Leadership non-conformity, Top Management's involvement in Problem Solving

Booker

Starting to get Involved
#1
Dear,

In 2021 we had NC for Control plan 8.5.1.1, this year the same NC. Therefore automatically NC for Problem Solving 10.2.3 along with Leadership 5.1.
We see that the auditor did not see clear involvement of Top Management's attention in problem-solving.

Is there any hint around from your experience, on how to tackle and formally involve Top Management in Problem Solving? And improve Leadership?

Thank you.
 
Elsmar Forum Sponsor

John C. Abnet

Teacher, sensei, kennari
Leader
Super Moderator
#4
how to tackle and formally involve Top Management in Problem Solving? And improve Leadership?
Well....this question is as old as the standard itself ;)

There is no silver bullet for this. Often the individual responsible for the QMS (not how it's supposed to work....but often a reality), tries to make leadership think the way that QMS responsible individual thinks. I've sat in both of those chairs (i.e. QMS whipping boy and also Executive Leadership). I would counsel to view it through the eyes of executive leadership. What are the things that keep them awake at night? What/where are THEIR priorities? Then engage in discussions with Top Management on those topics. Instead of trying to "tell" them what they should be doing and how the QMS works....ASK them what their concerns and stresses are. ASK them if they see the QMS as an asset or a stone in the shoe (I/you can guess the answer). Then align what stresses them with how the QMS can possibly assist. This engagement and empathy with/for Top Management will put you/the QMS on a RELATIONSHIP path that can help achieve the "engagement" the standard requires.

It's not an overnight fix.

Hope this helps.
Be well.
 

optomist1

A Sea of Statistics
Super Moderator
#6
Hi Booker, a bit more I have found that issuing to management a periodic (weekly/bi-weekly) problem solving spreadsheet/or similar summary to delineate the problems, who, when and close out dates. The offenders or late responders are clearly identified and escalated for further action(s).

Hope this helps...Optomist1
 

malasuerte

Involved In Discussions
#7
Dear,

In 2021 we had NC for Control plan 8.5.1.1, this year the same NC. Therefore automatically NC for Problem Solving 10.2.3 along with Leadership 5.1.
We see that the auditor did not see clear involvement of Top Management's attention in problem-solving.

Is there any hint around from your experience, on how to tackle and formally involve Top Management in Problem Solving? And improve Leadership?

Thank you.
Well explain to them:
5.1: Top management shall demonstrate leadership and commitment with respect to the quality management system by: a) taking accountability for the effectiveness of the quality management system; h) engaging, directing and supporting persons to contribute to the effectiveness of the quality management system;

And then follow

10.2.3: The organization shall have a documented process(es) for problem solving including:a) defined approaches for various types and scale of problems (e.g., new product development, current manufacturing issues, field failures, audit findings);

-----In your documented process, build a table that outlines when leadership needs to be involved.
 

Tidge

Trusted Information Resource
#9
Is there any hint around from your experience, on how to tackle and formally involve Top Management in Problem Solving? And improve Leadership?
Frankly: In a majority of cases, I wouldn't want "top management" involved with problem-solving. As @John C. Abnet wrote: Management will have a particular set of priorities that almost certainly will not lend themselves to the sorts of things a (big Q) Quality Professional considers a "problem." I also would be concerned about a (perhaps) stereotypical modes of thinking with folks at that level in an organization... I'll allow forum members' imaginations to come up with potential examples.

A reasonable approach to the problem is to have top management appoint a specific individual with the responsibility to report to them specified (quality, production, whatever encompasses the realm of "problems") metrics, and have a pre-determined process for problem solving... if the process is going to be an ad hoc approach that top management wants to be involved with... OK, I suppose... but it is more than likely they would prefer to have someone at a lower level address non-conformances, etc. If top management establishes the plans and policies, they should be (mostly) covered.
 

Randy

Super Moderator
#10
Frankly: In a majority of cases, I wouldn't want "top management" involved with problem-solving. As @John C. Abnet wrote: Management will have a particular set of priorities that almost certainly will not lend themselves to the sorts of things a (big Q) Quality Professional considers a "problem." I also would be concerned about a (perhaps) stereotypical modes of thinking with folks at that level in an organization... I'll allow forum members' imaginations to come up with potential examples.

A reasonable approach to the problem is to have top management appoint a specific individual with the responsibility to report to them specified (quality, production, whatever encompasses the realm of "problems") metrics, and have a pre-determined process for problem solving... if the process is going to be an ad hoc approach that top management wants to be involved with... OK, I suppose... but it is more than likely they would prefer to have someone at a lower level address non-conformances, etc. If top management establishes the plans and policies, they should be (mostly) covered.
Total truth finally! You ought to see the "deer-in-the-headlights" look I get when I ask about the "competence" of people doing whatever......... Competence extends to "Top Management" and that opens 2 things immediately and starts entry into 2 others

Opens
1- Pandora's Box
2- A nest of snakes

Starts entry into
1- Minefield
2- Quicksand

Many, not all, but many, "Top Management" types have neither the skills, expertise, knowledge, background, wherewithal, understanding or anything else in their bag of tricks to fall back on with a vast majority of problems presented to SME's for resolution. Having a title or position does not make one omniscient, most of the time it just makes them paid better.

Take a good, hard, long gander at a lot of "Top Management" and you might find a financial whiz, great organizer, great PR type, nice smile, someone who knew someone, or rich uncle, but a serious person to get seriously involved in solving a "real" problem? Forget it, you'll wind up with nothing more than a talking head, taking up time and space with pretty teeth.

Formal involvement of Top Management in problem solving? Only if it's in their trick bag to begin with, other than that, involvement in a review of everything, ups-downs-ins-outs, and any decision necessary to toss $$ after it when needed.

Without anything more than what you provided.......Stupid NC not worth the ink.

1- What is the exact requirement for TM formal involvement?

2- What is the definition of "formal involvement"?
 
Last edited:
Thread starter Similar threads Forum Replies Date
Robinson A Management Development and Leadership Skills General Information Resources 4
J Disappointed in leadership buy-in to QMS Quality Manager and Management Related Issues 68
Q Example Process orientation to the process leadership, management, goals (tasks of the top management) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
L Lean Transformation - How do you get Senior Leadership engaged Human Factors and Ergonomics in Engineering 6
Q Tips for Action Requests on Communication and Leadership ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
I Questions to ask when auditing for Organizational Leadership and Planning for the QMS? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
I ISO 9001:2015 - "Resources" - handled by leadership team? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
A Leadership Role in Designing QMS - Upper Management Support Quality Manager and Management Related Issues 16
R The formation of Leadership in the Workplace Quality Manager and Management Related Issues 2
V Leadership and Organization Styles in Different Countries Coffee Break and Water Cooler Discussions 0
M IATF Tool for Leadership and Planning - 2017 IATF 16949 - Automotive Quality Systems Standard 0
K ISO 9001:2015 Leadership and Commitment ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
A Leadership Responsibility in an ISO 9001:2015 Quality Management System ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
C Auditing Clause 5 - Leadership in ISO9001:2015 Internal Auditing 4
S ISO 9001 Clause 5 - Leadership (as a Process?) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 29
P Leadership Standards - New job as Quality Manager Quality Manager and Management Related Issues 9
V Manager wont take the lead ....Leadership wont provide clarity....what to do? Quality Manager and Management Related Issues 6
S What could be the Leadership Strengths of an Organization? Misc. Quality Assurance and Business Systems Related Topics 9
B Demonstrating Leadership Skills in a Job Interview Career and Occupation Discussions 7
M Leadership Attributes - Getting buy-in on Quality from other functions Quality Manager and Management Related Issues 24
C ASQ: Leadership from Ballroom to Boardroom and the shop floor ASQ - American Society for Quality 12
K "Leadership Philosophy" Funny Stuff - Jokes and Humour 6
T CQL (Council on Quality and Leadership) Accreditation - Advice and example documents Hospitals, Clinics & other Health Care Providers 3
B Effect of Inept Leadership and Mismanagement on an Organization Coffee Break and Water Cooler Discussions 13
W Behavioral Psychology; Leadership - Getting the job done Philosophy, Gurus, Innovation and Evolution 9
J Free Basic Guide to Leadership and Supervision by Carter McNamara, PhD. Book, Video, Blog and Web Site Reviews and Recommendations 3
Steve Prevette ASQ Leadership Meeting Oct 16 - 18, 2005 ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 13
R ASQ Section Leaders: Anyone going to the ASQ Leadership Summit in October? ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 3
C Shakespeare's Lessons in Leadership: Macbeth The Reading Room 30
C Shakespeare's Lessons in Leadership: Hamlet Registered Visitor Articles Archive 64
C Leadership Drives Customer Focus Registered Visitor Articles Archive 0
C Improving the Quality of Leadership Registered Visitor Articles Archive 21
F Using non-randomized clinical study for change in existing 510(k) device? US Food and Drug Administration (FDA) 1
L Non Applicability of Clauses in ISO13485 for Medical Devices Medical Device and FDA Regulations and Standards News 4
B Transport Validation For Non-sterile Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 4
W Posting Non-Quality System instructions on the Production Floor Manufacturing and Related Processes 13
T Justification of use of non-harmonized standards for MDR conformity Other Medical Device Related Standards 12
L Saudi regulations for Japanese non sterile scopes Japan Medical Device Regulations 0
D Is a lost calibrated tool an non-conformance for an audit? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 58
malasuerte Performance of ISO 9001 certified vs. non-certified manufacturing companies ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
cgaro62 Does FDA apply to a non-medical 13485 certified custom manufacturing company? ISO 13485:2016 - Medical Device Quality Management Systems 11
K Non-Device MDDS Clarifications (FDA) US Food and Drug Administration (FDA) 7
S Non-approved supplier? Supplier Quality Assurance and other Supplier Issues 3
R FMEA's for non-manufacturing sites FMEA and Control Plans 4
D Shelf life of non sterile class IIb product. ISO 13485:2016 - Medical Device Quality Management Systems 1
ChrisM Class 1 non-sterile device, need certified QMS or not? EU Medical Device Regulations 2
N Non-dairy Creamer US Food and Drug Administration (FDA) 3
G Shipping Validation of Non-Sterile Parts? Other Medical Device and Orthopedic Related Topics 9
Edward Reesor Class I non-sterile "Shelf Life" labeling (EU/UK) CE Marking (Conformité Européene) / CB Scheme 4
E Comparing process parameters on non-normal batches Capability, Accuracy and Stability - Processes, Machines, etc. 11

Similar threads

Top Bottom