Nonconformance Training in Best Practices

U

uhohraggy

#1
Does anyone know of any training courses, or webinars on nonconformance management best practices?

We are having a few debates within my organization.
1) Do nonconformances require a corrective action as part of the NCMR process?

2) Do NCMR's need to be closed prior to allowing this shipping of the product?


Our current process and most (almost all) of the experience in our organization is that corrective actions must be part of the NCMR process and only escalate to a CAPA for systemic issues. Since the NCMR cannot close until the CA is completed, the NCMR does not need to be closed in order to ship the material as long as the correction to the material has been approved by the MRB and completed (if in fact a correction is needed). Of course we have one approver that believes this is completely wrong. Hoping a best practices reference or training can align people.
 
Elsmar Forum Sponsor

Marcelo

Inactive Registered Visitor
#2
1) Do nonconformances require a corrective action as part of the NCMR process?
NCs requires corrections (action to eliminate a detected nonconformity), then it needs to be analyzed to verify of there?s a need for corrective actions (to deal with root causes which are related to processes).

2) Do NCMR's need to be closed prior to allowing this shipping of the product?
They need to be corrected.

Does anyone know of any training courses, or webinars on nonconformance management best practices?
No, sorry.
 
U

uhohraggy

#3
If nonconformances only need to be corrected how are you ensuring compliance with 21CFR100


(3) Identifying the action(s) needed to correct and prevent recurrence of nonconforming product and other quality problems;
I've seen this as an audit finding many times.
 

Marcelo

Inactive Registered Visitor
#4
(3) Identifying the action(s) needed to correct and prevent recurrence of nonconforming product and other quality problems;
Sorry, you are right, I should have said that the NCs might need correction, or a related actions such as be thrown away.

However, the escalation for a corrective action is to be analyzed after the first action.

The correction acts on the detected NC, CA acts on the root cause of the process.

For you to ship, you need to correct or whatever the particular problem. You may need to change the process, but you do not need that to ship.
 

TWA - not the airline

Trusted Information Resource
#5
Muddy waters here...

Marcelo, scrapping faulty parts is also a correction just like e.g. reworking the parts. Unfortunately the wording of 21 CFR 820.100 is a bit misleading in my opinion: a) actions needed to correct = correction, b) actions needed to prevent (the same) non-conformity from occuring again = corrective action, c) actions to prevent other quality problems = preventive action.
And "identify the action(s) needed" means an assessment and this could result in "no action required", e.g. if it was a singular event that cannot happen again...
 

John Broomfield

Staff member
Super Moderator
#6
uhohraggy,

Please bear in mind that the following dispositions of nonconforming product are design changes and should be reviewed and approved or not approved as such:

  1. Use as is, and
  2. Repair.
Many organizations say rework when they mean repair and vice versa.

Rework is not a design change because the nonconforming product is reworked to conform to the original specification.

Repairs do not conform to the original design unless, of course, the designer also specified approved repairs for common nonconformities.

Naturally, for your customer to continue the business relationship, you will be expected to determine actions to stop recurrence.

But determining these actions should not stop shipment of product verified as meeting the original or changed requirements.

This subject should be taught thoroughly in any certified lead auditor class.

But it is too small to command its own course except, perhaps, on YouTube.

John
 

TWA - not the airline

Trusted Information Resource
#7
John,

but rework still would need to be considered a kind of change even though design = specifications would stay the same, right?. Rework involves additional process steps that are not part of the initial DMR and therefore 820.90 b(2) requires an evaluation of "any adverse effect from the rework upon the product".
 

John Broomfield

Staff member
Super Moderator
#8
John,

but rework still would need to be considered a kind of change even though design = specifications would stay the same, right?. Rework involves additional process steps that are not part of the initial DMR and therefore 820.90 b(2) requires an evaluation of "any adverse effect from the rework upon the product".
TWA,

Yes, but they are covering all bases including cases where the supplier misnames repair as rework.

John
 
R

Reg Morrison

#9
Just to remind people that not always a nonconformity can be corrected. For example, a late delivery to a customer. Even if the supplier agrees to a credit back to the customer for a late delivery, that issue can not be fixed from the perspective that the product would have gotten to the customer late.

A potential late delivery can be "corrected" with expedited shipment, expedited production, etc.

Certainly, if there is a systemic issue of late deliveries, a corrective action could be justified.

As to the OP challenge, when a regulatory auditor requires corrective action for issues that are prone to happen again, such as typos, for example, the solution is: you pretend you do corrective action and they pretend to believe that will never happen again. And they live happily ever after....:sarcasm:
 

John Broomfield

Staff member
Super Moderator
#10
Reg,

Yes, there's something to be said for designing service processes according to their opportunity and risk - or at least validating them as we do for special processes.

And all companies deliver services with or without products.

John
 
Thread starter Similar threads Forum Replies Date
K Nonconformance on training - Not following own processes (IATF 16949) Internal Auditing 14
Q Third Party Audit Nonconformance for Training effectiveness IATF 16949 - Automotive Quality Systems Standard 20
K Missing Information in Training Records - Is it a Major Nonconformance? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 23
D ISO9001:2000 - Training Needs and Requirements - Audit Nonconformance ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
C Internal Audit Training Help - Audit Nonconformance Training - Internal, External, Online and Distance Learning 11
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 9100, Nadcap and related Aerospace Standards and Requirements 25
Q 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
Q 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 9100, Nadcap and related Aerospace Standards and Requirements 20
Q 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 9100, Nadcap and related Aerospace 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 9100, Nadcap and related Aerospace Standards and Requirements 5
P Examples of Nonconformance, Corrective Action Requests, and Root Cause Analysis Nonconformance and Corrective Action 2
Q Should I initiate CAPA for a nonconformance not recorded? Nonconformance and Corrective Action 25
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 9100, Nadcap and related Aerospace 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
Similar threads


















































Top Bottom