ISO 9001 Tips and Advice
Magnitude
Level
Twenty years ago when I first started out in ISO
the president of the company I worked for made a very insightful evaluation of
the ISO 9001 standard. He said, "For years my people have been making
stupid mistakes over and over, but with our Corrective Action process now they
have to get creative to mess up!" He had captured the essence of
corrective action. It's okay to "mess up" it's not okay to repeat it.
The question remains, how do you create a
corrective action system that works and not a system that you have to
constantly work? The answer is Magnitude Level.
Customer Complaints (required):
Any customer complaint above “X” dollars to the customer or our organization, any customer complaint resulting in injury to the customer, any complaint that is reoccurs “X” number of time within “X” time frame, any customer complaint that at the discretion of the Management Representative or Management Review team requires formal corrective action.
Magnitude levels can be both Objective and Subjective.
Process Performance (required):
Any goal or objective that falls out of acceptance criteria by less than 5% for less than or equal to two months requires correction.
Any goal or objective that falls out of acceptance criteria by less than 5% for more than two months requires formal corrective action.
Any goal or objective that falls out of acceptance criteria by more than 5% for one month requires formal corrective action.
Now you have a system that my organization can actually live with and will provide return on investment.
Woody
ISO Consultants for Healthcare
