SBS - The best value in QMS software

How do you perform verification of a NCR (Nonconformance)?

R

Rockanna

#1
We were escalating verification tasks when the CA was not implemented nor effective. Is this required? Could you reopen the original NCR CA and have the original owner enter in another CA or finally implement the CA stated. Help Please. :frust:
 
Elsmar Forum Sponsor

Jim Wynne

Staff member
Admin
#2
Re: How do you perform verification of a NCR?

You can do it however you want to. It makes good sense to revisit a CA when it's been shown to have been ineffective. Whether you open a new one or reopen the original is up to you.
 
R

Rockanna

#3
Re: How do you perform verification of a NCR?

Everything I have ever read is you need to have an escalation process, such as, actions where timely and/or effective CA's are not achieved and determining if additional NCP exists due to the CA not being effective or implemented. :ca:
 

Jim Wynne

Staff member
Admin
#4
Re: How do you perform verification of a NCR?

Everything I have ever read is you need to have an escalation process, such as, actions where timely and/or effective CA's are not achieved and determining if additional NCP exists due to the CA not being effective or implemented. :ca:
Like all corrective actions, the type an extent of escalation should be based on the status and importance of the product in question. It's not too unusual for well-informed corrective actions to turn out wrong. If CAs are continually ineffective, then you have a different sort of problem and the whole system needs to be reviewed.
 
R

Rockanna

#5
Re: How do you perform verification of a NCR?

Thank you. How do you state you perform your verification of CA's?:read::evidence:
 

Jim Wynne

Staff member
Admin
#6
Re: How do you perform verification of a NCR?

Thank you. How do you state you perform your verification of CA's?:read::evidence:
In my own situation there's a form for CAs and in it there's a section for verification details. The written procedure says that CA is verified at the appropriate time (or according to customer requirements).
 
R

Reg Morrison

#7
Re: How do you perform verification of a NCR?

We were escalating verification tasks when the CA was not implemented nor effective. Is this required?
In the context of ISO 9001, the status of corrective actions should shall be assessed during management reviews. While you might NOT need to discuss each and every delinquent/ineffective corrective actions, if the problem is systemic, it should be discussed during such reviews and addressed.

The concept of "escalating" unresolved corrective action requests is sound, but, as always, it should not be used indiscriminately. Sometimes, there are reasonable justifications for a few corrective actions to linger and/or take longer than anticipated.
 
R

Rockanna

#8
Re: How do you perform verification of a NCR?

What is the expected timeframe for a long corrective action to be implemented?:
 

Jim Wynne

Staff member
Admin
#9
Re: How do you perform verification of a NCR?

What is the expected timeframe for a long corrective action to be implemented?:
There is no general expected timeframe. Sometimes a CA can be completed almost immediately, and other times the verification has to wait for a new production run, which could be months. The key is that people who "own" corrective actions have to take responsibility and see them through as promptly as possible.
 

John Broomfield

Staff member
Super Moderator
#10
Re: How do you perform verification of a NCR?

Product nonconformity (NCR) is closed when the nature of the nonconformity is recorded, nonconforming product is dispositioned and the records are complete.

This may include verification of rework or repair dispositions or the proper disposal of any scrapped products.

Corrective action to stop recurrence of each type of product nonconformity may not be worth the effort.

If CA is beneficial then you may verify removal of the containment measures and test any mistake-proofing. You may also verify removal of the root causes.

Undetected root causes may remain but the management system exists to enable the organisation to learn. Given evidence of honest and sincere effort to determine and remove the root causes, I would probably close the corrective action (CAR) then.

Your CAR form should require the CA-responsible manager record the root causes and verify their removal. But you may see evidence that the CA responsible person is not monitoring the effectiveness of their CA. Or they tossed the CA back to you for verification after a token effort.

In short, use your best judgment to keep people engaged in detecting, removing and verifying removal of the root causes from the system.

Of course, we all avoid using CARs as weapons at all costs.

John
 
Thread starter Similar threads Forum Replies Date
M How to perform Chelex DNA Method Verification in the lab General Measurement Device and Calibration Topics 2
K How to perform Verification for a Gage that is used in Destructive Testing Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
C Do I need to perform design verification Design and Development of Products and Processes 3
J How & how often to perform verification of Test Software of Automatic Test Equipment? General Measurement Device and Calibration Topics 3
E When to perform accelerated aging studies and transport test(OQ or PQ) Qualification and Validation (including 21 CFR Part 11) 4
G Should I perform Gage R&R only at the beginning of a new project? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 6
F Who can sit in/perform an API audit? Oil and Gas Industry Standards and Regulations 2
V Supplier wants to perform pre-qualifications prior to every run instead of locking in parameters. Supplier Quality Assurance and other Supplier Issues 7
M MDR requires the NB to perform "tests in order to check that the quality management system" EU Medical Device Regulations 3
M Define voltage and frequency to perform tests 61010-1 and 61326-1 for CE certification CE Marking (Conformité Européene) / CB Scheme 4
M Informational How to perform a clinical evaluation of medical devices – Part 2 – Level of clinical evidence and what sufficient clinical evidence means Medical Device and FDA Regulations and Standards News 9
L Gage R&R studies for identical Devices - Need to confirm the requirement to perform them Reliability Analysis - Predictions, Testing and Standards 2
M Informational How to perform a clinical evaluation of medical devices – Part 1 – Overview and sample of activities Medical Device and FDA Regulations and Standards News 0
blackholequasar Internal Auditing Inspiration - Getting volunteers to perform internal audits. Internal Auditing 22
E Input to ANOVA 1-WAY - How can I perform this analysis in minitab? Using Minitab Software 2
B AS9102 FAI & Lower Level Drawings - How should we perform the FAI? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
M Perform a coating weight test within 3 hours of processing the parts Manufacturing and Related Processes 2
D How to ensure independence and authority necessary to perform QM tasks ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
Q How to perform Process Capability for true position Statistical Analysis Tools, Techniques and SPC 10
H Do you have to perform an full internal prior to IATF 16949 audit? IATF 16949 - Automotive Quality Systems Standard 21
J Internal Audit clarification - How to perform the audits IATF 16949 - Automotive Quality Systems Standard 6
S When will notified bodies be ready to perform audit to the MDR? EU Medical Device Regulations 1
chris1price Is there a regulatory (MDD, MDR, FDA, ISO, etc) requirement to perform a mock recall? CE Marking (Conformité Européene) / CB Scheme 4
P Can CEO perform internal audit Internal Auditing 11
B How to perform a MSA - GRR (Gage R&R) A&R/ANOVA Vs GUM/VDA Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
W DCMA and AS9100C - Dedicating a week and 5 auditors to perform a AS9100C audit AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
W How to perform validation for an epoxy curing station Manufacturing and Related Processes 3
C How to perform Gauge R & R on Automated Test & Measurement Equipment Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 8
E How do you perform a GR&R for system software generated values? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
B Do I need to perform Gage R&R on a Digital Temperature & Humidity Gage Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 18
G Plant Relocation - Is it necessary to perform FAI? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 13
L Who can perform ISO 9001:2008 Internal Audit prior to our Registration Audit? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
R Registrars offering to perform Second Party Audits - Have they failed their role? Registrars and Notified Bodies 105
V Is it required to perform Process Validation for food or dietary supplements? Food Safety - ISO 22000, HACCP (21 CFR 120) 4
E Should companies that perform calibration services be ISO 17025 accredited? ISO 17025 related Discussions 13
W Hiring an External Auditor to perform our AS9100 Compliance Audits AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
E How to perform Discrimination check for Dial Indicator? General Measurement Device and Calibration Topics 2
A Do we need to perform Qualification and Validation? ISO 13485:2016 - Medical Device Quality Management Systems 3
A Does ISO/TS 16949:2009 require us to perform Final/Pre-dispatch Inspection? IATF 16949 - Automotive Quality Systems Standard 5
N Example of how to perform a Visual Attribute Gage R&R Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
J How do you perform a S3 Stability Study for a Non-Replicable Measurement System Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
K Do we need to perform Analytical Method Validation upon Relocation? General Measurement Device and Calibration Topics 5
R Looking for service provider to perform residual dirt test, GME7061 General Measurement Device and Calibration Topics 2
J Is MS Outlook a sufficient reminder to perform yearly supplier evaluations? Quality Manager and Management Related Issues 10
T How to perform an MSA on Cross Hatch Test Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
P Is it necessary to perform Root Cause Analysis for each failed part? Problem Solving, Root Cause Fault and Failure Analysis 16
R Can a Distributor perform Packaging Validation? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Geoff Cotton Lego perform space jump Coffee Break and Water Cooler Discussions 0
E How to perform a DCC Audit (Document Control Processes) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
BradM Can Minitab version 16 perform Neural Network Analysis Using Minitab Software 1

Similar threads

Top Bottom