DERAILED SYSTEM

DERALIED SYSTEM

A new technology for the Manufacturing industry, put it on the right track.??

Developed this Hybrid technology in the United States of America, practiced in a high precision manufacturing shop, developed process improvement, and building quality products techniques. SPC was not a viable tool for a high precision manufacturing shop where the lost size varies from One part to thousands of parts. Compelled by the customer requirements forced to invent a solution to help the manufacturing community, that lead to invent Industrial Statistics, when implemented that produced 100% quality products and all the customers were very happy on quality performance. That technology patented and copyrighted in The United States of America and that product is ready for you to use in your shop to control quality of the manufactured products, reduce the cost of operation and reduce waste plus more advantages. Noticed there are many flaws in our government regulations, ISO and other standards created and mandated to use in the manufacturing sectors, this need to be revised to put more value for the users and the customers.

Let me tell you, technology has improved several folds since the introduction of Statistical process control after the industrial revolution, at that time the manufacturing process was in an infant stage, SPC sampling inspection technique was used to sort out good parts from the manufactured lot. It is shocking that industries are still using the same age-old technique that gives only between 68% to 99% yield max, uncertainty or risk is the inherent problem the biggest setback of this system.

HOW DO YOU KNOW THE MEDICAL DEVICES IN THE HOSPITALS PERFORMS 100% WITHOUT FAIL? THINK ABOUT IT!! DO YOU WANT THOSE MACHINES HOOKED ON TO YOUR LOVED ONES IN THE HOSPITAL?

I was reading some of the articles/reports and survey results on Medical Device Manufacturers, FDA GMP/CGMP, ISO 9001, ISO 13485, and FDA 21 CFR 820 and more.

The good news is this... FDA 21 CFR Part 820 and ISO 13485 are very similar. In fact, the “new” ISO 13485:2016 is in one-to-one alignment with FDA 21 CFR Part 820.30 regarding Design Controls. This is good news and means you can establish a “one size fits all” quality system, encompassing Design Controls too, will that work?

If you are going through medical device product development, there are at least 4 parts of a quality system that you need to put in place:

1. Design Controls

2. Risk Management

3. Document Control & Records Management

4. Supplier Management

The table below compares the FDA clauses for Design Controls to ISO 13485:2016 clauses regarding Design & Development.

Design Controls FDA 820.30 ???????????Design & Development ISO 13485:2016

(a) General ???????????????????????????????????????7.3.1 General

(b) Design and development planning 7.3.2 Design and development planning

(c) Design input ???????????????????????????????7.3.3 Design and development inputs

(d) Design output ?????????????????????????????7.3.4 Design and development outputs

(e) Design review ?????????????????????????????7.3.5 Design and development review

(f) Design verifications ?????????????????????7.3.6 Design and development verification

(g) Design validation ????????????????????????7.3.7 Design and development validation

(h) Design transfer ???????????????????????????7.3.8 Design and development transfer

(i) Design changes ????????????????????????????7.3.9 Control of design and development changes

(j) Design history file ???????????????????????7.3.10 Design and development files

Sec. 820.22 Quality audit says,

Each manufacturer shall establish procedures for quality audits and conduct such audits to assure that the quality system follows the established quality system requirements and to determine the effectiveness of the quality system. Quality audits shall be conducted by individuals who do not have direct responsibility for the matters being audited. Corrective action(s), including a reaudit of deficient matters, shall be taken when necessary. A report of the results of each quality audit, and reaudit(s) where taken, shall be made and such reports shall be reviewed by management having responsibility for the matters audited. The dates and results of quality audits and reaudits shall be documented.

Subpart O - Statistical Techniques

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.

(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.

Authority:?21 U.S.C. 351, 352, 360, 360c, 360d, 360e, 360h, 360i, 360j, 360l, 371, 374, 381, 383; 42 U.S.C. 216, 262, 263a, 264.

Source:?61 FR 52654, Oct. 7, 1996, unless otherwise noted.

Above materials are taken from the published articles and FDA 21 CFR

Bottom line is this, to meet the requirements of the ISO 13485, ISO 9001, FDA 21 CFR Part 820 and many other standards, manufacturers are making a mountain of paper works in the form of quality procedures, manufacturing procedures, Inspection and testing, product validation, process validation and many other documents. The irony is that having all these policies and procedures, products or components are found defective and ends up in the MRB (Material Review Board) room for evaluation and disposition by the customers, manufacturers and by FDA officials.

Since the system is not descriptive, it allows or accept a certain percentage of defects or defective products supported by the Statistical clause, I wonder even the Federal officials knew the blunders they made and pass on to the manufacturers and they expect outcome a reliable quality product? I do not think so because of the uncertainty in the whole system, if we could remove uncertainty from the system we will be in win-win situation.

Let us make the story short, to eliminate the small and major risks during the design process, manufacturing process – internal or external issues, “use the most effective tool The Industrial Statistics” along with the “Transformational Quality Management System”. Once this system installed in place, manufacturers will see a tremendous amount of improvement in the manufacturing process, an effective tool to manage and control the suppliers and the defect rates would go down amazingly low or near zero. Operational cost would go way down to an optimum level and the Quality of the manufactured final product would meet or exceed the customers’ expectations, there is no magic in this.

Please draw the attention of the policy or procedure makers of the FDA 21 CFR Part 820 to define clauses to make more visible, transparent and policies and procedures make simple, avoid making volumes of documents of no value, make something value added, do not make the prestigious FDA regulations “A blind man’s Blunt tool”, adapt a different approach to communicate with the process owners in a manner the documents are transparent and visible.

I am willing to give a presentation to the policy or procedure makers of the FDA 21CFR part 820 and other similar regulations that controls the Aerospace, Automotive, Defense and other general engineering phases. It is a fact that the organizations are reluctant to make changes to the nonproductive system, rather than they love to live with the deficiencies.

What our industries are needed is the Industrial Statistics and Transformational Quality Management systems, to build and deliver to the customers exactly what they want.

Review the web site https://www.qem-inc.com that gives the services offered to the manufacturing industries. Since the pandemic struck our Nation, performance of the industries is sagging, supply chain is in greatly affected. Only solution is to promote-Make in America-rebuild our manufacturing base stronger, do not waste time, act quickly to change the policies. It is also a known fact that the knowledge gap is widening, experienced workers are hard to find, employee are quitting their jobs because they are sick and tired of the ill treatment from the management, why not give training to the working personals now to make them more knowledgeable and productive, we can do it, let this New year 2022 be the year of Transformation.

Thank you,

Bob Matthew

Contact: Message 714-783-8911