TS16949 - No "For Reference Only" Gages allowed?

[The Specialist]

Agreed! 'For reference' on anything which is in an unknown state is an oxymoron, isn't it? The issue is not whether an auditor likes it, the issue is, it's not an effective system!

Why, oh, why do people insist on confusing people and expecting them to want to adopt the QMS? If you give a tool or a document to someone, then you want them to reference it! If you don't know if that tool or document is correct for the job, then you don't want to have anyone reference it, do you? Seriously? We need to put some of these myths and legends to bed. All 'for reference' does is fools some auditors - and two we know of aren't fooled!

There are differing views on this.

In the industry I work in it is commonplace to categorise monitoring/measurement devices, instruments and gauges and label them accordingly, incl:

'For Information Only'
'By Request'
'Operationonal'
'SHE'
'GMP'

The purpose is to tie in with calibration procedures as to the minimum requirement for calibration frequency (e.g.) of devices in each category.


The purpose of marking-up non-critical/refference only devices is to demonstrate that they have been 'considered' as part of the RA/IA and categorisation process and are appropriately controled/maintained.

Without identifying the device, it is not immediately clear that a category as been assigned and that it has not just been 'missed' or ignored.

 

[Big Jim]

Agreed! 'For reference' on anything which is in an unknown state is an oxymoron, isn't it? The issue is not whether an auditor likes it, the issue is, it's not an effective system!

Why, oh, why do people insist on confusing people and expecting them to want to adopt the QMS? If you give a tool or a document to someone, then you want them to reference it! If you don't know if that tool or document is correct for the job, then you don't want to have anyone reference it, do you? Seriously? We need to put some of these myths and legends to bed. All 'for reference' does is fools some auditors - and two we know of aren't fooled!

Andy,

I cannot fully agree with you.

The auditor IS wrong. He is making up his own rule. He isn't paying attention to the requirement in the standard "Where necessary to ensure valid results". It looks like you have lost sight of it too!

That said, my personal feeling (which cannot be audited to) is that why would you risk measuring something with an unknown status, add more value to it with continued processing, and then allow the possibility of failing it later necessitating either scrap or rework?

My OPINION is that identifying a measuring device as "reference only" is usually a stupid thing to do. However, the standard doesn't prohibit people from doing stupid things.

 

[The Specialist]

Andy,

My OPINION is that identifying a measuring device as "reference only" is usually a stupid thing to do. However, the standard doesn't prohibit people from doing stupid things.

I think that this is an irresponsible statement and serves only to undermine/criticise others’ methods.

There may well be reasons why an organization may wish to identify equipment in this way.

The important thing (as an organisation) is to have a clear policy/method around categorisation of instruments and devices, RA/IA and to control/verify/calibrate etc. in accordance with this policy/procedure.

There is nothing inherently ‘stupid’ about that!

 

[AndyN]

In the industry I work in it is commonplace to categorise monitoring/measurement devices, instruments and gauges and label them accordingly, incl:

'For Information Only'
'By Request'
'Operationonal'
'SHE'
'GMP'

Could you give us some idea of the practical differences between these types of markings? What differentiates them apart from the labels?

 

[The Specialist]

Could you give us some idea of the practical differences between these types of markings? What differentiates them apart from the labels?

'For information only':
(e.g. a pressure gauge on a process water ring main, prior to water treatment) - where there is no impact on product or health and safety, but the engineering maintenance team find it useful as a 'rough' gauge as to the system health.

This instrument will never be calibrated and (may be) replaced if damaged or faulty/not working.

‘By Request’:
Similar to ‘for information only’ but may on occasion be calibrated by request of (e.g.) maintenance engineer, as the device may be more directly linked with fault reporting (as determined by FMEA study)

‘Operational’: This will be calibrated, but the frequency will be no more frequent than 12-monthly and may be 24-monthly (as required through risk assessment) – This device will be part of (e.g.) a process equipment item and is giving a value or measurement which is not critical to the quality of the process output, but is of use to operators using the equipment.

‘SHE’: This will be calibrated in accordance with Risk assessment/ Impact assessment. The frequency and tolerance for accuracy determined through assessment. – This device monitors or controls Health and Safety aspects of the equipment/system/process and as such may be critical in maintaining a safe working environment.

‘GMP’: This will be calibrated in accordance with Risk assessment/ Impact assessment. The frequency and tolerance for accuracy determined through assessment. – This device monitors, controls, records process ‘critical’ functions or parameters. There is a direct correlation to the parameter or function (etc) that this device controls/measures/monitors and the quality of the final product and/or required product specifications/ batch documentation.

 

[Big Jim]

I think that this is an irresponsible statement and serves only to undermine/criticise others’ methods.

There may well be reasons why an organization may wish to identify equipment in this way.

The important thing (as an organisation) is to have a clear policy/method around categorisation of instruments and devices, RA/IA and to control/verify/calibrate etc. in accordance with this policy/procedure.

There is nothing inherently ‘stupid’ about that!

Just like there is nothing keeping companies from having stupid rules, there is nothing keeping me from having stupid opinions. It is an opinion. I must stress that as an opinion, I will not audit to it.

I still think it is incredibly stupid to continue adding value to a part long after it should have been scrapped, which is what can happen from using "reference only" devices. Call it a stupid opinion if you want, but in my opinion, it is valid and not the least bit irresponsible.

 

[vanputten]

In our design process we have tools that are for reference only. In the beginning steps of the design process, we have tools that are not calibrated and are used as a reference to know if a initial design parameters are close to a value. When we do formal correlation of the design to the design inputs, we use calibrated equipment. We use some For Reference Only equipment in the beginning of the process and we use calibrated equipment for key design steps towards the end of the process, when we formally measure parameters of product requirements. Any issue with using non-calibrated For Reference Only equipment in the initial steps will be detected by the checks and balances performed with calibrated equipment. Sometimes we use non-calibrated and calibrated equipment simultaneously where the calibrated equipment monitors and checks the output of the non-calibrated equipment.

I believe it is possible to have For Reference Only equipment. It depends on how it is used and what you variation you are trying to understand.

 

[AndyN]

Andy,

I cannot fully agree with you.

The auditor IS wrong. He is making up his own rule. He isn't paying attention to the requirement in the standard "Where necessary to ensure valid results". It looks like you have lost sight of it too!

Not really, Jim. Doesn't an auditor also use their experience of what an effective system, properly implemented actually 'looks like'. From your posts, you do, in this case, because you've explained why (although I wouldn't have used the word stupid, uneducated, maybe)

I'm approaching it from a management point of view. Firstly, I don't want anyone doing non value added activities on my 'line'. Just like 'Lean' thinking. So, with that thought, if I have an operator who is running a gap gauge around, let's say a panel fit line with an unqualified gauge, marked for reference only' and they aren't making any value added decisions about the fit, they have no place on the line or the person who wrote the instruction to do that needs help...

If they are kicking out product for out of spec panel fit and the gauge turns out to be 'for reference only' and worn etc, then I'll be all over the waste of time/effort etc which goes with this silliness...

 

[bobdoering]

If it a gage that is on the control plan, then there is no place for "For Reference Only" in a TS16949 quality system, because it is not for reference only.

If it is not on the control plan, then you have two issues: is it in a location where somebody might use it for a control plan measurement? If so, not good.

Second, if it is not being used for Control Plan activities OR laboratory activities (DV, PV, etc.), then does it fall under anything auditable by TS16949? E.g., a tape measure for plant layout - does it need calibrated? Probably not - nobody believes a plant layout anyway.... In that case for reference only maybe applicable so that it does not end up in use for quality measurements. If you have a granite plate no longer used for measurements - but used as a table for a balance to minimize vibration or for assembly, it may be for reference only or some other designation, to ensure there is evidence it should NOT be used fro measurement.

That is NOT as minimalist of a notion that some people have concerning usage of steel rules and such for process or product evaluation. This designation is for those things outside that scope.

 

[Big Jim]

Not really, Jim. Doesn't an auditor also use their experience of what an effective system, properly implemented actually 'looks like'. From your posts, you do, in this case, because you've explained why (although I wouldn't have used the word stupid, uneducated, maybe)

I'm approaching it from a management point of view. Firstly, I don't want anyone doing non value added activities on my 'line'. Just like 'Lean' thinking. So, with that thought, if I have an operator who is running a gap gauge around, let's say a panel fit line with an unqualified gauge, marked for reference only' and they aren't making any value added decisions about the fit, they have no place on the line or the person who wrote the instruction to do that needs help...

If they are kicking out product for out of spec panel fit and the gauge turns out to be 'for reference only' and worn etc, then I'll be all over the waste of time/effort etc which goes with this silliness...

Nice Red Herring.

What has it got to do with "where necessary to ensure valid results" and its application to the auditor making up his own rule that reference only devices can never be used?