know the advantages of documented systems governed by closed loop control
ISO and QS create documented structured systems. Growth requires structured systems. Without them a technical company cannot grow, but will fall apart when they attempt to grow beyond a certain point, as exemplified in our previous "Drop Dead" example. Large advanced customers want suppliers that can grow as they grow.
Large advanced companies realize the training advantage of using documented production instructions or specifications.
Without documented process, training is 100% accomplished one-on-one by your experienced people. Training is done in addition to their regular work load. Attention drawn away from production process results in defective products.
With documented process, documents do 80 % or more of the training of new people; greatly diminishing negative effects on product quality. Training can be done on a much larger scale; large groups can be trained by document, making growth easy without negative impact on product quality.
ISO and QS in a nutshell
QS and particularly ISO are only generic outlines of structures that should be present in any and all business. To save time, if you require proof of this, read the very short ISO 9001 outline. QS is in many ways identical to ISO but has more product qualification features, process qualification features, and product failure analysis.
What ISO may cause to be present and what must be present in functional technical production manufacturing is accurately documented production procedures inclusive of measurement and test procedures, documented maintenance of production and test equipment, and documented engineering systems all governed by closed-loop-control.
Closed loop control is when a test data point exceeds control limits causing preventative actions by engineers to result in changes in documented manufacturing or test procedures that prevent that specific error from ever occurring again.
Field failures cause preventative action in lesser companies. A field failure is when the product fails in the hands of the end user. In a "Better Company" failure is caught on the test floor, almost never in the field by a customer.
The main feature of ISO and QS is audits...most people think of audits executed by the ISO registrar. But, what a good ISO auditor audits are internal audits...that is audits your company systematically executes on itself. Your company must learn to efficiently and effectively implement self audit, the product of which is the only path to sound technical manufacturing systems and subsequent growth.
A good auditor begins in your files with an out of control test data point. They follow it in reverse to engineering design change control documents, then to production specification change control documents, and finally production specifications where they should find new production and test procedures countering the error. If not there, you have no system and no control.
