Any Suggestions Will Be Welcomed

[qualityegghead]

Suffice it to say that I have been in the quality environment since 1980. Yes I am old, and quite proud of it. I have been auditing for almost as long. I say all of that to give a little credence to my experience. Thankfully I do not know it all and I'm still learning much to do with you fine people. Here's my issue. The company I work for is certified to AS9100D & ISO13485 bc we manufacture motors for almost every industry you can imagine from the size of a vitamin to a size you can walk through. We have recently made it through one of the toughest 3rd party audits that I have ever experienced or even heard of. Not because our QMS is in sad shape. But at the same time we aren't perfect.
We have utilized red bins that are all labeled "Nonconforming Material" for well over 15 years. We had several in each cell. All employees were well aware of the red bins and how to use them. Our new registrar's auditor who visited us for our recertification AS9100D audit issued us a Major Finding with Containment requirements for our Nonconforming Material process not being functional. When asked about it she whipped out 9100-2016 - Series Clarifications taking us to page 16 and the 'clarification' for "positively controlled". We explained to her that our motors will not pass electrical testing AT ALL if any of the components were NC. Her response was "the Standard doesn't care". What is expected is disposal of all of our red bins and replacing them with lockable containers. We have 75+ production cells. We purchase (12) of the cheapest lockable containers and with locks cost us around $200.00. This entire company is in chaos trying to strategically place the 12 containers where operators can walk to them. In analyzing the risk that is created now because operators cannot always immediately leave their processes just to discard NC material. We have more of a risk of NC getting into the value stream then we ever did using the red bins that have been audited since 2005. She is costing us a boat load of money and time. DO I have any recourse?

 

[Sidney Vianna]

Going from memory here, so double check. As far as I remember the positive control requirement applied to the parts that HAD ALREADY BEEN DISPOSITIONED as scrap. Components in a nonconforming parts bin have not (typically) been dispositioned yet, in most cases in my experience.

 

[Big Jim]

Suffice it to say that I have been in the quality environment since 1980. Yes I am old, and quite proud of it. I have been auditing for almost as long. I say all of that to give a little credence to my experience. Thankfully I do not know it all and I'm still learning much to do with you fine people. Here's my issue. The company I work for is certified to AS9100D & ISO13485 bc we manufacture motors for almost every industry you can imagine from the size of a vitamin to a size you can walk through. We have recently made it through one of the toughest 3rd party audits that I have ever experienced or even heard of. Not because our QMS is in sad shape. But at the same time we aren't perfect.
We have utilized red bins that are all labeled "Nonconforming Material" for well over 15 years. We had several in each cell. All employees were well aware of the red bins and how to use them. Our new registrar's auditor who visited us for our recertification AS9100D audit issued us a Major Finding with Containment requirements for our Nonconforming Material process not being functional. When asked about it she whipped out 9100-2016 - Series Clarifications taking us to page 16 and the 'clarification' for "positively controlled". We explained to her that our motors will not pass electrical testing AT ALL if any of the components were NC. Her response was "the Standard doesn't care". What is expected is disposal of all of our red bins and replacing them with lockable containers. We have 75+ production cells. We purchase (12) of the cheapest lockable containers and with locks cost us around $200.00. This entire company is in chaos trying to strategically place the 12 containers where operators can walk to them. In analyzing the risk that is created now because operators cannot always immediately leave their processes just to discard NC material. We have more of a risk of NC getting into the value stream then we ever did using the red bins that have been audited since 2005. She is costing us a boat load of money and time. DO I have any recourse?

I'm pretty sure you have a hard nosed auditor that won't be satisfied with anything less than what they have told you and you may need to get the certification body involved.

I do see a slight snag by labeling the bins as "nonconforming material" as that suggests that it has already been dispositioned as scrap.

May I suggest that they be relabeled as "suspect material". The requirement for positive control or conspicuously and permanently marked starts, as Sidney pointed out, AFTER it has been dispositioned. Frequently, that determination is made by someone with the authority to declare a part is nonconforming, not just suspected as nonconforming. Have someone with the competency and authority to declare it as nonconforming and either move them to a locked area or render them unusable by destroying a prominent feature so there is no possible way for it to be used.

 

[ChrisM]

I'm pretty sure that you have a non-conforming auditor......

 

[qualityegghead]

First let me thank you all for the quick response. Our operators know the difference between 'drop' or excess material and NC Material. What they placed in the red bins was in fact NC Material. That's not the issue. The issue is the bins were open (i.e. not lockable). She used the 'Clarifications' document to support her decision to make it a Major with Containment. Just in the few days that all this has taken place, our employees are negatively impacted, production is slowed and locked containers seem to have communicated to some of our employees that there has been a loss of trust in them. As earlier stated, the NC Material process has weathered customer audits and annual audits for ISO13485 and AS9100 since this company was first certified in 2005. I completely understand that each auditor is different. But this is the very first time in all my years in the quality environment that I have experienced an audit being detrimental to a company. So, again it isn't the actual physical material that is an issue, the issue is we were using red bins that were easily identifiable but that the auditor determined could be accessed and the NC Material used in product. Which was explained to her that it wouldn't be in the bin if it would yield a functionally acceptable motor. This has a very good possibility of impacting out recertification since she has rejected more than one containment response. I just need to know what recourse a company has when the expected Containment & CA results in higher risk within the process. I hope I'm making myself clear. Again, thank you for quickly pouncing on this like a pack of wolves.

 

[qualityegghead]

I'm pretty sure you have a hard nosed auditor that won't be satisfied with anything less than what they have told you and you may need to get the certification body involved.

I do see a slight snag by labeling the bins as "nonconforming material" as that suggests that it has already been dispositioned as scrap.

May I suggest that they be relabeled as "suspect material". The requirement for positive control or conspicuously and permanently marked starts, as Sidney pointed out, AFTER it has been dispositioned. Frequently, that determination is made by someone with the authority to declare a part is nonconforming, not just suspected as nonconforming. Have someone with the competency and authority to declare it as nonconforming and either move them to a locked area or render them unusable by destroying a prominent feature so there is no possible way for it to be used.

Thanks for the reply Big Jim. In our industry the production of motors is a little different than most manufacturing environments. When producing motors, the material is either acceptable or not. With motors the magnetic wire windings are encased in epoxy or varnish to prevent movement or abrasion. If the motor fails Hi-Pot testing, resistance testing or any other electrical testing the motor cannot be reworked. There are several 'stations' within each cell. At each station, when value is added to the assembly it immediately gets tested to prevent non-functionality from staying in the value stream. If the assembly of a component fails testing it is immediately replaced and tested again. The component known to prevent compliant function is determined to be NC Material. We train our operators thru a system based on competency. Part of that skill set is being competent inside and out of your process and understanding the physics and functionality of the motor. Some critical processes do not allow the operator to immediately leave their station to place their NC Material in a container that is now 30 to 50 feet (or more) away.

 

[ChrisM]

Who has interpreted "positively controlled" as meaning "under lock and key" rather than just being in a red container that is prominently labelled as "nonconforming material"?

 

[qualityegghead]

Who has interpreted "positively controlled" as meaning "under lock and key" rather than just being in a red container that is prominently labelled as "nonconforming material"?

The auditor had us reference the 9100-2016 Series Clarifications document which can be found on the IAQG website. On page 16 it 'clarifies' section 8.7 as follows:

The auditor's determination is "lockable" boxes for our material. We have a 3rd party company pick up or 'scrap' or material we cannot use and this company has provided us with a certificate of destruction for years.

 

[John Predmore]

Hello @qualityegghead-
Remember, AS9100 has added expanded language to the ISO-9001 baseline, which other quality standards derive from. In the aerospace industry, there have been horror stories of FOD or counterfeit or fraudulent parts causing literal disaster, and I think that is the reason for the tough stance. Section 8.7 has bold text (which means supplemental requirements unique to AS9100) which reads "Product dispositioned for scrap shall be conspicuously and permanently marked, or positively controlled, until physically rendered unusable."

In my factory, we have a locked room to keep scrapped parts with restricted access, where we also secure experimental material, non-conforming parts for which a disposition decision has not yet been made, and even suspect parts which have not yet been deemed NC.

Furthermore, 8.7 also includes the bold text "The organization’s nonconformity control process shall be maintained as documented information including provisions for: − defining the responsibility and authority for the review and disposition of nonconforming outputs and the process for approving persons making these decisions; [text continues]". Our interpretation is we need to document, not only the identity of the person(s) making disposition decisions, but how that person was deemed qualified and approved to make the decision. We also have controls over our waste stream, so if 100 pounds of material is scrapped, we need a receipt for a 100 pounds of material and a definitive statement how it was disposed of.

 

[qualityegghead]

Hello @qualityegghead-
Remember, AS9100 has added expanded language to the ISO-9001 baseline, which other quality standards derive from. In the aerospace industry, there have been horror stories of FOD or counterfeit or fraudulent parts causing literal disaster, and I think that is the reason for the tough stance. Section 8.7 has bold text (which means supplemental requirements unique to AS9100) which reads "Product dispositioned for scrap shall be conspicuously and permanently marked, or positively controlled, until physically rendered unusable."

In my factory, we have a locked room to keep scrapped parts with restricted access, where we also secure experimental material, non-conforming parts for which a disposition decision has not yet been made, and even suspect parts which have not yet been deemed NC.

Furthermore, 8.7 also includes the bold text "The organization’s nonconformity control process shall be maintained as documented information including provisions for: − defining the responsibility and authority for the review and disposition of nonconforming outputs and the process for approving persons making these decisions; [text continues]". Our interpretation is we need to document, not only the identity of the person(s) making disposition decisions, but how that person was deemed qualified and approved to make the decision. We also have controls over our waste stream, so if 100 pounds of material is scrapped, we need a receipt for a 100 pounds of material and a definitive statement how it was disposed of.

Thanks for your response on this topic, John! Much appreciated. Yes, sir, our authorized list of people approved to disposition is restricted in the drop-down list of names within specific fields of the electronic document(s). Having an aerospace background myself and proud 'papa' of all 100 B1-B bombers, I do understand the historical reasons for much of the revisions through the years. As an old auditor myself I would think there would be a sprinkling of common sense when looking at processes through the different and amazing levels of complexity, with an understanding that not everyone needs a speeding ticket for exceeding the posted limit by 1 mile an hour. I was raised believing auditing should improve processes. Not hinder them.