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Deviation of Temperature (after calibration)

CCP

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#1 dyiah89

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Posted 11 January 2018 - 03:48 AM

Hi guys,

 

I have some  doubts. In my previous audit findings, the findings are about 'calibration of sealing bar for my CCP3 which are sighted deviation temperature more than +- 2 ◦C. "

 

How am i gonna to solve this findings? My critical limits for this CCP 3 are 140 ◦C to 200 ◦C.

But the calibration show have deviation .

 

Do I have to revise my critical limit? But to do may need i to do validation study again.

 

Can anybody help me?

 

Thanks =)


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#2 Charles.C

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Posted 11 January 2018 - 11:01 AM

Hi guys,

 

I have some  doubts. In my previous audit findings, the findings are about 'calibration of sealing bar for my CCP3 which are sighted deviation temperature more than +- 2 ◦C. "

 

How am i gonna to solve this findings? My critical limits for this CCP 3 are 140 ◦C to 200 ◦C.

But the calibration show have deviation .

 

Do I have to revise my critical limit? But to do may need i to do validation study again.

 

Can anybody help me?

 

Thanks =)

 

Hi dyiah,

 

Sorry but I cannot understand whether yr problem was with the calibration data or the critical limits ? Or both ?

 

Calibration is not directly related to critical limits other than possibly via end-point corrections..

 

Can you explain with numbers as to what was the auditor's criticism ?


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Kind Regards,

 

Charles.C


#3 dyiah89

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Posted 12 January 2018 - 01:30 AM

Hi dyiah,

 

Sorry but I cannot understand whether yr problem was with the calibration data or the critical limits ? Or both ?

 

Calibration is not directly related to critical limits other than possibly via end-point corrections..

 

Can you explain with numbers as to what was the auditor's criticism ?

 

Hi charles,

 

Below is the auditor's findings.

 

Based on the calibration of sealing bar for packing machines, sighted deviation more than ±2° 1) Machine Sanko 2 (Horizontal) Set = 200 Actual = 199.9 Indicated = 198 Correction = -2.1 2) Machine SN1 (vertical) Set = 149 Actual = 139.9 Indicated = 142 Correction = +2.1  3) Machine Sanko 4 (Vertical) Set = 200 Actual = 199.9 Indicated = 198 Correction = -2.1

 

The problems is the temperature is my CCP 3. How am i gonna answer to this findings? My critical limits for this CCP 3 are 140 ◦C to 200 ◦C.

Please advise me.

 

Thank You..


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#4 Charles.C

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Posted 12 January 2018 - 10:42 AM

Hi charles,

 

Below is the auditor's findings.

 

Based on the calibration of sealing bar for packing machines, sighted deviation more than ±2° 1) Machine Sanko 2 (Horizontal) Set = 200 Actual = 199.9 Indicated = 198 Correction = -2.1 2) Machine SN1 (vertical) Set = 149 Actual = 139.9 Indicated = 142 Correction = +2.1  3) Machine Sanko 4 (Vertical) Set = 200 Actual = 199.9 Indicated = 198 Correction = -2.1

 

The problems is the temperature is my CCP 3. How am i gonna answer to this findings? My critical limits for this CCP 3 are 140 ◦C to 200 ◦C.

Please advise me.

 

Thank You..

 

Hi dyiah,

 

I assume the value designated "actual" temperature is that indicated by a reference instrument.

 

I assume the value designated "indicated" temperature is that shown by the temperature thermocouple in the machine.

 

I assume the data is for 3 different units whose temperature gauges are stated to have a maximum tolerance of +/- 2.0degC.

 

If as above, seems to me the data indicates that at the quoted temp. reference points, machines 1-3 require correction factors of +1.9, -2.1, +1.9 degC respectively (cf. yr values of -2.1,+2.1,-2.1)degC

 

Regardless, if the problem is that the allowed tolerance is max. +/- 2.0degC, my interpretation indicates a problem for temperature gauge in machine 2 such that 2 options are normally available, ie -

 

(1) adjust the zero on the machine temperature gauge.

(2) if (1) not possible then replace the temperature gauge.

 

Perhaps i have misunderstood yr problem. If so, please clarify.


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Kind Regards,

 

Charles.C


#5 dyiah89

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Posted 13 January 2018 - 03:30 AM

Hi dyiah,

 

I assume the value designated "actual" temperature is that indicated by a reference instrument.

 

I assume the value designated "indicated" temperature is that shown by the temperature thermocouple in the machine.

 

I assume the data is for 3 different units whose temperature gauges are stated to have a maximum tolerance of +/- 2.0degC.

 

If as above, seems to me the data indicates that at the quoted temp. reference points, machines 1-3 require correction factors of +1.9, -2.1, +1.9 degC respectively (cf. yr values of -2.1,+2.1,-2.1)degC

 

Regardless, if the problem is that the allowed tolerance is max. +/- 2.0degC, my interpretation indicates a problem for temperature gauge in machine 2 such that 2 options are normally available, ie -

 

(1) adjust the zero on the machine temperature gauge.

(2) if (1) not possible then replace the temperature gauge.

 

Perhaps i have misunderstood yr problem. If so, please clarify.

 

 

Hi Charles,

 

There are notes in my calibration certification stated that ' The estimated uncertainty of the calibration results given is +/- 0.9 ◦C. at 95 % confidence level".

 

For now, what I need to do is to zero or replace the temperature gauge right? Have any other option other than that?

 

Based on your solution, it is okay if I used Infra red thermometer to check all the sealing bars to ensure the reading are within the limit?

 

My biggest problems is how i am gonna to write the corrective action to send back to my auditor. 

 

Btw thanks for your advise=)


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#6 Charles.C

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Posted 13 January 2018 - 04:24 AM

Hi Charles,

 

There are notes in my calibration certification stated that ' The estimated uncertainty of the calibration results given is +/- 0.9 ◦C. at 95 % confidence level".

 

For now, what I need to do is to zero or replace the temperature gauge right? Have any other option other than that?

 

Based on your solution, it is okay if I used Infra red thermometer to check all the sealing bars to ensure the reading are within the limit?

 

My biggest problems is how i am gonna to write the corrective action to send back to my auditor. 

 

Btw thanks for your advise=)

 

Hi dyiah,

 

Not sure as to the Standard involved (if any). This may be relevant to yr options.

 

The interpretation/usage of Calibration Certificates in the context of temperature critical limits can be complicated. Can see the lengthy discussion in this thread -

 

http://www.ifsqn.com...ence-equipment/

 

Particularly see the linked document in Post 5 which is IMO very useful and readable.

My own conclusion is summarised in Post 19 but as you can see, this is subjective.

 

Can also see this short thread -

 

http://www.ifsqn.com...ing-ccp-limits/

 

Yr options depend on things like -

 

(a) whether yr current thermocouple/gauge has a zero adjust ?.

(b) whether yr declared calibration tolerance has been exceeded or not ?.

(c) whether a suitable calibrated alternative gauge exists ?.

(d) whether you can change yr critical limits ?.


Edited by Charles.C, 15 January 2018 - 06:01 PM.
corrected link

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Kind Regards,

 

Charles.C


#7 Sofia

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Posted 14 January 2018 - 05:55 PM

Hello there,

 

You need to take the calibration tolerance into consideration when setting up your CCP limits. So if you have a probe with calibration tolerance +/- 2 C then your critical limits need to change.

For example our CCP for deep chill temperature is 3C but because the probe have tolerance +/- 0.5C we had to change the CCP temp to 2.5 C.

 

Sofia


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#8 Charles.C

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Posted 15 January 2018 - 06:27 PM

Hello there,

 

You need to take the calibration tolerance into consideration when setting up your CCP limits. So if you have a probe with calibration tolerance +/- 2 C then your critical limits need to change.

For example our CCP for deep chill temperature is 3C but because the probe have tolerance +/- 0.5C we had to change the CCP temp to 2.5 C.

 

Sofia

 

Hi Sofia,

 

Thanks for input.

Might add that the details can in practice be subjective. See the 1st link in Post 6.


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Kind Regards,

 

Charles.C


#9 Ryan M.

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Posted 16 January 2018 - 10:57 PM

Your critical limits should be outside of your normal operating limits to give you buffers for any calibration errors, corrections, or operations variability.  Why in the world would you operate your equipment right at the edge of your critical limits?  If those temperatures are needed on those pieces of equipment then you need to re-evaluate your critical limits and re-validate as necessary.

 

For example, in our pasteurization process the critical limit is 280 degrees F minimum.  We operate around 292 degrees F and our temperature devices can have a deviation up to 2 degrees F.


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