Calibration Engineer

1

Qualifications Pack- Calibration Engineer

Contents 1. Introduction and Contacts.….…..P1

2. Qualifications Pack……….…........P2

3. OS Units……………..………….……....P3

4. Glossary of Key Terms.…….......P21

5. Nomenclature for QP & OS.…..P23

technology consul t ing

What are Occupational Standards(OS)? 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

Contact Us:

ESSCI, New Delhi Electronics Sector Skills Council of India 422, Okhla Industrial Estate, Phase-III, New Delhi-110020 E-mail: [email protected]

SECTOR: ELECTRONICS

SUB-SECTOR: Medical Electronics

OCCUPATION: Medical Device Calibration

REFERENCE ID: ELE/Q8002

ALIGNED TO: NCO-2004/NIL

Calibration Engineer: The Calibration Engineer tests and standardizes medical

devices as per device manufacturer’s specification or customer requirement.

Brief Job Description: The individual at work compares the measurements of

medical device with the master equipment and then certifies medical device

as standardized or non-standardized as per device manufacturer’s

specification or customer’s requirement.

Personal Attributes: The job requires the individual to have attention to

details, safety and hazards orientation, willingness to travel with equipment

and stamina for working under different type of climatic and controlled

conditions.

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Introduction

QUALIFICATIONS PACK - OCCUPATIONAL STANDARDS FOR ELECTRONICS INDUSTRY

Qualifications Pack For Calibration Engineer

2

Qualifications Pack Code ELE/Q8002

Job Role Calibration Engineer

Credits(NVEQF/NVQF/NSQF) [OPTIONAL]

TBD Version number 1.0

Sector Electronics Drafted on 08/02/14

Sub-sector Medical Electronics Last reviewed on 24/03/14

Occupation Calibration Next review date 24/03/15

Job Role Calibration Engineer

Role Description Testing medical devices under controlled conditions; comparing measurements of medical device with the master equipment and certifying as per specified standard

NVEQF/NVQF level

Minimum Educational Qualifications

Maximum Educational Qualifications

4

ITI

Diploma

Training Not Applicable

Experience Minimum one year in medical device testing

Applicable National Occupational

Standards (NOS)

Compulsory:

1. ELE/N8006 Calibrate Medical Devices on site

2. ELE/N8007 Calibrate Medical Devices in house

3. ELE/N9909 Coordinate with colleagues and co-workers

4. ELE/N9910 Maintain safe and secure work environment Optional: Not applicable

Performance Criteria As described in the relevant OS units

Job

Det

ails

ELE/N8006 Calibrate medical devices on site ------------------------------------------------------------------------------------------------------------------------------------------

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Overview

This unit is about testing medical devices at customer’s premises as per device manufacturer’s specification against standardized master equipment.

ELE/N8006 Calibrate medical devices on site

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Unit Code ELE/N8006

Unit Title (Task)

Calibrate medical devices on site

Description This unit is about testing medical devices at customer site as per device manufacturer’s against standardized master equipment

Scope This unit/task covers the following:

Engage with customer

Prepare for on site visit

Perform calibration on site

Achieve productivity and quality standards

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

Element Performance Criteria Engaging with customer

To be competent, the user/ individual must be able to: PC1. check enquiry from the customer PC2. engage with customer to know the details of calibration requirements PC3. review customer’s enquiry to find out the service feasibility PC4. provide quotation to customer if service provision is feasible PC5. inform customer if service provision is not feasible PC6. Document queries received as per the standard operating procedure (SOP) PC7. receive written or verbal work order from the customer with details of

medical devices to be calibrated PC8. fill up contract review and job card based on the work order received from

the customer

Preparing for on site visit

To be competent, the user/ individual must be able to: PC9. collect the tools and master equipment as per the device list PC10. perform complete inspection of master equipment as per the SOP before

leaving for customer’s site PC11. carry master equipment to customer’s location taking full precautions as

mentioned in the SOP

Calibrating device To be competent, the user/ individual must be able to: PC12. operate medical device and master equipment under same conditions and

take measurements as per SOP PC13. record all the measurements in the job sheet as per the SOP PC14. compare the measurements of medical device with standardized master

equipment PC15. label the medical device as ‘passed’ if no difference is observed in these

measurements PC16. label the medical device as ‘failed’ if difference is observed in these

measurements PC17. reset medical device to tune with standardized master equipment if it is

within the scope of calibration work PC18. complete the documentation related to resetting the medical devices as per

the SOP

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ELE/N8006 Calibrate Medical Devices on site

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PC19. inform customer about failed medical devices PC20. issue calibration certificates for checked medical devices mentioning ‘passed’

or ‘failed’ results along with feedback form as per the SOP

Achieving productivity and quality standards

To be competent, the user/ individual must be able to: PC21. achieve 100% monthly target of number of medical devices calibrated PC22. meet the quality standard to avoid revisit

Knowledge and Understanding (K)

A. Organizational Context

(Knowledge of the

company /

organization and

its processes)

The individual on the job needs to know and understand: KA1. company’s policies on: incentives; quality, safety and delivery standards, and

personnel management KA2. importance of the individual’s role in the company KA3. reporting structure KA4. company’s competences to calibrate variety of medical devices

B. Technical Knowledge

The individual on the job needs to know and understand: KB1. medical devices and their applications KB2. their test and calibration methods and instruments used KB3. electrical, electronic and mechanical parts of devices and assembly processes KB4. dismantling and re-assembly of devices KB5. common electric and electronics involved in medical devices KB6. Electrostatic Discharge (ESD) precautions KB7. quality standards to be followed KB8. visit plan and customer handling

Skills (S) [Optional]

A. Core Skills/

Generic Skills

Reading and writing skills

The user/individual on the job needs to know and understand how: SA1. to read job sheet, product circuit diagram, product operation and service

manual SA2. to read calibrating procedures for different medical product models SA3. to write job card as per customer’s calibration requirements SA4. to document information and measurements of calibration process as per SOP

Communication skills

To be competent, the user/ individual must be able to: SA5. ask questions on specifics e.g., model, make, AMC SA6. Assess standard of calibration to be used SA7. assess location for calibrating medical devices. SA8. listen to supervisor for specific calibration related instructions for different

types of medical devices SA9. express the information, both technical and non-technical, to seniors and

colleagues for benchmarking best calibrating practices


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Teamwork and multitasking

The user/individual on the job needs to know and understand how: SA10. to share work load as required SA11. to achieve the calibrating medical devices targets with the help of co-workers

B. Professional Skills

Component related skills

The user/individual on the job needs to know and understand how: SB1. different types of PWAs, plastic parts, electronic components, LCD, brass

inserts and accessories like connectors, wires, cables behave in different temperatures and humidity levels

Decision making

The user/individual on the job needs to know and understand how: SB2. when to seek supervisor’s advice during calibrating of medical devices, e.g.,

some new model of medical device is to be calibrated

Problem solving

The user/individual on the job needs to know and understand how: SB3. to solve work related problems like specified condition are not available at site

for calibration process

Using tools and machines

The user/individual on the job needs to know and understand how: SB4. to use diagnostic and measuring devices like gas flow analyser, electrical safety

analyser, various simulators, x-ray analyser, cathode ray oscilloscope (CRO), digital storage oscilloscope (DSO), biomedical test equipment, energy calibrator and CT-PT calibrator

Reflective thinking

The user/individual on the job needs to know and understand how: SB5. to improve calibration process SB6. to reduce repetition of errors


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NOS Version Control

NOS Code ELE/N8006



Industry Electronics Drafted on 08/02/14

Industry Sub-sector Medical Electronics Last reviewed on 24/03/14

Next review date 24/03/15

ELE/N8007 Calibrate medical devices in house

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Overview

This unit is about testing medical devices in calibration lab as per device manufacturer’s specification or customer’s requirement under specified conditions and with the help of standardized master equipment.

ELE/N8007 Calibrate Medical Devices in house

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Code ELE/N8007

Unit Title (Task)

Calibrate medical devices in house

Description This unit is about testing medical devices in calibration lab as per device manufacturer’s specification or customer’s requirement under specified conditions and with the help of standardized master equipment

Scope This unit/task covers the following:

Engage with customer

Receive work order from customer

Perform calibration in lab



Element Performance Criteria Engaging with customer

To be competent, the user/ individual must be able to: PC1. check enquiry from the customer PC2. engage with customer to know the details of calibration requirements PC3. review customer’s enquiry to find out the service feasibility PC4. provide quotation to customer If service provision is feasible PC5. inform customer If service provision is not feasible PC6. document the queries received as per the SOP

Receiving work order To be competent, the user/ individual must be able to: PC7. receive written or verbal work order from the customer with details of

medical devices to be calibrated PC8. fill up contract review and job card based on the work order received from

the customer

Calibratingin lab To be competent, the user/ individual must be able to: PC9. receive medical devices from the customer PC10. complete the documentation as per the SOP PC11. issue lab code to received medical devices for calibration PC12. clean the medical devices as per the SOP PC13. keep the medical device along with master equipment at same place and

specified temperature, humidity & ‘G’ value for specified time (minimum 2 hours) mentioned in the SOP. This process is also known as Soaking.

PC14. switch on medical device and master equipment and let them warm up for 30 minutes to get the optimal performance of electronic components, i.e., wire-up the device

PC15. take measurements after 30 minutes as per SOP and record on job sheet PC16. compare the measurements of medical device with standardized master

equipment PC17. label the medical device as ‘passed’ if no difference is observed in these

measurements PC18. label the medical device as ‘failed’ if difference is observed in these

measurements

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PC19. reset medical device to tune with standardized master equipment if it is within the scope of calibration work

PC20. complete the documentation related to resetting the medical devices as per the SOP

PC21. inform customer about failed medical devices PC22. issue calibration certificates for checked medical devices mentioning ‘passed’

or ‘failed’ results along with feedback form as per the SOP


To be competent, the user/ individual must be able to: PC23. achieve 100% monthly target of number of medical devices calibrated PC24. meet the quality standard to avoid rework



(Knowledge of the

company /

organization and

its processes)

The individual on the job needs to know and understand: KA1. company’s policies on: incentives; quality, safety and delivery standards, and

personnel management KA2. importance of the individual’s role in the company KA3. reporting structure KA4. company’s competences to calibrate variety of medical devices


The individual on the job needs to know and understand: KB1. medical devices and their applications KB2. their test and calibration methods and instruments used KB3. electrical, electronic and mechanical parts of devices and assembly processes KB4. dismantling and re-assembly of devices KB5. common electric and electronics involved in medical devices KB6. Electrostatic Discharge (ESD) precautions KB7. quality standards to be followed KB8. customer handling


A. Core Skills/

Generic Skills

Reading and writing skills

The user/individual on the job needs to know and understand how: SA1. to read job sheet, product circuit diagram, operation and service manual SA2. to read calibration and resetting requirements of different modules SA3. to read calibrating procedures for different medical product models SA4. to write job card as per customer’s calibration requirements SA5. to document information and measurements of calibration as per SOP

Communication skills

To be competent, the user/ individual must be able to: SA6. ask questions on specifics e.g. model, make, AMC SA7. standard of calibration to be used SA8. listen to supervisor for specific calibration related instructions of different

types of medical devices SA9. express the information, both technical and non-technical, to seniors and


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colleagues for benchmarking best calibrating practices


The user/individual on the job needs to know and understand how: SA10. to share work load as required SA11. to achieve the calibrating medical devices targets with the help of co-workers


Component related skills

The user/individual on the job needs to know and understand how: SB1. different types of PWAs, plastic parts, electronic components, LCD, brass

inserts and accessories like connectors, wires, cables behave in different temperatures and humidity levels

Decision making

The user/individual on the job needs to know and understand how: SB2. when to seek supervisor’s advice during calibrating of medical devices e.g,

some new model of medical device is to be calibrated

Problem solving

The user/individual on the job needs to know and understand how: SB3. to solve work related problems like specified condition are not available at site

for calibration process

Using tools and machines

The user/individual on the job needs to know and understand how: SB4. to use diagnostic and measuring devices like gas flow analyser, electrical safety

analyser, various simulators, x-ray analyser, cathode ray oscilloscope (CRO), digital storage oscilloscope (DSO), biomedical test equipment, energy calibrator and CT-PT calibrator

Reflective thinking

The user/individual on the job needs to know and understand how: SB5. to improve calibration process SB6. to reduce repetition of errors


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NOS Version Control

NOS Code ELE/N8007




Industry Sub-sector Medical Electronics Last reviewed on 24/03/14


ELE/N9909 Coordinate with colleagues and co-workers

--------------------------------------------------------------------------------------------------------------------

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Overview

This unit is about the individual’s level of communication with colleagues and other departments within the organisation. It determines the ability to work as a team member to achieve the required deliverables on schedule.


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Unit Code ELE/N9909

Unit Title (Task)

Coordinate with colleagues

Description This OS unit is about communicating with colleagues and seniors in order to achieve smooth work flow

Scope This unit/ task covers the following:

Interact with supervisor or superior

Coordinate with colleagues


Element Performance Criteria Interacting with supervisor

To be competent, the user/ individual must be able to: PC1. understand and assess work requirements PC2. understand the targets and incentives PC3. understand new operating procedures and constraints PC4. report problems in the field PC5. resolve personnel issues PC6. receive feedback on work standards and customer satisfaction PC7. communicate any potential hazards at a particular location PC8. meet given targets PC9. deliver work of expected quality despite constraints PC10. receive positive feedback on behaviour and attitude shown during

interaction

Coordinating with colleagues

To be competent, the user/ individual must be able to: PC11. interact with colleagues from different functions and understand the nature

of their work PC12. receive spares from tool room or stores; deposit faulty modules and tools to

stores PC13. pass on customer complaints to colleagues in a respective geographical area PC14. assist colleagues with resolving field problems PC15. resolve conflicts and achieve smooth workflow PC16. follow the company policy during cross functional interaction



(Knowledge of the

company /

organization and

its processes)

The individual on the job needs to know and understand: KA1. company’s policies on: incentives, delivery standards, and personnel

management KA2. importance of the individual’s role in the workflow KA3. reporting structure

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The individual on the job needs to know and understand: KB1. how to communicate effectively KB2. how to build team coordination


A. Core Skills/

Generic Skills


The individual on the job needs to know and understand how: SA1. to deliver product to next work process on time


Decision making

The individual on the job needs to know and understand: SB1. how to report potential areas of disruptions to work process SB2. when to report to supervisor and when to deal with a colleague depending on

the type of concern

Reflective thinking

The individual on the job needs to know and understand: SB3. how to improve work process

Critical thinking

The individual on the job needs to know and understand: SB4. how to spot process disruptions and delays


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NOS Version Control

NOS Code ELE/N9909




Industry Sub-sector IT Hardware Last reviewed on 24/03/14


ELE/N9910 Maintain safe and secure work environment

--------------------------------------------------------------------------------------------------------------------

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Overview

This unit is about the individual’s effort to maintain a safe, healthy and secure working environment.


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Unit Code ELE/N9910

Unit Title (Task)

Maintain safe and secure working environment

Description This OS unit is about following adequate safety procedures to make work environment safe

Scope This unit/ task covers the following:

Follow standard safety procedures while handling an equipment

Participate in company’s safety drills and workshops


Element Performance Criteria Following safety measures

To be competent, the user/ individual must be able to: PC1. comply with safety procedures followed in the company PC2. take adequate safety measures while handling hazardous materials or tools PC3. follow Electrostatic Discharge (ESD) measures for electronic components PC4. escalate matters about hazardous materials or things found in the premises PC5. use safety materials such as gloves, goggles, masks, etc. PC6. take adequate safety measures while on work to prevent accidents PC7. ensure zero accidents in work PC8. avoid damage of components due to negligence in ESD procedures PC9. ensure no loss for company due to safety negligence

Participating in drills and workshops

To be competent, the user/ individual must be able to: PC10. participate in regular safety drills for being prepared in the event of a fire or

natural calamity PC11. help others during the drill or calamity PC12. administer basic first aid PC13. participate in company organised games and fitness sessions such as yoga,

etc. PC14. maintain good posture for working so that long term health problems do not

arise



(Knowledge of the

company /

organization and

its processes)

The individual on the job needs to know and understand: KA1. company’s policies on: incentives, delivery standards, and personnel

management KA2. company occupational safety and health policy followed KA3. company emergency evacuation procedure KA4. company’s medical policy

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The individual on the job needs to know and understand: KB1. how to maintain the work area safe and secure KB2. how to handle hazardous material KB3. how to operate hazardous tools and equipment KB4. emergency procedures to be followed such as fire accidents, etc.


A. Professional Skills

Handling safety equipments

The individual on the job needs to know and understand: SB1. the purpose of using safety materials such as gloves, etc. SB2. how to use safety equipment such as fire extinguisher during fire accidents


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NOS Version Control

NOS Code ELE/N9910




Industry Sub-sector IT Hardware Last reviewed on 24/03/14



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Keywords /Terms Description

Sector Sector is a conglomeration of different business operations having similar business and interests. It may also be defined as a distinct subset of the economy whose components share similar characteristics and interests.

Sub-sector Sub-sector is derived from a further breakdown based on the characteristics and interests of its components.

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

Function Function is an activity necessary for achieving the key purpose of the sector, occupation, or an 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 OS.

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

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

Occupational Standards (OS)

OS specify the standards of performance an individual must achieve when carrying out a function in the workplace, together with the knowledge and understanding they need to meet that standard consistently. Occupational Standards are applicable both in the Indian and global contexts.

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

National Occupational Standards (OS)

NOS are occupational standards which apply uniquely in the Indian context.

Qualifications Pack (QP) QP comprises the set of OS, together with the educational, training and other criteria required to perform a job role. A QP is assigned a unique qualifications pack code.

Unit Code Unit code is a unique identifier for an Occupational Standard, which is denoted by an ‘N’

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

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 OS they are looking for.

Scope Scope is a 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 quality of performance required.

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.

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.

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

Def

init

ion

s


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Core Skills/ Generic Skills

Core skills or generic skills are a group of skills that are the key to learning and working in today’s world. These skills are typically needed in any work environment in today’s world. These skills are typically needed in any work environment. In the context of the OS, these include communication related skills that are applicable to most job roles.

Keywords /Terms Description

ESD Electrostatic Discharge

NOS National Occupational Standard(s)

NVQF National Vocational Qualifications Framework

NSQF National Qualifications Framework

NVEQF National Vocational Education Qualifications Framework

PMD Patient Monitoring Device

PWA Printed Wiring Assembly

QP Qualifications Pack

Acr

on

yms


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Annexure

Nomenclature for QP and NOS

Qualifications Pack

[ABC]/ Q 0101

Occupational Standard An example of NOS with ‘N’

[ABC] /N0101

Q denoting Qualifications Pack Occupation (2 numbers)

QP number (2 numbers)

9 characters

[Insert 3 letter codes for SSC]

9 characters

N denoting National Occupational Standard Occupation (2 numbers)

OS number (2numbers)

Back to top…

[Insert 3 letter code for SSC]


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

Sub-sector Range of Occupation

numbers

Passive Components 01 - 10

Semiconductors 11 - 20

PCB Manufacturing 21 - 30

Consumer Electronics 31 - 40

IT Hardware 41 - 50

PCB Assembly 51 - 55

Solar Electronics 56 - 60

Strategic Electronics 61 - 65

Automotive Electronics 66 - 70

Industrial Electronics 71 - 75

Medical Electronics 76 - 80

Communication Electronics 81 - 85

PCB Design 86 - 90

LED 91 - 95

Sequence Description Example

Three letters Industry name ELE

Slash / /

Next letter Whether QP or NOS Q

Next two numbers Occupation code 01

Next two numbers OS number 01

Calibration Engineer

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