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Presenter: Nzugua Michael Evans
Senior Physicist, mtrd,
Msc nuclear science bias on nuclear instrumentation- ongoing
Email: michael.nzugua@mtrd.go.ke, nzuguam22@gmail.com,
1
Equipment Management
Equipment-Management 01
introduction
Instrumentation Equipment: Collective term for devices which are used for ,Indicating, Measuring
and Recording physical quantities- Mass, Force and Temperature
for proper functionality these devices will need to be
Equipment Management: Is the proper use and maintenance of equipment in the most efficient
and effective manner. This includes but not limited to
a. Calibration
b. Validation
c. Servicing and Repair- Preventive and Corrective Maintenance
d. Equipment inventory.
02
Equipment-Management
Section 1
Equipment Calibration and Validation
03
Equipment-Management
Calibration.
Defin: is the process of comparing a reading on one piece of equipment with another piece of equipment which has been referenced to a known set of
parameters. The equipment used as a reference should itself be directly traceable to equipment that is calibrated according to ISO/IEC 17025-int stds
accreditation of testing and calibration labs.
Importance of calibration
a. confidence in results you control
defines accuracy , reliability, repeatability and quality of measurement.
minimizes measurement uncertainty
disadvantage of not calibrating
a. cost of reputation
b. injury, death and major environmental disasters
frequency of calibration;
we should always consider cost of calibration as an investment and a potential result of an incorrect reading as a cost of not making the investment.
Most standard practice is to calibrate annually and the calibrating lab provides printed calibration certificate for customer to retain as a proof of quality
standard.
n/b calibration is vitally important wherever measurement are important.it enables users and businesses to have confidences in the result that they
monitor, record and subsequently control.
04
Equipment management
Case study1.- temperature calibration.
05
Equipment-Management
Case study2: mass balance calibration
Measured value,gms True value,gms Error,gms
0 0 0
49.998 50 -0.002
99.998 100 -0.012
149.996 150 -0.004
199.999 200 -0.015
249.999 250 -0.001
299.99 300 -0.010
349.999 350 -0.001
399.988 400 -0.012
449.989 450 -0.011
499.997 500 -0.003
Equipment-
Management 06
For Accuracy
1 Place 5 gm. on the weighing pan.
2 Note the weight.
3 Calculate the difference between the weight in certificate and observed weight.
4 Repeat the above steps using 50gm & 100 gm. weights.
5 Record the reading in Annexure-I.
Annexure I
date Internal
calibration
Observed
wt for 5gm
difference Observed
weight for
50gm
difference Observed
weight for
100gm
difference Calibrated
by
Checked
by
No. Actual wts from certificates tolerance
1 5gm
+/- 0.01gm
2 50.0gm
+/- 0.01gm
3 100.0gm
+/- 0.01gm
Equipment-management 07
For precision
1.Place 5 gm. in the weighing pan.
2 Note the weight .
3 Repeat the above two steps nine times.
4 Record the weight in Annexure-II .
Calculate the Standard deviation.
Calculate the measurement uncertainty using following equation.
Measurement uncertainty = 2XSD/Actual weight from certificate
Frequency Internal verification and accuracy = quarterly
Precision: quarterly
Calibration date Date last calibration done Next due for calibration
Instrument detail
Instrument name Instrument make Instrument id no
observation
Theoretical weight Actual weight from certificates Observed
weights
Measurement
uncertainty
tolerance
5.0gm 5.0g 4.9 Not more than 0.10
4.8
4.9
4.9
4.8
4.8
𝑠𝑑 =
∑ ∣ 𝑥 − 𝑥 ∣ 2
𝑛 − 1
∧ 0.5
2XSD/actual weight
from cert
Equipment-
Management
08
Validation/ Verification.
verifying and documenting with high degree of assurance that a specific equipment will perform consistently according to predetermined
specifications.
validation activities can be described in three stages.
1 – Equipment Design: Defined during this stage based on knowledge gained through development and scale-up activities.
2 – Equipment Qualification: The design is confirmed as being capable of reproducible commercial manufacturing.
3 – Continued Equipment Verification: Ongoing assurance is gained during routine usage that the equipment remains in a stable state.
Types of validation
A) Prospective validation (or premarket validation)
Establishing documented evidence prior to process implementation that a system does what it proposed to do based on preplanned
B) Retrospective validation
used for equipment in operation that have not undergone a formally documented validation process. Validation of these is possible using
historical data to provide the necessary documentary evidence that the process is doing what it is believed to do. Therefore, this type of
validation is only acceptable for well-established processes and will be inappropriate where there have been recent changes in equipment.
C) Concurrent validation
used for establishing documented evidence that the equipment do what they purport to do, based on information generated during actual
This approach involves monitoring of critical steps to show that the equipment is stable.
D) Revalidation
Repeating the original validation effort, includes, review of existing performance data. is essential to maintain the validated status of the ,
equipment. Possible reasons for starting the process include:
1.The transfer of an equipment from one place to another.
2.Changes to the equipment eg spares, that could affect output.
3.The necessity of periodic checking of the validation results.
4.Significant (usually order of magnitude) increase or decrease in equipment output.
5.Sequential results that fail to meet specifications.
Equipment
management
09
Why validation:
1.reduces risk of non-compliance with regulatory agencies
2.improves efficiency and quality
3. cost savings
4. less standby equipment.
5.Reduction of variation in results
6. improvement of overall production reliability and availability.
Equipment-Management 10
Case study 1: Electronic Balance
y = 1x + 0.0005
R² = 1
0
200
400
600
0 100 200 300 400 500 600
true
value
measured value
true value v/s measured value
True value: value on the
calibration certificate
Measured value: value from the
equipment under verification
Image 2 Image 3
Image 1
Measured
value,gms
True value,gms Error,gms
0 0 0
49.998 50 -0.002
99.998 100 -0.012
149.996 150 -0.004
199.999 200 -0.015
249.999 250 -0.001
299.99 300 -0.010
349.999 350 -0.001
399.988 400 -0.012
449.989 450 -0.011
499.997 500 -0.003
Equipment Management
11
Section 2
Equipment maintenance and inventory
servicing
repair
12
Equipment-Management
Maintenance
Equipment-Management 13
Equipment maintenance Benefits
Performance
high level
Test results
Variation/
Time
Lowers
repair costs
Lengthens
lifespan
.
14
Equipment Maintenance Benefits contd
Reduces
interruption
of services
Increases safety
Greater
customer
satisfaction
Equipment-Management
.
Equipment life span/consideration
Selection
and
acquisition
Installation
Calibration/
performance
evaluation
Maintenance
Trouble-
shooting
Service
and
repair
Retiring
equipment/
disposition
Equipment management 15
Equipment Management Overview
1. assign responsibilities for all activities
2. train all personnel on requirements and maintenance needs
3. monitor equipment management activities:
a. ensure all procedures are followed
b. review all records routinely
c. update procedures as needed
Equipment management 16
. Preventive Maintenance
 routine cleaning
 adjustment,
replacement of
equipment parts
Equipment Management 17
.
Equipment-Management 18
Implementing a Maintenance
Program
 assign responsibility
 develop written
policies and
procedures
 maintain records
 train staff
.
Equipment-Management 19
Develop a Maintenance Plan
For each piece of equipment establish
routine maintenance plan to include:
frequency of all maintenance tasks
function checks
routine replacement of parts
.
Equipment-Management 20
Create an Equipment Inventory Log
Record:
 instrument type, model number,
serial number
 location in laboratory
 date purchased
 manufacturer and
vendor contact information
 warranty, note expiration date
 spare parts. Cost and ordering information
.
Equipment-Module 3 21
Troubleshooting/corrective
maintenance: What is the source of the
problem?
Sample?
Reagent?
Water,
Electricity?
Equipment?
21
Equipment management
.
Equipment-Management 22
When in-house efforts fail:
call manufacturer or
other technical expert
look for options to continue service
 obtain back-up instrument from central
stores or manufacturer
 refer sample to nearby laboratory
.
Equipment-Management 23
Service and Repair
manufacturers
laboratory must schedule routine
manufacturer’s maintenance
warranty may require repair handled
by manufacturer
in-house service technicians
.
Equipment-Management 24
Retiring Equipment / Disposal
.
Equipment-Management 25
Retiring Equipment / Disposal
.
Equipment-Management 26
Documents
Develop written procedures for:
 routine
maintenance
 function checks
 calibration
 troubleshooting
 manufacturer’s
service
.
Equipment-Management 27
Dedicated Log Book
 Routine maintenance:
 calibration/validation
 service repair
by manufacturer
 all problems
 Function checks
.
Equipment-Management 28
Recording Problems
date problem occurred, equipment
removed
from service
reason for breakdown or failure
corrective actions taken
date returned to use
change in maintenance or in function
checks
.
Equipment-Management 29
Example of equipment logbook
.
Equipment-Management 30
Example of equipment logbook
.
Equipment-Management 31
Example of equipment logbook
Equipment inventory
-For all lab equipment and their status
LABORATORY EQUIPMENT AND ACCESORIES INVENTORY 2020
S/No MB No./ MTRD Serial No. Name of
Equipment
Manufacturer/ Calibration
Status
Test in which
the equipment
is used for
Equipment Condition Remarks/
Space capacity
Working Not Working Obsolete
List per
category i.e.
soils, Bitumen
Indicate where
applicable
Indicate where
applicable
Indicate Name
e.g. Cone
Penetrometer
Indicate
Manufacturer/
M ake e.g ELE,
Controls etc
Indicate last
date of
calibration
where
applicable &
attach
calibration
certificate
Equipment use
or specific test
for the
particular
equipment
Tick if working Tick if not
working but
repairable
Tick if obsolete Status of
management of
unused and
obsolete
equipment
Equipment management 32
.
Equipment-management
33
Summary
An equipment maintenance management program will address:
 equipment selection
preventive maintenance
procedures for troubleshooting and repair
Documents and records will include:
inventory of all laboratory equipment
Information provided by the manufacturer on operation, maintenance, and
troubleshooting
records of all preventive maintenance and repair activities
.
Equipment management 34
Key Messages
A well-organized equipment maintenance program provides:
High level of performance and greater confidence in the reliability of
results.
Fewer interruptions in test performance, lower repair costs, and
elimination of premature replacement of equipment.
Increased safety for laboratory workers will result from well-
maintained equipment.
N/B: developing mtrd equipment management guideline.
A major part of equipment maintenance is
PREVENTIVE maintenance
thank you, ahsante, merci…
Equipment management 35
LQMS
Equipment-Module 3
Equipment management
Questions?
Comments?
Organization Personnel Equipment
Purchasing
&
Inventory
Process
Control
Information
Management
Documents
&
Records
Occurrence
Management
Assessment
Process
Improvement
Customer
Service
Facilities
&
Safety 36

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Equipment Management Presentation

  • 1. Presenter: Nzugua Michael Evans Senior Physicist, mtrd, Msc nuclear science bias on nuclear instrumentation- ongoing Email: michael.nzugua@mtrd.go.ke, nzuguam22@gmail.com, 1 Equipment Management Equipment-Management 01
  • 2. introduction Instrumentation Equipment: Collective term for devices which are used for ,Indicating, Measuring and Recording physical quantities- Mass, Force and Temperature for proper functionality these devices will need to be Equipment Management: Is the proper use and maintenance of equipment in the most efficient and effective manner. This includes but not limited to a. Calibration b. Validation c. Servicing and Repair- Preventive and Corrective Maintenance d. Equipment inventory. 02 Equipment-Management
  • 3. Section 1 Equipment Calibration and Validation 03 Equipment-Management
  • 4. Calibration. Defin: is the process of comparing a reading on one piece of equipment with another piece of equipment which has been referenced to a known set of parameters. The equipment used as a reference should itself be directly traceable to equipment that is calibrated according to ISO/IEC 17025-int stds accreditation of testing and calibration labs. Importance of calibration a. confidence in results you control defines accuracy , reliability, repeatability and quality of measurement. minimizes measurement uncertainty disadvantage of not calibrating a. cost of reputation b. injury, death and major environmental disasters frequency of calibration; we should always consider cost of calibration as an investment and a potential result of an incorrect reading as a cost of not making the investment. Most standard practice is to calibrate annually and the calibrating lab provides printed calibration certificate for customer to retain as a proof of quality standard. n/b calibration is vitally important wherever measurement are important.it enables users and businesses to have confidences in the result that they monitor, record and subsequently control. 04 Equipment management
  • 5. Case study1.- temperature calibration. 05 Equipment-Management
  • 6. Case study2: mass balance calibration Measured value,gms True value,gms Error,gms 0 0 0 49.998 50 -0.002 99.998 100 -0.012 149.996 150 -0.004 199.999 200 -0.015 249.999 250 -0.001 299.99 300 -0.010 349.999 350 -0.001 399.988 400 -0.012 449.989 450 -0.011 499.997 500 -0.003 Equipment- Management 06
  • 7. For Accuracy 1 Place 5 gm. on the weighing pan. 2 Note the weight. 3 Calculate the difference between the weight in certificate and observed weight. 4 Repeat the above steps using 50gm & 100 gm. weights. 5 Record the reading in Annexure-I. Annexure I date Internal calibration Observed wt for 5gm difference Observed weight for 50gm difference Observed weight for 100gm difference Calibrated by Checked by No. Actual wts from certificates tolerance 1 5gm +/- 0.01gm 2 50.0gm +/- 0.01gm 3 100.0gm +/- 0.01gm Equipment-management 07
  • 8. For precision 1.Place 5 gm. in the weighing pan. 2 Note the weight . 3 Repeat the above two steps nine times. 4 Record the weight in Annexure-II . Calculate the Standard deviation. Calculate the measurement uncertainty using following equation. Measurement uncertainty = 2XSD/Actual weight from certificate Frequency Internal verification and accuracy = quarterly Precision: quarterly Calibration date Date last calibration done Next due for calibration Instrument detail Instrument name Instrument make Instrument id no observation Theoretical weight Actual weight from certificates Observed weights Measurement uncertainty tolerance 5.0gm 5.0g 4.9 Not more than 0.10 4.8 4.9 4.9 4.8 4.8 𝑠𝑑 = ∑ ∣ 𝑥 − 𝑥 ∣ 2 𝑛 − 1 ∧ 0.5 2XSD/actual weight from cert Equipment- Management 08
  • 9. Validation/ Verification. verifying and documenting with high degree of assurance that a specific equipment will perform consistently according to predetermined specifications. validation activities can be described in three stages. 1 – Equipment Design: Defined during this stage based on knowledge gained through development and scale-up activities. 2 – Equipment Qualification: The design is confirmed as being capable of reproducible commercial manufacturing. 3 – Continued Equipment Verification: Ongoing assurance is gained during routine usage that the equipment remains in a stable state. Types of validation A) Prospective validation (or premarket validation) Establishing documented evidence prior to process implementation that a system does what it proposed to do based on preplanned B) Retrospective validation used for equipment in operation that have not undergone a formally documented validation process. Validation of these is possible using historical data to provide the necessary documentary evidence that the process is doing what it is believed to do. Therefore, this type of validation is only acceptable for well-established processes and will be inappropriate where there have been recent changes in equipment. C) Concurrent validation used for establishing documented evidence that the equipment do what they purport to do, based on information generated during actual This approach involves monitoring of critical steps to show that the equipment is stable. D) Revalidation Repeating the original validation effort, includes, review of existing performance data. is essential to maintain the validated status of the , equipment. Possible reasons for starting the process include: 1.The transfer of an equipment from one place to another. 2.Changes to the equipment eg spares, that could affect output. 3.The necessity of periodic checking of the validation results. 4.Significant (usually order of magnitude) increase or decrease in equipment output. 5.Sequential results that fail to meet specifications. Equipment management 09
  • 10. Why validation: 1.reduces risk of non-compliance with regulatory agencies 2.improves efficiency and quality 3. cost savings 4. less standby equipment. 5.Reduction of variation in results 6. improvement of overall production reliability and availability. Equipment-Management 10
  • 11. Case study 1: Electronic Balance y = 1x + 0.0005 R² = 1 0 200 400 600 0 100 200 300 400 500 600 true value measured value true value v/s measured value True value: value on the calibration certificate Measured value: value from the equipment under verification Image 2 Image 3 Image 1 Measured value,gms True value,gms Error,gms 0 0 0 49.998 50 -0.002 99.998 100 -0.012 149.996 150 -0.004 199.999 200 -0.015 249.999 250 -0.001 299.99 300 -0.010 349.999 350 -0.001 399.988 400 -0.012 449.989 450 -0.011 499.997 500 -0.003 Equipment Management 11
  • 12. Section 2 Equipment maintenance and inventory servicing repair 12 Equipment-Management
  • 13. Maintenance Equipment-Management 13 Equipment maintenance Benefits Performance high level Test results Variation/ Time Lowers repair costs Lengthens lifespan
  • 14. . 14 Equipment Maintenance Benefits contd Reduces interruption of services Increases safety Greater customer satisfaction Equipment-Management
  • 16. Equipment Management Overview 1. assign responsibilities for all activities 2. train all personnel on requirements and maintenance needs 3. monitor equipment management activities: a. ensure all procedures are followed b. review all records routinely c. update procedures as needed Equipment management 16
  • 17. . Preventive Maintenance  routine cleaning  adjustment, replacement of equipment parts Equipment Management 17
  • 18. . Equipment-Management 18 Implementing a Maintenance Program  assign responsibility  develop written policies and procedures  maintain records  train staff
  • 19. . Equipment-Management 19 Develop a Maintenance Plan For each piece of equipment establish routine maintenance plan to include: frequency of all maintenance tasks function checks routine replacement of parts
  • 20. . Equipment-Management 20 Create an Equipment Inventory Log Record:  instrument type, model number, serial number  location in laboratory  date purchased  manufacturer and vendor contact information  warranty, note expiration date  spare parts. Cost and ordering information
  • 21. . Equipment-Module 3 21 Troubleshooting/corrective maintenance: What is the source of the problem? Sample? Reagent? Water, Electricity? Equipment? 21 Equipment management
  • 22. . Equipment-Management 22 When in-house efforts fail: call manufacturer or other technical expert look for options to continue service  obtain back-up instrument from central stores or manufacturer  refer sample to nearby laboratory
  • 23. . Equipment-Management 23 Service and Repair manufacturers laboratory must schedule routine manufacturer’s maintenance warranty may require repair handled by manufacturer in-house service technicians
  • 26. . Equipment-Management 26 Documents Develop written procedures for:  routine maintenance  function checks  calibration  troubleshooting  manufacturer’s service
  • 27. . Equipment-Management 27 Dedicated Log Book  Routine maintenance:  calibration/validation  service repair by manufacturer  all problems  Function checks
  • 28. . Equipment-Management 28 Recording Problems date problem occurred, equipment removed from service reason for breakdown or failure corrective actions taken date returned to use change in maintenance or in function checks
  • 32. Equipment inventory -For all lab equipment and their status LABORATORY EQUIPMENT AND ACCESORIES INVENTORY 2020 S/No MB No./ MTRD Serial No. Name of Equipment Manufacturer/ Calibration Status Test in which the equipment is used for Equipment Condition Remarks/ Space capacity Working Not Working Obsolete List per category i.e. soils, Bitumen Indicate where applicable Indicate where applicable Indicate Name e.g. Cone Penetrometer Indicate Manufacturer/ M ake e.g ELE, Controls etc Indicate last date of calibration where applicable & attach calibration certificate Equipment use or specific test for the particular equipment Tick if working Tick if not working but repairable Tick if obsolete Status of management of unused and obsolete equipment Equipment management 32
  • 33. . Equipment-management 33 Summary An equipment maintenance management program will address:  equipment selection preventive maintenance procedures for troubleshooting and repair Documents and records will include: inventory of all laboratory equipment Information provided by the manufacturer on operation, maintenance, and troubleshooting records of all preventive maintenance and repair activities
  • 34. . Equipment management 34 Key Messages A well-organized equipment maintenance program provides: High level of performance and greater confidence in the reliability of results. Fewer interruptions in test performance, lower repair costs, and elimination of premature replacement of equipment. Increased safety for laboratory workers will result from well- maintained equipment. N/B: developing mtrd equipment management guideline. A major part of equipment maintenance is PREVENTIVE maintenance
  • 35. thank you, ahsante, merci… Equipment management 35
  • 36. LQMS Equipment-Module 3 Equipment management Questions? Comments? Organization Personnel Equipment Purchasing & Inventory Process Control Information Management Documents & Records Occurrence Management Assessment Process Improvement Customer Service Facilities & Safety 36