How to satisfy the Management Review requirement without a meeting?

M

MEDQA

#1
PLEASE HELP

I need to complete implementing an ISO 9001 compliant QMS in warp speed. I have a grip on most processes. I have a history with 13485. I have come to realize that a MEETING is not required for management review. I need input / guidance on how to satisfy Management review w/out the meeting. I know we are reviewing these things, I'm just NOT feeling confident that I can sell it that way, as I have never participated in a Non meeting Management Review.

thanks to all :mg:
 
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Richard Regalado

Trusted Information Resource
#2
Re: How to satisfy Managment Review w/out a meetingf

Delegate the required (and desired) inputs to the management review to named persons in the organization. Information of audit results could be delegated to the lead auditor. Changes to the QMS maybe to the QMR or for external changes due to legislation to the Compliance Officer.

All of these information be sent (read: emailed) to top management. Top management reviews these information and revert back with their response.

Ensure the context of management's response is in alignment with the required management review outputs.
 

Ajit Basrur

Staff member
Admin
#3
Re: How to satisfy Managment Review w/out a meetingf

PLEASE HELP

I need to complete implementing an ISO 9001 compliant QMS in warp speed. I have a grip on most processes. I have a history with 13485. I have come to realize that a MEETING is not required for management review. I need input / guidance on how to satisfy Management review w/out the meeting. I know we are reviewing these things, I'm just NOT feeling confident that I can sell it that way, as I have never participated in a Non meeting Management Review.

thanks to all :mg:
No shortcuts please :)

My :2cents: is that the meeting is very important as everyone can talk and discuss face to face. Just slot in some time and could even plan a lunch meeting - people would love it !
 

Big Jim

Super Moderator
#4
Re: How to satisfy Managment Review w/out a meetingf

I've posted on this before. It can be done, but the effort to do it effectively may be more than it's worth.

In western cultures the harmony to make it work usually just isn't there.

The technique for having a management review can follow the pattern of a Japanese practice known as Ringi.

In Ringi, a document is drafted by a member of management concerning an improvement he wishes to propose. This document is known as a Ringushi. The Ringushi is passed from one manager to another, and each manager makes comments on the Ringushi. The Ringushi circulates until there is concurrence. Once concurrence is reached, if the determination is to go ahead, implementation is instant.

To apply this to management review, collect all the data pertinent to the inputs, and pass them to the management review team, collecting their comments along the way. The last item of the inputs is recommendations for improvement. Once the management review team reaches consensus on the recommendations for improvement and resources needs are determined, management review is complete except for the implementation of the action items. Implementation doesn't take place in conventional management review either.
 

somashekar

Staff member
Super Moderator
#5
MEDQA.... you are the MR....right ?
The requirement is that your management reviews all the necessary inputs and gives out meaningful outputs for the improvement of the QMS ...right ?
So do not take a big bundle to the management. From all the areas that management concern has to be demonstrated, prepare from the information and data available the plan for each, the check done on them and the direction these process areas are heading towards...(the inputs)
You find them in the right direction ... discuss with management (the person responsible) and find out if this still needs to be tweeked a bit to improve. Record the impressions and thoughts...(the outputs)
You find some in the other diretion... discuss with the management (the person responsible) and suggest your action to tweek them to improve. Never make the mistake of proposing new resources without exploring all other options available. Record the impressions and thoughts...(the outputs)
Let us know if you feel there is a need for anything more than this ~~~
 
Last edited:

Richard Regalado

Trusted Information Resource
#6
Re: How to satisfy Managment Review w/out a meetingf

But in multi-national corporations, time is NOT all you need for a face-to-face meeting. You would need hotel bookings, transfer, airline tickets, food, representations, etc.

All for something which you can accomplish using technology and infrastructure that is already there such as email, Skype (TM), etc.

Use technology to enable the management system.

Besides, top management would surely love to review the inputs and provide outputs on their iPad while sunbathing in the Bahamas. :)

Get the job done with what you have.

Don't get obsessed with meetings and minutes. There are other methods. Focus on the real issue. The issue is NOT the meetings. NOT the minutes. NOT the consensus. The issue is ACCOUNTABILITY. Meetings or not make sure you get this.
 
M

MEDQA

#7
Yes, i am the MR.

Thanks for the suggestions.

I have to search the boards a bit more for other references, sit back look at the requirements and try to forget about how we satisfied this requ. on a different project.

I also need to sell it or train a director on the requirement and be prepared to answer questions etc. (might go okay, might not be very successful)

I will be back for more support on this and other subjects.

I also need to investigate other ways to evaluate and communicate suppliers. Some of our suppliers are the ONLY supplier and therefore it does not matter if we spend $50k+reworking their materials b/c we can't go anywhere else.
 

Jim Wynne

Staff member
Admin
#8
The whole point of the requirement for management review is to provide evidence that top management is actually engaged in the operation of the the QMS. Here's what ISO 9001:2008 says, in part:

"Top management shall review the organization's quality management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness."

I think the "planned intervals" thing is mostly what prompts the idea that a meeting or some sort of event is necessary, and I think the phrase should be gotten rid of. At any rate, this is the responsibility of TOP management. There is only one "top." If the input required by the standard is provided to the top manager on an ongoing, continual basis, and the top manager hasn't completely abdicated responsibility, it should be a simple matter for her to (a) review the inputs "at planned intervals," (b) make a record of same and (c) provide the output required by the standard.

Does no one think it odd or ironic that some underling is given the responsibility to organize a meeting to accomplish what the standard clearly states is top management's responsibility? What can we say about a company whose top management has to be periodically prodded into doing its job?

 
M

MEDQA

#10
Specifically relating to the subject of Management Review... Do we need to identify who top management is or who is required to participate?

It was an issue in the past with another project where our procedure listed who would be present in the meetings. Then certain people rarely if ever showed up. Someone from the top was ALWAYS present, just not everyone from the list.

thanks
 
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