Hi ThirdPlanet,
Surprisingly I received a question similar to yours. This person was asking me about clause 8.4 and what she needed to do. But as I talked about that I also mentioned the connection to the Management Review.
Here is the answer I provided (Copy Paste of a piece of my email without editing)
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First, Clause 8.4 is classic for KPIs management. (Key Performance Indicators)
So what you should have normally is a procedure for each of the KPI.
Let's say for CAPA (clause 8.5), you have your procedure describing your CAPA and inside this procedure, you include a chapter about KPIs to tell you how you are measuring that this process is working well.
Usually, I am not putting numerical numbers inside the procedure but I create a document referenced on this procedure.
On this document, I list all the KPIs:
- How I measure them
- What are the thresholds
- When is it considered as a trend
- What should I do if a trend appears
etc,
On this document, I list not only CAPA but also complaints, document control, Supplier issues (SCAR), Audit observations... with all the information related to KPIs. I list them in a separate document as they can maybe change from one year to another. So instead to change all your procedures, you just change this document.
Typical KPI for CAPAs are:
- Timeliness: How long this CAPA should stay in the investigation before to move to implementation of the actions
- Aging: How long this CAPA has been opened
- Extensions: How many extensions of timeline you had to issue
Threshold:
- Timeliness: CAPA should move to investigation within 45 days
- Aging: CAPA should not be open more than 2 years
- Extensions: 0 extensions without good justification
Trending:
- If Timeliness is RED (more than 45 days) during 3 months, a full investigation to be done on the process.
...
For each KPI you should define what you consider a trend and justify it. Cannot say that RED during 1 year is OK.
Don't put too much KPI. Just those related to your Quality System.
- CAPA, NC, Observations
- Customer Complaints
- Product scrap or failure during production
- Supplier issues
- Maintenance reports, Service reports...
(These are linked to Clause 8.4 inputs)
All those data should normally be gathered and discussed during your Management Review. You can open actions related to these KPIs to improve them. Then during that management review, you should define if your Quality System is efficient or not. (I never saw someone saying that it's not efficient as we are trying to have a justification for all potential issue.) If you estimate anyway that your Quality System is not efficient, you need to put in place a project (CAPA) and evaluate the reason and actions you should implement to correct that.
Your management review should be every quarter so tracking of the actions is more under focus.
So if I should summarise:
- Procedures should mention that this process is under performance review through KPIs
- Official KPIs for each process are listed on a separate document (This document should be referenced on the procedures)
- If threshold pass or if there is a trend, implement the actions that were agreed on the procedure.
- All the data are reviewed during the management review. And management should assess if Quality System is efficient (And write it on the report)
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Let me know if this helps you to see the difference or the connection between Data Analysis and Management Review.