SBS - The best value in QMS software

Non Conformity (Nonconformance) Report & Preventive Action Requirements

C

CBAL08

#21
#21
Help

Having trouble in differentiating Non conformity and Corrections taken.....( or say Corrective action---long term Preventive action)
The process for non conformity as per the Standard says- " Take actions to eliminate the detected non conformity ( Is this Corrections or immediate actions taken as part of Corrective action?)
Any help on Where does Non conformance process stops and CAPA starts.

AS far as I understood...whenever a defect is found ( In house... Production..... products for repair from Customers ( is this NC/ complaints)......incoming inspection etc) - A NC is opened.....then product is segregated and awaits untill the decision for Rework/Reject/ Return/Repair is made.

1. Can further investigation be handled with CAPA?
2. For simple cases could we just close the NC without a CAPA?


If anyone has a simple NC form ....would really appreciate if shared? Or anyone to help me out with this confusion?

Thank you !
 
Standard Work Instruction Software by Dozuki
Elsmar Forum Sponsor
B

Big Jim

Super Moderator
#22
#22
CBAL08 said:
Help

Having trouble in differentiating Non conformity and Corrections taken.....( or say Corrective action---long term Preventive action)
The process for non conformity as per the Standard says- " Take actions to eliminate the detected non conformity ( Is this Corrections or immediate actions taken as part of Corrective action?)
Any help on Where does Non conformance process stops and CAPA starts.

AS far as I understood...whenever a defect is found ( In house... Production..... products for repair from Customers ( is this NC/ complaints)......incoming inspection etc) - A NC is opened.....then product is segregated and awaits untill the decision for Rework/Reject/ Return/Repair is made.

1. Can further investigation be handled with CAPA?
2. For simple cases could we just close the NC without a CAPA?


If anyone has a simple NC form ....would really appreciate if shared? Or anyone to help me out with this confusion?

Thank you !
Click to expand...
You get to choose which nonconformances need only correction and which ones need to be escalated to corrective actions.

Now that I have said that, you probably should nearly always treat audit nonconformances with corrective actions. If it showed up in an audit, it probably needs more than just correction.

I don't particularly like the term "CAPA". It tends to lead toward confusion as to what is a corrective action and what is a preventive action.
 
T

tkdinesh

#23
#23
Corrective Action should be intiated for the existing Non conformities to prevent them recurring again.
So if you make proper root cause analysis and taking CA,the problem will not happen again.So there is no preventive action for the present/existing Non conformity.CA is reactive in nature.
For Example,
you are making an excavation without any protection,some one falls inside.Now you are making a barricade to protect people falling inside.This is CA.
In the same case,before making an excavation,you are making barricade to protect people falling inside.This is PA.PA is proactive in nature.

Dinesh
 
Q

qusys

Trusted Information Resource
#24
#24
tkdinesh said:
Corrective Action should be intiated for the existing Non conformities to prevent them recurring again.
So if you make proper root cause analysis and taking CA,the problem will not happen again.So there is no preventive action for the present/existing Non conformity.CA is reactive in nature.
For Example,
you are making an excavation without any protection,some one falls inside.Now you are making a barricade to protect people falling inside.This is CA.
In the same case,before making an excavation,you are making barricade to protect people falling inside.This is PA.PA is proactive in nature.

Dinesh
Click to expand...
It is ok.
Prevention works on potential non conformities, while corrective action acts when non conformity happened , addressing the root cause.:bigwave:
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
G Dealing with non conformity caused by Supplier Components detected in the production line IATF 16949 - Automotive Quality Systems Standard 14
S Can we provide training plan as corrective action for IATF 16949 Non conformity? IATF 16949 - Automotive Quality Systems Standard 9
qualprod Non conformity, do nothing? Employee experiencing "hard times" ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 26
D Root Cause on Non-Conformity Against Quality Manual Problem Solving, Root Cause Fault and Failure Analysis 9
M Auditing a Contractor in EMS and Non Conformity Report General Auditing Discussions 1
A IATF 16949 - Non-conformity on 5.1.1.2 Process effectiveness and efficiency IATF 16949 - Automotive Quality Systems Standard 5
B IATF 16949: Definition Major/Minor Non-conformity IATF 16949 - Automotive Quality Systems Standard 6
E Non Conformity due to Outsourced Internal Audit Error ISO 14001:2015 Specific Discussions 2
J Non-Conformity Overreach - We recently switched our EU Authorized Representative ISO 13485:2016 - Medical Device Quality Management Systems 6
R Non-Conformity Report from Notified Body - MEDDEV Guide is not Legally Binding EU Medical Device Regulations 16
B A question of Non-conformity specifics - AQAP2120 (The MOD's equivalent to ISO9001) General Auditing Discussions 1
Q Non Conformity of Support Processes - Need another NC form? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
Q Non Conformity in Audit: Missing Deputy Rule ISO 13485:2016 - Medical Device Quality Management Systems 10
S Internal Audit - Non conformity not easily fixable (Sales and Contracts) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 30
S Some departments don't have Quality Objectives - Non Conformity? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 68
S HR Manager refusing to create Quality Objectives - Is this a Non-Conformity? Quality Manager and Management Related Issues 11
H Product Non-Conformity and Document Change Request Forms - Corrective Action needed? Nonconformance and Corrective Action 16
A Declaration of Conformity for non-CE Mark products CE Marking (Conformité Européene) / CB Scheme 2
Q How do you define repeated non conformity (aka Recurrence)? Nonconformance and Corrective Action 24
T A confusing Non-conformity - No defined QMS processes intended for 'Management' ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
A Non-EU countries who use your EC Certificate & Declaration of Conformity Other Medical Device Related Standards 3
eternal_atlas Identification of ISO 9001 Clause to a specific Non-Conformity General Auditing Discussions 7
C Show cause letter given as a result of a minor non-conformity raised by CB Quality Manager and Management Related Issues 6
L Completed Non-conformity report examples needed! ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
T Non-conformity - Not performing Supplier Development on one specific supplier IATF 16949 - Automotive Quality Systems Standard 25
A Communicating to our employees: consequences to customer of non-conformity IATF 16949 - Automotive Quality Systems Standard 3
D TS 16949: 2002 section 7.6.1 - MSA non conformity at registration audit IATF 16949 - Automotive Quality Systems Standard 2
K Major Non-Conformity During Initial TS16949 Audit Nonconformance and Corrective Action 2
M Record Falsification - What clause to raise a non-conformity? Records and Data - Quality, Legal and Other Evidence 20
B Does FDA Registration QSR need to cover non-medical devices for contract repackager? US Food and Drug Administration (FDA) 1
A Brexit Mandate for EU Authorised Representative for non medical devices CE Marking (Conformité Européene) / CB Scheme 3
E Accredited vs. non-accredited labs for 60601 compliance in the US IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
E Accredited vs. non-accredited labs for 60601 compliance in the US Other Medical Device Related Standards 0
C Non-sterile reusable surgical instruments - FDA sterilization requirement Other Medical Device Related Standards 2
L Water requirement for Non-sterile topical OTCs Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
B Procedure packs with non-medical devices EU Medical Device Regulations 1
W Non Sterile Medical Device Environmental Tests Other Medical Device Related Standards 4
S Advice on how to reduce overhead of handling non-conforming material Nonconformance and Corrective Action 7
G Team to analyze a non conformance Customer Complaints 26
J Promoting and marketing of a non approved device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
G 0 non conformities in registrar audits over 4 years Management Review Meetings and related Processes 12
K CE Marking Class 1 (Non sterile) medical device CE Marking (Conformité Européene) / CB Scheme 3
M Supplier requirements - Major supplier is a Non-Profit registered with ICCBBA (FDA UDI) Supply Chain Security Management Systems 12
S Non parametric test for semi-quantitative data. Statistical Analysis Tools, Techniques and SPC 5
B Free Sales Certificate for Non Medical Devices Other Medical Device Related Standards 2
P Ppk results shown as asterisk after the transformation of Non-normal data Using Minitab Software 4
I When is necessary to have RoHS declaration on non-electrical parts? REACH and RoHS Conversations 1
Johnnymo62 Non Aerospace topics - Anything for military trucks, trailers, Humvee type vehicles? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
M Who are the go to companies for non-destructive hardness testing? General Measurement Device and Calibration Topics 3
R Non conformance (NC) or Corrective & Preventive action (CAPA) CE Marking (Conformité Européene) / CB Scheme 7

Similar threads

Top Bottom