What should be the manufacturing vision for 2024-2025 and beyond.
Published
Question by James McMahon
What should be the manufacturing vision for 2024-2025 and beyond?
Answer is Do it or Doom.
So many things are happening in this world today and believe me that attracts many of us and run after those new inventions without thinking about the consequences and benefits of technology. We have technologies that one day will destroy the world, I don’t want to spell them here, you already know it.
Truth and justice have gone or are being diminished from the face of the earth. Just few examples:
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- Take the case of Boeing 737 Max 9, two crashes took the lives of many, door plugs came off during flight, and many other defects on 737. When the FAA failed to identify and address the issues and so did the NTSB. Boeing CEOs Dave Calhoun and Dennis Muilenburg both neglected to implement sound quality procedures to check and balance the performed by the assemblers and buyoff the process by the assembler and the line inspector. All these shop travelers are legal documents and should be handled according to the procedures. There are several videos in the you tube, and you may very well assess the criticality of the abuse of the assembly process itself. It appears the total negligence of FAA, NTSB, CEOs of the Boeing company and some Politicians involved in the process.
- Same issues in a different form goes to the medical device manufacturers, mainly engineering design issues, manufacturing process control and sub tier manufacturing suppliers. Heavy use of Statistical Process Control is another cause of product failures in almost all the manufacturing industries.
- It is worth clarifying the nature of Statistics, used in different forms to measure the quality of the manufactured medical devices. A significant proportion of device recalls were attributed to faulty design of product. FDA found that approximately 44% of the quality problems that led to voluntary recall actions during the 6year period were due to lack of design control. A subsequent study of software-related recalls from 1983 – 1991 indicated that over 90% of all software related failures were due to design related errors in both hardware and software. Let us review CFR Title 21, Part 820 Quality System Requirements: - Quality system procedure Sec. 820.250 Statistical techniques. 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. Sampling plans, when used, shall be written, and based on a valid statistical rationale.
- AS 9100 – Quality Management Systems. Almost all the manufacturing industries across the globe rush for the audit and certification to ISO 9001 or AS 9100 standards. According to the Oxebridge, there are ISO/AS 9100 Registrars print the certification for a fee at various Countries. What is the validity of the certification? When I go to the Aerospace companies for defect investigation, the management at that facility was very proud to say that they got the ISO/AS 9100 certification and walked me through their shop to show the Banners all over the shop with the title ISO/AS 9100 certified. After the walk through, simply asked for the management minutes of meeting, upon review the report says some activities in the MRB area. My question is in general – If the ISO/AS standards and the SPC system help to make quality products, Why the products are rejected and end up in MRB cage? That gives evidence that the Certification process/systems do not support or help to make quality products. If that is the reality of Quality, what is the point in wasting money and time? Time to look for other viable systems that help to build quality products consistently.
- Another mockery, ridicule in the Quality management system is use of SPC to measure quality compliance of the products they make. The horror thing with SPC, it is a data dependent system, no product or process knowledge, decisions are made based on the data collected from the inspection sheet. This system existed several decades ago, that did not guarantee quality products anyway, but the publicity is worldwide, and all the industries are hooked on to it. ISO & SPC are the problem, they are the parasites to suck your resources, you keep mum, because you do not know what is happening or what they are doing in front of your nose. CEOs and managers, open your eyes and see reality. If you don’t change the system, the downfall of our prestigious manufacturing profession will be doomed, I can guarantee that.
This system is a three-fold or three in one management system. It oversees the engineering design and configuration control, manufacturing processes and control and tailor quality attributes along with the manufacturing process that delivers quality products every time. Process mapping is another component of the system, that dictates or guides the machining process and or the assembly process to assure quality products are made, tested to the specifications or per the customer requirements, packaged and delivered to the destination. A U.S. patented software is used to check all the variables to assure that meets GD&T requirements before even cutting the chips, this is to assure that nothing is left behind to take complete accountability of the requirements. This is a very transparent system; the customer is involved in this process and sub-tier suppliers are also bound by contract to follow the principles of the system. Even no exemption to the suppliers who supplies their end products to the prime contractor.
Advantages:
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- Elimination of rejection and rework cost
- No need of using the SPC system at all
- Machine operator is trained to do the critical dimensional check and document.
- Software could create charts and graphs from inspection data by the operator.
- The charts and graphs would help the management and the customer to ensure the quality of the manufactured products.
- No need for ISO/AS certification and audit by the registrar or by third party.
- Second party audit and certification are more value added and increase interaction with the customer.
- Elimination of undue stress on the manufacturer to comply with the ISO/AS standards is reduced and focus on the job that increased productivity.
- Customer satisfaction brings more business and a higher profit margin.
- Promise the manufacturing industries to take up the challenges and win the competition years ahead.
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03/21/2024 1:37pm EDT