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7.6 Control of Monitoring and Measuring Equipment vs. 7.6.1 Measurement Systems Analy

G

GoKats78

#1
Please share your thoughts and insight concerning the following ISO/TS 16949:2009 situation.

Our TS Registration auditor says that ALL measuring and test equipment systems listed in a Process Control Plan must be calibrated and have Statistical studies conducted to analyze the variation present in the results because of what is said in 7.6.1.

7.6.1 Measurement systems analysis

Statistical studies shall be conducted to analyze the variation present in the results of each type of measuring and test equipment system. This requirement shall apply to measurement systems referenced in the control plan. The analytical methods and acceptance criteria used shall conform to those in customer reference manuals on measurement systems analysis. Other analytical methods and acceptance criteria may be used if approved by the customer.

Example: Pyrometer used to measure temperature, which is an internal Process requirement that could potentially affect a product requirement (Mechanical Properties) that is checked prior to shipment to the customer.

-------------------------------------------------------------------------------

I believe that this only applies to measurement devices that are used to provide evidence of conformity of product to determined requirements because of what is said in 7.6.

7.6 Control of monitoring and measuring equipment

The organization shall determine the monitoring and measurement to be undertaken and the monitoring and measuring equipment needed to provide evidence of conformity of product to determined requirements.

Example: Instron Robotic Mechanical Testing Machine used to measure Mechanical Properties (yield, tensile strength, etc.), which is a Product requirement of our customers.

Situations like this will only make people take things out of their Process Control Plans that should be in there for all the right reasons.

Please advise. Thank You.
 
Elsmar Forum Sponsor
#2
Re: 7.6 Control of Monitoring and Measuring Equipment vs. 7.6.1 Measurement Systems A

In a way we are talking apples and oranges... or perhaps apples and bushels of apples.

Calibration relates to specific measuring devices, whereas MSA relates to family or type of device. For example, if you use micrometers, you need to perform an analysis on micrometers, but not on each individual mic. On the other hand, each individual mic used will be required to be calibrated (or verified).
 
G

GoKats78

#3
Re: 7.6 Control of Monitoring and Measuring Equipment vs. 7.6.1 Measurement Systems A

That really doesn't address the concern..we have items (such as scales and thermo-couples) called out in the control plan..they are either calibrated and certified (as per 7.6) . The scales measure raw product ....we have never done any MSA on them as all product characteristics are checked later (via chemical and mechanical properties testing). we have never done any MSA on the thermocouples...but our auditor is stating that it is required..

This guy seems hung up on these two clauses and there interaction...
 

Howard Atkins

Forum Administrator
Staff member
Admin
#4
Re: 7.6 Control of Monitoring and Measuring Equipment vs. 7.6.1 Measurement Systems A

There are 2 separate requirements which are not dependent on one another.

7.6.1 is unquestionable "This requirement shall apply to measurement systems referenced in the control plan. " there is NO place for discussion

The requirements of 7.6
The organization shall determine the monitoring and measurement to be undertaken and the monitoring and measuring equipment needed to provide evidence of conformity of product to determined requirements.
The organization shall establish processes to ensure that monitoring and measurement can be carried out and are carried out in a manner that is consistent with the monitoring and measurement requirements.
Please note that there is also a requirement for "monitoring and measurement can be carried out"
Process control is a requirement of TS and a part of the control plan

Annex A (normative) Control plan

c) Process control ⎯ process parameters,
⎯ process-related special characteristics,
⎯ machines, jigs, fixtures, tools for manufacturing.
In regard to issues such as thermocouples they should be verified and linearity and bias studied as required according to their use.
MSA does not mean GRR specifically or at all.

The philosophy of TS is prevention not detection so the performance of thermoucouples correctly will prevent errors and save corrections
 
G

GoKats78

#7
Re: 7.6 Control of Monitoring and Measuring Equipment vs. 7.6.1 Measurement Systems A

Good point...that is what happens when you try to do things from memory....and for someone else!
 

qusys

Trusted Information Resource
#8
Re: 7.6 Control of Monitoring and Measuring Equipment vs. 7.6.1 Measurement Systems A

Please share your thoughts and insight concerning the following ISO/TS 16949:2009 situation.

Our TS Registration auditor says that ALL measuring and test equipment systems listed in a Process Control Plan must be calibrated and have Statistical studies conducted to analyze the variation present in the results because of what is said in 7.6.1.

7.6.1 Measurement systems analysis

Statistical studies shall be conducted to analyze the variation present in the results of each type of measuring and test equipment system. This requirement shall apply to measurement systems referenced in the control plan. The analytical methods and acceptance criteria used shall conform to those in customer reference manuals on measurement systems analysis. Other analytical methods and acceptance criteria may be used if approved by the customer.

Example: Pyrometer used to measure temperature, which is an internal Process requirement that could potentially affect a product requirement (Mechanical Properties) that is checked prior to shipment to the customer.

-------------------------------------------------------------------------------

I believe that this only applies to measurement devices that are used to provide evidence of conformity of product to determined requirements because of what is said in 7.6.

7.6 Control of monitoring and measuring equipment

The organization shall determine the monitoring and measurement to be undertaken and the monitoring and measuring equipment needed to provide evidence of conformity of product to determined requirements.

Example: Instron Robotic Mechanical Testing Machine used to measure Mechanical Properties (yield, tensile strength, etc.), which is a Product requirement of our customers.

Situations like this will only make people take things out of their Process Control Plans that should be in there for all the right reasons.

Please advise. Thank You.
Did you sign a PPAP with your customer?
If so, you should have agreed with it the reference manual for the analytical studies or alternative methods for each measurement or test systems recalled in the control plan ( form incoming to shipping through production):bigwave:
 

Howard Atkins

Forum Administrator
Staff member
Admin
#9
Re: 7.6 Control of Monitoring and Measuring Equipment vs. 7.6.1 Measurement Systems A

Did you sign a PPAP with your customer?
If so, you should have agreed with it the reference manual for the analytical studies or alternative methods for each measurement or test systems recalled in the control plan ( form incoming to shipping through production):bigwave:
PPAP is irrelevant this is a requirement of TS that the customer cannot waive.
There must be a MSA study- it does not have to be to a specific PPAP part
The PPAP handbook says
2.2.8 Measurement System Analysis Studies
The organization shall have applicable Measurement System Analysis studies, e.g., gage R&R, bias,
linearity, stability, for all new or modified gages, measurement, and test equipment. (see the Measurement Systems Analysis reference manual).
This is less than the standard!:agree1: which requires
"This requirement shall apply to measurement systems referenced in the control plan. "
This has no relevance to the requirements of PPAP
 
P

pldey42

#10
Re: 7.6 Control of Monitoring and Measuring Equipment vs. 7.6.1 Measurement Systems A

It seems to me that the answer lies in the requirement, and an understanding of what quality management means.

7.6.1 Measurement systems analysis

Statistical studies shall be conducted to analyze the variation present in the results of each type of measuring and test equipment system. This requirement shall apply to measurement systems referenced in the control plan.

Classical quality management principles include Deming's idea that variation is bad and should be reduced. While defects introduced by measurements system variation might (not will, might) be detected in product test and inspection, there's an expense in rejecting or reworking them – an expense that's passed on to the customer and makes the business less competitive. (Also, if product tests and inspections are performed on a sampling basis there's surely a risk of passing on some defective product to the customer.)

So it seems to me that the requirement means what it says – reduce or eliminate variation that might be introduced by all the measurements called up in the control plan using MSA. As Howard observes, the idea is to proactively prevent defective product from being made, because it's cheaper to do it right than to do it wrong and then scrap, rework or accidentally deliver it.

If that means that people will omit items from the control plan it seems to me they need an education in why they're doing control plans, and specifically the benefits in terms of reduced costs, scrap and rework of reducing measurement systems variation. And then an education in MSA ...

Hope this helps,
Pat
 
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