk and impact of not following the defined procedures/work instructions

Company/ KA2. escalation matrix for reporting identified issues, hazards and breakdown

Organisation and

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its processes) KA3. types of documentation used in the organization, importance of maintaining the same and different methods of recording information KA4. impact of various practices on cost, quality, productivity, delivery and safety

KA5. the importance of complete and accurate documentation KA6. reason and impact of problems affecting the equipment

KA7. measures, steps and possible solutions that have been identified/taken to

address previous problems

KA8. procedure for reporting any imbalances to the appropriate authority


KB1. different kinds of standard reference material

Skills (S)

Writing skills

A. Core Skills/ The user/ individual on the job needs to know and understand how to:

Generic Skills SA1. record and communicate details of work done to appropriate people using

written/typed report SA2. maintain proper records as per given format SA3. work on basic computer applications

Reading skills




job sheets, procedures, basic machine control panels, material labels and safety information as provided

SA6. use and interpret the various coding systems as per company norms

Oral Communication (Listening and Speaking skills) The user/individual on the job needs to know and understand how to:

SA7. comprehend information shared verbally

SA8. disclose information only to those who have the right and need to know it SA9. communicate confidential and sensitive information discretely to authorized

person as per the SOP B. Professional Skills Analytical thinking


SB1. suggest improvements(if any) in process/formats for reports/documentation based on experience and observation

SB2. use available data and computer software to create required documentation SB3. pay attention to detail when capturing information Plan and Organise The user/individual on the job needs to know and understand how to:

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SB4. effectively plan and allocate ownership for documentation/information within the team

SB5. take responsibility for completing one’s own work assignment SB6. plan and prioritize reporting/documentation based on criticality and urgency

Critical Thinking

Not Applicable Decision Making

Not Applicable

Customer Centricity Not Applicable

Problem Solving

Not Applicable

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NOS Version Control

NOS Code LFS/N0221



Industry Sub-sector




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LFS/N0222 : LFS/N0222: Identify and resolve any issues related to installation, operation or maintenance of HVAC

National Occupational

Standard

Overview

This NOS is about the knowledge, understanding and skills required by a Maintenance Supervisor HVAC for supervising the work of personnel to identify problems through inspection, identifying any issues hampering the working of HVAC and analysing the findings.

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LFS/N0222 : Identify and resolve any issues related to installation, operation or maintenance

of HVAC

Unit Code LFS/N0222

Unit Title Identify and resolve any issues related to installation, operation or maintenance of

(Task) HVAC Description This NOS unit is about the Maintenance Supervisor HVAC supervising the work of

personnel to identify problems through inspection, identifying any issues hampering

the working of HVAC and analysing the findings.


• Inspection

• Analysis



Inspection To be competent, the user/individual on the job must be able to:

PC1. inspect maintenance works to ensure compliance with standard procedures

PC2. undertake immediate actions to resolve sudden errors or faults in equipment

or functionality system

PC3. identify non-conformities to the company maintenance SOP

Analysis PC4. analyse potential causes of non-conformities to standards

PC5. evaluate the need for action to ensure that problems do not recur and ensure

zero productivity loss due to idle machine/equipment

PC6. suggest corrective action to address problem

PC7. review effectiveness of corrective action

PC8. interpret the results of the inspection correctly



Context

(Knowledge of the KA1. different quality management systems (ISO-9000, TS16949, ISO-14001,

Company/ OHSAS-18000)

Organisation and KA2. methods of disposing of materials, importance of appropriate disposal and

its processes) implications of not following the material disposal procedure

KA3. importance of identifying non-conforming products and dealing of the

same

KA4. risk and impact of not following defined procedures/work instructions

KA5. escalation matrix for reporting identified issues, hazards and breakage

KA6. which protective equipment to be used and how

KA7. potential hazards, actions to minimize the same and basic disaster

management

KA8. impact of various practices on cost, quality, productivity, delivery and

safety

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of HVAC

KA9. procedures for reporting any unresolved issues and hazards KA10. methods of reporting incidents where standard operating procedures are

not followed KA11. characteristics of the material and equipment required in setting up HVAC

and its maintenance


KA13. implications of inaccurate measuring and testing instruments and

equipment

KA14. the reason and impact of the occurrence of problems

KA15. measures, steps and possible solutions that have been taken/identified to

address the previous problems

KA16. the appropriate authority for reporting any imbalances KA17. the correct method for carrying out corrective actions outlined for each problem

KA18 company manual and SOP


KB1. methods, materials and equipment used in installing, repairing and

maintaining heating, refrigeration and air handling equipment

KB2. different standard reference materials

KB3. occupational hazards and safety precautions of the work



shutdowns and procedures to follow in the event of a power outage KB5. energy management systems

KB6. methods of using test and diagnostic equipment used in the calibration and

repair of chillers, boilers, control systems, refrigeration system, air quality

and electrical systems

KB7. methods of using testing equipment, related test methods and purpose of

tests

KB8. quality requirements of materials and equipment

KB9. operating requirements, parameters and corrective action required where

operation is outside specified operating parameters KB10. environmental issues and controls relevant to the process, including waste/rework collection and handling procedures related to the process


KB12. operational health and safety (OHS) hazards and controls, including

limitations of protective clothing and equipment relevant to the work

process

KB13. how to perform statistical analysis of test data

Skills (S)

Reading Skills

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of HVAC A. Core Skills/ The user/ individual on the job needs to know and understand how to:

Generic Skills



job sheets, procedures, basic machine control panels, material labels and safety information as provided

SA3. read various coding systems as per company norms Writing skills


SA4. do legible entries with permanent ink SA5. write detailed reports for investigation

Oral Communication (Listening and Speaking skills) The user/individual on the job needs to know and understand how to:

SA11. communicate with upstream and downstream teams

SA12. communicate with people in a proper form and manner and use language that is open and respectful

SA13. resolve any difficulties in relationships with colleagues , or get help from an

appropriate person, in a way that preserves goodwill and trust B. Professional Skills Problem Solving


SB1. identify, define and resolve installation, operation and maintenance problems using a structured methodology and objective parameters


permanent/long-term solutions SB3. explore new approach of doing things to resolve issues SB4. analyse past data, information and knowledge to identify solutions Decision Making


SB5. evaluate multiple options on defined, objective parameters SB6. apply commercial awareness as a decision parameter

SB7. act objectively, rather than impulsively or emotionally when faced with

difficult/stressful or emotional situations Analytical Thinking


SB8. apply basic science, statistics and mathematical knowledge to understand the root cause of the issue

SB9. pay attention to equipment/apparatus operations detail SB10. suggest improvements(if any) in current ways of working SB11. improve processes by interacting with others and adopting best practices

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of HVAC Critical Thinking


SB12. apply balanced judgement to different situations SB13. provide sound, constructive, and objective opinions Plan and Organize

Not Applicable

Customer Centricity

Not Applicable

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of HVAC

NOS Version Control

NOS Code LFS/N0222



Industry Sub-sector




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LFS/N0101 : Maintain a healthy, safe and secure working environment in the life sciences facility

National Occupational

Standard

Overview

This NOS is about the knowledge, understanding and skills required by a Maintenance Supervisor to ensure healthy, safe and secure working environment and manage emergency procedures in the life sciences facility.

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Unit Code LFS /N0101

Unit Title Maintain a healthy, safe and secure working environment in the life sciences facility

(Task)

Description This NOS unit is about a Maintenance Supervisor HVAC monitoring the working

environment and making sure that it meets the requirements for health, safety and

security in the pharmaceutical/contract research/biopharmaceutical facility/

manufacturing/ testing/ analysis/ research laboratory.

Scope This unit / task covers the following:

Ensuring healthy, safe and secure working environment:

• self monitor and adhere to safety principles and standards

• ensure behavioural safety by workmen to cGMP and applicable safety standards on the shop floor/ laboratory

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

Managing emergency procedures:

• illness

• accidents

• fires

• other reasons to evacuate the premises

• breaches of security

Performance Criteria (PC) wrt the Scope


Ensuring healthy,

To be competent, the user/individual on the job must be able to:

safe and secure PC1. observe and comply with the company’s current health, safety and security

working environment policies and procedures

PC2. while carrying out work, use appropriate safety gears like head gear, masks,

gloves and other accessories as mentioned in the guidelines

PC3. report any identified breaches in health, safety, and security policies and

procedures to the designated person

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

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

competently and within the limits of their authority

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

PC7. identify and recommend opportunities for improving health, safety, and

security to the designated person

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

records legibly and accurately

Managing emergency PC9. report any hazards that the individual is not competent to deal with to the

procedures relevant person in line with organizational procedures and warn other people

who may be affected

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

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B. Organisational The user/ individual on the job needs to know and understand: Context

(Knowledge of the KA1. legislative requirements and company’s procedures for health, safety and

Company/ security and individual’s role and responsibilities in relation to this Organisation and KA2. what is meant by a hazard, including the different types of health and safety

its processes)

hazards that can be found in the workplace

KA3. how and when to report hazards

KA4. limits of individual responsibility for dealing with hazards

KA5. the organization’s emergency procedures for different emergency situations

and the importance of following these

KA6. the importance of maintaining high standards of health, safety and security

KA7. implications that any non-compliance with health, safety and security may

have on individuals and the organization

KA8. health hazards and its implications if any in the production process

B Technical The user/ individual on the job needs to know and understand: Knowledge

KB1. different types of breaches in health, safety and security and how and when to

report these

KB2. evacuation procedures for workers and visitors

KB3. how to summon medical assistance and the emergency services, where

necessary

KB4. how to use the health, safety and accident reporting procedures and the

importance of these

KB5. different types of occupational health hazards

KB6. knowledge of chemical substances, their characteristics and required

precaution and safety measures

Skills (S)

A. Core Skills/ Writing skills

Generic Skills The user/ individual on the job needs to know and understand how to:

SA1. complete accurate, well written work with attention to detail

Reading skills


SA2. read instructions, guidelines, procedures, rules and service level agreements



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SA3. listen effectively and orally communicate information accurately B. Professional Skills Decision making


SB1. make decisions on suitable courses of action

Plan and Organise The user/ individual on the job needs to know and understand how to:

SB2. plan and organize work to meet health, safety and security requirements Problem solving The user/ individual on the job needs to know and understand how to:

SB3. apply problem solving approaches in different situations Analytical thinking The user/ individual on the job needs to know and understand how to:

SB4. analyse data and activities Critical thinking The user/ individual on the job needs to know and understand how to:

SB5. apply balanced judgments to different situations Customer Centricity

Not Applicable

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NOS Version Control

NOS Code LFS/N0101



Industry Sub-sector

Pharmaceuticals and Last reviewed on

15/05/15 Bio Pharmaceuticals

Occupation

Manufacturing, Quality, Next review date

01/06/16

Supply Chain, R&D

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Qualifications Pack For Maintenance Supervisor/In Charge – HVAC – Life Sciences

Annexure

Nomenclature for QP and NOS

Qualifications Pack 9 characters

LFS/ Q 0101

LFS

QP Number (2 numbers)

Q denoting Qualification Pack

Occupation (2 numbers)

Occupational Standard

An example of NOS with ‘N’

9 characters

LFS / N 0101

LFS

OS Number (2 numbers)

N denoting National Occupational Standard

Occupation (2 numbers)

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The following acronyms/codes have been used in the nomenclature above:

Sub-Sector Range of Occupation Numbers

Pharmaceutical and Biopharmaceutical 01-10 and Contract Research

Pharmaceutical 11-20

Biopharmaceutical 21-30

Contract Research 31-40

Sequence Description Example

Three letters Industry name LFS

Slash / /

Next letter Whether QP or NOS Q/N

Next two numbers Occupation code 01

Next two numbers OS number 01

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CRITERIA FOR ASSESSMENT OF TRAINEES

Job Role Maintenance Supervisor/In charge – HVAC – Life Sciences Qualification Pack LFS/Q0209 Sector Skill Council Life Sciences Sector Skill Development Council

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 this criteria 5. To pass the Qualification Pack , every trainee should score a minimum of 70% in every 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 Assessment Criteria of Total Marks

Out Of Theory Skills Outcome Outcome Practica

(500)

l

LFS/N0219 PC1. coordinate with stores

(Monitor assembly, to determine which installation, parts should be ordered

\operation and

for installation or as maintenance of

4 2 2

spare parts like HVAC

HVAC as per SOP)

equipment, air filters,

centrifuges, dryers, etc

100

PC2. assist in maintaining

proper levels of

materials/supplies to 5 2 3

ensure timely and

efficient completion of

necessary task PC3. assist in purchase of

materials and ensure

prevention of defects 4 2 2

and maintenance of

quality as per

requirement PC4. identify the areas where

new installations are 4 2 2

required in coordination

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with the manufacturing

and quality teams PC5. assist in approving

purchases of materials 5 2 3

and equipment PC6. identify defect/problem

4 2 2

in inappropriate sample

PC7. start, operate, monitor

and adjust HVAC

equipment to ensure

proper working (such as 5 2 3

air flow and turbulence,

pressure

differentiations, filter

efficiencies) PC8. ensure compliance with

all regulations and

company policies, 4 2 2

including qualification

and requalification as

per GMP standards PC9. review all work orders

before and after 5 2 3

completion

PC10. take corrective action

in response to typical 4 2 2

faults and

inconsistencies

PC11. set up appropriate

equipment or apparatus 5 2 3

for testing correctly

PC12. calibrate the

equipment periodically 5 2 3

as per the SOP

PC13. identify defective

equipment/apparatus

and steps to be taken 4 2 2

like support preventive


PC14. verify the equipment

accuracy by comparing 5 2 3

with the standard

reference

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PC15. respond to emergency calls

for system and equipment 4 1 3

failure

PC16. set and adjust controls 5 2 3 PC17. cover technical support desk

during absence of Technical 4 2 2

Support team PC18. assist relevant stakeholders

of HVAC with technical

support; technical data,

development and 5 2 3

maintenance of user

manuals, FAQ’s, technical

support phone calls and

warehouse tasks PC19. ensure that maintenance

helper is working as per the 5 2 3

SOP PC20. take up the results of the

findings with the appropriate 5 2 3

authority PC21. carry out disposal of waste

and leftover tested material 5 2 3

safety as per the SOP PC22. dispose all materials used in

the experiment safely as per

health and safety 4 2 2

management system of the

company

Total 100 43 57 LFS/N0220 PC1. inspect the manpower

(Prepare requirement based on 2 1 1

effective maintenance required

maintenance PC2. identify the material

schedules and requirements for carrying 3 1 2

ensure smooth maintenance flow of work)

PC3. plan schedule for 100


(including preventive 6 3 3

maintenance) while ensuring

that work is not hindered

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PC4. select the suitable

alternatives in case the

appropriate equipment and 6 2 4

materials are not available

for maintenance and inform

the appropriate person

PC5. plan the schedule of

workmen for maintenance 4 2 2

process

PC6. inform the workmen of the 3 1 2

maintenance schedules

PC7. display the appropriate

signage for the work being 3 2 1

conducted PC8. assign and distribute work

3 1 2

orders and work requests

PC9. prepare vacation schedule

for all employees and ensure 6 2 4

that work is not affected

adversely

PC10. ensure that there is adequate

ventilation for the work 3 1 2 being carried out

PC11. ensure that work is carried 4 2 2

out on time

PC12. ensure that the workmen are 3 1 2

on time as per the schedule

PC13. ensure that they are carrying

out their work without 3 1 2 disturbing others

PC14. provide technical assistance 4 2 2

when requested

PC15. deal with accidental damage,

if any, caused while carrying 4 2 2

out the work

PC16. report to the appropriate

person any disturbances in 4 2 2

material flow or equipment

PC17. identify and report to the

appropriate person any

additional work required that 4 2 2

is outside one’s responsibility

or skill

PC18. follow workplace procedures

to deal with any accidental 6 3 3

damage caused during the

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installation and maintenance

process and adhere to 5S and

TPM guidelines

PC19. ensure that, on completion

of the work, the area is left 6 3 3

clean and dry and meets

requirements

PC20. ensure that the equipment,

materials and personal

protective equipment that

were used are returned to 4 2 2

the right places making sure

they are clean, safe and securely stored

PC21. train staff in safety

procedures and maintain 4 2 2

safety data sheets for crews

PC22. ensure that the waste garnered from the activity is

4 2 2

disposed in an appropriate

manner

PC23. determine time and cost

estimates for installation and 7 3 4

maintenance

PC24. replenish any necessary 4 2 2

supplies or consumables

Total 100 45 55 LFS/N0221 PC1. report

(Carry out data/problems/incidents as 7 3 4

reporting and applicable in a timely

documentation manner 100

for maintenance PC2. report to the appropriate

activities) authority as laid down by the 7 3 4 company

PC3. follow reporting procedures

as prescribed by the 10 5 5

company PC4. inform supervisors of

completed and outstanding 7 3 4

work orders PC5. identify documentation to

be completed relating to 8 4 4

one’s role

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PC6. record details accurately in 9 4 5

the appropriate format

PC7. prepare complete job

documentation including

site assessments, daily

status reporting, assessment

reports, post installation 10 5 5

reporting, lessons learned,

opportunity for

improvement, serial number

and other relevant

information

PC8. maintain time, materials and 10 5 5

equipment use reports

PC9. maintain records of all data

attendance and provide 6 3 3

effective training to all staff

members PC10. complete all documentation

within stipulated time 6 3 3

according to company

procedure

PC11. ensure that the final

document meets the

requirements of the 6 3 3

individuals who requested it

or make any amendments

accordingly PC12. make sure documents are

available to all appropriate 5 2 3

authorities to inspect

PC13. respond to requests for

information in an

appropriate manner whilst 5 2 3

following organizational

procedures

PC14. inform the appropriate

authority of requests for 4 2 2

information received

Total 100 47 53

LFS/N0222 PC1. inspect maintenance works

(Identify and

to ensure compliance with 100 13 6 7

resolve any

standard procedures

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issues related to PC2. undertake immediate

installation, actions to resolve sudden

operation or errors or faults in 12 6 6

maintenance of equipment or functionality

HVAC) system

PC3. identify non-conformities to

the company maintenance 13 7 6

SOP

PC4. analyse potential causes of

non-conformities to 12 6 6

standards

PC5. evaluate the need for action

to ensure that problems do

not recur and ensure zero 12 6 6

productivity loss due to idle

machine/equipment

PC6. suggest corrective action to 12 6 6

address problem

PC7. review effectiveness of 13 7 6

corrective action

PC8. interpret the results of the

inspection correctly 13 6 7

Total 100 50 50

LFS/N0101 PC1. observe and comply with

(Maintain a the company’s current 100 10 5 5

healthy, safe and

health, safety and security

secure working policies and procedures

environment)

PC2. while carrying out work, use

appropriate safety gears like

head gear, masks, gloves 10 5 5 and other accessories as

mentioned in the guidelines

PC3. report any identified

breaches in health, safety,

and security policies and 10 5 5

procedures to the

designated person PC4. responsible for maintaining

discipline at the shop-floor/ 10 5 5

production area PC5. identify and correct any

hazards that the individual 10 5 5

can deal with safely,

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competently and within the

limits of their authority

PC6. adhere and comply to

storage and handling 10 5 5

guidelines for hazardous

material

PC7. identify and recommend

opportunities for improving 10 5 5

health, safety, and security

to the designated person

PC8. complete any health, safety

and security records legibly 10 4 6

and accurately

PC9. report any hazards that the

individual is not competent

to deal with to the relevant

person in line with 10 4 6

organizational procedures

and warn other people who

may be affected PC10. follow the company’s

emergency procedures 10 5 5

promptly, calmly, and

efficiently

Total 100 48 52

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