DOOMSDAYS ARE ON THE WAY
What is happening in this world? War is all over for various reasons, natural calamities like earthquake, heavy rain, mudslide due to heavy rain several are killed, various sickness like Covid-19 and more. Cheating and looting is a routine, break ins to the shops and stores looting the merchandise, break ins to the drug stores to steal drugs and other merchandise, drugs are freely available in the market through agents, and it is even sold in our schools, guns are being used without any control, violence and killings are a normal incidence daily.
Computer technology has become a nuisance, it used to be helpful for the community for Banking, money transactions and various purposes, now that technology is being used to hack the banks, demand ransom money from businesses, families, casinos, breaking into the Pentagon, stealing all secret documents, technology, even the simple mobile phone has turned into committing various crimes, identity theft and many more I am not able to put all the collection of troubles the people endure these days.
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Now look at the industry side what are the issues and troubles the manufacturing industries go through to bring their products to the market. Years back when the industrial revolution started American made products were in great demand and customers must wait months to get their products especially Automotive cars etc. Because the manufacturers had a full conscience to make quality products to get customers recognitions and business growth. They had very limited quality control standards to comply with to run the business and some of them are MIL-Q- 9858 Quality Program Requirements, MIL-I-45208 Inspection System Requirements, MIL-STD-45662 Calibration system requirements, MIL-STD-1535 Supplier Quality Assurance Program Requirements and MIL-STD-1520 Corrective Action and Disposition System for Non-Conforming? Materials and at that time only required second party certification, second party means the customer approval of the system that is it.
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Things are different now, as the years go by, so does the technical knowledge of the management has dropped so they could not provide guidance to build quality products and that brought opportunities for the foreigners (like ISO group) to get into our system and grabbed all of them and came up with their own QMS standard-ISO 9001 etc. Our technical management was very happy to go for it so that their job would be secured and if the quality did not work, they could easily blame others. Example, look at what has happened at the Boeing Company, they eliminated quality check and balance process even at the airplane assembly lane. This is one side of the manufacturing sector, similar problems exist in Automotive, Medical device manufacturers, Defense industries and general engineering areas. Overall, we can say that our manufacturing industries need some relief or knowledge to design & manufacture quality products for a reasonable price to the consumers.
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The existing quality management system supported by the ISO 9001registration, certification and audit, SPC system, Six Sigma, lean six sigma all these are nothing but a rip off, pure cheating that no one has complained about it. Because the management is living with this defective system, they do not know the right and wrong just following the crowd, they think it is better to keep quiet rather than sounding alarm and let us continue using it. We know for sure one day the whole system will be redefined for the future of all the manufacturing industries and that will be the beginning of the cultural change for a better future.
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This is what I do not understand, where is our government supposed to oversee the contracting function, what is the role of Senate and Congress and else who controls what, the contracts, what to put in there to get the best quality product or service, I think there is a gap in the system, communication gap. If you do not know what you are quoting in the contract, do not do that, because manufacturing industries all over the USA are going to abide by the instruction/the wording you put there. See the example below:
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Here the question is how does the contracting authority know that statistics are the reliable tool and technique to manage and control the quality of the manufactured product, especially medical devices? See section of CFR Title 21 Part 820 Quality system requirements. Power Point Presentation slides from 60 – 63 are provided for clarity of demonstration. Since I do not have an example of contracts from other agencies like – Aerospace, Automotive, Defense, Space and other General engineering enterprises to show as an example how the Quality requirements are defined therein.
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The point I wanted to make here is that Statistics is not the right tool or technique to use in an engineering field or in a manufacturing field. Just give an example to convey the difference between the Statistics & Engineering/Mathematics
1 + 1= 1.85 with 0.15 margin of error, Uncertainty, Failure or Risk. Results of Statistics
1 + 1= 2.0 This is absolute. Mathematical result. Which one you choose to build quality?
Conclusion: Any product(s) designed, manufactured using Statistical technology, that product will exhibit/will have defect within the product during the performance of the unit. Therefore, in my humble opinion the application of Statistical principles and sampling techniques should be removed from the contract.
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Let us see the damage done by ISO 9001. This is the QMS standard for the manufacturing industries and I am not aware of the source of the contract where it came from, maybe it could be from DOD, aerospace, government or else. I was not involved with the contractual requirement, and I was on the implementation side of ISO 9001 and the quality management at that time never explained why it is required, I was just following the order from the management. But I do know the consequences caused by this standard. This is somewhere in 1980s-time frame, order came from the management all the suppliers should get certified to ISO 9001. At that time most of the industries were supported by the small businesses owned and operated by Mom & Pop family, they were not familiar with the writing of extensive quality manuals and procedures, and they never had the budget to make those changes to their organization. Finally, most of the small businesses closed, unable to compete with the growing need for the ISO 9001 requirement & implementation of the same.
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Start of Disaster, the biggest problem to the industries. Suppliers are not getting the components to make the assembly of their main products, that caused delay in delivering the products to their customers. Started out sourcing engineering jobs to other countries, especially to China, unknowingly started transferring the technology to other countries, that made threat to American technology and the loss of jobs to millions of people, that affected the economy. ISO 9001 business brought nothing but problems. Oxebridge company did an extensive research and comments on ISO 9001 certification, audit and problem with that process are given some examples, their web site is a good source of information about the cheating and free sale of ISO 9001 certificates for a price. Bottom line is this ISO 9001 registration, certifications have no added value to the customer or suppliers. Common trend of the suppliers has their ISO 9001 registration and certification done, they implemented SPC system, six sigma, lean six sigma and still they have 5% to 8% MRB activities, that tells me that ISO system is not a good viable system to build quality products.
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HxGN-ETQ-QM_Perception_vs_reality-Report-16P-Letter-EN-Web.pdf – Product Recalls according to HEXAGON/etq. Published article from the web 813-2024
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Latest Headlines from Oxebridge - [email protected] - Gmail (google.com) Nine ISO certificates at once July 15, 2024
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Latest Headlines from Oxebridge - [email protected] - Gmail (google.com) ISO 8001 CD Scrapped. Aug 12, 2024
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Where do we/our manufacturing industries go from here?
About thirty plus years of working at various manufacturing industries, I have collected various mode of rejections and issues caused to the main product lines and when I summed up that shows a common cause of failures, and the following are the major ones:
1.???? Dimensional problem – out of engineering drawing dimensions
2.???? Dimensional problem – Supplier furnished products
3.???? Engineering drawing issues – GD&T terminology
4.???? Communication – Internal & External
5.???? Tooling and Fixtures – Design of fixtures to hold the parts are defective
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Here are the Solutions:
Install the Hybrid Technology “Industrial Statistics” that tailor’s quality into the manufacturing process and delivers quality products every time. Once this program is implemented there is no need of ISO 9001 certification and use of SPC (statistical process control) R SPC software is part of this program that creates data needed to control the manufacturing process and the process mapping guides the operational steps with critical advice so that no room for error. Second party certification is recommended instead of ISO 9001 certification
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What Industrial Statistics does?
1.???? Collect contractual requirements and delivery schedules
2.???? Review engineering drawing or model to see any gap exists, if any correct them
3.???? Review specifications and any additional requirements done to the product
4.???? Any secondary operations like heat treat, hard anodize, chrome plate etc.
5.???? Special tools, gages to be used or furnished by the customer as part of the contract
6.???? Have the suppliers keep a record of capability, repeatability and calibration of all their manufacturing machines current and each machine identified with serial number
7.???? Use the R SPC software program to feed all the variables and create master data
8.???? NC/CNC machine programmer use the master data to program the NC/CNC machine
9.???? Issue calibrated measurement tools and gages to the operator and have them inspect the part enter the data into the R SPC program.
10. Train the operator to follow the instructions as per process mapping instructions.
11. Revise the configuration control system, if the engineering drawing causes more rejection
12. Outside suppliers should follow the same instructions and keep records for verification.
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