Include cost of quality (and other wastes) in an ISO 9001 system?

Bill Levinson

Industrial Statistician and Trainer
#1
Understanding How Management Involvement Impacts the Risk of Quality Cost by Roderick Munro raises the point

"The ISO community has, to date, not created a standard around quality costs: for those who are registered or seeking registration to the ISO 9001:2015, the word cost does not appear in the auditable requirements; however, managers are required to understand the risks to the business and ensure that resources are being utilized effectively."

Jessen Yeoh adds, Why you should integrate lean principles and practices into management systems (a concept touched upon by IATF 16949 in a couple of clauses). I myself put together an unofficial lean management system (LMS) standard to piggyback onto ISO 9001:2008 much as IATF 16949 piggybacks onto ISO 9001:2015 back in 2012 or so, and Yeoh offers an add-on for ISO 9001:2015.

I think ISO 9001:2015 has the potential to deliver much more value to users if users expand on it to attack all forms of waste as opposed to just poor quality. Risks and opportunities can include not only those related to quality but also those related to any unnecessary cost or inefficiency (waste or muda). It is to be remembered that poor quality is only one of the Toyota production system's Seven Wastes, and the only one that announces its presence by causing trouble. The others are invisible to cost accounting systems and are often present 100% of the time because they are built into the job. There is even a crossover into ISO 14001 and ISO 50001 if we recognize that any material or energy (not just environmental aspects) input that does not come out as a saleable product is waste.



 
Elsmar Forum Sponsor

Bill Levinson

Industrial Statistician and Trainer
#5
Unfortunately BSi withdrew BS 6143:

BS 6143-1:1992

BS 6143-2:1990

Along with Phil Crosby and Bill Conway, these standards helped me and many clients to recognize and eliminate waste.
BS 6143-1:1992 - Guide to the economics of quality. Process cost model – BSI British Standards looks like it addresses cost of poor quality (for which AIAG released a much more recent manual) so it looks like there is a need to address invisible costs--the kind not recognized by the cost accounting system. There is a huge opportunity to improve performance by recognizing and addressing these wastes. Even the TPS Seven Wastes are not all-inclusive; Henry Ford's four wastes are. Ford said you can waste time, material and energy, and not much else.

(1) Waste of the time of things (cycle time) <==> Inventory and overproduction, also waiting and transportation (all will be reflected by higher cycle time; inventory may be the cause or the effect, per Little's Law)
(2) Waste of the time of people (waste motion)
(3) Waste of material ==> ISO 14001 (plus attention to non-environmental aspects)
(4) Waste of energy ==> ISO 50001

Also, waste of the time of things could include waste of the time of assets for which paying work is available, such as a train, truck, ship, or aircraft remaining idle when it could be working.
 
Thread starter Similar threads Forum Replies Date
N FDA UDI - Label vs. Labeling - Does the insert need to include UDI? Other US Medical Device Regulations 0
G Any good examples of CAPA forms that include a risk based approach? ISO 13485:2016 - Medical Device Quality Management Systems 5
A EN ISO 14971:2019 does not include the Annex Zs ISO 14971 - Medical Device Risk Management 4
R Do Medical Device Complaints include Clinical Trials? Medical Device and FDA Regulations and Standards News 3
S 510k: What to include if your own device is the predicate US Food and Drug Administration (FDA) 5
Watchcat Does 820.30 include the manufacturing process? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
Watchcat Does ISO 13485 7.3 include the manufacturing process? ISO 13485:2016 - Medical Device Quality Management Systems 14
G Control Plan - Include the processes for each sub component? APQP and PPAP 2
B Does EN ISO 15223-1:2016 include the graphic symbols to be added to software and IFU? Other Medical Device Related Standards 9
M Technical File (STED) labelling - When you compile tech files do we have to include all the product labels? EU Medical Device Regulations 2
B MDSAP for OEM products in Canada for in vitro diagnostic test kit to include lancing device Other Medical Device Related Standards 0
F Determining what type of scrap to include in my internal PPM calculation Quality Manager and Management Related Issues 5
Q ISO 9001:2015 Clause 8.3 - Is it possible to exclude one product but include it in other? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
Q Calibration laboratory scope - Include software such as Gagetrak or Mini tab used? General Measurement Device and Calibration Topics 3
M Include IFU in Class II Medical Device Marketing Brochure? US Food and Drug Administration (FDA) 2
Q MDSAP Regions and how to include in procedures Other Medical Device Related Standards 2
G How to include machine error in uncertainty calculations? Measurement Uncertainty (MU) 5
P Quality objectives - must they include CAPA and internal audit topic? ISO 13485:2016 - Medical Device Quality Management Systems 28
B Quality Policy does not include a commitment to comply with legal requirements Quality Management System (QMS) Manuals 5
K Does ISO 13485:2016 - 7.2.3 Customer Communication include Marketing? ISO 13485:2016 - Medical Device Quality Management Systems 1
M Does nonconforming product include reagents/disposables? ISO 13485:2016 - Medical Device Quality Management Systems 1
S Manufacturing Work Instruction examples that include process pictures Manufacturing and Related Processes 3
Q To include Context and Interested Parties in Process Map? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Q Does CE Marking include compliance to WEEE and packaging waste? CE Marking (Conformité Européene) / CB Scheme 4
T Does nonconforming product disposition include parts bought from the supplier? IATF 16949 - Automotive Quality Systems Standard 15
shimonv Does 510(k) submission need to include UDI Data Other US Medical Device Regulations 6
Q Where to include other types of Nonconformities ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
Paul Simpson Does Knowledge Management include aspects of Information Security? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
J How to understand the word "include" in IATF 16949 IATF 16949 - Automotive Quality Systems Standard 2
Crimpshrine13 IATF 16949 Audits to include Processes and Products from Non Subscribing Customers IATF 16949 - Automotive Quality Systems Standard 20
E Updating DHF (Design History File) to include Alternative Component 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
N Include homogeneity uncertainty into budget table for thermocouples Measurement Uncertainty (MU) 1
J What does "other relevant management roles" include? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
I As a part of validation, should i include the acceptance criteria of CPk index >1.33? Qualification and Validation (including 21 CFR Part 11) 4
M Changing FMEA template to include Detection Ranking for the PFMEA FMEA and Control Plans 2
WEAVER Gage R&R Sample Selection - Can we include NG Samples? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 12
V ICH Q3 - To "Include OR Not to Include" impurities below reporting threshold General Measurement Device and Calibration Topics 2
P What to include in a Clinical Evaluation Plan EU Medical Device Regulations 2
D Include non-automotive in TS16949 Registration Scope IATF 16949 - Automotive Quality Systems Standard 1
G Does AS9100 Certificate include ISO 9001 Certification? AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 9
B COA (Certificate of Analysis) - What information should they include? ISO 13485:2016 - Medical Device Quality Management Systems 2
H What does the PEM-gate review include? Manufacturing and Related Processes 3
P What should a Quality Plan Include and Examples Misc. Quality Assurance and Business Systems Related Topics 3
C Document Control - Details to include on Documents Document Control Systems, Procedures, Forms and Templates 2
D Need to include Premise of Outsourced Call Center in ISMS Surveillance Audit? IEC 27001 - Information Security Management Systems (ISMS) 4
C Include *ALL* business processes in QMS? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
F Wireless Dongle - Include in Medical Device Testing? IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
M How to include Gas Measurement Equipment Servicing & Calibration Scope to ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
D IMR (Individuals and Moving Range) Chart for Short-Run SPC - How much data to include Statistical Analysis Tools, Techniques and SPC 1
T Health Canada - Device Changes to include in License Renewal Canada Medical Device Regulations 3
Similar threads


















































Top Bottom