SBS - The best value in QMS software

Validation of Special Processes - Are Casting and Forging Special Processes

J

John Martinez

#11
#11
If a casting is not machined (and nothing said here that it was not), or other type of NDT, then yes, 7.5.2 woud be applicable. As long as the forging had a representative sample forged, and if applicable heat treated, and destructive tested to determine the properties, then, again, yes.

Here is the key "where the resulting output cannot be verified by subsequent monitoring or measurement and, as a consequence, deficiencies become apparent only after the product is in use or the service has been delivered."
 
Free Trial of DISCUS Desktop
Elsmar Forum Sponsor
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
J ISO 13485 - 7.5.2 cleanliness , 6.4.2 validation of special processes, and 6.4.2 contamination ability to be exempt? ISO 13485:2016 - Medical Device Quality Management Systems 5
M AS9110C Clause 8.5.1.2 Validation and Control of Special Processes for Repair Station AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
W AS9100D Clause 8.5.1.2 Validation and Control of Special Processes AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 37
N Validation of Special Processes - N/A of ISO 13485 Clause 7.5.2 ISO 13485:2016 - Medical Device Quality Management Systems 12
S Validation Of Outsourced Special Processes under AS9100 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 14
V Validation & which processes are called special processes & why not all the processes Manufacturing and Related Processes 9
F Process Validation of 'Special Processes' - How do I? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
C 7.5.2 Validation of processes - Special Processes - Transportation Service Industry ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
R Validation of Processes for Injection Moulding - Special Process? Clause 7.5.2 IATF 16949 - Automotive Quality Systems Standard 9
S OEM full range calibrations vs Validation special test points Medical Device and FDA Regulations and Standards News 0
L Injection Moulding Process (Special Process) Validation Food Safety - ISO 22000, HACCP (21 CFR 120) 2
T "Special Process" Validation Requirements (21 CFR Part 820) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 15
M Application of Special Process - Validation and FAI in Wind Tunnel Testing AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
D Special 510k - Data Results of the Design Verification and Validation Other US Medical Device Regulations 3
S Special Process Validation - ISO9001 Clause 7.5.2 - How do I go about it? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 33
D "Special Production Process" Validation and TS16949 Clause 7.5.2.1 IATF 16949 - Automotive Quality Systems Standard 5
C Special Process Validation - Electroplate - 7.5.2 of AS9100B AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
I Validation of Special Process - Soldering ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
K Process Validation - Hand soldering of components & wires on PCB - Special Process? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
A special process validation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
T Passivation Validation - Is passivation is considered a "special" process by the FDA? ISO 13485:2016 - Medical Device Quality Management Systems 1
mustomutlu Process Validation Final Report Other Medical Device and Orthopedic Related Topics 2
P Software verification and validation procedure IEC 62304 - Medical Device Software Life Cycle Processes 4
Y SaMD Verification and Validation SOP and Plan IEC 62304 - Medical Device Software Life Cycle Processes 3
C Spreadsheet Validation and Release Qualification and Validation (including 21 CFR Part 11) 2
M Packing Validation & Accelerated Aging Test ISO 13485:2016 - Medical Device Quality Management Systems 2
M Sterile packing validation tests to be performed and protocol Other Medical Device and Orthopedic Related Topics 1
H Software Validation for FFS Packaging Machine Qualification and Validation (including 21 CFR Part 11) 1
Q ISO 13485 7.5.6 Validation - Off the shelf Software ISO 13485:2016 - Medical Device Quality Management Systems 3
M ERP / QMS related software standards for Validation IEC 62304 - Medical Device Software Life Cycle Processes 6
C ISO 19227 Validation Cost Other Medical Device Related Standards 2
A CNC Mill and Lathe - Validation Manufacturing and Related Processes 2
N Example for design and development planning,input,output,review,verification,validation and transfer Misc. Quality Assurance and Business Systems Related Topics 4
N Sterilization Protocol Change in Validation Process and further impacts ISO 13485:2016 - Medical Device Quality Management Systems 1
B Oracle Cloud ERP Validation during Quarterly Patch ISO 13485:2016 - Medical Device Quality Management Systems 1
D Software validation team Misc. Quality Assurance and Business Systems Related Topics 3
W LTPD, AQL, Ppk and Cpk validation sampling plan table Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
J Validation Sample Size for Tray Seal Qualification and Validation (including 21 CFR Part 11) 3
F AS9100 - Validation, FAIR's, ITAR and Sub-Contracting AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
R PCBA process validation Qualification and Validation (including 21 CFR Part 11) 2
A ISO 17025 - Methods validation and clients ISO 17025 related Discussions 3
S Sterilization validation after changing sterilization process provider Qualification and Validation (including 21 CFR Part 11) 3
B Sterilization Validation Plan Other Medical Device Related Standards 3
D Difference between Test Method Validation and Gage R&R Qualification and Validation (including 21 CFR Part 11) 18
T Laboratory Verification after validation ISO 17025 related Discussions 3
silentmonkey Rationalising the level of effort and depth of software validation based on risk ISO 13485:2016 - Medical Device Quality Management Systems 10
D Questions regarding process validation ISO 13485:2016 - Medical Device Quality Management Systems 6
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 3

Similar threads

Top Bottom