Difference between "data analysis" and "management review"

[thirdplanet]

I'm a little confused about how "data analysis" and "management review" are related, or possibly, redundant?

Both say they "do" something in order to ensure or demonstrate that the QMS is "suitable, adequate, and effective"

Several inputs are listed for both, "feedback" and "audits" are common to both.

Both appear to cover the data from monitoring process performance, as well as the actual output of the process itself. For instance, monitoring the performance of the "feedback" process, but also, the feedback itself.

Both appear to initiate CAPA's given the wording in the standard.

Any help would be appreciated. I'm pretty sure management review would be best as a single procedure. But I'm not sure if data analysis is more "distributed" and could simply take place as needed throughout the QMS. For instance, inside management review.

 

[Scanton]

I don’t know about everyone else, however my data analysis takes the form of KPI’s that are collated and reported on a monthly basis. This information is reviewed at my quarterly objectives reviews, and all of this information is fed into my annual management review. So from my standpoint, the difference "data analysis" and "management review" is that the former is conducted much more frequently than the latter.

 

[medical_eng]

Hi thirdplanet,

Interesting post. If you are referring to clause 8.4 in ISO 13485:2016, this is one example of many where (in my opinion) the standard confounds its focus on the product/production process meeting requirements versus checking (or closing the loop on) whether the QMS is operating properly. Both are important, but the QMS is the ***Management System*** and thus has 'oversight' of any direct product or process measurements/controls.

The best chance to keep this all clear and have it make sense is to separate any product/process measurements from any measurements related to the QMS itself (like internal audit NCs and customer feedback metrics). Both then are inputs to management review.

My 0.02$ Hope it helps.

 

[somashekar]

Any data from any process, analysed statistically or otherwise, with the intention of giving the status or inference of the measured process forms the data analysis.

Management review is the process of agreement or disagreement of the status or inference, and further setting new directions, to be reviewed again after a defined time-frame. This direction may also include to maintain status, and to include any new analysis of the available data or to gather new data and analyse.

 

[moounir]

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)

------------------------------- Start --------------------------------------------
...
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)
...
---------------------------------- END ------------------------------------------------------

Let me know if this helps you to see the difference or the connection between Data Analysis and Management Review.