SBS - The Best Value in QMS software

Establishing Internal Audit Nonconformity Level Criteria - Major vs. Minor?

S

stanislavd

#1
During our internal audits we have found that the different auditors have different criteria for what is Major/Minor nonconformity? Is there any documented criteria how to classify the observations/nonconformities found during the audit? I am also a little bit curios how external auditors manage this...
 
Last edited by a moderator:
Elsmar Forum Sponsor

Antonio Vieira

Involved - Posts
Trusted Information Resource
#3
In the case of QS-9000 those things are clearly defined.
They should also be for ISO 9001..., but unfortunately it’s not the same for different registrars.:(
 

Coury Ferguson

Moderator here to help
Staff member
Super Moderator
#5
stanislavd said:
During our internal audits we have found that the different auditors have different criteria for what is Major/Minor nonconformity? Is there any documented criteria how to classify the observations/nonconformities found during the audit? I am also a little bit curios how external auditors manage this...

In my opinion, a Major is one that has shown to be plant/business wide (breakdown) and a Minor is one that is found only to exist as one time and not plant/business wide.

Coury Ferguson
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#6
Not all NC's are created equal

Al Rosen said:
There is no distinction for internal audits. There are only non conformities.
That is correct. However, an organization might decide to rank/rate their internally discovered nonconformities in order to prioritize actions on the ones that have a higher impact or risk. Not all nonconformities will affect the organization in the same manner. So a "risk evaluation" approach might be beneficial.

If an organization decides to develop a criteria to "rate" NC's, such as critical, major, minor, etc... they can develop their own system.
 
#7
Sidney Vianna said:
That is correct. However, an organization might decide to rank/rate their internally discovered nonconformities in order to prioritize actions on the ones that have a higher impact or risk. Not all nonconformities will affect the organization in the same manner. So a "risk evaluation" approach might be beneficial.
Indeed. It is up to the organization.

I must say however, that I have always found the major/minor discussion a totally unnecessary complication in internal audits. We do not use it.

/Claes
 

Ragnar

Involved In Discussions
#8
At our facility we have decide that an internal audit finding with potential to negitivly impact our customer gets a "Major" ranking while findings that do not potientialy impact our customer are concidered "Minor" an example would be nonconforming product not properly identified or segregated from production would equal a major N/C because that product could be shipped. An expired Quality Alert still hanging in the work cell would equal a minor. We as an audit team have also included ANY repeat audit finding where corrective actions were not adaquate and root cause not properly determined would also receive a "Major" rating.
So far no complaints about our approach from the registrar.:cfingers:
 

Antonio Vieira

Involved - Posts
Trusted Information Resource
#9
Ranking the nonconformities in internal audits can be a very wise decision.
I do it all the time.
It’s also a good idea when you have quality objectives related to the number of nonconformities in internal audits.
This way you can state a number of observations, a number of minor nonconformities and a number of major nonconformities as maximum values for this kind of objective to be achieved.
Anyway it’s also a good idea to rank these nonconformities just to be in accordance with what 3rd and 2nd party audits are doing...
 

Cari Spears

Super Moderator
Staff member
Super Moderator
#10
Claes Gefvenberg said:
...I have always found the major/minor discussion a totally unnecessary complication in internal audits. We do not use it.
Same here. Our internal audit findings are either nonconformances or opportunities for improvement.
 
Thread starter Similar threads Forum Replies Date
A Help establishing regulatory requirements - Plastic dental cartridge syringe US Food and Drug Administration (FDA) 0
K ISO 13485 section 5.3 Quality Policy - No framework for establishing and reviewing quality objectives ISO 13485:2016 - Medical Device Quality Management Systems 2
N Use part of high risk device for establishing low risk device EU Medical Device Regulations 0
J ISO 13485:2016 Section 6.2 - Documenting the process for establishing competence ISO 13485:2016 - Medical Device Quality Management Systems 6
M Establishing a FTQ (First Time Quality) process for an engine assembly line Quality Tools, Improvement and Analysis 1
R Establishing the quality policy for ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
N Establishing a monthly scrap cost target Lean in Manufacturing and Service Industries 11
T Establishing -F- datum - need advice Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
S Establishing a Gage R&R Studies Program in a Testing Laboratory Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
M Establishing traceability from calibrated glassware to non calibrated ones General Measurement Device and Calibration Topics 5
O Establishing SPC for small batches of 10-15 units Statistical Analysis Tools, Techniques and SPC 10
M Establishing Metrics - Where do you document metrics? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
alonFAI Establishing a Receiving Inspection Procedure Document Control Systems, Procedures, Forms and Templates 5
optomist1 Establishing Sigma or Capabilty Indices for Automotive Safety Quality Tools, Improvement and Analysis 1
S Establishing an MSA Plan and Justification Suggestions wanted Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
M Establishing a QMS - What Daily/Weekly/Monthly activities in Auto Industry IATF 16949 - Automotive Quality Systems Standard 4
T Help establishing a good Customer Complaints Procedure? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
V Process Validation Guidance establishing the Integration with QbD - April 2012 Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
M Establishing Ranges for Weights for Calibration Verification of a Micro-Balance Calibration Frequency (Interval) 1
D Preparing for ISO 29001/API Q1- Establishing Control Features Oil and Gas Industry Standards and Regulations 3
D Establishing Key Process Characteristics (KPC's) Quality Tools, Improvement and Analysis 6
C New Quality Manager - Establishing Teams in different Business Units Quality Manager and Management Related Issues 4
H Noob Frequency Distribution and establishing achievable goals Using Minitab Software 2
K How to apply IEC 62366 and what shall be changed in establishing a Technical File ISO 13485:2016 - Medical Device Quality Management Systems 2
M Establishing monthly production targets with varying number of employees Lean in Manufacturing and Service Industries 6
A Why do I need batch size in establishing control plan to certain AQL?? AQL - Acceptable Quality Level 4
E Need help establishing a DMR (Device Master Record) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
K Basis for Establishing Gage Tolerancing - "Gage Maker's Tolerances" General Measurement Device and Calibration Topics 4
K Establishing the Environmental Aspects and Impacts for a Septic Tank Miscellaneous Environmental Standards and EMS Related Discussions 5
M Establishing simple procedure and work instruction using chart or photo or video Document Control Systems, Procedures, Forms and Templates 2
L Criteria for Establishing Control Plan Sample Size and Inspection Frequency FMEA and Control Plans 7
K Inventory Management - Establishing a procedure for Inventory Management Document Control Systems, Procedures, Forms and Templates 2
K Establishing Item Codes for Production Raw Materials Misc. Quality Assurance and Business Systems Related Topics 2
O Establishing the current value of KPI's (Key Performance Indicators) Manufacturing and Related Processes 1
Y Establishing and Measuring Individual Performance to Product Quality Standards Misc. Quality Assurance and Business Systems Related Topics 5
C Establishing alert and action limits for clean room bioburden Other Medical Device and Orthopedic Related Topics 9
E Establishing a biocompability test lab for testing EN 10993 series EU Medical Device Regulations 1
D Establishing and controlling process capability - Meaning of Phrases Capability, Accuracy and Stability - Processes, Machines, etc. 2
P Establishing Thickness Specifications from Measured Data Capability, Accuracy and Stability - Processes, Machines, etc. 11
A Initial condition for establishing significant environmental aspects Miscellaneous Environmental Standards and EMS Related Discussions 1
S Establishing Control of Regulations that concern my company Quality Manager and Management Related Issues 12
D Establishing New Training Procedure - Past Training of Existing Employees Training - Internal, External, Online and Distance Learning 6
J Establishing Proposal Metrics in a Factory Construction Company Quality Tools, Improvement and Analysis 6
A How to do Equipment Validation - Establishing our ISO 13485 QMS procedures Qualification and Validation (including 21 CFR Part 11) 34
B True Position without tertiary datum? Establishing a proper rotation Inspection, Prints (Drawings), Testing, Sampling and Related Topics 12
Coury Ferguson Interpretation of IAF Guide 62 - Establishing the Competence of the Auditors Registrars and Notified Bodies 11
H Establishing Employee Competencies and Training - Future Training Plan ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
P China - Establishing Quality Systems for Chinese Suppliers Supplier Quality Assurance and other Supplier Issues 8
Q Feedback System (8.2.1) - Requirements for "..establishing a documented procedure..." ISO 13485:2016 - Medical Device Quality Management Systems 5
Douglas E. Purdy Transition to ISO 9001:2000 - RFI - 009, RFI-003, & Establishing a QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9

Similar threads

Top Bottom