What is the difference between AS9100D 9.3.2.f and 9.3.3.a

QE1993

Involved In Discussions
#1
Namely, what is the standard intending when they want us to discuss OFI's as in input to mgmnt review versus as an output?

For 9.3.2.f, should we discuss what OFIs have already been taken and 9.3.3a should be OFI's that should be taken as an outcome of the review?

If it's the former, how is that different from 9.3.2e - the effectiveness of actions taken to address risk and opportunities?
 
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John Predmore

Quite Involved in Discussions
#2
From AS9100:D
9.3.2 Management Review Inputs The management review shall be planned and carried out taking into consideration ... information on the performance and effectiveness of the QMS, including trends in: ... [a list] ... f. opportunities for improvement.
9.3.3 Management Review Outputs The outputs of the management review shall include decisions and actions related to: a. opportunities for improvement; ... [list continues]

The same words Opportunities for Improvement are listed in both inputs and outputs. In 9.3.2, before the M.R., you are planning to discuss performance and effectiveness ... of your firm's efforts on OFIs. I suppose "trends" could include meta-data such as how many OFIs identified, OFIs from which sources, how many chosen to pursue, what percent complete, average time to project completion, and so on.

In 9.3.3, the record of the M.R. shall include decisions and actions related to OFIs [which arise at the M.R.], (based on the context of other items on the list).

I suppose discussing the management and trends of OFIs might be a different topic from effectiveness of actions taken to address risks and opportunities, those actions could include audit findings, Corrective Actions and other projects beyond OFIs. If there is overlap, that is okay too.
 

pziemlewicz

Involved In Discussions
#3
Use 9.3.2 like an agenda of items to be covered in your Management Review meetings, fitting each of your KPI's under one of sub-clauses.

At the end of the Management Review meeting, you should have the items listed in 9.3.3 covered in your meeting minutes and/or a Management Review Action Items list.

Usually an opportunity brought to the meeting as an input translates into an assigned action on output. A KPI trending downward as a meeting input should result in an investigation of OFI for output.
 

QE1993

Involved In Discussions
#4
From AS9100:D
9.3.2 Management Review Inputs The management review shall be planned and carried out taking into consideration ... information on the performance and effectiveness of the QMS, including trends in: ... [a list] ... f. opportunities for improvement.
9.3.3 Management Review Outputs The outputs of the management review shall include decisions and actions related to: a. opportunities for improvement; ... [list continues]

The same words Opportunities for Improvement are listed in both inputs and outputs. In 9.3.2, before the M.R., you are planning to discuss performance and effectiveness ... of your firm's efforts on OFIs. I suppose "trends" could include meta-data such as how many OFIs identified, OFIs from which sources, how many chosen to pursue, what percent complete, average time to project completion, and so on.

In 9.3.3, the record of the M.R. shall include decisions and actions related to OFIs [which arise at the M.R.], (based on the context of other items on the list).

I suppose discussing the management and trends of OFIs might be a different topic from effectiveness of actions taken to address risks and opportunities, those actions could include audit findings, Corrective Actions and other projects beyond OFIs. If there is overlap, that is okay too.
This is what I thought and was afraid of. That's my problem. We have no formal system for tracking/trending OFI's, other than CAs; however, CA's are their own specific input, so I don't think 9.3.2.f would be the appropriate place to talk about them.

Right now, 9.3.2.f, I'm just having each manager present any OFI's (these are all undocumented) they've already taken in their departments. There's no statistics or numbers behind it.

How do other people document OFI's and is it different from your CAPA system?
 

pziemlewicz

Involved In Discussions
#5
I use a PowerPoint deck/template for the meeting. Process owners put in their assigned slides/date beforehand. I print the slides w/ notes (3/page) and keep minutes on the printout as the meeting goes; afterwards this is scanned in as a record.

Alongside of this, I use 3W for Managment Review Action Items that come from the meeting. This is a living document (xls with auto-filter).

The combination of these two has served me well in audits (4 auditors, across 2 registrars).
 

Big Jim

Trusted Information Resource
#6
One of the better treatments I have seen on this is handled on the management review agenda.

The last topic under inputs is "Potential Opportunities for Improvement (potential action items). The first topic under outputs is "Approved Opportunities for Improvement (new action items).
 

Kirby

Involved In Discussions
#7
I just recently "signed-up" on this site but I've been consulting it for a few years, I think the concept is great and the "members" are super, thanks for everybody that shares their knowledge, experiences, and expertise.

Big Jim, do you think you'd be willing to share that agenda?
 

John Predmore

Quite Involved in Discussions
#8
How do other people document OFI's and is it different from your CAPA system?
I am the Quality Manager at a small company. We keep separate "logs" in spreadsheets of Corrective Action projects and Improvement projects, and other metrics we are tracking such as Non-conforming product and Document Control Log. Our management team reviews our QMS quarterly, and I report on both lists as well as trends in metrics. One of our Quality Objectives is to continually improve our QMS, and our metric is number of improvement projects closed in a time frame. A lot of the small projects we start every week improve product quality or communications or some other aspect of our system, I just remember to put them on the list. The Operations Manager and I meet monthly to review all our logs, and two of us strive to keep all the lists up-to-date. Keep It Simple, Silly.
 
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