MSA - Is Measurement Systems Analysis required in R&D? TS 16949 Clause 7.6.1

K

kaczmar

#1
Hi,

I'm wondering how to interpretate the ISO TS clause 7.6.1:

Statistical studies shall be conducted to analyse 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.

In case, when we have R&D center (non production unit) is it necessary to do MSA?
 
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bobdoering

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#3
Hi,

I'm wondering how to interpretate the ISO TS clause 7.6.1:

Statistical studies shall be conducted to analyse 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.

In case, when we have R&D center (non production unit) is it necessary to do MSA?
Required? Probably not. Worthwhile? One would think so. After all, don't you make decisions based on your measurement equipment? How do you answer if your gages are the right ones for the work you are doing? I hope you do not use the traditional urban legend approach that was popular on the shop floor...
 

v9991

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#4
i agree with bobdoering,
any equipment which forms part of the process described in product life cycle would come under the scope of the requirement.

we tried to suggest two different criterias [viz., interms of frequency of verifications & validation activities...] for equipments belonging to R&D and manufacturing. BUT could not find enough justification to totally exclude R&D equipment from the requirements.

thanks
valiveti.
 
P

prototyper

#5
Whilst I agree it is good practice to perform MSA on all equipment types used in the organisation, the requirement in the standard is "This requirement shall apply to measurement systems referenced in the control plan".
 

v9991

Trusted Information Resource
#6
Whilst I agree it is good practice to perform MSA on all equipment types used in the organisation, the requirement in the standard is "This requirement shall apply to measurement systems referenced in the control plan".

how would you justify, if you are suggesting that the R&D equipments 'need-not/may-not' be included in the control plan;[or in other words, in what scenarios you will be able to justify.

thanks
valiveti
 
P

prototyper

#7
R&D is not necessarily linked directly to production and the product realisation process.

Research can include activities which take place long before the prototype stage. Prototyping is the first part of the product realisation process which would require a control plan.
 

v9991

Trusted Information Resource
#8
thanks prototyper; that is clear; but

i work in regulated industry where GMPs are relevant standards [Pharma & devices...]; i am not aware of any such narrow-interpretation [if you allow me to say so!] by regulatory agencies while verifying the compliance/systems.

Even for basic research which is governed by GLPs, i think there are definite requirements in place for controls/evaluation of compliance of equipments.

just thought of adding the background of my posts.

thanks.
valiveti.
 
P

prototyper

#9
Bear in mind, TS16949 is automotive and some research activity may not be as critical as in pharmaceuticals.
 
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