:bonk:What is the difference between equipment and device with reference to clause no. 7.6 of ISO 9001:2000 standard.
And is it mandatory to get equipment/devices used in production to be calibrated as first para of clause 7.6 says about devices used to check requirements stated customer (refer 7.2.1)
further I can elaborate this by giving an example.
Suppose I am manufacturing one shaft on lathe machine, so their are equipments/devices which will be used for measuring the product during production (so whether these equipments/devices will be covered under 7.6 or 6.3 of ISO 9001:200)), and at the same time i am having few more equipments/devices which will be used to measure final product (as agreed in 7.2.1).
So, kindly give your opinion about which equipments/devices to be included within the purview of calibration requirement and whether equipment/devices used in production are to be calibrated.

Regards

Ajay:biglaugh:

:bonk:What is the difference between equipment and device with reference to clause no. 7.6 of ISO 9001:2000 standard.
And is it mandatory to get equipment/devices used in production to be calibrated as first para of clause 7.6 says about devices used to check requirements stated customer (refer 7.2.1)
further I can elaborate this by giving an example.
Suppose I am manufacturing one shaft on lathe machine, so their are equipments/devices which will be used for measuring the product during production (so whether these equipments/devices will be covered under 7.6 or 6.3 of ISO 9001:200)), and at the same time i am having few more equipments/devices which will be used to measure final product (as agreed in 7.2.1).
So, kindly give your opinion about which equipments/devices to be included within the purview of calibration requirement and whether equipment/devices used in production are to be calibrated.

Regards

Ajay:biglaugh:

Hello Ajay,

Welcome to The Cove! :bigwave:

The "equipment" mentioned in clause 6.3 is considered process equipment. This equipment has to be "suitable" per 7.5.1 c). Suitability is accomplished by acquiring the "right" equipment and regular (preventive) maintenance.

The monitoring and measuring "devices" mentioned in 7.6 are considered inspection/testing tools and are subject to calibration at regular intervals or prior to use.

Did this clarify?

Stijloor.

And is it mandatory to get equipment/devices used in production to be calibrated as first para of clause 7.6 says about devices used to check requirements stated customer (refer 7.2.1)Like in most interpretation issues, it is very hard to to give an answer that covers all possible scenarios. There are production equipment that that should have their associated instrumentation and gages calibrated and there are measuring devices that can not be truly calibrated.

For example, imagine you are welding a structural member of an aircraft. The welding procedure specification was "qualified" (validated). Even though that weldment will undergo a number of inspections, such as magnetic particle, x-ray, etc..., it is critical that the "qualified" weld process is followed. That typically includes control of a number of parameters, such as amperage, voltage, gas flow, etc... Such parameters are monitored with gages of the weld machine, which is a process (production) equipment. Such gages must be calibrated to ensure that the parameters are being followed.

As a rule of thumb, if you are dealing with (special) processes that require tight control of physical, chemical , etc. parameters for the output to be satisfactory, such instrumentation should be calibrated.

Examples of inspection devices which are not truly "calibrated" (but verified) are rulers, tape measures, templates, fixtures, etc...

Like in most interpretation issues, it is very hard to to give an answer that covers all possible scenarios. There are production equipment that that should have their associated instrumentation and gages calibrated and there are measuring devices that can not be truly calibrated.

For example, imagine you are welding a structural member of an aircraft. The welding procedure specification was "qualified" (validated). Even though that weldment will undergo a number of inspections, such as magnetic particle, x-ray, etc..., it is critical that the "qualified" weld process is followed. That typically includes control of a number of parameters, such as amperage, voltage, gas flow, etc... Such parameters are monitored with gages of the weld machine, which is a process (production) equipment. Such gages must be calibrated to ensure that the parameters are being followed.

As a rule of thumb, if you are dealing with (special) processes that require tight control of physical, chemical , etc. parameters for the output to be satisfactory, such instrumentation should be calibrated.

Examples of inspection devices which are not truly "calibrated" (but verified) are rulers, tape measures, templates, fixtures, etc...
I have quoted one example which I will repeat again. Kindly send your opinion on this.

"Assume I am involved in forging and machining activities". One of my customer asked me a shaft (his requirement is a shaft as per his drawing, material grade EN18 without internal flaws, I have checked the grade of material before starting forging) and during production I heat material in furnace for open forging, there are temperature gauge in furnace, whether these needs to be calibrated.. Secondly after the material cools down, I will do the required turning and while doing this I use Vernier Calipers, Micrometers and few Fixtures, whether these needs to be calibrated, and finally during my final inspection I check internal flaws in shaft through ultra sonic tester, whether these needs to be calibrated.

If yes, which line in standard is demanding and if no, where is this detail indicated in standard.

Need your opinion.

Regards

Ajay

Hello Ajay,

Welcome to The Cove! :bigwave:

The "equipment" mentioned in clause 6.3 is considered process equipment. This equipment has to be "suitable" per 7.5.1 c). Suitability is accomplished by acquiring the "right" equipment and regular (preventive) maintenance.

The monitoring and measuring "devices" mentioned in 7.6 are considered inspection/testing tools and are subject to calibration at regular intervals or prior to use.

Did this clarify?

Stijloor.
I have quoted one example which I will repeat again. Kindly send your opinion on this.

"Assume I am involved in forging and machining activities". One of my customer asked me a shaft (his requirement is a shaft as per his drawing, material grade EN18 without internal flaws, I have checked the grade of material before starting forging) and during production I heat material in furnace for open forging, there are temperature gauge in furnace, whether these needs to be calibrated.. Secondly after the material cools down, I will do the required turning and while doing this I use Vernier Calipers, Micrometers and few Fixtures, whether these needs to be calibrated, and finally during my final inspection I check internal flaws in shaft through ultra sonic tester, whether these needs to be calibrated.

If yes, which line in standard is demanding and if no, where is this detail indicated in standard.

Need your opinion.

Regards

Ajay

7.5.1.d) & 7.6 a). BINGO?

Oh brother.....:rolleyes:

7.5.1.d) & 7.6 a). BINGO?

Oh brother.....:rolleyes:


I must be missing something......:frust:

I have quoted one example which I will repeat again. Kindly send your opinion on this.

"Assume I am involved in forging and machining activities". One of my customer asked me a shaft (his requirement is a shaft as per his drawing, material grade EN18 without internal flaws, I have checked the grade of material before starting forging) and during production I heat material in furnace for open forging, there are temperature gauge in furnace, whether these needs to be calibrated.. Secondly after the material cools down, I will do the required turning and while doing this I use Vernier Calipers, Micrometers and few Fixtures, whether these needs to be calibrated, and finally during my final inspection I check internal flaws in shaft through ultra sonic tester, whether these needs to be calibrated.

If yes, which line in standard is demanding and if no, where is this detail indicated in standard.

Need your opinion.

Regards

Ajay


All the gages after the line need to be calibrated, because they affect product quality. The temp gage in the furnace is a process gage which needs to be calibrated because it affects product quality. Both types are "necessary to ensure valid results." Any of them would be a problem if they do not show accurate measurements.

...Suppose I am manufacturing one shaft on lathe machine, so their are equipments/devices which will be used for measuring the product during production (so whether these equipments/devices will be covered under 7.6 or 6.3 of ISO 9001:200)), and at the same time i am having few more equipments/devices which will be used to measure final product (as agreed in 7.2.1).
So, kindly give your opinion about which equipments/devices to be included within the purview of calibration requirement and whether equipment/devices used in production are to be calibrated.

Regards

Ajay

All of the gages you cite must produce valid results, therefore you must verify if they are providing accurate measurements. Therefore they must be calibrated/verified to determine that they are accurate.

I must be missing something......:frust:If yes, which line in standard is demanding and if no, where is this detail indicated in standard.

the invisible ink

It's been a very busy week....long days. Between that and football games. ;) Now I need a break. :yes:

Thanks Sidney.

Stijloor.

Helmut has it, as usual!

Any equipment which uses measuring devices/indicators etc. to demonstrate parameters which are necessary for process control (e.g. heat, pressure, time, speed etc.) have to be of known accuracy etc. Therefore, they should be calibrated/verified.

Any equipment used subsequently to inspect/test particular features/characteristics (e.g. size, shape, finish etc.) after further processing and are used to determine product conformance also have to be of known accuracy etc. - and therefore calibrated/verified.

It's simple - really..........!!