Is this a Major AS9100 QMS change - Quality Concerns

#1
We currently run our Quality concerns through Qpulse and are going to change the structure/flow of the quality concerns process within Qpulse, previously we had a corrective action section within the quality concern process where we could add root cause/corrective and preventative action, we also specified the requirement to attach an 8D if the concern process was serious enough to warrant one. We are now going to alter the concern process within Qpulse to reflect the 8D flow. My question is, is this classed as a major change to the QMS and as such does it need to be recorded and if so how? We have an ECN process for recording engineering changes but my opinion is that this is not the correct format for recording QMS changes.
 
Elsmar Forum Sponsor

doctall41

Involved In Discussions
#2
We currently run our Quality concerns through Qpulse and are going to change the structure/flow of the quality concerns process within Qpulse, previously we had a corrective action section within the quality concern process where we could add root cause/corrective and preventative action, we also specified the requirement to attach an 8D if the concern process was serious enough to warrant one. We are now going to alter the concern process within Qpulse to reflect the 8D flow. My question is, is this classed as a major change to the QMS and as such does it need to be recorded and if so how? We have an ECN process for recording engineering changes but my opinion is that this is not the correct format for recording QMS changes.
Ian,
I assume you have a documented Procedure stating how you handle Corrective Actions. All you need to do is make a revision to that procedure stating what you will now be doing within Qpulse.
 

Big Jim

Super Moderator
#3
You may be confused with major changes that need to be reported to the certification body. Things that could indicate changes needed in the audits. Things like moving to another facility, adding a facility, adding shifts, significant changes in management, and even that the company was bought out by another company.

As noted above, changes in you documentation need not be reported, but they need to be available for the auditor to review.
 
Thread starter Similar threads Forum Replies Date
W Major NCRs within AS9100 - What is the most frequent reason for Major NCRs? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
N Meeting AS9100 Rev C Requirements - Major help wanted AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 27
T Key Characteristics - Critical vs. Major vs. Minor - AS9100 vs. MIL-STDs AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
B Classifying findings as Major vs. Minor findings in the AS9100 world AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
M AS9100 Getting Started - What time frame /cost / major obstacles can we expect AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
Scanton Double Major for the same infraction? IATF 16949 - Automotive Quality Systems Standard 1
M Major vs. Minor for Internal Audits? Internal Auditing 10
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, NADCAP and Aerospace related 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
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
A Where are the rules for when a repeat minor nonconformance becomes a major? IATF 16949 - Automotive Quality Systems Standard 36
P Major Finding Elevation - Do I elevate this minor finding to a major one? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 14
J IATF 16949 registration - Major Nonconformance Finding IATF 16949 - Automotive Quality Systems Standard 9
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, NADCAP and Aerospace related 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
M Increase in Major TS16949 Audit Findings IATF 16949 - Automotive Quality Systems Standard 14
S Could I issue major finding for Inadequate Procedures Supplier Quality Assurance and other Supplier Issues 17
T Defining Major vs. Minor Changes to Procedures ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
D Is Failure to achieve a Goal a Major Non-Conformance? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
C Notification to Customers regarding Major Audit Finding IATF 16949 - Automotive Quality Systems Standard 25
J Follow up on Major Audit Finding General Auditing Discussions 15
C ISO 9001:2008 Audit Major Finding - Dial Calipers not set to zero ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
N Formula that will calculate the NoGo Major Diameter of an M20 x 1.5 6H Thread gage Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
6 Print Callout for a Special Thread - 1.173-18 UNS-3A Major Dia. Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
D When to complete FAA Form 337 (Major Repair and Alteration) Federal Aviation Administration (FAA) Standards and Requirements 4
C Measurements of Major Diameters of plug thread gages General Measurement Device and Calibration Topics 12
S What are the implications of a major NC during a TS 16949 surveillance audit? IATF 16949 - Automotive Quality Systems Standard 3
U-DOG Major Nonconformance - We had a control in place that was not on the control plan IATF 16949 - Automotive Quality Systems Standard 14
H Internal Audit Major Nonconformity or Not? Quality Manager and Management Related Issues 24
R Classification of Major & Minor Defects AQL - Acceptable Quality Level 10
M What are the major causes of Forklift Accidents? Occupational Health & Safety Management Standards 13
Q Raising a Major Nonconformance during an Internal Audit Internal Auditing 23

Similar threads

Top Bottom