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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Qualifications Pack For Maintenance Supervisor/ In Charge - HVAC – Life Sciences
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
Qualifications Pack For Maintenance Supervisor/ In Charge - HVAC – Life Sciences
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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LFS/N0219 : Monitor assembly, installation, operation and maintenance of HVAC as per SOP
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
The user/ individual on the job needs to know and understand how to:
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
The user/individual on the job needs to know and understand how to:
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
The user/individual on the job needs to know and understand how to:
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
The user/individual on the job needs to know and understand how to:
SB5. apply balanced judgement to different situations SB6. apply basic mathematical and statistical knowledge
Problem solving
The user/individual on the job needs to know and understand how to:
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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LFS/N0219 : Monitor assembly, installation, operation and maintenance of HVAC as per SOP
NOS Version Control
NOS Code LFS/N0219
Credits(NSQF) TBD Version number 1.0
Industry Life Sciences Drafted on 15/12/14
Industry Sub-sector
Pharmaceuticals, Last reviewed on
25/02/15 Biopharmaceuticals
Occupation Manufacturing Next review date 01/06/17
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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
Element Performance Criteria
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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LFS/N0220 : Prepare effective maintenance schedules and ensure smooth flow of work
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
Knowledge and Understanding (K)
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
KA5. use of monitoring and measuring devices
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
KB5. common causes of variation and corrective action required
KB6. operational health and safety (OHS) hazards and controls, including limitations
of protective clothing and equipment relevant to the work process
KB7. 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
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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LFS/N0220 : Prepare effective maintenance schedules and ensure smooth flow of work
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
The user/ individual on the job needs to know and understand how to:
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
Oral Communication (Listening and Speaking skills)
The user/individual on the job needs to know and understand how to:
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
The user/individual on the job needs to know and understand how to:
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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LFS/N0220 : Prepare effective maintenance schedules and ensure smooth flow of work
SB7. identify alternate approaches/resource deployment/equipment utilization to ensure schedule adherence
SB8. 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:
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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LFS/N0220 : Prepare effective maintenance schedules and ensure smooth flow of work
NOS Version Control
NOS Code LFS/N0220
Credits(NSQF) TBD Version number 1.0
Industry Life Sciences Drafted on 15/12/14
Industry Sub-sector
Pharmaceuticals, Last reviewed on
25/02/15 Biopharmaceuticals
Occupation Manufacturing Next review date 01/06/17
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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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LFS/N0221 : Carry out reporting and documentation for maintenance activities
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.
Scope The unit/ task covers the following:
• Reporting
• Recording and Documentation
• Information Security
Performance Criteria (PC) w.r.t. the Scope
Element Performance Criteria
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
Knowledge and Understanding (K)
A. Organisational The user/individual on the job needs to know and understand:
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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LFS/N0221 : Carry out reporting and documentation for maintenance activities
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
B. Technical The user/individual on the job needs to know and understand: Knowledge
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
The user/individual on the job needs to know and understand how to:
SA4. read and understand manuals, SOPs, health and safety instructions, memos, reports, job cards etc.
SA5. read and interpret images, graphs, diagrams for typical product specifications,
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
The user/individual on the job needs to know and understand how to:
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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LFS/N0221 : Carry out reporting and documentation for maintenance activities
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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LFS/N0221 : Carry out reporting and documentation for maintenance activities
NOS Version Control
NOS Code LFS/N0221
Credits(NSQF) TBD Version number 1.0
Industry Life Sciences Drafted on 15/12/14
Industry Sub-sector
Pharmaceuticals, Last reviewed on
25/02/15 Biopharmaceuticals
Occupation Manufacturing Next review date 01/06/17
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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.
Scope The unit/ task covers the following:
• Inspection
• Analysis
Performance Criteria (PC) w.r.t. the Scope
Element Performance Criteria
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
Knowledge and Understanding (K)
A. Organisational The user/individual on the job needs to know and understand:
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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LFS/N0222 : Identify and resolve any issues related to installation, operation or maintenance
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
KA12. use of monitoring and measuring devices
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
B. Technical The user/individual on the job needs to know and understand: Knowledge
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
KB4. 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 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
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. how to perform statistical analysis of test data
Skills (S)
Reading Skills
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LFS/N0222 : Identify and resolve any issues related to installation, operation or maintenance
of HVAC 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 Writing skills
The user/ individual on the job needs to know and understand how to:
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
The user/individual on the job needs to know and understand how to:
SB1. identify, define and resolve installation, operation and maintenance problems using a structured methodology and objective parameters
SB2. identify and objectively evaluate both temporary/short-term and
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
The user/individual on the job needs to know and understand how to:
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
The user/individual on the job needs to know and understand how to:
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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LFS/N0222 : Identify and resolve any issues related to installation, operation or maintenance
of HVAC Critical Thinking
The user/individual on the job needs to know and understand how to:
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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LFS/N0222 : Identify and resolve any issues related to installation, operation or maintenance
of HVAC
NOS Version Control
NOS Code LFS/N0222
Credits(NSQF) TBD Version number 1.0
Industry Life Sciences Drafted on 15/12/14
Industry Sub-sector
Pharmaceuticals, Last reviewed on
25/02/15 Biopharmaceuticals
Occupation Manufacturing Next review date 01/06/17
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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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Nat
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LFS/N0101 : Maintain a healthy, safe and secure working environment in the life sciences facility
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
Element Performance Criteria
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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LFS/N0101 : Maintain a healthy, safe and secure working environment in the life sciences facility
Knowledge and Understanding (K)
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
The user/ individual on the job needs to know and understand how to:
SA2. read instructions, guidelines, procedures, rules and service level agreements
Oral Communication (Listening and Speaking skills)
The user/ individual on the job needs to know and understand how to:
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LFS/N0101 : Maintain a healthy, safe and secure working environment in the life sciences facility
SA3. listen effectively and orally communicate information accurately B. Professional Skills Decision making
The user/ individual on the job needs to know and understand how to:
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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LFS/N0101 : Maintain a healthy, safe and secure working environment in the life sciences facility
NOS Version Control
NOS Code LFS/N0101
Credits(NSQF) TBD Version number 1.0
Industry Life Sciences Drafted on 26/06/14
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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Qualifications Pack For Maintenance Supervisor/In Charge – HVAC – Life Sciences
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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Qualifications Pack For Maintenance Supervisor/In Charge – HVAC – Life Sciences
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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Qualifications Pack For Maintenance Supervisor/In Charge – HVAC – Life Sciences
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
maintenance activities
PC14. verify the equipment
accuracy by comparing 5 2 3
with the standard
reference
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Qualifications Pack For Maintenance Supervisor/In Charge – HVAC – Life Sciences
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
maintenance activities
(including preventive 6 3 3
maintenance) while ensuring
that work is not hindered
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Qualifications Pack For Maintenance Supervisor/In Charge – HVAC – Life Sciences
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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Qualifications Pack For Maintenance Supervisor/In Charge – HVAC – Life Sciences
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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Qualifications Pack For Maintenance Supervisor/In Charge – HVAC – Life Sciences
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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Qualifications Pack For Maintenance Supervisor/In Charge – HVAC – Life Sciences
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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Qualifications Pack For Maintenance Supervisor/In Charge – HVAC – Life Sciences
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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