ISO 9k2k 8.2.3

Mike S.

Happy to be Alive
Trusted Information Resource
#21
MG,

You're right of course -- my only point is/was that what may be appropriate and necessary for a manufacturer of 10,000 automobile tires per day is not necessarily appropriate for Mom and Pop's Bakery. If I were advising them, I doubt I'd ask Mom and Pop to calculate Cp's and CpK's. Complaints on a run chart, maybe.

Many times I've seen people, departments, and even whole companies expend valuable time and money to generate and maintain complex charts, graphs, and other statistical measures for the sole purpose of having something sexy-looking to show a customer or auditor. That is what I push to avoid.
 
Elsmar Forum Sponsor
M

M Greenaway

#22
Mike

It could be argued that we need to know certain properties of our process, such as mean, standard deviation, and process capability in order to improve our process.

These calculations are not difficult, and can be entirely automated in a spread sheet.

For example if mom and pop want to maintain a max of 3% complaints per month they will want to know if their process is capable of achieving this. A simple understanding of processes will tell them that all processes vary, hence they would surely like to know if their process variation keeps them within their target of 3% max complaints.

Also they would need to know how their process is performing in order to target actions for continual improvement of their cake making process. As such they would need to know common and special causes of variation in their process, which could be highlighted through a run chart.

It is very simple stuff.
 
Thread starter Similar threads Forum Replies Date
J Engineering having a hard time defining Objectives - ISO 9k2k 5.4.1 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
J Management Representative Requirements - ISO 9k2k Clause 5.5.2a interpretation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 38
N ISO 9K2K documentation (records) for small scale tool rooms or job shops Document Control Systems, Procedures, Forms and Templates 1
P Process Audit Worksheets for ISO 9k2k - Marketing Analysis Process Audits and Layered Process Audits 2
W Re: Training for ISO 9K2K General Auditing Discussions 15
D Is ISO 9001:2000 (9k2k) HARDER than the 1994 Version? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
R QS Shop upgrading to ISO 9K2K QS-9000 - American Automotive Manufacturers Standard 1
K TS 16949 & ISO 9K2K BENEFITS QS-9000 - American Automotive Manufacturers Standard 1
chris1price Archiving of paper records - ISO 9001 7.5.3.1b Records and Data - Quality, Legal and Other Evidence 2
M Transferring ISO 17025 from one company to another ISO 17025 related Discussions 1
D Common practices in ISO 9001 deployment ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
Q ISO 9001-2015 Internal audit finding Internal Auditing 12
B ISO 17025:2017 risk management Risk Management Principles and Generic Guidelines 0
P Audit check for IT company (ISO 9001) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
M Label Making & Printing Standards ISO / ASTM ISO 13485:2016 - Medical Device Quality Management Systems 5
Sidney Vianna Interesting Discussion Should ISO 9004 be changed from a guidance standard to a requirements standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
Ed Panek ISO 13485:2016 Section 5.5.3 ISO 13485:2016 - Medical Device Quality Management Systems 3
Q Do these certificates of calibration meet ISO 9001 requirements for traceability to NIST? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
ebrahim QMS as per ISO 13485, Clause 4.2 Requirements for regulatory purposes for Medical Devices Authorized Representatives. ISO 13485:2016 - Medical Device Quality Management Systems 3
S ISO 2768-mk print call out Other ISO and International Standards and European Regulations 11
T ISO 17024, clauses 4.3.8. and 5.1.1. Other ISO and International Standards and European Regulations 4
C ISO 14001:2015 6.1.3 Compliance Obligations - Legal requirements monitoring ISO 14001:2015 Specific Discussions 0
C Requirement to link Quality Manual to ISO 9001 clause numbers? ISO 13485:2016 - Medical Device Quality Management Systems 13
D ISO 13485 scope (implantable) - Polymers for dental application EU Medical Device Regulations 9
W First time being audited (ISO 9001), asking for advice ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
John C. Abnet ISO 26262 ISO 26262 - Road vehicles – Functional safety 3
Marc ISO 26262- Road vehicles – Functional safety ISO 26262 - Road vehicles – Functional safety 0
John C. Abnet ISO 26262 IATF 16949 - Automotive Quality Systems Standard 0
A ISO/DIS 15223-1:2020 - Country of manufacture label (IEC 60417 No. 6049) - Which national law requires this symbol? Other Medical Device Related Standards 0
P ISO 14644 Class 8 Cleanroom Air Filter Requirements Other Medical Device Related Standards 4
K PDCA cycle and ISO processes alternative model Quality Management System (QMS) Manuals 14
N ISO 13485 7.3.9 Change control in medical device software ISO 13485:2016 - Medical Device Quality Management Systems 6
A ISO 13485 procedure change and reflect to legacy manufacture items ISO 13485:2016 - Medical Device Quality Management Systems 2
D ISO 13485 & CE Certification for Surgical Gloves CE Marking (Conformité Européene) / CB Scheme 0
S ISO 11137- Simulated product vs SIP Other Medical Device Related Standards 2
D Which ISO Standard to purchase? ISO 13485:2016 - Medical Device Quality Management Systems 7
V ISO 10360-5: 2020 Gap analysis and Action plan Excel .xls Spreadsheet Templates and Tools 1
Q ISO 9001 - Reseller Exclusions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
S Inventory Listing and ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 3
C ISO 45001 6.1.2.1 Hazard Identification Occupational Health & Safety Management Standards 1
T The difference between ISO 14644-3:2005 and ISO 14644:2019 Other Medical Device Related Standards 2
S Any ISO standards around Artificial Intelligence and Machine Learning? Medical Information Technology, Medical Software and Health Informatics 4
R AS9100D internal audit checklist or ISO 9001 2015 to AS9100 D AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
M ISO 13485:2016 Certification Scope ISO 13485:2016 - Medical Device Quality Management Systems 2
N ISO 9001 - Training business with fewer than 5 employees ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
P Should eIFU link per ISO 15223-1:2016 be added to labels out of scope of Reg 207/2012? EU Medical Device Regulations 1
J Opportunity in ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 27
D Reports under change management | ISO 13485:2016 & ISO 9001:2015 ISO 13485:2016 - Medical Device Quality Management Systems 3
P ISO 8 classified medical manufacturing room Qualification and Validation (including 21 CFR Part 11) 1
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

Similar threads

Top Bottom