verifikasi timbangan dan cara menentukan metode verifikasi timbangan

1. VERIFIKASI
TIMBANGAN
Johannes Erwanto
Business Unit Manager of PT Almega Sejahtera

2. AGENDA
 Dasar (Rujukan) Verifikasi
 Memilih Alat Yang Digunakan Untuk Verifikasi
 Metode Uji Verifikasi
 Menentukan Keberterimaan Hasil Verifikasi
 Frekuensi Verifikasi
 Question & Answer

3. Dasar (Rujukan) Verifikasi
Good Action Is Needed
Evaluation of risk ?
Good Weighing Practice™ is a risk-based
program for managing weighing systems
allowing you to improve control of your whole
measuring process. It is based on a defined
set of activities…..

4. Dasar (Rujukan) Verifikasi
Are we doing too little
or too much?
ISO 9001: 7.6 Control of Monitoring and Measuring Devices
“Measuring equipment shall be calibrated or verified at specified
intervals … against measurement standards traceable to
international or national measurement standards … The
organization shall assess and record the validity of previous
measuring results when the equipment is found not to conform to
requirements. The organization shall take appropriate action on the
equipment and on any product affected.
Playing it by the rules: Food

5. Dasar (Rujukan) Verifikasi
Courtesy Novartis
How do we
put this into
practice?
What GMP/GLP says about weighing:
“Automatic, mechanical or electronic equipment…
shall be routinely calibrated, inspected or checked according to a
written program designed to assure proper performance. Written
records of those inspections shall be maintained.”
21 CFR part 211, US GMP for Pharma
Playing it by the rules: Pharmaceuticals

6. Memilih Alat Yang Digunakan Untuk Verifikasi

7. Memilih Alat Yang Digunakan Untuk Verifikasi
User Benefits
 Cost savings – only what is
needed for routine testing, two
weights rather than entire weight
set
 Low cost of ownership –
recalibration costs lower for two
weights vs. entire set
 Time savings – easy and quick
tests supported by
METTLER TOLEDO SOPs
 Option to add 3rd weight for
specific testing, e.g. minimum
weight determination
 Ergonomically designed weight
handling accessories included
CarePacs for Routine Testing

8. Memilih Alat Yang Digunakan Untuk Verifikasi
Different Objective of Calibration and User Tests
 Assessment of complete balance
performance by testing all relevant
weighing parameters
 Assessment of weighing accuracy
requirements
Objective of the two testing
methods is different!

9. Metode Uji Verifikasi
Sensitivity [SE]
• Sensitivity [SE] is the change of the indicated value divided by the load
change on the balance.
Indication
Load
• Ideal characteristic curve
• Characteristic curve with
sensitivity deviation

10. Metode Uji Verifikasi
Repeatability Test Limits
Control limit = Required accuracy*smallest net weight / k
Warning limit = Control limit / Safety factor
For a safety factor of 1, the warning limit is identical to
the control limit
The smallest possible test limit is 0.4d. 1% * 40mg / 2 = 0.2mg
Example:
XP205
Accuracy: 1%
Impact: high
Smallest net: 40 mg
Safety factor: 2
Expansion factor: 2

11. Menentukan Keberterimaan Hasil Verifikasi
Control limit exceeded: Balance has to be marked
as „out of control limits“ and shall not be used
anymore. MT has be contacted.
Warning limit exceeded: No immediate action
necessary, but balance has to be kept under
surveillance
Example:
XP205
Accuracy: 1%
Impact: high
Safety factor: 2
GWP SOP‘s for Routine Testing
provide more information for the user

12. Frekuensi Verifikasi
Impact (for business and for consumer)
Weighing
accuracy
low medium high
1 %
0.1 %
0.01 %
10 %
Our Experience put into Practice

13. QUESTION ?
Answer

14. THANK YOU!
FOR YOUR PARTICIPATE