Quality

Lay foundation to Quality

Manufacturing industries owners, CEOs and other decision makers, I would like to help you to sow the seeds of quality and reap the benefits. I will walk you through the process and help you to install the most powerful system “Industrial Statistics”, everything is transparent, visible, cost effective and an effective tool to communicate with your supply chain and customers about quality.

These are the burning questions and issues.

a.????? I have no Ph D or other famous degrees, but I do have the God given talents and basic engineering degree and many other training credentials to understand the process and process control.

b.???? Over the forty years God has taken me through most of the manufacturing industries and the processes to understand the key controlling factors to hold the critical variables to get quality yield and learned the defect characteristics and how to fix them to eradicate.

c.????? My engineering education and the knowledge gained always stayed as a beacon to shed light to the dark side of engineering issues and the manufacturing & process control areas and able to correct them without any centuries of old data. I remember late Dr. Eward Deming said during his televised meeting that “yesterday’s data will not predict the future” he was referring about the process control using the SPC data, it is unknown how many of the audience captured that message correctly.

d.???? Data has its own enemy, if the data collected are not in chronological order prediction of the behavior of the process would be difficult. Random sampling and prediction would have more errors on judgment of quality of the product or process.

This is what I would do to identify any product problems.

1.???? Go through the entire MRB data to identify the components or assemblies that brought to MRB evaluation, this is only to identify the root cause (RC-1).

2.???? Evaluate the components or assemblies engineering drawing to see any gaps in there, also check the manufacturing process to assure that process was good or that made inferior quality product. Identify and correct the problem one by one. (RC-2)

3.???? After identifying the issues, review the assembly process to assure that was done in accordance with the contractual requirement (RC-3). If you look at the issues with your statistical knowledge mind (non-technical knowledge) you may not see any issues, but the engineering or scientific mind would reveal many issues.

Let us examine why our strong manufacturing base, once made quality products, you name any products like Automotive vehicles, general household’s items, Office equipment’s-Parker ink Pens, my father proudly clipped on to his pocket so that is visible to others; famous all over the world. Our education system dropped the ball and no more technical education and hands on training to support our manufacturing industries.

Our manufacturing companies were/are filled with non-technical educated management, and they were carrying the pride of our history, but they have no technical skills. With their ignorance, technical knowledge making quality products was a challenging issue. Business opportunists were always looking for a chance to get into the market to make money and sure enough an organization from Switzerland, ISO group, took all our American quality standards and combined all together and formed a standard ISO 9001. Crook will always find a way to resolve the issues, and they find out to outsource manufacturing process to China, “a Communist nation always looking for a chance to get into American market and steal the technology by hook or crook”. A survey sent out by the Boeing management to get feedback of the technical/nontechnical management about outsourcing. My response was not to send our technology to China and mentioned that “do you want to send your children to China for an employment?” and finally that happened they sold America to China and that begins the downfall of our manufacturing industries.

Biggest enemies to our manufacturing industries are the ISO 9001 & SPC (statistical process control)

Quality clause imposed by FDA on medical device manufacturers.

“Let us go to the source and educate them to remove the Quality clause

(e) FDA Quality system procedure

Sec. 820.250 Statistical techniques.

(a) Where appropriate, each manufacturer shall establish and maintain procedures for identifying valid statistical techniques required for establishing, controlling and verifying the acceptability of process capability and product characteristics.

Sec. 820.250 Statistical techniques.

(b) Sampling plans, when used, shall be written, and based on a valid statistical rationale.???? Each manufacturer shall establish and maintain procedures to ensure that sampling methods are adequate for their intended use and to ensure that when changes occur the sampling plans are reviewed. These activities shall be documented”.

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It is not that an easy task, but we can do it with minimum financial impact to our industries / our government.

The following actions should be taken without any fail or cutting corners, it may seem difficult at the very first look of it, but it is much easier you feel it when done or implemented. Cost savings are huge, and the ROI has never been measured before.

Change the process without fail & do it now.

1.???? Change the dirty clothes and put on the new game changer- Industrial Statistics

2.???? Remove or eliminate the use of ISO 9001 & SPC, Sampling inspection etc. from all government, defense, FDA and general contracts and endorse to meet or exceed our old quality standards MIL-Q-9858 and MIL-I-45208, MIL-STD-45662, MIL-STD-1535 and MIL-STD-1520 according to the nature of the products being made.

3.???? Use Industrial Statistics as a medium or standard to control the quality & manufacturing of the product under any contract. Use R SPC software to define and control the manufacturing process in-house or at the outside suppliers, with the condition that the outside suppliers should follow the Process mapping system furnished by the customer contractually.

4.???? Invest in engineering education with practical experience as part of the curriculum that will help the students to understand the engineering principles and the manufacturing technology of the product. When the new batch of students comes out, they will be able to take up the manufacturing process very easily and increase productivity and build quality products.

5.???? If we do change above things as a minimum, America will be leaping forward to building a world class strong manufacturing powerhouse.

6.???? Quality management system is not a commando to dictate and control the engineering design, manufacturing and supply chain management according to their manifesto, rather it should be a transparent communication process to help the process owners.

7.???? Look at the web sites below and see the ways they lure the people to sign up into their system and they know how to brainwash you with their magical presentation materials. Since you have no technical know-how on products & process, you just sit and listen up to a point you reach out for your checkbook to sign a contract. That is all they wanted it; the rest is your problem.

8.???? I have the Best and most rewarding program and system that will help your company to make and sell quality products every time, but I have no fund to launch big advertisement campaign, for those who are interested, my doors are open. My action plans are open, transparent and visible to all process owners, that guarantee cost reduction, waste elimination and excellent quality output whether it is in-house or at the outside suppliers.

9.???? Contact: [email protected] or [email protected]. Visit: https://www.qem-inc.com.

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