Compliance ≠ ‘quality’
The quality of the product an organization provides to the market is a ‘reflection’ of the quality of operations. The quality of operations is a ‘reflection’ of the quality of the Quality Management System (QMS). When operating in a regulated environment, compliance is a requirement, however it is only one dimension of quality. Obtaining, and sustaining, a high-quality outcome doesn’t just happen, it requires leadership…
“Quality is never an accident; it is always the result of high intention, sincere effort, intelligent direction and skillful execution; it represents the wise choice of many alternatives.” origin unknown
How is quality defined? One dictionary I referenced provides the following:
the standard of something as measured against other things of a similar kind; the degree of excellence of something.
a distinctive attribute or characteristic possessed by someone or something.
Interesting. Standard of something, measured against other things of similar kind, a distinctive attribute or characteristic possessed by someone or something?
Perhaps you recall a famous quote from Fujio Cho, who was the Honorary Chairman of the Toyota Motor Corporation? I believe he characterized the approach to high performance the best when he said…
“We get brilliant results from average people managing brilliant processes – while our competitors get average or worse results from brilliant people managing broken processes”
Good people and good processes produce good product. Performance.
Definition of quality: The standard of process performance, measured against the aggregate of Quality System processes, inclusive of the capability of people to execute those processes, will be reflected in product quality. Quality can be measured across three dimensions of performance:
Compliant to applicable regulation and standards
Effective in obtaining results
Efficient in operational execution