ISO 9001 Clause 7.6 Tamper Seals - Alternatives to Tamper-Proof Seals

I posted this once before but could not find the previous thread, my apologies.

7.6 d) of ISO 9001 states that equipment be safe guarded against adjustment that would invalidate the measurement. Are there other alternatives to tamper-proof seals?

Re: 7.6 Tamper Seals

GregRus said:

I posted this once before but could not find the previous thread, my apologies.

7.6 d) of ISO 9001 states that equipment be safe guarded against adjustment that would invalidate the measurement. Are there other alternatives to tamper-proof seals?

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What type(s) of equipment are we talking about here, Greg?

Re: 7.6 Tamper Seals

A few things come to mind...

* labels on balances indicating they shouldn't be moved
* instructions with calibrated weights to ensure they are properly handled
* storage of certain equipment out of direct sunlight / in environmentally controlled areas
* instructions on how to store equipment properly after use

Re: 7.6 Tamper Seals

Andy,

Any equipment directly used in the manufacture of a suppliers product. This is really a general question.

Thx,
Greg

Yodon really hit what I was thinking of.

The tamper seals are most applicable on what I would term as "older" equipment, where there were manual adjustment screws, pots, etc.

Those should still be safeguarded.

Yodon's suggestions extend the notion of providing protection for other type instruments. Take an analytical balance that the calibration mode can be accessed from the interface. Is it password protected? Can that portion be locked out or something?

Re: 7.6 Tamper Seals

GregRus said:

Andy,

Any equipment directly used in the manufacture of a suppliers product. This is really a general question.

Thx,
Greg

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I'm not sure I'd extend the idea to those things that have been listed previously - it's pretty clear to me what the requirement is stating and I don't think there's any need to get creative with interpretations! Some equipment has "adjustability" available to an operator. Some hard dimensional gauges (I think our other friends were thinking electronic instrumentation) and even micrometers can be adjusted. Sure some older electrical equipment had a hole where you could stick a small screwdriver and adjust a pot (we still have to consider that 3rd world countries aren't as advanced, but the standard still applies). So the idea extends to using setting varnishes, waxes, paints hole fillers (White out) and all manner of gunk which can at least give some indication if it's been tampered with. It really depends on the actual adjuster/mechanism. I've seen alum 'bungs' used to fill holes, all kinds of stuff.

If it's home-made test equipment, then the design might be such that adjustments are not accessible from 'outside'. I've also seen equipment placed in a locked box, with the 'business end' poking through an access hole. Sometimes you have to get creative!

Is there a tamper proof paint available? On the current instrument I am calibrating, there is a red paint on the pot. I am concerned that someone is tampering with the pots and making adjustements.

Someone suggested nail polish...

SGCalLab said:

Is there a tamper proof paint available? On the current instrument I am calibrating, there is a red paint on the pot. I am concerned that someone is tampering with the pots and making adjustements.

Someone suggested nail polish...

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Nail polish works ...

Note that it’s not that you’re going to make it impossible to remove, just that it’s not by accident & that you can tell it was removed.

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This is so nicely said by JaxQC

Whereever you have knobs for setting, the common tendency of operators is to go fiddle with it. When you make some simple stoppers that prevents free adjustment and still provides the leverage for adjustment within the validated range, and educate the user to escalate matters to higher levels when normal operation shows some malfunction, you are good in safe guarding against adjustment that would invalidate the measurement.

I?ve always been happy with the wax or glue gun but some paints are available. Google search only, I?ve never used them myself.

3M Scotch-Seal Tamper Proof Sealant 1252
Dykem Tamper Proof Torque Marker "Cross Check 83314"

Another option is tamper evident stickers which may be cleaner.