From Dr. W. Edwards Deming’s 14 Points: Drive out fear, so that everyone may work effectively for the company.
By definition, in order to improve something, a change has to occur. I have benchmarked several companies and it seems that those that do the best with their improvement efforts have a workforce that embraces change. If, on the other hand, there is a culture of fear and the workers are terrified to try something different, nothing will improve. Continue reading
A quality manual is supposed to describe a quality management system (QMS), a system of processes working together to output product. A quality manual defines a QMS, whether or not ISO 9001 certification is among management’s objectives.
OPERATIONS AT THREE LEVELS
A work instruction (level three QMS documentation) describes operations at an activity level. It describes how specific activities are supposed to be carried out. “Insert nut A onto bolt B and torque to 20 lbs.” Defining operations according to ISO 9001 requirements at this level, instead of defining them according to internal processing requirements, is not useful to anyone, nor is it necessary. Continue reading
MEET BOB’S MACHINE
Bob’s Machine was operating successfully before ISO 9001 came along. Bob was introduced to ISO 9001 when it appeared among his largest customer’s supplier requirements. Although the requirements of ISO 9001 were unclear, the requirement to become ISO 9001 certified needed no clarification.
Bob’s objective became to ‘get certified.’ Unknown to Bob, what the standard requires is a demonstrably effective quality management system (QMS). To ‘get certified,’ Bob needed to sensibly document the system of processes currently operating to output product. To Bob, those processes were (in order of appearance): Sales, Purchasing, Receiving, Production, and Shipping. Continue reading
Baldrige and ISO 90001? They can’t be twins. They’re different animals.
When ISO 9000 was first released as an international standard in 1987, it was not without an American competitor: the national Malcolm Baldrige Award. Though ostensibly not intended to compete with ISO 9001, Baldrige did compete with ISO 9001. Baldrige has been hindering an understanding of ISO 9001 and how to apply it since the nearly simultaneous release of these two quality initiatives in the late 80s. Born nearly at the same time, it seems quality professionals often treat them as twins. Continue reading
The question as to whether a process approach is required of ISO 9001 will be laid to rest, should the language of ISO 9001:2015 Committee Draft (CD) prevail. Specifically, the first sentence of sub-clause 4.2.2, headed ;Process approach’: “The organization shall apply a process approach to its quality management system.” That’s pretty clear. Continue reading