Troublesome Production Manager is not interested in Quality

[antho10359]

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?

[Wes Bucey]

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
before you do anything rash.

[Govind]

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!

Regards,
Govind.

[Claes Gefvenberg]

Wes and Govind have both provided good advice already, but I have a few things to add.

Originally Posted by antho10359

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.

Originally Posted by antho10359

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.

Originally Posted by antho10359

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

[db]

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.

[Steve Prevette]

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"?

[Mike S.]

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 . 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.

[Wes Bucey]

Originally Posted by Mike S.

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 . 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.