Re-validation NCR - In which cases re-validation of processes is required

#1
Hey everyone,

After API conducted audit, they issued 1 NCR to us regarding re-validation process.

Non conformance/Concern Description
The procedure does not state in which cases re-validation of processes is required.

Can anyone send me sample of re validation procedure plz.

Our score is NDT inspection and thread repair.

Thanks in advance :)
 
Elsmar Forum Sponsor

kuyakut

Involved In Discussions
#2
Re: Re-validation NCR... PLEASE HELP

Hi,
You can add these in your validation programme procedure
Re-validation is required for crucial equipment and/or for
the following changes and condition;
- Changes to / of the equipment
- Location (Machine / Site)
- Validated controlled process parameters (changes on
non-controlled parameter , revalidation is not required)
- Supplier / Material
- Environment
- Product design changes​
- Negative trend in quality indicators

Kuyakut
 
Thread starter Similar threads Forum Replies Date
S TUV NCR No: 2 - Aseptic processing validation has not been performed ISO 13485:2016 - Medical Device Quality Management Systems 4
S TUV NCR No: 1 - Autoclaving: The process validation does not comply ISO 13485:2016 - Medical Device Quality Management Systems 8
P ETO Sterilization Validation Process and an NCR - ISO 13485:2003 CMDCAS audit ISO 13485:2016 - Medical Device Quality Management Systems 1
Y We found out we have been using a equipment without validation for past 4 years Quality Manager and Management Related Issues 6
Z Is IQ necessary for laser marking validation? EU Medical Device Regulations 3
E 13485:2016, Sections 4.1.6, 7.5.6 and 7.6 - Validation of Software - Need some Advice please ISO 13485:2016 - Medical Device Quality Management Systems 2
A Validation of Forced Aeration Process ISO 13485:2016 - Medical Device Quality Management Systems 3
E Mentor for Test Method Validation (TMV) Design and Development of Products and Processes 2
M API 4F/7K/8C Design Package Validation Oil and Gas Industry Standards and Regulations 1
I ISO 2233:2000 Question - Medical Device Shipping/Transportation Validation Other ISO and International Standards and European Regulations 1
T Annual Validation as a detection mode on a PFMEA? FMEA and Control Plans 5
B TMV - Selection of TM's for Validation ISO 13485:2016 - Medical Device Quality Management Systems 5
S Forced ServiceNow validation - No change in our current user and functional requirements IT (Information Technology) Service Management 6
P Human Factors / Usability validation in the time of COVID Human Factors and Ergonomics in Engineering 9
C Template for Excel Validation Reliability Analysis - Predictions, Testing and Standards 5
M IT validation for a paper based MD repair company QMS ISO 13485:2016 - Medical Device Quality Management Systems 6
P Unrealistic Packaging Validation Sample Size 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 13
D Test summary report example for design validation wanted - ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 1
M Is Validation of Plating Processes required and who is responsible? Qualification and Validation (including 21 CFR Part 11) 11
T ISO 13485 - Process validation at critical suppliers ISO 13485:2016 - Medical Device Quality Management Systems 7
K Software Validation for Measurement Tools used in Process Validation ISO 13485:2016 - Medical Device Quality Management Systems 2
Stoic Manual soldering processes - 100% verifiable, or always requiring validation? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 15
P Design verification driven by new equipment. How is this different than process validation? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
S Rees System Validation Qualification and Validation (including 21 CFR Part 11) 1
K PQ validation qualification - Asked to write a PQ protocol ISO 13485:2016 - Medical Device Quality Management Systems 6
Stoic Are any medical device companies using the 2011 FDA process validation guidance instead of GHTF/SG3/N99-10:2004? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
K Old medical devices -> 7.3.7. Design and development validation ISO 13485:2016 - Medical Device Quality Management Systems 1
S SOP for ISO 13485:2016 Quality related Software validation ISO 13485:2016 - Medical Device Quality Management Systems 9
Y Retrospective Validation - Class I device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 10
S High voltage testing - ISO 17025 - 7.2.2 Validation of methods and 7.3 Sampling ISO 17025 related Discussions 3
M Production approval testing - Alternative ideas for Validation Reliability Analysis - Predictions, Testing and Standards 4
M Validation of two nearly identical products Other Medical Device Regulations World-Wide 5
J Requested Validation plan and reports Manufacturing and Related Processes 4
S Validation Records - Very young QMS Qualification and Validation (including 21 CFR Part 11) 2
M Test method validation - Is MSA (MSA1, MSA2, MSA3 and linearity) a good solution? Medical Device and FDA Regulations and Standards News 1
G Devices from IQ, OQ or PQ process to be used for verification, validation and summative? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
K ERP System Software Validation - ISO13485 2016 4.1.6 Design and Development of Products and Processes 8
W ASTM F1929 dye penetration test - Validation for in-house testing ISO 13485:2016 - Medical Device Quality Management Systems 13
Bev D Verification and Validation of Measurement Systems Misc. Quality Assurance and Business Systems Related Topics 0
Y Does Solidworks (2D/3D drafting modules) need validation? Other Medical Device and Orthopedic Related Topics 5
D Software validation in Medical Equipment Other Medical Device and Orthopedic Related Topics 20
K Validation of new machine (second machine of the same type) Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 2
A Literature review/HACCP validation of metal detection Food Safety - ISO 22000, HACCP (21 CFR 120) 0
Y Packaging validation for non-sterile Medical Equipment Other Medical Device Related Standards 1
A Our auditor told if we didn't have a patent we would have to do a validation or verification ISO 13485:2016 - Medical Device Quality Management Systems 6
N Design Verification & Process Validation - Statistical sample sizes Design and Development of Products and Processes 2
E Equipment Qualification - IQ/OQ per ISO 13485:2016 section 7.5.6 Process validation ISO 13485:2016 - Medical Device Quality Management Systems 7
Q Clean Line Validation ISO 13485:2016 - Medical Device Quality Management Systems 6
D 510K and Changes to Verification and Validation US Food and Drug Administration (FDA) 2
H EO Sterilization Validation - Sterility Testing and Load Configuration Other Medical Device Related Standards 1

Similar threads

Top Bottom