ISO 9001:2015 - Record requirements for out of calibration tool

[Ninja]

Howdy, ... , Totally on board with Sidney (a rare enough thing and nice to see).

it was a torque screwdriver. ... and doesn't impact the quality of the product.

We had a tool that the calibration house reported as out of calibration, so we took it out of service

Why would you send it out for calibration then? Do you send your coffeemaker out for temperature calibration?
On the same line...why did you take it out of service?
If you don't care about the torque, at least it's a screwdriver, right? ...and you don't just need the screws in...

why send it to an outside lab for calibration?

Yup...that...thanks Sidney.

I would mark the thing as "calibration not required"...and then (just as a CYA) would put a statement in the calibration record as to WHY calibration was not required. Soup to nuts...15 minutes.

 

[Big Jim]

We are preparing for our annual surveillance audit, and in reviewing prior CARs(so I can ensure we are prepared to show effectiveness) I came across a CAR I'm not sure why we were written up for. Kind of late as it's said and done, but just for my understanding... We had a tool that the calibration house reported as out of calibration, so we took it out of service but we had no records of who decided what and took what actions so we were written up. Specifically - ISO 7.1.5 requires that "The organization shall determine if the validity of previous measurement results has been adversely affected when measuring equipment is found to be unfit for its intended purpose, and shall take appropriate action as necessary.". To make sure we're in compliance today, I read ISO section 7.1.5 as well as our internal procedures and I don't see where it specifically says records must be maintained. Am I misunderstanding or missing something?

Interesting question. Especially since it was a requirement in ISO 9001:2008 to keep a record of the investigation. I usually recommended writing up the investigation using the corrective action system so you didn't need to create another recording method.

Since it is clear that ISO 9001:2015 doesn't mandate that you keep a record of the investigation, keep in mind that an auditor can still pursue if you are doing it or not by interview. Also keep in mind that if you do determine that that you shipped nonconforming product you will need to write a nonconformance.

So it may still be a good idea to document the investigation.

 

[somashekar]

Thanks guys. I like how pragmatic the people on this forum are, or said another way how you keep the perspective of quality as well as what makes good business sense.

In our specific business, we sell relatively low cost products and if we were to go overboard we wouldn't be making money. In regards to the finding we were written up for, it was a torque screwdriver. It is used for consistency and doesn't impact the quality of the product. To clarify a bit more if screws were falling out of products customers wouldn't be happy, but it's not a situation where if the screw isn't tightened to x inch / lbs the product won't work. I don't see anywhere where it says a record is required, so was this a valid CAR - where is the requirement that we violated?

"Its used for consistency and doesn't impact the quality of the product"
You have taken all the steps to have a calibrated torque screwdriver for consistency purpose which is a very valid quality characteristic, there by giving assurance for your low cost product.
Having done this much, have you mentioned the reference of this torque screwdriver in your final inspection / test records., even if you have only one such torque screwdriver ?
This habit of having the reference of the unique instrument that is used in your setup, appearing in your inspection records., will help in the valid traceability of such products down the line as well as in the field depending upon your identification / traceability procedure in place.
When the torque screwdriver was taken out of service being reported as out of calibration, you could respond with confidence that the previous batches were traced based on your inspection records, and verified to have been good, A record of such verification would not be required based upon your risk based thinking.
I see it all about how your calibration process is made to interact with the identification and traceability process and the records process you have established.

 

[Jim Wynne]

In regards to the finding we were written up for, it was a torque screwdriver. It is used for consistency and doesn't impact the quality of the product.

What does "...used for consistency..." mean? Why bother if it doesn't mean anything? Is there a torque specification? If not, then how do you know if "consistency" has been achieved?

 

[embedded]

This is a really good discussion. I'll follow up with the design team to see if we can move away from these torque screwdrivers for this application, we did this for a number of other applications but not entirely sure why they didn't want to move away for this particular application(note these are tiny screws, picture the screws that hold your phone together, pretty much the same application here).

Here is where I'm really confused though. Doesn't the ISO specification or our procedures explicitly have to say a record is required/retained for this to be a finding? I'm also a new internal auditor and my understanding is a finding is a non-conformance that is situation where a requirement was not met. I don't see the requirement stating a record is retained so I don't understand how this could be a non-conformance / finding. Can you help me to better understand?

 

[Jim Wynne]

This is a really good discussion. I'll follow up with the design team to see if we can move away from these torque screwdrivers for this application, we did this for a number of other applications but not entirely sure why they didn't want to move away for this particular application(note these are tiny screws, picture the screws that hold your phone together, pretty much the same application here).

Here is where I'm really confused though. Doesn't the ISO specification or our procedures explicitly have to say a record is required/retained for this to be a finding? I'm also a new internal auditor and my understanding is a finding is a non-conformance that is situation where a requirement was not met. I don't see the requirement stating a record is retained so I don't understand how this could be a non-conformance / finding. Can you help me to better understand?

In order to address the question directly, please give us the exact text of the whole NC statement.

 

[Sidney Vianna]

I don't see the requirement stating a record is retained so I don't understand how this could be a non-conformance / finding. Can you help me to better understand?

As you insist on this aspect, let me offer the following takes:

1. As already mentioned previously in this discussion, IRRESPECTIVE, of a record being explicitly required or not, audits are based on OBJECTIVE EVIDENCE. So, as an auditor, internal or external, your system has to establish evidence that the out of tolerance condition has been identified, evaluated, analyzed and dispositioned by a competent and authorized individual, as the standard requires.

2. I can EASILY make a case that such scenario falls under 8.7.2 - nonconforming output, which mandates records to be retained. The situation where parts were produced with a tool that is later found to be out of specification is CLEARLY a nonconforming output.

Voilá.

 

[Big Jim]

As you insist on this aspect, let me offer the following takes:

1. As already mentioned previously in this discussion, IRRESPECTIVE, of a record being explicitly required or not, audits are based on OBJECTIVE EVIDENCE. So, as an auditor, internal or external, your system has to establish evidence that the out of tolerance condition has been identified, evaluated, analyzed and dispositioned by a competent and authorized individual, as the standard requires.

2. I can EASILY make a case that such scenario falls under 8.7.2 - nonconforming output, which mandates records to be retained. The situation where parts were produced with a tool that is later found to be out of specification is CLEARLY a nonconforming output.

Voilá.

1. Objective evidence isn't limited to documents and records. It also includes what is learned from interview and observation. If the standard does not require a record be kept and auditor CANNOT insist on seeing one.

2. At this point it is NOT clear the the out of calibration tool resulted in nonconforming product. An engineering study probably needs to be undertaken to determine if the screws are too tight or too loose. A study that might be little more than taking one of the assemblies in question and taking a screwdriver to the screws in question.

Your point that 8.7.2 could be applied in a situation like this is well taken, but it is too soon to make a conclusion from the evidence submitted so far.

 

[Sidney Vianna]

. At this point it is NOT clear the the out of calibration tool resulted in nonconforming product. An engineering study probably needs to be undertaken to determine if the screws are too tight or too loose. A study that might be little more than taking one of the assemblies in question and taking a screwdriver to the screws in question.

Irrespective of the conformity status of the product, the situation is WITHOUT A QUESTION, a nonconforming output. The output being the assembly process. The torque requirements were off spec. So, nonconforming output has to be addressed and record is mandatory.

 

[Big Jim]

Irrespective of the conformity status of the product, the situation is WITHOUT A QUESTION, a nonconforming output. The output being the assembly process. The torque requirements were off spec. So, nonconforming output has to be addressed and record is mandatory.

How did you establish that there was a torque spec? The OP did not say so in any of his posts. Finding a torque tool is use doesn't establish that a torque spec is in play.