I am from a company who makes Product Identification & Printed Electronics.
We just had our AS9100 audit for recertification. One of our findings is we need to come up with a way to control are non-conforming parts. I wanted some input from other companies, as we generate thousands of little parts daily. We also have stainless and aluminum that we recycle, along with polycarbonate material that we dispose of in the trash, that will need cut or somehow destroyed before going into a receptacle. Some ideas the auditor gave us is locked bins or locked rooms. To many of our production associates/supervisors will need access to have parts stored in a locked room. Another suggestion was to destroy the product to make it unusable with a hammer, bend, dents, etc. Either way we see this will be a donating task to implement. I need some input/ideas moving forward, please help!
I am an auditor for ISO9001:2015, not AS9100, but I am curious about the finding. Could you please state the actual finding from the report? (including the AS9100 requirement). What is the evidence of non-conformance?
I would like to know what has changed since the original certification audit with control of non-conforming materials. Your method was once acceptable-you got certified- so why is it nolonger in compliance? What changed? Is it an auditor issue or a QMS issue?
As a process engineer and quality mgr, I don't like process defects getting locked up in storage because they are then out-of-sight/out-of-mind until the storage is full or a belated report flags a $$ problem. Process non-conformances need visibility to drive improvement. That's a topics for another discussion!
Mark
Hi Jodi
To minimize non-conformance’s I would recommend implementing between a three and six sigma depending on the need.
As to the suggestion of a locked container or room I would recommend to designate key personnel and backups to place parts to be recycled in the locked room with an established frequency from a designated area everyone has access to. This way you can be in compliance and not have to provide access to everyone making the locking mute.
Hope this helps.
Adela
Hi Jodi,
Without more specifics of the issue, it is hard to provide guidance. However, there are other ways to ‘control’ non-conforming product that does not include a locked room. I work at an ISO 13485 facility, and we have limited space to store our NC product. In order to clearly differentiate saleable product from non-conforming, we wrap our skids of cases with red cellophane and place a red cone on top of it and stage it separately from production. Is the finding more related to control of scrap/non-conforming product off the line, if so perhaps a coloured bin system would work. Yellow for rework, red for scrap, etc.
I’ve seen a lot of various options for scrap disposition processes that were created over the years. From large steel parts utilizing red spray paint which material handler team members would use, all the way down to electronic components, pins and connector parts, using a red tote system controlled by quality personnel in a locked fenced area (Bond Area/MRB Area), and large signage on recycling containers that were stored in opposite ends of the facility away from normal production areas. Physical deformation/cutting of product was also used at one facility to prevent the unauthorized reworking/repairing (counterfeit) of product as well.
Unfortunately, this task overall in my experience does hit the headcount and as Adela mentioned, reduction of scrap/process improvement hopefully will be high on the minds of your overall team as a long-term solution.
With ISO or AS systems, most requirements fall into a process. I could not tell from your post if the overall Control of Nonconforming Outputs process was solid other than the physical control aspect or was the entire process in question?
Jesse
Good luck
Michael Goff
Director of Quality Assurance
IronMountain Solutions
mike.goff@imsinc.us
@Jodi Gallagher
Like others are saying, without the details it's hard to know where the auditor is coming from, but also like the others, I can't resist giving an opinion!
You describe recycling and trash as the place most non-conforming materials go. If those bins are well marked, color-coded, etc. and your employees are trained, and your policy is clear that the process is to put scrap into designated bins, then I don't see a non-compliance unless that is your program and it's not being followed.
There is a difference between “we don't have an official program for dealing with scrap” and “we aren't following our official program for scrap” and the two have different corrective actions, but a locked room is almost certainly overkill and a simpler, cheaper solution most likely exists.
Bottom line is that your auditor may be an expert at finding gaps, but you and your team are the experts at how to solve those gaps at your organization and the auditor needs to trust that you can find your own solution, not rely on their proposed solution.
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If you just need to contain your defective scrap parts, then it needs to be clearly identified as scrap and if needed segregated from non scrap parts, which implementing the best solution will very much depend on your product type and processes.
If you need to establish a control system for your nonconforming products that will be very different, which I suggest starting with mapping your processes and identifying where and when inspection needs to take place for what specs and define the criteria for each for what is acceptable and what is not.
Hope that will help...
@Jodi Gallagher
Hi Jodi, I return to continue my thoughts and clarify a bit.
Assuming the auditor's finding is valid, please do a Root Cause Analysis to find the solution. Do not jump into solution space without doing the due diligence. Containment of the non-conformancing product may not be the answer-what was the evidence sited as the reason for the Finding? The auditor's suggestion is just that, and as commented by Mr. Farrell: it is your system you decide what is the appropriate solution.
Begin determining why, and where, the system failed, assuming it was functioning when the certification was originally issued.
Need help with RCA? Check with Duke Okes for plenty of advice and an excellent book to help guide the way.
Dear Jodi,
Please help us understand the criteria, I presume that AS9100 rev D (in italics) is the appropriate ref. that is being used by the Aerospace auditor.
8.7 Control of Nonconforming Outputs
8.7.1 The organization shall ensure that outputs that do not conform to their requirements are identified and controlled to prevent their unintended use or delivery…
− taking actions necessary to contain the effect of the nonconformity on other processes, products, or services;…
The organization shall deal with nonconforming outputs in one or more of the following ways:
…
b. segregation, containment, return, or suspension of provision of products and services;
What I think you need help with ideas is
Product dispositioned for scrap shall be conspicuously and permanently marked, or positively controlled, until physically rendered unusable.
I am thinking more along the lines of enabling the rendered unusable such as a heavy duty paper shredder or grinder that drops it into a normal waste bin (small parts and labels???). Either that or tip it in a waste disposal thrasher instead of a locked room for later disposal anyway…
Did he find a couple of setup runoffs @ the station to warrant this?
Hope this helps,
Ernest
@Jodi Gallagher
Jodi,
I am a little late to this discussion, but I do have a few thoughts/comments on this NC.
As some have asked, what is the real NC as written in the audit report. Is it against the AS9100 clause, or is it that your organization was not following an internal documented process? AS9100 does require you to have the process as documented information with certain minimum requirements. So again the question is the NC about not following the AS9100 requirements or is it against your documented process, which could be either not being followed or not in compliance with the AS9100 requirements. Without more information, I tend to think it might be more towards not following your own process, since previous audits have not picked this up as an NC. But again, without knowing the exact reason/written NC it is hard to say.
Since you specifically mention this is about scrap, the requirement is it shall be conspicuously and permanently marked, or positively controlled, until physically rendered unusable. Nothing in this about scrap says locked room. In my current organization, small scrap items are put in bins, color coded and clearly identified as scrap. Larger items, that won't fit in the bins are marked as scrap and put on a shelf, marked for scrap/nonconforming items. When the bins are full they are moved from the production area (along with items marked scrap from the shelves) and moved to a warehouse until disposition. In the warehouse there is a section that is clearly marked off for scrap/nonconforming items. As a government contractor, we further segregate the scrap by contract. Access to the warehouse is limited to material handlers for the company and logistics personnel for the projects. Licensed/approved scrap dealers is sufficient for most items, without us doing anything else to the scrap material. We do have some contracts where we need to physically render the items unusable, often times with a requirement for a government customer to witness. That is almost always for electronic components. For that a large sledge hammer usually works. As a government contractor our process for scrap is also compliant with FAR Clause 52.245-1
All of this is in our documented processes.
One other thing that I think worth mentioning. As a lead auditor and a trainer of auditors, all the way up to and including lead auditor, I am wondering about your auditor's “suggestions" on how to take care of the NC. As auditors, we are all human and develop relationships with our clients. We see a lot of best practices in the companies we audit. But during an audit, an auditor should not cross over into “consulting.” So I am curious if this was done during that part of the audit unsolicited, if the auditor was asked and in a human way just responded, or if it came up as part of a post audit discussion, over some lunch, coffee, etc.
