TMV - Selection of TM's for Validation

#1
Hi all,

I am new to Test method Validation in Medical Device industry>

1. Does anyone know how to select test methods for TMV.
2. I have been reading about Variability and Attributes methods. Is there a checklist or set of questions which would make it easier to find test methods which would require Validation?? I know that not all test methods needs to be validated.
3. Say for example, a test method have steps involved to measure the final voltage output. What if its measured using a custom tool which is calibrated. Do we still have to validate considering there wont be any variability when we use a calibrated gage ??
4. In that case, does it mean a test method need not be validated if the testing equipment are calibrated?? I know these could be dumb questions but wanted to understand the TMV process.

Thanks in advance,
Bala
 
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levatorsuperioris

Involved In Discussions
#2
1,2 its no different from TMV in any industry, all test methods require Ver or Validation. Only exceptions are test methods written in standards.
3 - yes you need to validation
4 see 3.

Only difference is the level is based on risk per 14971.

Seeing your thought processes - you may want to take a step back and or get some help, you are making a lot of assumptions that typically end with very expensive results.
 

levatorsuperioris

Involved In Discussions
#3
TMV and MSA is a fairly extensive topic - but please keep in mind alot of what you are typing would flash danger signs in seasoned QMS people.

TMV is 1) measurement tool x part x user performign the measurement. Calibration would at *best cover 1. Gage R&R alone does nto cover MSA, you need also gage qualification as well. The same rules 10x Resolution, etc all apply.
 

levatorsuperioris

Involved In Discussions
#4
Think of MSA as documentation that 1) You have an correct tool to do the measurement (including calibration, resolution, installation), 2) The tool works for measuring the part (Accuracy), 3) Operators can consistently measure the part (Precision). All these activities are done proportional with the risk of what is being measured.
 

Tidge

Quite Involved in Discussions
#5
I'll speak to two elements of the original post:

2. I have been reading about Variability and Attributes methods. Is there a checklist or set of questions which would make it easier to find test methods which would require Validation?? I know that not all test methods needs to be validated.
As a rookie, I do not recommend focusing on a choice between "variability" or "attribute" at this point in the learning process. The choice between the two is more appropriate for study designs... the choice of which will be used to establish the effectiveness/suitability/success of a test method. It is best to identify what it is you actually care about, and then you will know what kind of study will be appropriate for establishing if a proposed method is valid (or not).

This is just my experience: If a person is first researching the topic of Variable v. Attribute studies because one of the two choices is requiring "too many" samples, it is almost certain that such a person hasn't thought through their actual needs. Full disclosure: this is based on analysis of historical data and no actual study was performed! The forum crew can give better examples, but a simple explanation of the difference is this: an attribute measurement will show the result in one of several specified 'buckets', a variable measurement will show the result on a continuous spectrum. The choice of attribute v. Variable measurements has consequences for the 'state of knowledge' of any given measurement. But I digress.

3. Say for example, a test method have steps involved to measure the final voltage output. What if its measured using a custom tool which is calibrated. Do we still have to validate considering there wont be any variability when we use a calibrated gage ??
I think there are a few issues in this question which can confuse things. The first element of confusion is the nature of the 'custom tool'. If the custom tool relies on an accepted methodology, then "validation" of the method is not necessary (1). Many test methods have already been validated.

No matter what the tool is used in a method, the tool must be initially qualified and routinely verified to be appropriate to be used in the method. This is the purpose of a robust calibration program. Most 'off-the-shelf' measurement tools will be purchased with expected ranges, precisions and accuracies and can be subjected to (established, see above) calibration methodologies. Many 'custom tools' will require such things to be established before they can be subject to a robust calibration program. I think the original post isn't clear enough is this is the nature of the 'custom tool.'

I think the original post also confuses the concept of 'variability'. Variability in measurements is not eliminated by using calibrated equipment.

(1) Mileage varies when it comes to the question of 'what is an accepted methodology', so I will offer a couple of general examples before circling back to the question of voltage measurements. Some examples of things that I would consider accepted methodologies for specific types of measurements:
  1. Using a evenly marked linear scale to measure linear distances; this is an example of the method being evident from first principles. It doesn't mean that there isn't a published ASTM standard for this, but everyone should accept that it is appropriate to use a ruled straight edge to measure straight lengths.
  2. Using a published test method (preferably one subject to a committee of experts) specific to the measurement in question. Standard organizations (e.g. ASTM, UL) will have methods that have already been established as valid (for the scope of the method).
Specific to the subject of 'voltage measurement', if the 'custom tool' relies on something that is (essentially) first principles you are not obligated to validate the method that using something akin to a voltage divider (or a circuit with a reference diode and/or a n 8-bit A/D converter or, or, or) is appropriate for measuring voltage. You are however obligated to demonstrate the accuracy, precision, stability, etc. of the tool.

Some more general experience of mine: If the explanation of the method doesn't pass a 'red-faced test', the proponent of the method will get into trouble. If a tool (or other materials or environments) used in a test method are not suitably qualified (including calibrations for the tools) the proponent will get into trouble.[/QUOTE]
 

chris1price

Trusted Information Resource
#6
Ensuring the equipment is calibrated is just the first step in method validation. Calibration is usually performed under closely controlled conditions. TMV is looking at the repeatability and reproducibility in the real world, where operators, production lines, etc are employed.

Differentiating between attribute and variable is straightforward; attribute is pass-fail, yes-no, go-nogo; variables delivers a number.

My advise would be to walk through your specifications, processes and procedures looking for any test that could effect the release of product, you should focus on first. Then move to incoming materials which require acceptance activities.

A final piece of advise, get a copy of the AAIG MSA guidance, this is the best source of guidance I have seen.
 
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