Stop the Madness

Is your Quality System inundated and overwhelmed with investigations, documentation, and bureaucracy?

Does it seem that you spend your whole day jumping from one fire to another?

The best way to render a Quality System ineffective is to treat every issue equally.

When all things are treated equal, the Quality System can become ineffective at addressing critical issues because it is struggling to stay afloat in an ocean of documentation and investigations.

When everything is elevated to crisis level, people stop paying attention to anything. If the fire alarm in your office goes off everyday when there is no fire, then you start ignoring the alarm. The same applies to Quality Systems. It is very important for an effective Quality System to readily identify and separate critical issues from mere inconveniences. Inconveniences need to be addressed, but they don’t need to be addressed in the same manner and method as a potential product impacting issue.

Consider the triage process for medical units. They must quickly decide on which patients are in critical condition and which patients can wait for their care. When done correctly, all patients receive the appropriate attention with the appropriate urgency. Non-critical patients are not neglected nor are they treated before critical patients.

Quality Systems need to be monitored to evaluate their effectiveness at identifying and addressing critical issues promptly without neglecting inconveniences all together.

Of course, the best case scenario is to prevent non-conformance events from happening in the first place. We need to stop simply reacting to issues and inconveniences and start looking for better ways to prevent their future occurrence.

Over time, the Quality System and manufacturing process should be fine tuned to eliminate the background noise (inconveniences) so critical issues can be clearly identified and investigated in a timely manner.