Nonconformance opened as incorrect expiration date placed on received product. Escalate to CAPA?

CPhelan

Starting to get Involved
#1
Hello,
Yesterday I opened an NC as it was brought to my attention of a number of received items which had the incorrect expiration date on them. Fortunately we had greatly under reported the shelf life.

Based on our receiving incoming material procedure we stated that material with no listed retest/expiration date should be automatically given a 1 year retest/expiration date. After contacting the manufacturers we were given additional information that material which does not have listed expiration date has a given retest/expiration of 5 years. In the NCR we have captured all of the known items, noted that the receiving SOP needs to be updated, review of all similar items to determine if correct shelf life is needed.

Initially I thought a NC was enough for this but as the workload is growing and the document updates are growing also just want to ask a community of SMEs if a corrective action should be opened or whether this can be resolved as an NC. Basically our documentation did not account for information we didn't have.
 
Elsmar Forum Sponsor

William55401

Involved In Discussions
#2
It's your QS and you have visibility to what your procedures state. Following your procedures takes precedence. Always. When I read the thread, I am wondering if each item received resulted in it's own NC for incorrect shelf life. If that's the case, multiple NC on the same issue may trigger a trend in your system and result in escalation to CAPA. When I think about NC's, local correction of issues is an expected outcome. You can process the NCs by correcting the shelf life. By making the local correction, you keep that product moving. When the process that caused the issue is in question, CAPA is a reasonable solution that decouples process improvements from the local issue.
 
Last edited:

CPhelan

Starting to get Involved
#3
Thank you William. Yes my concern is that the process did not provide enough information for the user to apply the correct information. I have gathered the items as one NC. The issue can be corrected by the NC process. Multiple parts have been affected and this is the first nonconformance we have had related to receiving.
 

Ninja

Looking for Reality
Trusted Information Resource
#4
You're wondering how to clean up the blood spilt...are you still bleeding?
You found the problem, and multiple cases of the results...did you fix the problem yet?

If no: I would open a CA and fix the problem through it.
If yes, and it was a simple fix...who assigned the NC?
If you launched the NC...just fix it and move on...OFI at best.
If an outside party launched the NC (audit, etc.)...you pretty much have to run it through CA.

Either way...don't get too lost in the paperwork...make sure the problem is fixed and the bleeding has stopped.
 

CPhelan

Starting to get Involved
#5
You're wondering how to clean up the blood spilt...are you still bleeding?
You found the problem, and multiple cases of the results...did you fix the problem yet?

If no: I would open a CA and fix the problem through it.
If yes, and it was a simple fix...who assigned the NC?
If you launched the NC...just fix it and move on...OFI at best.
If an outside party launched the NC (audit, etc.)...you pretty much have to run it through CA.

Either way...don't get too lost in the paperwork...make sure the problem is fixed and the bleeding has stopped.
Thanks Ninja. We are doing an investigation as part of the NC to find affected items but believe this will be resolved solely as an NC.
 
Thread starter Similar threads Forum Replies Date
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
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
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 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
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
M Corrective Action for a Recurring Nonconformance Nonconformance and Corrective Action 16
G Nonconformance Categories - QMS web app to support ISO9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
Similar threads


















































Top Bottom