Food Processing Plants vs. Pharmaceutical Plants

But when you look at a Food Plant where do you find the regulations?

Depending on the type of food plant. Bakery, Dairy, Cheese, Meat.....Equipment, Location...some regulations are USDA, 3A, FDA, WDA, CDFA....

Your allowed to be out of spec but how much tolerance do you get?

Out of spec of what? you give no reference, answer can vary.

Lets say the pressure of your system is centerlined at 10 psig. What percentage are you allowed to be above or below that reading?

Can vary, do you have a quality manual?

Are those tolerances listed in a set of regulations? Especially if you are trying to be a ISO-9001 company.

Depends on what it going to be used for. Usually equipment/process would spec. this out.

p911

Great start Phoenix911.

if you are an iso 9001 compliant company, your quality system will have documented work instructions for critical operations that affect process or product quality. Those work instructions will either themselves have within, or cite a process reference with the values to be maintained.

In the absence of documented work instructions and evidence of training of personnel to those instructions, and in the absence of availability of those instructions, it is not ISO 9001 compliant quality system.

Its just BS. If I worked at a food plant, I'd expect my management to provide me with the operating parameters, and to be the authorities on the applicable regulations. They have the responsibilities and authorities.

Every ISO 9001 compliant company I have visited has a Quality Department that has trained specialists familiar with the applicable regulations, specifications. And process control methodology.

milo

Thanks milo,

I like to add, if its not in you quality manual, you can always append it and write it in.

When I did one for ASME, I was to put down when our calibration instrument should be calibrated with our master. It could be every ever year, 2 years, 5 years or 100 years, just so long as it written down. of course I put it within reason. Traceability was the main topic.

When I set up a company to be ASME certified, I thought to certify them to be ISO also. The company did 20 million a year but it was a still a small family business. There was a lot of reduncy there, And I wanted to eliminate the fat, but the fat turned out to be the nephews of the owners of the company, and they needed the jobs. So I did not push it. I chose my battles I could win.

p911

Hi p911,

You describe perfectly the way are most of the businesses. More authority for some and less responsibility for most or a few. You describe the way we create certified or certificated companies by accommodating some and don't train or obligate another.

When we are in trouble, we tell everyone that the cause of that is the "neighbour".

This is the raison I worked in 23 different organizations during my five decades, Gil.

I do not quite understand your position, reading it could go both ways.

You have to understand the full dynamics of what is going on.

But when I mentioned traceability and responsibility, this actually points to not so much an individual person but the position. such as QA, or Engineering manager. But the traceability is complete. You know who was weak link, but if it was an ex-employee, there is no law against incompetents, you keep it with who has the biggest insurance policy, and that is the company.

This is done because it listed in the manual, and if/when the QA or engineer leave and a new one takes its place, you do not have to revise the manual. And the responsibility goes up, if the Engineer said, I wasn't in charge at the time, it was his boss, if the QA wasn't in charge of the position, it was his boss, until it reaches the president. Yes the buck gets passed, but it stops at the top.

Now this company, I found out after I left, and I suspected it while I was there, that it falsified records and certifications to show it was ASME certified, but wasn't. And since I was getting it certified, the position of the insurance company didn't want to hear it as long as we were getting certified. Hell, talking about stirring the pot of a bee's nest. I pushed on to make things right.

What I did is since it was a family run organization, I listed one person name, and that was the president of the company, he was also the owner. And it would be his responsibility to revise the manual to remove his name when he leaves/retires. otherwise it would follow him. I explained it to him, that since it was his company, other positions would change with in the year with people coming and going. His would remain the same. I did this over 12 years ago and he's still there.

He did mentioned to put the names of his nephews in these positions, because they would be there. My response was, no they were incompetent. I it would be my responsibility to do such a derelict thing.

A good example is when the oversight commitee qeustioned the president of Toyota, Mr. Toyata. As Truman had on his desk, the buck stops here.

p911

Hi p911,

What you put in your comment is exact or good. What I try to communicate that it's never or practically never happens the same way.

Just an example to illustrate the picture. One of the most reputed US paint manufacturer send every month a list of defective paint to seller of their products. This list can be 20 to 45 different products. One paint doesn't cover the way supposed, another wasn't filtered or dispersewd correctly. They ISO certified and have QC lab with competent technical people. These products became unsellable to customers but taken back and replaced by better products to maintain business. If I take paints from other companies, practically all of them, the results will be the same.

With this, I want to tell that beautiful sentences do not run businesses. We just talk about it but the reality is much different!

p911, Don't be upset with these but that's what's happening outthere.

Why the new person cannot revisit and change the manual, standard operating procedures? If everything is good, I accept the close the book but if they have difficulties, the first thing is open the manual and start to correct it.

Another impossible situation is the layer or layers of positions with different knowledge and authority. ISO and others certifications must eliminate what makes difficult in first place. Impose a layer of one or two "only". That way, everything get done fast and well!

Jobs and Wozniack did miracles in the early years of Apple because Markula wasn't behind them and told them what to do. Why both went out? Because the company grew to a level where meeting was more important than production and action.

Again, p911, you explain how things are done. It's like that. I agree with you. I catch it but all these explanations and actions cost a fortune and because too much money is needed to be certified and get the certification, everyone pass around in the first place but mostly later.

I lost my best job, after creating everything with the father to build manufacturing behind an existing $70 million/year retail business, and lost with the son within 16 months from 11% after tax profits to nothing through bankruptcy. When the son became the president, he told everyone that he was the "boss". The next day I resigned!

I hope these give you to see realities with a different eye, Gil.

I understand, one has to enforce these quality procedures and it does not happen by itself. it takes diligence and commitment...i.e. ....hard work constantly.

And when one chance the manual, you have to understand if there are any other items this change would effect.

A good example is USDA regulations, One paragraph change would conflict with the very next paragraph. When this happens you better be in good standings with the inspector, he'll shut you down. And ignore the paragraph your in standing with and enforce the conflict revised paragraph.

Nothing is perfect, but it is better to have somewhat of a standard reference than nothing.

When the son became the president, he told everyone that he was the "boss". The next day I resigned!

I dealt with too many of these people who's only credentials for their position is their job description on their business card.

That is one of many reasons I quit. I had a choice between integrity and a job. And if you don't respect yourself at the job, it does not pay. I look at it, I came into this position with integrity, and I paid too high a price to give it up, and I rather leave with it.

p911

Hi p911,

It's hard to be knowledgeable about the subject, doer, responsible, and committed to someone else's company. I understand fully what's your feeling. I went out because I knew the son.

In most companies, hard to follow a logical path by describing and designing the flow of processes, teach people what and how to do, and use statistics to find problems. 9 out of 10 people will be against this simple procedure. It's too simple to be good for them.

One word about our meat plant who killed 20 persons; they never closed the plant, they just don't know what was the problem initially, but later they put everything on the equipment and a particular point of this equipment, and told a big "SORRY" to all inconveniences. They advertise, sell, and they are all around from Jt-John to Vancouver.

Thanks for the confirmation about the hard way to get something, Gil.

Hi Milo,

We talking about food making people and organizations. You mention that "In the absence of documented work instructions and evidence of training of personnel to those instructions, and in the absence of availability of those instructions, it is not ISO 9001 compliant quality system." How come a food plant can operate without very precise and written standard operating procedures? It's impossible?! I worked all my life in the paint and coating industry and I created those documents and trained personally everyone in every position. How you can control contamination problems like we experience in our country, Canada during the last few years. Salmonella and other man killing food was sold throughout the country. It's the same in the US, I am sure. What do EPA, FDA, and other citizen protecting agencies?

For these cases, I wrote in another blog that education must be directed to create useful people for the community and not promote individualism. We got the experinces with the auto and financial institutions, and we have to save them by paying CEOs perks' and high salaries for inability to maintain a company viable or better, profitable.

In most businesses some has authority but practically no one has responsibility for nothing. Meat industry should be absolutely controlled and tightly supervised.

Our meat handling company killed around 20 people and finally they said it was not their fault but the equipment manufacturer, making something that was not accessible by the cleaners, so bacteries grew freely at that place and invaded the rest. They, the meat plant, operate again.

Who should legislate and impose strict working conditions? If someone is aware of something, please let us know! Gil.

Hi Gil. Nice talking with you.

"How come a food plant can operate without very precise and written standard operating procedures? It's impossible?!"

Reading the original post makes it clear to me that there is at least one plant out there where someone doesn't have those.

And they didn't claim to BE iso 9001 compliant- they were working on it.

milo

Hi Milo,

You have the best question of the day but this company operated without the knowledge that certain places on most equipment need to clean differently that washing a table. When no one knows and/or understands what must be done, someone dies outthere by eating the contaminated meat. It happened to around 20 or so. I really don't try to find the exact numbers. Today, this company produces the same meats for countrywide sales.

Honest with you, I answer to the blog by memory without any documentation about them. I can get some details about this company's certification. It takes a few days, that's all! If you need I will do it. The "facts" are there!

Also, I already talk with one of an old worker, Central-American, not working there anymore but a good man and he cannot read English! The workplace is in Toronto, Ontario, Canada. Hello??!! You got the picture?

The company doesn't talk about certifications because it will be more difficult for them to tell people that they are good. Eliminate difficulties by not talking about problems. Smallest the problem, the more easily everyone can pass over it.

I was criticized, named crazy by many when I put a number above an elecric outlet and it was designed to plug electric fork-lifts only. This was a very small in a big book but everyone talked about it except the workers, and they were frustrated because I passed time about it by thinking, making and putting the plate with the number above the outlet, and write down in the book as SOP. Workers were happy. It was no responsibility for them! Just do it! It's "simple",isn't it? People like complicated, makes confusion and we can talk about it! I'm an action man.

Life is a war and you have to get out without hurts, Gil.

Hi Kid,

Pharmaceuticals need a perfect "image", so customers can swallow easily every pills avialable on the market. I admit that they have that "image".

The meat plant operators probably "lobbied" or pressed and "lobby" and press today the controlling people and they have no disturbances. A glue manufacturer is more controlled by governments and other supervisors than meat plants. Unions can do nothing with them. They are good and powerful.

Let me know who could change the status quo, Gil.