ISO 15189, QA & how to calibration for Balance, refrigerator and centrifuge?

[Kelukelu]

I have some problems, because I'm going to write for WI.

1.Is it any international standard calibration procedure for Balance, refrigerator ,centrifuge and others?

2. Can I test equipment using the development method that by myself ? (just simple measuring, not like use the hysteresis check, precision, accuracy...etc)

3. Is it correct for the uncertainty formula ?

Uncertainty and standard deviation:

*Uwr =Maximum standard deviation of reading x coverage factor ( 95% confidence)
*Ubr=Instrument uncertainty x coverage factor ( 95% confidence)
*Uc = √Uwr^2 + Ubr^2

e.g.
The acceptance criteria:
speed +-10% of the display


4. What is the role of QA ? Is QA double check the equipment or just verification for the test procedure to match the document (WI).
Or can it the test request one technician only , not need other technician to verification?


The more details for procedure (reference others company) and calculation as below

Balance :
Full calibration : off-centre loading, hysteresis check, precision and accuracy ( Departure from Nominal value).
Half year: precision.
daily: scale value check
each weighing : zero check

Temperature controlled enclosure
- nine point test for two years,
- centre point test for six month

Centrifuge:
Take 10 more reading.

Thank you very much.

 

[Stijloor]

I have some problems, because I'm going to write for WI.

1.Is it any international standard calibration procedure for Balance, refrigerator ,centrifuge and others?

2. Can I test equipment using the development method that by myself ? (just simple measuring, not like use the hysteresis check, precision, accuracy...etc)

3. Is it correct for the uncertainty formula ?

Uncertainty and standard deviation:

*Uwr =Maximum standard deviation of reading x coverage factor ( 95% confidence)
*Ubr=Instrument uncertainty x coverage factor ( 95% confidence)
*Uc = √Uwr^2 + Ubr^2

e.g.
The acceptance criteria:
speed +-10% of the display


4. What is the role of QA ? Is QA double check the equipment or just verification for the test procedure to match the document (WI).
Or can it the test request one technician only , not need other technician to verification?


The more details for procedure (reference others company) and calculation as below

Balance :
Full calibration : off-centre loading, hysteresis check, precision and accuracy ( Departure from Nominal value).
Half year: precision.
daily: scale value check
each weighing : zero check

Temperature controlled enclosure
- nine point test for two years,
- centre point test for six month

Centrifuge:
Take 10 more reading.

Thank you very much.

A quick bump.

Can someone help?

Thanks!!

Stijloor.

 

[v9991]

1.Is it any international standard calibration procedure for Balance, refrigerator ,centrifuge and others?

for balance at-least there are couple of references...
apart from pharmacopoeia...
http://ts.nist.gov/WeightsAndMeasures/CalibrationProcedures.cfm
http://www.epa.gov/pesticides/methods/atmpmethods/QC-05-03.pdf
http://www.epa.state.il.us/water/water-quality/methodology/refrigerator-temp-sop.pdf

http://gmponblog.vinvarun.biz/2008/08/sop-calibration-of-balances.html
http://www.research.usf.edu/cm/SOP's/S1114_2_Refrigerator_Freezer_Unit_Use_Monitoring_7_08.pdf

(not all of them are traceable!!!)

for refrigerator... apart from simple verification of temperature against set value(acceptance criteria depends on the purpose/usage of refrigerator); a study of annual(periodic) mapping(with load and without load) of temperature zones using a data logger (multiple probes) is recommended.

for centrifuge, again is specific approach, (is it Temp. controlled, pre-programmable..etc.,) depending on features, it will bring in simple set-value verification of temperature and timer; to an extreme of plc controls qualification.

2.Can I test equipment using the development method that by myself ? (just simple measuring, not like use the hysteresis check, precision, accuracy...etc)

not sure whether u want to avoid hysteresis or else do you want to develop some inhouse method; in either case they have to be justified to specific equipment and application/usage of it.
as per performing calibration using that inhouse method, traceability of standards have to be maintained.

4.What is the role of QA ? Is QA double check the equipment or just verification for the test procedure to match the document (WI).
Or can it the test request one technician only , not need other technician to verification?

i believe QA role in routine activities is that of verification and ensuring compliance to procedure; the activity of double check(/verification) could be employed through a accountable/second person from same function. (if QA becomes part of this step, then periodic audit/review would have to be assigned to independent person!!! right?)

about repeat/redundant testing, is not a good idea, (it may also mean that defining a procedure for scenario of handling failures in either of the proposed duplicate testing etc., instead it would be good idea to make the initialtesting itself pretty robust-sensitive-depth)

unless you have specific scenario... (dynamic environment, sensitivity, instrument performance etc)

The more details for procedure (reference others company) and calculation as below
Balance :
Full calibration : off-centre loading, hysteresis check, precision and accuracy ( Departure from Nominal value).
Half year: precision.
daily: scale value check
each weighing : zero check
Temperature controlled enclosure
- nine point test for two years,
- centre point test for six month
Centrifuge:
Take 10 more reading.

its desirable to have justification&relevance to your operations-purpose of use of equipment;

note : above comments based on general pharma/QA experience. hope they are relevant to iso as well.

 

[BradM]

I have some problems, because I'm going to write for WI.

1.Is it any international standard calibration procedure for Balance, refrigerator ,centrifuge and others?

There are several procedures available for each of these instrument groups. For balances, there is Handbook 44. If these balances are used in GLP setting, you will need to address the precision as specified in USP 41. I'm not sure about international standards for refrigerators and centrifuges. Primarily, I think it would depend on the instrument. If the equipment have indicators, they can be verified for accuracy. Otherwise, some level of maintenance/ verification would need to be defined for the equipment.

2. Can I test equipment using the development method that by myself ? (just simple measuring, not like use the hysteresis check, precision, accuracy...etc)

It depends on the equipment, what you will be using it for, and the level of risk. I would be leery to suggest abbreviated testing, without knowing the equipment history and use.

4. What is the role of QA ? Is QA double check the equipment or just verification for the test procedure to match the document (WI).
Or can it the test request one technician only , not need other technician to verification?

Well... that's kind of a loaded question also. It would depend on your process and what activities the QA function are engaged in. It really does all depend. There are some technicians performing highly automated work using controlled data capturing system, that may not require any QA intervention. Others might require review. It's really difficult for me to say.

The more details for procedure (reference others company) and calculation as below

Balance :
Full calibration : off-centre loading, hysteresis check, precision and accuracy ( Departure from Nominal value).
Half year: precision.
daily: scale value check
each weighing : zero check

Again, it would depend on the risk exposure for the balance and to me, it's history. If it is a new balance with auto-balance/auto-calibration, the level (and frequency) of checks would be far less than the older balance that tends to drift. I like how you have more in-depth verification less frequently. Again, all those intervals really depend on the equipment history and process requirements.

Temperature controlled enclosure
- nine point test for two years,
- centre point test for six month

Centrifuge:
Take 10 more reading.

For these, I'm really unsure. Your # of test probes seems to suggest a standard size enclosure. The # of probes for a benchtop oven will be different than those required for a large steam sterilizer.

 

[BradM]

It seems to me (I'm really unsure here...) that maybe the attempt is to develop a calibration approach, and apply it to the equipment. That's pretty good for some situations and things.

However, I would think that you should let your process help develop your requirements. Has any of this equipment been qualified as part of a validated process?

For a start, I would develop a master sheet/equipment sheet/ master record/ or whatever terminology or such that you choose. It should list what the equipment is, what it is used for, validated parameters (if they exist), and what the use is of the equipment.

After you gather this information and production and such agree as to it's use, then you can ascertain what level of verification, what test points/tolerances, and what frequency is needed.

Then, you need to keep track as to how the equipment is performing. If the equipment is passing tests with little/ no error (as a % of tolerance), then you might can relax how often you verify it.

My apologies that I have provided generic/evasive responses. I would just hate to suggest something that works well for the process I'm involved with; only for it to be a dismal failure/excessive/ not comprehensive enough for your failure.

If all else fails, an alternative for the balances might be to find a competent lab to calibrate them for a while. They will have the proper training and equipment to check them correctly, and can assist you in developing a trend history on the balances and such.

 

[Kelukelu]

Thank you for your comments! I write these comments for the maintenance of a great help!
In fact, I mentioned to the test methods, reference to an international committee; its such a great organization and a long history.
The committee is too prestigious, to some extent be regarded as a leader, and they took ISO 15189, so I just follow their testing methods rather than established test method by myself.
But the method they used is a bit esoteric,as uncertainty calculation and academic approach, so I hope here looking for some simple and practical way.