Does Management Review need to be a Formal Meeting?

[JaneB]

I have a question not regarding Management review but about follow up of the meeting.
as per our system we perform Management reviews every four months.
However, follow up is the weak area since no body respond to it. I used Ms. Outlook tasks, emails, one to one meetings etc but nothing worked.
In the review meeting I have been the real scapegoat since everybody has some job to do except MR. he just waste time.
What's the solution.

Hard to diagnose the problem (& thus suggest a solution) without knowing why this is happening. There's all kinds of possible reasons... please provide some more background and why you think they don't follow up. For example:

• Who calls the meeting?
• Is it integrated into the organisation, or seen as a thing apart?
• Who chairs it?
• What's the agenda?
• Who attends?
• What other meetings/review activities take place?
• What's management commitment like?
• How is your organisation doing at CA and PA?? Doing it effectively?
• What have external auditors said about this important area?

Doing management review effectively includes follow-up - just holding a meeting certainly isn't enough. How is the requirement of 5.6.2 (f) met?

 

[Michael Malis]

Yes, if you are in the Medical Field.

You require to review all the elements of the Q. System with the upper management to make sure that they are aware of the issues (complaints, CAPA's, trends, product recalls) and have the right amount of resources to solve problems...

 

[JaneB]

Yes, if you are in the Medical Field.

This is the ISO 9001 forum. As has already been pointed out - exhaustively - nowhere in that Standard does it require a meeting.

Yes, review IS required. No one is disputing that. But the format or forum for that review (or reviews) is not mandated. (Rightly so).

You say 'if you are in the Medical field' it does... would you please quote the relevant authority - ie, which clause/sub-clause of the relevant Standard are you basis your opinion on? Is it possible you're thinking of another Standard instead?

 

[harry]

........................................ Doing management review effectively includes follow-up - just holding a meeting certainly isn't enough. How is the requirement of 5.6.2 (f) met?

Yes, if you are in the Medical Field.

You require to review all the elements of the Q. System with the upper management to make sure that they are aware of the issues (complaints, CAPA's, trends, product recalls) and have the right amount of resources to solve problems...

Hi Jane, I think Michael's post as quoted above was made to express agreement with the last part of your previous post.

And to Michael, Welcome to the forum. I know you are new here and one of the good practice that I would like to recommend is to 'quote' the part of any post that you are replying. Just use the 'QUOTE' button (beside 'Edit').

 

[JaneB]

Hi Jane, I think Michael's post as quoted above was made to express agreement with the last part of your previous post.

Really? You you may be right, Harry, but I reached a different conclusion and read Michael's post as a 'Yes' to the question asked in the title ie, Yes you must have a meeting if you are in the medical field.

There you go, Michael, two completely different interpretations of your post - but welcome to the Cove all the same

Good advice though, that it's easier to be clear if the Quote button is used.

 

[Wes Bucey]

This is the ISO 9001 forum. As has already been pointed out - exhaustively - nowhere in that Standard does it require a meeting.

Yes, review IS required. No one is disputing that. But the format or forum for that review (or reviews) is not mandated. (Rightly so).

You say 'if you are in the Medical field' it does... would you please quote the relevant authority - ie, which clause/sub-clause of the relevant Standard are you basis your opinion on? Is it possible you're thinking of another Standard instead?

I'm pretty familiar with ISO 13485 (medical devices) and FDA regulations for both medical devices and pharmaceuticals and I don't recall any requirement for meeting. I, too, would be extremely interested to learn of a citation in any Standard or Regulation mandating meeting versus review.

 

[Big Jim]

I'm currently working out the agenda items for MR and I'm just thinking if all agenda items must be treated as a discussion thread in the MR meeting.

Let me clarify my point.

As per the standard, the following MR inputs are to be:
a) results of audits,
b) customer feedback,
c) process performance and product conformity,
d) status of preventive and corrective actions,
e) follow-up actions from previous management reviews,
f) changes that could affect the quality management system, and
g) recommendations for improvement.

If i use technology and send MR members an email, for example monthly status update with nice graphs, statistics etc... on Customer complaints etc.. and invite members for comments. Can same address item b)?

I can also do a similar status on Corrective actions, without having to formally convene a meeting.

I hope that i'm not too forward-looking.

Awaiting your comments.

Thanks

And I must add that your list has missed a required topic or two. They are little stealthy as they are not part of the list form 5.6.2 and 5.6.3. They are hidden in the last sentence of 5.6.1. They are the quality policy and quality objectives.

I must also weigh in here with the no meeting required by the standard crowd. I have a few clients that have their management review without meetings. The most unusual one uses a form of Japanese management style called "ringi". A document (the "ringushu") is passed from manager to manager. Each manager makes notes along the way. It circulates until all come to agreement. It is not a Japanese company, and they do not use this method for other decision making. To bad that they don't, as their management reviews are VERY effective. Some of their other decisions have not done so well.

 

[jkuil]

ISO TR 14969:2004 Medical devices — Quality management systems — Guidance on the application of ISO 13485:2003 states that the method of carrying out the review should suit the organization’s business practices and could consist of

• a formal face-to-face meeting, a teleconference or other method form of electronic meeting, or
• partial reviews at various levels within an organization, reporting to the top management who review the reports.

It doen't say again that a meeting is required in the latter bullet. However, in my experience a management review is most effective when managers can discuss the input metrics. E.g. can anyone show me some metrics which can be read/reviewed without explanation. It is not only numbers that count, it is the story behind it. Every manager will have its own perspective on the data, and the more these perspectives are shared and discussed, the more effective the management review (and the organization as a whole) will be.

So, please look a what would be the most effective practice in your organization as the technical report requires. Even though this TR might not apply to your industry, I do think this is best practice.
Possibly, in QMMIKE's case the MR method was not effective, resulting in the incorrectly written NC.

 

[Michael Malis]

ISO TR 14969:2004 Medical devices — Quality management systems — Guidance on the application of ISO 13485:2003 states that the method of carrying out the review should suit the organization’s business practices and could consist of

• a formal face-to-face meeting, a teleconference or other method form of electronic meeting, or
• partial reviews at various levels within an organization, reporting to the top management who review the reports.

It doen't say again that a meeting is required in the latter bullet. However, in my experience a management review is most effective when managers can discuss the input metrics. E.g. can anyone show me some metrics which can be read/reviewed without explanation. It is not only numbers that count, it is the story behind it. Every manager will have its own perspective on the data, and the more these perspectives are shared and discussed, the more effective the management review (and the organization as a whole) will be.

So, please look a what would be the most effective practice in your organization as the technical report requires. Even though this TR might not apply to your industry, I do think this is best practice.
Possibly, in QMMIKE's case the MR method was not effective, resulting in the incorrectly written NC.

Thanks Jan,

This is right on target...face-to-face meeting or partial review at various levels. However, with "various level review" you can't collect feedback from everyone at the same time. Therefore, this type of review will not be as effective as face to face meeting! In addition, you need to get an agreement from everyone that your QS is effective or has same issues and require some actions.

 

[jkuil]

Examples of multilevel MRs that can be very effective:

• For a multisite organization MRs are held per site, reporting the results to the corporate executive MR.
• A MR is conducted per business unit, again results reported to the corporate MR

In these cases the corporate MR can be held at lower frequency than the lower level MRs.