I am just curious to find out if most people address Management Review in the Quality Manual (only) or if you have a Management Review procedure? Please post to the poll. Also, if anyone would like to share their procedure please do so.

mshell

I never liked having a MR procedure when I was quality manager. I felt it was a waste of time & effort. I typically recommend using a form. It helps to ensure that all of the required inputs, outputs, and topics are covered. I posted an example of one recently in another thread...

I am leaning in the direction of a form as well. I have referenced Management Review in all of the relevant procedures and the quality manual. I do not want to create a procedure if it can be avoided.

We have a process map for Business Planning and Management Review included in the QPM accompanied by a couple of paragraphs of text.

howste,

I think that I found the form that you referenced. I have modified it just a bit. Let me know what you all think. Will this satisfy the requuirements for Management Review? :bigwave:

Thanks,

Michelle

We have a procedure for MR. Of course, there is no requirement for a MR procedure, but for us it makes sense to have one. In fact there is no requirement for a MR meeting per se...

We are required to review the organization's quality management system, at planned intervals.

/Claes

I am leaning in the direction of a form as well. I have referenced Management Review in all of the relevant procedures and the quality manual. I do not want to create a procedure if it can be avoided.Our Management Review Procedure is an organization-wide document. It is NOT a Work Instruction, but a broadly-written document which allows creativity and THOUGHT by managers in setting or modifying timetables for review of different processes throughout the organization. Similarly, it allows some processes to be reviewed by a single manager and others to include several managers and manager levels to deal with processes which may encompass more than one department.

The key ingredient is flexibility to conform to the needs of our organization as they may be perceived at a particular point in time. (For instance, we do not defer a management review on a "hot" item just because it isn't due for review until next quarter. Similarly, we don't drop everything to review a non-critical process just because the Corrective Action Report hits the manager's desk today.) Many items do not require a committee meeting for action to be determined (modify or let stand) and can be reviewed by one person or several by circulating the folder containing information to the appropriate manager(s).

Michelle, Have you addressed process performance from 5.6.2c? You may have it covered in the objectives, but it's not clear when the form is blank. It could meet the requirements, depending on what information you put into it.

Of course the real test to see if the form works for you is to try it out. If it's easy to use and reminds you to include all of the "right stuff" then it's great. If it's cumbersome and gets in the way, then tweak it some more or work something else out.

You are right, I did overlook process performance. :o (thanks) As for the objectives, they are not set at this point so I could not include them. I am still working on getting the quality policy in writing.

Michelle

i like to keep the QA manual so generic that it doesn't change much, so i do a procedure (one pager or even a flow chart showing the minimum input, who is responsible for the report/handout for the topic, minimum attendance...and the out put....also use a form for agenda and minutes (same form, and similar to above) mark it up during the meeting and attach it to the reports presented and its done...also keep an action item log for the management team to use at "unplanned meetings" that feeds back.

We try to keep it simple.

I never liked having a MR procedure when I was quality manager. I felt it was a waste of time & effort. I typically recommend using a form. It helps to ensure that all of the required inputs, outputs, and topics are covered. I posted an example of one recently in another thread...

I would tend to agree. :agree:

Our Manual states what the standard states...very little variation.

Our documented process states the frequency, provides details of the agenda, and indicates minimum attendence requirements.

Our agenda is the checklist for the review to make sure all appropriate topics have been addressed.

Thanks to all for the input. I do believe that I am going to limit the definition of Management Review to the Quality Manual rather than create another procedure. I will use an approved form to ensure that all topics are covered.

Thanks again,

Michelle :bigwave:

We try to keep it simple.

Randy,

Excellent. Simple and Effective (KISS).
As of yesterday (I have a new Boss) we are planning to throw out ALL of our procedures. Our QM will become a process flow manual (show each department: Who, What, Where, When and Why). Our WI and Forms will remain the same (How and Records). We will possibly have the 'Basic 6' as procedures or as Quality WI (most likely). Our new tier will be Policy, Manual, WI. Thus eliminating an entire tier of paperwork. I should put this up as a new thread.

Sorry Michelle. My answer is that currently we have Man Rev in the QM and A procedure. See attached QSP.

Greg B

Very simple Greg. I like it.

Thanks,

Michelle

We use a procedure, but it is pretty generic. Any input/suggestions on this one? To date I haven't committed to a particular form or checklist because each department provides their information in such varying ways throughout the country. We have one of those sample plan registrations that hinges on 6 different manufacturing locations. We hold one large corporate wide management review each year, with about 4 at each location per year.

Thanks!

Hi everyone,

We had our Certification Audit yesterday and one of the findings that we have:
We were not able to show sufficient evidence that the quality policy and quality
objectives were reviewed to ensure its continuing suitability, adequacy,
and effectiveness, which was against the requirements of clause 5.6.
What are other records that we need to show as evidence? How are
we going to interpret clause 5.6 to enable us to show the conformance
to the said clause?

Thanks in advance.

Best regards,
Raffy

Ok, I see.

5.6.1 requires us to assess ...opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives.

Records from management reviews shall be maintained (see 4.2.4).

If you do the above and make certain that the MR records show it, you should be in the clear...

/Claes

A Management Review Matrix is always a good way to show what went into the analysis of suitability etc. It gives a visual formula of the mix that went into the review process. Include the policy and objectives review in the matrix as part of the mix for each other contributor. When, for example, the contributor Internal Audits is reviewed, consider the effect on policy and objectives and put that into the IA documentation. If this is done with each contributor (which should happen anyway) there should be no question for the auditor.

Dave

We have a Management Review Process, an Agenda and keep minutes as a record along with the agenda.
Paula

Hi everyone,

Thank you for all the inputs.
Yesterday, we conduct a mangement review highlighting
all issues on our previous finding and we made a format
the same with the attached file. Thank you Paula, for the attachment.
And we add a column in our Status of Action Items to track and monitor
the status of each action items. The first column would address the Description
of Activities To Address the Open Actions.

Hi Dave,
How am I going to correlate each item in a Management Review Matrix?
Please advise.

Thanks. :thanx:

Raffy :cool:

My goal is to integrate management review into normal business management processes. We define these processes in our quality manual, and together they ensure all requirements of the standard are met:

1. Weekly operations review & focus meetings: Each Monday we have a meeting of the top management team that focuses on business issues, resource allocation, team/project alignment around objectives, project review, etc. On each other weekday leaders from one of our four focus areas (business generation, operations, technology & development, and support) have a meeting to cover projects, issues, actions, etc., for that functional area (thus the term focus meetings).

2. Monthly current reality meetings: All leaders (managers & supervisors) attend this meeting that focuses on analyzing the current organizational reality as measured by KPI's and the actions to be taken to address identified process, product/service and other deficiencies and improvement opportunities. Within any quarter every major department presents current reality and actions, which is challenged and refined in the meetings.

3. Finally we have a 6-month management review meeting that focuses more on the big-picture review of the QMS. We ensure that all requirements of the standard are met through all three review processes, but don't rehash in this meeting anything that's already dealt with in the other meetings, which tends to make this a very focused and effective meeting.

Key to all of this is from a compliance standpoint is that outputs from all of these meetings are documented and decisions/actions tracked in a database that includes assignments and a badgering process to ensure closed loop action. Our auditor saw this at our last surveillance audit for the first time and loved it. From an internal perspective the weekly and monthly meetings were already in place and simply needed proper records and follow-up added, so it integrates our QMS as a way of business. I know it's not what's thought of as traditional managment review, but it works well for us.

A very good post on the subject of MR, and I missed it...:mybad: . Anyway, now that I found it:
Our auditor saw this at our last surveillance audit for the first time and loved it. From an internal perspective the weekly and monthly meetings were already in place and simply needed proper records and follow-up added, so it integrates our QMS as a way of business.Chessie, this looks great. He should be pleased.

I know it's not what's thought of as traditional managment review, but it works well for us.Not traditional? I'll say it's not. You obviously came up with something that actually works, and that is not always the case. Good job.
:applause:
/Claes

My goal is to integrate management review into normal business management processes. We define these processes in our quality manual, and together they ensure all requirements of the standard are met...

While my organization has a similar set-up to yours, we don't define it in our Quality Manual. It goes into a lower level documentation - didn't wish to clutter up our QM with information. :D

We also have scheduled dates for these meetings. No one can say that they "forgot" about the meeting...they are held on the same day at the same time in the same location...no if's, no and's, no but's.

Operations Review - An "information only" session held on the first Friday of every month. Every department gets up and quickly talks about all yellows and reds on their Key Indicators without going into details or any analysis.

Key Indicators Meeting - Department and crew-specific meeting, attended by Senior Management, too. All deparments have a Key Indicator meeting to review Key Indicators and status of Action Plans (i.e., improvement projects). How's and why's are discussed here as well as countermeasures if none have been thought up by those responsible. Admin, HR, and Shipping are on the 2nd Tuesday, Melt Shop is on the 2nd Wednesday, Rolling Mill is on the 2nd Thursday (that'd be today...in about 1.5 hours), Engineering is the 2nd Friday, QC is on the 3rd Friday.

EMS Review - Exactly what is sounds like. Held on the 2nd Monday.

Business Management System Review - Meeting to go above and beyond the requirements of ISO 9001:2000. Held on the 3rd Monday. They see more than just the numbers from Key Indicators and project status. They get information on Customer Complaints, trends, and the status of the health of the BMS at a high level...not the details I provide at the Key Indicator and OP Review meetings.

Morning Production Meeting - Outgoing and Incoming Supervisors talk, Manager is present (during week), all H&S concerns, downtime, problems, etc. Thirty minutes max!

Key to all of this is from a compliance standpoint is that outputs from all of these meetings are documented and decisions/actions tracked in a database that includes assignments and a badgering process to ensure closed loop action. Our auditor saw this at our last surveillance audit for the first time and loved it. From an internal perspective the weekly and monthly meetings were already in place and simply needed proper records and follow-up added, so it integrates our QMS as a way of business. I know it's not what's thought of as traditional managment review, but it works well for us.

We try to do these meetings for more than just compliance. It's communication...it's allowing everyone to have access to the information they need to do their job. There is, of course, real-time data available through the computer, but these meetings allows for an "executive summary" of the month we've just completed.

Each level of meeting has a set agenda, with designated topics to be reviewed. Minutes are maintained for every meeting.

Sometimes, it feels as if we have too many meetings...information overload, so to speak...but that is only because I'm one of the 7 people who strive to attend all levels of meetings....Senior Management is the other.

RCB, it looks like you've done a great job of finding what works in your environment, and you're right...it is conceptually similar to what we do, but clearly aligned with your needs.
We try to do these meetings for more than just compliance.
Exactly! :yes: My approach is to deal with compliance almost as an afterthought in all areas of our QMS. That sometimes results in unorthodox processes but it also ensures that what we do adds value on its own. Of course I'm not above using the standard as leverage once in awhile (closed loop follow-up process for example). ;)

Randy,

How do you measure Cost of Quality at TDM?

Just to let you know, I'm not at TDM any more but I can still answer your question.

There were a bunch of things to take into consideration, we were a prototype shop and changes were constant. It was imperative that the contract and amendments to contracts were specific and up to date.
We did studies to determine how much time it took to build a particular assembly {i.e. hood assembly, door assembly, etc.}. Any time that was added to those bench marks and NOT covered by a change authorization was considered rework. I had a standard charge per hour {average wage + machine time/engineering time} and doubled it. In some cases it is better to triple the cost to get closer to actual reverberations though. This will take into account lost oportunities {should be working on other jobs}, timing compressions {to make deliveries}, ripple affect {timing changes to other departments}, lost customer confidence, excessive freight, etc.

The Management Review has to be in the manual.

We have a procedure as well... just for clarification.

And we don't use forms... because forms don't leave room for innovation.

As an auditor, I hate to see forms. Tells me that the company doesn't know how to conduct a management review.

The Management Review has to be in the manual.It does? :confused: Where is that requirement? We mention it in our process overview and have a reference to all documented procedures. That's all.

/Claes

It does? :confused: Where is that requirement? We mention it in our process overview and have a reference to all documented procedures. That's all.

/Claes

Claes,
We now do the same. It is mentioned in the manual, but not expanded on, it directs you to our one page flowchart procedure. Which happens to be back at Post number #15 (7th Nov) in this thread. It is part of our KISS principle.

Example Management Review Procedure (http://elsmar.com/Forums/attachment.php?attachmentid=1547)

Greg B

Here are the process diagram and text from our QPM that I referenced in the beginning of this thread.

I haven't seen Garry around for a while - but he would surely recognize his work - I modified the diagram he so kindly shared with us to reflect our Mgt Rev. One of my favorite new quotes comes from SteelMaiden: "My lack of imagination is usually made up for by my ability to take an idea and modify or improve upon it." MY MANTRA!!

Another of the attachments is our Auditing and Management Review Schedule - I create an agenda per meeting, which is also a Meeting Memo, so people can prepare for the meeting in advance. I've attached some samples of our agenda and minutes as well. These are what I've prepared so far for our meeting next month - they all already say "minutes" in the header because once we have our meeting I will add our comments, ideas, goals we've set, etc. I just open the document and insert my handwritten minutes.

We have a procedure for management review but I would like to obsolete it and add the requirements in the quality manual otherwise it is plain duplication.

I also use the management review minutes as the record. It includes all inputs and outputs in descriptive style. Also there are several input charts to substantiate the minutes.

If there are other important matters relating to the overall objectives or quality system, we have weekly management meeting to discuss these issues. It also covers the requirement of internal communication.

We include Mgt review in the manual and in a separate document called Strategic Planning. This document list all regular and ongoing meetings that deal with planning and problem solving. Each meeting is given a title, contains a brief description of what the purpose is and lists any mandatory attendees as well as optional attendees...

We include Mgt review in the manual and in a separate document called Strategic Planning. This document list all regular and ongoing meetings that deal with planning and problem solving. Each meeting is given a title, contains a brief description of what the purpose is and lists any mandatory attendees as well as optional attendees...
As described, "Strategic Planning" is the Agenda and subsequent RECORD of the meetings which include management review. If you do not include the record of who actually attended and what action items were actually discussed, you are missing a good opportunity to keep everything in one nice, neat package.

I guess I forgot to include the obvious. It is the meetings in listed in the strategic planning procedure that absolutely must provide meeting minutes, therfore ensuring records are maintained.

I guess I forgot to include the obvious. It is the meetings in listed in the strategic planning procedure that absolutely must provide meeting minutes, therfore ensuring records are maintained.

Don't beat yourself up too bad - I've had to create a new meeting in order to meet the Mgt. Review requirements within ISO 9001:2000. Our executive group does a great job of having cross-functional offsite and planning sessions, but they don't keep public minutes, so instead of integrating a review of the QMS into the strategic meetings we have separate meetings. Yes it is inefficient, but just another example of how you can adjust business practices to meet requirements. The sad part is that they do a great job, they just don't see the value in integration and documentation at their level.

Don't beat yourself up too bad - I've had to create a new meeting in order to meet the Mgt. Review requirements within ISO 9001:2000. Our executive group does a great job of having cross-functional offsite and planning sessions, but they don't keep public minutes, so instead of integrating a review of the QMS into the strategic meetings we have separate meetings. Yes it is inefficient, but just another example of how you can adjust business practices to meet requirements. The sad part is that they do a great job, they just don't see the value in integration and documentation at their level.
My take on the issue:

Minutes must be kept
Minutes do not have to be "public"
[public within the organization - they certainly do not have to be public outside the organization]
"Action" items must be disclosed to the people they affect
A summary of items deferred or denied action should also be disclosed to affected persons
One of the major shortcomings of "suggestion programs" at organizations (suggestions need management review) is lack of feedback to individuals making suggestions as well as to the organization as a whole on items considered and rejected (to reduce duplicate suggestions and to act as a guidepost for future suggestions) together with a rationale for rejection.

In my opinion this all depends on the size & functions of the organization. It could be mentioned in the Quality Manual as well as could be a seperate procedure. Intention should be to improve the organization.

My take on the issue:
[public within the organization - they certainly do not have to be public outside the organization]


I umderstand from a FDA Audit POV that they can not review the minutes from MR meetings - (5th amendment - protects us).
However, what if the External ISO Auditor wants to look at them, should we allow it?

Craig.

I umderstand from a FDA Audit POV that they can not review the minutes from MR meetings - (5th amendment - protects us).
However, what if the External ISO Auditor wants to look at them, should we allow it?
My further take on the question:
Any auditor (short of one with a court order or search warrant) may determine if the organization has a management review system by seeing the written procedure and even by seeing a filing cabinet (or computer menu) of reports of the reviews, BUT no organization is required to disclose the substance of those reviews to third parties any more than they would show trade secrets to third parties (trade secrets could include secret formulas, marketing strategies, or just salary levels of individuals.)

If you would be willing have those reports printed on the front page of the New York Times or Wall Street Journal, or sent to all your competitors, by all means, feel free to let an auditor browse through them.

My further take on the question:
Any auditor (short of one with a court order or search warrant) may determine if the organization has a management review system by seeing the written procedure and even by seeing a filing cabinet (or computer menu) of reports of the reviews, BUT no organization is required to disclose the substance of those reviews to third parties any more than they would show trade secrets to third parties (trade secrets could include secret formulas, marketing strategies, or just salary levels of individuals.)

If you would be willing have those reports printed on the front page of the New York Times or Wall Street Journal, or sent to all your competitors, by all means, feel free to let an auditor browse through them.BIG disagreement here. Third party auditors (at least the serious ones) will demand to see the contents of the management review records, in order to ensure that the minimum requirements for input and output are being satisfied. Your proposal is not supported by the Standard since you are not required to have a procedure for management reviews, nor you are required to have hard copies of such records. For a company that has only electronic copies of the management review records, what would they do? Point a computer to the auditor and tell: Trust me we have records of management reviews in the hard disk drive of this computer. This is a ludicrous suggestion....

Further, such records will determine if action items from previous reviews have been dealt with or not. Any 3rd party auditor worth his/her salt would not accept not having access to such records.

All of the records are protected by confidentiality clauses and, I can guarantee to you that it happens hundreds of times every day, around the World and, still, you will never see that (leaked information) on the front page of the NY Times, Wall Street Journal, or any other newspaper anywhere. The Regulatory Auditors approach to review of records is different.

Waiting for the return fire....

BIG disagreement here. Third party auditors (at least the serious ones) will demand to see the contents of the management review records, in order to ensure that the minimum requirements for input and output are being satisfied. Your proposal is not supported by the Standard since you are not required to have a procedure for management reviews, nor you are required to have hard copies of such records. For a company that has only electronic copies of the management review records, what would they do? Point a computer to the auditor and tell: Trust me we have records of management reviews in the hard disk drive of this computer. This is a ludicrous suggestion....

Further, such records will determine if action items from previous reviews have been dealt with or not. Any 3rd party auditor worth his/her salt would not accept not having access to such records.

All of the records are protected by confidentiality clauses and, I can guarantee to you that it happens hundreds of time every day, around the World and, still, you will never see that (leaked information) on the front page of the NY Times, Wall Street Journal, or any other newspaper anywhere. The Regulatory Auditors approach to review of records is different.

Waiting for the return fire....
Not to pick a fight, but could you cite chapter and verse in the requirements for 3rd party auditors that they have to see the CONTENT of the management review versus the fact the management review process exists?

It seems to me the methodology you describe treads dangerously close on the auditor making a DECISION about the efficacy of the management review versus the presence of a management review.

Determining the presence seems a viable audit function. Determining whether the content meets the auditor's concept of "minimum requirements for input and output are being satisfied" seems more like an advising or consulting function than auditing.

One of the major complaints I hear about third party auditors is "they tried to tell me how to run my business."

Next, the auditor will be determining whether the method of training an employee to perform a task is sufficient. Following that, the auditor will reinspect product and determine the inspection process is inadequate and that there is insufficient attention to transferring information to a continuous improvement program.

After that, the auditor will determine whether the Contract Review process is adequate and whether the auditee is charging too much or not enough money for a product or service.

Perhaps the auditor will take biological samples from surfaces in the lavatory and determine the infrastructure does not meet the auditor's concept of hygiene.

All of these items, of course, are spelled out specifically in EVERY third party registrar contract that the auditee will comply with any request by an auditor, no matter whether the auditor can cite a Standard clause to justify the request.

Although I, personally, argue for open disclosure by management, I recognize and respect the right (even necessity) for some managements to keep things VERY CLOSE to their vests. Coming from a background of dealing with mergers and acquisitions and public offerings of debt and equities, I can see where some managements may be very loathe to disclose information for fear of regulators pawing through back history to see who might have garnered inside information on a pending transaction.

The option, of course, is for managements to keep TWO sets of management review minutes - one for their own personal use and one for the auditor (smell kind of like Enron to anyone?)

If anyone senses a strong odor of irony here, it is all intended.

Not to pick a fight, but could you cite chapter and verse in the requirements for 3rd party auditors that they have to see the CONTENT of the management review versus the fact the management review process exists?

It seems to me the methodology you describe treads dangerously close on the auditor making a DECISION about the efficacy of the management review versus the presence of a management review.

Determining the presence seems a viable audit function. Determining whether the content meets the auditor's concept of "minimum requirements for input and output are being satisfied" seems more like an advising or consulting function than auditing.

One of the major complaints I hear about third party auditors is "they tried to tell me how to run my business."

Next, the auditor will be determining whether the method of training an employee to perform a task is sufficient. Following that, the auditor will reinspect product and determine the inspection process is inadequate and that there is insufficient attention to transferring information to a continuous improvement program.

After that, the auditor will determine whether the Contract Review process is adequate and whether the auditee is charging too much or not enough money for a product or service.

Perhaps the auditor will take biological samples from surfaces in the lavatory and determine the infrastructure does not meet the auditor's concept of hygiene.

All of these items, of course, are spelled out specifically in EVERY third party registrar contract that the auditee will comply with any request by an auditor, no matter whether the auditor can cite a Standard clause to justify the request.

Although I, personally, argue for open disclosure by management, I recognize and respect the right (even necessity) for some managements to keep things VERY CLOSE to their vests. Coming from a background of dealing with mergers and acquisitions and public offerings of debt and equities, I can see where some managements may be very loathe to disclose information for fear of regulators pawing through back history to see who might have garnered inside information on a pending transaction.

The option, of course, is for managements to keep TWO sets of management review minutes - one for their own personal use and one for the auditor (smell kind of like Enron to anyone?)

If anyone senses a strong odor of irony here, it is all intended.


Gee, Wes, generally your posts are pretty sound, but this one seems to be meandering off into the distance. Sure, if we extrapolate to the extreme, we can imagine all kinds of evils.

But, I have to agree with Sidney. Auditing managment review and contract review and training, etc. for effectiveness is basic and common to almost any appropriate 3rd party audit, at least if performed by an experienced auditor. We generally avoid financials, and in rare cases I have had a client ask if a particular business document could be excluded as it contained sensitive data. Never been an issue. Generally this kind of business record would be peripheral to the quality audit, and was easy to exclude.

But, if I simply accept a client saying they had a meeting, would be akin to them telling me they did an internal audit as well.

We don't evaluate the business decisions a client makes. We evaluate whether the meeting was appropriate and covered the required inputs/outputs.

Truly cannot recall where a client and I ever had an issue over it.

The Management Review has to be in the manual.

We have a procedure as well... just for clarification.

And we don't use forms... because forms don't leave room for innovation.



QS required a procedure for MR, but you are being considerably more specific than either ISO or TS requires. Cl 4.2.1.d merely says documents needed to control a process. MR Requirements may be defined in the manual, a procedure, an agenda template, or not at all. It is up to the organization. Fortunately for us auditors, most folks define them in the manual or a procedure, but we cannot require that.

As an auditor, I hate to see forms. Tells me that the company doesn't know how to conduct a management review.

Forms don't necessarily mean they don't know how to conduct a management review. I created a template "form" for a consulting client which defines the process and reduces the amount of redundant writing. In fdact, the client and I think it is a wonderful form, and no one has ever suggested I don't understand management review.

IAOB and ANAB both strongly stress that auditors need to be a little more flexible in their approach. When clients have tried to make a system they thought the auditor would like, it was never as effective as when they created one they liked.

Not to pick a fight, but could you cite chapter and verse in the requirements for 3rd party auditors that they have to see the CONTENT of the management review versus the fact the management review process exists?.
Wes, we are so far apart in this discussion that I don’t believe we would EVER reach common ground here, but just for your edification, ISO 19011 is the accepted “guidance” standard that “rules” 3rd party audit activities.

From ISO 19011:

6.5.4 Collecting and verifying information
During the audit, information relevant to the audit objectives, scope and criteria, including information relating to interfaces between functions, activities and processes, should be collected by appropriate sampling and should be verified. Only information that is verifiable may be audit evidence. Audit evidence should be recorded.

Practical help — Sources of information
The sources of information chosen may vary according to the scope and complexity of the audit and may include the following:

d) records, such as inspection records, minutes of meetings, audit reports, records of monitoring programmes and the results of measurements;

So, there is no chapter and verse that tells exactly that, just like there is no chapter and verse that states that auditors have to base their assessment on objective evidence. But if we were to follow your approach and extend it a bit, any audit would boil down to a single question:

Auditor: Does your QMS comply with ISO 9001:2000?
Auditee: Yes.
Auditor: Good. Here it is your certificate.

We just state that management reviews are conducted in the quality manual. The 3rd party auditors need to validate them according to the standards requirements (9001) 5.6.2 and 5.6.3. That must be in the form of a record (fundamentals and vocabulary 3.7.6 "document stating results achieved or porviding evidence of activities performed"). You don't have to have a procedure but you must have a document (3.7.1 or 3.7.2) that relates to the standards requirements. Since I am a recipient of 3rd party audits, I put the burden on the auditor to validate the record. I need only to show that a record exists of the managment review.

I am just curious to find out if most people address Management Review in the Quality Manual (only) or if you have a Management Review procedure? Please post to the poll. Also, if anyone would like to share their procedure please do so.

mshell


As for your question. It is basically up to you to determine how you want to document the Management Review (via procedure or policy). I have documented the Management Review process in a working procedure.

As for the other discussions. Let me throw this question out there:

Would not an Management Review Meeting Agenda that identifies the parties involved and certain discussions, meet the intent of ISO9001:2000?


Coury Ferguson
Program/Contracts Manager

Would not an Management Review Meeting Agenda that identifies the parties involved and certain discussions, meet the intent of ISO9001:2000?

How will the agenda address the 5.6.1 requirement of "...at planned intervals..."?

Don't get me wrong, I am a firm believer in the agenda. It promotes consistency in Management Review...and no one can say "I didn't know we were going to talk about that." :)

How will the agenda address the 5.6.1 requirement of "...at planned intervals..."?

Don't get me wrong, I am a firm believer in the agenda. It promotes consistency in Management Review...and no one can say "I didn't know we were going to talk about that." :)

That is where the procedure or policy would define the intervals.

That is where the procedure or policy would define the intervals.

Thank you for the clarification. Your question about an agenda meeting the intent led me to interpret you saying a procedure/policy was not needed.

As for your question. It is basically up to you to determine how you want to document the Management Review (via procedure or policy). I have documented the Management Review process in a working procedure.

As for the other discussions. Let me throw this question out there:

Would not an Management Review Meeting Agenda that identifies the parties involved and certain discussions, meet the intent of ISO9001:2000?


Coury Ferguson
Program/Contracts Manager


Any document that identifies your intentions could meet the intent. A procedure, agenda, paragraph in the manual. In ISO, the "level" of the document is no longer an issue. Records must be kept. I actually use the agenda as a template, and enter the records and info into each relevant section.

Thank you for the clarification. Your question about an agenda meeting the intent led me to interpret you saying a procedure/policy was not needed.

In my company we use an Agenda and the attached document to report the results of the Management Review. Participants names removed

I have had no issues come about with this document.


Coury Ferguson
Program/Contracts Manager

In my humble opinion the way we perform Management Review should be described only in the Quality Manual. Procedures directly related to the QMS should only be those necessary by the standard (6 subjects for ISO 9001 or 7 for ISO/TS).
The quality manual is the right place for us to write all the function of the system.
Last week I made a Quality audit to an organization with a Quality Manual of 5 pages. Is this really a Manual or a brochure?
Today, if I make a QMS, but had no need of registration, I wouldn’t make any of those 6 or 7 procedures. Procedures are just for technical subjects. :rolleyes:

Procedures directly related to the QMS should only be those necessary by the standard (6 subjects for ISO 9001 or 7 for ISO/TS).


The standard does not limit you to six or seven procedures (4.2.1.c). The very next sentence (4.2.1.d) says, "and any other documents needed..."

Of course a system needs other documents to run, and they can be procedures, work instructions, videos...anything.

The standard is trying to loosen up this legalism, and we keep trying to put it back. Why?

Of course a system needs other documents to run, and they can be procedures, work instructions, videos...anything.
The standard is trying to loosen up this legalism, and we keep trying to put it back. Why?

One thing I’ve learned during all the years working in the quality management field is that in any organization, the number of documented procedures is directly proportional to the knowledge of the workers doing the activities.
If you have very trained personnel, you need few papers telling them how to perform their work.
If the standard (ISO 9001) didn’t require 6 areas for documented procedures, in my QMS, I wouldn’t have any. Normally I write in the Quality Manual the “policies” related to all requirements of the standard, but I avoid, as much as possible to have documented procedures or instructions.
We are not supposed to teach a civil engineer how to build a house because he learned that at University, the same way we should have papers written to tell a worker how to do his job. What we must have is highly trained personnel.
This is the reason why documented procedures trend to be shorter or even disappear during the evolution of every company. (In some cases they are there, but they are completely useful).;)

One thing I’ve learned during all the years working in the quality management field is that in any organization, the number of documented procedures is directly proportional to the knowledge of the workers doing the activities.
If you have very trained personnel, you need few papers telling them how to perform their work.
If the standard (ISO 9001) didn’t require 6 areas for documented procedures, in my QMS, I wouldn’t have any. Normally I write in the Quality Manual the “policies” related to all requirements of the standard, but I avoid, as much as possible to have documented procedures or instructions.
We are not supposed to teach a civil engineer how to build a house because he learned that at University, the same way we should have papers written to tell a worker how to do his job. What we must have is highly trained personnel.
This is the reason why documented procedures trend to be shorter or even disappear during the evolution of every company. (In some cases they are there, but they are completely useful).;)


I agree with your comments. Some of my clients embed their procedures into their quality manual. I agree they don't have to be separate documents. Even the six (minimum) required ones can be imbedded if it is clear that is how you handle procedures. The level is not the important point.

I agree in regards to the Competency level. If we have a highly skilled workforce then we do not require as detailed instructions s greenfield company but we must always allow for the lowest common denominator which will always be the 'New Guy'

Here is my Competency slide used to illustrate where Work Instructions etc fit in the scheme of things within our company

I voted for the Procedure but somewhat we do both. The Quality Manual only references that we do a Mgmt Review and nothing more. The procedure identifies everything that is ISO 9001 required plus extras that we want to add into the meeting.
Our Agenda follows the exact structure of the procedure and then the meeting minutes are an exact structure of the agenda itemizing everything discussed.

I have found that process flowcharts for Mgmt Review do not "cut it" in our audits - my procedure flies thru audits. In fact, the auditor almost never has any questions to ask. He just sits there takes notes and we're done. It's awesome! All tap-dancing has been eliminated. :applause:

I use a 1 page process map (detailed flowchart) of the management review process that clearly shows the required and desired inputs/outputs and the link to CAPA and CI. In conjunction with the Management Review record (agenda) that incorporates followup, assignment, metrics, etc., the process has really proven to be consistent at every client and the third party auditors rarely have any questions or comments. Clients love it and it make me look really good.

Take a look at www.PinnacleEG.com or send me an e-mail if you want more info or have any questions or comments.

I voted for neither - I've rarely found a 'procedure' to tell managers how to manage has added much value, though there is some value in identifying the various levels & forums that management review takes place on, particularly in larger organisations.
It can, for example, happen at different levels. One tool I've often used successfully to show that is a matrix - I've attached an example, which is for a department that was successfully certified, but was part of a large corporation which wasn't. So we needed to show what happened where, and what the department could control, and what it couldn't.

In smaller organisations, I've usually found that one or both of having things defined in job descriptions and/or making sure there's something like a standing Agenda in place works fine. The absolute last thing you want is a bunch of managers sitting in a room looking at each other blankly, wondering what a 'management review' meeting is & how they'd know if they were having one. In my view, their regular management meetings ARE management review, and often all that needs to happen is to make sure they're generating some records of their decisions/actions.

I voted for neither - I've rarely found a 'procedure' to tell managers how to manage has added much value, though there is some value in identifying the various levels & forums that management review takes place on, particularly in larger organisations.
It can, for example, happen at different levels. One tool I've often used successfully to show that is a matrix - I've attached an example, which is for a department that was successfully certified, but was part of a large corporation which wasn't. So we needed to show what happened where, and what the department could control, and what it couldn't.

In smaller organisations, I've usually found that one or both of having things defined in job descriptions and/or making sure there's something like a standing Agenda in place works fine. The absolute last thing you want is a bunch of managers sitting in a room looking at each other blankly, wondering what a 'management review' meeting is & how they'd know if they were having one. In my view, their regular management meetings ARE management review, and often all that needs to happen is to make sure they're generating some records of their decisions/actions.
Jane,
Welcome to the cove (another Aussie that isn't watching the games - lol). I like your matrix but will this really cover the clause in the Standard? In my post a while back in this thread (http://elsmar.com/Forums/showpost.php?p=64430&postcount=15) I included a basic flow chart that dictates the points of the standard and will cover as a procedure. Of course we already discuss all of the other business topics that are in your matrix and maybe we should put something similar in our Manual to show our core business meetings. Good post and I hope your Karma reflects it ~grin~

Thanks for the good karma wishes Greg! And no, my attention span for games hoopla is very limited.

Re. your question:
I like your matrix but will this really cover the clause in the Standard?
I don't fully understand the question. If you mean, have I used it and had client organisations certified without problem, the answer is yes, many. If you mean: does the document all by itself cover the requirements of clause 5.6, the answer is no, of course not.
But my belief & experience is that one doesn't need documentation to meet this clause. The only real measure is the implemented system itself (any documentation is only a component of the system, not the system itself.) And the implemented system has to be demonstrated.

I think many systems & people make too much of the 5.6 clause. Or they think that ALL the inputs & outputs have to take place in one single forum or procedure or meeting. They don't! They can, & often are, best dealt with in different forums, and sometimes by different people.

But I also don't think there is a 'single best way' to do it: it really depends on the organisation and what they have in place, & what's practical and workable. I've had clients certified using NO 'management review document' (policy or procedure whatsoever). For example, one company was having quarterly directors meetings (2 equal directors). So I just made sure their agenda covered the 5.6 inputs (which meant adding a couple of items only), and their minutes at least covered the outputs. Then coached them through the first couple... no problem. If I encountered an external auditor demanding a 'management review procedure' I'd fire the auditor as not being adequately able/intelligent enough to interpret the Standard.

I used this matrix in this instance, because it helped clarify who did what, when & where, & also met the requirements for the framework review (5.3.c) and wherever a single thing can meet multiple requirement, it's often efficient to do it that way.

Jane,

Great reply. You are correct we do not require a procedure for it as our business uses a 'Balanced Score car' and our various weekly, monthly and annual meetings cover all pf the things we need. We opted for the single page procedure I referred to only to meet the basics of the standard, Although as I said we do not need it as we can prove what we do. We could probably get rid of a lot of the stuff we used for the 2000 changeover as they are really hangovers from the last standard (things we could not let go of). We are slowly but surely depleting our paper based system but we have a few Senior managers that like to horde things. I tell them that are restrictive and auditable but still they cling..

Here's my two cents.

We've got a seperate procedure for mgt review, which i like, because it points out the significance a bit more, contents is pretty much like Gregs. We've very recently decided to stop our quarterly reviews though, because i felt they resemble "quality meetings" too much in my opinion, and in the end there were a lot of actions on the agenda, and very little strategic reviewing being done. Ongoing quality business needs to be in the normal meeting structure as far as i'm concerned, no special quality meetings, and once a year we look back on our fiscal year and let the management have their say at how things are going in the management review.

Ongoing quality business needs to be in the normal meeting structure as far as i'm concerned, no special quality meetings

Could not agree with you more. It IS normal business, not something apart. When it becomes that, we move, I hope toward the day I'm dreaming of, when a/ the term 'quality meeting' stops being a dirty phrase and b/ has fallen into disuse. OK, now I'll get off my soapbox.:)

The Management Review is documented in Policy Manual, which may flow down to second tier procedure and a third tier form to cover all the points as listed in the standard/Manual. The form must cover all the requirements noted in the Policy Manual and should be used as a point of discussion covering all the details among Managers or interested parties. But what is the most important is to summarize the completed form into a one page Executive Summary thus bringing the most pressing issues of the points listed in the QMS Standard/Manual to the attention of the President/CEO ect..., to keep a finger on the QMS pulse of the company and influence a cycle of continuous improvement from Management without the continuous improvement and Managements’ support a Management review is just paper in a file.

Whilst in full agreement with Richard Main's post 67 (above). I recommend a procedure and a mention in the manual, given that, Management Review meetings are a periodical event (very frequent anually) that assess the quality of an organization. The procedure should address the elements of ISO 9001:2000 clause 5.6 Management Review, 5.6.2 Review input, 5.6.3 Review output.

While I have a "less is better" mentality toward proceduralization, there is one thing I think should be systematic. That's the timeframe to hold the meeting.

For example, I was recently at a company that held mgt review in March and has their int audits in May/Jun in preparation for the ext audit during the summer. (The int auditor gets to sign off on mgt review, the ext auditor signs off on mgt review and int audit effectiveness regarding the int audit of mgt....)

Is that a valid mgt review regarding 5.6.2 a) regarding the "inputs of audits" when the next time mgt review is held the audit info (ext & int) is 9 months old?

I think a doc template is fine as a control for mgt review.

For example, I was recently at a company that held mgt review in March and has their int audits in May/Jun in preparation for the ext audit during the summer. I think that organizations that systematically schedule their internal audits just prior to a registrar surveillance audit are, for the most part, missing the point of what internal audits should accomplish. "Cleaning up house" (or trying to) just prior to an external audit shows that management doesn't get it. Very likely, the internal audit schedule matches exactly the same processes/areas that the CB is scheduled to audit, doesn't it?

(, the ext auditor signs off on mgt review and int audit effectiveness regarding the int audit of mgt....) :mg: Say what? The CB auditor signs off on management review? Wouldn't that compromise the "separation of power"? :nope:

While I have a "less is better" mentality toward proceduralization, there is one thing I think should be systematic. That's the timeframe to hold the meeting. .

I don't think management review is, or should be, a single meeting. I think it works best when it's a framework of meetings, held regularly.

I was recently at a company that held mgt review in March and has their int audits in May/Jun in preparation for the ext audit during the summer. (The int auditor gets to sign off on mgt review, the ext auditor signs off on mgt review and int audit effectiveness regarding the int audit of mgt....).

Sounds like the cart before the horse to me. One doesn't (or shouldn't!) be doing internal audits to prepare for the external audit! One does them for the reasons listed in the Standard (which do NOT include preparing for the external audit). Also, it sounds like a tick the box approach, not really embracing the principles.

[/QUOTE] Is that a valid mgt review regarding 5.6.2 a) regarding the "inputs of audits" when the next time mgt review is held the audit info (ext & int) is 9 months old?..[/QUOTE]
Re. inputs, just perhaps. But the timeframe is horrendous... I'd be looking to see whether corrective/preventive action were taking place in a timely fashion. And if I were auditing, I'd be certainly looking further (seeing what evidence exists or doesn't) with questions in my mind. On the face of it, this isn't quite enough information, but it does raise possible concern.

But one needs to look at results. For example, if there's an effective system of dealing with things raised during the audit, and the MR is just the final signoff, then it could be OK. But I also think there's 2 kinds of MR: the regular ones which need to happen very frequently, and the less frequent, stand back and take a helicopter view type, which don't. It's possible to confuse them.


I think a doc template is fine as a control for mgt review.[/QUOTE]

The hardest part for me is how to track the departments and request what information they should submit ts16949 a manufacturing firm
this is my first year of ts .
Thanks any help would be appreciated

The hardest part for me is how to track the departments and request what information they should submit ts16949 a manufacturing firm
this is my first year of ts .
Thanks any help would be appreciated

Welcome to the Cove, Mike :D

It's hard to tell what you're looking for. You've posted on a thread about management review; is your question related? What do you mean by "track the departments"? Give us a little more information and we'll be able to help you better.

Ok I want to deleop a chart that I can get the message across to people
for they can submit their trend data for a management review meeting.
maintenance > production up time
purchasing > supplier evualation > delivery conformnce
Production > parts produced
I am haveing a hard time getting organized and getting the mesaage to the
departments .

also i would like this to work on a monthly basis too .
I have seen some matrixs in the past but just can not visualize them
Thanbks mike

Thanks Mike V

All too many times we focus only on what is required by the standard and completely overlook the strategic benefit of the requirements. I look at the Quality System like a chess game. You strategically deploy your chessmen (system procedures/requirements) to win the game (improve quality).

So back to the initial post, are procedures required? The first thing I do is throw ISO requirements out the window... just for a moment. I ask what strategic benefit will this requirement bring the company? Does having a written procedure/work instructions make things better, easier or faster? I use the following as criteria when deciding if a procedure is necessary?

-Can the document be used as an effective training tool? I was taught that these documents should be used as a training tools, to establish performance standards, etc. Having procedures written in a format just to satisfy ISO requirement will never bring the benefit it is intended to bring. Written procedures are also an effective way to document best methods/lessons learned.
-Will the document collect dust after it is created? If the document will never be read, don't create it. Also if documents are used for training, it is important to keep them up to date. If someone goes to a procedure because they have a question of how something needs to work, and the procedure doesn't answer their question, they will never read it again.
-Is the procedure required by ISO. We can't forget ISO too long, nor can we ignore personal preferences of individual ISO auditors/registrars.

For the purpose of ISO/TS 16949:2002 I've KISS'ed it in some kind of a comprehensive way; once you've written the QM, QP, and the form:
- show the QM to your auditor when he’ll ask whether “you guys are doing it?”;
- show the QP to the managers when they ask “shall I(!!!????) do it????!!!!”, and
- update few numbers in the form to have the Mgmt Review meeting record ready in 10 minutes.

To achieve the goal:
- in the QM: copy/paste the chapters of the standard when replacing "Organization will do" with "<your Company name> is doing";
- in the QP: assign the responsibilities for all of the standard requirements to specific position's holders (as it has been committed in the QM; see the attached QP),
- prepare the form in a form of a template of Mgmt Review meeting summary (see the attached form).

P.S. I am not sure that the attached are the latest revisions; somebody may still want to verify the attachments vs. the requirements of TS.....:notme:

All too many times we focus only on what is required by the standard and completely overlook the strategic benefit of the requirements. I look at the Quality System like a chess game. You strategically deploy your chessmen (system procedures/requirements) to win the game (improve quality).

So back to the initial post, are procedures required? The first thing I do is throw ISO requirements out the window... just for a moment. I ask what strategic benefit will this requirement bring the company?

(Bold mine). Could not agree with you more ML. And organisations who take that approach tend to have sound, well developed systems that work really well for them... as well as getting/maintaining certification, which is as it should be IMO.


... once you've written the QM, QP, and the form:
- show the QM to your auditor when he’ll ask whether “you guys are doing it?”...

To achieve the goal:
- in the QM: copy/paste the chapters of the standard when replacing "Organization will do" with "<your Company name> is doing"

Alex, why on earth would you waste time on this kind of mindless 'cut & paste'? If, as an auditor, someone tried to dump a QM in front of me with that kind of wholesale cut &paste of the Standard's wording a/I'd question severely whether they actually understood it and b/I'd start seriously looking for real evidence of how when & where management review was done.

And oh yah, I'd be infinitely more impressed in a company where I encountered someone adopting the sort of intelligent approach indicated by mlthompson.

Alex, why on earth would you waste time on this kind of mindless 'cut & paste'?

This is
1.) to ensure commitment of the top management to all applicable requirements of QMS (by copying the standard <+ other relevant, as appropriate> requirements to the Quality Manual the way I've advised - it's an easy and precise way to address all the standard requirements - just copy/paste + give a reference to QP where the requirements are addressed to specific Managers - then QM will serve as an indexed collection of ready answers to ANY question of an external auditor of the kind "are you doing what chapter # 6.5.4.1 of the Standard requires?" - then go to chapter #6.5.4.1 of the QM, find in which QP the requirements are addressed to Managers, then call the ppl (hopefully it won't be addressed to your own self!:bigwave: ) and ask for objective evidence);
2.) to address all the requirements of the QMS (as the top management has committed in the QM) to the Company Managers in a precise and efficient manner (by copying the requirements <as committed in the QM> to the QP + assign responsibility to specific managers - then the QP will also serve as the criteria for internal audit(s) to ensure that ALL the requirements of the QMS are implemented as intended + objective evidence is readily available).;)

For the purpose of ISO/TS 16949:2002 I've KISS'ed it in some kind of a comprehensive way; once you've written the QM, QP, and the form:
- show the QM to your auditor when he’ll ask whether “you guys are doing it?”;
- show the QP to the managers when they ask “shall I(!!!????) do it????!!!!”, and
- update few numbers in the form to have the Mgmt Review meeting record ready in 10 minutes.

To achieve the goal:
- in the QM: copy/paste the chapters of the standard when replacing "Organization will do" with "<your Company name> is doing";
- in the QP: assign the responsibilities for all of the standard requirements to specific position's holders (as it has been committed in the QM; see the attached QP),
- prepare the form in a form of a template of Mgmt Review meeting summary (see the attached form).

P.S. I am not sure that the attached are the latest revisions; somebody may still want to verify the attachments vs. the requirements of TS.....:notme:


If I am understanding your post correctly, you are advocating just lightly skimming over your system, "just to satisfy the auditor." If so, that would be a shame. Many people have that viewpoint, but it is why there is such a gaping hole between Toyota/Honda vs GM/Ford. If I am misunderstanding your comment, I apologize, and please clarify.

ISO and TS is not about passing audits, it's about tuning, aligning and optimizing the performance of every process in the organization.

I have to accept your apologies, because my idea is not about "lightly skimming over" requirements of QMS, but about simplifying and standardizing maintenance of the formal sides of QMS.
My concept is about addressing ALL of applicable requirements of a QMS in a simple straight-forward manner, by the word of standard(s). I would define it as: "help others to do whatever they believe is to improve the bottom-line, when encouraging them by the power of management commitment to the requirements of QMS (as committed in QM an addressed in QP-s) and when "lightly skimming over" creation of sufficient objective evidence for ALL requirements of QMS".

ISO and TS is not about passing audits, it's about tuning, aligning and optimizing the performance of every process in the organization.

Just to illustrate my idea:

I would strongly disagree with the quoted statement because from my point of view the ISO/TS 16949:2002(E) is about (0.2) <- this is the number of the TS chapter> promoting "the adoption of a process approach when developing, implementing and improving the effectiveness of a quality management system, to enhance customer satisfaction by meeting customer requirements."
Please take a second to count number of misinterpretations of the standard requirements in the quoted statement (*) and to feel my vision.
Also when you have spent precious time writing the sentence (aka re-inventing the "bicycle" of the purpose of TS, which is already determined in the TS chapter number 0.2): I have just copied/pasted the standard requirement in one KISS'ed and mistake-proof way.
Wouldn't you now agree with feasibility of my concept?

(*) I believe that it is possible to count at least 4 (probably 5) misinterpretations of fundamental requirements of TS (which may potentially lead to 4 or probably 5 major audit observations at a level of "management commitment", would this relatively short statement be quoted in a QM):
TS is not about "tuning", "aligning" and "optimizing the performance" of "every process" and not only in "organization" (it also has an influence on suppliers of the organization)... now how would you please show me that an organization has adopted "a process approach when developing, implementing and improving the effectiveness of" its "quality management system, to enhance customer satisfaction by meeting customer requirements" without stating it in a QM and (if and as applicable) addressing it in QP's?:cool:

I have to accept your apologies, because my idea is not about "lightly skimming over" requirements of QMS, but about simplifying and standardizing maintenance of the formal sides of QMS.
My concept is about addressing ALL of applicable requirements of a QMS in a simple straight-forward manner, by the word of standard(s). I would define it as: "help others to do whatever they believe is to improve the bottom-line, when encouraging them by the power of management commitment to the requirements of QMS (as committed in QM an addressed in QP-s) and when "lightly skimming over" creation of sufficient objective evidence for ALL requirements of QMS".Who can argue with someone who has a signature "Keep it simple & stupid"?:lol:

My concept is about addressing ALL of applicable requirements of a QMS in a simple straight-forward manner, by the word of standard(s).

Alex,
I wonder if you have asked your senior management what they think of the system you've set up, & whether they'd agree that it's 'simple & straightforward'? I don't find it either, based on the sample documents you've supplied which I've looked through. And there's a big difference between simple & simplistic.

It's this kind of very simplistic, 'numbered clause by numbered sub-clause by clause' approach that I've found over many, many years of experience actually turns people OFF quality, not on. (But then, that kind of approach is poles away from mine). OK, it may/perhaps gets you through audits... but I'd lay odds most people actually loathe the system & find it cumbersome, unfriendly, bureaucratic & hard to work with.

And if as a senior manager/exec. I was expected to read through a 'MR Summary doc' of 6 pages of stuff like the following quotes, PLUS all the clause numbers & referenced documents & graphs & tables etc to try & find out anything useful, let alone what I wanted to know, I think I'd be wondering why I ever bothered! If this is the summary, heaven save me from the full version. There's an interesting draft article (http://elsmar.com/Forums/showthread.php?p=184414#post184414)posted by Craig in the reading room that might offer some further perspective.

Quote from your MR Review doc:

9. Summary of regular reporting and evaluation of the cost of poor quality (5.6.2.j, 5.6.1.1, 8.4.1 and 8.5.1) and of product conformity (5.6.2.c). (These results of the quality management system performance will be recorded to provide an evidence of achievement of the quality objectives specified in the business plan (5.6.1.1)).

A.K. has introduced trend of total manufactured vs. scrapped quantities.

Comment: None.

10. Employee motivation and empowerment (6.2.2.4), including the survey results (form 6-TR-004).
A.K. has introduced summary of surveys (form # 6-TR-004, Rev. 0): one answer has been corrected within a follow-up with an employee; the rest of the answers have been correct.

Comment: None.

11. The need for changes to the quality management system, including quality policy (5.6.2.l, 5.1.c).
The Quality policy will be reviewed to ensure that the Policy is suitable (5.1.e) and appropriate to the purpose of Xxx Inc. (5.1.a); and provides a framework for establishing and reviewing of the quality objectives (5.1.c).
If quality policy is updated: the Quality Manager will ensure that the updated quality policy includes a commitment to comply with requirements and continually improve the effectiveness of the quality management system (5.1.b); is communicated and understood within the organization (according to the procedure number QP-62-01, Training and awareness) as well as through publishing of the quality policy across the company (5.1.d).

F.D. has confirmed the commitment to achieve the TS 16949:2002 registration.
A.K. has introduced a proposal draft of a new Quality Policy (see also chapter 10. hereinafter).

A need in update of the quality policy has identified; A.K. has presented a draft of the updated policy to the management review.
The draft has been reviewed to ensure that to ensure that the Policy:
- is suitable / appropriate to the purpose of Xxx Inc.;
- provides a framework for establishing and reviewing of the Quality Objectives
The draft has been approved by the management review.
The final draft of the review is attached hereinafter.

Comments:
None


And this is just a small portion... the mind boggles. How, for example, can the rest of the employees' answers to a survey on motivation be "correct"??
You want to keep it 'simple & stupid'. Indeed.

All the company wide procedures are defined in the manual.
Like MRM, Internal audits, etc etc.
I thought it is easy for us.

I wonder if you have asked your senior management what they think of the system you've set up, & whether they'd agree that it's 'simple & straightforward'?
Of cause they did(!!!!); moreover I've gotten full support from those ppl and they have personally and quite consciously signed each of the QP's! :cool:

I'd lay odds most people actually loathe the system & find it cumbersome, unfriendly, bureaucratic & hard to work with.
NOBODY EVER DID (including ALL managers and auditors)!!!!!
As the designer of the system I have been getting strictly compliments.:o

How, for example, can the rest of the employees' answers to a survey on motivation be "correct"??
They were trained and have chosen correct answers from the multiple-choice questionnaire (I've posted example somewhere).

And if as a senior manager/exec. I was expected to read through a 'MR Summary doc' of 6 pages
I've been fascinated with your assumption that a top management may be interested to read summary of a management review(???).
I trully believe that the summary is not intended for reading by the top management.
Why would they read the body of the review when they have heard all that at the meeting(!?).
I guess that maximum what they may probably be wiling to take another look at after the review is the attachments to the review such as e.g. trend of "production scrap" or summary of customer complaints, etc.).
My template of the mgmt review summary is only intended
a.) to provide documented evidence of the event of the review (truly amusing reading for external auditors!) and
2.) to document requests for CAPA initiated at the review (to be then taken to a CAPA follow-up log).
My way our annual mgmt review takes less than two hours to get all the stuff reviewed;
that is less than half of the time the reviews have taken with the ancestor Quality Manager (that time for QS system).
Moreover: instead of the time spent, that review has not covered many of the standard requirements (each one may be a major audit finding!).
1.) The management has been really grateful to me for saving their time.
2.) My template fool-proves that ALL the requirements of TS are reviewed and indexed after the TS chapters (that helps me when auditors are looking to find the evidence);
3.) the quotations from the standard in the mgmt review summary template are mostly not intended to be even read at the reviews (these are a reminder for me to direct the discussion);
4.) the way the review is conducted promotes initiation of important and to-the-point CAPA (mostly replaced by XXX in the template I've posted); even where the management have not identified a need in improvement: the evidence of the review of the required input is provided;
so, at our company and all-around everybody are just happy with my approach:biglaugh:

Most of the few quality mgmt systems, which I’ve seen had very little relation to their Scopes.
QM and QP's in such systems were usually
- full of good intentions of their creators;
- written in a form of work instructions and
- provided with extensive flow-charts detailing and specifically telling what and how different people shall do different stuff!:bonk:
All that instead of addressing specific requirements of Scope to specific position holders…
This approach is very not uncommon and somehow those systems even getting through audits...
I guess it mostly happens at companies not willing to clearly assign responsibilities.
My approach is that managers shall read the QP's, however may not do so.
In our system it is the responsibility of each Manager to do whatever it takes to improve the bottom line (with absolutely no need to look into QP's), while the QP's are created to ensure that whatever right stuff ppl at the Company do, the way they want: it will eventually be according to the QP's.

at our company everybody are just happy with my approach:biglaugh:

That's great. I wouldn't go near it in a pink fit, but then I don't have to. It's your system & your company & if it works for you, terrific.

I will appreciate having a specific example for "why not" or for "how to do it better"!:thanks: in advance!: )

I will appreciate having a specific example for "why not" or for "how to do it better"!:thanks: in advance!: )

See attached.

WOW, that's awesome!: )
...however, it takes some time to make a digest from the standard... potential for mistakes.... who cares how it looks... who will appreciate the additional effort????... management does not care what's in the summary / not reading it... auditors will not care... good ppl have spent their time writing the standard... why should I struggle to improve acceptable stuff for no reward...

Copy/paste the standard requirements: takes minimum time, may look awful; comprehensive, mistake- and bullet-proof!: ) :o

So, it looks like that you had no principal problems with my idea of addressing of all standard requirements in QP's(?)...
Were your concerns related only to the lack of arrangement / adaptation / cutting the blah-blah from/of the requirements of the standard?
:thanx:

WOW, that's awesome!: )


Thank you. But let's be clear about what it is & what it's not - it's only a small cosmetic suggestion to improve one tiny part of a bigger thing. The bigger thing remained untouched.

...however, it takes some time to make a digest from the standard... potential for mistakes.... who cares how it looks... who will appreciate the additional effort????... management does not care what's in the summary / not reading it... auditors will not care... good ppl have spent their time writing the standard... why should I struggle to improve acceptable stuff for no reward...

Well, yes, and exactly so. And that's also exactly WHY my grave misgivings and profound aversion to such cumbersome & simplistic 'cut & paste' type systems.

Yes, I know all too well that it takes time, thought and effort to make something truly appear as simple, and to be useful & user-friendly. Without making that effort - just adopting a 'cut & paste' approach is simplistic. Looks simple, but actually it really isn't. You've got absolute masses of duplication and immense numbers of words among your various documents - yeah, I know that word processors make it incredibly easy to do that... doesn't mean it's a good idea. Apart from anything else, such duplication means time & effort required for someone to sort through & figure them out, not to mention effort to mainain in case of any change.

For the Review 'Summary' document you supplied, as you yourself say:
management does not care what's in the summary / not reading it... auditors will not care...

So, the big question is: why on earth would you do it like this??? Who and what is it really for - purpose & audience being the 2 key things to establish before creating anything. If you are creating documents that are, as they appear to be, mainly for the auditors' benefit, then I severely question the value. Can you really not run a 'management review' without duplicating all the words of the relevant Standards twice (once in the procedure, again in the summary)?


So, it looks like that you had no principal problems with my idea of addressing of all standard requirements in QP's(?)...

No. That's a big - and false - conclusion to leap to, and I don't know how you managed it given that I've stated repeatedly and strongly that I am adamantly opposed to that kind of simplistic approach. I just responded to a request.

How one might do it better overall is a much bigger question and one I've already written about in this & other threads.

What I've done with many of these kinds of simplistic clause-based systems (and believe me, I've seen way too many and been asked by companies to simplify many when they finally realised how painful they were) is to throw them away completely, and start off with the business itself, and what it does - ie, a true process approach - rather than the clauses of the Standard.

Just one specific example: the same MR result could be achieved via a single page Agenda (at most) plus the supporting docs of course, & then some kind of record of outcomes which would be perhaps 2 pages (at absolute most) summary of outcomes with any specific Actions, including who, what & by when. Oh, and yes of course, adequately trained & experienced personnel. But I wouldn't & don't advocate MRs that are solely focussed on the QMS: I like to see management review as integrated into the whole business.




Were your concerns related only to the lack of arrangement / adaptation / cutting the blah-blah from/of the requirements of the standard?

Nope. Absolutely not. As already said, many times, I profoundly dislike such 'clause by clause' systems. Instead I advocate & use an approach that makes the effort to look at the business itself, and its language, and context, and how it operates & does business, and then works out how to fit the requirements of the Standard around the business and most definitely NOT THE OTHER WAY AROUND. Because that adds infinitely more value, from being easier to operate in & with to requiring less effort to maintain.

By way of example, your Review document lists things in this order:

1. Scope of the Quality Management System and the Exclusions
2. Follow-up actions from previous management reviews (5.6.2.e).
3. Changes that could affect the quality management system
4. Results of internal and external quality audits
5. Customers' satisfaction with product supplied...

This 'order of business' is inwardly focussed & doesn't match the interests or priorities of any business owners or executives/senior managers I've had experience or worked with. I've yet to come across any who prioritise 'system scope' and 'audit results' before the $$ and customers, for example. And I fully agree with them.

They're much more likely to want to know 'how are we doing', eg:
1. Revenue & cashflow
2. Sales & marketing - especially new business
3. Business competition, risks, possible changes
4. Customers satisfaction/feedback
5. Processes, plant, equipment, etc...

See the difference?

Any competent quality professional should be capable of seeing that their agenda & interests does cover the requirements of the relevant Standard/s.

But have a QMS, or its documents or a 'management review' structured around & based on clauses & sub-clauses? Nope & a thousand times no. As you can tell, this is something I feel passionately about. :nopity:

As I already said, it's that kind of approach that turns people off or burns them. 'Oh', they say, 'that quality stuff's really hard, you have to do all that tedious stuff'...

OK, perhaps as you say the current system is much better than what they had before & thus they like it better than what they had before. In which case congratulations.

But just because something is now a dull ache instead of a raging toothache doesn't mean it's great. And it could be oh, so very much better.

WOW, thank you, JaneB, for the interesting discussion!: )

Can you really not run a 'management review' without duplicating all the words of the relevant Standards twice (once in the procedure, again in the summary)?
I've tried to do so at an MD company, where management has adopted an approach somewhat (I guess) similar to your suggestions: the mngng director told me (a young engineer at that time) on numerous occasions not to pay much attention to those papers ("it's all politics, also we pay them some money for the cert.") and to concentrate on a "real stuff", such as process validation, technological improvement(s), process control, etc.!: ) :bonk:
Needless to say that their management review has historically had exactly (I swear!) the agenda you proposed!: )))
1. Revenue & cashflow
2. Sales & marketing - especially new business
3. Business competition, risks, possible changes
4. Customers satisfaction/feedback
5. Processes, plant, equipment, etc...
And I has been really tight on time with those engineering department's jobs (the mentioned process validation, technological improvement(s), process control, etc.) to make mgmt review meeting template like the one I've posted.
Then we have done the review in their "regular format":
1. Revenue & cashflow
2. Sales & marketing - especially new business
3. Business competition, risks, possible changes
4. Customers satisfaction/feedback
5. Processes, plant, equipment, etc...
Guess what: in a short time P&G-hired ppl came to audit our relatively small company (to aid P&G in seeking of an mfg partner!!!$$$!!!) and I've ended with 11 pages of 10-height, single spaced list of nonconformance findings (it turned into 30+ pages of requests for corrective action, what means "just re-establish your QMS") including major contents missing from the mgmt review.:yes:
The guys started with a standard requirement, wanted to see it addressed in QM, in QP and then, if addressed in the docs: asked to see an objective evidence. :lmao:
(Was that an FDA auditing approach? I've then moved to automotive quality and still don't know... however I so liked the principle that, as you see, keep following it since then!)

The TS requirements related to management review in my recent QMS are duplicated not twice (as you've guessed): the requirements are TRIPLICATED ; and I am proud of that; and I feel very well on having it, and I will never do less than that!:agree1:
1. in the QM: copy/paste from TS, replace "organisation shall" with "Xxx Inc is" + reference to a QP vs. each of the "shall's" + keep the index of TS -> to document the mgmt commitment;
2. In the QP: copy/paste from the QM + replace "organization is" with "it is the responsibility of Manager X to" + keep in brackets numbers of the reference TS chapters -> to address the responsibility;
3. in the "mgmt review summary" form: copy/paste from the QP including the numbers of the TS's chapter and ID of the responsible mngr + leave some place for comments to fill at the review -> to ensure that you have not missed to review and to record the output from review of any little standard-required thing.

The result is:
1.) Nothing is prescribed for obligatory review and recording unless it's required by TS (and no any unnecessary head movements)!
2.) Bullet-proof reliability of the action and record taken vs. any audit (where are you, the P&G guys??:bigwave: ).
3.) Anybody at our Company is welcome to propose additional topics for the review (I am always asking for the proposals and, if fact, our former HR manager has once been wiling to add smthing, and I've added the topic - you can see it in the template thoroughly marked as "this is an optional input for the review", just for the purpose of keeping track of the silly proposal and removing it outta the review template by a first chance!!!!! :spam:
And nobody (except of the former HR manager) has ever proposed to add anything else to the review; that instead that me and my "mgmt review template" are both open for any suggestions and additions!:bighug:

Somehow I feel (I may be wrong) that you suggest me to add stuff like "Revenue & cashflow" to the review??
I guess that, upong getting the proposal, our managing director will call promptly some really intensive care psychological emergency ambulance to aid my own self!: )
Why shall I force this :topic: to our mgmt review???
The TS does not specifically want us to review it... :nope:
Moreover, I'd strongly recommend to any quality manager (unless specifically asked to) to leave review of this topic for whom it may concern.
Personally I guess that our mnging director is spending months of his work and private time discussing this topic with the controller, shareholders, creditors, suppliers, customers and maybe others… of course, raising this topic at our annual management review may really be one of his secret wishes he has never told me about.:truce:

At the same time I want to see anybody from the top mngmnt asking me to remove smthng from my mgmt review template:cool:
It will never happened because the template consists of a MINIMUM REQUIRED stuff (not counting the mentioned topic, which is <an optional input for the review>) and anything taken out off the template may potentially result in a major audit finding (do I need it?).

While I am truly agree that the template is far from perfection (who is not??) in terms of aesthetics / formatting, prioritization and English language: it is addressing (unless I've missed smth) the minimum requirements of TS for management review in our QMS and I guess that it may not have any other places for improvement!!!!!!!!!!!!!!!!!

For the conclusion:
I feel like you are backing an idea to drive improvement first by
<good intention, common sense and well knowledge> and then by fulfillment of <standard requirements>(?);
when I am putting first the standard requirements.
What do you think?

Yes, it's been interesting, but I think it's time to agree to disagree, Alex.

You want it 'simple & stupid'. I don't. And completely fail to understand how any quality professional could have 'simple & stupid' as their goal.

But you can't have it both ways. You said:

management does not care what's in the summary / not reading it... auditors will not care...

Therefore my response, then why would you do it that way?

I've tried to do so at an MD company, where management has adopted an approach somewhat (I guess) similar to your suggestions: the mngng director told me (a young engineer at that time) on numerous occasions not to pay much attention to those papers ("it's all politics, also we pay them some money for the cert.") and to concentrate on a "real stuff", such as process validation, technological improvement(s), process control, etc.!: )

This is the old 'tried that once, didn't work' argument. Yeah, clearly you got it wrong. But following advice not to pay much attention to the requirements is a foolproof recipe for failure, innit? If major contents were missing from the mgmt review, that's your responsibility. Your response is apparently a point by rigid point duplication of all the words of the Standard - mine is very different.


I care about quality. And love when people I work with realise that the Standard's requirements themselves really are the 'real stuff'... :)
But I don't expect them to come to that realisation throught the often dreary words themselves, which take some understanding & experience to apply & interpret intelligently.

But just because you failed once doesn't mean it'll never work or it can't work. It means that didn't work. Means you have to analyse why, try something else - the old PDCA itself....

Alex, I do think you draw very concrete & unsupported conclusions from very flimsy/little evidence - you've done it several times responding to my posts. For example, I said [management] is "much more likely to want to know how are we doing" and provided the points they do care about in order of priority. I didn't say 'here is the exact agenda items you should use'.

As I've said, if the system works well for you, & all are happy with it, fine. It isn't my system - it's yours. My suggestions are based on my experience of what I believe works better. But if, as you say, you will 'never do less than have it in triplicate' etc. then I don't see much point in further discussion. You see, I'm interested always in looking for improvements, & I don't think I'd say "I'll never do less than X' or 'I refuse to ever think about not doing Z'.

I focus on 9001 and not TS or automotive, both being fields I stay well away from. But the various organisations I work with/have worked with (large & small) have sound, functioning living & breathing quality management systems that are embedded in what they do. (Some of them discuss $$ at MR, some don't - depends on the org). But not a one of them would say 'management doesn't care/read this stuff' nor an auditor either. I think in fact this is where we started, because I think that management is very interested in a real system, when they can see that is 'what they do', and not some mass of verbiage that appears very remote and low value.

There clearly are different objectives and different approaches applied to ISO and TS implementations. Some people just want to maintain a system in a time-efficient manner. Some want to use their system to wring out every improvement they can get. Some wish for improvement, but don't feel their company will cooperate.

As a consultant, obviously I prefer the "use their system to wring out every improvement they can get" approach. However, each company is permitted to choose their path and improvement vector. If they choose wisely, the company benefits. If they choose poorly, or execute poorly, the company will suffer for it.

To paraphrase Jane's comment, we hore Lawyers to understand the law, an translate requirements into terms and practices their companies can follow and implement. The job of Quality Managers is to take ISO or TS standards, and translate the requirements into terms and practices their companies can follow and implement.

I would not expect managers to have more than a passing familiarity with the specific language of the standard (though it would be nice). They have their own assigned responsibilities. It is your job to translate and simplify, commonize and standardize the requirements into their processes.

The job of Quality Managers is to take ISO or TS standards, and translate the requirements into terms and practices their companies can follow and implement.
What do you call "terms" and "practices"?
Are these "<quality> policy" and "<quality> procedures"?

I would not expect managers to have more than a passing familiarity with the specific language of the standard (though it would be nice). They have their own assigned responsibilities.
Then where are their responsibilities assigned?
In our QMS these responsibilities are assigned in QP's and are not different from the requirements of TS.
I guess that under "language" you probably mean "wording"(?); then I do strongly agree that managers may not remember what is written in the QP's; the managers shall just do the right thing, when anything done right to the purpose of a Company shall be automatically supported by respective QP's.

It is your job to translate and simplify, commonize and standardize the requirements into their processes.
What do you call "processes"?
Are these maybe "Quality Procedures" of "Work Instructions"?
I guess that it is what the standard stands for (to "simplify, commonize and standardize requirements" applicable to a QMS)...

Although I believe is is good management practice to use a "standard format" for keeping records of the Management Review and recommend such to any client, there is only a requirement for keeping records of the review.
RickT

What do you call "processes"?
Are these maybe "Quality Procedures" of "Work Instructions"?


Alex, you appear to be missing some of the quite basic knowledge of fundamental principles, essential for any quality professional. Are you really not aware that the 'process approach' is one of the 8 fundamental principles upon which ISO 9001 is based? Or don't understand what that means?

But that you are asking these types of questions, & querying if processes are perhaps procedures or work instructions is a clear indication of a fundamental lack of understanding.

If you need specific definitions, suggest you consult ISO 9000:2007, QMS Fundamentals and Vocabulary.

The ISO official site has an abundance of info available on understanding a process approach, and processes. There's an abundance of threads and information in this forum on what processes are, and explaining the difference between process and procedure, for example. Some effort put into searching for these and reading should result in greater understanding.

According to ISO/TC 176/SC 2/N525R section 7 - Demonstrating conformity with ISO 9001:2000:

"Where the organization has no specific internal procedure for a particular activity, and this is not required by the standard, (for example, clause 5.6 Management Review), it is acceptable for this activity to be conducted using as a basis the relevant clause of ISO 9001:2000. In these situations, both internal and external audits may use the text of ISO 9001:2000 for conformity assessment purposes."

You can check it at http://www.iso.ch/iso/en/iso9000-14000/explore/transition/2000rev7.html

So, I guess, it doesn't matter where you described it as long as you can demonstrate it.

tony s

Thank you all for such detailed info. Many thanks.

Stephen Pearce :thanx:

Good to know that this question is still bugging us.;)

Hi. I worked as an FDA investigator (Level II Certified International Medical Device Investigator) for over 21 years- primarily in the medical device arena. Currently, I am a contract international medical device consultant.

The management review process is tricky depending whether you are an ISO certified company and/or a company that is inspected by the FDA.

FDA investigators, unlike the ISO auditors and consultants, are allowed to examine your management review procedure BUT NOT your management review records. Similarly, with internal audit and vendor audit records as well.

FDA does not require firms to have quality manuals. This is an ISO term.

However, it seems that many firms, no matter FDA regulated or ISO certified use a 3 tier written procedure system:

The first tier is an overall quality manual.
The second tier is detailed written instructions dealing with general quality system areas (such as design controls, CAPA, complaints, training, audits, calibration, etc).
The third tier is working instructions specific to the individual equipment, processes, tests, devices, etc.

If you choose to have a quality manual it needs to detail the management review process, otherwise, you'll need an additional written procedure dealing with the management review process.

Remember, no matter if you have one procedure or hundred's, they are not written to please the FDA, ISO Notified Body, or other outside government/ auditing facility/consultant, but as aids to the managers and employees of the firm.

The FDA regulations, ISO standards, etc. are the minimum not the maximum. Thus, depending upon firm size, operations, employees, etc., you may need simple procedures or an encyclopedia. Too little written information is bad, cause it lacks detail and too much may cause operations steps to be missed/ not documented properly.

I hope this helps. :)

Since it is a company wide document so we have described it in the quality manual.

I reference Management Reviews in our Quality Manual, but I do not have a formal procedure or work instruction. We are a small company, so I send out an Agenda to all of the Process Owners, all of which are required to attend the meeting. Each Process Owner is required to complete a Management Review Worksheet form used to detail training needs, resource needs, identify system problems and success, list new goals, and also provide comments about the procedure for which they are the owner. These worksheets become a permanent part of the Management Review Minutes as an attachment. EVERY auditor who has reviewed my recording system has said that it is more detailed and comprehensive than many systems seen at larger companies. Just make sure you addresses each of the five processes (Management, Sales, Quality, Engineering, and Production) in your meeting with output for continual improvement.