jackerman64
Corp Quality Sys *****
FIRST:
Could someone please provide some examples to help me understand the difference between some bulleted items in 9.3.2 - Management Review Input Requirements.
Many seem redundant or severely overlapping and I don't understand why they are called out so many times in so many ways.
For example, what is the difference between:
9.3.2 C2. The extent to which quality objectives have been met VERSUS
9.3.2 C3. Process Performance.
Our quality objectives are our KPI's which indicate how our processes are performing – I’m not grasping any difference unless for 9.3.2 C2... Are they asking that I perform additional math and state: Our goal was 90%, we hit 80% so the extent we reached our objective was 88.89%?
SECOND:
What is the difference between:
9.3.2 C3. ... and Conformity of Products... VERSUS
9.3.2 C4. Nonconformities... VERSUS
9.3.2 C5. Monitoring and Measuring Results VERSUS
9.3.2.1 d. Product Conformance
NC’s and CA’s would also be covered in 9.3.2 C1, 9.3.2 C4, 9.3.2 C6 and (I think) 9.3.2 E (CA Verifications) which, altogether encompass the results of 9.3.2 C5 if the results do not meet requirements.
THIRD:
6.1.2 b2 states
"The organization shall plan how to evaluate the effectiveness of these actions."
How do you accomplish this evaluation for each Management Review and how do you report it in Management Review?
Most of our Risk Analysis is done within FMEA's and Process Maps (which include Risk Identification, rating and Mitigation, as necessary).
It's not feasible to review these each month for every product and procedure.
I think I'm missing the point - there must be a simplified way.
CALGON :mg: Take me away.....
Could someone please provide some examples to help me understand the difference between some bulleted items in 9.3.2 - Management Review Input Requirements.
Many seem redundant or severely overlapping and I don't understand why they are called out so many times in so many ways.
For example, what is the difference between:
9.3.2 C2. The extent to which quality objectives have been met VERSUS
9.3.2 C3. Process Performance.
Our quality objectives are our KPI's which indicate how our processes are performing – I’m not grasping any difference unless for 9.3.2 C2... Are they asking that I perform additional math and state: Our goal was 90%, we hit 80% so the extent we reached our objective was 88.89%?
SECOND:
What is the difference between:
9.3.2 C3. ... and Conformity of Products... VERSUS
9.3.2 C4. Nonconformities... VERSUS
9.3.2 C5. Monitoring and Measuring Results VERSUS
9.3.2.1 d. Product Conformance
NC’s and CA’s would also be covered in 9.3.2 C1, 9.3.2 C4, 9.3.2 C6 and (I think) 9.3.2 E (CA Verifications) which, altogether encompass the results of 9.3.2 C5 if the results do not meet requirements.
THIRD:
6.1.2 b2 states
"The organization shall plan how to evaluate the effectiveness of these actions."
How do you accomplish this evaluation for each Management Review and how do you report it in Management Review?
Most of our Risk Analysis is done within FMEA's and Process Maps (which include Risk Identification, rating and Mitigation, as necessary).
It's not feasible to review these each month for every product and procedure.
I think I'm missing the point - there must be a simplified way.
CALGON :mg: Take me away.....