I have been working in the quality field for more than 25 years. I recently accepted a position as the Director of Quality Assurance and Regulatory Compliance for a Class 2 medical device manufacturer. The company is a family-owned operation that has been around for about 20 years.

Within the first few days of my arrival, I began to receive friendly warnings regarding the conduct of the production manager. I passed these off as more office gossip than fact.

After my first 6-weeks I am finding myself issuing 3 to 4 major non-conformances a day most of which relate directly to the conduct of the aforementioned production manager. It seems this gentleman has only one thing in mind …. Move product out the door … period…..and anything (or anybody) gets in his way he goes totally hostile. He has a complete lack of regard for quality assurance. I have found him shipping unreleased product…moving serial numbers between products …changing product designs (undocumented of course)…. using home made documents whenever the need arises…. It goes on and on.

Just before you ask how does this guy get to keep his job, he keeps the production numbers at all time highs plus I really think the family is physically afraid of him. He rules his employees by intimidation. In discussions with other managers they all know he’s a problem yet no one seems willing to step up.

I have numerous quality problems but all roads lead to this guy. I have set up quality training. He refuses to come or let his employees come. He just ignores the non-conformances.

Has anyone ever run into a situation like this?

I understand and sympathize with your situation.

In my opinion, you need a PRIVATE sit down with the owners (preferrably off-site.) At that meeting you will outline what you have witnessed and documented. THEN, you will outline what the ramifications to their business will be if bad product which cannot be adequately traced is discovered at one of the next links in the supply chain. Most especially, you will give them a lesson on the horrors of dealing with the FDA. FDA may be lax in some things, but when they seize on an opportunity to rummage through an organization's records (or lack of records), the situation becomes a feeding frenzy for attorneys and outside consultants. Some smaller companies have been put out of business because they don't have the financial strength to recoup after the FDA drains their treasury.

Worst of all is the possibility of criminal charges being brought.

If you don't have confidence you can do this alone, sometimes you can find a respected fellow professional at your local ASQ Section who will sit in the meeting with you and back up what you say.

If you don't have the personal credibility to get the private sit down with the owners, you will have a very stressful period while you look for other employment.

Please read the entire thread about ethics and whistleblowing
http://elsmar.com/Forums/showthread.php?t=9939 (http://elsmar.com/Forums/showthread.php?t=9939)
before you do anything rash.

Antho,
This is rather a difficult situation. If I were you, I would first focus on winning the trust of the business owner (or head of the operations). It is not easy to win against a person who has been operating so long even though this person is terribly wrong, unethical.

Scenario # 1
Since you work for medical device and it is a regulated industry, you may want to review the non-conformances if they are in violation with the provincial/ Federal regulations. Also if they are in violation with any exporting country regulations. In this situation, it does not matter if this person keeps the production number high, by preventing anymore non-conformances and performing risk assessment, taking actions on the shipped products, you may protect against any major product liability suits.

Collect these facts and meet the business owner in person, explain the situation as to how the business violates the regulations and explain the risk to public.

If the business owner is afraid of this manager rather than protecting the public, you may want to seriously consider being a “whistle Blower” and quit job. There is no point in working for this organization and risk your reputation and career.

Scenario# 2
If the non-conformances are non violation to regulations and no risk to public and merely a non-compliance to your Quality management system, Check the customer complaints and collect the facts to prove that the your “External failure cost” is high % of Revenue and hence “high production number” means nothing.

Scenario# 3
If the non-conformances are non violation to regulations, No abnormal Customer returns that would strengthen your argument and still merely a non-compliance to your Quality management system, then assess your specification.

To give some benefit of doubt, there could be a history you may not be aware of. Your design function would have forced a product to production floor with unreasonable specification beyond the capability of manufacturing. May be this Production manager is showing dissatisfaction by not respecting the product design

Scenario# 4
None of the above.
This person has no formal quality training. He thinks just by pumping up the production number without any regards to Quality Management system will keep his job and business growing and has personality issues.
- Continue to do your good work. Try to earn trust from the management and rapport from this production manager so that gradually make him realize the importance QMS.


Final note:
Some production managers with no regards to quality management system are common in any industry. Just the magnitude is different from one to another. It is not necessarily the fault of this Product manager. It is the fault of the Senior Management to let this “culture” survive this long.
It is the Senior Management that let the culture of putting “Quantity” before “Quality”.
Hence, going back to my opening statement: try to win the trust of the senior management.

Bottom line, if you don’t have your senior management supporting you, it is not anything you do as new comer.

(While I typed offline and was about to post…Wes has posted in split seconds echoing similar sentiments! :D

Regards,
Govind.

Wes and Govind have both provided good advice already, but I have a few things to add. Just before you ask how does this guy get to keep his job, he keeps the production numbers at all time highs plus I really think the family is physically afraid of him. He rules his employees by intimidation. In discussions with other managers they all know he’s a problem yet no one seems willing to step up.I can understand that. They have probably tried and been steam rolled. Still, nothing will change unless they do so.I have numerous quality problems but all roads lead to this guy.Yes, I see. He has created quite a little empire for himself, hasn't he? But: As emperor he cannot rule all alone: He must have some loyal followers (not only due to fear), or his position would not be so strong. Who are they? They are key people in a situation like this. You will probably not be able to convert him, but you may be able to reach them.Has anyone ever run into a situation like this? Not of that magnitude, but I think many or most of us have been in similar situations... Not only concerning quality issues. Every once in a while during our careers we will encounter someone making our task very hard or impossible to accomplish.

Summary: Unless you can turn him or somehow get rid of him (Which would probably be the best thing for the company in the long run) I can see but one option: To find a better place.

/Claes

I go back to my "Pain" Theory. People will not change until the pain of staying the same exceeds the pain of change. There are undoubtedly problems that cause pain, but up til now, the manager doesn't "feel the pain". Sometimes we need to tie the pain the person is feeling to the current state. We can lead that person to discover the root of the pain, and then change might be more tolerable.

One suggestion I haven't seen so far is to actually talk to the production manager. Now before doing so, I would go in with sufficient data, such as the actual non-conformance costs, and a set of data as to how much the delays and corrections and rework have cost "his" (or her?) productivity. Also, I would be armed with the potential fines or repercussions the company would face. I would at least go to the production manager first and give that person the benefit of the doubt.

Dr. Deming did say "How would they know different"?

You have some good advice already given above. But... My gut tells me talking to this particular guy will result in hostilities directed your way or termination (yours) as soon as he can do it. You threaten his "empire" and he does not believe in what you are saying -- his actions prove it. #1, especially in your field, CYA ASAP :ca: . Do not let yourself be put in a position of blame if something goes bad. Document everything and, if legal, take copies home or to a safe-deposit box depending ont he seriousness of what is happening. Then talk to the owners and document the results of the conversation. (In some states you can secretly record conversations, in some you can't, not that I'd suggest such a thing...) Only you know how bad things really are, what danger this presents to the public, and what dangers it presents to you. You need to follow your conscience -- and maybe an attorney's advice.

You have some good advice already given above. But... My gut tells me talking to this particular guy will result in hostilities directed your way or termination (yours) as soon as he can do it. You threaten his "empire" and he does not believe in what you are saying -- his actions prove it. #1, especially in your field, CYA ASAP :ca: . Do not let yourself be put in a position of blame if something goes bad. Document everything and, if legal, take copies home or to a safe-deposit box depending ont he seriousness of what is happening. Then talk to the owners and document the results of the conversation. (In some states you can secretly record conversations, in some you can't, not that I'd suggest such a thing...) Only you know how bad things really are, what danger this presents to the public, and what dangers it presents to you. You need to follow your conscience -- and maybe an attorney's advice.If the situation in YOUR opinion is bad enough that you would consider taking document copies off-site before talking to owners, then you should definitely talk to an attorney before talking to owners.

I don't want to scare you or sound alarmist, but I do want you to be able to confide in someone other than us here in the Cove - it is NOT PRIVATE!

Do not tell us details in public Forum. Please do not be a hero until you provide protection for yourself and family.

It should be sufficient for you to know that the majority of us here in the Cove would agree something is wrong if you are reporting the situation accurately. That alone should be your trigger to assess for yourself whether the bosses are aware of and CONDONE the nonconforming activities of the production manager. If they are, going to the bosses before you do some other things to protect yourself is just careless.

I can't stress strongly enough that you need a confidant (preferrably an attorney who specializes in this sort of thing) who can look at the situation through dispassionate eyes and advise you. You are dealing in a highly regulated industry where a false step can bring disaster to an organization and terrible fallout to everyone related to the situation.

You need an exit strategy before you proceed further.

A while back my company hired a salaried production floor manager. He came in saying he would cut our die set-up and coil change-over times in half (which I know is possible to do) and that he would work whatever hours were necessary.
Our die changeovers/coil changes have gone longer. Our orders are currently cut almost in half and it takes more hours to produce less product. We are having more suspect and NC product made as well which makes my life busier.
I went out to the floor last week I had reached my limit and I shut down a line. It was not set up right. I could see the stock was buckled from the feeder to the die. I told the floor manager and he ignored me. I stood my ground and would not let it run. This week he hit a few parts without changing anything and there was terrible varriation (almost a mm between two consecutive parts) he tried to blame the die. He said look it is hitting here and here and here. I said if the stock was coming in straight and centered it would not be hitting any of those places. He changed stuff in the die and things got worse. I blew a gasket. After he tried a little of this and a little of that he became frustrated and said I had to make the call on what to do. I gave a list of three things. He did one and said it is not working still. I told him the to do the other two things he did one and said it is better but still a problem. The owner came out and told him to do the last thing and we will find out if we are back in business this afternoon. Almost a week later!!!
The owner likes the guy because he works all kind of hours with no overtime pay. This is how he tries to make up for his lack of understanding of process set-up and quality principles like standardization and process control.
I think I gained some resect from him or put fear into him either way I do not care my life is going to be sorting hades for the next week or more because I did not put my foot down sooner.
My advice stand up against him now or pay later(like I am). If he is not your boss take a stand that is why you were hired. If you do not understand the processes yet get them under your belt and learn customer requirements and expectation first, then be your customers advocate. You are the conscience of your organization let them hear you if there are real issues. Start with the production manager and take your stand, hire ups may have to get involved but they won't if everything goes by the status quo. Change takes effort. I wish i would have followed my own advice a month or two ago.
Mark

It has been my experience (having been a production supervisor) that this guy may well be following orders (Ship! Ship at any cost!) from a higher authority. Most if not all production people are rated on their delivery not their quality. Quality is paid lip service at the end of the month.
I sincerley believe that this gentlemen is driven by a demand to meet certain goals, and yes his income depends on it! So before wading in, study the situation much more closely than you have, and determine in your own mind the benefits of pursuing the owners to correct a situation that they may have demanded.
In my experience I have seen many red tags torn up in front of my eyes and been approached by management level to back off. The only industry that was not this way was the Aerospace Industry (at least for me) where if any supervisor was setting quality on the back burner i could issue a white Quaranteen tag attached to the department door and that department was shut down until auditors good determine the extent of the products affected and corrective action could be taken.
:2cents:

I'm always sorry to learn of situations where Quality suffers because of ignorance and/or stubborn behavior on the part of individuals.

Applying the principles of Quality to Mark's situation, we might say the "root cause" of the Quality problem was failure of the parties to have an adequate Contract Review, wherein the lines of authority and responsibility would have been spelled out in a less haphazard manner.

Simply stated, it is not enough to merely empower someone to shut down a production line when a Quality problem is suspected, there has to be an efficient and effective process to Correct the situation and Evaluate the correction to determine its effectiveness.

Many old hands (like me) have become so powerful in our organizations, we tend to forget or make light of the power clashes we survived to reach our current status. We would do well to keep those conflict resolution tools sharp to use if and when we move on to a new organization or when our current organization is taken over by another.

Thanks for the timely reminder! I think I'm going to sharpen my own tool kit in case I need it in the near future.

This may be a little off-topic, but this thread brings to mind a favorite story of mine that comes from my father.

He was the sales manager at a foundry. The foundry had recently been built, using a highly automated casting line from West Germany. There was a large order for a casting that had cooling fins on it, and almost all of the castings were coming out of the end of the line (up a shaker conveyor from the basement) with the fins broken.

The engineers could not understand it, the metal was well within specifications and the design was sound. Management could not understand it either. My father had worked his way up from 3rd shift foreman in another foundry to sales, so he actually left the office building and walked over to the foundry. He watched the sand mold be made by the machine, blowing in the sand around the pattern. He watched the cope and drag get assembled, and the metal poured. He watched the casting cool in the sand, and then get knocked out of the sand mold and sent down to the basement for final cooling prior to loading on the shaker conveyor back up to the main floor. He went down to the basement.

At this point, along came a worker with a 20 pound sledge. The worker raised the sledgehammer above his head, and swung and hit the casting. Sand flew off. Cooling fins flew off. My father asked the worker what in the world he was doing. The response:

"Knocking the sand off the casting"

Steve's story is a good reminder of the value of "management by walking around."

Too often, "experienced" managers, under the press of "important things to do," content themselves with looking at statistics and listening to theories instead of getting out from behind the LMD (long mahogany desk) to see for themselves.

20 pound sledge sounds a little like M&M candy inspector who discarded 50% of the product because they were "W's":bonk:

20 pound sledge sounds a little like M&M candy inspector who discarded 50% of the product because they were "W's":bonk:
They must have fired the inspecter I still get about 50% W's. :D

Mark

From your post this manager is running the show. It happens a lot, what usually happens is that someone else comes along that is worse and takes his place. I would go to top management, tell them the story ( they know) and have them let him know that this is what they want and things will need to change. Eventually this company will fall to the wayside and go out of business. I would imagine that the turnover in his department is very high, many are disgruntled, customer returns are high and the writing is on the wall and this will flow to other areas. "Dick Taters" died with Hitler and this guy need to be overthrown. MHO

This is a very grave matter.

If the manager is being allowed to run the show without checks and balances, to live in his own little empire, there appears to be a deeper problem. Apparently the ownership isn't aware of the facts and responsibilities involved with being in a regulated industry. How can you run a company of this kind and not know there are systematic requirements?

Ignorance is not an excuse in this issue. If the operations are shut down, the ownership will also be out of jobs. Their apparently not realizing this is even more worrisome than the manager's actions.

Most troubling of all is the possibility that they are not ignorant at all, but are operating with the same devil-may-care, Enronistic culture, thinking their lives will not be damaged. This could be an adult version of the adolescent infallibility fable (a phsychological condition that encourages dangerously reckless behavior) out of naivete, or they could actually be doing this on purpose: ship it, we'll get our money while we can.

I fear no progress would be made in trying to talk with the manager. He has reached this point over a long period, and I doubt such a person can be evangelized by you right now. If you think it's possible that the leadership actually doesn't know how serious this is, they need to be told of the potential consequences.

The Quality Rep doesn't get to claim ignorance. I agree with Wes, to seek legal counsel at once and form your exit plan...and do not give more details in a public place like this.

Meanwhile, I encourage you to behave in an appropriate manner as a Quality Manager: issue stop shipment orders, nonconformance reports, etc. which would show you are trying to influence the system--even if you know it's futile. Make sure the information reaches the head office. It is important to show you are putting forth the effort your position commonly demands.
:2cents:

I must say I am a little taken aback by all the advice to go get a lawyer. There sounds like there is a lot of opportunity here. You can either run away now, or work on the system, work with the people. What is the worst that is going to happen? The company will fire you. That action would likely get a lot of this stuff out in the open that certain people may not want to have in the open (if it is truly as bad as some assume).

At least for me personally, I could have gotten a lawyer early on and fought outside the system. Instead I made the decision to work within the system and even in the worst times the system was afraid to get rid of me.

I must say I am a little taken aback by all the advice to go get a lawyer. There sounds like there is a lot of opportunity here. You can either run away now, or work on the system, work with the people. What is the worst that is going to happen? The company will fire you. That action would likely get a lot of this stuff out in the open that certain people may not want to have in the open (if it is truly as bad as some assume).

At least for me personally, I could have gotten a lawyer early on and fought outside the system. Instead I made the decision to work within the system and even in the worst times the system was afraid to get rid of me.
Respectfully, I'm not surprised that, if handled right, the system would be afraid to get rid of you--were you a nuke in the example you gave? Here, the situation may be harder to control.

Safety Officers deal with this problem as Quality Managers do. I served in the Navy with a Safety Officer who was a civilian Industrial Hygienist before her commission. She wouldn't give details, but she had joined because her career had been damaged. An esteemed colleague around here also had to deal with this kind of problem. So have I, on a lesser scale. It happens.

I do encourage the QM to work with the system, but meanwhile legal advice still seems like a good idea so he can protect his professional reputation. The person can take the counsel as information upon which to base his decisions--nothing wrong with that.

If I remember right, part of the original advice was given so copies of supporting evidence were not taken in a detrimental manner. The person must behave appropriately because this problem may not be fixable.

were you a nuke in the example you gave?

I should first say every example is just an example. Even mine. May not be appropriate for anyone else. And there is no learning by example, only learning through theory. But story telling can be powerful.

With that said, if you are interested my story can be found at http://in2in.org/resources/2004/prevette_pushing_the_envelope_from_within.pdf

Happy New Year.

I agree with Steve for the most part. But if I am reading between the lines Steve it sounds like your advice would include cover your heiny with documentation or at least that is what I think you mean by "even in the worst times the system was afraid to get rid of me" statement. If you get fired for doing your job then call a lawyer. If you know that the companies action will or is likely to cause harm to someone then call the regulators anonymously and let them force the issue. If you are not sure of the legal issues involved consult an attorney to determine your liability and how best to protect your name as you try to resolve issues.

JMO,
Mark

I agree with Steve for the most part. But if I am reading between the lines Steve it sounds like your advice would include cover your heiny with documentation or at least that is what I think you mean by "even in the worst times the system was afraid to get rid of me" statement. If you get fired for doing your job then call a lawyer. If you know that the companies action will or is likely to cause harm to someone then call the regulators anonymously and let them force the issue. If you are not sure of the legal issues involved consult an attorney to determine your liability and how best to protect your name as you try to resolve issues.

JMO,
Mark
Yes, document the H*** out of what you do, and keep your nose absolutely clean, do not stray from your path. Don't make yourself vulnerable to a cheap shot.

I need to be clear about the points I made and include the reasoning behind those points.

Working for major corporations and most governments pretty much assures the bosses will follow certain protocols before condemning an employee to be fired or (most cases) shunted off to a "do nothing" job out of the mainstream - (in New York City, troublesome cops are sent to walk a beat on Staten Island and are forever locked out of the promotion track.)

Small, closely held companies are much different in the way they deal with employees who get on the wrong side of management. Employees are fired on the spot. Any work references for future employment will be thinly veiled "blacklists."

The original poster saidThe company is a family-owned operation that has been around for about 20 years.

Within the first few days of my arrival, I began to receive friendly warnings regarding the conduct of the production manager. I passed these off as more office gossip than fact.

After my first 6-weeks I am finding myself issuing 3 to 4 major non-conformances a day most of which relate directly to the conduct of the aforementioned production manager. It seems this gentleman has only one thing in mind …. Move product out the door … period…..and anything (or anybody) gets in his way he goes totally hostile. He has a complete lack of regard for quality assurance. I have found him shipping unreleased product…moving serial numbers between products …changing product designs (undocumented of course)…. using home made documents whenever the need arises…. It goes on and on.

Just before you ask how does this guy get to keep his job, he keeps the production numbers at all time highs plus I really think the family is physically afraid of him. He rules his employees by intimidation. In discussions with other managers they all know he’s a problem yet no one seems willing to step up.
If this were a company in the garment trades, the "gentleman" under discussion could easily be a mafioso who did, indeed, have the owners intimidated.

In only six weeks, it is virtually impossible for the poster to know the relationships and alliances which exist behind the scenes. He has no idea what the true relationship is between the "gentleman" and the owners. One thing I can almost guarantee - the poster has a much likelier chance of being on the short end of the stick in any confrontation.

Absent any information to the contrary, the Quality issues are not interpreted as immediately threatening to Life, Health, Safety. This takes away the urgency in curing the nonconformances and covering one's tail from government regulators.

Jobs are hard to come by. There is no reason to make the process of finding a new one even harder by having to overcome a negative reference.

The poster's primary obligation is to himself and his family. The very fact he writes us here is prima facie evidence he doesn't feel able to enter into a confrontation without more backup. The poster has been in Quality for 25 years - that means he has seen a lot of errors and mistakes and recognizes that these nonconformances are not from ignorance, but from willful disregard of in-house and government regulation. Whenever "willful" comes into play, smart folks should look for cover.

The balance of my remarks (lawyers, etc.) were meant to help fortify that "cover" and to avert any foolish or rash action which could end in his job termination before he was ready to leave.

I believe Wes has stated the situation quite well, Certainly anyone with a degree of experience can recognize and seperate willfull acts from some unconscious behavior.
There exist, like it or not, companies who directly order the use of non-conforming parts and ship same. You and I will never change this condition and I believe, that human nature being what it is will never correct itself. In one instance of nonconforming parts the president of the company stated

"Gentlemen we will use these rejected parts. Make it as easy or as hard on yourself as you need to but understand in the end we will use these parts!"

There is no way to argue with the president of the company with out endangering your lively hood. Of course you begin looking for an exit strategy and make your way as soon as possible.

There is no way that the owners are ignorant of this behavior and as I stated earlier probably condone it. In my days of production supervision the adage was
"PRODUCTION, LOTS OF PRODUCTION, COVERS UP MANY SINS".

I relate to this thread.
I have been the unwitting victim of work colleagues who have used my initial idea's to climb the corporate tree, and we know what you may see when you look up the tree.
It seems that wherever you go in the world, you get the self preservation rule applying to many. the many tend to ask you lots of innocent questions relating to trivial business matters such as some that are asked here at the Cove.
The trivial questions get answered and the pareto principle then applies :mg: .
I'm sure I don't need to explain.
Values change for sure and, I have become sickened by what I see in the business world regarding values and beliefs.
Anyhow, I certainly relate to this thread.
Wallace.

I don't mean to get off point here.

The facts are there are a lot of organizations which have an "implicit" policy of "what can we get away with?" - a net which encompasses organizations as big as GM (Unsafe at Any Speed) to mom and pop shops that fudge inspection data.

The point is "How does a person correlate his own personal ethics with the need to make a living?"

Anyone who thinks it is an easy decision or simple to walk away from a job that forces a person to go against his personal code needs to walk in the shoes of the poor guy facing mortgage payments, health payments and food payments for a family of four or more for a little while.

That said, regardless of how painful the decision, I believe it is always better to find a graceful exit than to be embroiled in unethical or even illegal behavior. Finding that "graceful exit" should be a higher priority than exposing the suspect behavior of others.

One of the reasons I usually suggest consulting with an attorney when you find yourself in a touchy situation is that attorneys are trained to be dispassionate and to look out for the client's interest.

A quick perusal of this thread will demonstrate we Covers are not always dispassionate about such situation. We tend to measure the situation against what we "wish" we could do if we were in the same situation versus what we "should" or really would do. Many of us harbor secret (and not so secret) dreams of being able to say, "Take this job and shove it!" The reality is that few of us really do when push comes to shove. The further reality is the majority of us hope and pray we do NOT have to face that decision.

When my dad and some of his friends talked about their WWII experiences over a few beers, the recurring theme was they had done some heroic things (and some not so heroic), but they were always scared of being wounded or killed. They all had Purple Hearts and other medals, but they were united in their view they would rather not have made the decisions which earned those medals and only performed their deeds when the alternate choices had probability of even worse outcomes.

So take a tip from my dad and his buddies: be heroic if you must, but only when the alternates have a worse prognosis for you.