During Gage R&R, is calculation of ndc value required?

antoine.dias

Quite Involved in Discussions
#11
Room for interpretation

I know there is room for interpretation here.

If you read the text in ISO TS again you have to use the analytical techniques AND acceptance criteria as stipulated in the manual.
The manual clearly says ndc should be 5 minimal.

Best regards,

Antoine
 
Elsmar Forum Sponsor

Jim Wynne

Staff member
Admin
#12
antoine.dias said:
I know there is room for interpretation here.

If you read the text in ISO TS again you have to use the analytical techniques AND acceptance criteria as stipulated in the manual.
The manual clearly says ndc should be 5 minimal.

Best regards,

Antoine
I don't want to extend this too far, but what it says is it "ought to be," and that's if you do ndc calculation at all. There is no basis for an audit finding if ndc calculation isn't done at all.
 

antoine.dias

Quite Involved in Discussions
#13
I agree that we should not drive this too far.
No further discussion if required or not.

But

IMO when the ndc is too low ------- this means something ------- and I would try to do something about that and not point fingers at auditors.

Best regards,

Antoine
 

Jim Wynne

Staff member
Admin
#14
antoine.dias said:
I agree that we should not drive this too far.
No further discussion if required or not.

But

IMO when the ndc is too low ------- this means something ------- and I would try to do something about that and not point fingers at auditors.

Best regards,

Antoine
:agree: Absolutely.
 
K

Kim Yong Kil

#15
antoine.dias said:
When your ndc results are too low this can mean the following (amongst others) :

The samples you have taken do not represent the usual spread in your process. (It very often occurs people are taking 10 consecutive parts from the machine - which is very wrong for the study)

The second may be that your choice on measuring equipment was wrong. (It cannot recognise enough classes in the measuring results)

There may be several more reasons, but IMHO those are the most frequent.

In the direction of the " requirement " for ndc calculation :

In item 7.6.1 of ISO TS 16949 the following can be found:
Quote:
The analytical methods and acceptance criteria used shall conform to those in customer reference manuals on measurement systems analysis.
Other analytical methods and acceptance criteria may be used if approved by the customer.
Unquote

If the MSA manual 3rd edition is the reference manual for a customer of subject company, IMO the auditor has the right to write a non conformity.

Best regards,

Antoine
Thanks Antonie..

I am very confusing.....:bonk:
What is mean ndc in MSA 3rd manual? NDC is "requirement"??? or "just reference".........
 

antoine.dias

Quite Involved in Discussions
#16
Requirement or not.

That's the whole discussion about.

Some say it is a requirement, some say it is not.

Both CAN be right. - Depending on your customer's requirement.

But anyway,
If I were in your place I would look how I can improve the situation.
I suggested a couple of things in an earlier mail on this subject.

Best regards,

Antoine
 
W

wcsf - 2008

#17
In TS everything is based on customer requirement. However our TS auditor principle is that everything will based on their own requirements....I think IATF has to relook into this. What has been said (no CSR but auditor issue NCR based on reference manual) is very common. This has made this standard not fully and sincerely accepted but just have to do it for customer. It will ended up like QS9000 very soon.

From my experience, ndc has no useful meaning besides what ahs been said by Antoine. If your GRR/TV is <27%, your ndc will always >5 (recommended value from MSA manual). What will happen to those system where their GRR is 28% which is still <30% but ndc is <5. Can it be accepted?? (Of course I know it again based on CSR).

I also know that quite a lot of auditors do not even understand the statistical concept behind the ndc.

I have a very good example of an auditor when this guy questioned why the samples are taken from different production lot across different time, he was saying " MSA stand for Measurement System Analysis and nothing to do with production sample. You just need to take the calibration standard and use it......"" Can you imagine what kind of auditor quality we have now?? but the management likes it.....
 
T

tristan

#18
hi everyone,

(not too sure if i should post this here or in the ATE threads or in SPC topics on practical significance)

my supplemental scenario is: NDC calculation is required as per CSR or internal requirement, and it fails (<5). However, the situation is that effective resolution cannot be further improved, ie. ATE is of new technology (same situation in AIAG MSA 3rd ed, page 46). The ATE also measures devices with very small variability, ie. went through highly capable processes before testing.

my question: can i use a practical significance concept to decide that i ignore an ndc < 5?

thanks! :)
 

Jim Wynne

Staff member
Admin
#19
hi everyone,

(not too sure if i should post this here or in the ATE threads or in SPC topics on practical significance)

my supplemental scenario is: NDC calculation is required as per CSR or internal requirement, and it fails (<5). However, the situation is that effective resolution cannot be further improved, ie. ATE is of new technology (same situation in AIAG MSA 3rd ed, page 46). The ATE also measures devices with very small variability, ie. went through highly capable processes before testing.

my question: can i use a practical significance concept to decide that i ignore an ndc < 5?

thanks! :)
The language you quote from the AIAG manual is wonderfully ambiguous, which is typical of AIAG writing, I'm afraid. Here's the salient paragraph:
Eventually, there are situations that reach a stable, highly capable process using a stable, "best in class" measurement system at the practical limits of technology. Effective resolution may be inadequate and further improvement of the measurement system becomes impractical. In these special cases, measurement planning may require alternative process monitoring techniques. Only qualified, technical personnel familiar with the measurement system and process should make and document such decisions. Customer approval shall be required and documented in the Control Plan.
One possible translation from AIAG gobbeldy-gook to plain English: If process requirements exceed the capability of the best available measurement system, do the best you can, but make sure your customer approves it.
 
Thread starter Similar threads Forum Replies Date
D Reducing Within Part Variation during a Gage R&R Study Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 26
G Attribute Gage R&R - Number of Samples - OFI during our TS-16949 surveillance audit Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 14
K Silver Plating corroding possible during SMT Manufacturing and Related Processes 10
B How many nonconformances have you received on average during IATF audits? General Auditing Discussions 24
Q Summative Usability Evaluation Testing: prior or during Clinical Investigation? Human Factors and Ergonomics in Engineering 6
M ECG lead leakage currents - How to specify ECG leads during electrical safety testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
M Disabling measurement data during fault conditions IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
B Oracle Cloud ERP Validation during Quarterly Patch ISO 13485:2016 - Medical Device Quality Management Systems 1
H Obligations as a contract manufacturer during an MDSAP audit ISO 13485:2016 - Medical Device Quality Management Systems 5
A OEM On-Site Calibration issues during Covid19 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
silentmonkey How to decide what characteristics need to be verified during incoming inspection? ISO 13485:2016 - Medical Device Quality Management Systems 5
C Documentation hold during submissions? ISO 13485:2016 - Medical Device Quality Management Systems 0
C 21 CFR 803 malfunction detected during packaging - report? Other US Medical Device Regulations 1
L Open Positions During AS9100 Audit AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
L Internal audit during COVID-19 restrictions ISO 13485:2016 - Medical Device Quality Management Systems 5
S Heat Sealers Upper and lower limit setting during OQ for Heat Sealer Qualification and Validation (including 21 CFR Part 11) 0
John Broomfield Guidance on Safe Working During Covid-19 Pandemic Misc. Quality Assurance and Business Systems Related Topics 5
Stefan Mundt AS9100D Major nonconformity due to recurrence of a NC during a subsequent CB audit. AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
K Things to learn during lockdown.... Safety-related books/articles/threads Book, Video, Blog and Web Site Reviews and Recommendations 2
S Is there a standard for sample size during R&D phase Other ISO and International Standards and European Regulations 18
Randy Remote auditing (for disaster, disease, disturbance etc...) during the Neo Coronavirus Pandemic and Social Distancing Registrars and Notified Bodies 7
K Analysis variation among the lots during cpk calculation. Design and Development of Products and Processes 1
G Question about Non-conformances during New Product Introduction Nonconformance and Corrective Action 14
G Is it common to do a repeatability check during calibration of an instrument? General Measurement Device and Calibration Topics 5
E Received a Major finding during IATF Surveillance audit for loss of BIQS Level 3 (more than 6 SPPS in 6 months)...how should we address SYSTEMIC CA? IATF 16949 - Automotive Quality Systems Standard 11
F Bayes Success run Theorem for sample size during OQ&PQ Qualification and Validation (including 21 CFR Part 11) 4
R What happens during a Stage 1 MDSAP audit? ISO 13485:2016 - Medical Device Quality Management Systems 4
M Informational US FDA – URGENT/11 Cybersecurity Vulnerabilities in a Widely-Used Third-Party Software Component May Introduce Risks During Use of Certain Medical Dev Medical Device and FDA Regulations and Standards News 0
A Microbial exposure during use - Requirement 11.1(c) EU Medical Device Regulations 1
GreatNate What to expect during an ISO 9001 audit Manufacturing and Related Processes 42
B Evaluation of Basic Safety during EMC Immunity or Climate Testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
G Non Conformance During ISO 9001 Audit - Not All Internal Audits Completed General Auditing Discussions 19
S Change value of target during a batch Capability, Accuracy and Stability - Processes, Machines, etc. 0
D Electrical Safety During Medical Device Development IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
S How to consider the relevant standards during development of ISO13482:2016 for IVD manufacturing Blood grouping Other Medical Device Related Standards 6
M Informational Draft ANSM’S GUIDELINE Cybersecurity of medical devices integrating software during their life cycle Medical Device and FDA Regulations and Standards News 0
A How to manage the QMS system and SOP during the transition from MDD to MDR EU Medical Device Regulations 4
M MDR Annex IX Chapter I, 2.2 (c) - Device identification procedures during manufacture. EU Medical Device Regulations 1
B How to reply NCR on ineffectiveness of corrective action during IATF external audit? This is repeated issue whereby some mistake was done. IATF 16949 - Automotive Quality Systems Standard 7
R Major nonformance finding was given during a closing meeting of a ISO9001 certification audit General Auditing Discussions 76
P NCMRs on in-proccess rejections - Products that fail during assembly ISO 13485:2016 - Medical Device Quality Management Systems 2
A Doubt on multiple inspection carrying out for same balloon number during Stage Inspection and Final Inspection? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
V System suitability or stability during continuous usage Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 0
A Determining the Scope of the QMS during Stage 1? Registrars and Notified Bodies 11
G How many samples you require to test during PQ for validation of a equipment? ISO 13485:2016 - Medical Device Quality Management Systems 1
I Quality of Potable Water Testing Parameters during Purified Water Validation Qualification and Validation (including 21 CFR Part 11) 1
S Document Handling during an Audit General Auditing Discussions 6
T Is 510k Anesthesia group particularly picky/difficult to work with during 510k? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
A Scheduled during our company's inventory activity - ISO 9001 audit question ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
A ISO/IEC 27001 - Issue during implementation of system IEC 27001 - Information Security Management Systems (ISMS) 3

Similar threads

Top Bottom