Interesting Discussion "World Class Product" based QM. I need advice.

KNOWLEDGE_SEEKER_21

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#1
Does anyone has some type of "roadmap" to implement a non-ISO based QM for a company that wants to revamp its QMS to focus on "product quality" only. Yes I know it sounds ridiculous but this is what our VP is asking for. He no longer wants ISO and is asking to revamp the entire QMS and write the QM.

Does anyone has some experience on this unique situation? Which roadmap would you recommend? I honestly don't know where to start! I'm a CQE but no experience as a QM but I was assigned since my manager left the company.
 
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Ed Panek

QA RA Small Med Dev Company
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#2
Before Japan and TQM there were craftsmanship standards. This is going to be a funny thread though.
 

Sidney Vianna

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#3
He no longer wants ISO and is asking to revamp the entire QMS
Unless you dig deep and find exactly his objections to "ISO" (whatever that is), there is no way you will be able to accomplish this "mission".

What many people resent about "ISO" is, in great part, asinine, valueless bureaucracies and other SELF-IMPOSED non-value added activities. Product quality HAS TO BE the outcome of a well thought out system. In my experience, the overwhelming majority of cases where top management badmouth "ISO" is the result of their absence during system development and allowing, by omission, processes being put in place that were detrimental to the business objectives.

There are infinite ways of complying with "ISO". Some organizations see the light and understand the breadth and depth of a business-savvy QMS. Others curse at the darkness.
 

KNOWLEDGE_SEEKER_21

Starting to get Involved
#4
Unless you dig deep and find exactly his objections to "ISO" (whatever that is), there is no way you will be able to accomplish this "mission".

What many people resent about "ISO" is, in great part, asinine, valueless bureaucracies and other non-value added activities. Product quality HAS TO BE the outcome of a well thought out system. In my experience, the overwhelming majority of cases where top management badmouth "ISO" is the result of their absence during system development and allowing, by omission, processes being put in place that were detrimental to the business objectives.

There are infinite ways of complying with "ISO". Some organizations see the light and understand the breadth and depth of a business-savvy QMS. Others curse at the darkness.
I completely understand. Believe he can't grasp the concept, we try several times (directly and indirectly) but no luck. I told him that ISO is just a facilitator, a systematic-process approach designed to facilitate that world-class quality and that the QM is just basically a documented framework that outlines all the QMS core processes (interactions and associated inputs and outputs). How simple is that? He has two master degrees but can't grasp the concept.

He claim that he does understand but that since ISO is not required by the customer and that "not everything" in ISO adds value then we should refocus to be a WCM. He was also a bit disappointed that the last auditor really didn't do much and we easily passed the audit. His logic is that "how come we passed the audit and yet there are tons of customer complaints" lol.

I was expecting some kind of "optimism" around here but I guess I will need to start looking for a new job.
 

Sidney Vianna

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#5
His logic is that "how come we passed the audit and yet there are tons of customer complaints" lol.
Normally, the people who ask those questions are the same ones that, directly or indirectly conspire to have the cheapest, easiest, least impeding Certification Body providing their ISO 9001 certificate. That's exactly why I was so vociferous when people suggested that the best type of CB auditor is the blind gopher type, because they always give a clean bill of health to everyone, irrespective of system performance.

Now that you have mentioned that the organization has a significant number of customer complaints, that should be more than enough proof for the need of a SYSTEM to handle and prevent future complaints. If he does not grasp that, it is hopeless.
 

Tagin

Trusted Information Resource
#6
I completely understand. Believe he can't grasp the concept, we try several times (directly and indirectly) but no luck. I told him that ISO is just a facilitator, a systematic-process approach designed to facilitate that world-class quality and that the QM is just basically a documented framework that outlines all the QMS core processes (interactions and associated inputs and outputs). How simple is that? He has two master degrees but can't grasp the concept.

He claim that he does understand but that since ISO is not required by the customer and that "not everything" in ISO adds value then we should refocus to be a WCM. He was also a bit disappointed that the last auditor really didn't do much and we easily passed the audit. His logic is that "how come we passed the audit and yet there are tons of customer complaints" lol.

I was expecting some kind of "optimism" around here but I guess I will need to start looking for a new job.
If that's his genuine view (that ISO 9001 is a disappointment), then it seems like a great opportunity for you - you get to pick and choose what elements you want from 9001 and use your creativity and skills to add in other new and novel elements, and create a QM that is both better than 9001 and is hopefully more tailored to your business. Sounds like fun to me!
 

KNOWLEDGE_SEEKER_21

Starting to get Involved
#7
If that's his genuine view (that ISO 9001 is a disappointment), then it seems like a great opportunity for you - you get to pick and choose what elements you want from 9001 and use your creativity and skills to add in other new and novel elements, and create a QM that is both better than 9001 and is hopefully more tailored to your business. Sounds like fun to me!
Thanks a lot. I really needed to read something like this. I honestly 50/50 right now if I should take challenge or start looking for a new job.
Which roadmap would you take? If you don't have one just please describe the steps. I've been brainstorming and this is what I have so far:

1. Recognize the need to change: Develop a vision for the new QMS and mass email to all employees for project awareness.
2. Initial Assessment: GAP Analysis, Gemba Walks and Risk/Opportunity Identification.
3. Determination of strategies and methodologies to fill the gaps. Identify new KPI's, and potential barriers when introducing change.
4. Set new quality goals for QMS transition.
5. Documentation of new QM
6. New QM training/orientation.
7. QMS implementation per new/revised procedures
8. Create Audit Team: Train them and conduct initial internal audits.
9. Resolve internal audit findings per RRCA and verify effectiveness.
10. Anchor Changes: Final Gap Analysis, Final Gemba Walks and Develop Plan and closure.
11. Final Internal Audits.
12. Resolve final audit findings and verify effectiveness.
13. Create self-assessments and send them to all QMS core processes owners.
14. Review final performance using systematic approach.
15. Lessons learned review and congratulate the collective efforts of everyone involved.
 

Tagin

Trusted Information Resource
#8
Thanks a lot. I really needed to read something like this. I honestly 50/50 right now if I should take challenge or start looking for a new job.
Which roadmap would you take? If you don't have one just please describe the steps. I've been brainstorming and this is what I have so far:

1. Recognize the need to change: Develop a vision for the new QMS and mass email to all employees for project awareness.
2. Initial Assessment: GAP Analysis, Gemba Walks and Risk/Opportunity Identification.
3. Determination of strategies and methodologies to fill the gaps. Identify new KPI's, and potential barriers when introducing change.
4. Set new quality goals for QMS transition.
5. Documentation of new QM
6. New QM training/orientation.
7. QMS implementation per new/revised procedures
8. Create Audit Team: Train them and conduct initial internal audits.
9. Resolve internal audit findings per RRCA and verify effectiveness.
10. Anchor Changes: Final Gap Analysis, Final Gemba Walks and Develop Plan and closure.
11. Final Internal Audits.
12. Resolve final audit findings and verify effectiveness.
13. Create self-assessments and send them to all QMS core processes owners.
14. Review final performance using systematic approach.
15. Lessons learned review and congratulate the collective efforts of everyone involved.
I like it overall. Three thoughts:
1) 'Develop a vision' is a huge chunk, and deserves to be its own step (or couple of steps). This is where some real pie-in-the-sky thinking can take place. Asking "what if?"...like "what if we didn't need procedures?", "what if the QMS were entirely hands-off AI?", "what if nonconformances fixed themselves?" I know, I know, these kinds of questions can seem farfetched and unrealistic, but its what can spur innovation, and move mindsets into new terrain of what is possible.
2) Is there a budget for this? Can you afford, say, to have someone write an eQMS tailored specifically to what you want, so you can run a no-compromise QMS? Maybe even one so good that your company spins it off as a product to sell?
3) Throughout those steps....be wary of the old ways, the old paradigms, sucking you back into the Borg collective. (Do you really need audits? It's the 21st century, why not have the system continually audit itself?)
 

yodon

Staff member
Super Moderator
#9
To me, this is a pretty telling statement:

He claim that he does understand but that since ISO is not required by the customer and that "not everything" in ISO adds value then we should refocus to be a WCM. He was also a bit disappointed that the last auditor really didn't do much and we easily passed the audit. His logic is that "how come we passed the audit and yet there are tons of customer complaints" lol.
What's going on that you have tons of customer complaints? Clearly your system isn't working as intended and so it's not too far a stretch for management to think that there's no value in it. Putting a different label on a broken system won't help.
 

KNOWLEDGE_SEEKER_21

Starting to get Involved
#10
I like it overall. Three thoughts:
1) 'Develop a vision' is a huge chunk, and deserves to be its own step (or couple of steps). This is where some real pie-in-the-sky thinking can take place. Asking "what if?"...like "what if we didn't need procedures?", "what if the QMS were entirely hands-off AI?", "what if nonconformances fixed themselves?" I know, I know, these kinds of questions can seem farfetched and unrealistic, but its what can spur innovation, and move mindsets into new terrain of what is possible.
2) Is there a budget for this? Can you afford, say, to have someone write an eQMS tailored specifically to what you want, so you can run a no-compromise QMS? Maybe even one so good that your company spins it off as a product to sell?
3) Throughout those steps....be wary of the old ways, the old paradigms, sucking you back into the Borg collective. (Do you really need audits? It's the 21st century, why not have the system continually audit itself?)

Tagin,

Thanks a lot for helping me out. Sorry for my lack of creativity but can you please explain further the following two ideas (I'm very interested):

1. "Nonconformance's fixing themselves" and "have the system continually audit itself".

Thanks!
 
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