Management Review: Separate Procedure or Description in Quality Manual?

How do you address Management Review?

  • Quality Manual (only)

    Votes: 16 18.8%
  • Management Review Procedure

    Votes: 22 25.9%
  • Both

    Votes: 38 44.7%
  • I use a simple form (agenda)

    Votes: 9 10.6%

  • Total voters
    85
A

Alex Kobzar

#91
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?
 
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J

JaneB

#92
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.
 

Helmut Jilling

Auditor / Consultant
#93
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.
 
A

Alex Kobzar

#94
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)...
 
R

RickT

#95
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
 
J

JaneB

#96
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.
 

tony s

Information Seeker
Trusted Information Resource
#97
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 - Sorry - Dead Link removed.

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

tony s
 
Last edited by a moderator:

Weiner Dog

Med Device Consultant
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. :)
 
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