What to do about Non Conformance forms that are deleted or missing?

#1
Hello all,

I noticed that in the non conformance log in my new company, some forms are not complete and some are missing and some are "removed from list".
What can I do about these Non conformance forms?
What's the best way for Quality to approach it?

Thanks in advance,
Mit
 
Elsmar Forum Sponsor
#3
So should I raise one NC for all the missing/removed from list NC and say that CAPA actions will be implemented for it not to occur again?

Thanks!
 

Michael_M

Trusted Information Resource
#5
I would issue 1 CA.

There may be multiple root causes, and multiple corrective actions assigned the the 1 corrective action. I would do this so you only have 1 document to go to if you find the same issue happening again later. For example, you write seperate NC's, 1 NC due to 'missing' and 1 NC for deleted. A year from now, you find that an NC was "missing". You only open the 1 NC against missing and investigate why that specific corrective action failed, in my mind, you need to also investigate the 'deleted' CA as well. They are related and if one failed, the other has a good chance to fail as well. If everything is in one NC (multiple CA's within that specific NC), everything within the NC can be looking into easily.
 
Thread starter Similar threads Forum Replies Date
M Generic "Compliant Procedure" and "Non-conformance" forms needed Document Control Systems, Procedures, Forms and Templates 1
G Team to analyze a non conformance Customer Complaints 26
R Non conformance (NC) or Corrective & Preventive action (CAPA) CE Marking (Conformité Européene) / CB Scheme 7
blile Increasing PFMEA occurrence ranking after non-conformance FMEA and Control Plans 4
S Non-Conformance and Deviations ISO 13485:2016 - Medical Device Quality Management Systems 4
C If it doesn't prevent a non-conformance, is it a preventive action? IATF 16949 - Automotive Quality Systems Standard 13
T Non conformance product identification and traceability 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
I Non-Conformance vs OFI -- your best descriptions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 61
W Non-Conformance from recent Audit carried out on Purchasing AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
C Neglect or legitimate deferral? Is excessive workload or lack of resources in a department or a team a valid root cause for a non-conformance? Problem Solving, Root Cause Fault and Failure Analysis 12
G Non Conformance During ISO 9001 Audit - Not All Internal Audits Completed General Auditing Discussions 19
C Fact or fiction - Repeat minor becomes a major IATF non-conformance IATF 16949 - Automotive Quality Systems Standard 7
P Line accums as a non-conformance? Supplier Quality Assurance and other Supplier Issues 2
S Returned product due to Customers fault, is it a Non-Conformance? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
I AS9100D Non-conformance for 10.2.1 b 2 and 10.2.1. b 3 e and f - Corrective Action AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
P Are red non-conformance bins required anywhere in the ISO or IATF standards? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
I "We don't have enough resources" as an Audit Non-conformance Response General Auditing Discussions 14
G Informational Is Past due calibration a non-conformance if tagged "Do Not Use"? General Measurement Device and Calibration Topics 9
D Minor non-conformance for not receiving a CofC from a heat treater Manufacturing and Related Processes 10
P Minor Non-Conformance - Maintenance Records Not Fully Completed ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 24
qualprod Minor non-conformance for not controlling local regulation laws? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 20
GoSpeedRacer How to handle operator involvement in the non conformance ISO 13485:2016 - Medical Device Quality Management Systems 5
M Non-Conformance Report for Concession ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
qualprod An uncontrolled record is it a non-conformance? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
V Difference between Non-Conformance, Variance and Deviation ISO 13485:2016 - Medical Device Quality Management Systems 7
M Closing of a Non Conformance Nonconformance and Corrective Action 5
K Corrective and preventive action for Non Conformance on PFMEA FMEA and Control Plans 30
D Is Failure to achieve a Goal a Major Non-Conformance? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
W Can you have a Corrective Action without a Non-Conformance? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
K Bottle Labeling Machine Problems - Non conformance in FCMG industry Nonconformance and Corrective Action 8
M Procedure Non-Conformance=Corrective Action? Document Control Systems, Procedures, Forms and Templates 14
M Class II Medical Device Design Control Non Conformance 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
L Root Cause for Minor Non-conformance regarding Supplier Delegation Nonconformance and Corrective Action 5
D Calibration & Test Laboratory Non-Conformance Procedure Example wanted General Measurement Device and Calibration Topics 3
J Non-Conformance for Not Taking Exclusion AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 14
V Is non-conformance (incident) required for any observation in equipment qualification Nonconformance and Corrective Action 5
N Non conformance Report to Risk Management-Plan ISO 14971 - Medical Device Risk Management 16
C The prudence of combining non-conformance reports with corrective/preventive action Nonconformance and Corrective Action 10
P Definition Nonconformance or Non-Conformance? Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 4
T Non Conformance Report Training Suggestions Training - Internal, External, Online and Distance Learning 5
B Combining both Deviation and Non-Conformance Processes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
J Non Conformance Area Policies Misc. Quality Assurance and Business Systems Related Topics 8
P Non Conformance Reporting in GMP in the Control of Materials Nonconformance and Corrective Action 1
G Writing up BRC audit non-conformance Internal Auditing 9
M Definition Major vs. Minor Non Conformance Definitions Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 14
J Can An External Auditor Also Write The Same Non-Conformance As An Internal Auditor? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
G Management Review Non-Conformance - Meeting Measurable Goals and Objectives ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
T External Communications - Should this have been raised as a Minor Non-Conformance? Miscellaneous Environmental Standards and EMS Related Discussions 12
W Internal Audit Non Conformance Tracking Logs and NC Systems ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
Q Non Conformance Closure by including it on another Corrective Action ISO 13485:2016 - Medical Device Quality Management Systems 8

Similar threads

Top Bottom