Why do 'we' and ?our? QMS?s stop working? What are the Failure Modes?

N

noboxwine

#1
Have I missed something along the way ?

!Hola! For just a minute, disregard ISO / QS / TS / AS. All that’s a heaping pile of BS. Twelve years of this gig from QE to Eng Mgr to Director have afforded me a cornucopia of lessons. We well understand that us Quality types are of somewhat sound mind and stand for the best interest of our respective organizations. Unequivocally, we have the cerebral aptitude to constitute a strategy to diminish cost and preserve a confident customer base. Yet, I ask you, why do 'we' and ‘our’ QMS’s stop working? Throw out the semantics, oblique vernacular and decorate thyself with an ever-dwindling commodity dubbed common sense. In case you’re still scratching your head, the attached chart may reveal the answer. The intent of this post is not sarcastic. It’s to solicit your opinions to see if I may have missed something throughout this safari. Have a great day and may all the data points in your 1.67 Cpk be inside spec limits (see, because you can have, well, never mind). Have a nice day.
:bonk: :thedeal: :frust: :confused: :mad:
 

Attachments

Elsmar Forum Sponsor

Mike S.

Happy to be Alive
Trusted Information Resource
#2
Nobox,

You sound a bit frustrated and in need of venting some steam. Sounds like your day must be going about the same way as mine! Some Mondays are worse than others and this is a bad one. Anyway...

FWIW your comments and chart are meaningful in my opinion. Not the be-all and end-all, but important. I've always thought that the #1 most important component of any well-functioning QMS (or just plain MS as Jim Wade would have us say/think) is the top management's committment. Nothing else is close IMO. I urge anyone who thinks otherwise to step up onto the mound and make his/her best pitch.

Having said that, the sad reality is that most of us (90%+??) have to work with top management groups that show less than the optimal level of commitment and support. Still, because of our very nature and the jobs we have, we “Q people” usually work our tails off to make the best of what we get. Rarely in life, in any area of endeavor, are we working under optimal circumstances/conditions, and our job situations are often that way as well. But usually the source of frustration comes from seeing opportunities to greatly improve the situation for the good of all but not being able to get others to see what we see. Frustration grows in direct proportion to the degree of ease with which the ignored problem could be solved and/or the degree of risk involved in not making the change. Sometimes despite our best efforts we just have to watch the inevitable painful event happen even though we know how to prevent it. It is similar to the feeling a parent gets when they see a child heading down the wrong path yet despite all of their best efforts the parent cannot get the child to see the problems ahead on that path so the child ends-up having to “hit the wall” and feel the pain themselves, which often causes the parent the same or worse pain. I’m not so egotistical to suggest we as Quality workers or parents are always right, but often history shows us that we are, and thus we end-up frustrated to varying degrees. The goal, I guess, is to try to put ourselves in situations where we can minimize the frustration, but we will never eliminate it.
JMHO.

Okay, enough crappy Monday philosophical blathering from me.
 
E

energy

#4
Re: Have I missed something along the way ?

noboxwine said:

Twelve years of this gig from QE to Eng Mgr to Director have afforded me a cornucopia of lessons. We well understand that us Quality types are of somewhat sound mind and stand for the best interest of our respective organizations.
Nobox,

Your profile says Quality Manager. The above shows Quality Engineer to Eng Mgr to Director. Director of Engineering? Quality? Do you have "Quality" in your title, now? Most people who jumped to Engineering from Quality rarely return. They are also inclined to, in least in my experience, overlook things that Quality types moan about.

Call me dense, but your graph shows Management Commitment rising way up into the effectiveness of the QMS. I know it's a red line. Is this what you desire? Is this what you have? Is it a picture of a bad thing or a good thing? Mike S. got it, I guess. I'm a bit slower. I can't blame it on Mondays. Just call me curious. :bonk: :ko: :smokin:
 
N

noboxwine

#5
Oh how easy it is.

Mike S. said:

Nobox,

You sound a bit frustrated and in need of venting some steam. Sounds like your day must be going about the same way as mine!
Actually not a bad day for Monday and no specific event caused the post. Thanks for letting 'vent' nonetheless ! It's comical now as opposed to a couple years ago. I simply have looked back over the companies I have worked/consulted for and the solution is simple. I know why one ran single digit dPPM's and another ran 25,000. A commitment, not lip service, from the guy in charge to improve and maintain quality was all it took. There simply is no science in delivering a product as advertised..............................:biglaugh:
 
M

M Greenaway

#6
Nobox

Is top management commitment all it takes ?

Or is this just the pre-requisite first building block of an effective system ?
 
N

noboxwine

#7
Since '65 ? I was not even thought of !

.
energy said:
Nobox,

Your profile says Quality Manager. The above shows Quality Engineer to Eng Mgr to Director. Director of Engineering? Quality? Do you have "Quality" in your title, now? . :bonk: :ko: :smokin:
Hey veteran mucka ! Thought you might bite on this one. I am now just a low life QM after a few other stints in and around it. Found out that big $$ and high profile is not what it's all cracked up to be. Even for a single guy, it's hard to spend it when you never leave the office ! Anyway, the titles have changed but the heartfelt commitment to excellence never did. Yet, God only knows why I still do this. The occasional sense of satisfaction, I guess. Kinda like golf. You can beat yourself into submission for 4 hours and on the 18th hole you drain a 30-foot birdie putt that makes all the bad shots go away. The graph, based upon my experience, simply shows that an effective system is directly proportional to the level of management commitment. If you get the support necessary, it’s just not too difficult. Top Mgmt is unequivocally the biggest roadblock on this planet. Have a day !
:thedeal:
 
N

noboxwine

#8
They're the main ingredient !

M Greenaway said:

Nobox

Is top management commitment all it takes ?

Or is this just the pre-requisite first building block of an effective system ?
Mgmt Commitment is the foundation. Then, us analytical, anal- retentive quality types come in and develop a recipe for acheiving the objectives.:cool: I've never seen it fail when true commitment is there.
 
E

energy

#9
Re: Since '65 ? I was not even thought of !

noboxwine said:

Hey veteran mucka ! Thought you might bite on this one. I am now just a low life QM after a few other stints in and around it.
I got it now! Low life QM? That's what Engineers call me:vfunny: It's a living. Every day I am reminded by these " living large" executive types that they do not have a clue what a QMS is and what it should consist of. So, besides making more cash, we're even! :biglaugh: Our QM rewards are.......uh......ah...somewhere. I got mine 3 months ago. Approx. 2%. That was considered in the upper half. Pwew! Don't tell anybody. We don't need QM envy!:ko: :smokin:
 
N

noboxwine

#10
Re: Re: Since '65 ? I was not even thought of !

energy said:



I got it now! Low life QM? That's what Engineers call me:vfunny: It's a living. Every day I am reminded by these " living large" executive types that they do not have a clue what a QMS is and what it should consist of. So, besides making more cash, we're even! :biglaugh: Our QM rewards are.......uh......ah...somewhere. I got mine 3 months ago. Approx. 2%. That was considered in the upper half. Pwew! Don't tell anybody. We don't need QM envy!:ko: :smokin:
It'll be our little secret !:bigwave:
 
Thread starter Similar threads Forum Replies Date
L Clause 0.4 of ISO 9001 and EHS - Where should I stop the inclusion of EHS in my QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
T QMS Compliance Department KPIs AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 20
A E-signatures for QMS? ISO 13485:2016 - Medical Device Quality Management Systems 2
A Document control system for QMS in Google Drive? Document Control Systems, Procedures, Forms and Templates 6
W Looking for IATF 16949 (and ISO 17025) QMS software Suggestions Quality Tools, Improvement and Analysis 8
B Does anyone copyright their internal QMS documents? Document Control Systems, Procedures, Forms and Templates 24
M Possible topic for Master thesis topic - MDR and QMS ISO 13485:2016 - Medical Device Quality Management Systems 4
A Help understanding what it takes to implement a QMS that is ISO 13485 compliant ISO 13485:2016 - Medical Device Quality Management Systems 4
A New to QMS and regulatory... advice on training/certification? ISO 13485:2016 - Medical Device Quality Management Systems 1
Q UK QMS Requirements UK Medical Device Regulations 2
B QMS On-Boarding ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
M Questions concerning QMS and/or company specific nonconformance Customer Complaints 2
B ISO cl. 5.3 - Ensuring that the integrity of the QMS is maintained ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
T Scalable QMS AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
J Using an online software to maintain your QMS Quality Assurance and Compliance Software Tools and Solutions 7
I QMS and ISO 9001 Misc. Quality Assurance and Business Systems Related Topics 11
E Visual Management Boards & QMS ISO 13485:2016 - Medical Device Quality Management Systems 8
S Disparity between Job Descriptions in QMS & Contract ISO 13485:2016 - Medical Device Quality Management Systems 7
qualprod Minimize tomention other positions to ease the QMS management ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
S QMS certificate and Samlping EU Medical Device Regulations 0
H Mapping QMS+business processes in a medical device with class I and IIa+b Process Maps, Process Mapping and Turtle Diagrams 3
Y Must Initial importers have any QMS? US Food and Drug Administration (FDA) 1
qualprod QMS global effectiveness? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Q 13485 QMS turnkey ISO 13485:2016 - Medical Device Quality Management Systems 10
K New to Medical Device QMS and would like advice ISO 13485:2016 - Medical Device Quality Management Systems 20
N QMS standard for a research based Organisation Quality Manager and Management Related Issues 1
Moncia Integrated QMS and audit Other ISO and International Standards and European Regulations 5
J New QMS Auditor - seeking opportunities to gain audit experience Career and Occupation Discussions 3
Sam Lazzara Record signature requirements in proposed FDA 21 CFR 820 QMS Regulation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
qualprod External consultant into a QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
S Changing PCB Assembler and impact on QMS and MDD CE Certificate EU Medical Device Regulations 2
ChrisM Class 1 non-sterile device, need certified QMS or not? EU Medical Device Regulations 2
A CDRH Learn and DICE for Building a QMS 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
A QMS inside a Non medical device firm ISO 13485:2016 - Medical Device Quality Management Systems 4
S HELP in setting-up QMS Quality Tools, Improvement and Analysis 4
S How long the QMS must be maintained after device EOL? ISO 13485:2016 - Medical Device Quality Management Systems 6
K Processes interaction of QMS Process Maps, Process Mapping and Turtle Diagrams 4
P Can I exempt products/services from my AS9100 QMS? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
J0anne QMS Implementation Iran ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
adir88 Substantial Change to QMS (Annex IX, Chapter I) EU Medical Device Regulations 0
Watchcat When to begin putting together postmarket production QMS for a mobile app? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 13
B QMS Functional Safety Checklist ISO 26262 - Road vehicles – Functional safety 0
D Proof QMS compliance for class I ISO 13485:2016 - Medical Device Quality Management Systems 1
A Need career advice on QMS & HSE (No hands on experience) Career and Occupation Discussions 6
M Sharing QMS Documents with Customers Document Control Systems, Procedures, Forms and Templates 13
M Options when MSA acc. to VDA 5 is NOK (Qms > 30%) Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 0
D QMS Realignment after business splits into 2 different companies AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
G One-person QMS - possible? ISO 13485:2016 - Medical Device Quality Management Systems 18
A SaaS SaMD - Impact QMS ISO 13485:2016 - Medical Device Quality Management Systems 2
S ISO9001 QMS: Quality Manual Examples & Templates ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14

Similar threads

Top Bottom