SBS - The best value in QMS software

Effect of Major and Minor NonConformances during Registration audit - TS 16949

Elsmar Forum Sponsor
U

Umang Vidyarthi

#12
To further help out, the requirements for grading NC's are nothing to do with ISO 9000(or as far as I can remember, the accreditation rules/requirements of ISO/IEC 17021 (or the 'old' Guide 62). It's the individual registrars' interpretation, whereas, the IATF lay down the specifics. Indeed, many ISO 9000 registrars don't use 'major' and 'minor'.

The practice of clearing a minor NC during the audit is generally frowned on, by most accredited registrars (not auditors), because in principle a finding should lead to corrective action, not correction (that's not my view, BTW)
Even in the case of minor NC the corrective action followed by preventive action is a must,in absence of which 'correction'(interim/premilinary solution) alone is of no value.Correct me if I am wrong.

Umang
 
#13
Even in the case of minor NC the corrective action followed by preventive action is a must,in absence of which 'correction'(interim/premilinary solution) alone is of no value.Correct me if I am wrong.

Umang
That is totally dependent on the contents of the NC - just because it's written as an NC (and no-one argues against it), doesn't mean it needs or justifies anything other than a simple fix...........
 

Helmut Jilling

Auditor / Consultant
#15
Andy! you got it; Thanks for getting my point of view.

I completely understand the difference between major and Minor, but why IATF categories the NC 's in Major and Minor, when in both cases the audittee would not get the certification and furthermore this is contrary to ISO 9000 . If there is no difference then IATF can refer only one type of NC.
This is just food for thoughts
The automotive customers, especially the Big 3 have defined majors and minors as far back as QS-9000 and ISO 9001. I thought it derived from Guide 62, but I don't have a copy with me. I know it was mandatory in QS and TS.

TS further said nonconformities can no longer be closed on site during an audit. The concern was many companies just rushed solution sinto place, without giving appropriate thought and implementation.

Minors frequently are closed offsite. Most Major NC's require a return visit.

There are a lot of differences between Majors and Minors and I think it is very logical to define them as such. A breakdown in a system should not be viewed as a single lapse in a small requirement.
 
#16
Refering to my handy-dandy pocket copy of ISO/IEC 17021 :notme: (which replaces the Guide 62), I couldn't find any references to grading non-conformances.
 

Stijloor

Staff member
Super Moderator
#17
Refering to my handy-dandy pocket copy of ISO/IEC 17021 :notme: (which replaces the Guide 62), I couldn't find any references to grading non-conformances.
That's correct.

ISO 19011, clause 6.5.5 states: "Nonconformities may be graded." No specific information on the criteria for "Major" or "Minor" nonconformities.
 
U

Umang Vidyarthi

#18
That's correct.

ISO 19011, clause 6.5.5 states: "Nonconformities may be graded." No specific information on the criteria for "Major" or "Minor" nonconformities.
The clause cited ibid,does not make anybody wiser.May some one bring out the general criteron for gradation,if it exists.:notme:
Umang
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#19
We had a similar discussion in this thread.
A breakdown in a system should not be viewed as a single lapse in a small requirement.
I agree that system breakdowns are serious and should be treated differently than minor non-conformities, but our accredited certification process treats both minors and majors as requiring corrective actions. So, following the logic, let's imagine that a third-party audit finds a few obsolete documents or a small number of gages being used with expired calibration dates. Both instances would normally be categorized as minor non-conformities and expected to be dealt with via a corrective action. Realistically, it is very likely that such issues will recur in the future, even though organizations "implement corrective actions" to fix these minor problems. So either, we, as quality professionals are not very serious about corrective actions, or, we should not be issuing corrective action requests to minor infractions that are bound to repeat themselves.

 

Stijloor

Staff member
Super Moderator
#20
The clause cited ibid,does not make anybody wiser.May some one bring out the general criteron for gradation,if it exists.:notme:
Umang
I know, I know.... I was just stating what I found and confirm that there are no references in ISO 17021 nor ISO 19011. Just trying to help Umang....

Stijloor.
 
Thread starter Similar threads Forum Replies Date
M Office and manufacturing site relocation effect on Device Technical File CE Marking (Conformité Européene) / CB Scheme 2
Q Autoclave and Sample Container - Pressure-steam cooking's effect Reliability Analysis - Predictions, Testing and Standards 1
J EU ISO 13485:2016 Recertification Audit - Effect of 10 Minor Nonconformances EU Medical Device Regulations 2
C Design for Assembly in DFMEA - Failure Effect of Sub-System(s) FMEA and Control Plans 5
supadrai Effect of a Merger on Acquired Company's Medical Device Licenses Other Medical Device Regulations World-Wide 2
H New FAQ & SI -IATF 16949 - Effect in april and june 2018 IATF 16949 - Automotive Quality Systems Standard 0
G Effect of ISO9001 2015 transition on ISO IEC 80079-34 Other ISO and International Standards and European Regulations 3
N PFMEA no effect ratings FMEA and Control Plans 15
Ron Rompen The Effect of Heat on Production and Quality Human Factors and Ergonomics in Engineering 14
Q Risk Tools in ISO 31010 - Root Cause Analysis vs. Cause-and-effect Analysis ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
K Determining Effect of Failure without a DFMEA (Design FMEA) FMEA and Control Plans 1
D Is it okay to CE mark the product until the RoHS2 directive goes into effect? CE Marking (Conformité Européene) / CB Scheme 7
N Reason for determining no adverse effect on reworked product ISO 13485:2016 - Medical Device Quality Management Systems 8
S Seeking Feedback on ASQ Guide to Failure Mode and Effect Analysis FMEA and Control Plans 2
D Effect of Fixtures on Test Method Validation Design and Development of Products and Processes 1
P Cyclic Effect Factoring in DOE (Design of Experiments) Quality Tools, Improvement and Analysis 1
C CFDA MD regulation_20140331 - Comes into effect June 01, 2014 China Medical Device Regulations 33
M Effect of Boil Test on Passivated SS Medical Instruments Manufacturing and Related Processes 11
F Power supply certification and its effect on testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
R Does the SIC have an effect on the ISO scope on your certificate? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
C Severity of Effect on Process (Manufacturing/Assembly Effect) Scrap or Reworking FMEA and Control Plans 3
M BS EN ISO 15223-1:2012 replaces EN 980 - What is the effect of the change? Quality Manager and Management Related Issues 44
C Cause and Effect Matrix Template Document Control Systems, Procedures, Forms and Templates 0
B Changes that could effect the Quality Management System - Management Review ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
R Length Out of Specification - How do I perform Cause and Effect Diagram? Nonconformance and Corrective Action 6
A Comparing Effect of Process Parameters on Equipment Performance during Start Ups Statistical Analysis Tools, Techniques and SPC 3
P Control of "manufacturing material" that has adverse effect on the medical device? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
B Effect of Soldering on Tin Plating Manufacturing and Related Processes 5
D Effect of Puncture Orientation on Force Value Other Medical Device Related Standards 1
P Process FMEA with the effect "brakes are broken" - Is it nonconformity? IATF 16949 - Automotive Quality Systems Standard 7
S Root Cause Analysis & Cause and Effect Diagram Customer Complaints 5
M Effect of double ETO (Ethylene Oxide) Sterilization ISO 13485:2016 - Medical Device Quality Management Systems 13
V What effect has Supply Voltage on product performance? IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
A Main Effect - Interaction Plots - 2 Level Factorial DOE with 18 Runs Using Minitab Software 8
V Effect of sample size on Cpk results? Using Minitab Software 2
Chennaiite FMEA Severity Rating for Potential Manufacturing Effect mentioned in the FMEA manual FMEA and Control Plans 9
A Cause and Effect Analysis - Hardness of Rubber (i.e., durometer) Quality Tools, Improvement and Analysis 11
Ajit Basrur Pre Filled Syringes (PFS) - Effect of Containers on the Contents 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
R EMP (Evaluating the Measurement Process) Studies for Bias Effect Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 6
I Quantifying the Effect of Excessive Within-Part Variation Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
B Sampling Plan - AQL effect on Sample Size AQL - Acceptable Quality Level 9
S The Effect of implementation of an Integrated Management System & EFQM ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
Q Cause and Effect Worksheet Quality Tools, Improvement and Analysis 2
M Effect of your Quality Role on your life Coffee Break and Water Cooler Discussions 31
N Uncertainty for Humidity Probes - Temperature Effect from 0.5?C dew point = 1.3%rh Measurement Uncertainty (MU) 2
A Effect of %GRR (% Gage R&R) on Cpk Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 13
C Evaluation of Bearing (Effect) of a Deviation on Quality Nonconformance and Corrective Action 10
M Pygmalion Effect - Communication The Reading Room 11
M Recommendations for detecting "Triangle Effect" Inspection, Prints (Drawings), Testing, Sampling and Related Topics 11
ScottK Telecommuting may have the opposite effect on workers in the office. Career and Occupation Discussions 0

Similar threads

Top Bottom