Community Discussion Category Topics

ISO 9001:2015 - Measurement, analysis and evaluation

12

Hi friends, I need a guide. Is there a simple template or method to measure, analyze and evaluate a set quality ...

Dienye Atemie Mar '21

Tool combinations you have found useful

15 81

We all know about the basic quality tools, the new tools, and all the others. Nancy Tague's book is perhaps the best ...

Douglas Wood Dec '20

Dec '20

Great discussion item, Doug. Yes, I have a trio of well known tools I use often with problem-solving CAPA type ...

Dec '20

Dear Doug,
It seems that I only use tools in combinations. Years ago I noted that each issue analysis or ...

Dec '20

Greg,
Thank you for the points you make. I have intuitively felt these 3 stages apply, but you put it into words very ...

Dec '20

Greg,
I like your three stage model for problem-solving and I think I have intuitively approached most major ...

Dec '20

Dear Doug and Carl,
I have a perspective on this "singularity of tool selection" approach. Ishikawa and Kume both ...

Jan '21

Dr. Watson,
Your post brings to mind a few things.

First of all, it took 5 years to realize the use of integrated tool ...

Jan '21

I'm a bit surprised at how few responses this post has gotten. Perhaps no one has 'tool strings' that they rely on? We ...

Jan '21

Doug, thanks for the memory reminder of what tools start a string of other tools for analysis or problem solving. ...

Jan '21

Grace,
Thank you for your 'string' If we can find out what others do, we may find more commonality than you expect.

...

Jan '21

1. Observe & Audit Process/Interview People [P]
2. Key Observations/Data Collection [P]
3. Data Analysis> ...

Quality Improvement Project Tasks from Dr. Imai's ...

3 17

I have found this helpful as project task items for a Kaizen initiative. This is from Imai's Gemba Kaizen (pp. ...

Daniel Zrymiak Oct '20

Oct '20

Dear Dan,
The similarities should not be surprising. Please remember that Imai summarizes what he sees in ...

Oct '20

Hello Gregory Watson ‍ ,

Thank you indeed for the clarification. I would like to apply this outside of the factory in ...

Oct '20

For me, the mention steps for problem solving, looks very familiar if I am thinking at 8D or even more, at QRQC.

At ...

MSA Webinar, Oct 16, 2020

3 17

Hello fellow members, I am giving a webinar on continuous MSA on Oct 16 at 10AM Central time Here is the link: ...

James Bossert Sep '20

Sep '20

Hi James Bossert ‍

this is great, thank you for sharing

Dan

Sep '20

Thanks Dan, it is a basic talk but hopefully people will get something from it. How are you doing?

Sep '20

Thanks Jim, due to COVID and having to school/supervise School-age grand-boys while parents are at work, I've ...

Quality Tools to Cope with the Pandemic

1 17

The COVID pandemic has changed the way we work. As part of strategies to prevent infections, many organizations ...

Eileen Serrano Aug '20

Aug '20

As I am working remotely from home, the safeguards relate to the steps taken as an individual citizen and ...

How does robust process management help you control ...

17 103

First, why is this important? Because every manager needs to help control risk for the organization. Since 2015, ...

Douglas Wood Jul '20

Jul '20

Hi Douglas Wood ‍

This is the most impressive bibliography I have seen for a myASQ post. Congratulations on such a ...

Jul '20

Nice article Doug. Robust is the right word. Robust means to me both effectiveness and value return.

I like the we ...

Jul '20

In the interest of brevity, I did not mention Hans Rosling's book Factfulness. He echos Kahneman, and adds some key ...

Jul '20

I like the process turtle diagram. There are many 'tools' we know in quality that are powerful aids in general ...

Jul '20

I agree with my colleagues that this is a well thought out and written message. Thank you, Doug. I like the idea of ...

Jul '20

OK, here is a question I would love to hear back on:

Has anyone seen what they consider "best practice" in managing ...

Jul '20

The risk based process excellence has multiple approaches for robustness.

Here are my two cents about PFMEA. ...

Jul '20

Following.

Mr. King, this is a great question. My organization is resistant to changes in this regard, having ...

Jul '20

Mr. Bryant,
I sympathize. I do have a few ideas that may help, if you have not done them already. First, during or ...

Jul '20

Mr. Trehan,
In your experience, have you seen where a firm sets a 'magic line' for the RPN in FMEA, and says anything ...

PDCA

3 31

How well does your company culture embrace the concept of Plan-Do-Check-Act (PDCA)…or have they forgotten what ...

Kathleen Labedz Jul '20

Jul '20

I think that different methods embrace PDCA in their own fashion. Agile and Sprints are managed in a cyclical way ...

Jul '20

Hi Katie,

Thank you for sharing this PDCA refresher. Your opening sentence rings very true with me on a personal ...

Jul '20

Hi Katie ,
My field is pharmaceuticals, radiopharmaceuticals and most recently cosmetic industry . I found ...

Risk Based Quality Systems Audits for Medical Devices ...

4 46

Greetings ASQ Members, Would anyone have suggestions on tools/tips for developing a risk based approach to ...

Wayner Williams Oct '19

Oct '19

Hi Wayner,

The Aspect Failure Mode Effect Analysis, a FMEA based tool can be used for risk based implementation.

...

Oct '19

FMEA .. its simple to follow and there is provision for constant review and re evaluation of risks

Oct '19

Good afternoon;

A great resource you may want to consider is Barry Craner. I had the honor of participating in the ...

Apr '20

I am offering a webinar on this in May. Attached is a secure pdf file with more information. Webinar Aplomet RBQA ...

What are good Quality Indicators for Clinical ...

3 4

Hello, We are a clinical laboratory and in the process of improving our quality indicators. I'm wondering what ...

Doan-Trinh Nguyen Mar '20

Mar '20

Hello,

Participating in an external quality or proficiency test program such as EMQN provides data on the whole ...

Mar '20

I recommend that you check out the CLSI guideline "HS1-A2: A Quality System Model for Health Care," in which the ...

Mar '20

I'm not sure whether your lab is a stand-alone lab or is connected to a larger organization, but I would start by ...

Calibration vs Verification of Measuring ...

10 93

Looking for collaboration on a standard that prescribes gauge management activities in our business Is anyone ...

Barbara Lynch Feb '20

Feb '20

I work in an industry where we have to meet NSF-14. What paragraph are you looking at?

Feb '20

Hi Ryan,
It is section 9.4.1 and 9.4.2. We are complying with the weekly verification, but it seems excessive. ...

Feb '20

7.1.5.2 of ISO9001:2015 talks about calibration, but very light compared to earlier versions of ISO. We treat ...

Mar '20

Hi Ryan,
It is section 9.4.1 and 9.4.2. We are complying with the weekly verification, but it seems excessive. ...

Mar '20

Barbara,

As I mentioned earlier - We treat the weekly verification like you described - one block per week. We ...

Mar '20

ISO 9001 does not address calibration. It tells us to control our monitoring and measuring resources and ensure ...

Mar '20

Debra,

You are absolutely correct that ISO9001 doesn't specify a frequency. I apologize if my earlier comments ...

Mar '20

A common 483 finding is "calibrated instrument used outside of it's calibrated range". It is best to calibrate ...

Mar '20

NIST requires that as a minimum you calibrate at 25%, 50% 75% and 100% of the range of the instrument. This covers the ...

Mar '20

Hi, Larry. Can you provide the source for the NIST requirement? Thanks!

Quality Management Division

Discussion Topic List

ISO 9001:2015 - Measurement, analysis and evaluation

Tool combinations you have found useful

Quality Improvement Project Tasks from Dr. Imai's ...

MSA Webinar, Oct 16, 2020

Quality Tools to Cope with the Pandemic

How does robust process management help you control ...

PDCA

Risk Based Quality Systems Audits for Medical Devices ...

What are good Quality Indicators for Clinical ...

Calibration vs Verification of Measuring ...