SBS - The best value in QMS software

Systems Approach or Process Approach? Micro level of managing

  • Thread starter systems_thinker
  • Start date
C

Craig H.

#51
Thanks, Randy!

I just got Quality Press today, and there are 4 books on Lean. Anyone have any favorites for the basics?

Craig
 
Elsmar Forum Sponsor
#52
Craig H. said:
Thanks, Randy!

I just got Quality Press today, and there are 4 books on Lean. Anyone have any favorites for the basics?

Craig
Learing to See by Mike Rother (VSM)
Lean Thinking by Womak, Jones and Roo
The Machine that Changed the World, by Womak
The Goal by Goldratt
Critical Chain by Goldratt

The Goal and Critical Chain are written as novels. They get the point across and keep your attention at the same time. Loved them.

You can find a whole bunch at http://www.searchmanufacturing.com/Manufacturing/Lean/books.htm

Hope that helps.
 
Last edited by a moderator:
R

Randy Stewart

#53
Most of mine came from U of M Engineering but you can find the books.
The 2 that I've referenced more are Intro to Industrial and Systems Engineering (Prentise Hall) and Engineering Phychology and the Human Response (Harper Collins).
You can try www.lean.org for the training material and the main book "Lean Thinking"
 
S

systems_thinker

#54
Craig H. said:
Thanks, Randy!

I just got Quality Press today, and there are 4 books on Lean. Anyone have any favorites for the basics?

Craig
Lean Thinking by Womack and Jones is a good primer. Becoming Lean by Liker has case studies showing implementation approaches and results. For hard theory, the LEI (www.lean.org) workbooks (Learning to See, Creating Continuous Flow, Seeing the Whole) are good. Duggan's book, Creating Mixed Model Value Streams is also good.

There's an excellent report which you can download free showing a Lean implementation approach, available from http://www.cf.ac.uk/carbs/lom/lerc/centre/goinglean.pdf. It is published by the UK's Lean Enterprise Research Center at Cardiff University. The Lean Enterprise Academy in the UK at http://www.leanuk.org/home.htm also has many valuable reports and articles available for free downloading.

TOC implementation is a little more problematic and good books are harder to come by. The Goal and The Race by Goldratt are business novels which advance TOC principles. You might want to visit his website at www.goldratt.com for other resources. www.northriverpress.com publishes an extensive library of TOC books and learning tools.

Remember, when it comes to applying this stuff, there are no experts - just people with more experience. A key part of the Lean implementation process is learning as you go and acquiring the insights you need to make it work in your operation.

Cheers,

s_t
 
Last edited by a moderator:

Kevin Mader

One of THE Original Covers!
Staff member
Admin
#55
Questions...

Some questions that I am asking myself as I read this thread:

1. What is the AIM of the System?
2. What is the AIM of a Quality Management System?
3. What is the AIM of an ISO Quality Management System?
4. Are they fundamentally different, or, are they themselves interrelated?
5. If the theory is that 90+% of change does not result in an improvement, which holds the best potential for improvement: first-order change or second-order change?
6. Can Value be increased, or does it follow a similar path such as Entropy Theory?

Anyone (everyone)??

Regards,

Kevin
 
R

Randy Stewart

#56
Kevin,
I don't see the correlation in #6. I can't say I'm an expert on Shannon Entropy but I do know a little about entropy in thermodynamics. If my memory serves me correctly it is tied to energy (not the sheriff) and states something like changing from 1 equilibrium to another my chaos will increase. If I'm correct then I don't see how value and chaos can be interchanged.

However look at this example for a paradox. Lets use tire changing. As a customer the only value added op is putting on new or rotating the tires. There is nothing else. So if they do it by a single hand jack or the hydraulic lift the value will not be increased. Time may be reduced but to offset the cost of the lift, the customer cost may increase.
Now lets look at the operation itself. The ONLY value added step in the whole tire changing operation is the moment the lug breaks loose and the moment it tightens! The rest of the spinning in muda.
(I didn't make this up folks, this is actually from a formula one racing study.) So in order to reduce the muda, I can go a couple of ways: Reduce the amount of spin on each lug or reduce the number of lugs. Through evaluation of the alternatives we come up with the pros and cons of each. 1) I can only achieve minimal savings by reducing the spin of each lug before hindering safety. I'll limit it to 50% improvement before there are not enough threads to safely hold on the lug nut. 2) In order to achieve maximum reduction (0 lugs) I lose the ability to change the tire (permanently affixed) but, if I mount the rim/tire on a serated (sp?) spindal (keeps the tire from just spinning on the hub) and secure it using only 1 lug, I have reduced the non-valued operation by 80%!
But remember the only value real added operation to the customer is that the tires are changed.
So you have to develop process improvements based on required throughput and ensuring the value to the customer isn't changed or hindered.
How about raising the car up, the only value added portion is when it allows removal or installation of the tire. So does it matter if I use 1 hand jack, 4 hydraulic jacks or the lift?
It can go on and on. :bonk:
 
S

systems_thinker

#57
Randy Stewart said:
Kevin,
I don't see the correlation in #6. I can't say I'm an expert on Shannon Entropy but I do know a little about entropy in thermodynamics. If my memory serves me correctly it is tied to energy (not the sheriff) and states something like changing from 1 equilibrium to another my chaos will increase. If I'm correct then I don't see how value and chaos can be interchanged.

However look at this example for a paradox. Lets use tire changing. As a customer the only value added op is putting on new or rotating the tires. There is nothing else. So if they do it by a single hand jack or the hydraulic lift the value will not be increased. Time may be reduced but to offset the cost of the lift, the customer cost may increase.
Now lets look at the operation itself. The ONLY value added step in the whole tire changing operation is the moment the lug breaks loose and the moment it tightens! The rest of the spinning in muda.
(I didn't make this up folks, this is actually from a formula one racing study.) So in order to reduce the muda, I can go a couple of ways: Reduce the amount of spin on each lug or reduce the number of lugs. Through evaluation of the alternatives we come up with the pros and cons of each. 1) I can only achieve minimal savings by reducing the spin of each lug before hindering safety. I'll limit it to 50% improvement before there are not enough threads to safely hold on the lug nut. 2) In order to achieve maximum reduction (0 lugs) I lose the ability to change the tire (permanently affixed) but, if I mount the rim/tire on a serated (sp?) spindal (keeps the tire from just spinning on the hub) and secure it using only 1 lug, I have reduced the non-valued operation by 80%!
But remember the only value real added operation to the customer is that the tires are changed.
So you have to develop process improvements based on required throughput and ensuring the value to the customer isn't changed or hindered.
How about raising the car up, the only value added portion is when it allows removal or installation of the tire. So does it matter if I use 1 hand jack, 4 hydraulic jacks or the lift?
It can go on and on. :bonk:
It's an excellent answer, Randy. The only comment I'd add is that any improvement only make sense within the context of the goal of the system. We proceed to the local improvements from specifying the system goal (value specification) from the customer's perspective. "From the customer's perspective" is critical because all too often we think we know what value the customer wants when, in actual fact, we are way wide of the mark.

Once the goal is known, the key then is to identify the leverage points in the system where, if we change them, will result in significant change to the system's behaviour. Thus, identifying which processes to improve, and the best way to improve them, becomes critical. Too often, energy is dissipated on improving processes which have no effect on the overall behaviour of the total system (local optima).

Keep in mind that improving processes may not be the only way forward - we may be able to eliminate them altogether to the system's advantage. "Simplify, combine and eliminate" are 3 key words that one should remember when looking at operational improvements.

s_t
 
N

NYHawkeye - 2005

#58
systems_thinker said:
TOC implementation is a little more problematic and good books are harder to come by. The Goal and The Race by Goldratt are business novels which advance TOC principles. You might want to visit his website at www.goldratt.com for other resources. www.northriverpress.com publishes an extensive library of TOC books and learning tools.
After you get through The Goal, I would recommend taking a crack at The Theory of Constraints and Its Implications For Management Accounting by Noreen, Smith, and Mackey (you can find it on the North River Press web site). It provides a good, quick overview of TOC principles and opens up the very interesting discussion of accounting and the negative impact it can have on managing a system for improvement.

If you are then ready for a challenge I would look at Goldratt's Theory of Contraints, A Systems Approach to Continuous Improvement by Bill Dettmer. This book provides a great opportunity to learn about the "thinking tools" and the theory part of the Theory of Constraints. Be ready to read it a couple of times, however, because it is heavy into logic and is not light reading.
 
N

NYHawkeye - 2005

#59
Kevin Mader said:
1. What is the AIM of the System?
2. What is the AIM of a Quality Management System?
3. What is the AIM of an ISO Quality Management System?
4. Are they fundamentally different, or, are they themselves interrelated?
I would propose the the AIM of the System, Quality Management System, and an ISO Quality Management System must be interrelated and should not be in conflict. In fact, once they are properly aligned the distinction between these artificial (political) boundaries becomes unimportant.

By ensuring that the goals of all elements of the system are aligned and interrelated it becomes easier to identify the 10% of the improvement opportunities that will result in true improvement to the total system.
 

Raffy

Quite Involved in Discussions
#60
How I would implement a Process Approach in a Service Industry?

Thanks in advance.

Best regards,
Raffy
 
Thread starter Similar threads Forum Replies Date
Marc Flow charts - Show Me Yours! Systems Approach - Process Mapping Process Maps, Process Mapping and Turtle Diagrams 28
H From Quality to Business Excellence: A Systems Approach to Management The Reading Room 3
Le Chiffre Online training available for ISO/IEC 17021-1: Requirements for bodies providing audit and certification of management systems Training - Internal, External, Online and Distance Learning 3
Sidney Vianna Release of ISO 10013:2021, Quality management systems – Guidance for documented information Other ISO and International Standards and European Regulations 0
optomist1 How Secure Are Our Software Systems Software Quality Assurance 7
C Barcode Labelling - Mistake Proofing Ideas & Systems Manufacturing and Related Processes 2
P IQ, OQ, PQ protocol, and report templates for Distributed Control Systems in Pharmaceutical Manufacturing Systems. Qualification and Validation (including 21 CFR Part 11) 0
S User evaluation for self monitoring blood glucose test systems US Food and Drug Administration (FDA) 4
S Manufacturing Execution Systems Software Costs Manufacturing and Related Processes 0
Ajit Basrur FDA News Harmonizing and Modernizing Regulation of Medical Device Quality Systems (7-2020) US Food and Drug Administration (FDA) 6
R Requirements for MDR Article 22 Systems EU Medical Device Regulations 1
N EU MDR - Applicability Article 22 Systems and Procedure Packs CE Marking (Conformité Européene) / CB Scheme 4
K Best Measurement Systems Demos in California? General Measurement Device and Calibration Topics 1
Bev D Verification and Validation of Measurement Systems Misc. Quality Assurance and Business Systems Related Topics 0
M Risk and Corrective actions - Currently no FMEA's - Car systems Risk Management Principles and Generic Guidelines 8
R MDR Article 22: Systems and procedure packs Other Medical Device Regulations World-Wide 12
M Informational US FDA Final Guidance – Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings – Labeling Considerations Medical Device and FDA Regulations and Standards News 0
D Why are pharma companies automating QMS systems? Quality Management System (QMS) Manuals 2
Ajit Basrur FDA News Harmonizing and Modernizing Regulation of Medical Device Quality Systems US Food and Drug Administration (FDA) 18
M Informational TGA Consultation: Proposed clarification of the regulatory requirements for medical device systems and procedure packs Medical Device and FDA Regulations and Standards News 2
M Different procedure templates for different standards - We have two different management systems ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
H Question about implications of performing Firmware upgrade via MDDS - Medical Device Data Systems 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
M Routine testing of medical electrical systems - What specific electrical safety tests should be performed? IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
M Informational US FDA final guidance – Marketing Clearance of Diagnostic Ultrasound Systems and Transducers Medical Device and FDA Regulations and Standards News 0
M Informational TGA – Guidance on Therapeutic Goods (Conformity Assessment Standard for Quality Management Systems) Order 2019 Medical Device and FDA Regulations and Standards News 0
J Is Design Validation required for fixtures or test systems used to manufacture a product? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
R Timeframe for IATF 16949 certification to accumulate evidence of conformance of systems? IATF 16949 - Automotive Quality Systems Standard 2
M How to calculate benefits? Moving some developed non controlled software/automation systems Service Industry Specific Topics 2
Z Security for Approvals - Cloud based Complaint, NC, and CAPA systems Qualification and Validation (including 21 CFR Part 11) 8
N EU MDR Basic UDI-DI and Technical Documentation for Systems EU Medical Device Regulations 22
pbojsen Computerized Learning Management Systems (Training systems) recommendations? ISO 13485:2016 - Medical Device Quality Management Systems 3
Sidney Vianna Safety Management Systems - SM-0001 Standard for Aviation Organizations AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
M Interview question - IMS (Integrated Management Systems) a necessity or an ISO mistake? ISO 14001:2015 Specific Discussions 10
AnaMariaVR2 Pharmaceuticals News Transdermal and Topical Delivery Systems: FDA & EMA Guidance US Food and Drug Administration (FDA) 0
M Training to help Familiarize myself to the Standards and the way these systems work AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
pbojsen Intuitive Quality Design and Documentation Systems ISO 13485:2016 - Medical Device Quality Management Systems 12
D Use of password managers on validated computer systems (21 CFR Part 11) Medical Information Technology, Medical Software and Health Informatics 2
ScottK What Became of Alamo Consulting or Alamo Learning Systems Consultants and Consulting 5
R Custom Records and Quality Systems - Products that change frequently Other US Medical Device Regulations 3
W ISO 14155 - Electronic clinical data systems - Definition Other Medical Device Related Standards 0
B NEED HSE-MS Gap Analysis between 2 existing Management Systems Occupational Health & Safety Management Standards 0
Q Practical guide to scan for Risks in all QMS systems without missing any ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
B Records Destroyed - Hurricane Harvey has likely destroyed our Quality Systems Records Records and Data - Quality, Legal and Other Evidence 10
U CE Marking of Customized Ruggedised Computer Systems Solutions CE Marking (Conformité Européene) / CB Scheme 5
E Rich O2 Environment Testing Laboratories (Clause 11.2.2 ME EQUIPMENT and ME SYSTEMS) IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
V Systems to Handle Development and Batch Analysis in same Laboratory Qualification and Validation (including 21 CFR Part 11) 3
E ME (Medical Equipment) Systems - IEC 60601-1 Clause 16.1 Interpretation IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
M IATF 16949 Clause 7.1.5.1.1 - What are "inspection equipment systems"? IATF 16949 - Automotive Quality Systems Standard 4
A Integrated Management Systems - ISO 50001 and ISO 9001 possible? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
V Upgrading Systems from CFR 211 to CFR 820 (drug+device combination) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7

Similar threads

Top Bottom