This year has been an adventure into the unknown. By the end of March, many of us were enclosed in makeshift offices at home, while others were looking at production lines that were only partially staffed.
Looking back at my quality career since 1984, I remember contributing to a quality manual of a Motorola Division in 1987-88 for ISO 9001 certification.
Lean approaches are beneficial for the development and maintenance of management systems compliant with ISO 9001, ISO 13485, ISO 14001 ISO 45001 standards and 21 CFR 820 FDA regulation.
If ever there was a time for risk-based thinking, it would be now. During this strange season, the entire world seems to be shutting down as the pandemic disrupts lives and businesses.
The warmth of spring brings flower and green lawns, and it also brings awards and recognition to the quality profession. Recognition abounds; both Quality Magazine and ASQ have dedicated significant time and resources promoting, validating and now honoring individuals who have made a significant impact to the quality community.
When ISO has a quality management standard revision to release, there is much anticipation—and perhaps a bit of apprehension—among users as to the significance of the changes.
With so much focus on customers, companies can lose sight of their most valued asset—their people—and the critical roles they play in the success of their organizations. Organizations are the employees, and customer service and quality are dependent on these skilled, motivated people.
The problem would go away only to return every few months. The manufacturing mystery continued for about seven months, with each failure costing $26 in raw material alone.