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

[Sidney Vianna]

You are correct that the OP did not explicitly mention there is a torque spec for the assembly process, but that was the only plausible explanation for the scenario, since it costs money to send a torque tool to an outside cal lab and the OP already mentioned that they are cost conscious and have revised other similar manufacturing instructions to get rid of torque specs.

If there was no torque spec requirement, the corrective action to the original NC would have been to drop the torque adjustable tool from the assembly process.

 

[Johnnymo62]

Consistency and screws not falling out are requirements Embedded mentioned. I would think there should be a torque requirement. Threads can strip from over-torque or cross threading. They may look properly seated but come loose and fall out later.

 

[Big Jim]

You are correct that the OP did not explicitly mention there is a torque spec for the assembly process, but that was the only plausible explanation for the scenario, since it costs money to send a torque tool to an outside cal lab and the OP already mentioned that they are cost conscious and have revised other similar manufacturing instructions to get rid of torque specs.

If there was no torque spec requirement, the corrective action to the original NC would have been to drop the torque adjustable tool from the assembly process.

You have made two bad assumptions. First ". . . that was the only plausible explanation . . . ". Not even the smartest of those on this planet can possibly know all plausible explanations. That's why auditors need to ask questions.

Second there could be a variety of reasons to continue to use a calibratable torque tool. It may be that it is what they had and didn't want to buy another tool. This could be particularly true for an electric powered screwdriver, which would make assembly faster. The fact that it was sent out for calibration by habit is not conclusive evidence that using a calibrated torque screw driver was required.

It is my belief that there was not enough evidence provided to write a nonconformance. True, after digging deeper (asking more questions) it may turn out to be a nonconformance, but jumping to conclusions and writing bad nonconformances is a very bad reflection on the entire ISO 9001 scheme.

As one who helps others with understanding what ISO 9001 really means, you especially need to stay on guard to not do that.

 

[Big Jim]

Consistency and screws not falling out are requirements Embedded mentioned. I would think there should be a torque requirement. Threads can strip from over-torque or cross threading. They may look properly seated but come loose and fall out later.

Indeed, torque specs become meaningless when cross threaded. Also if the screw is too long so it is bottoming out.

 

[Sidney Vianna]

You have made two bad assumptions. First ". . . that was the only plausible explanation . . . ". Not even the smartest of those on this planet can possibly know all plausible explanations. That's why auditors need to ask questions.

You might not be aware, but we are NOT in an audit here. We are in a forum trying to help people who come with questions. You might not be following the situation here. The OP wanted to make sure there is no chance of a repeat NC for lack of records when devices are found to be out of tolerance, upon verification of the as-received condition in a calibration lab. So, his query is about a requirement for a record to exist, to what I have already provided my answer.

 

[Big Jim]

You might not be aware, but we are NOT in an audit here. We are in a forum trying to help people who come with questions. You might not be following the situation here. The OP wanted to make sure there is no chance of a repeat NC for lack of records when devices are found to be out of tolerance, upon verification of the as-received condition in a calibration lab. So, his query is about a requirement for a record to exist, to what I have already provided my answer.

I am aware. I read the whole thread before responding. Not being in an audit is no excuse for inaccurate information though. Would you like to leave it there or should I get into your comment about the corrective action which is misleading?

 

[Sidney Vianna]

Please, by all means, we are here to learn. What inaccurate information am I spreading? I definitely don't want to do that, as my personal goal here at this space is to provide accurate and relevant information. If I am not doing that, I want to be the first one to know.

Thanks.

 

[Big Jim]

Would you agree on the definitions of correction and corrective action as defined in ISO 9000:2015?

correction - action taken to eliminate a nonconformity

corrective action - action taken to eliminate the cause of a nonconformity and to prevent recurrence

If you do then what you suggested would only be the correction and not the corrective action. At this point little has been said about cause even if there is concurrence that a nonconformity exists. Corrective action has to speak to the cause of the nonconformance.

Perhaps what you meant was that removing the requirement to use a calibrated torque screwdriver would be the beginning of a thorough corrective action.

Poorly written nonconformance responses are rampant in the ISO 9001 world, and it would help to not contribute to the confusion, accidntly or not.

If you don't agree with those definitions, please fill us in.

 

[embedded]

Lots to think about, thanks everyone.

I'm a new quality manager, still trying to get my head around everything. Really appreciate all of your help!