My father wanted me to go for medicine, but because of financial difficulty, God the father pushed me towards engineering. After my engineering education/diploma, I was thrown into the job market in various aspects of manufacturing and quality. Manufacturing industries are suffering a lot in the hands of statisticians and process ignorant self-proclaimed professionals. We need a renewed quality management system that is transformational.

You can model your TQM System based on the products or projects you are working on. Just an example: MIL-Q-9858 or any solid standards that give you a clear direction. TQM System may vary for aerospace, automotive, medical devices, space and general industries. Select the appropriate standard and build your quality manual, make sure to show the important instructions in your manual. What makes the quality system most powerful is the process management and control document, that is your confidential document, not part of the quality manual.

Without profound knowledge you cannot build any system, same goes with the TQMS, follow the elements given below at a minimum to build a strong system that never fails.

TRANSFORMATIONAL QMS: PROACTIVE PROCESS MANAGEMENT & CONTROL SYSTEM

1. INDUSTRIAL STATISTICS – That has R SPC software to help you to build process maps.
2. CONTRACT REQUIREMENTS – Extract the deliverables from the contract
3. SPECIFICATION – That helps to make the product or service in the contract
4. ENGINEERING DRAWING – As specified in the contract
5. ENGINEERING MODEL - As specified in the contract
6. MAN – Knowledge, training, GD&T and application
7. MACHINE – Understanding the machines, tools, capability
8. METHOD – Different methods, machine setups to optimize the process
9. MEASUREMENT – Different measurement methods and tools, metrology
10. ENVIRONMENT – Machine behavior according to the climate change
11. TOOLING – Various types of tooling, workholding, cutting tools, various metals
12. NC/CNC PROGRAAMMING – Programming of NC/CNC/DNC machines, revision control of the programs
13. SUPPLIERS’ MANAGEMENT – Supply chain management, communication, understanding their capability and ability to do the project
14. PROCESS MAPPING – A communication system that specifically project related
15. SECOND PARTY CERTIFICATION – Customer certification of the system, eliminate third party registration and certification
16. INSTALL R SPC SOFWARE PROGRAM – This program helps to create process maps and instructions to make CNC/NC/DNC programs, process control.
17. CUSTOMER INTERACTION AND INVOLVEMENT – Keep customers informed of what you do and how the project is progressing and how the quality is built into the manufacturing process.
18. COST REDUCTION – Reduce redundancy, eliminate waste, save operational time
19. RESULT – 100% QUALITY PRODUCTS

Besides my engineering education, I have gone through several statistical and management trainings and finally got my Green Belt certification. I did not get what I was looking for from the Green belt program—to build quality into the manufacturing process. I have developed my own technology and patented it – “Solid Model of Statistical Process Control” United States Patent Number 7,457,679 B2. Based on that solid model, a mathematical Model of Bell Curve created software called R SPC (Reversed Statistical Process Control) that tells how to make the planning and all necessary information to process a manufacturing project.

The publicity on SPC has made a huge impact on our manufacturing industries. It was an explosion, the universities and colleges and consultants started teaching statistics, data collection, creating charts and graphs to find the root cause of the problem. The outcome is a mess, kind of brainwashing, students gave up their normal intelligence to learn technical matters and adapted statistical tools.

Another devil in the system is ISO 9001. If the objective is quality, ISO 9001 certification, and implementation of statistical tools and techniques to build quality products, how come the manufactured products have alarming rate of failures? Aircrafts are falling, medical devices are being recalled for various defects. Is the FDA controlling these out-of-control systems or processes? See the example below:

[CFR – CODE OF FEDERAL REGULATIONS TITLE 21

PART 820 QUALITY SYSTEM REGULATION

Sec. 820.20 Management responsibility

*Quality policy.

*FDA (1) Device recalls caused by faulty design. (2) 44% of the recalls were caused by faulty design of the products. (3) Over 90% of the product recalls were caused by due to design related issues

*Sec. 820.250 Statistical techniques.

*Where appropriate, each manufacturer shall establish and maintain procedure for identifying valid statistical techniques required for establishing, controlling and verifying the acceptability of process capability and product characteristics.]

Now, most of the manufacturers in other countries just pay a fee and they will get ISO 9001 certification. Please refer to The Indefensible: Registry of ISO Certificate Mills and Accreditation Mills

My goal is to teach our industries the most productive hybrid tool and benefits, it can be done at your facility using your failure data and students from the data obtained from the manufacturers or others.

Your feedback is most appreciated.