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A Matter of Passivation

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  • #51862

    k
    Participant

    I’m back. I’ve taken some leaps of faith and opened my mouth (via email) on some issues of compliance / legality.Β  We are a contracted OEM for a major medical device supplier. This customer requires component parts / sub-assy’s (stainless steel of 300 series) to be passivated prior to final ass’y & shipment. We are not required to ship sterile, but clean.
    We have a purchase order of final ass’y (rework order) that underwent passivation as sub-ass’y, but had to take apart & rework threads for galling/binding.Β  The Mfg Mgr & Engineer here (I am Quality Mgr) want to just ship them off to meet our customer due date for the reworks and contend that passive layer will be removed once knob/thread are used anyway.
    I have done a great deal of research on passivation in the past week, emailed our passivation vendor if final ass’y of different 300 grades of SS can be passivated. If we dissassemble the parts to re-passivate them, order will be late.
    Our passivation vendor suggested not to passivate entire assembly as chemical bleed could occur & the differing metals.
    Mfg Mgr is now upset because I sent email correspondence to the passivation vendor – for fear it’s in writing and they could share that with the customer who also uses that vendor.
    My contention is I do not feel comfortable side-stepping passivation. It is breaking our contractual terms as far as processing and it is unethical. The Mfg Mgr felt bad initially, but then decided since it was supposedly our last PO w/ the customer that it would be “okay”. Now we have a new order for these parts (we’re under contract) and I don’t want my name on these parts that weren’t processed to their specifications.
    What to do?Β  The Mfg Mgr will make the final decision….

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    #181229

    GB
    Participant

    K,
    You know the answer from both the ethical and “CYA” perspectives.
    Stop the fearfulness and make the right decision.
    “What you do in life, echoes in eternity”
    -From Gladiator, the Movie

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    #181230

    k
    Participant

    Thanks. I know what’s right, but the Mfg Mgr is going to do what he wants, consults w/ Engineer.Β  (Blind leading blind!)Β  Β How do I convince them without alienating them, if that’s possible?

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    #181233

    GB
    Participant

    You know the culture.
    You know the players.
    You know the answer…

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    #181237

    Vallee
    Participant

    Think about the recent peanut contamination scandal… who knew and who will be part of the civil and criminal case? I am assuming you have an ethics hot-line, if you are absolutely correct about your comments… use it. HF Chris Vallee

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    #181238

    k
    Participant

    Thanks Chris. Believe me, the peanut debacle is constantly on my mind…Β  I would love to whistleblow on the situation here, but uncertain where to go…Right now I can’t afford to lose or leave this job… Any ideas; this is a small company. We don’t even have an “HR” department!

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    #181240

    Nolan
    Participant

    Wait a minute K, before you throw yourself in front of the train, assess the potential downside of your product not meeting delivery requirements. It’s one thing to allow a potentially fatal disease to infiltrate a food product (Chris’ example) and to ship a piece of metal without passivation.
    Measure what could go wrong as a result ofΒ your company’s actionsΒ vs. you sitting at home on your couch (until foreclosure is finalized) being proud of your actions.

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    #181242

    Vallee
    Participant

    “It is breaking our contractual terms”. Les, While I don’t want K fired anymore than the last person, would he get fired if the customer found out and then become the scapegoat? Is the manager ready to sign a letter of acknowledgment that he condoned the shipment with full awareness of the issue and resolve the QA manager completely? We all have taken shortcuts whether we want to admit it or not… but is the person making the decision ready to put his/her name on it? After all it gets easier and easier to lie don”t it?

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    #181244

    Nolan
    Participant

    I agree Chris. It’s certainly a Catch 22 and I feel badly for K. AND, only K can measure all the nuances of the situation. I’m just saying slow down a bit before you jump on your white horse.
    Lying is a horrible alternative to anything…not to mention it’s a sin. However, there are tradeoffs in life and if it doesn’t involve one’s life…whatever, too much involved in this topic for me to preach about. Only K can decide.

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    #181245

    GB
    Participant

    Les.
    i said it before and I’ll say it again:
    Your situaltional ethics are really scary.Β Β  Her product is bound for a medical market…

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    #181251

    Nolan
    Participant

    You can’t make that comment with what you now knowΒ hb – you don’t know the potential ramifications of not having the product passivated. Recall I asked K to consider that.
    Solely because it’s used in a medical application does not mean the Failure Mode has any significant impact. Determining that is a crucial piece of the puzzle in this drama…
    So please don’t lecture me on my ethics.

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    #181253

    GB
    Participant

    Te potential liability here is staggering…
    Shocking, shocking, shocking…

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    #181265

    Vallee
    Participant

    Les,Very rarely have I seen a manager sign on the dotted line that it is okay to deviate and release others from responsibility if it is written in the contract to the customer. I use it to see what the manager really cares about. This is not riding in on the “white horse”, it is not getting run out sitting backwards on the back of the donkey.So not to passivate means that the material can react to each other. Even if this were not a safety issue it is a long term issue in corrosion. You will bite it in warranty costs or customer satisfaction later and foot whatever bill that is associated with it. ..of course at the end of the day, someone else can always be hired to say yes. It is usually the little yes’s that become major ones later.

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    #181289

    K,I haven’t read all the other posts, but I suspect you’ve been given some good advice.My advice is to make your company understand who is responsible for Quality. As the Quality Manager is sounds like you – but it isn’t. The manufacturing manager is responsible for Quality – your role is only to represent the customer and to advise.You’ve told the Mfg. Mgr. what the customer wants, so you’ve done your job. Just make sure you put it in writing – on paper and in duplicate.PS: Isn’t this what has happened in Banks recently?Good luck,
    Andy

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    #181304

    k
    Participant

    FMEA?Β  People in my company don’t even know what that means!Β  Yeah, it’s ridiculous how many “yes sirs” there are here. Shortcuts are almost encouraged. R&D is a joke.Β  Yet, I’m stuck in the middle. It’s really pathetic when the lead / only Mechanical Engineer doesn’t fully understand the significance of passivation.
    While it’s true that one cannot see a passivation layer with the naked eye, it can be tested for.Β  Also, we have enough issues with product staining/corrosion by way of hospitals failing to utilize proper cleaning & sterilization practices (i.e. high pH chemicals, improper drying, lack of pre-cleaning, etc.).Β  Besides that, our finished products are most often a compilation of various stainless steel grade components – risky to dump in the same solution for cleaning, sterilization, and passivation.
    Anyway, I have spoken my concerns to the Mfg Mgr. I believe he freaked out and the production staff involved w/ these products in question are dissassembling them (for re-passivation) as we speak.Β  I stressed I will not put my name on anything / submission paperwork w/ any unapproved deviations.
    My patience is so limited these days with this company. Especially when they’re launching new products w/out evidence (at least not documented or presented to me) of proper testing/validation.
    It’s a joke. I’m also an internal auditor by trade and have given up on performing any audits here since our last ISO surveillance.Β  It’s fruitless as I see all the problems on a daily basis. We received a stellar surveillance audit last year, with my diligence (not to put myself on white horse), but there’s only so much I can do when the Pres. refuses my input…
    I know, it’s a pity party.Β  If anyone has any advice on how to set up an ISO consulting LLC, please let me know.Β  This is on my mind 24/7!
    Thanks again for the input.

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    #181305

    Severino
    Participant

    In the future, provided your customer does not specify exactly which passivation spec to use (a lot of customers just say “passivation” on their drawings/specs) get yourself the following:

    Citiric acid passivation fluid (such as Citrisurf)
    Copper Sulfate
    You can then rework your threads, apply the citric acid locally to the reworked area, remove with isopropyl, and use the copper sulfate to test whether your topical application was effective.Β  Additionally, keep in mind that if you rework your threads without using any metallic tooling (say using scotchbrite) then you have not imparted any free iron into the surface and should not have to repassivate.
    Finally, understand that the presence of free iron in the surface of your part is not likely to be a concern for the safety of the patient.Β  It is likely to ensure that your parts do not rust after autoclaving (promotes longevity of hardware).Β  Therefore, because it is not a safety concern you would be well advised not to inact whistleblower on so small a concern.Β  In the end having the parts repassivated is probably the best route and appears to be the avenue you have chosen.

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    #181306

    k
    Participant

    Thank you for the passivation recommendation!Β  We’ve talked about passivating in-house w/ Citrisurf but I think there’s “fear” from Engineering/Mfg.Β  Who knows…
    Anything we can do to comply and eliminate potential corrosion is what I’m trying to accomplish.
    Thanks again!

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    #181311

    Nolan
    Participant

    Thank you Jsev. That is the answer I’ve been trying to get out of all of this – but have taken a severe beating over.
    What is the negative result of not passivating? Doesn’t appear to merit K’s financial ruin!
    So K – look for another job; but don’t lay down in front of the train over this!

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    #181319

    GB
    Participant

    Beating you up Les?Β  Come on…You know full well, that this string and the last string had nothing to do with Passivation, or quality standards…This is just a symptom of a ruinous situation that K has found herself in.Β Β Β  It’s about her mgmt’s lack of ethical behavior to tasks, conditions, standards and Customers and their pressure on her to OK the goods.Β Β  This is wrong.
    Bottom line, she should not sign off on anything as being compliant, when it’s not…K needs to document everything copiously and not give in to the pressure to pass it along with her stamp of approval.Β Β  If sh bends to their will, surely she’ll be thrown under the bus when Johnny law comes a-knockin’.
    Β 

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    #181322

    Nolan
    Participant

    No argument there HB.
    My only point, which apparently I was not skilled enough to properly articulate, was “How serious is the issue?” That question was never answered fully as I can tell.
    Should I be willing to sacrifice my job over a deadly disease in a product – YES! Should I sacrifice it because my boss steals paper clips – NO!

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    #181372

    Severino
    Participant

    At the end of the day, the best approach is to have the parts completely repassivated, but Citrisurf works fine too if your customer is not specific.Β  I’ve seen two posts from you thus far on concerns you have with your management and company.Β Β  I am by no means a BB, MBB, or even a certified GB, but I am a fairly experienced QE whose worked in Aerospace, Automotive and Medical Devices.Β  If you need viable advice or even a place to vent that is less high profile than these forumsΒ you can e-mail me at [email protected].Β 

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    #181374

    Tuguchi
    Member

    With your qualification I think you are much better and more qualified than many of those pretenders (fake belts!).Believe me they are only behind the title to gain some money .SS business is becoming like fast food:passing on-line exams without real preparation and then becoming GBs or BBs.Just consider india and dubai to recognize this fact!
    Good Luck

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    #181380

    Severino
    Participant

    Bah I’m a hack at best, but thanks for the kind words.Β  I just happen to have shared a common experience with the small to midsize manufacturing firm with the egocentric owner whose narrow minded focus dooms their company to sustained mediocrity.Β  As a result, I have a lot of coping mechanisms and some knowledge that can help others in a similar situation (as K appears to be in).
    In any event… cheers!

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    #181384

    Scott
    Member

    Customer Issue: to Passivate or not to Passivate.
    Part of Solution:Β  You need to perform the following experiments with the reworked parts, and reworked and repassivated parts.Β 
    Experiment:Β  Perform an acceleratedΒ reliability tests and see what happens, and be a little late with the delivery.
    Β 

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    #181400

    Scott
    Member

    Addition: I must modify my previous comment to more accurately state what I think you should do.Β 
    Customer Issue: to Passivate or not to Passivate a re-worked part.
    Part of Solution:Β  You need to perform the following experiments with (1) the original parts before reworking, (2) reworked parts, and (3) reworked and repassivated parts.Β 
    Experiment:Β  Perform an acceleratedΒ reliability tests and see what happens.Β  The copper sulfate solution suggested by Jsev607 can be coupled with a salt spray and high humidity high temperature for accelerated corrosion testing. Β 
    What about finding an autoclave and running the three types of parts (original, reworked, reworked and repassivated) for 100 cycles Β– could this me done in two days (this would be like a HAST test with higher temperatures and pressures being better than lower pressures).Β  Β Β 
    What I donΒ’t know: What does the passivation really do?Β  Grow and oxide; if so how thick is the oxide and how porous is the oxide? Β Is the passivation process diffusion controlled; if so, the density of the oxide maybe a function of the oxide thickness?Β  Does the passivation remove free iron which could result in two dissimilar metals in contact thereby initiating corrosion?Β  How effective is the Citrisurf (which I assume is an environmentally friendly substitute for a more nasty acid solution like nitric) at growing a dense oxide and dissolving free iron?Β 
    Analysis: When you subject all three types of parts to the accelerated reliability test, you have a nice B vs. C comparison. Β Since you are short on time, some information is better than none.Β  Β Β Β 
    Question: What would you do if a quick accelerated reliability test showed that reworked parts without repassivation appeared to look as good as the original part?
    Β 

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    #181424

    Severino
    Participant

    Rick –
    Your advise is sound except that the current management structure where K works sounds like they would not allow her to impact delivery to the degree necessary to perform your suggested testing.Β  My understanding (and I won’t claim to be an expert) is as follows:

    Passivation is utilized to remove free iron from the surface of stainless steel parts due to contact with high carbon steel tooling during machining operations (as well as a few other less common sources).Β 
    Free iron does what all iron does, it rusts.Β  Stainless steel can rust as well, but is much less susceptible due to the high chromium content in the structure.Β  When free iron is present however, it acts as a catalyst for rusting of the stainless.
    The act of passivating a second time (after rework) should have little adverse impact to the product because there is either free iron or there isn’t.Β  If there’s none, nothing happens.Β  If there is some itΒ gets removed.Β 
    There is an associated risk though if the geometries are complex and lend themselves to retaining the acid used during the passivation process (prolonged exposure to acid will cause rust… go figure).Β  This is why K’s customer requires the subs to be passivated and not the entire assembly at one time.Β  Because the geometry of the parts is unaltered the risk remains the same for the first passivation cycle as it does for the second (with the added understanding that you have also given your supplier 2x the normal opportunity to screw up).
    The final thing to understand is that most hospitals, ORs, etc. are not gentle with their equipment (especially in orthopaedics).Β  So depending on what segment of the medical device industry K is servicing, I wouldn’t get too hung up on the quality of the passivation since the surgeon is likely to pound the snot out of it and ruin the passive layer anyway.
    Again, there is a lot of merit to what you are suggesting and perhaps long term, K could do such a study that would give her the objective evidence to show that rework using Citrisurf is a viable option that can be utilized in the future (although if her customer employs a metallurgist my experience has shown that they tend to be very steadfast in their opposition to citric acid passivation [both topical and immersion]Β even in the face of mountains of data).

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    #181446

    Scott
    Member

    Jsev07,
    A Bit of Slang: Wow! I like your detailed explanation.Β  Understanding as much science surrounding a problem is a significant part of good engineering.Β 
    What is next: The next part of good engineering for KΒ’s type of problem is to obtain data an estimate the risk.Β  This effort is worth while from several points‑of‑view.Β  Here are just few: (1) KΒ’s company will have an estimate of the risk associated with their decision; (2) If there are customer complaints an 8D report can be assembled quickly Β– a good 8D report can be the difference between keeping and loosing a customer; (3) It builds their data base and understanding of the passivation layer; and (4) it provides an opportunity to learn how to perform rapid reworks in house.Β 
    Thoughts: I wonder how many diagnostic KΒ’s company has available.Β  SEM, optical microscopy, cross sectioning, ultrasound, etc.Β 
    One More Question:Β  What is the risk of a part becoming nonconforming with the 2nd passivation treatment.Β  Since the passivation process appears to be more selective for free iron removal, my guess is the risk is minimal.
    Β 

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