Filling totes and pails - when is a calibrated scale / flowmeter required in ISO 9001

[Dan M]

Hello all. We are a chemical products manufacturer who operates some warehouses (distribution centers). Our warehouses will routinely repack our products into smaller containers, such as 330-gallon IBC containers, drums, or pails. Some of the warehouses do not have the proper measuring equipment and rely on visually filling to a known volume. For example, if selling 200 gallons, they will fill the 330-gallon IBC to the 200 gallon graduation mark stamped on the plastic bladder.

There is another scenario where they may fill 5 gallon pails, visually approximating the volume by filling to the top of the container. In this instance, the product is sold as one (1) ea, not billed by the gallon.

The clause of ISO 9001 I am getting hung up on:

7.1.5.2 Measurement Traceability

When measurement traceability is a requirement, or is considered by the organization to be an essential part of providing confidence in the validity of measurement results, measuring equipment shall be:
a) calibrated or verified, or both, at specified intervals

So my questions are:
(1) Is there any precedent to use the visual markings on 330-gallon IBC to measure the volume filled and bill the customer based on this volume?
(2) If is acceptable under ISO 9001 to fill containers such as 5-gallons pails or 55-gallons drums to full (visually) if the containers are sold as one unit (one each) and we are not billing by pounds/gallons.

My rhetorical question:
So who decides when measurement traceability is a requirement if our customer has not defined it as a requirement? What if our organization does not consider measurement traceability to be an essential part of providing confidence in the validity of measurement results when it comes to the examples I stated above?

 

[Jen Kirley]

I once had a tape measure that measured about 1/8 inch short in every foot. Really! I wish I kept it... Measuring devices sold for cooking are known to vary somewhat in their accuracy. I would therefore not just trust markings on bladders or pails, and would wonder too if there is a fold in the bottom of that bladder that would affect its fill accuracy unless that was addressed during its insertion or before filling.

If you are selling a particular quantity, ISO is asking you to plan for a way to ensure you have controls in place to ensure your containers are holding what you claim they are.

My clients have almost all done this by weight, because scales are easy to calibrate and can be installed in conveyors. Fill height to container can also be done if you have made sure the containers and their fill levels are, in fact accurate. I suggest you can do that yourself but you will need to document your methods and keep a record of having performed them in order to show you have youor controls in place.

I hope this helps.

 

[John Predmore]

In a plant quality context, the word calibration includes checking or adjusting a measurement device to a national standard. ISO 9001 7.1.5.2 allows for verification or calibration, or both. The answer to your question is your organization decides how and how often to assure fitness of purpose for the measuring device.

In my factory, I do a sort of mental FMEA risk assessment to decide between outside calibration service and internal verification...
Of all potential product uses for a device, pick the one demanding the highest degree of accuracy and continue.
Severity: What would be the impact if the reading were high or low by 0.5%? 1%? 5%? How much is unacceptable?
Detection: How could it happen the device if off by that much? Would it happen gradually or suddenly? How soon before someone notices?
Occurrence: How frequently would you imagine it might happen that the device is off by that much? (This guides you to set verification interval.)
The answers to these questions help me make a risk-based decision.

 

[dwperron]

My rhetorical question:
So who decides when measurement traceability is a requirement if our customer has not defined it as a requirement? What if our organization does not consider measurement traceability to be an essential part of providing confidence in the validity of measurement results when it comes to the examples I stated above?

You are moving into the specialized territory of Legal Metrology. Those measurement requirements are determined by your local Weights and Measures officials, which can operate at the local, county, or state level. I would recommend that you talk with your local Weights and Measures people and find out what they require.

At the federal level, the guiding document for "Legal for Trade" metrology is from NIST:

NIST Handbook 44 - Current Edition

 

[Dan M]

Thanks to all for your replies.