Nonconformance Categories - QMS web app to support ISO9001

G

GregRus

#1
I'm leasing a QMS web app to support ISO9001. In the NCR module there are 2 levels of NCR classifications, NCR Category and NCR Failure Classification. I was told the NCR Category is a higher level, more general term and the NCR Failure Classification is more specific term.

The NCR Failure Classifications are straight forward but I'm struggling a bit with the NCR Categories. I created some broad ones, assembly, dimensioning, drawing, etc. but have difficulty ensuring all our NCRs are properly categorized.

We are a machine shop and assembler operation. I appreciate any guidance you can provide for the NCR Categories.
 
Elsmar Forum Sponsor
#2
I'm leasing a QMS web app to support ISO9001. In the NCR module there are 2 levels of NCR classifications, NCR Category and NCR Failure Classification. I was told the NCR Category is a higher level, more general term and the NCR Failure Classification is more specific term.

The NCR Failure Classifications are straight forward but I'm struggling a bit with the NCR Categories. I created some broad ones, assembly, dimensioning, drawing, etc. but have difficulty ensuring all our NCRs are properly categorized.

We are a machine shop and assembler operation. I appreciate any guidance you can provide for the NCR Categories.
We have here an example of my biggest fear about software to help people implement ISO 9001 - the fact that there's a deal more complexity that is really necessary. That said, is there any guidance from the authors of this app to help understand what they expected you'd put in these classifications?
 

somashekar

Staff member
Super Moderator
#3
Hi Greg ...
You want two category: Take MAJOR / MINOR
You want four: Take CATASTROPHIC / MAJOR / MINOR / TRIVIAL
So what are you going to do next.
The standard wants you to take appropriate corrective action, based on the effects of the nonconformities encountered.
So its simply your choice to catagorize.
I just wish you see the effects of the NC and decide the appropriate CA and not be unduly bothered about categorization.
 
P

pldey42

#4
I agree with Andy. If I were leasing software I would expect a manual and clear guidance, by phone if necessary. And yes, software can make life more complex, not always helpfully.

But here's my guess:

First, the idea that one is more general and the other more specific is either wrong or, indeed, making things more complicated than they need to be.

Assuming that they actually serve different purposes, here's how I'd guess they're supposed to be used:

Category is like major and minor, an indicator of the impact of the NC upon the customer, to be used when prioritising corrective actions. It might include a critical category as well, for emergencies that are bigger than major and risk serious contractual issues with the client if not fixed with the utmost haste.

The Failure Classification would be completed after finishing the root cause analysis part of the corrective action and would indicate the underlying cause of the problem - bad requirements spec, bad design, manufacturing fault, bad part, bad raw materials and so forth. It would be used for analysis of trends so that deeper corrective or preventive actions could be used to eliminate recurring root problems. Whether these are corrective or preventive is a moot point; the thing is, subtle problems in complex processes can be hard to spot and expensive to fix, and analysis of root cause data from several nonconformities can help.

Just a guess which I hope helps,
Pat

P.S. It's only a tool. If you don't find a field helpful, you can always ignore it.
 
Thread starter Similar threads Forum Replies Date
T Internal Nonconformance procedure thoughts (AS9100) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
C NCR (Nonconformance System) Software Nonconformance and Corrective Action 7
L How to deal with an ISO 13485 Supplier Audit nonconformance ISO 13485:2016 - Medical Device Quality Management Systems 17
E When to generate a nonconformance report ISO 13485:2016 - Medical Device Quality Management Systems 6
K Counterfeit parts prevention - Audit Nonconformance - AS9100 8.2.2 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 25
qualprod When to write up a nonconformance and require a NCR - We produce labels ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
PhilM Nonconformance report, Customer complaint investigations and RMAs ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
M Medical Device Directive - Seeking common nonconformance write up scenarios CE Marking (Conformité Européene) / CB Scheme 2
CPhelan Nonconformance opened as incorrect expiration date placed on received product. Escalate to CAPA? Nonconformance and Corrective Action 4
qualprod Ineffective follow up of people performance - Audit Nonconformance ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
Q AS9120 7.5.3.2 Control of Documented Information - Audit Nonconformance AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 20
qualprod Criteria to raise a Nonconformance based on KPI values ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 39
L AS9100 D- Handling Nonconformance Documentation for an organization that outsources most of the work. AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
G Timing allowed by IATF to close a Remote Site Minor Nonconformance IATF 16949 - Automotive Quality Systems Standard 2
R Visually impacting graphics for Nonconformance status metrics for Management Report Nonconformance and Corrective Action 5
J ISO 13485 Audit Nonconformance written against 6.3 Infrastructure ISO 13485:2016 - Medical Device Quality Management Systems 25
PastorBee13 IATF 16949 Audit Nonconformance Responses per 5.1.1.2 - Format IATF 16949 - Automotive Quality Systems Standard 11
A What ISO 9001:2015 clause could be used to write nonconformance for not updating licensed driver list? General Auditing Discussions 8
S Nonconformance to a Note in ISO13485 clause 6.2 Human Resources Effectiveness ISO 13485:2016 - Medical Device Quality Management Systems 13
A API Spec Q1 9th Edition - 12 month Internal Audit Schedule Audit Nonconformance Oil and Gas Industry Standards and Regulations 10
A Where are the rules for when a repeat minor nonconformance becomes a major? IATF 16949 - Automotive Quality Systems Standard 36
R ISO 9001:2015 9.3 - Required inputs to the management review - Audit Nonconformance Manufacturing and Related Processes 14
K Which clause would best fit this Nonconformance? (Supplier Related) Internal Auditing 2
W Minor Audit Nonconformance Against Determining the scope of QMS IATF 16949 - Automotive Quality Systems Standard 12
J IATF 16949 registration - Major Nonconformance Finding IATF 16949 - Automotive Quality Systems Standard 9
Ajit Basrur Are inputs to the nonconformance process required to be identified? Nonconformance and Corrective Action 21
N Responding to NADCAP nonconformance - Control of External Documents AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
P Examples of Nonconformance, Corrective Action Requests, and Root Cause Analysis Nonconformance and Corrective Action 2
qualprod Should I initiate CAPA for a nonconformance not recorded? Nonconformance and Corrective Action 25
K Nonconformance on training - Not following own processes (IATF 16949) Internal Auditing 14
J Audit opportunity for improvement raised to nonconformance months after the audit General Auditing Discussions 7
GStough Pushback on a Nonconformance Found in a Supplier Audit General Auditing Discussions 22
K NCR or CA? We're taking any issue we have and saying its a nonconformance Nonconformance and Corrective Action 11
GStough Nonconformance Found Outside the Audit Scope - Supplier Audit General Auditing Discussions 16
R Closing out an API/ISO QMS Audit Nonconformance - Magnetic Particle Examination Inspection, Prints (Drawings), Testing, Sampling and Related Topics 5
Q Nonconformance Raw Material Treatment in ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
C Recurring Nonconformance - Missing Deadline for Closing a Corrective Action Problem Solving, Root Cause Fault and Failure Analysis 14
N Laboratory Audit Nonconformance - Maintenance of Standards ISO 17025 related Discussions 10
K Internal Auditing a previous Nonconformance? Internal Auditing 19
D Interpretation of new IAQG ruling - Audit duration for nonconformance verification AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
Q Customer Complaint Vs. Nonconformance - CAPA SYSTEM Customer Complaints 2
D Nonconformance on document control - Unapproved document on production server Document Control Systems, Procedures, Forms and Templates 4
P Ratio of Supplier with a nonconformance vs. Supplier without a nonconfomance Supplier Quality Assurance and other Supplier Issues 10
W Nonconformance Recurrence Response Help General Auditing Discussions 4
dubrizo If Quality Objectives are not known to employees, is it a Nonconformance? General Auditing Discussions 7
xfngrs Automotive Industry Nonconformance Database wanted - Preferably SharePoint based Quality Assurance and Compliance Software Tools and Solutions 5
Gman2 Processes sharing the same nonconformance during an audit General Auditing Discussions 13
T Audit Nonconformance - ISO 9001:2008 Clause 6.2.2 - Competencies ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 20
J Audit Nonconformance for Design of Choke Manifold Oil and Gas Industry Standards and Regulations 4
L How to avoid Nonconformance Reoccurrence problems IATF 16949 - Automotive Quality Systems Standard 20

Similar threads

Top Bottom