Expired Materials (threadlocker) Audit Finding Classification?

B

BubbaDog56

#1
During a recent internal audit, bottles of expired threadlocker were found in use in a production area by the auditor, and written up as a finding under Verification of Purchased Product. Would this be the appropriate clause, or would Control of Non-Conforming Product be more applicable?
 
Elsmar Forum Sponsor

howste

Thaumaturge
Super Moderator
#2
Re: Expired Materials Finding Classification?

Are we talking about ISO 9001 or another standard? In ISO 9001:2008 I would say 7.5.5 Preservation of Product. They are not preserving conformity of the product if they apply expired materials to the threads.

7.4.3 Verification of Purchased Product would imply that the product came in from the supplier already expired, which is probably not the case.
 
Thread starter Similar threads Forum Replies Date
S Recertification Process for Expired Shelf Life Materials ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
H Expired packaging material - Expired unused Tyvek pouches Other Medical Device and Orthopedic Related Topics 2
Q Relabeler for patent expired product - design control responsibilities? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
T ISO13485 cert expired - Product still CE Marked CE Marking (Conformité Européene) / CB Scheme 1
A Medical Device Handling AFTER the device's specified lifetime has expired 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
J Use of expired perminant implantable sterile medical products ISO 13485:2016 - Medical Device Quality Management Systems 2
H Transition of EN 60601-2-22 ed.2 - Still listed, not expired IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
J Symbol for manufacturing date - Is ISO 980 expired? CE Marking (Conformité Européene) / CB Scheme 11
M Distribution Center has shipped Sterile Medical Device products that have Expired EU Medical Device Regulations 2
S New to ISO/TS16949 - Our QS-9000 certification has expired IATF 16949 - Automotive Quality Systems Standard 3
A Expired CMDCAS Certificate - Registrar has yet to send the new CMDCAS certificate Canada Medical Device Regulations 4
J CB Transfer Audit - AS9100 Rev. B to Rev. C but Rev. B Certificate is Expired AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
E Pyrogen Test for Expired Cryogenic Vials Other Medical Device and Orthopedic Related Topics 4
C When should an expired document be removed from use? Document Control Systems, Procedures, Forms and Templates 10
Marc Expired Patent Numbers and Patent Trolls World News 1
R Re-sterilization of product which sterilization date is expired Other Medical Device and Orthopedic Related Topics 7
R How long do I keep expired Calibration Certificates General Measurement Device and Calibration Topics 8
T CE Mark Validity despite expired 13485 Certification EU Medical Device Regulations 13
M Material shelf of life expired - Notify Customer/Violate which clause? IATF 16949 - Automotive Quality Systems Standard 5
S What are the consequences of having an expired ISO 9001:2000 Certificate ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
D Lacquer - Sub-contractor used expired lacquer on a product Nonconformance and Corrective Action 4
D Are Sales allowed Under an expired CE Certificate? ISO 13485:2016 - Medical Device Quality Management Systems 6
J Can I use the CMM after the Calibration has expired? Calibration Frequency (Interval) 18
S Performing Investigation of used returned expired devices 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
SteelMaiden Customer's Internal Audit - SQA - Supplier ISO 9001 Certificate Expired Internal Auditing 11
J Moisture sensitive device - New reel of a BGA with expired shelf life Other ISO and International Standards and European Regulations 5
R Ink and Label Shelf Life and Internal Concessions for Expired Stock ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 19
T ISO 13485 8.3 - Non-Conforming Materials - on-line rework or part of process? ISO 13485:2016 - Medical Device Quality Management Systems 11
P Flammability Testing of Aircraft Interior Materials Federal Aviation Administration (FAA) Standards and Requirements 0
K EU Shelf life claims for individual materials EU Medical Device Regulations 2
A Production of raw materials in university labs? Lean in Manufacturing and Service Industries 11
A We're currently looking for any studies performed on various PPE materials Qualification and Validation (including 21 CFR Part 11) 1
R Bill of Materials for a complex product - Industry best practice ISO 13485:2016 - Medical Device Quality Management Systems 2
N Medical Device claims that I make in my promotional/advertising materials Other Medical Device Regulations World-Wide 9
W My company is looking to start a materials testing lab that conforms to ISO17025:2017 ISO 17025 related Discussions 3
D Standard guide for shelf life determination of non sterile component with degradation materials Reliability Analysis - Predictions, Testing and Standards 1
R ASQ reference material clarification - Spiral bound materials allowed in ASQ Exam? Professional Certifications and Degrees 1
Sidney Vianna AS9100 News July 2019 AAQG/RMC CB Auditor Workshop - Presentation Materials AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
A Reduced Testing of Pharmaceutical Raw Materials Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 2
D 4M (Man, machine, method, materials) Management Manufacturing and Related Processes 3
M Maximum Height for the stored material or stock materials Occupational Health & Safety Management Standards 1
M Testing Tensile Strength of Materials AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
M Informational 2019 Meeting Materials of the General and Plastic Surgery Devices Panel Medical Device and FDA Regulations and Standards News 0
M Informational USFDA Final Guidance – Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices) Medical Device and FDA Regulations and Standards News 0
M Informational USFDA – Efforts to evaluate materials in medical devices to address potential safety questions Medical Device and FDA Regulations and Standards News 0
J Marketing and promotional materials - EU and MDR Specific EU Medical Device Regulations 12
M Medical Device News USFSA – 2019 Meeting Materials of the Obstetrics and Gynecology Devices Panel Medical Device and FDA Regulations and Standards News 0
J Control of Medical Device Marketing and Promotional Materials - EU regulation EU Medical Device Regulations 20
I Food Contact Materials Declaration of Compliance Inquiry - (EC) 1935/2004 Food Safety - ISO 22000, HACCP (21 CFR 120) 4
K ISO 9001:2015 AVL - New Chinese standards requiring all testing of materials be done in China ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 0

Similar threads

Top Bottom