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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.33
6. Assessment Criteria……………………………..P.35
technology consul t ing
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 13, Palam Marg, 3rd Floor, Vasant Vihar, New Delhi, 110057 Phone No.: +91 11 41042407/408 E-mail: info@lsssdc.in
Qualifications Pack-Maintenance Supervisor/In Charge -
Water – Life Sciences
SECTOR: LIFE SCIENCES
SUB-SECTOR: PHARMACEUTICAL AND BIOPHARMACEUTICAL
OCCUPATION: MANUFACTURING
REFERENCE ID: LFS/Q0210
ALIGNED TO: NCO-2004/ NIL
Maintenance supervisor, also known as Maintenance In charge is responsible for monitoring the assembly, installation and maintenance of water systems 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 water system 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 water system 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. The supervisor should be reliable, motivated and must have integrity.
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Introduction
QUALIFICATIONS PACK - OCCUPATIONAL STANDARDS FOR LIFE SCIENCES INDUSTRY
Qualifications Pack For Maintenance Supervisor/ In Charge – Water – Life Sciences
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Qualifications Pack Code LFS/Q0210
Job Role Maintenance Supervisor/In Charge – Water – Life Sciences
Credits(NSQF) TBD Version number 1.0
Sector Life Sciences Drafted on 15/12/14
Sub-sector Pharmaceutical and Biopharmaceutical
Last reviewed on 25/02/15
Occupation Manufacturing Next review date 01/06/17
NSQC approval on 20/07/2015
Job Role Maintenance Supervisor/In Charge – Water – Life Sciences
Role Description
Responsible for monitoring assembly, installation, operation and maintenance of water system 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 water system and maintaining a healthy, safe and secure working environment.
NSQF level Minimum Educational Qualifications Maximum Educational Qualifications
5
Diploma in Mechanical /ITI (Plumbing)
B.Tech in Mechanical preferable
Training (Suggested but not mandatory)
On the job training
Minimum Job Entry Age 18 Years
Experience
0-2 years
Applicable National Occupational Standards (NOS)
Compulsory: 1. LFS/N0223: Monitor assembly, installation, operation
and maintenance of water system as per SOP 2. LFS/N0220: Prepare effective maintenance schedules
and ensure smooth flow of work
Job
Det
ails
Qualifications Pack For Maintenance Supervisor/ In Charge – Water – Life Sciences
3 | P a g e
3. LFS/N0221: Carry out reporting and documentation for
maintenance activities
4. LFS/N0224: Identify and resolve any issues related to
installation, operation or maintenance of water system
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
Qualifications Pack For Maintenance Supervisor/ In Charge – Water – Life Sciences
4 | P a g e
Keywords /Terms Description
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 Description gives a short summary of the unit content. This would be 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 Understanding
Knowledge and Understanding are statements which together specify the technical, generic, professional and organisational specific knowledge that an individual needs in order to perform to the required standard.
National Occupational Standards (NOS)
NOS are Occupational Standards which apply uniquely in the Indian 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 Code
Qualifications Pack Code is a unique reference code that identifies a 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.
Def
init
ion
s
Qualifications Pack For Maintenance Supervisor/ In Charge – Water – Life Sciences
5 | P a g e
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.
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
ISO International Organization for Standardization
OHSAS Occupational Health and Safety Assessment Series
Acr
on
yms
LFS/N0223 : Monitor assembly, installation, operation and maintenance of water systems as per SOP
6 | P a g e
Overview This NOS is about the knowledge, understanding and skills required by a Maintenance Supervisor – Water for monitoring the assembly and installation of water system, ensuring that the operation is as per SOP, taking care of day to day engineering activities and carrying out tests as per specifications.
National Occupational
Standard
LFS/N0223 : Monitor assembly, installation, operation and maintenance of water systems as per SOP
7 | P a g e
Unit Code LFS/N0223
Unit Title (Task)
Monitor assembly, installation, operation and maintenance of water systems as per SOP
Description This NOS is about a Maintenance Supervisor monitoring the assembly and installation of water system according to requirements, ensuring that the operation of water system is as per SOP, taking care of day to day engineering activities, carrying out tests as per laid down method and 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 Installation
To be competent, the user/individual on the job must be able to:
PC1. coordinate with stores to determine which parts should be ordered for installation or as spare parts
PC2. assist in maintaining proper levels of materials/supplies to ensure timely and efficient completion of necessary tasks like maintenance of water systems
PC3. assist in purchase of materials and ensure prevention of defects and 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 operations of water systems PC7. maintaining purified water, distilled water, tap water and water for injection as
per the required specifications
Safety Checks PC8. start, operate, monitor and adjust water system equipment to ensure availability of water according to specification and sanitization for proper working
PC9. ensure that there are no leakages PC10. ensure compliance with all regulations and company policies, including
qualification and requalification as per GMP standards PC11. review all work orders before and after completion PC12. take corrective action in response to typical faults and inconsistencies PC13. set up appropriate equipment or apparatus for testing correctly. PC14. calibrate the testing equipment periodically as per the SOP
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/N0223 : Monitor assembly, installation, operation and maintenance of water systems as per SOP
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Maintenance
PC16. set and adjust controls PC17. identify defective equipment/apparatus and steps to be taken PC18. assist relevant stakeholders of the water systems with technical support;
technical data, development and maintenance of user manuals, FAQ’s, technical support phone calls and warehouse tasks
PC19. ensure that maintenance helpers are 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 materials safely 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 Context (Knowledge of the Company/ Organisation and its processes)
The user/individual on the job needs to know and understand: KA1. organisational coding of water system and company manual and SOP KA2. material and equipment used in the process and their function KA3. different quality management systems (ISO-9000, ISO-14001, OHSAS-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 water
system and its maintenance
KA9. use of monitoring and measuring devices
KA10. implications of inaccurate measuring and testing instruments and equipment KA11. the reason and impact of the occurrence of problems
KA12. measures, steps and possible solutions that have been taken/identified to
address the previous problems
KA13. the appropriate authority for reporting any imbalances
KA14. the correct method for carrying out corrective actions outlined for each
problem and should have proper CAPA to avoid any repeatability
B. Technical Knowledge
The user/individual on the job needs to know and understand: KB1. methods, materials and equipment used in installing, repairing and
maintaining water system equipment
KB2. working, installation of chillers, reverse osmosis (RO), etc
KB3. different standard reference materials
KB4. occupational hazards and safety precautions of the work KB5. different types of water systems and their features and working
KB6. testing equipment and related test methods and purpose of tests
KB7. quality requirements of materials and equipment and equipment as per the
required standards
LFS/N0223 : Monitor assembly, installation, operation and maintenance of water systems as per SOP
9 | P a g e
KB8. operating requirements, parameters and corrective action required where
operation is outside specified operating parameters
KB9. common causes of variation and corrective action required
KB10. operational health and safety (OHS) hazards and controls, including limitations
of protective clothing and equipment relevant to the work process
KB11. 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
KB12. environmental issues and controls relevant to the process, including waste/rework collection and handling procedures related to the process
Skills (S)
A. Core Skills/ Generic Skills
Reading 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: SA7. communicate with upstream and downstream teams SA8. communicate with people in a proper form and manner and use language that
is open, respectful, informative and transparent SA9. 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. plan and organize resources to ensure assembly, installation and maintenance
activities adhere to schedule SB2. multi-task and adapt to meet work timelines
LFS/N0223 : Monitor assembly, installation, operation and maintenance of water systems as per SOP
10 | P a g e
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:
SB7. apply balanced judgement to different situations SB8. apply basic mathematical and statistical knowledge
Problem solving
The user/individual on the job needs to know and understand how to: SB9. solve conflicts and negotiate on behalf of the team and within the team SB10. explore new ways of doing things SB11. 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: SB12. analyse operations data and information to identify assembly, installation and
maintenance needs SB13. pay attention to detail for identifying faults and anomalies SB14. spot process disruptions and delays and report and communicate to the
manager with solutions
Customer Centricity
Not Applicable
LFS/N0223 : Monitor assembly, installation, operation and maintenance of water systems as per SOP
11 | P a g e
NOS Version Control
NOS Code LFS/N0223
Credits(NSQF) TBD Version number 1.0
Industry Life Sciences Drafted on 15/12/14
Industry Sub-sector Pharmaceuticals, Biopharmaceuticals
Last reviewed on 25/02/15
Occupation Manufacturing Next review date 01/06/17
LFS/N0220 : Prepare effective maintenance schedules and ensure smooth flow of workand secure
12 | P a g e
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.
National Occupational
Standard
LFS/N0220 : Prepare effective maintenance schedules and ensure smooth flow of workand secure
13 | P a g e
Unit Code LFS/N0220
Unit Title (Task)
Prepare effective maintenance schedules and ensure smooth flow of work
Description This NOS unit is about a Maintenance Supervisor Water System 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 Schedules
To be competent, the user/individual on the job must be able to:
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 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
PC21. train staff in safety procedures and maintain safety data sheets for crews
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LFS/N0220 : Prepare effective maintenance schedules and ensure smooth flow of workand secure
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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 Context (Knowledge of the Company/ Organisation and its processes)
The user/individual on the job needs to know and understand: KA1. material and equipment used in the production process and their function
KA2. different quality management systems (ISO-9000, ISO-14001, OHSAS-18000)
KA3. importance of identifying non-conforming products and dealing of the same
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 Knowledge
The user/individual on the job needs to know and understand: 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
LFS/N0220 : Prepare effective maintenance schedules and ensure smooth flow of workand secure
15 | P a g e
A. Core 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 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
LFS/N0220 : Prepare effective maintenance schedules and ensure smooth flow of workand secure
16 | P a g e
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
LFS/N0220 : Prepare effective maintenance schedules and ensure smooth flow of workand secure
17 | P a g e
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, Biopharmaceuticals
Last reviewed on 25/02/15
Occupation Manufacturing Next review date 01/06/17
LFS/N0221 : Carry out reporting and documentation for maintenance activities
18 | P a g e
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.
National Occupational
Standard
LFS/N0221 : Carry out reporting and documentation for maintenance activities
19 | P a g e
Unit Code LFS/N0221
Unit Title (Task)
Carry out reporting and documentation for maintenance activities
Description This NOS unit is about the Maintenance Supervisor Water System 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 Documentation
PC5. identify documentation to be completed relating to one’s role 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 Context (Knowledge of the Company/ Organisation and
The user/individual on the job needs to know and understand: KA1. risk and impact of not following the defined procedures/work instructions KA2. escalation matrix for reporting identified issues, hazards and breakdown
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LFS/N0221 : Carry out reporting and documentation for maintenance activities
20 | P a g e
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 Knowledge
The user/individual on the job needs to know and understand:
KB1. different kinds of standard reference material
Skills (S)
Writing skills
A. Core Skills/
Generic Skills
The user/ individual on the job needs to know and understand how to: 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:
LFS/N0221 : Carry out reporting and documentation for maintenance activities
21 | P a g e
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
Problem Solving
Not Applicable
Customer Centricity
Not Applicable
LFS/N0221 : Carry out reporting and documentation for maintenance activities
22 | P a g e
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, Biopharmaceuticals
Last reviewed on 26/03/15
Occupation Manufacturing Next review date 01/06/17
LFS/N0224 : Identify and resolve any issues related to installation, operation or maintenance
of water system
23 | P a g e
National Occupational
Standard Overview
This NOS is about the knowledge, understanding and skills required by a Maintenance Supervisor - Water for supervising the work of personnel to identify problems through inspection, identifying any issues hampering the working of water system and analysing the findings.
LFS/N0224 : Identify and resolve any issues related to installation, operation or maintenance
of water system
24 | P a g e
Unit Code LFS/N0224
Unit Title (Task)
Identify and resolve any issues related to installation, operation or maintenance of Water System
Description This NOS unit is about the Maintenance Supervisor - Water supervising the work of personnel to identify problems through inspection, identifying any issues hampering the working of water system 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
PC6. suggest corrective actions to address problem
PC7. review effectiveness of corrective action
PC8. interpret the results of the inspection correctly
Knowledge and Understanding (K)
A. Organisational Context (Knowledge of the Company/ Organisation and its processes)
The user/individual on the job needs to know and understand:
KA1. different quality management systems (ISO-9000, ISO-14001, OHSAS-18000)
KA2. methods of disposing of materials, importance of appropriate disposal and 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 KA9. procedures for reporting any unresolved issues and hazards KA10. methods of reporting incidents where standard operating procedures are
not followed
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KA11. characteristics of the materials and equipment required in setting up water system 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 Knowledge
The user/individual on the job needs to know and understand:
KB1. methods, materials and equipment used in installing, repairing and maintaining different water systems
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. different types of water systems and their features and working KB6. methods of using testing equipment, related test methods and purpose of
tests KB7. quality requirements of materials and equipment KB8. operating requirements, parameters and corrective action required where
operation is outside specified operating parameters KB9. environmental issues and controls relevant to the process, including
waste/rework collection and handling procedures related to the process KB10. common causes of variation and corrective action required KB11. KB12.
operational health and safety (OHS) hazards and controls, including limitations of protective clothing and equipment relevant to the work process how to perform statistical analysis of test data
Skills (S)
A. Core Skills/ Generic Skills
Reading 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
LFS/N0224 : Identify and resolve any issues related to installation, operation or maintenance
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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: SA6. communicate with upstream and downstream teams SA7. communicate with people in a proper form and manner and use language that
is open and respectful SA8. 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
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, objective opinion
Plan and Organize
Not Applicable
LFS/N0224 : Identify and resolve any issues related to installation, operation or maintenance
of water system
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Customer Centricity
Not Applicable
NOS Version Control
NOS Code LFS/N0224
Credits(NSQF) TBD Version number 1.0
Industry Life Sciences Drafted on 15/12/14
Industry Sub-sector Pharmaceuticals , Biopharmaceuticals
Last reviewed on 25/02/15
Occupation Manufacturing Next review date 01/06/17
LFS/N0101 : Maintain a healthy, safe and secure working environment in the life sciences facility
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National Occupational
Standard
Overview This NOS is about the knowledge, understanding and skills required by a Maintenance Supervisor for ensuring healthy, safe and secure working environment and managing emergency procedures in the life sciences facility
LFS/N0101 : Maintain a healthy, safe and secure working environment in the life sciences facility
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Unit Code LFS /N0101
Unit Title (Task)
Maintain a healthy, safe and secure working environment in the life sciences facility
Description This NOS unit is about a Maintenance Supervisor Water System 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, safe and secure working environment
To be competent, the user/individual on the job must be able to: PC1. observe and comply with the company’s current health, safety and security
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 procedures
PC9. report any hazards that the individual is not competent to deal with to the
relevant person in line with organizational procedures and warn other people
who may be affected
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PC10. follow the company’s emergency procedures promptly, calmly, and efficiently
Knowledge and Understanding (K)
B. Organisational Context (Knowledge of the Company/ Organisation and its processes)
The user/ individual on the job needs to know and understand: KA1. legislative requirements and company’s procedures for health, safety and
security and individual’s role and responsibilities in relation to this
KA2. what is meant by a hazard, including the different types of health and safety
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 Knowledge
The user/ individual on the job needs to know and understand: 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/ Generic Skills
Writing 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
LFS/N0101 : Maintain a healthy, safe and secure working environment in the life sciences facility
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Oral Communication (Listening and Speaking skills)
The user/ individual on the job needs to know and understand how to: 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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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 Bio Pharmaceuticals
Last reviewed on 15/05/15
Occupation Manufacturing, Quality, Supply Chain, R&D
Next review date 01/06/16
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Annexure
Nomenclature for QP and NOS
Qualification Pack
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)
Occupation (2 numbers)
N denoting National Occupational Standard
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The following acronyms/codes have been used in the nomenclature above:
Sub-Sector Range of Occupation Numbers
Pharmaceutical and Biopharmaceutical and Contract Research
01-10
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 – Water – Life Sciences Qualification Pack LFS/Q0210 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 outcome
Assessment criteria of outcome Total Marks (500)
Out of Theory
Skills Practical
LFS/N0223 (Monitor assembly,
installation, operation and maintenance
of water system as per
SOP)
PC1. coordinate with stores to determine which parts should be ordered for installation or as spare parts
100 2
1 1
PC2. assist in maintaining proper levels of materials/supplies to ensure timely and efficient completion of necessary tasks like maintenance of water systems
4 2 2
PC3. assist in purchase of materials and ensure prevention of defects and quality as per requirement
4 1 3
PC4. identify the areas where new installations are required in coordination with the manufacturing and quality teams
4 2 2
PC5. assist in approving purchases of materials and equipment
4 2 2
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PC6. identify defect/problem in inappropriate sample
4 2 2
PC7. maintain purified water, distilled water, tap water and water for injection as per the required specifications
4 2 2
PC8. start, operate, monitor and adjust water system equipment to ensure availability of water according to specification and sanitization for proper working
4 2 2
PC8. ensure that there are no leakages
4 2 2
PC9. ensure compliance with all regulations and company policies, including qualification and requalification as per GMP standards
4 2 2
PC10. review all work orders before and after completion
4 1 3
PC11. take corrective action in response to typical faults and inconsistencies
4 2 2
PC12. set up appropriate equipment or apparatus for testing correctly
4 2 2
PC13. calibrate the testing equipment periodically as per the SOP
5 2 3
PC14. verify the equipment accuracy by comparing with the standard reference
4 2 2
PC15. respond to emergency calls for system and equipment failure
5 2 3
PC16. set and adjust controls 4 1 3
PC17. identify defective equipment/apparatus and steps to be taken
4 1 3
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PC18. assist relevant stakeholders of the water systems with technical support; technical data, development and maintenance of user manuals, FAQ’s, technical support phone calls and warehouse tasks
4 2 2
PC19. ensure that maintenance helpers are working as per the SOP
5 2 3
PC20. take up the results of the findings with the appropriate authority
5 2 3
PC21. carry out disposal of waste and leftover tested materials safely as per the SOP
5 2 3
PC22. dispose all materials used in the experiment safely as per health and safety management system of the company
5 2 3
Total 100 43 57
LFS/N0220 (Prepare effective
maintenance schedules and ensure smooth flow of work)
PC1. inspect the manpower requirement based on maintenance required
100
4
2 2
PC2. identify the material requirements for carrying maintenance
4 2 2
PC3. plan schedule for maintenance activities (including preventive maintenance) while ensuring that work is not hindered
3 1 2
PC4. select the suitable alternatives in case the appropriate equipment and materials are not available for maintenance and inform the appropriate person
3 1 2
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PC5. plan the schedule of workmen for maintenance process
4 2 2
PC6. inform the workmen of the maintenance schedules
4 2 2
PC7. display the appropriate signage for the work being conducted
3 1 2
PC8. assign and distribute work orders and work requests
4 2 2
PC9. prepare vacation schedule for all employees and ensure that work is not affected adversely
3 1 2
PC10. ensure that there is adequate ventilation for the work being carried out
4 2 2
PC11. ensure that work is carried out on time
4 2 2
PC12. ensure that the workmen are on time as per the schedule
3 2 1
PC13. ensure that they are carrying out their work without disturbing others
3 1 2
PC14. provide technical assistance when requested
4 2 2
PC15. deal with accidental damage, if any, caused while carrying out the work
2 1 1
PC16. report to the appropriate person any disturbances in material flow or equipment
4 2 2
PC17. identify and report to the appropriate person any additional work required that is outside one’s responsibility or skill
4 2 2
PC18. follow workplace procedures to deal with
4 2 2
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any accidental damage caused during the installation and maintenance process
PC19. ensure that, on completion of the work, the area is left clean and dry and meets requirements
3 1 2
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
4 2 2
PC21. train staff in safety procedures and maintain safety data sheets for crews
4 2 2
PC22. ensure that the waste garnered from the activity is disposed in an appropriate manner
4 2 2
PC23. determine time and cost estimates for installation and maintenance
2 1 1
PC24. replenish any necessary supplies or consumables 4 2 2
Total 100 47 53
LFS/N0221
(Carry out reporting and
documentation for
maintenance activities)
PC1. report data/problems/incidents as applicable in a timely manner
100
7 3 4
PC2. report to the appropriate authority as laid down by the company
7 3 4
PC3. follow reporting procedures as prescribed by the company
10 5 5
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PC4. inform supervisors of completed and outstanding work orders
7 3 4
PC5. identify documentation
to be completed relating
to one’s role
8 4 4
PC6. record details accurately
in appropriate format 9 4 5
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
10 5 5
PC8. maintain time, materials and equipment use reports
10 5 5
PC9. maintain records of all data attendance and provide effective training to all staff members
6 3 3
PC10. complete all documentation within stipulated time according to company procedure
6 3 3
PC11. ensure that the final document meets the requirements of the individuals who requested it or make any amendments accordingly
6 3 3
PC12. make sure documents
are available to all
appropriate authorities
for inspection t
5 2 3
PC13. respond to requests for information in an appropriate manner
5 2 3
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while following organizational procedures
PC14. inform the appropriate authority of requests for information received
4 2 2
Total 100 47 53
LFS/N0224 (Identify and resolve any
issues related to installation, operation or
maintenance of water systems)
PC1. inspect maintenance works to ensure compliance with standard procedures
100
14 7 7
PC2. undertake immediate actions to resolve sudden errors or faults in equipment or functionality system
12 6 6
PC3. identify non-conformities to the company maintenance SOP
13 6 7
PC4. analyse potential causes
of non-conformities to
standards
12 6 6
PC5. evaluate the need for action to ensure that problems do not recur
12 6 6
PC6. suggest corrective
actions to address
problem
13 6 7
PC7. review effectiveness of
corrective action 13 7 6
PC8. interpret the results of the inspection correctly 11 5 6
Total 100 49 51
LFS/N0101 (Maintain a
healthy, safe and secure
working environment in the life sciences
facility)
PC1. observe and comply with the company’s current health, safety and security policies and procedures
100
10 5 5
PC2. while carrying out work, use appropriate safety gears like head gear, masks, gloves and other accessories as
10 5 5
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mentioned in the guidelines
PC3. report any identified breaches in health, safety, and security policies and procedures to the designated person
10 5 5
PC4. responsible for maintaining discipline at the shop-floor/ production area
10 5 5
PC5. identify and correct any hazards that the individual can deal with safely, competently and within the limits of their authority
10 5 5
PC6. adhere and comply to storage and handling guidelines for hazardous material
10 5 5
PC7. identify and recommend opportunities for improving health, safety, and security to the designated person
10 5 5
PC8. complete any health, safety and security records legibly and accurately
10 4 6
PC9. report any hazards that the individual is not competent to deal with to the relevant person in line with organizational procedures and warn other people who may be affected
10 4 6
PC10. follow the company’s emergency procedures promptly, calmly, and efficiently
10 5 5
Total 100 48 52
Recommended