Articles Tagged with ''auditing''

When dealing with medical problems, the medical device should not add to these problems. Medical device manufacturing requires the highest quality—and industry takes no chances with this. Regulations are de rigueur. The need for quality of a bone screw should be obvious, and the same goes for any medical device.

One of the requirements for management system standards is that internal audits be conducted of the processes of the management system. 

Daniella Picciotti still remembers her first auditing experiences. On a supplier audit with more senior colleagues, it was difficult to determine her role. 

Increasingly complex customer and regulatory compliance requirements, tighter time-to-market schedules from customers who want greater product customization, and the constant pressure on costs and pricing make aerospace manufacturing one of the most challenging businesses in the world to compete in.

I was a group quality manager for an engineering company that made aero-engine parts. As part of the culture change program, I gave a presentation on examples of aircraft crashes and causes. A poorly machined blisk that caused an in-flight turbine failure, an oil-pipe with a thin wall in one area that cracked and leaked causing a fire, and an incident I personally saw, the crash of a military helicopter in Germany which was due to a series of quality failures. 

In automotive manufacturing, reducing quality costs can be like trying to bail out a leaking boat. You can empty bucket after bucket over the side, but you can’t get above water until you plug the leaks themselves.

The AS9100D transition timeline is moving towards mandatory assessments to the 2016 revision. Much has occurred since fall 2016 including the AS9100-series standard release, auditor training, certification body approval, and, of course, organizational implementation.