Major Nonconformance - We had a control in place that was not on the control plan

U-DOG

Starting to get Involved
#1
During my TS audit, the auditor visited a process and discovered we had a control in place that was not on the control plan.

He visited another process, he discovered we had a control in place that was not on the control plan.

He issued a Major Nonconformance stating it was "A number of minor nonconformities against one requirement."

:mg:

What can I say in my appeal?

Thanks
 
Elsmar Forum Sponsor

Marc

Hunkered Down for the Duration
Staff member
Admin
#2
What was the specific finding? Please cite the TS 16949 requirement the auditor cited.
 

U-DOG

Starting to get Involved
#3
In the first process we select a program by part number from the display panel. The program tells the machine how long to run the part. We have a first pc verification sheet to inspect the part to see if it did run the proper amount of time. The fact that we do not have the program control on the control plan was a minor.

The second minor was for not having poke yoke verification parts on the control plan.

The write up states: "The process to makes sure that control plans list the process controls for manufacturing process control is not fully effective."
 

somashekar

Staff member
Super Moderator
#4
In the first process we select a program by part number from the display panel. The program tells the machine how long to run the part. We have a first pc verification sheet to inspect the part to see if it did run the proper amount of time. The fact that we do not have the program control on the control plan was a minor.

The second minor was for not having poke yoke verification parts on the control plan.

The write up states: "The process to makes sure that control plans list the process controls for manufacturing process control is not fully effective."
Your intentions are good and your working documents are per good intentions. Your planning documents are poor. You do not revisit your control plans which is the identifier of your good intentions. Your QMS must begin to follow the proven PDCA in practice. You have to be aware how your documentation change process is built around the PDCA cycle and respect it by following same.
Say this in your appeal to have a normal NC...
Good luck.
 

U-DOG

Starting to get Involved
#5
:thanx: I actually used some of that for my root cause statement.

How do I defend two minors do not necessarily = "A number of Minor Nonconformities against one requirement can represent a total breakdown of the system." ????
 

somashekar

Staff member
Super Moderator
#6
:thanx: I actually used some of that for my root cause statement.

How do I defend two minors do not necessarily = "A number of Minor Nonconformities against one requirement can represent a total breakdown of the system." ????
In fact I do not see two nonconformity here.
I see that the established controls are not mapped in the control plan and for this there are two examples.
What is a major here ?
 
I

isoalchemist

#7
I see a non conformance with two supporting examples but not a major.

Now if the control plans were 3-5 years old and never reviewed in the interim I could see where the assessor might raise the level of the non conformances, but their should be more to support the major.:2cents: Good luck with that discussion
 
#8
:thanx: I actually used some of that for my root cause statement.

How do I defend two minors do not necessarily = "A number of Minor Nonconformities against one requirement can represent a total breakdown of the system." ????
You may wish to check in the small print of the registration agreement with the CB. I have know for some CBs to prescribe this type of thing - otherwise, it's a matter of judgement on the part of the auditor. For example, if these controls weren't in the control plan and there had been escapes to the customer, then it would be cause for a major.
 

U-DOG

Starting to get Involved
#9
The "major" was received for having two separate control plans from two separate processes with the same type of nonconformance - controls in the process not identified on the CP.

I do not agree these issues should be considered a "Major Nonconformance." His reasoning for declaring a Major was "A number of minor nonconformities against one requirement..."


thanks
 

Jim Wynne

Staff member
Admin
#10
With the release of the 4th Edition TS Rules on April 1, many CBs have taken the stance that all NCs are major unless the organization can convinve the auditor otherwise. This strategy is going to cause major (pardon the expression) heartburn all around the world, and this instance is a good example.

First, there is a significant difference between a control in place that's not cited on the control plan, and a control that is cited on the CP but missing in production. The former is minor in most cases, while the latter could reasonably be called major if it there were several instances. Without knowing more about the situation I can't give direct advice except to say that the approach in appealing the "major" categorization might be to point out that there is no risk to the customer(s).
 
Thread starter Similar threads Forum Replies Date
A Where are the rules for when a repeat minor nonconformance becomes a major? IATF 16949 - Automotive Quality Systems Standard 36
J IATF 16949 registration - Major Nonconformance Finding IATF 16949 - Automotive Quality Systems Standard 9
Q Raising a Major Nonconformance during an Internal Audit Internal Auditing 23
E Short Case Studies - Major/Minor Nonconformance, Observation or OK? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
J Major Nonconformance on Stage 2 Audit causes to start over Stage 1? IATF 16949 - Automotive Quality Systems Standard 2
5 Major Nonconformance for not "clearly" defining the "device lifetime" ISO 13485:2016 - Medical Device Quality Management Systems 2
T Red Metric on a Customer Scorecard is a Major Nonconformance AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 13
S Auditor says a Minor Nonconformance will become a Major Nonconformance General Auditing Discussions 8
C Major NADCAP Magnetic Inspection Nonconformance - How to answer it? Nonconformance and Corrective Action 2
J Can a Major Nonconformance be Open but 100% Resolved? IATF 16949 - Automotive Quality Systems Standard 6
M Is it necessary to classify nonconformance as minor, major, observations in an IQA? Internal Auditing 18
G Dangerous Act - Auditor says major nonconformance for safety (risk) issue Occupational Health & Safety Management Standards 21
J Time Frame for Responding to a Major Nonconformance - Registrar Audit ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
P Lack of 3rd Shift Internal Audit - Major or Minor NC (Nonconformance)? Internal Auditing 17
D Major vs. Minor Nonconformance - TS 16949 3rd Party Audit Question IATF 16949 - Automotive Quality Systems Standard 4
D Definition Major Audit Nonconformance - Definition of Major Nonconformance Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 9
K Missing Information in Training Records - Is it a Major Nonconformance? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 23
Douglas E. Purdy What is required of an organization when cited with a Major Nonconformance? TS16949 IATF 16949 - Automotive Quality Systems Standard 5
M What happens if a Major or Minor Nonconformance is found during Surveillance Audit ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
M Major/Minor Nonconformity - Nonconformance from last audit found again Nonconformance and Corrective Action 15
D Definition Major vs. Minor Nonconformance (Finding) - Difference and Definition Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 20
Randy Minor Nonconformance turning into a Major - Systemic failure throught an organization General Auditing Discussions 40
Q Nonconformance vs. Nonconformity - I cannot find major and minor, either! Nonconformance and Corrective Action 36
A Definition Major vs. Minor Nonconformance (Finding) - Internal Audit - Definition & Differences Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 38
W Major NCRs within AS9100 - What is the most frequent reason for Major NCRs? AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 5
R What's the major difference between Green Belt and Black Belt in term of training and project Six Sigma 3
Stefan Mundt AS9100D Major nonconformity due to recurrence of a NC during a subsequent CB audit. AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 1
B AIAG/VDA’s FMEA Manual Is a Major Advance (my take on this subject) FMEA and Control Plans 2
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
S Formula for Calculating NoGo Major Diameter for UN gages Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
C Fact or fiction - Repeat minor becomes a major IATF non-conformance IATF 16949 - Automotive Quality Systems Standard 7
N Validation procedure, Major NC CAP - Equipment Validation process is not effective ISO 13485:2016 - Medical Device Quality Management Systems 5
I Is this a Major AS9100 QMS change - Quality Concerns AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 2
K FAA Audit - Major nonconformity for lack of timely calibration of two devices EASA and JAA Aviation Standards and Requirements 5
Sidney Vianna Interesting Discussion Legal compliance as part of ISO 45001 accredited certification. Major OSHA penalties in the USA. Occupational Health & Safety Management Standards 15
Sidney Vianna Interesting Discussion How major corporations in the West keep failing to uphold their pledges of abolishing child labor in their cocoa supply chains Sustainability, Green Initiatives and Ecology 3
R Major nonformance finding was given during a closing meeting of a ISO9001 certification audit General Auditing Discussions 76
Y Informational Change control process - Major vs Minor change - Active class III medical devices ISO 13485:2016 - Medical Device Quality Management Systems 12
P Major Finding Elevation - Do I elevate this minor finding to a major one? AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 14
Sidney Vianna Top 10 Major and minor NC's during IATF 16949:2016 Audits IATF 16949 - Automotive Quality Systems Standard 8
G AIAG FMEA - Major customers of the FMEA process FMEA and Control Plans 3
M New Medical Device Accessory with New Function - Is this a major change? Other Medical Device Regulations World-Wide 3
C IATF 16949 : 2016 - How put in place a Containment for this kind of Major NC IATF 16949 - Automotive Quality Systems Standard 14
A ISO 14001:2015 transition audit - Major NC due to the procedure and audit plan ISO 14001:2015 Specific Discussions 10
C How does a major NC for a support site affect our certificate? IATF 16949 - Automotive Quality Systems Standard 2
AlienraverX How to appeal a major audit finding ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 26
W IATF 16949 Clause 6.1.1 - My first Major NCR (Management Review) IATF 16949 - Automotive Quality Systems Standard 57
K Outsourced Major Processes - Working for Two Sister Companies AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 1
T Non-addressed Minor Finding elevated to Major Finding Internal Auditing 37
B IATF 16949: Definition Major/Minor Non-conformity IATF 16949 - Automotive Quality Systems Standard 6
Similar threads


















































Top Bottom