Gauge R&R in Chemical Laboratory

qusys

Trusted Information Resource
#1
What about MSA implementation in a chemical Lab , doing gauge R & R for measurement and test they perform in the lab?
I know that for organization ISO TS certified, the statistical studies on equipment are mandatory for the equipment that are in the control plan or if the chemical lab performs that tests and evaluation that are present in the production control plan and whose correct results impact the quality of the product.
Is it right?
Thoughts?
 
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Ajit Basrur

Staff member
Admin
#2
Re: Gauge R&R in Chemical Lab

What about MSA implementation in a chemical Lab , doing gauge R & R for measurement and test they perform in the lab?
I know that for organization ISO TS certified, the statistical studies on equipment are mandatory for the equipment that are in the control plan or if the chemical lab performs that tests and evaluation that are present in the production control plan and whose correct results impact the quality of the product.
Is it right?
Thoughts?
Can you pls elaborate more on the nature of the chemical testing that you are refering ?
 

qusys

Trusted Information Resource
#3
Re: Gauge R&R in Chemical Lab

Can you pls elaborate more on the nature of the chemical testing that you are refering ?
One of this test that chemical lab does is related to the process contamination ( matallic contamination for instance)
Other tests are related to the analysis of concentration, conducivity, toxycity, microbiological etc.
The scope is extended in general to the incoming control of raw materials, process engineering, facilities, contamination control etc..
 

Ajit Basrur

Staff member
Admin
#4
Re: Gauge R&R in Chemical Lab

One of this test that chemical lab does is related to the process contamination ( matallic contamination for instance)
Other tests are related to the analysis of concentration, conducivity, toxycity, microbiological etc.
The scope is extended in general to the incoming control of raw materials, process engineering, facilities, contamination control etc..
I am familiar with analytiocal method validation (or Method Verification) where there are 8 parameters viz.

• Accuracy
• Precision
• Specificity
• Limit of detection
• Limit of quantitation
• Linearity and range
• Ruggedness
• Robustness

You can find information on the above from these guidance documents. Pls be reminded that I have highlighted this based on Pharmaceutiocal and the laboratories that comply to ISO 17025 requirements.

Technical Note 17 - NATA

Method Verification - AOAC

I have also attached these documents.
 

Attachments

qusys

Trusted Information Resource
#5
Re: Gauge R&R in Chemical Lab

I am familiar with analytiocal method validation (or Method Verification) where there are 8 parameters viz.

• Accuracy
• Precision
• Specificity
• Limit of detection
• Limit of quantitation
• Linearity and range
• Ruggedness
• Robustness

You can find information on the above from these guidance documents. Pls be reminded that I have highlighted this based on Pharmaceutiocal and the laboratories that comply to ISO 17025 requirements.

Technical Note 17 - NATA

Method Verification - AOAC

I have also attached these documents.
Thanks a lot, Ajit.
This is an internal lab that support the organization which operates in electronic devices manufacturing.
The organization is ISO TS and the lab is not 17025 certified because it is not mandatory.
It responds to 7.6.3 requirements for internal lab and the other applicable requirements of the standards.
So, given that the chem techinicians perform test of contamination that check for metallic contamination in mfg process, I asked if A MSA is due.
Chemical Lab has not any control plan.
 
N

NumberCruncher

#6
Re: Gauge R&R in Chemical Lab

Hi qusys

On a technicality, since the lab is not in the control plan, it looks like you don't have to do any MSA studies on the equipment / staff in the lab.

However, TS16949 states:

"7.5.1.1 Control plan"...

"The control plan shall list the controls used for the manufacturing process control,..."


From what you have said, the lab is part of the controls for the manufacturing process, both incoming materials and in-line process control. Why is the lab not on the control plan?

If your customers and external auditors satisfied with this then there is no problem, but it does seem a bit odd.

NC
 

qusys

Trusted Information Resource
#7
Re: Gauge R&R in Chemical Lab

Hi qusys

On a technicality, since the lab is not in the control plan, it looks like you don't have to do any MSA studies on the equipment / staff in the lab.

However, TS16949 states:

"7.5.1.1 Control plan"...

"The control plan shall list the controls used for the manufacturing process control,..."


From what you have said, the lab is part of the controls for the manufacturing process, both incoming materials and in-line process control. Why is the lab not on the control plan?

If your customers and external auditors satisfied with this then there is no problem, but it does seem a bit odd.

NC
Thanks for response.
The chemical performs some test only for a certain number of raw materials ( some chemicals such ammonia, H2O2 etc, no gases), just as an additional control for incoming quality. In any case we rely on CoA and CoC for raw materials and bulk gases .
Other test performed by Chemical Lab are related to the purity of DI Water used in the mfg process, besides there have been recently introduced metalic contamination tests in some mfg areas, in this case such test , done on dummy production items, are carried to chemical lab and analysed by techs by means of certain procedure.
Currently these tests have not been inserted in the production control plan yet.
:bigwave:
 

Statistical Steven

Statistician
Staff member
Super Moderator
#8
Re: Gauge R&R in Chemical Lab

I would refer to ICH Q2R1 for Analytical Method Validation. Methods need to validated to show that are fit for their intended purpose.
 

qusys

Trusted Information Resource
#9
Re: Gauge R&R in Chemical Lab

I would refer to ICH Q2R1 for Analytical Method Validation. Methods need to validated to show that are fit for their intended purpose.
Yes, I know this. We are validating the methods but the plan is not completed yet.
Can you please provide an example to validate a method for chemical lab?
Consider that the lab is not ISO 17025 certified, but the organization has ISO TS.
As to MSA for this, what about? Do Gauges R&R necessary as per what I said?
thanks:bigwave:
 

Statistical Steven

Statistician
Staff member
Super Moderator
#10
Re: Gauge R&R in Chemical Lab

Yes, I know this. We are validating the methods but the plan is not completed yet.
Can you please provide an example to validate a method for chemical lab?
Consider that the lab is not ISO 17025 certified, but the organization has ISO TS.
As to MSA for this, what about? Do Gauges R&R necessary as per what I said?
thanks:bigwave:
Any laboratory test (i.e. chemical test) should be qualified and/or validated. MSA is not different than the precision and accuracy part of Q2R1. A typical protocol for a chemical test would have multiple runs, multiple samples and multiple operators. You can also have multiple days if day to day is a source of variation.
 
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