SBS - The best value in QMS software

ISO 9k2k 8.2.3

G

GARY MOORE - 2009

#1
Are initiatives such as, through put yield, sampling plans IAW ANSI/ASQC Z1.4, and auditing, cover this clause and the need for statistics without performing SPC on every lot of products?

We also perform lean black belt programs at our facility.
 
Elsmar Forum Sponsor
#2
Process monitoring

Gary, first of all welcome to the Cove!:bigwave:

8.2.3 does not specify the "how" or "how much" to monitor or measure your processes. That is up to you. If the methods you choose demonstrates the ability to achieve planned results then they should be good enough.

SPC is NOT required. Now, if you are looking at TS, the rules are different.
 
M

M Greenaway

#4
Gary

As db has stated SPC is not mandated by the ISO9001 standard, which is one of the worst crimes commited by the writers of this document.

My humble opinion for what its worth is that in order to understand the performance of your processes you MUST analyse them using proven statistical techniques. ISO9001 harps on about the importance of process management, yet fails to highlight the crucial part of process management, i.e. the understanding of variance, and need for statistical analysis of process performance.
 
M

M Greenaway

#5
Jim

Yes the standards do hint at the use of such techniques - I really think they should have driven the message home by making it into real requirements of the standard. But again I guess this is beyond the remit of ISO9001, as it doesnt actually tell us HOW to do anything.
 

Mike S.

Happy to be Alive
Trusted Information Resource
#6
Martin and Jim,

I agree that, properly used, statistical techniques can be amazingly powerful and useful tools. I'm curious -- where would you have Mom and Pop's Cake Shop implement statistical techniques, and what techniques would you recommend?
 
M

M Greenaway

#7
Mike

If mom and pop are going for ISO9001 certification then they must have quantifiable quality objectives and they must monitor, measure and analyse their processes. Now whatever it is they are measuring I would say it must be done statistically. Your measurement of capability can be done against your quality objectives.
 
E

energy

#8
I hear you

Mike S. said:

Martin and Jim,

I agree that, properly used, statistical techniques can be amazingly powerful and useful tools. I'm curious -- where would you have Mom and Pop's Cake Shop implement statistical techniques, and what techniques would you recommend?
Mike S.

They do not have full blown complicated industry sanctioned statistical techniques employed. It can be real simple. Like this:

# of complaints vs number of orders....Goal 3%
# of complaining customers vs total customer base....Goal 2%
Average order filling time....Goal 2 minutes
stale returns vs total number of orders...Goal 2

Nothing fancy...use a Pie Chart :biglaugh: :ko: :smokin:
 
#9
KISS

From energy (welcome back!)

Nothing fancy...
Many times we tend to put more focus on the tool than we do the analysis. I agree w/energy use the KISS (keep is simple stupid, or political correct...keep is short and simple). Don't confuse statistical techniques with SPC.
 

Mike S.

Happy to be Alive
Trusted Information Resource
#10
I was kinda thinkin' along the same lines as db and Energy. IMO, Mom and Pop don't need to calculate their CpK or have a bunch of x-bar/R charts hanging around. But it was sounding to me like Martin and Jim were sanctioning formal SPC as the only way to go in every circumstance (maybe I misunderstood), so I wanted to see what their actual ideas were. I'm still kinda unsure what exactly they would use for Mom and Pop. Can you be more specific Martin and Jim?

Maybe part of the confusion is what, exactly, represents a "statistical technique"? Is a pie chart a statistical technique? Is calculating an average of orders per month a statistical technique simply because "average" is a statistical term?
 
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
J Opportunity in ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
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
B ISO 6508 and portable hardness measurement instruments General Measurement Device and Calibration Topics 0
M Scope for ISO 13485 Certification of a Translation Service Provider ISO 13485:2016 - Medical Device Quality Management Systems 14
S Knee Implant (Femoral -Cobalt chrome)-Sub chronic toxicity test (ISO 10993-11)choice of root Medical Device and FDA Regulations and Standards News 2
Sidney Vianna Release of ISO 10013:2021, Quality management systems – Guidance for documented information Other ISO and International Standards and European Regulations 0
K Integrating ISO 9001:2015 with ISO 17025:2017 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Q ISO 13485 7.5.6 Validation - Off the shelf Software ISO 13485:2016 - Medical Device Quality Management Systems 3
A ISO 13485 Certification for Resin Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 4
R Remote Audits for ISO 9001 (or any other standard) General Auditing Discussions 29
A ISO 13485 Sterilization Clause Applicability ISO 13485:2016 - Medical Device Quality Management Systems 7
K ISO 13485 and compliance of electronic signature ISO 13485:2016 - Medical Device Quality Management Systems 5
T ISO 13485 - Assembly instructions written vs. online ISO 13485:2016 - Medical Device Quality Management Systems 5
M ISO 13485:2016 internal audit checklist Medical Device and FDA Regulations and Standards News 5
D ISO 17021 Certificate Registrars and Notified Bodies 1
X ISO 17025 certification for Laboratory for online gambling products ISO 17025 related Discussions 3
C ISO 19227 Validation Cost Other Medical Device Related Standards 2
N 93/42/EEC certification without ISO 13485 EU Medical Device Regulations 3
T Relationship between ISO 9001 and ISO – IEC BS EN 870079- 34 2020 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
M How Specific in an ISO 13485:2016 Scope for a Contract Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 9
A ISO 13485 for Class 1 Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 7
S Sequence of ISO 9001:2015 Implementation Steps ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
qualprod Business Continuity Planning in ISO 9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
T Help with BS EN ISO - IEC 80079-34 2020 (Explosive atmospheres QMS) Other ISO and International Standards and European Regulations 0
C Sampling - ISO 16269-6 vs ISO 2859 Other ISO and International Standards and European Regulations 0
Brizilla Employee Data Privacy Policy - ISO 9001:2015 requirement(s)? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
R ISO 17025 - ISO Guides 33 & 80 ISO 17025 related Discussions 1
0 ISO 13485:2016 Chapter 8 Integration of the subsections ISO 13485:2016 - Medical Device Quality Management Systems 3
S ISO 9001:2015 Internal Auditing Internal Auditing 8
Q Process: Knowledge Section 7.1.6 of ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
N ISO 27001 for Jumb Burger - Risk Assessment sheet IEC 27001 - Information Security Management Systems (ISMS) 10
H What ISO certification is for an IT department? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
M Change in Constitution / Ownership of firm -------ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 1
P ISO 9001 certification with zero customers? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
M ISO 14971 Determination of Competent Persons ISO 14971 - Medical Device Risk Management 4
R Clinical accuracy and repeatability of IR(infrared) thermometer, no maximum error criteria is recommended in ISO Other Medical Device Related Standards 11
Q The scope of ISO 21534 Other Medical Device Related Standards 0
A What must be recorded? (ISO 9001:2015, subclause 10.2) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
M ISO 14971:2019: Criteria for overall residual risk ISO 14971 - Medical Device Risk Management 4
B Updated IATF 16949 - Will IATF 16949 get revised when ISO 9001:202X is released? IATF 16949 - Automotive Quality Systems Standard 4

Similar threads

Top Bottom