How do we satisfy the requirement that "all elements of the entire quality system" are reviewed during Management Review? I was told that you may have to present the full text of QS-9000 at the Management Review. THANKS.

Lyndon -
There is no requirement that the full text of QS9000 be presented at a review. The standard says you must review "all elements of the entire quality system". One way to do this would be to review your internal audit program during this "review". This would classify as reviewing the entire system. A lot of companies that I am familiar with approach it this way. Your management rep is also required to report on the quality system to your management for review. If you already have some sort of regular meeting concerning your company's performance, a brief note by the mgmt. rep about the quality system would also work.

In essence, internal audits have to address your tier 2's - upon which your 'quality' systems are based. and the, as Scott said, your review will suffice.

We conduct a management review once every 3 months. Do the management review need to review all the elements of the entire quality system everytime?

Nope. Not everything every time.

In the QS9000 requirement for management review, the keywords are "continuing suitability" and "effective". How have you defined/proven those characteristics of your quality system?

thanks

Paul

Audit summaries, customer complaints, and corrective actions reviewed at management meetings gives our plant staff a good cross-section of how effective our quality system is doing. When non-conformances generated from these 3 system illustrate that we have a "problem" are it is a good indicator that we have a system(s) that is ineffective. In addition, machine yields, downtime(4.9/PM), scrap(4.13), and Cpk reports (4.9, 4.20) are also reviewed to determine the continuing suitability and effectiveness of our quality system. If any of these areas warrant more attention, the management review session become more frequent.

These are not the only indicators of ineffective systems, for example I had a quality engineer track all the design changes of product that have been approved for production. It seemed that there was an inordinate amount of design changes after the product was approved for production. The numbers were tracked and reported during management review, which indicated that communication between our design group (APQP problem)and process engineers was not as effective as it should be.

Paul,

Suitability changes as the standard, voluntary or otherwise, changes. QS9000, 3rd edition is different than the 2nd edition. ISO 9000:2000 will be different than ISO 9000:1994. Your program needs to evolve with standard, otherwise your prgram becomes unsuitable. Suitability audits can be compared to desk studies of your Quality Program (your documents) where it is compared to the standards requirements. Suitability is also defined by you. You need to at a minimum satisfy the requirements of the standard, but many Quality Systems go beyond the standard requirements. For those items, you have to review and determine if these things are still practical for your organization. Are they value added operations, or once were and now are waste? You management group decides that.

Christian has given some good examples of measuring system effectiveness. You may want to ask senior management about other measures that they may like to see. This creates better buy in at these meetings. Other results of system effectiveness comes from Internal Quality Audits, where 'compliance' to your Quality Program is reviewed. Compliance audits determine how well you stick to the program. Another good point brought up by Christian is 'system ineffectiveness'. These are generally measures of nonconformance, the problems, where action plans or action plan committees can be determined during management review. I personally like to keep a balance (not necessarily 50/50) of problems and successes. If you heavily skew the mix of the meeting to either side, you end up having a Pep Rally or a Gripe Session (neither are really productive).

Regards, Kevin

Back to the group...

[This message has been edited by Kevin Mader (edited 03-03-99).]

Glad to hear you came through in good shape. For quality goals, I'll be simple and say look at your metrics.

Any specifics? The auditor who did our pre-assessment felt we need to show effectiveness. We are going through cost of quality, corrective actions, internal audits, etc. in monthly Managemetn review meetings. He says its not good enough. What am I missing?

What metrics do you have? Scrap? What else? Your management should be setting some type of metric based goals. The question is, how are you doing against your metrics?

So - a quality goal may be a 2% reduction of scrap or a reduction in nonconformances by 10% might be a goal.

What can you quantify with data?

On another level, you might consider process improvements (you set certain goals with an FMEA, for example).

Thanks for the info! Pre-assessment was this week and we came out with no majors! - Thanks to alot of help from this forum.
Gota problem though... Can someone help me out on what some standard quality goals would be?

Dawn,

What I like to keep in mind when creating, what I refer to as the key business statistics, I try to pick processes with easily measured output (meaningful to the organization). Mark mentioned scrap. While this is captured as dollars in your Cost of Quality reporting, how about the output? How many parts per million defective, what processes feed into the "scrap" process, how much from each, what are the top x reasons contributing to scrap, what are the top x products accounting for a majority of the scrap? The list can be as big as you want it to be. Start small, keep it manageable.

The idea is to determine where you are today (measured output). Each organization is different, so ask your senior managers what they would like to see.

Determine your inputs (contributors to scrap). I would suggest statistical tools here; SPC, Pareto, and the like.

Determine your quality goals (reduce scrap). If you are using SPC, you may be able to determine if the process is capable and predictable. In this case, you will be able to set practical goals. If you do not, then it becomes a more difficult task, and goals are set arbitrarily. This does not mean that your organization shouldn't use arbitrarily set goals. It is important to keep in mind that their is danger in setting arbitrary goals (you don't meet your goal, the group becomes disinterested, or a reverse goal is achieved).

I like to pick a measure or two from key business processes. This way you can determine system effectiveness beyond the scope of internal quality audits and corrective action programs. I hope this helps.

Back to the group...

[This message has been edited by Kevin Mader (edited 03-09-99).]

Qualification - all have to be done once a year, but not all of them at every meeting if you meet more than once a year.

Has anyone seen any changes in interpretations by registrars?

How do we show evidence that all elements are reviewed.

the records (minutes?) of the meetings should provide that evidence

If you use a basic form as an agenda and you annotate that form during the meeting you have your evidence. The file Mgmt_rev.pdf in the http://Elsmar.com/pdf_files/ directory is an example of a very simple management review form (agenda). It is for a very small company and is from several years - so you would have to update it and adjust it for your company, but that's not a big deal.

In so far as specifically addressing each element once a year, ask yourself how you do it. Some companies do this by way of dicsussion of presentation of audit findings (internal and external). If at 1 meeting you discuss audits (which should touch on every element - even if no findings were found in an element, that should be stated) you annotate that you did so.

If your auditor then says something like "Well, I see you wrote that you discussed audit findings and you say you touched on every element but how do I know you actually discussed every element..." I would suggest you get ready to request a different auditor. There is a point where things become 'stupid'. To go to the extreme a company would have to record every meeting on audio tape (at least) to catch every detail and to provide proof (evidence) of every detail discussed.

> > A recent ISO9001 continuous assessment highlighted that our management
> > review was lacking in the suitability (are the systems you have the
> > "right" systems) portion. The problem is the objective evidence. We were
> > told that usually the problem part of the management review is the
> > effectiveness (are your systems operating as they are documented)
> > portion and not the suitability portion.
> >
> > I am looking for how others are fulfilling the suitability portion of
> > the management review and how you provide the objective evidence.
> >
> > Thanks,
> > Ryan Fleser
> > FLESERR -- VTC.COM

Subject: Re: Q:Management Review/O'Leary
Date: Mon, 21 Apr 1997 20:02:35 -0600
From: ISO Standards Discussion <JENNEJOHNN@UWSTOUT.EDU>

From: picker.com "Daniel J. O'Leary"

In management reviews we address the problem with a statement in the minutes. We believe that suitability is a conclusion that you draw based on the information presented. We may say the system is suitable or we may say it is suitable after some changes have been made.

Our minutes, the quality record, have these defined requirements.

The meeting AGENDA

List of attendees
1. Strengths of the Quality System noted during meeting
2. Weakness of the Quality System noted during the meeting
3. Corrective action assignments made during made during the meeting
4. A statement of the suitability and effectiveness of the documented procedures and instructions
5. A statement of the need to redefine management's Quality Policy, Quality Objectives, and commitment to Quality
6. Objective evidence of effectiveness presented during the meeting

The minutes of the meeting are reviewed and approved by the Quality System Management Representative and the Vice President & General Manager.

Dan O'Leary CQA, CQE, CQM, CRE
picker.com

QS requires that a yearly review of the quality system is conducted. Our approach is to review each of the elements with the element coordinators and the management representative.

Please give me some feedback on what others do at mgt review meetings.

We hold a management review meeting once per six months. In this meeting, we will review 1) system effectiveness reported by element coordinator 2) nonconformities analysis 3). The achievement of quality goal.

Actually, I wonder how to evaluate the effectiveness of system. Is there any good measurement tool?

Any reply is appreciated.

best regards,
jessie from Taiwan/R.O.C.

We do management review in 5 phases:

1: Daily production meeting with managers. (Review daily requirements and quality/production concerns)

2: Weekly meeting of the QS-Steering Committee. (Review continuous improvements, process assessment results, corrective action progress)

3: Monthly Management Review Meeting. (PPM, C/A Results, Customer Satisfaction, Process Capability, Delivery, Downtime, PPAP, Continuous Improvement, Employee Satidfaction, Internal Audit Results.

4: Quarterly Management Review. (Same as monthly review plus Meeting Business Plan Objectives, Policy Review, System Suitability and Effectiveness, Internal Audit Results and Schedules)

5. Yearly Employee review. (Training Effectiveness, Performance etc...)

Each of these reviews has an agenda that ensures all areas noted in the quality system are reviewed and documented.

Al Dyer

To evaluate the effectiveness of the quality system, I conduct monthly assessments to determine if various segments of the quality system are being utilized and executed. This information is reported to management and compare with previous months data.

Look for Mgmt_rev.pdf in:
The Elsmar Cove Free Files directory (http://Elsmar.com/pdf_files/)

I feel the methodology as followed by AL DYER can be appropriate.

However alternate methodology can be used as long as ALL elements are covered during the CROSS FUNCTIONAL management reviews.

However it would be required at each stage to review the effectiveness of the elements.
For examples to take one case...
Say SPC : How many operations are now within control?

In how many cases are the process capabilities more than a set value?

What is the effectiveness of actions decided earlier about the same?

Any further actions needed?

Any additions/deletions to the list of operations on SPC ...?

And so on ..

HOWEVER IT IS NOT MANDATORY TO HOLD SUCH REVIEWS AT AN YEARLY FREQUENCY... ALTHOUGH IT MAY BE APPROPRIATE..YOU CAN DEFINE THE FREQUENCY AS APPRPRIATE TO YOUR BUSINESS AND FOLLOW THE SAME.

Thanks
e.s.deo

[This message has been edited by e.s.deo (edited 26 October 2000).]